ACADIA Pharmaceuticals Inc.

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. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session toward the end of today's call. 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 Sankovich, our President, who will discuss our pipeline progress. Our Chief Financial Officer, Elaine 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 presentation 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 that differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC. Your caution 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 five. We've made important and significant progress on our three strategic pillars. As a reminder, this year we are focused on driving the growth of nucleoside for patients with Parkinson's disease psychosis, delivering on the dementia-related psychosis opportunity, our second indication for nucleoside, and developing innovative new treatments for unmet needs in CNS with three 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 three strategic pillars enables us to execute on that promise. Let's turn to slide six to review. For the second quarter of 2020, New Plaza 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 healthcare 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 to $450 million, representing 30% growth year over year at the midpoint of the range. who are confident in driving the long-term market opportunity for nucleoside and PDP and look forward to the addition of DRP. Let's move to the DRP opportunity on slide seven. Our supplemental NDA for dementia-related psychosis was accepted for filing by the FDA with a PDUFA date of April 3rd, 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're 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 eight. We continue to make important progress in our late stage development pipeline. We've now initiated our second pivotal study, ADVANCE-2, into negative symptoms of schizophrenia. This phase three trial will enroll approximately 386 patients and evaluate them in a double bond fashion for 26 weeks with a 34 milligram dose of Pimivanserin. Our Rett Syndrome Lab Interphase 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 new Placid 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. The closet 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 and 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 Nuclosid 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 Nuplaza. We also continue to invest in improving inpatient access services and easing the prescription fulfillment process for healthcare practitioners. Sequential volume growth in the specialty pharmacy channel contributed to strong overall performance. Thank you. Thank you. Thank you. 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 DuPloset 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 nuplasid. We are also continuing to expand our digital and social platforms to further activate nuplasid requests. Now let's turn to our second potential indication for Pimivanserin, 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 will 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 CIRMO, 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 nine 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 a comment related to DRP S&DA. 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 pimovancerin in the negative symptoms of schizophrenia, and Trophinatide for Rett Syndrome. Earlier this year, we licensed a novel M1 PEM 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 the negative symptoms program. I am happy to announce that we have initiated our phase 3 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-II study design. Similar to the design of the previous positive study, ADVANCE-II 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 endpoint 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 endpoint in patients receiving 34-milligram dose, we are now evaluating this dose of Pirmavanserin in advance too. Building on the learnings of our two 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 in net sales in Q2 of 2019. This was driven by approximately 17% volume growth year over year. The growth 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 Timavansarin and 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. Non-cash 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 New Plaza and have raised the lower end of the guidance range. We now forecast 2020 net sales to be between $430 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 to $280 million from previous range of $270 to $285 million. The reduction reflects a reduction in development expenses for adjunct to the MDD. We now expect GAAP SG&A to be between $400 to $420 million from previous range of $425 to $445 million. This reduction reflects lower costs associated with the timing of investments to prepare for our DRP launch. We continue to anticipate non-cash, stock-based compensation expense to be between $90 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 to $590 million, increased from our previous guidance of $470 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 New Plaza and PDP. Our SNDA for DRP has been followed by the FDA with a BDUFA date of April 3rd, 2021. We've advanced our phase three programs in the negative symptoms of schizophrenia and Rett syndrome, and we licensed an inborn PAM program from Vanderbilt. We look forward to keeping you updated on our progress, our continued momentum of New Plaza, and the breadth and depth of our pipeline position at 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? Certainly. Ladies and gentlemen, if you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key. Our first question comes from the line of Tazine Ahmed from Bank of America. Your question, please.

Good afternoon. Thanks for taking my questions. 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 have closed back down again. How are you thinking about, you know, 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? Thank you.

Sure. Sure, Jezeen. I'm going to ask Michael to just comment on, you know, 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, or 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 terms of our dynamics?

Yeah, Steve, I think, you know, if I look at it from a setting of care perspective, you know, we saw very strong response to the tactics you outlined. Allyson McMillan Youngblood, were, quite frankly, dealing with a lot. They had nursing staff they had to deal with. It 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, they're very disruptive and have a high degree of caregiver burden. That's still a major issue. And so the role for New Plaza in that situation has not been diminished by anything You know, by the pandemic. And, you know, frankly, from the doctor or patient setting 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've put in place. So I think, you know, you said it well in regards to our competence in our establishing the guidance.

Okay. As it relates to new patient starts, can you give us any kind of color about comments that physicians have given you about their Thank you for joining us.

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, we think that's a really big advantage for New Plaza. So I think we're very well positioned for that. We're hearing good feedback and response to our tactics on that one.

Okay, thank you.

Thank you. Our next question comes from the line of Corey Casimo from J.P. Morgan. Your question, please.

Hey, good afternoon, guys. Thanks for taking the questions. 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 new plazid 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 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 timeline? Is that something that's sometimes seen within this division? Thanks a lot.

Yeah, thanks, Corey. I'll answer the first question. I'm going to ask Serge to answer the second one. So in terms of pricing, you know, 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 for pairs for Nuplazid, and as we 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 PIM of answering 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 will be very well prepared to deliver our value proposition Budget Impact Modeling, Health Economics Survey, HBARES, 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 HBARES. Okay, great. Serge, you want to take the second question, Corey, now?

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 viewed 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 3rd action date. And as you mentioned, yes, on a few occasions, it did occur that they complete their review prior to that action date. 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 3rd. Okay, terrific. Thank you very much.

Thank you. Our next question comes from the line of Ritu Baral from Cowan. Your question, please.

Hey, guys. Thanks for taking the question. Michael, you alluded to talent recruitment timelines. 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, you want to go first?

Yeah, sure. Thanks for the question, me too. So when I mention talent, you know, 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 3rd 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 a little 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 New Plaza and so this is Allyson McMillan Youngblood

Yeah, 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.

Thank you. Our next question comes from the line of Jason Butler from JMP Securities. Your question, please.

Hi. It's Brian for Jason. Thanks for taking the question. 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? Thanks.

Sure. Thanks so much for the question. Michael?

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 Salesforce'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 rep, actually, as well.

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. Got it.

Okay. Thank you.

Thank you. Our next question comes from the line of Nina Pitrito-Garg from Citi. Your question, please.

Hey guys, thanks for taking the question and 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, you know, if telemedicine does kind of end up sticking around for a longer period of time or there is kind of this 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? Thanks.

Michael, 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, you know, PDP is a very, very disruptive disease. Allyson McMillan Youngblood, And I think what we're really seeing with the new stars 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. It's not a choice. In many cases, there's a clear mandate for treatment.

Great. Thanks so much.

Thank you. Our next question comes from the line of Salvine Richter from Goldman Sachs. Your question, please.

Great. Thanks for taking the question. This is Andrea. I'm for Salvine. You know, 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 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 in-person and in-person. And 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. I 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 still mid to high teens or high teens now?

That's correct.

Got it. Okay. Thank you.

Thank you. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your question, please.

Thanks for taking the question. Congrats, Steve and team, on a good quarter of progress in Topline. I 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 ads. And then kind of, I don't know if you can deconvolute that, but new patient ads versus, say, persistence. And then I had a follow-up for the pipeline.

Yeah, thanks, Charles. Michael, do you want to start? I'll add any color. Yeah, sure. Yeah, thanks for the question, Charles. No, those were new patient ads 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?

Yeah, and what was the contribution of persistence or current patience? Yeah. Right, yeah.

We continue to see high and consistent fulfillment rates, so I think that Thank you for joining us.

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 Allyson McMillan Youngblood We're operating at the beginning of the second quarter.

That's helpful added color. As you know, new patient ads have not been universally a thing that can occur easily in this current environment across neuroscience. If I could just ask one question for Surge, 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. Thank you very much. Thank you. Thank you. 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, you know, we will provide anything that FDA would require, but this is a fairly standard process in terms of providing the additional safety information.

Okay, that's helpful. Thank you for taking my questions.

Thank you. Our next question comes from the line of Paul Matej from Stifel. Your question, please.

Great. Thanks so much for taking my questions. 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 PDP, Allyson McMillan Youngblood, under PDUCA 5 should be telling you its final decision on whether or not they'll be holding a panel. Thank you so much.

Yeah, 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. 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 a sponsor of their decision to hold the advisory committee no later than 60 workdays from the timing of the advisory committee. That's what a general expectation is. So if you think about end of January, beginning of February, This is what expectation is, what essentially in reality happens, it's a different thing.

Yep, yep, okay. Makes sense. Thanks for all the clarification. Appreciate it.

Thank you. Our next question comes from the line of Alan Carr from Needham & Company. Your question, please.

Hi, this is Joey on for Alan. Thanks for taking our questions. Congrats on the quarter. Just two quick ones. In terms of, you know, 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? Thank you.

Yeah, thanks so much for the question. In terms of additional indications for PIMA Bansarin, The indications we've discussed are the indications that we are pursuing with PIM. We haven't talked a lot about it, but we do have a program to leverage the learnings that we have from PIM of answering 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 PIM of answering. I do think, you know, given the very favorable tolerability profile with pembavancerin and given the efficacy that we've seen with it, 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, you know, as we've said before, you know, Business development is a very important part of our strategy. We've built a strong organization with very strong R&D and commercial capabilities and want to leverage that not only for the PIM advance and opportunity, but also as we grow other companies' transactions. 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.

Thank you. Our next question comes from Sumat Kulkarni from Kenaccord. Your question, please.

Thanks for taking my questions. 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 newish 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. You know, as you progress, compounds usually don't get cleaner. They get dirtier. As you progress, you know, generally you just have more and more hurdles to cross. And I'd also say that the field that we're operating in, in terms of Parkinson's 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, you guys have anything else to add?

Yeah, thanks. To our knowledge, these efforts are in early clinical stages of development. So we still have years of clinical development before these products, 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 any 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 in DRP, and a large untreated population. So there are patients who have the disease and could benefit from treatment. So not only these large existing markets, but there are large potential markets to grow into. Great.

Thanks much.

Thank you. Thank you. Our next question comes to the line of Jay Olson from Oppenheimer. Your question, please.

Oh, hey, guys. Congrats on the quarter and thanks for taking my question. I was curious if you're planning to have any ex-U.S. study sites for ADVANCE-II, and I was wondering if you could share your latest thoughts on seeking approval for Pima-Vanserin outside the U.S. for schizophrenia or any other indications.

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

Yes. For the ADVANCE-II, our negative symptom second pivotal trial, All of the sites will be XUS. Actually, the trial is done completely outside of the United States.

As to your second question, as we said before, we frameshifted our strategy on XUS 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 us not moving forward in the broad adjunctive MBD 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. Thank you for that. And then since you have additional unexpected time to prepare for your Thank you so much for the question. Michael, do you want to take that? Yeah, sure. So I think one of the advantages we have is because of the pandemic

We can 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 more than cognition 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 Thank you. We have time for one further question. Our final question for today comes from the line of Gregory Renza from RBC Capital Markets. Your question, please.

Thank you for sticking me in and congratulations on the quarter. I just wanted to follow up on an earlier question and commentary on DRP potential pricing for PIM. And while 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 medical events, from being a multi-indication program. Thank you.

Yeah, 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 the PEMV answering, no drug approved. The only drugs 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 we don't have those liabilities. So they're very similar dynamics between PDP and DRP. As it relates to adjunctive As we've 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 antidepressant signal, but 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, we're going to 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 20 times the size of PDP. So now operating in two indications with very similar dynamics, very similar unmet need, Thank you.

And I'll sneak just one last one in, helpful commentary on BDC, Steve, and it sounds like sort of a stay-tuned approach. I was 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. Thank you again very much.

Yeah, you know, in some respects, in our industry, those of us looking for assets, you know, we have to compete against the capital markets too. And so, as I've indicated before, you know, 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 the capital markets, particularly for private companies. And that has knocked down 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 you know 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 you know with every challenge comes opportunity and I think you know 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 I look forward to updating you on our progress next quarter.

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