Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Second Quarter 2020 Financial Results Conference Call. My name is Jonathan, and I will be your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed..

Thank you. Good afternoon, and thank you for joining us on today's call to discuss ACADIA's second quarter 2020 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q2 2020 financial performance and provide a review of our business.

Also joining us today is Michael Yang, our Chief Commercial Officer, who will provide updates on our commercial initiatives; and Dr. Serge Stankovic, our President, who will discuss our pipeline progress.

Our Chief Financial Officer, Elena Ridloff, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call up for your questions. I would also like to point out that we're using supplement slides, which are available on the Events and Presentations section of our website.

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 within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events or future results 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.

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. I'll now turn the call over to Steve..

Thank you, Mark. Good afternoon, everyone, and thank you for joining us today. Please turn to Slide 5. We've made important and significant progress on our 3 strategic pillars.

As a reminder, this year, we are focused on driving the growth of NUPLAZID for patients with Parkinson's disease psychosis; delivering on the dementia-related psychosis opportunity, our second indication for NUPLAZID; and developing innovative new treatments for unmet needs in CNS with 3 candidates in our early and late-stage development pipeline.

At ACADIA, our mission is to improve the lives of patients with CNS disorders by developing and commercializing new medicines. Our focus on these 3 strategic pillars enables us to execute on that promise. Let's turn to Slide 6 to review.

For the second quarter of 2020, NUPLAZID achieved $110.1 million in net sales, a 32% year-over-year increase, driven by strong commercial execution. These strong results are reflective of the fact that we adapted quickly to the evolving environment resulting from the COVID-19 pandemic.

Our commercial team is executing at a high level and successfully engaging both virtually and in person with health care practitioners. As a result of our team's successful execution, we've raised the lower end of our net sales guidance.

We now expect full year net sales to be between $430 million to $450 million, representing 30% growth year-over-year at the midpoint of the range. We are confident in driving the long-term market opportunity for NUPLAZID in PDP and look forward to the addition of DRP. Let's move to the DRP opportunity on Slide 7.

Our supplemental NDA for dementia-related psychosis was accepted for filing by the FDA with the PDUFA date of April 3, 2021. The filing of the application is an important next step as DRP is a devastating and highly disruptive disease and represents a significant unmet need, not only for the patients but also for their caregivers and family members.

We are highly confident in both the efficacy and safety data supporting our submission and look forward to continuing to work with the FDA to facilitate their review. Please turn to Slide 8. We continue to make important progress in our late-stage development pipeline.

We've now initiated our second pivotal study, ADVANCE-2, in the negative symptoms of schizophrenia. This Phase III trial will enroll approximately 386 patients and evaluate them in a double blind fashion for 26 weeks with a 34-milligram dose of pimavanserin. Our Rett syndrome LAVENDER Phase III study recommenced patient enrollment in June.

We anticipate top line results in the second half of next year. In addition, we are focused on business development to grow our development pipeline and leverage our internal R&D and commercial capabilities.

For example, earlier this year, we licensed the M1 PAM program from Vanderbilt, and we will continue to invest in our future through additional business development opportunities that complement our long-term growth strategy. With that, I will now turn it over to Michael to discuss our commercial performance and highlights..

Thank you, Steve. Today, I would like to review our second quarter performance, which highlights the fundamental strength of our business and gives us confidence in the long-term expectations for the NUPLAZID franchise. This was another strong quarter of commercial execution, setting us up for another year of double-digit volume growth.

For dementia-related psychosis, we're making good progress with our launch preparations. Please turn to Slide 10. NUPLAZID continues to transform the standard of care for patients with PDP. We have driven positive momentum through our best-in-class virtual engagements and by our rapid innovation in response to the evolving environment.

In the second quarter, we delivered net sales of $110.1 million, driven by year-over-year volume growth of 17%. This growth was fueled by enhanced patient identification tactics such as leveraging electronic health records and clinical pathways, enabling patients to be diagnosed and prescribed NUPLAZID remotely.

We are utilizing our digital platforms to stimulate patient and caregiver conversations with their physicians about the troubling symptoms of PDP and potential treatment with NUPLAZID. We also continue to invest improving in patient access services and easing the prescription fulfillment process for health care practitioners.

Sequential volume growth in the specialty pharmacy channel contributed to strong overall performance. Monthly fulfillment rates for both new and continuing patients in the quarter remained consistently high.

In the long-term care setting, managing the COVID-19 situation has resulted in adjustments to facility operations in terms of nursing staff, infection control and decreases in new resident admissions, which impacted new patient growth this quarter.

However, we have seen things stabilize recently and directionally showing signals of improved market metrics. Despite these challenges, we believe NUPLAZID is performing well in LTC. And in fact, according to Acuvia, NUPLAZID outperformed most other major promoted brands in a long-term care setting.

We have recently established new partnerships with key stakeholders in the long-term care space, demonstrating the importance of disease education and timely patient identification, and we believe these partnerships will further advance NUPLAZID as standard of care. Let's review our 2020 growth initiatives further on Slide 11.

The sales team has been functioning at a high level in the virtual environment, and we recently have been able to return to the field in certain areas. Moving forward, I'm pleased to report that the recent new patient start trends have returned to pre-COVID levels in the SP channel.

We have introduced several new initiatives to support the field and drive continued growth, including on-demand virtual speaker programs with nationally recognized KOLs, virtual patient case learning programs and COVID-specific educational materials to optimize care via telemedicine, including topics on social isolation and caregiver tips.

In addition, we continue to enhance our integrated patient and caregiver disease awareness campaigns to stimulate conversations with their physicians about PD psychosis and NUPLAZID. We are also continuing to expand our digital and social platforms to further activate NUPLAZID requests.

Now let's turn to our second potential indication for pimavanserin DRP on Slide 12. Our DRP launch preparations, including disease awareness initiatives and talent recruitment are on track. We are planning for both in-person and virtual scenarios, and we'll be well positioned to execute our launch plans.

We are continuing to prepare the market via marketing-driven disease state education initiatives, including refreshing new and engaging content on MoreThanCognition.com, our disease education website, and partnering with third-party HCP sites such as Sermo, Doximity and Medscape to leverage disease education content from our site to theirs.

We are also participating in virtual medical congresses, such as last month's Alzheimer's Association International Conference, or AAIC. As many of you are aware, AAIC is an extremely influential international meeting dedicated to advancing dementia science.

ACADIA sponsored a virtual disease education booth, held an oral presentation on the open-label HARMONY data and presented 9 additional posters, some of which highlight the significant burden of DRP and the need to treat. With that, I'd like to turn it over to Serge to discuss our R&D pipeline..

Thank you, Michael, and good afternoon. Please turn to our development pipeline on Slide 14. Allow me to start with the comments related to DRP sNDA.

We are very pleased that the FDA has filed our sNDA for dementia-related psychosis and communicated to us that they have not identified any potential review issues and are not planning to hold an advisory committee meeting. We look forward to working with FDA on the review of our application.

In addition, we continue to advance our late-stage programs for pimavanserin in the negative symptoms of schizophrenia and trofinetide for Rett syndrome. Earlier this year, we licensed a novel M1 PAM program from Vanderbilt University and look forward to advancing this program as well.

Consistent with our strategy, we remain focused on developing innovative new treatments, and that is reflected in our growing and advancing pipeline. Let's start on Slide 15 with negative symptoms program. I'm happy to announce that we have initiated our Phase III study ADVANCE-2 for the negative symptoms of schizophrenia.

Please recall, this would be the second pivotal study for this indication. The first of which, ADVANCE, reported positive results in November of last year. The negative symptoms of schizophrenia remains a very significant unmet need with no FDA-approved treatment options available. Slide 16 provides a high-level view of the ADVANCE-2 study design.

Similar to the design of the previous positive study, ADVANCE-2 is a 26-week study evaluating pimavanserin as an adjunctive treatment for schizophrenia patients with predominant negative symptoms while controlling for their positive symptoms. The primary end point is the change from baseline on the negative symptom assessment 16 item scale.

Applying the learning from the positive ADVANCED study, where we observed the robust results on the primary end point in patients receiving 34-milligram dose, we are now evaluating this dose of pimavanserin in ADVANCE-2. Building on the learnings of our 2 previous studies in schizophrenia, ADVANCE-2 will be conducted in non-U.S. clinical trial sites.

Rett syndrome is a rare and debilitating disorder with the unmet need highlighted here on Slide 17. Working with the study investigators, we were able to recommence enrollment in our LAVENDER study in June. We are working on a site-by-site basis to be able to once again enroll patients into the study.

We anticipate being able to announce top line results in the second half of 2021. With that, I will now turn the call over to Elena to discuss our financial performance..

Thank you, Serge. Today, I'll discuss our second quarter results and our updated 2020 financial outlook. Please turn to Slide 19. In the quarter, we recorded $110.1 million in net sales, an increase of approximately 32% compared to $83.2 million of net sales in Q2 of 2019. This was driven by approximately 17% volume growth year-over-year.

The gross-to-net adjustment for Q2 2020 was 11.3%. Weeks of inventory in the channel at the end of the second quarter were consistent with previous quarters. Moving down the P&L. GAAP R&D expenses decreased to $64.3 million in the quarter compared to $67.3 million in Q2 2019.

The decrease is largely due to lower development costs associated with pimavanserin in schizophrenia and DRP. GAAP SG&A expenses increased to $84.3 million in the second quarter from $68 million in the second quarter of last year. This is largely due to increased advertising and promotional spend as well as an increase in personnel and related costs.

Noncash stock-based compensation expense during the quarter was $19.5 million compared to $20.4 million for the same period in 2019. Cash used in operations during the quarter was $36.9 million compared to $38.4 million for Q2 2019. Our cash balance at the end of the quarter was $658.6 million. Please turn to Slide 20.

For the full year, we expect continued strong growth for NUPLAZID and have raised the lower end of the guidance range. We now forecast 2020 net sales to be between $430 million and $450 million. The revised revenue range reflects year-over-year growth of approximately 30% at the midpoint.

Our net sales guidance continues to incorporate a range of assumptions related to the duration and impact of the COVID-19 pandemic. On the expense side for 2020, we are decreasing our GAAP R&D guidance to be between $265 million to $280 million from previous range of $270 million to $285 million.

The reduction reflects a reduction in development expenses for adjunctive MDD. We now expect GAAP SG&A to be between $400 million to $420 million from previous range of $425 million to $445 million. This reduction reflects lower costs associated with the timing of investments to prepare for our DRP launch.

We continue to anticipate noncash stock-based compensation expense to be between $90 million and $100 million in 2020. We will end 2020 with a strong balance sheet and expect our year-end cash balance to be approximately $570 million to $590 million, increase from our previous guidance of $470 million to $500 million.

And with that, I'll turn the call back over to Steve..

Thank you, Elena. Please turn to Slide 22. Since the beginning of the year, we've achieved $200 million in net sales in the first half for NUPLAZID in PDP. Our sNDA for DRP has been filed by the FDA with the PDUFA date of April 3, 2021.

We've advanced our Phase III programs in the negative symptoms of schizophrenia and Rett syndrome, and we licensed an M1 PAM program from Vanderbilt. We look forward to keeping you updated on our progress for continued momentum of NUPLAZID and the breadth and depth of our pipeline position ACADIA for long-term growth.

In closing, I would like to thank our employees for their continued commitment and passion as we advance the business. I'll now open up the call for questions.

Operator?.

[Operator Instructions]. Our first question comes from the line of Tazeen Ahmad from Bank of America..

Congrats on a strong quarter. Just wanted to get your thoughts on how you're seeing activity thus far in 3Q. Obviously, you can't guide on a quarterly basis. But just any kind of general comments you can provide? It does seem that the pandemic is kind of moving its way through different geographies.

We have heard from some physicians that offices did open for a bit and then it closed back down again.

How are you thinking about uncertainty in terms of the ability of doctors to keep seeing new patients at a pace that you're comfortable with? And can you just give us a sense of the sensitivity for your guidance for the rest of the year on that particular item?.

Sure, Tazeen. I'm going to ask Michael to just comment on the dynamics that we're seeing broadly. But before he does, I'll just simply say that I think the quarter that we just reported is, as I mentioned, a reflection of how quickly we've been able to adapt to kind of the new world that we're all living in with this pandemic.

And what we've seen is very strong execution irrespective of whether we're seeing doctors in person, in their offices or in person in long-term care facilities, we're doing this remotely.

And again, I think that's a testament to the strong relationships that we have and the quick pivot that we made, which we've talked about pretty extensively in the past as soon as the pandemic hit. And in terms of guidance, we're very confident in the guidance that we've updated today through the remainder of the year.

Michael, do you have anything else you want to add just in term of core dynamics?.

Yes, Steve. I think if I look at it from a setting of care perspective, we saw very strong response to the tactics you outlined in the office setting. We haven't seen any increase in discontinuations. And we see, as I mentioned, recent trends to pre-COVID levels in terms of our new to brand. So that's very good.

I think in long-term care, things have stabilized of late. Recently, there was a period where the long-term care facilities were, quite frankly, dealing with a lot. They had nursing staff they had to deal with that was turning over infection control. But we're seeing that, again, as I said, stabilized.

We're pleased with our performance relative to the peers in that setting. So if you look at the patient journey, the need to treat the patient with these symptoms that are very disruptive and have a high degree of caregiver burden, that's still a major issue.

And so the role for NUPLAZID in that situation has not been diminished by any -- by the pandemic. And frankly, from the doctor or patient standard of care, we're well positioned to help the patient whether it's in the nursing home, whether it's telemedicine or in the office as a result of some of the tactics we have put in place.

So I think you said it well in regards to our confidence in our establishing the guidance..

Okay.

As it relates to new patient start, can you give us any kind of color about comments that physicians have given you about their ease of being able to diagnose patients or key patients for the first time virtually and then get them on drug?.

Yes. Michael, the....

Yes, sure. I think that, obviously, telemedicine is being adopted and optimized across the channel. But I think the thing with PDP is that it's likely a patient that's already been diagnosed with Parkinson's. So in this case, there's already likely a relationship with a physician.

And so the ability for the physician to diagnose, get samples, verify their reimbursement, insurance and ship directly to the home and we think that's a really big advantage for NUPLAZID. So we're not -- I think we're very well positioned for that. We're hearing good feedback on and response to our tactics on that one..

Our next question comes from the line of Cory Kasimov from JPMorgan..

I have two of them for you. One is something we've started to get more from investors.

And it's whether we should assume NUPLAZID pricing stays stable once DRP comes online, assuming, of course, it's approved? Given the increased addressable patient population, is that a safe assumption based on the strength of the data you have there? And then the second question I have, I know it's only been a few weeks, but if have you gotten any additional color from the FDA on why you did not get priority review? And do you believe there's any potential opportunity for the agency to accelerate that time line? Is that something that's sometimes seen within this division?.

Yes. Thanks, Cory. I'll answer the first question. I'm going to ask Serge to answer the second one. So in terms of pricing, as we said, it's a little premature to comment on pricing at this juncture. But I wouldn't necessarily assume that we would need to change price for DRP. One, we currently enjoy very good access from payers for NUPLAZID.

And as we've said before, the dynamics between PDP and DRP are very similar. Two, the payer mix is very similar in DRP, and in such cases, we believe it would be seen as an important line extension where there are no currently approved treatments to what we already have.

And finally, it's important that we demonstrate how pimavanserin can provide value for patients and caregivers above and beyond the off-label standard of care that we see today.

As such, we're already developing and we'll be very well prepared to deliver our value proposition, budget impact modeling, health economic survey to payers, which we deliver in anticipation of launching in DRP. So we feel very good about the dynamics, very good about the data set that we have.

And as we progress, and as I've said before, once we have final labeling language, we'll be in a position to kind of firm up the dynamics that we're seeing today with payers..

Okay, great..

Serge, do you want to take the second question Cory has?.

Yes. Yes, thanks. As discussed previously, we engaged with the FDA. In their communication back to us, they reaffirmed that based on their preliminary review, they view the filing as appropriate for a standard review and did not provide any additional color to us.

Considering where we are in the review cycle, at this time, we really don't anticipate receiving additional details regarding the classification. Instead, we are focusing on working with FDA and facilitating review toward the April 3 action date.

And as you mentioned, yes, on few occasions, it did occur that they complete their review prior to that action day. But it's very -- it's early and hard for us to speculate whether that may be the case in our case. So we are focused on facilitating review and on the action day of April 3..

Our next question comes from the line of Ritu Baral from Cowen..

I think, Michael, you alluded to talent recruitment time lines. Can you talk a little bit about how you're preparing for the DRP launch? Given you've got some extra time, what sort of hires are you looking to make? And then the follow-up to that question is for Elena.

As you took down SG&A on lower DRP spend, should we just think of it as sort of a forward shift into 2021? Or do you see actual net savings to launch costs given the fact that there could be a larger virtual component than classic launches?.

Michael, do you want to go first?.

Yes, sure. Thanks for the question, Ritu. So when I mentioned talent, obviously, what we've done first is hiring. We've begun to hire and identify the leadership level. We already have a good leadership team in place for PDP. We're broadening that out, and that's how we start to build a slate of talent to begin to be in preparation for expansion.

Obviously, now the expansion has been shifted because of the April 3 date, and we're adjusting to that now, but we'll be well prepared to expand our footprint and leadership team and sales team. We're doing also a lot of virtual disease education and market preparation at this moment. So we're getting the benefit of this extra time to prep the market.

And I think just one other thing to think about here is we're really already on the market for NUPLAZID, and so this is a lot of things we already have in place. We're loaded in the payers. We have a very successful patient support services team. So we're really getting this extra time to be extra prepared to launch and prep the market.

So I think we're in good shape, virtual or face-to-face, whatever we see that comes at us in April..

Yes. And just on the SG&A question, Ritu. The savings this year is the result of a timing shift. And as Michael mentioned, moving the field team hiring to the early part of next year. We've been engaging in PDP very well virtually.

And so regardless of whether we're in a virtual or in-person environment, we think there's key investments we'd want to make on the field team expansion to support a successful launch..

Our next question comes from the line of Jason Butler from JMP Securities..

It's Roy in for Jason. We've had a couple on the marketing efforts, interesting with the new patient start strength. I wonder if you could discuss a little more the COVID-specific materials you mentioned earlier.

And then what percentage of the sales force has been able to actually have the in-person interaction with providers?.

Sure. Thanks much for the question.

Michael?.

Yes, great question. So what we've been able to do is obviously put out some sheets and educational material, especially around social isolation, caregiver tips on how to engage in a telemedicine environment. Those have been well received. We've been doing a lot of, as I mentioned, virtual disease ed and medical promotion programs.

It's difficult to say what exact percentage the field is engaged, but what we do have is a fairly sophisticated algorithm that we automate and load into the sales force's computer system that is enabling them to diagnose or really release them to a face-to-face visit or not.

So that varies depending on the COVID risk levels that the algorithm spits out for our team, and we've been very successful, I think, executing that on a case-by-case, county-by-county basis..

Okay. Great. So it varies by reps actually as well..

So it can vary by rep by even in the rep -- inside the rep's territory that they have one county could be red and one county could be green..

Our next question comes from the line of Neena Bitritto-Garg from Citi..

Congrats on the quarter. So you talked about how the pace of new starts has come back to kind of pre-COVID levels recently. So I'm just wondering how much of that do you think is due to physician offices reopening versus just patients and physicians getting more comfortable with telemedicine.

And what I'm really trying to get at is, if telemedicine does kind of end up sticking around for a longer period of time or there is kind of reclosing of some of the offices, should we expect to see new starts continuing to remain at kind of pre-COVID levels? Or could we actually see a drop if things do kind of shut down again?.

Michael, do you want to take that?.

Sure, great. That's a great question. I think that I would start really to answer that question is really at the patient disease level and PDP is a very, very disruptive set of symptoms and it causes a significant burden on the family and the caregiver. And so that, I think, puts it into a kind of an urgent need to treat.

So I think that, as I mentioned earlier, what we try to do is capture that patient-physician, diagnostic and treatment paradigm no matter what the setting is. It could be in the nursing home, it could be in the telemedicine, as you asked, or could be in the face-to-face office setting.

And I think what we're really seeing with the new starts is just a response to our ease of process to enable that to happen. And I think it speaks to the urgency to treat. And I don't think that is really going to abate if physicians aren't open. I think that's still going to always be a situation. This is not a choice.

In many cases, there's a clear mandate for treatment..

Our next question comes from the line of Salveen Richter from Goldman Sachs..

This is Andrea on for Salveen. Elena, maybe as a follow-up to your prior comments there, given the increase in virtual efforts as you look towards the DRP launch, do you still expect to grow the team to about 400 to 500 personnel as you've previously mentioned? And then I have a follow-up question..

Sure. So as Michael mentioned, we're preparing for a range of scenarios of both virtual and person -- and in-person. And we will -- we believe expanding the sales force will be supportive of a strong DRP launch, and we'll be able to provide more specifics as far as exact sizing as we get closer..

Got it. And then maybe just to go back to PDP, given the efforts that you outlined to drive that PDP growth and to continue that, just wondering if you have updated thoughts on the penetration into the market. I think previously, you were saying around the mid-teens. So just would love to hear if you have an updated thought on that..

I think what we've said is high teens most recently and that continues to be the case..

Sure.

So mid -- so still mid- to high teens or high teens now?.

That's correct..

Our next question comes from the line of Charles Duncan from Cantor Fitzgerald..

Congrats, Steve and team, on a good quarter of progress and top line. Wanted to ask you -- I'm a little bit intrigued with the new patient ad commentary.

And I'm just trying to figure out if that's really commentary going into the second half of the year or if in the quarter, there was really good new patient adds? And then kind of, I don't know if you can deconvolute that, but new patient adds versus, say, persistence. And then I had a follow-up for the pipeline..

Yes. Thanks, Charles. Michael, do you want to start? I'll add any color..

Yes, sure. Yes. Thanks for the question, Charles. No, those were new patient adds in the quarter. So I think it speaks to the strength of the business, especially as I related to on the SP side of the business.

And I forget -- what was your second part of your question?.

Yes. And what was the contribution of persistence or current patients? Yes..

Right. Yes. We continue to see high and consistent fulfillment rates. So I think that, I think, was consistent from prior quarters. We've really seen that actually since the 34-milligram launch. And so that, I think, was continued..

And do you feel....

Sorry, just to add a brief annotation. So as Michael mentioned, the -- and as we discussed on the last quarter, we saw the decrease in new patient starts at the beginning of the pandemic. And we indicated that we were seeing things stabilizing and beginning to return.

And what we've seen now, just in the last few weeks, is now we're kind of back at the same level of new patient starts that we were prior to the pandemic.

So I think that's just, again, reflective of the fact that we've adapted, physicians have adapted, patients have adapted, and we're in a position now where, as Michael mentioned, the symptoms of this disorder are very burdensome. They're burdensome on patients, caregivers, et cetera.

So it's really not something that you can ignore or just defer for a significant period of time.

So as we look forward, we expect, given that we're still in a fairly fluid situation with this pandemic, but we expect that we and physicians and patients will be in a better position to operate in a more normal fashion than we did during the -- we were operating at the beginning of the second quarter..

That's helpful added color. As you know, new patient adds have not been universally a thing that can occur easily in this current environment across nursing. If I could just ask one question for Serge. And that is relative to the DRP.

I understand that the regulatory process is ongoing, but do you anticipate any kind of milestone analysis, additional information that you'll be providing to the agency, such as safety in PDP or anything else during the time between now and April?.

What we anticipate is a standard update at 120 days, which essentially you're providing a safety update for all of the new safety information, which includes, of course, the new data and accumulated between the cut-off date for your original application to the cut-off date for the 120-day update as well as pharmacovigilance data and the information.

So it's a comprehensive safety information for the agency. That's a standard process. And other than that, I do not anticipate any additional updates for us providing it. Of course, we will provide anything that FDA would require, but this is a fairly standard process in terms of the -- providing the additional safety information..

Our next question comes from the line of Paul Matteis from Stifel..

Great. I appreciate it. I just had a couple on PDP and then just one quick regulatory follow-up. On PDP, can you just speak to guidance and kind of your expectations for volume? I think you guys took a price increase at the end of June.

So how did that factor into the update? Second, on script data, I know scripts for this drug and a lot of specialty drugs can always be hard to interpret.

But is there any channel that IMS is more or less biased to, given that -- I think in the past 4 weeks, it's showing a year-over-year decline? Wondering if that is more long-term care bias than anything else.

And then just on the regulatory side, I was curious, given -- with the standard review time line, is there a certain date or general time frame in which the FDA under PDUFA 5 should be telling you its final decision on whether or not they'll be holding a panel?.

Yes. Thanks for the questions, Paul. Okay.

Elena, you want to go, then Michael, then Serge?.

Sure. So on the volume question, with regards to guidance, the guidance range assumes mid- to high teens volume growth year-over-year, which is pretty consistent with our previous guidance range.

And Michael, you want to take the script question?.

Sure. Thanks for the question, Paul. So 75% of our business is in the SP and, what we call, the SD non-LTC channels. Acuvia does not capture prescriptions in those channels. So effectively, they're only really capturing and projecting the long-term care channel, which is about 25% of our volume.

So you probably saw that Acuvia showed us down in the lower single digits, and you're seeing us report sequential volume growth. So that tells you that the 75% of our business was growing, and we saw a modest decline in long-term care..

I'll tackle the regulatory question here, Paul. Typically, it is expectations that the FDA will notify sponsor of their decision to hold the advisory committee no later than 60 workdays from the timing of the advisory committee. That's what general expectation is.

So if you think about end of January, beginning of February, vis-à-vis, our action date for the advisory committee and pool about 60 workdays, then that puts us somewhere in November as the latest time where the agency would notify us if they change their mind about the advisory committee. So this is what expectation is.

What essentially, in reality happens is a different thing..

Our next question comes from the line of Alan Carr from Needham & Company..

This is Joey on for Alan. Congrats on the quarter. Just two quick ones.

In terms of looking at other indications for pimavanserin, in terms of additional label expansion, are you taking a look at some additional indications perhaps? And in terms of the BD front, are you looking to be more active there in terms of acquiring new assets going forward?.

Yes. Thanks much for the question. In terms of additional indications for pimavanserin, the indications we've discussed are the indications that we are pursuing with Tim. We haven't talked a lot about it, but we do have a program to leverage the learnings that we have from pimavanserin to bring other molecules forward.

None of those molecules are in the clinic yet, but we do have a battery of compounds that we're advancing. And it may well be that we pursue with those compounds, indications that we will just never get to with pimavanserin.

I do think, given the very favorable tolerability profile with pimavanserin and given the efficacy that we've seen with it, there is -- there certainly are additional indications that you would want to pursue with this kind of pharmacological profile. So we may get to some of those with additional molecules.

On the BD front, I would just say that, as we've said before, business development is a very important part of the strategy. We've built a strong organization with very strong R&D and commercial capabilities and want to leverage that not only for the pimavanserin opportunity, but also as we grow the company's transaction. So we'll continue to do that.

As I've said before, you will see additional deals. It's an important part of our business..

Our next question comes from the line of Sumant Kulkarni from Canaccord..

NUPLAZID is well positioned to be the first drug to be approved for DRP, but recently, we have seen some other companies talk about their pipeline programs in DRP as well.

So given this new-ish competitive dynamic, what are your assumptions on the runway you might have to be alone in the market as the only specifically approved branded product for DRP?.

Well, I'll start. And Serge or Michael, feel free to jump in if you have additional color you'd like to add. But first, I'll say we're way ahead of anyone else. Two, we all know the hazards of this industry. As you progress, compounds usually don't get cleaner. They get dirtier. As you progress, generally, you'd have more and more hurdles to cross.

And I'd also say that the field that we're operating in, in terms of Parkinson disease psychosis, dementia-related psychosis, continuing to advance in negative symptoms of schizophrenia. These are all very, very large markets with room for multiple large drugs.

So from a competitive perspective, I think we continue to enjoy a very, very strong competitive position.

Michael or Serge, do you guys have anything else to add?.

To our knowledge, these efforts are in early clinical stages of development. So we still have years of clinical development before this product, if successful, would actually reach the market. So I think, as Steve said, we are way ahead.

And plus, we accumulated significant amount of safety and tolerability data, and that's really a critical aspect of anywhere clinical work in this vulnerable patient population..

And Steve, the only thing I would add to your comments on the market is that there's still a very significant -- both in PDP and DRP, a large untreated population. So there are patients who have the disease and could benefit from treatment. So not only are these large existing markets, but they are large potential markets to grow into..

Our next question comes from the line of Jay Olson from Oppenheimer..

Congrats on the quarters. I was curious if you're planning to have any ex U.S. study sites for ADVANCE-2. And I was wondering if you could share your latest thoughts on seeking approval for pimavanserin outside the U.S. for schizophrenia or any other indications..

Yes.

Serge, do you want to take the first question, I'll take the second?.

Yes. For the ADVANCE-2, our negative symptom second pivotal trial, all of the sites will be ex U.S. Actually, the trial is done completely outside of the United States..

As to your second question, as we said before, we framed -- shifted our strategy on ex U.S. filings in order to be in a position where we could accumulate or better optimize the number of indications that we're pursuing during a single 10-year data exclusivity period. So that has not changed. We'll continue to assess that as we go forward.

Obviously, now with -- it's not moving forward in the broad adjunctive MDD population that simplifies the calculus a little bit. We're still looking at negative symptoms of schizophrenia, of course, DRP and PDP..

Great. That's very helpful.

And then since you have additional unexpected time to prepare for your DRP launch with the standard review, can you talk about how you plan to leverage that extra time and what learnings you may have captured from virtual education and promotional strategies in the past few months that could benefit a virtual DRP launch if needed?.

Yes. Thanks much for the question.

Michael, do you want to take that?.

Yes. Sure. So I think one of the advantages we have is because of the pandemic we can do a little bit more -- we have a little bit more time to do the disease state education. We're leveraging that. As you heard on virtual medical meetings like AAIC and future meetings, also with our MoreThanCognition website.

We're doing a lot of virtual education programs with speaker training on disease state education. So we're, I think, doing a lot more with the physicians who could potentially be educators on this market, profiling offices and profiling the market.

So we're taking it, I guess, more strategically in time to get more general on our -- more details on our commercial operations as we prepare for launch. And as I've said earlier, we are doing very well in the virtual environment today. So again, if we're in a face-to-face, that would be great.

But if not, we're going to be well positioned to launch this product in a virtual environment and leverage the learnings that we've had through PDP. So I think it's a good news story for us in regards to NUPLAZID already being in the market. We have a lot of existing infrastructure to leverage, and we're just putting that to best use..

Our final question for today comes from the line of Gregory Renza from RBC Capital Markets..

Congratulations on the quarter. I just wanted to follow up on an earlier question and commentary on DRP potential pricing for PAM and I appreciate the prematurity.

I'm just wondering, in broad strokes, if you could perhaps comment a bit on -- now that MDD is out of the picture, how some of those dynamics in MDD could either simplify or introduce some direction to how you would approach establishing value for DRP, especially in light of pimavanserin being a multi-indication program?.

Yes, sure. So I'll start. Michael, feel free to jump in. I think as we've indicated before, the dynamics between PDP and DRP are very similar. Prior to pimavanserin, no drug approved. The only drug used are off-label dopaminergic previous generation antipsychotics. They're very complicated to use in these populations.

They can undermine the kind of primary symptom of the disease in the case of Parkinson's. They can impair motor function. In the case of dementia, they impair cognition. And so -- and we don't have those liabilities. So they're very similar dynamics between PDP and DRP.

As it relates to adjunctive MDD, as we've said -- as we said all along through the entire development program, we're looking for a profile that would be dramatically differentiated in order to break into that market where there are other drugs approved and they're generic.

And so what we saw is an antidepressive signal, but it wasn't -- it didn't -- we didn't replicate the kind of highly differentiated profile that we'd expected.

So as a consequence of not moving forward in adjunctive MDD, it does, again -- that we'll use the same phrase, it does make the calculus a little bit more straightforward there because, of course, adjunctive MDD is dramatically large. It's twice the size of DRP or 20x the size of PDP.

So now operating in 2 indications with very similar dynamics, very similar unmet need, very significant value that we're delivering in those patient populations, it does make pricing more simplified as we think about moving forward in PDP and DRP..

Got it. And I'll sneak with just one last one in. Helpful commentary on BD, Steve. It sounds like sort of a stay tuned approach.

I was just wondering if you could provide some quick color on the landscape, and that is just the competition for assets that are in your wheelhouse, how some of the drivers of not just COVID but valuations are potentially helping those dynamics evolve..

Yes. In some respects, in our industry, those of us looking for assets, we have to compete against the capital markets, too. And so as I've indicated before, sometimes, the capital markets are the biggest competitor you have.

And so with this very, very tragic pandemic that we're all operating in today, a consequence is it's created more uncertainty in capital markets, particularly for private companies. And that has knockdown effects in terms of actionability of assets and the calculus that owners of those assets are doing.

So I think that's a good thing for business development, generally speaking. And we're already seeing that in some of the interactions that we're having, and I'm sure others are as well.

So I think with every challenge comes opportunity, and I think that we are very well positioned to continue to capitalize on the capabilities that we built, both in R&D as well as in commercial.

But more recently in the business development arena, we've got a strong balance sheet, we've got access to capital, we've got strong commitment from our management team, our Board, our large shareholders. And so as I mentioned, it's an important part of our business, and I think we're very well positioned to continue to be successful at it..

Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Steve Davis, CEO, for any further remarks..

Great. Thank you, operator, and thanks again, everyone, for joining us today. We greatly appreciate it and look forward to updating you on our progress next quarter..

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day..