Q2 2020 ACADIA Pharmaceuticals Inc Earnings Call

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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 Arnold.

Jonathan: 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.

And only mode, we will be facilitating a question and answer session toward the end of today's call I would now like turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Jonathan: 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 because it's got the Katie second quarter 2020 financial results.

Mark C. Johnson: 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 Stankovich, 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 supplementary slides, which are available in the events and presentation section of our website.

Joining me on the call today from Acadia or Steve Davis, Our Chief Executive Officer will provide an overview of our Q2 2020 financial performance and provide a review of our business.

Also joining us today, it's Michael Yang our Chief commercial officer will provide updates on our commercial initiatives and Dr. <unk>, 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 feed for final remarks, and opening the call up for your question.

I would also like to point out that where you can 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'll be making a number of forward looking statements within the meaning of the private Securities Litigation Reform Act up 95. 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.

Mark C. Johnson: 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.

Change and involve a number of risk and uncertainties that may cause actual results to differ materially.

These factors in other words associated with our business can be found in our filings made with the FCC Youre cautioned not to place undue reliance on these forward looking statements, which are made only as of today. Thanks.

Mark C. Johnson: Please be careful 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.

Now I'll turn the call over to Steve.

Thank you Mark good afternoon, everyone and thanks for joining yesterday, please turn to slide five.

We've made important significant progress and archery strategic pillars. As a reminder, this year, we're focused on driving the growth in Dubai is it for patients with Parkinson's disease psychosis.

Stephen R. Davis: 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 and 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 deliver on that promise. Let's turn to slide six to review. For the second quarter of 2020, Neplazid achieved $110.1 million in net sales, a 32% year-over-year increase driven by strong commercial execution.

Delivering on the dementia related that goes opportunity, our second indication for new blinded and developing innovative new treatments run it needs in CNS with three candidates in our early and late stage development pipeline.

At Acadia, our mission is to improve the lots 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 2020 buys it achieved $110.1 million, a 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 cold with 19 and Didnt.

Stephen R. Davis: 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 Guide. We now expect full-year net sales to be between $430 and $450 million, representing 30% growth year-over-year at the midpoint of the range.

Our commercial team is executing at a high level unsuccessful engaging both virtually in person with health care practitioners.

As a result for our team 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 40 and $50 million, representing 30% growth year over year at the midpoint of the range.

We are confident dropping to long term market opportunity pretty buys in PDP and look forward to the addition of GRP.

Stephen R. Davis: We are confident in driving the long-term market opportunity for Nuclasa and PDP and look forward to the addition of DR. 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 a PDUFA date of April 3, 2021. The following 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 8.

Let's move to the GRP opportunity on slide seven.

Our supplemental in D.A. for dementia related SEKCO since was accepted for filing by the FDA due to date of April Threerd 2021.

The following of the application is an important next step is ERP 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 you have to facilitate their review.

Please turn to slide it.

We continue to make important progress in our late stage development pipeline.

Stephen R. Davis: We continue to make important progress in our late stage development process. We've now initiated our second pivotal study, ADVANCE 2, in the negative symptoms of schizophrenia. This Phase 3 trial will enroll approximately 386 patients and evaluate them in a double-bond fashion for 26 weeks with a 34 milligram dose of Imivan. Additionally, our Rett Syndrome Lab Interface 3 study recommenced patient enrollment in June.

We've now initiated our second pivotal study advance to the negative symptoms of schizophrenia.

This phase three trial will enroll approximately 386 patients and evaluating the double blind fashion for 26 weeks with a 34 milligram dose in the danger.

Our Rett syndrome, lavender phase three study reconvenes patient enrollment in June.

We anticipate topline results in the second half of next year.

In addition, we're focused on business development to grow our development pipeline and leverage our internal R&D and commercial capabilities. For example earlier this year, we licensee in one Pant program from Vanderbilt and we will continue to invest in our future through additional business development opportunities that complement our long term growth strategy.

Stephen R. Davis: 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 said, I will now turn it over to Michael to discuss our commercial performance and highlights. Thank you, Steve.

With that I'll now turn it over to Michael to discuss our commercial performance in hot.

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 closet franchise.

This was another strong quarter of commercial execution setting us up for another year of double digit volume growth.

Michael Yang: 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 Plazid 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 preparation. Please turn to slide 10.

For dementia related psychosis, we're making good progress with our launch preparations please turn to slide 10.

The Plaza 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 a rapid innovation in response to the evolving.

Jeremy.

In the second quarter, we delivered net sales of $110.1 million driven by year over year volume growth of 17%.

Michael Yang: Ploset continues to transform the standard of care for patients with PDP. We have driven positive momentum through our best-in-class virtual engagement and 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 Neuplazid Remote. 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 neuplasma. 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. Additionally, monthly fulfillment rates for both new and continuing patients in the quarter remain consistently high.

This growth was field by enhanced patient identification tactics, such as leveraging electronic health records and clinical pathway, enabling patients to be diagnosed and prescribed new blodgett remotely.

We are utilizing our digital platforms to stimulate patient and caregiver conversations with your physicians about the troubling symptoms of PDP and potential treatment with deposit.

We also continued to invest improving 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 remain consistently high.

In the long term care setting managing that called at 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 are seeing things stabilize recently and directionally showing signals of improved market metrics.

Despite these challenges we believe deposit is performing well in LTC and in fact, according to a few via new plugged. It outperformed most other major promoted brands in a long term care setting.

Michael Yang: 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 Nuplazit is performing well in LTC, and, in fact, according to Acubia, the product 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 advanced the plaza.

As standard of care.

Let's review our 2020 gross initiatives further on slide 11.

The sales team has been functioning at a high level and the virtual environment and reach we recently have been able to return to the field in certain areas.

Michael Yang: 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 DuPlaza as a 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 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.

Moving forward I'm pleased to report that's a recent new patient starts trends have returned to pre coated levels in the SP channel.

We have introduced several new and initiatives to support the field and drive continued growth, including on demand virtual speaker programs with nationally recognized care wild.

Virtual patient case learning programs and coated specific educational materials to optimize Caribbean Tele medicine, including topics on social isolation and caregiver jets.

In addition, we continue to enhance our integrated patient and caregiver disease awareness campaigns to stimulate conversations where their physicians about PD psychosis and new Plaza.

We're also continuing to expand our digital and social platforms to further activate deposit requests.

Now, let's turn to our second potential indication for Pimavanserin GRP on slide 12.

Our GRP launch preparations, including disease awareness initiatives and talent recruitment are on track.

Michael Yang: In addition, we continue to enhance our integrated patient and caregiver disease awareness campaigns to stimulate conversations with our physicians about PD psychosis and neuplasia. We are also continuing to expand our digital and social platforms to further activate New Closet requests. Now let's turn to our second potential indication for Pimivansirin, 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 plan.

We're planning for both in person and virtual scenarios, and we'll be well position 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 more than cognition, dotcom or disease education web site and partnering with third party HCP sites, such as Sermo Dr. Timothy and Medscape.

The leverage disease education content from our site to theirs.

We are also participating in virtual medical Congresses, such as last month, Alzheimer's Association International conference or a I see.

Michael Yang: We are continuing to prepare the market via marketing-driven disease state education initiatives, including refreshing new and engaging content on morethencognition.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 AA As many of you are aware, AAIC is an extremely influential international meeting dedicated to advancing dementia science.

As many of you are aware a I see is an extremely influential international meeting dedicated to advancing dementia science.

Acadias sponsored a virtual disease education Bose.

Held an oral presentation on the open label Harmony data presented at nine additional posters.

Of which highlight.

Significant burden of deer, Pete and the need to treat.

With that I'd like to turn it over to surge 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 de Rps and da.

Unknown Attendee: ACADIA sponsored a virtual disease education booth, held an oral presentation on the open label Harmony Data, and presented nine additional posts, some of which highlight the significant burden of DRP and the need to. 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-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're very pleased the D.F.D.A. has filed our San Diego for dementia related say causes and communicated to us that they have not identify any potential review issues and are not planning to Halden Advisory Committee meeting.

We look forward to working we'd have deal and the review of our application.

In addition, we continued to advance our late stage programs for Pimavanserin in the negative symptoms of schizophrenia and phenotype for Rett syndrome.

Unknown Attendee: We look forward to working with FDA on the review of our application. In addition, we continue to advance our late-stage programs for pimovansirin in the negative symptoms of schizophrenia and trophinatide 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.

Earlier this year, we license inaugural Am one Pam program from 1 billion Reals University and look forward to advancing this program as well.

Consistent with our strategy, we remain focused on developing you know, but the new treatments and that is reflected in our growing and advancing pipeline.

Unknown Attendee: 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 at Ben's II 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 remain a very significant unmet need, with no FDA-approved treatment options available. Slide 16 provides a high-level view of the advanced two-study design. Similar to the design of the previous positive study, ADVANCE2 is a 26-week study evaluating pimavansirin as an adjunctive treatment for schizophrenia patients with predominant negative symptoms while controlling for their positive.

Let's start on slide 15, we the negative symptoms program.

I'm happy to announce that we have initiated our phase three study advance to the negative symptoms of schizophrenia.

Please recall this would be the second people worked on study for this indication the personal which advance reported positive results in November of last year.

The negative symptoms of schizophrenia remains a very significant unmet need with no way of D.A. approved treatment options available.

Slide 16 provides a high level view of the advanced who started design.

Similar to the design of the previous positive study advance to is the 26 week study evaluating pimavanserin as an adjunctive treatment for schizophrenia patients we've put a dominant negative symptoms while controlling for their positive symptoms. The primary endpoint is the change from baseline.

Unknown Attendee: 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 robust results on the primary endpoint in patients receiving 34 mg dose. We are now evaluating this dose of pifnovansirine in ADVANCE II. Building on the learnings of our two previous studies in schizophrenia, ADVANCE II will be conducted in non-U.S. clinical trial sites. Rett syndrome is a rare and debilitating disorder with an unmet need highlighted here on slide 17.

The negative symptom assessment 16 item scale.

Applying their learning from the positive advanced study, where we observed and a robust results on the primary endpoint in patients receiving 34 milligram dose. We're now evaluating these those of Pimavanserin in advance to.

Building on the learnings of our two previous studies in schizophrenia.

Vince do will be conducted the 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 11, they're starting June.

Unknown Attendee: Working with the study investigators, we were able to recommence enrollment in our lavender study in June. We're working on a side-by-side 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.

We're working on a side by sides basis to be able to once again enroll patients into the study.

We anticipate being able to announce topline results in the second the top 2021.

With that I will now turn the call over to Atlanta to discuss our financial performance.

Thank you starts today I'll discuss our second quarter results and our updated plenty plenty financial outlook. Please turn to slide 19.

In the quarter, we recorded $110.1 million it nets out an increase of approximately 32% compared to $83.2 million of net sales in Q2 2019.

Elaine Ridloff: 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 GrowthKinet 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.

This is driven by approximately 17% volume growth year over year.

Of course cannot adjustment for Q2 2020 was 11.3%.

We couldn't inventory in the channel the ended the second quarter were consistent with previous quarters.

Elaine Ridloff: Moving down the P&L, GAAP R&D expenses decreased to $64.3 million in the quarter compared to $67.3 million in Q2. The decrease is largely due to lower development costs associated with timivansirine and schizophrenia and DRP. GAAP ST&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.

On down the piano GAAP R&D expenses decreased to $64.3 million in the quarter compared to $67.3 million Q2 2019.

The increase is largely due to lower development costs associated with Nancy, Iran, and schizophrenia ERP.

GAAP asking <unk> expenses increased $84.3 million in the second quarter from $68 million in the second quarter 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 with a quarter with $658.6 million.

Please turn to slide 20.

For the full year, we expect continued strong growth when you Plaza and have raised the lower end of the guidance range. We now forecast 2020 nets out to be between 430 and $450 million.

Elaine Ridloff: Please turn to slide 20. For the full year, we expect continued strong growth for New Plazid 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 mid- Our next 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 a previous range of $270 to $285 million. The reduction reflects a reduction in development expenses for adjuncts to the MDD.

Revised revenue range reflects year over year growth approximately 30% at the midpoint.

Our net sales guidance can you say incorporate range of assumptions related to the duration that impacted the cobot night.

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 $285 million.

The reduction reflects a reduction development expenses for jobs as Andy.

We now expect gap as she needs to be between 400 $420 million from previous range of 425 to 445 million.

Reduction reflects lower costs associated with the timing of investments to prepare for RDR piedmont's.

We continue to anticipate noncash stock based compensation expense me between 90 and $100 million 2020.

Well I'm 2020 of the strong balance sheet and expect our yearend cash balance to be approximately 570 $590 million increase from our previous guidance of 470 $500 million.

Elaine Ridloff: We now expect GAAP SG&A to be between $400 to $420 million from the 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, up from our previous guidance of $470 to $500 million.

I'll turn the call back over to you.

Thank you Elena please turn to slide 22.

Since the beginning of the year, we've achieved $200 million net sales in the first half for new client in PDP.

Alright, Cindy April GRP has been filed by the FDA with a PDUFA date of April Threerd 2021.

We've advanced our phase three programs and negative symptoms of schizophrenia and Rett syndrome.

We licensed and then one pant program from bank.

Look forward to keep you updated on our progress were continued momentum, but why is it and that breadth and depth of our pipeline position Acadia for long term growth.

Stephen R. Davis: And with that, I'll turn the call back over to Steve. Thank you, Elena. Please turn to slide 22.

In closing I'd 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.

Stephen R. Davis: Since the beginning of the year, we've achieved $200 million in net sales in the first half for Nuflazat and PDP. Additionally, our SNDA for DRP has been followed by the FDA with a BDUFA 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 N1 PAM program from Vanderbilt. We look forward to keeping you updated on our progress toward continued momentum for Nuplazit 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 to 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.

Certainly ladies and gentleman, who have a question at this time. Please press Star then one and you touched on telephone. If your question has been answered and he'd like to remove yourself from the Q. Please press the pound <unk>. Our first question comes from wind up because he and I meant from Bank of America. Your question. Please.

Good afternoon. Thank for taking my question Congrats on a strong quarter I'm just trying to get your thoughts on how you're seeing activity. Thus far in Threeq. You. Obviously, you can't guide on a quarterly basis, but just any kind of general comments you can provide it does seem that the path.

That make it kind of moving its way through different geographies.

I've heard from some physicians that office instead open for a bit and let it pulls back down again, how are you thinking about you know uncertainty in terms of the ability of doctors to see new patients entities that you're comfortable with and can you just give us an offensive the sensitivity for your guidance for the rest of the year on that particular.

Operator: Our first question comes from the line of Tazeen Ahmad from Bank of America. Your question, please. Good afternoon.

Right. Thank you.

Sure sure Dizzying, Oh, I'm going to its Michael to just comment on the dynamics that we're seeing broadly but before he does I'll just simply say that you know I think the quarter that we just reported is I mentioned, a reflection of how quickly we've been able to adapt to a kind of new world and we're all living in pandemic.

Tazeen Ahmad: Thanks for taking my questions. Congratulations on a strong quarter. I 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 they closed back down again.

And what we've seen is very strong execution.

Irrespective of whether we're seeing doctors in person in their offices.

Im personally long term care facilities, we're doing this remotely and again I think that's a testament to the strong relationships that we have.

Andy quick to that that we made which we've talked about pretty extensively in the past soon as dependent because and in terms of guidance. We're very confident in the in the guidance that we've.

Tazeen Ahmad: 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 of your guidance for the rest of the year on that particular item? Thank you. Sure, sure, Tazeen.

That weve updated today.

Sure.

Michael you have anything else you had just in terms of board dynamics.

Yes, Steve I think you know if I look at it from a a setting of care perspective, you know we saw very strong response to the tactics you outlined.

Stephen R. Davis: 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, you know, 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.

In the in the office setting.

We haven't seen any increase in Discontinuations and we see as I mentioned, you know pre recent trends to pre coated levels in terms of argue to Brad 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.

We're quietly.

Quite frankly dealing with a lot a they had nursing staff they had to deal with it was turning over infection control.

Stephen R. Davis: 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, 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 broad dynamics? Yeah, Steve, I think, you know, if I look at it from a setting of care perspective, we saw a very strong, We have a very good 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.

But we're seeing that again as I said save lives. We're pleased with our performance relative to the appears in that setting. So if you look at the patient journey, you know that need to treat a patient with these symptoms that 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 by any you know by the pandemic.

And you know frankly from the Doctor patient gets into care, we're well positioned to help the pacing whether it's in the nursing home, whether its tele medicine or in the office as a result of some of the tactics. We didn't put in place. So I think you set well in regards to our confidence in our in our establishing the guidance.

Okay as it relates to new patient starts can you give us any kind of color about comments that positions have giving you about their ease of being able to diagnose patients or C. Patients for the first time virtually and then get them on drugs.

Michael Yang: 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 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 our peers in that setting. But 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 of New Ploset in that situation has not been diminished by any, you know, by the pandemic.

Yeah, Mike Yeah here.

Yeah sure I think that obviously tele medicine is.

Being adopted and and optimized across a across the channel but the.

The thing with PDP is that it's it's likely a patient that's already been diagnosed with Parkinson's. So in this case, there's already likely a relationship with the physician and so the ability for the physician to diagnose.

Get samples.

Michael Yang: And, you know, frankly, from the doctor or patient standing in the 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 establishing the guidelines. 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 ease of being able to diagnose patients or see patients for the first time, you know, virtually, and then get them on drugs? Yeah, Mark.

You know verify their reimbursement insurance and ship directly to the home. We think that's a really big advantage for for new closet. So we're not I think we're very well positioned for that we're hearing that feedback on and response to our tactics on that one.

Okay. Thank you.

Thank you aren't next question comes from a line of Cory Kasimov from JP 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 from investors and its whether we should assume your plaza pricing stays stable. Once D. R. P comes online assuming of course its group.

Michael Yang: Yeah. Sure. Yeah, sure. I think that, obviously, telemedicine is being adopted and optimized across the channel.

Given the increased addressable patient populations that are 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.

Michael Yang: 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, verify their reimbursement and insurance, and ship directly to the home.

To accelerate that timeline, that's something that's that sometimes seen within this division. Thanks a lot.

Yeah, I think score it.

I'll answer the first question I'm Gonna have surged to.

Michael Yang: And we think that's a really big advantage for new closets. 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. Okay, thank you. Thank you. Our next question comes from the line of Corey Casimo from J.P. Morgan. Your question, please.

Into the second one so in terms of pricing.

You know as we've said worked a little premature to comment on pricing at this juncture.

But I wouldn't necessarily assume that we would need to change price for GRP.

One we currently enjoy very good access prepares for deposit and as we've said before the dynamics between PDP, India, Turkey are very similar.

To the payer mix is very similar into European and.

Corey Casimo: One is something we've started to get more from investors, and it's whether we should assume the 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?

Such cases, we believe it would be seen as an important line extension.

Where there are no currently approved treatments on its what we already have a and finally, it's important that we demonstrated how can adventure and can provide value for.

Patients and caregivers above and beyond the off label standard of care that that's what we see today.

Yes, that's where we're already developing and will be very well prepared to deliver our value proposition.

Getting back modeling healthy economic surveyed fares.

Which we deliver in anticipation of launching into your fee. So we feel very good about the dynamics very good about the dataset that we have and as we progress and as I've said before once we have final labeling language I will be in a position to kind of form up.

Stephen R. Davis: Thanks a lot. Yeah, thanks, Corey. I'll answer the first question. I'm going to ask Serge to answer the second one.

Stephen R. Davis: So in terms of pricing, you know, as we said, we're a little premature to comment on pricing at this juncture. But I wouldn't necessarily assume that we need to change prices for DRP. One, we currently enjoy very good access for payers for nupliazid. And as we said before, the dynamics between PDP and DRP are very similar. Two, the payer mix is very similar in DRP.

Dynamics that we are we're seeing today with theirs.

Okay great.

Third you want to take the second question for him.

Yes, yes things.

As discussed previously Reengaged with you have D.A. in their communication back to us they re affirmed that based on their preliminary review.

The year the filing is appropriate for a standard review and did not provide any additional color to us.

Stephen R. Davis: And in such cases, we believe it would be seen as an important line extension where there are no currently approved treatments that are similar to what we already have. And finally, it's important that we demonstrate how payment bundling can provide value for patients and caregivers above and beyond the off-label standard of care that we see today. And as we progress, and as I 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. Okay, great. Sir, do you want to take the second question before we end? Yeah, yes, thanks.

Considering where we are in the review cycle at this time, we really don't anticipate receiving additional details regarding the classification instead, we're focusing on.

Working with M.D.A. and facilitating review so where are the April toured the action date and as you mentioned, yes, even in on fuel occasions. It did look were good day completed their review.

Hi, or two that action date, but it's very early.

Early and hard for us to speculate whether that maybe the case in our case. So we are we're focused on on facilitating review and on D. action date of April Turkey.

Unknown Attendee: 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.

Okay terrific. Thank you very much.

Unknown Attendee: 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 completed their review prior to that action date, but it's early and hard for us to speculate whether that may be the case in our case.

Thank you aren't next question comes from the lined up to borrow from Cowen Your question. Please.

Hi, guys. Thanks for taking the question.

I think Michael you alluded to talent recruitment timelines on can you talk a little bit about how you're preparing for the PRP launch given you've got some extra time, what sort of hires or you are looking to make and then beyond the follow.

To that question, it's for Elaina as he took down astute and lowered the ERP spend should we just think of it is sort of a forward shift into 2021 or do you see actual.

Unknown Attendee: So we are focused on facilitating the review and on the action date of April 3rd. Okay, terrific. Thank you very much. Thank you. Our next question comes from the line of Ritu Baral from Cowan.

Ritu Subhalaksmi Baral: Your question, please. Hey guys, thanks for taking the question. I think, 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?

Net savings to launch costs, given the fact that.

Though there could be a larger virtual component and.

Classic launches.

Michael you want to go first.

Yeah sure Ah Thanks to the question, we too so when I mentioned talent you know obviously, what we've done first is hiring.

Michael Yang: 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 this? Classic Launches. Marco, do you want to go first?

And the higher and identify the leadership level, we already had a good leadership team all in place for PDP.

Broadening that out 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.

Michael Yang: Yeah, sure. Thanks for the question, Ritu. So when I mentioned 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, 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 work. We're doing also a lot of virtual disease education.

And market preparation.

At this moment. So you know, we're getting the benefit of us and we'll extra time to prep the market.

And I think just one other thing to think about here is where we're really already on the market for you pause it and so this is a lot of things we already have in placement loaded in the payers, we have a very successful patient support services team.

Michael Yang: And we're adjusting to that now, but we'll be well prepared to expand our footprint and leadership team and sales team. You know, we're also doing a lot of virtual disease education and market preparation at this moment. So, you know, we're getting the benefit of a little extra time to prepare the market, you know, and I think just one other thing to think about here is, you know, we're really already on the market for Neuplazid. And so there are a lot of things we already have in place; we're loaded into 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 prepare the market. So I think we're in good shape, virtual or face to face, whatever we see that comes at us in April. Yeah, and just on the SG&A question, Ritu, the savings this year are the result of a timing shift, and as Michael mentioned, moving the field team hiring to the early part of next year.

So we're really getting this extra time to to be extra prepared.

To launch in prep the markets. So I think we'll are in good shape virtual or face to face whatever we see a that comes out as a in April.

Yeah, just on the S. Genie question route to the savings. This year is the result of a timing shifts as Michael mentioned and 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 theres key investments so you'd want to make on the field team expansion.

To support a successful launch.

Elaine Ridloff: 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 are key investments we'd want to make in the field team expansion to support a successful launch. Thank you. Our next question comes from Jason Butler from JMP Securities. Your question, please. Hi, it's Bryan on behalf of Jason.

Thank you. Our next question comes from the line up Jason Butler from JMP Securities. Your question. Please.

Hi, it's going for Jason Thanks for taking the questions how to couple on the marketing efforts interesting what is the new patient starts strength I Wonder if you can discuss a little more the.

Cobot specific materials, you mentioned earlier and then what percentage of the Salesforce has been able to actually have the in person interaction with providers. Thanks.

Jason Nicholas Butler: Thanks for taking the question. We've had a couple on the marketing efforts. Interesting with the new patient start strengths. 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 in-person interactions with providers?

Sure. Thanks, much for the question Michael.

Yeah, Great Great question. So what we've been able to do is you know, obviously put out some sheets and and educational material.

Especially around social life isolation.

Michael Yang: Thanks. Sure. Thanks much for the question, Michael. Yeah, great, great question. So what we've been able to do is, you know, obviously put out some sheets and educational material, especially around social isolation, caregiver tips on how to engage in a telemedicine environment. www.academia.com. 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 patients for a face-to- Okay, great. So it varies by reps, actually, as well. It can vary by rep by even in the rep could even inside the rep's territory that they have, one county could be red, and one county could be green.

Caregiver tips on how to engage in a tele medicine environment.

Those have been well received.

We've been doing a lot as I mentioned virtual disease that unmet medical promotion programs, it's difficult to say what exact percentage. The field is engaged but what we do have is a and fairly sophisticated.

Algorithm that we idled automate and load into the sales forces a computer system.

That is delayed aimed at enabling them to diagnose or really released MTO face to face visit or not so.

That that varies depending on the code at risk levels that the algorithm spits out for our team and within a very successful I think executing that on a 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 reps territory that they have one county could be you, Brad Red and one county could be green.

Got it okay. Thank you.

Michael Yang: Got it. Okay. Thank you. Thank you. Our next question comes from the line of Neena Bitritto, Garg from Citi. Your question, please. Hey guys, thanks for taking the question and congrats on the quarter. 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 closing of some of the offices, should we expect to see new starts continuing to remain at kind of pre- Or could we actually see a drop if things kind of shut down again?

Thank you. Our next question comes from a line of Nina between to Garner from Citi. Your question. Please.

Hey, guys. Thanks for taking my question and congrats on the quarter.

Talking about how the pace of new starts has come back to kind of pre cobot levels recently, so I'm just wondering how much of that do you think is due to.

Physician offices, preopening versus just patients and physicians getting more comfortable telling medicine, and what I'm really trying to get out as you know if telemedicine does kind of end up sticking around for a longer period of time or there is kind of this re closing of somebody else's should we expect to see new starts continuing to remain at kind of precluded levels.

Or could we actually see a drop of things do kind of shut down again. Thanks.

Sure Great. That's a great question I think that I would start really that answer that question is is really at the patient disease level and you know at PDP is a very very disruptive a set of symptoms in it and and causes a significant.

Neena Marie Bitritto: Thanks. Michael, do you want to take that? Sure. Great. That's a great question. I think that the answer to that question is really at the patient disease level. And, you know, PDP is a very, very disruptive set of symptoms, and it causes a significant burden on the family and the caregiver.

Burden on the family and the caregiver and 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 tried to do is capture that patient physician.

No diagnostic and treatment paradigm.

No matter, what the setting is it could be in the nursing home it could be in the tele medicine as youve asked or could be in the face to face office setting.

Michael Yang: And so that, I think, puts it into a kind of urgent need to treat. So I think that, as I mentioned earlier, what we try to do is capture that patient-physician, you know, diagnostic and treatment paradigm, no matter what the setting is. It could be in the nursing home, it could be in the telemedicine setting, as you asked, or it could be in the face-to-face office setting.

And I think what we're really seeing with a 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 a situation is not a lot that's not a choice in many cases, there's a clear mandate.

Michael Yang: 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. Thank you. Our next question comes from the line of Salveon Richter from Goldman Sachs. Your question, please. Thanks for taking the question. This is Andrea.

For treatment.

Great. Thanks, so much.

Thank you. Our next question comes from a line of Salveen Richter from Goldman Sachs. Your question. Please.

Thanks for taking my question. This is Andrew I'm for Salveen.

No no Atlanta, maybe as a follow up to your your prior comments there. It's been the increase in virtual efforts as you look twice the RP lunch. He still expected growth. It team to about 400 500 personality previously mentioned and then I've a follow up question.

Salveon Richter: I'm first solving. Um, 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'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 in-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.

Sure. So as Michael mentioned, we're preparing for a range of scenarios as most virtual in person to person and we will we believe expanding the sales force will be supported the restaurant ERP launch and well be able to provide more specifics as far as exact size it gets it.

Closer.

Got it and then maybe just to go back to PDP and 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 where I'm staying around the mid teens. It just a bunch of here if you haven't updated.

Elaine Ridloff: 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.

<unk>.

I think what we've said is high teens, most recently that continues to be pace.

Check summit, so still mid to high teens or hiking now.

Elaine Ridloff: 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. Transcripts provided by Transcription Outsourcing, LLC. 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. Congratulations, Steve and team, on a good quarter of progress and a top line.

That's correct.

Got it okay. Thank you.

Thank you aren't next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your question. Please.

Thanks for taking the question Congrats Stephen team on a good quarter of progress and topline.

Wanted to ask you a little bit intrigued with the new new patient add commentary in a I'm just trying to figure out if that's really commentary going into the second half a year or if in the quarter. There was really good new pick new patient adds and and then kind of I didn't know if you can do.

Charles Cliff Duncan: Wanted to ask you, I'm a little bit intrigued with the new 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 were 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 appointment for the pipeline. Yeah, yeah. Thanks, Charles. Michael, do you want to start? I'll add any color.

Convolute that but new patient adds versus say persistence and then I had a follow up for.

For the pipeline.

Yeah, Yeah. Thanks, Charles Michael you want to start I'll add any color.

Yeah sure Yeah. Thanks, a question Charles now those were new patient adds in the quarter.

So I think it speaks to the strength of business, especially as it relates as it related to on the S.P. side of the business.

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

Michael Yang: Yeah, sure. Yeah, thanks for the question, Charles. No, those were new patient ads in the quarter.

Yeah, and what was it come what was the contribution of persistence or earn current patient yeah.

Michael Yang: So I think it speaks to the strength of the business, especially as I relate it to the SP side of the business. [inaudible] And I forget, what was the second part of your question? Yeah, and what was the what was the contribution of persistence or current current patients? Right, yeah, we continued to see high and consistent fulfillment rates. So I think that was consistent from prior quarters. We've really seen that since the 34 milligram launch, and so that, I think, was continued. Interrupted. And how do you feel?

Right, Yeah, we continued to see hi, 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 into that I think was was continued.

In terms of use it.

Sorry, sorry, just to add it to refill annotation that so you know as Michael mentioned, the the and as we discussed on the last quarter. We saw the decrease in new patient starts at the beginning of the pandemic.

Michael Yang: I'm sorry, just to add a brief annotation that, as Michael mentioned, and as we discussed in the last quarter, we saw a 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 that we're kind of back at the same level of new patient starts that we were prior to the pandemic. So, you know, 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.

And Ah, we indicated that we were seeing things stabilizing and beginning to return.

What we see now just in the last few weeks fees now what kind of back at the same level of new patient starts. It we were prior to the trend in it so I.

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 the the do you.

Symptoms of this disorder or very burdensome burdensome on patients caregivers et cetera. So it's really not something that you can ignore or just the for significant period of time, so as we look forward.

Stephen R. Davis: So it's really not something that you can ignore or just defer for a significant period of time. 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, than we were operating at the beginning of the second quarter. That's helpful. I added color.

We expect.

Given that we're still in a fairly fluid situation with his pandemic, but we expect that we and physicians and patients will be in a better position too.

Operating in a more normal fashion then.

We did you during <unk>, we were operating at the beginning of the second quarter.

Yeah. That's helpful added color has you know no new patient adds have snap and universally.

The thing that can occur easily in this current environment across neuroscience, if I could just to ask ask one question for a surge in that and that is relative to the TRP i. I understand that.

Unknown Attendee: 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 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 this time between now and April? What we anticipate is a standard update at 120 days, which essentially means that you're providing a safety update for all of the new safety information, which includes, of course, the new data and accumulated between the cutoff date for your original application to the cutoff date for the 120-day update, as well as pharmacovigilance data. And the information, so it's comprehensive safety information for the agency. That's a standard procedure.

Regulatory process is ongoing but do you anticipate any kind of milestone analysis and additional information that you will be providing to the agencies such as a safety in PDP or anything else. During this time between now and April.

What we anticipate is a a standalone update.

Hundreds and plenty days, which essentially you're providing a safety obligated for all of the new safety information, which includes of course as the new data and accumulated.

Between the collateral base for your original application to the copper based for the funding 20 day after day as well as Pharmacovigilance day that any information so it's a comprehensive shaping formation.

For the agency, that's a standard process.

Unknown Attendee: And other than that, I do not anticipate any additional updates from 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 additional safety information. Okay, that's helpful. Thank you for taking my questions. Thank you. Our next question comes from the line of Paul Matei from Stiefel.

And in other than that I do not anticipate any additional abra dates.

For us for a bargain gain its of course as a you know with the we will provide anything get the FDIC would require but this is a fairly standard process in terms of the providing additional safety information.

Okay. That's helpful. Thank you for taking my questions.

Thank you aren't next question comes on line to Paul Matteis from Stifel. Your question. Please.

Paul Matei: 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?

Great. Thanks, so much for taking my questions I appreciate it I said a couple on 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 ended June so how did that factor into the update I'm sorry.

Elaine Ridloff: Second, on Scrip data, I know Scrips for this drug and a lot of specialty drugs. I'll 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 four weeks it's showing a year-over-year decline, wondering if that is more a long-term care bias than anything else, and then just on the regulatory side, given the standard review timeline, is there a certain date or general time frame by which the FDA, under PDUFA V, should be Thank you so much. Yeah, thanks for the questions, Paul. Okay, Elena. Do you want to go, then Michael, then Serge?

And on script data I know scripts for for this drug and a lot of specialty drugs can always be hard to interpret but is there any channel that I M. S is more or less bias to given that it I think in the past four weeks, it's showing a a year over year declined wondering if that it's more long term care bias than anything else and then just on the regulatory.

Side I was curious given with the synergy review timeline is there are certain gate or general timeframe in which the FDA under Paducah five should be telling you. It's final decision on whether or not they'll be holding a panel. Thank you so much.

Yeah. Thanks for your questions Paul Okay. Elena you want to go then Michael than search.

Sure. So on a volume question with regards to guidance the guidance ranges standards, a mid to high teen sign growth year over year, which is pretty consistent with our previous guidance.

Elaine Ridloff: So on the volume question with regard 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.

Guidance range and Michael you want to take that question.

Sure. Thanks to the question Paul So 75% of our business is in the S P and what we call the.

The non LTC channels Acumedia does not capture prescriptions in those channels. So effectively there are only really capturing and projecting the long term care channel, which is about 25% of our volume. So you probably saw that acute care showed us down in a lower single digits and you're seeing us.

Michael Yang: 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, you know, sequential volume growth. So that, you know, tells you that 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 expected that the FDA will notify sponsors of their decision to hold the advisory committee no later than 60 workdays from the time of the advisory committee.

Report, you know a sequential volume growth.

You know tells you that the 75% of our business was growing and we saw a modest decline in long term care.

Okay.

[noise].

I'll talk hold of the regulatory question here Ah Paul.

Typically it is expectations that the ever D.A. will not to place phones are.

Oh.

Their decision to call the Advisory Committee and no later than 60 working days from the timing of the advisory committed.

That's what a general expectation is so if you think about.

Unknown Attendee: That's what the general expectation is. So if you think about, So, you know, the end of January and the beginning of February, vis-à-vis our action date for the advisory committee and pool of about 60 workdays, then that puts us somewhere in November, where the latest time the agency would notify us if they change their mind about the advisory committee. So, you know, this is what expectation is, what, essentially, in reality, happens. It's a different thing. Yep. Yep. Okay. It makes sense.

You know end of January beginning of February.

Vis-a-vis hour or action date for the advisory comedian pool about 60.

Workdays stand that puts that puts us somewhere in November.

The latest time, where de agency would notify us if they change their mind about the advisory Committee so.

You know this is this is what expectation is more financially in reality happens is with the accordion thing.

Yep Yep, Okay makes sense. Thanks for all the clarification appreciate it.

Paul Matei: Thanks for all the clarification. I 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 behalf of Allen.

Thank you. Our next question comes in a line of Alan Carr from Needham and company. Your question. Please.

Hi, This is Joey on for Alan Thanks for taking her question congrats on a quarter just two quick ones.

Alan Carr: Thanks for taking our questions. Congratulations on the quarter. Just two quick ones.

Stephen R. Davis: In terms of, you know, looking at other indications for Pimivansirin in terms of additional label expansion, are you taking a look at some additional indications, perhaps? And on 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 Pimivantrin, the indications we've discussed are the indications that we are pursuing with PIM. We haven't talked about it a lot, but we do have a program to leverage the learnings that we have from Pimivantrin 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.

In terms of Ah you know looking at other indications for.

Some of answer in terms of additional label expansion are you taking a look at at some additional indications, perhaps and in terms of.

The BD front are you looking to be more more active there in terms of acquiring new assets going forward. Thank you.

Yeah. Thanks much for the question.

In terms of additional indications for Pimavanserin.

The indications we've discussed or the indications there that we are pursuing with Tim.

We we haven't talked a lot about it but we didn't 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 compounds that we're advancing.

Stephen R. Davis: And it may well be that we pursue indications that we will just never get to with Tim McVanter. I do think, you know, given the very favorable tolerability profile that we have been answering 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.

And it may well be that we pursue.

With those compounds indications that we will just never get to with him have answered.

I do think.

You know given the very favorable tolerability profile with them of answering and given the the efficacy that we've seen with it a there is that 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 a with additional additional molecules on the BD Brian.

Stephen R. Davis: On the BD front, I would just say that, as we've said before, business development is a very important part of our strategy. We built a strong organization with very strong R&D and commercial capabilities and want to leverage that not only for demand and opportunity, but also as we grow the company 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. Thank you. Our next question comes in the line from Sumant Kulkarni from Kennecord.

I would you say that as we as we've said before.

This is developing is very important part of our strategy.

We've built a strong organization with very strong R&D in commercial capabilities.

And once the leverage that.

Only positive answered opportunity, but also speak as we grow or the company transaction. So well continue to do that as I've said before you will see additional deals.

It's an important barber business.

Thank you. Our next question comes on line of Sumant Kulkarni from Canaccord. Your question. Please.

Sumant Satchidanand Kulkarni: 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 they have additional colors you'd like to add.

Hi, Thanks for taking my questions.

The pleasant is well positioned to be the first drugs to be approved for DFI, but recently have you seen some other companies talk about that pipeline programs and yes. He has moved so given this newish competitive dynamic what are your assumptions on that until you might have to be alone in the market as the only specifically approved branded product pretty happy.

Well I'll start and surgery, Michael who read a jump in if you have additional color you'd like to add but.

First I will say, we're way ahead of anyone else.

Stephen R. Davis: 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.

To a we all know the hazards of this industry.

You know as you progress compounds, usually don't get cleaner they get dirtier.

Stephen R. Davis: As you progress, you know, generally 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, and 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?

As you progress.

The generally should have more and more hurdles to cross.

And I'd also say that.

The field to.

There were operating in terms of Parkinson's disease psychosis Dimensionalize that goes is.

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 physician.

Michael or surge does anything else there.

Yeah, I'm feeling that.

Stephen R. Davis: Yeah, I've got that. Go ahead. Yeah, thanks.

Go ahead Sir.

Yeah, thanks to our to our knowledge.

Unknown Attendee: To our knowledge, these efforts We are in the 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 have accumulated a significant amount of safety and tolerability data, and that's really a critical aspect of any work, 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 gap, both in PDP and in DRP, https://www.academia.com. Great, thanks much. Got it.

His efforts.

In early clinical stages of development so.

We still have a.

Our years of clinical development before this brought our if successful would actually reach the markets. So I didn't I think as Steve said, we're way ahead and plugs, we accumulated significant amount of safety and Tolerability data and that's really a critical aspect.

Anywhere a clinical work is one that are about 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 India RP.

And and a large untreated populations of their patients who have the disease and could benefit from treatment. So.

No one of these large existing markets, but there are large potential markets to grow into.

Unknown Attendee: Thank you. Thank you. Our next question comes from the line of Jay Olson from Oppenheimer.

Great. Thanks much.

Jay Olson: 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-Venturin outside the U.S. for schizophrenia or any other indications. Sir, do you want to take the first question?

Got it thank you.

Thank you aren't next question comes on line of GE 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 too 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.

Yeah surgeon and take the first question out there so.

Yes.

<unk>.

Unknown Attendee: Yes. For the advance to our negative symptoms second pivotal trial, all of the sites will be ex-U.S. In fact, the trial is done completely outside of the United States. As to your second question, as we said before, we've 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.

For the advance to our negative symptoms second pivotal trial.

All of the sites will be ex U.S. actually the trial is done completely outside of United States.

It's your second question.

As we said before we frame shifted our strategy on ex us filings.

In order to be in a position where we could accumulate.

Or better optimize the number of indications that were pursuing during a single 10 year data exclusivity period.

So that is not change will continue to assist that as we go forward, obviously now with the it's not moving forward in the broad adjunctive mbd.

Stephen R. Davis: We'll continue to assess that as we go forward. Obviously, now that we are 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 PTSD.

Population that that simplifies the calculus, a little bit we're still.

Looking at negative symptoms schizophrenia of course, the European PDP.

Stephen R. Davis: That's very helpful. Thank you for that. 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? Yeah, thanks so much for the question, Michael. Would you like to take that?

Right. That's very helpful. Thank you for that and then since you have additional unexpected time to prepare fear the European launch with the standard review can you talk about how you plan to leverage that extra time and what learning. He may have captured from virtual education and promotional strategies in the past few months.

That could benefit a virtual D RP launch if needed.

Yeah. Thanks, much for the question, Michael I'll take that yeah.

Sure. So I think a one of the advantages we have is because of the pandemic.

Michael Yang: Yeah. Sure, so one of the advantages we have is that because of the pandemic, we can do a little bit more, have a little bit more time to do the disease state education. We're leveraging that, as you heard, at 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.

We can do a little bit more we have a little bit more time to do the disease State education were leveraging that as you heard on.

Virtual medical meetings, like Hey, I see in future meetings also with a more to then cognition website.

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

Michael Yang: So we're, I think, doing a lot more with the physicians who could potentially be educators in this market, profiling offices, and profiling the market. So we're taking it, I guess, more strategically in time to get 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 meeting, that would be great, but if not, we're gonna be well positioned to launch this product in a virtual environment and leverage the learnings that we've had through PDP. So I think.

So we're taking it I guess more strategically.

In time to to get more general on our more details on our.

Commercial operations as we prepare for lunch and as as I 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 it's not we're gonna be well position to launch this product in a virtual environment and leverage learnings that we've had two PDP. So I think.

Michael Yang: It's a good news story for us in regards to new products already being on the market. We have a lot of existing infrastructure to leverage, and we're just putting that to the best possible use. Great, that's very helpful.

It's a good news story for us in regards to deposit already being on the market. We have a lot of existing infrastructure to leverage and we're just putting that to best use.

Great Thats very helpful. Thanks, again for taking the question.

Jay Olson: Thanks again for taking the questions. 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. Hey, Steve and team.

Thank you we have time for one further question. Our final question for today comes from the line of Gregory rents from RBC capital markets. Your question. Please.

Hi, Stephen Kim. Thank you first they came in and congratulations on on the quarter just wanted to follow up on an earlier question a commentary on the ERP potential pricing for Pam and I appreciate the the prematurity I'm just wondering in broad strokes.

Gregory James Renza: Thank you for speaking to me and congratulations on the quarter. I just wanted to follow up on the 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 light of PIM vents from being a multi-indication program. Yeah, sure. So I'll start. Michael. Feel free to jump in.

Strokes, if you could perhaps a comment a bit on now that a MDD is out of that picture, how some of those dynamics and MDD could either simplify or introduce some direction to how you would approach establishing value for Ford ERP, especially in light of convince from being.

A multi indication program. Thank you.

Yeah sure.

So I'll start Michael feel free to jump in.

I think as we if we we've indicated before the dynamics between PDP, India appear very similar.

Stephen R. Davis: I think, as we've indicated before, the dynamics between PDP and DRP are very similar. Projects have been bantering, no drug approved, and the only drugs used are off-label dopaminergic previous generation antipsychotics.

Prior to its been bathroom no drug approved the.

The only drug used or off label dopaminergic previous generation anti psychotics.

They are very complicated using these populations.

Stephen R. Davis: They're very complicated to use in these populations because 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.

They can undermine the kind of primary symptom of the disease indicates the parkinsons they can appear motor function.

In the case of.

Dementia, they impair cognition.

Stephen R. Davis: And so, and we don't have those liabilities. So they're very similar dynamics between PDP and DR. As it relates to adjunctive MDD, 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 was 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 larger; it's twice the size of DRP or 20 times the size of PDP.

And so and we don't have those those liabilities so they're very similar dynamics between PDP and Directv.

As it relates to adjunctive in D. as we've said as we said all along through the entire developer program.

We're looking for profile that would be dramatically differentiated in order to.

Break into that market, where there are other drug approved and their generic.

And so what we saw is anti depressants signal, but it wasn't a it didnt, we'd 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 to the.

He was the same phrase it does make the calculus a little bit.

More straightforward there.

Because of course jumped in India is dramatically largest twice the size of de RP.

Or 20 times the size of PDP. So so now operating in.

Stephen R. Davis: So now operating in two indications with very similar dynamics, very similar unmet needs, and 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. Thank you. And I'll sneak just one last one in.

Two indications with very similar dynamics very sick.

Similar unmet need very significant value that we're delivering in those patient populations. It does make pricing.

More simplified is we think about the moving forward in PDP into European.

Got it thank you and I'll sneak just one last one in public commentary on BD, Steven It sounds like sort of the stay tuned upfront you just wondered if you could provide some quick colour on the landscape, but that is just the competition for assets that are in your wheelhouse, how some of the drivers of not just coated but valuations are potentially I hope.

Gregory James Renza: Helpful commentary on BDC, Stephen; it sounds like sort of a stay-tuned approach. I was wondering if you could provide some quick color on the landscape, that is, just the competition for assets that are in your wheelhouse, and how some of the drivers of not just COVID but valuations are potentially helping those dynamics evolve. Thank you again very much.

Being those dynamics of <unk>. Thank you again very much.

Stephen R. Davis: Yeah, you know, I, I, I, 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 that it's created more uncertainty in the capital markets, particularly for private companies, and that has knocked down effects in terms of the actionability of assets and the calculus that owners of those assets are doing.

Yeah, you know I I [laughter] I in some respects.

In our industry those of us looking for assets.

You know we have to compete against the capital markets suit.

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.

Consequence is it's created more uncertainty in the 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 you know we're already seeing that in some of the interactions that were happening and I'm sure others or as well.

Stephen R. Davis: 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 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 all, 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. I think we are very well positioned to continue to be successful.

So I think you know with every challenge comes opportunity and I think you know I think that we're very well position to continue to capitalize on the capabilities that we built both in R&D as well as in commercial but all but.

More recently in the.

Business development Arena, we've got strong balance sheet, we get access to capital we've got strong commitment from our management team our board our large shareholders and so it was I mentioned, it's an important part of our business I think we're very well positioned to continue to be successful at it.

Stephen R. Davis: 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.

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

Stephen R. Davis: 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.

Great. Thank you operator, 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.

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