Q3 2021 ACADIA Pharmaceuticals Inc Earnings Call

Gigi: Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals third quarter 2021 Financial Results Conference Call. My name is Gigi, and I'll be your coordinator for today. I would like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals third quarter 2021 financial results Conference call. My name is Gigi and I'll be your coordinator for today I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Okay.

Mark C. Johnson: Today's call is to discuss Acadia's third quarter 2021 financial results. Joining me on the call today from Acadia are Steve Davis, our chief executive officer, who will provide an overview of our Q3 2021 financial performance and a review of our business operations.

Today's call to discuss <unk> third quarter 2021 financial results.

Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q3 2021 financial performance and a review of our business operation.

Mark C. Johnson: Also joining us today is Brendan, our chief operating officer and head of commercial, who will provide updates on our commercial performance. Dr. Serge Stankovic, our president, will discuss our pipeline progress, and our interim chief financial officer, Mark Schneier, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call for your question. I would also like to point out that we are using supplementary slides, which are available in the events and presentation section of our website.

Also joining us today is Brian <unk>, our chief operating officer, and head of commercial who will provide updates on our commercial performance Dr. Serge Stankovic, our president will discuss our pipeline progress and our interim Chief Financial Officer, Marc Schneier 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'd also like to point out that we were using supplemental slides, which are available on the events and presentations section of our website.

Mark C. Johnson: 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 of 1995. These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, or future results, are based on current information and assumptions that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially.

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.

<unk> and involve a number of risks and uncertainties that may cause actual results to differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC you are cautioned not to place undue reliance on these forward looking statements, which are made only as of today's date.

Mark C. Johnson: These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. I'll now turn the call over to Mark. Thank you, Mark. Good afternoon, everyone.

I'll now turn the call over to Steve.

Thank you Mark good afternoon, everyone and thank you for joining us today.

Stephen R. Davis: And thank you for joining us today. I'd like to start with a quick recap of our commercial performance, followed by a regulatory update for Bimavanserin and a preview of our coming catalysts. Please turn to slide 4.

I'd like to start with a quick recap of our commercial performance followed by a regulatory update preventative answering.

The preview of our coming catalyst, please turn to slide four.

Stephen R. Davis: First, I'd like to take a moment to remind everyone of our announcement last week that Brendan Tien has been promoted to the position of chief operating officer and head of commercial. Brendan has been a tremendous leader for our team, and I'm very excited to be able to further leverage his deep experience and strong capabilities. While Brendan will take you through our commercial update in greater detail in a minute, let me just say that, on a macro level, the Parkinson's disease market continues to be significantly impacted as a result of the pandemic.

First I'd like to take a moment to remind everyone of our announcement last week that Brendan Ken has been promoted to the position of Chief operating officer and head of commercial.

Brendan has been a tremendous leader for our team and I'm very excited to be able to further leverage his deep experience and strong capabilities.

Well Brendan will take you through our commercial update in greater detail in a minute let.

Let me just say that on a macro level. The Parkinson's disease market continues to be significantly impacted as a result of the pandemic.

Stephen R. Davis: Despite these challenges, Neuclizid has outperformed branded drugs in the space, and for the third quarter of 2021, Placid achieved $131.6 million in net sales. This represents a 9% year-over-year increase with sequential and year-over-year volume growth.

Despite these challenges NUPLAZID has outperformed branded drugs in this space and for the third quarter of 2021, NUPLAZID achieved $131 6 million and net sales.

This represents a 9% year over year increase with sequential and year over year volume growth.

Stephen R. Davis: As shown in the graph on the labs, our team has continued to execute with year over year and sequential growth each quarter since the beginning of the year. To be more precise, New Planet has outperformed a market basket of top prescribed brands in neurology and Parkinson's disease in the office-based setting. Similarly, it implies a continued strong outperformance in the long-term care market. Our strong relative performance underscores our team's ability to adapt and find ways to grow our brand.

As shown on the graph on the left our team has continued to execute with year over year and sequential growth each quarter since the beginning of the year.

To be more precise NUPLAZID has outperformed the market basket of Pompe prescribed brands in neurology, and Parkinson's disease, and the office space setting.

Similarly, NUPLAZID continued its strong outperformance in the long term care channel.

Our strong relative performance underscores our team's ability to adapt and find ways to grow our brand.

Stephen R. Davis: This includes our recently launched branded campaign targeting health care providers, which promotes and applies its unique safety profile specifically as it relates to the Parkinson's community. On the patient and caregiver front, we're in the process of launching a new TTC campaign aimed at solving one of our biggest COVID-related challenges, which is physicians not seeing as many PDB patients in person. As such, this DTC campaign is named for patients and caregivers who are at home and is designed to activate them to have a conversation with their doctor about their symptoms of psychosis and potential treatment with new clients. Our growth initiatives, new leadership, and strong relative performance give us confidence that we will further accelerate the growth of new blizzard into 2022.

This includes our recently launched branded campaign targeting healthcare providers, which promotes NUPLAZID unique safety profile, specifically as it relates to the Parkinson's community.

The patient and caregiver front, we're in the process of launching a new DTC campaign aimed at solving one of our biggest COVID-19 related challenges, which is positioned not seeing as many PDP patients in person.

As such this DTC campaigns aimed at patients and caregivers who are at home and is designed to activate them to have a conversation with their doctor about their symptoms of psychosis and potential treatment with NUPLAZID.

Our growth initiatives, new leadership and strong relative performance gives us confidence that we will further accelerate the growth of NUPLAZID into 2022.

Stephen R. Davis: Now let's move to our regulatory update regarding our SNDA for payment of answering on slide five. As you recall, at our Top A end of review meeting, the FDA made it clear that today they are looking at individual subgroups of dementia rather than DRP as a single group. Accordingly, they stated that they believe our best path forward is to conduct an additional study in each subgroup where we seek approval. However, at that meeting, the FDA also stated, based on additional analysis we've shared with them, that they are open to having another meeting to discuss whether there is a potential path to resubmission without an additional clinical study in any of the subcommittees.

Now, let's move to our regulatory update regarding our NDA for payment of answering on slide five.

As you recall at our top eight into review meeting the FDA made it clear that today. They are looking at the individual subgroups of da Vinci, rather than the ERP as a single group.

Accordingly, they stated that they believe are best path forward is to conduct an additional study in each subgroup, where we seek approval.

However at that meeting the FDA also stated based on additional analysis, we've shared with them that.

They are open to having another meeting to discuss whether there is a potential path to resubmission without an additional clinical study in any of the subgroups.

Stephen R. Davis: This meeting is now scheduled, and we expect to be able to report on the results of the meeting around year-end. When we look at our dementia subgroup data, it is very clear that we have the most data for Alzheimer's, which represents somewhere between 60 and 80% of all dementia patients in the U.S. Our database includes two independent clinical studies, providing evidence of Jimavansansansansans Antis psychotic efficacy in Alzheimer's disease Study 019 and the Harmony study.

This meeting is now scheduled and we expect to be able to report on the results of the meeting around year end.

When we look at our Dimitri subgroup data is very clear that we have the most data for Alzheimer's disease, which represents somewhere between 60 and 80% of all dementia patients in the U S.

Our database includes two independent clinical studies, providing evidence of heme advancements anti psychotic efficacy in Alzheimer's disease psychosis study of 109 and the harmony study.

Stephen R. Davis: Together, these studies demonstrate improvement in psychotic symptoms and reduction of risk of relapse of psychosis in ADP patients. At our upcoming meeting with the FDA, we look forward to sharing additional analyses we've done in response to feedback from the last meeting. We will provide more details on this opportunity in this section.

Together. These studies demonstrated improvement in Socratic symptoms and reduction of risk of relapse of psychosis in ADP patients.

At our upcoming meeting with the FDA, we look forward to sharing additional analyses we've done in response to feedback from the last meeting.

Serge will provide more details on this opportunity in this section.

Stephen R. Davis: As we look ahead, I'd like to highlight some important near-term catalysts as shown on slide 6. First, as I've noted, we look forward to providing an update from our meeting with the FDA around year-end. Second, we expect to announce top-on results from Lavender, our Pivotal-Fase 3 study for Trophenid and Reds syndrome later this quarter.

As we look ahead I'd like to highlight some important near term catalysts as shown on slide six.

First as I've noted, we look forward to providing an update from our meeting with the FDA around year end.

Second we expect to announce topline results from lavender, our pivotal phase III study for <unk> in Ret syndrome later this quarter.

Stephen R. Davis: And third, we expect to announce top-line results from a phase two proof of concept study evaluating ACP 044 in postoperative pain following bunionectomy surgery in the first quarter of 2022. Finally, our company is well poised for further expansion. We have a healthy balance sheet, a growing revenue base, and a best-in-class in-house R&D and commercial team. Business development continues to be a key priority of our strategy, and we continue to be very active in that. I would now like to turn the call over to Brendan to discuss our commercial performance. Thank you.

And third we expect to announce top line results from a phase II proof of concept study evaluating ACP hopeful for in post operative pain. Following bunionectomy surgery in the first quarter of 2022.

Finally, our company is well poised for further expansion.

Healthy balance sheet.

<unk> revenue base and best in class in House, R&D and commercial teams.

Business development continues to be a key priority of our strategy and we continue to be very active on that front.

I would now like to turn the call over to Brendan to discuss our commercial performance.

Thank you Steve.

Brendan P. Teehan: Today I'd like to review our third quarter performance for New Placid and Parkinson's Disease Psychosis. Please turn to slide 8. In the quarter, we delivered net sales of $131.6 million. This quarterly performance represents sequential demand growth, fueled by new patient starts and continuing patients with strong adherence and compliance rates. I'd like to start with a further dive into the current macro environment that we're operating in. As we've stated previously, the pandemic has disproportionately affected the Parkinson's disease patient population, significantly impacting the market. As shown on the slide, PD office visits and occupancy rates at long-term care facilities are still down significantly from pre-pandemic levels.

I'd like to review, our third quarter performance for NUPLAZID in Parkinson's disease psychosis, Please turn to slide eight.

In the quarter, we delivered net sales of $131 $6 million.

This quarterly performance represents sequential demand growth fueled by new patient starts and continuing patients with strong adherence and compliance rates.

I'd like to start with a further dive into the current macro environment that we're operating in.

As we stated previously the pandemic has disproportionately affected the parkinsons disease patient population significantly impacting the market.

As shown on the slide PD office visits and occupancy rates at long term care facilities are still down significantly from pre pandemic levels.

Brendan P. Teehan: Despite this, Neuplazid has continued to grow meaningfully throughout the period, with strong relative performance as compared to the overall Parkinson's disease and broader neurology market. More specifically, when we compare recent quarterly performance with pre-pandemic performance in 2019, we see the following. In the office-based setting, Carbidopa and Leavidopa are down 4%, and the top 10 Parkinson's brands, on average, are down 7% over that time period. And while the top 15 marketed neurology products are up 15%, New Placid is up fully 28% for that same time period.

Despite this NUPLAZID has continued to grow meaningfully throughout the period with strong relative performance as compared to the overall Parkinson's disease and broader neurology markets.

More specifically when we compare recent quarterly performance with pre pandemic performance of 2019, we see the following.

In the office space, setting carpet open levodopa or down 4% and the top 10, Parkinson's brands on average are down 7% over that time period.

While the top 15 marketed neurology products are up 15%.

Closet is up fully 28% for that same time period.

Brendan P. Teehan: Similarly, in the long-term care channel, Carbidopa and Leavidopa are down 12%, and the top 15 LTC brands are down on average 22%, while New Placid has grown 8%. Perhaps the most important of all of these data points is the Carbidopa and Leva Dopa total prescription trends. These are the fundamental PD movement disorder medications, and they have trended down during the pandemic. This decline clearly shows just how challenged the PD market has been over the past two years.

Similarly in the long term care channel carve it open and levodopa or down 12% and the top 15 LTC brands are down on average, 22%, while NUPLAZID has grown 8%.

Perhaps the most important of all of these data points is the carbon delta and leave it though but total prescription trends.

These are the fundamental PD movement disorder medications and they have trended down during the pandemic.

This decline clearly signifies just how challenged the PD market has been over the past two years. However against the backdrop of this environment NUPLAZID has continued to grow in both channels, giving us confidence in our future growth.

Brendan P. Teehan: However, against the backdrop of this environment, New Plazaid has continued to grow in both channels, giving us confidence in our future growth. We've had to adapt, and utilizing novel analytics and thoughtful implementation of our tactics, we have found new opportunities to grow new patient start. Our strong relative performance and continued growth across all channels underscores our commercial execution and gives us confidence that our tactics are working and will continue responding in the months ahead. Furthermore, our team is not simply waiting around for the macro environment to improve.

We've had to adapt and utilizing novel analytics and thoughtful implementation of our tactics have found new opportunities to grow new patient starts.

Our strong relative performance and continued growth across all channels underscores our commercial execution and gives us confidence that our tactics are working and will continue resonating in months ahead.

Furthermore, our team is not simply waiting around for the macro environment to improve we are buckling down and working even harder to ensure that we are interacting with and educating physicians patients and their caregivers on PD psychosis and treatment with NUPLAZID.

Brendan P. Teehan: We are buckling down and working even harder to ensure that we are interacting with and educating physicians, patients, and their caregivers on PD psychosis and treatment with New Plaza. Let's turn to slide 9 to continue the discussion on what we are doing to further grow the brand. To continue to drive brand choice and growth in the second half of the year, we have introduced two new important campaigns.

Let's turn to slide nine to continue the discussion on what we are doing to further grow the brand.

To continue to drive brand choice and growth in the second half of the year. We have introduced two new important campaigns, one focused principally on the health care provider or HCP audience and the other focused on engaging patients and caregivers.

Brendan P. Teehan: One focused principally on the healthcare provider or HCP audience, and the other focused on engaging patients and caregivers. On this slide, I'd like to discuss our new HCP-focused messaging platform that educates the treating community on the unique safety profile of New Plaza, specifically as it relates to Parkinson's. Our campaign is amplified across all promotional channels, including our field teams, and is responding well with H&F. This messaging incorporates market research insights focused on HCP's treatment goals for Parkinson's patients experiencing psychosis and specifically on Neuplazid's safety and tolerability profile in light of other important medical considerations. The most notable being the desire to avoid impacting motor function.

On this slide I'd like to discuss our new HCP focused messaging platform that educate the treating community on the unique safety profile of NUPLAZID, specifically as it relates to the Parkinson's community.

Our campaign is amplified across all promotional channels, including our field teams and is resonating well with hcp's.

This messaging incorporates market research insights focused on hcp's treatment goals for Parkinson's patients experiencing psychosis, and specifically on NUPLAZID safety and Tolerability profile in light of other important medical consideration.

Notable being the desire to avoid impacting motor function.

Brendan P. Teehan: Our messaging demonstrates a deep understanding of our clinician's treatment goals by leveraging important clinical data to better educate physicians on Neuplazid's safety and efficacy profile. While early in the rollout of this campaign, this messaging is resonating with physicians, and we see the opportunity to further increase diagnosis and capture a higher percentage of new PDP patients for Neuplazid moving forward. Slide 10 highlights our new direct-to-consumer campaign, which is intended to reach patients and caregivers at home and drive them to their physicians to have conversations about their symptoms of psychosis and treatment with new classes.

Our messaging demonstrates a deep understanding of our clinicians treatment goals by leveraging important clinical data to better educate physicians on NUPLAZID safety and efficacy profile.

While early in the rollout of this campaign. This messaging is resonating with physicians and we see the opportunity to further increase diagnosis and capture a higher percentage of new PDP patients for NUPLAZID moving forward.

Slide 10 highlights our new direct to consumer campaign, which is intended to reach patients and caregivers at home and drive them to their physicians to have conversations about their symptoms of psychosis and treatment with NUPLAZID.

This campaign should help solve one of our biggest COVID-19 related challenges patient staying at home and not seeing their physicians in person and therefore, not adequately discussing their symptoms or new treatment options.

Brendan P. Teehan: This campaign should help solve one of our biggest COVID-related challenges, patients staying at home and not seeing their physicians in person and, therefore, not adequately discussing their symptoms or new treatment options. Our campaign has been on air since mid-October.

Our campaign has been on air since mid October.

It tells an important patient caregiver centered story about the impact of PD psychosis.

Brendan P. Teehan: It tells an important patient and caregiver-centered story about the impact of PD psychosis. The ad introduces new plazid and its potential treatment benefits to both patients and their families. The ad also includes a critical component of disease awareness to help patients understand and recognize the signs and symptoms and prevalence of psychosis in patients living with Parkinson's. With the work our commercial team has been doing executing on the new message platform on the HCP side, this is the perfect time to introduce a new patient-centric campaign, drive new patients to their newly educated doctors, and grow the new Plazid brand.

Ed introduces NUPLAZID and its potential treatment benefits to both patients and their families.

It also includes a critical component of disease awareness to help patients understand and recognize the signs and symptoms and prevalence of psychosis in patients living with Parkinson's disease.

With the work our commercial team has been doing executing on the new message platform on the HCP side. This is the perfect time to introduce a new patient centric campaign drive new patients to their newly educated doctors and grow the NUPLAZID brand.

Of course, while we expect to see traction in the fourth quarter. The full benefit of these complementary campaigns will be mostly realized in next year's growth.

Brendan P. Teehan: Of course, while we expect to see traction in the fourth quarter, the full benefit of these complementary campaigns will be mostly realized in next year's growth. The bottom line is that patients and caregivers are in need of a better treatment option such as New Plaza, and patients and caregivers need to recognize the symptoms of psychosis and its connection to Parkinson's. We are confident our campaigns will accomplish this. I will now turn it over to you.

The bottom line patients and caregivers are in need of a better treatment options, such as NUPLAZID and patients and caregivers need to recognize the symptoms of psychosis and its connection to Parkinson's disease.

We are confident our campaigns, we will accomplish this.

I will now turn it over to Serge.

Thank you Brandon and good afternoon, everyone.

As Steve mentioned, we have had a constructive dialogue with the FDA and are looking forward to our upcoming meeting.

Serge Stankovic: Thank you, Brandon, and good afternoon, everyone. As Steve mentioned, we have had a constructive dialogue with the FDA and are looking forward to our upcoming meeting. While we continue to believe that evaluating PIMAvanserine as a treatment for the broad dementia-related psychosis indication is most appropriate, we understand the FDA's position and are preparing additional analysis to support Pimavanserine as a potential treatment for other dementias. Let's start the discussion on slide 12 with an overview of our Harmony data, specifically looking at the Alzheimer's disease subgroup, which, as Steve mentioned, is the most prevalent form of dementia.

While we continue to believe that evaluating <unk> as a treatment for the broad dementia related psychosis indication is most appropriate we understand the fda's position and are preparing additional analysis to support beam of answering as a potential treatment by diminish a subgroup.

Let's start the discussion on slide 12, with an overview of our harmony data specifically looking at the Alzheimer's disease subgroup, which as Steve mentioned is the most prevalent form of dementia.

Serge Stankovic: On the left side of the slide is an overview of Pimavanser's antipsychotic efficacy observed overall and in the Alzheimer disease subgroup, in the open label portion of the Harmony study, as well as the primary efficacy outcome in the double-blind portion. As we previously noted, Harmony was not power to show statistical significance by dementia subgroup.

On the left side of the slide is an overview of Primo answering antipsychotic efficacy observed overall.

In the Alzheimer disease subgroup in the open label portion of the hard one study as well as the primary efficacy outcome in the double blind portion.

As we previously noted higher money was not powered to show statistical significance by dimensional subgroup.

Serge Stankovic: However, we did prospectively plan exploratory efficacy analysis of the dementia subgroup. In the Alzheimer disease subgroups, we see that Alzheimer's disease subjects who remain on Pimavanserine were about 40% less likely to experience a relapse of psychotic symptoms compared with those on placebo, as shown with a hazard ratio of 0.62. Post hoc analysis of the Pimavanser in 34-migram dose group showed that the dose currently approved for treating PDP patients showed about 50% risk reduction with a

However, we did prospectively planned exploration <unk> analysis of dementia subgroups.

In the Alzheimer disease sub groups, we see that Alzheimer's disease subjects, who remain uncertain, where about 40% less likely to experience a relapse of psychotic symptoms compared with those on placebo.

As shown with hazard ratio of 0.62.

Post hoc analysis of the PMI by answering 34 milligram dose group.

Those currently approved for treating PDP patients showed about 50% risk reduction with a hazard ratio of 0.47.

Serge Stankovic: For context, this magnitude of effect is in line with what has been observed in numerous relapse prevention studies of comparable design for approved drugs in various psychiatric indications such as schizophrenia or depression. In addition, this benefit is further supported by a number of complementary analyses, some examples of which are listed on the right-hand side of this slide.

For context.

This magnitude of effect is in line with what has been observed Innumerous relapse prevention studies of comparable design for approved drugs in barrios psychiatric indications such as schizophrenia or depression.

In addition, this benefit is further supported by a number of complementary analysis.

Some examples of which are listed on the right hand side of this slide.

Serge Stankovic: These analyses consistently show antipsychotic efficacy across different endpoints within the Alzheimer disease subgroup, which clearly support the overall conclusion of the clinically meaningful benefit that Pimavanser demonstrated in the treatment of psychosis in Alzheimer's patients. Furthermore, these additional analyses also demonstrate and confirm Pimavanserine's observed antipsychotic treatment effect across all dementia subgroups, and thus provide further supportive evidence for the benefit of Pimavan Please turn to slide 13.

These analyses consistently show the antipsychotic efficacy across different endpoints within the Alzheimers disease subgroup, which clearly support the overall conclusion of the clinically meaningful benefit.

Understood and demonstrated in the treatment of psychosis and Alzheimers patients.

Furthermore, these additional analyses also demonstrate and confirm the monasteries observed antipsychotic treatment effect across all diminish of subgroups and thus provide further supportive evidence for the benefit of beam of answering in alzheimer disease psychosis.

Please turn to slide 13.

Serge Stankovic: In the upcoming meeting, we will also discuss with the FDA our positive O-19 study, a randomized placebo-controlled study of Pima Vancerin for the treatment of symptoms of psychosis in Alzheimer's disease patients. The primary efficacy outcome was positive, with a p-value equal to 0.045. In a pre-specified analysis of Alzheimer disease subjects with more severe psychotic symptoms, the magnitude of efficacy more than doubled with a P value equal to 0.011. In response to issues raised in the complete response letter, Acadia has conducted multiple sensitivity and responder analyses that support the primary efficacy conclusion.

In the upcoming meeting we will also discuss with the FDA. Our positive all 19 study a randomized placebo controlled study of cream of answering for the treatment of symptoms of psychosis and Alzheimers disease patients.

The primary efficacy outcome was positive with P value equal to 0.045.

In a pre specified analysis of Alzheimer's disease subjects with more severe psychotic symptoms the magnitude of efficacy more than doubled with a P value equal to 0.011.

In response to issues raised in the complete response letter Acadia has conducted multiple sensitivity in a responder analysis that support the primary efficacy conclusion.

Serge Stankovic: Note that the responder analysis shown on the right of the slide also demonstrated that Pimavanser had even greater efficacy in those patients with a higher severity of psychosis. To recap, Pima Vassarin has been evaluated in ADP patients across two independent clinical studies, and in addition to positive and clinically meaningful efficacy, has been well tolerated, and, importantly, has not shown a negative impact on cognition or motor function In our next meeting with the FDA, we will share several analyses and a substantial data set demonstrating the potential utility of Pimavanserin in the treatment of ADP in order to further examine the potential for resubmission without conducting additional clinical studies. Now, I would like to discuss our Pivotal Phase 3 study evaluating Drophenetide as a potential treatment for rat syndrome on slide 14.

Note that the responder analysis shown on the right of the slide also demonstrates that would be my answer and have even greater efficacy in those patients with the higher severity of psychosis.

To recap.

<unk> has been evaluated in ADP patients across two independent clinical studies and in addition to positive and clinically meaningful efficacy has been well tolerated and importantly has not shown negative impact on cognition or motor function.

In our next meeting with the FDA, we will share several analyses and a substantial data set demonstrating the potential utility of <unk> answer in the treatment of ADP in order to further examine the potential for a resubmission without conducting additional clinical.

Studies.

Now I would like to discuss our pivotal phase III study evaluating phenotype as a potential treatment for <unk> syndrome on slide 14.

Serge Stankovic: Lavender is a randomized, double-blind placebo control study in approximately 180 young females, age 5 to 20, with red syndrome. Patients are evaluated for 12 weeks. The co-primary endpoints are the Red Syndrome Behavioral Questionaire, or RSBQ, a caregiver assessment tool, and the clinical global impression of improvement, or CGIII, which is a physician assessment. We are currently on track to announce top-line results by year N. And importantly, we have agreement with the FDA that positive results from Lavender, in addition to supportive efficacy data from the previous Phase II study and the safety database we are collecting, could be sufficient to support a new drug application.

11, there is a randomized double blind placebo controlled study in approximately 180 young females age five to 20 with Ret syndrome.

Patients are evaluated for 12 weeks.

The co primary endpoints are ret syndrome, behavioural questionnaire or RSP Q, a caregiver assessment tool.

And the clinical global impression of improvement or CGI, I, which is a physician assessment.

We are currently on track to announce top line results by year end.

And importantly, we have agreement with the FDA that positive results from lobbing. There. In addition to supportive efficacy data from the previous phase two study and the safety database, we are collecting could be sufficient to support a new drug application.

Serge Stankovic: Finally, let me remind you that there is nothing approved for the treatment of RAD syndrome. RAD is a devastating and burdensome disease for both the patients and their caregivers, often requiring around-the-clock support. We have had several discussions with key opinion leaders and experts in the field.

Finally, let me remind you that there is nothing approved for the treatment of <unk> syndrome.

It is a devastating and burdensome disease for both the patients and their caregivers often requiring a round the clock support.

We have had several discussions with our key opinion leaders and experts in the field Dane.

Serge Stankovic: They inform us that even a modest improvement in symptoms could make a significant and very meaningful difference in the ability to care for patients and for their overall health. We look forward to announcing the results of this study in the near future. Slide 15 shows a summary of our Phase 3 program evaluating Pimavansarin for the treatment of the negative symptoms of schizophrenia, which includes two pivotal studies, our positive advance one study and advance two, which we initiated in the third quarter of last year. Please turn to slide 16 for an update on our ACP 044 program. Our ongoing phase two study evaluating ACPO 44 for the treatment of post-operative pain.

They inform us that even a modest improvement of symptoms could make a significant and very meaningful difference in da ability to care for the patients and for their overall functioning.

We look forward to announcing the results of this study in the near future.

Yes.

Slide 15 shows a summary of our phase III program evaluating beam of answering for the treatment of negative symptoms of schizophrenia, which includes talk people what those studies our positive advanced one study and advance to which we initiated in the third quarter over last year.

Please turn to slide 16 for an update on our ACP All 44 program.

Our ongoing phase two study evaluating ACP all 44 for the treatment of post operative.