Q4 2019 Earnings Call

Liz: Good morning, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' fourth quarter and full year 2019 financial results conference call. My name is Liz, and I will be your coordinator for today. At this time, all participants' lines are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. If at any time during the call you require assistance, please press star followed by zero, and a coordinator will be happy to assist you. I would now 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 Acadia Pharmaceuticals fourth quarter and full year 2019 financial results Conference call. My name is lists and all of your coordinator for today.

At this time, all participants' lines are in listen only mode.

We will be facilitating a question answer session towards the end of today's call.

If at any time during the call you require assistance. Please press star followed by zero and a coordinator we'll be happy to assist you.

I would now like to turn the presentation over to Mark Johnson, Vice President Investor Relations at Acadia. Please proceed.

Thank you it.

Mark C. Johnson: Thank you, Liz. Good afternoon, and thank you for joining us on today's call to discuss ACADIA's fourth quarter and full year 2019 financial results. Joining me on the call today from ACADIA are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q4 and full year 2019 financial performance and share our 2020 guidance and priorities. 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, Alaina Riboff, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening up the call for your questions. 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.

Thank you for joining us on today's call Acadias fourth quarter full year 2019 financial results.

Joining me on the call, Dave Mckay or Steve Davis, Our Chief Executive Officer will provide an overview of our Q4 Q4 and full year 2019, underperforming Char 2020 guidance and priorities.

Also joining us today is Michael Yang our Chief commercial officer.

<unk> updates on our commercial initiatives Dr. <unk>, our president will discuss our pipeline progress.

She financial Officer, Bob will then discuss.

Before turning it back to Steve Biomark and opening up the called for your questions. I would also like to point out that where do you think supporting slides are available on the events and presentations section or website.

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 Security Delegation 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.

Before we proceed I would first like to remind you that during our call today, making a number of forward looking statements meeting.

Securities Litigation Reform Act could you, maybe five before looking statements, including goals expectations plans and prospects.

Timing of events for future results based on current information assumptions expectations that are inherently subject to change all the number of risks and uncertainties.

Actual results could differ materially.

Actually another incident.

In our filings.

Stephen R. Davis: There is caution not to place undue reliance on these forward-looking statements, which are made only as of today's date. I will now turn the call over to Mark. Good afternoon, everyone, and thank you for joining us today.

We are cautioned not to place undue reliance on these forward looking statements, which remain only as of today 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: Please turn to slide 5. 2019 was a year of strong growth for ACADIA as we continue to transform the standard of care for patients with Parkinson's disease psychosis. Since launching in 2016, Duplazid, with its breakthrough selective keratonin inverse agonist profile, has been helping patients, caregivers, and families with a very high burden caused by Parkinson's disease psychosis. We continue to drive growth of new plasmids in PVP, and achieved $98.3 million in net sales in the fourth quarter of 2019. A 65% increase over the same period in 2008. Net sales for the full year 2019 were $339.1 million, which represents a 52% increase year-over-year.

Turning to slide five.

2019 was your strong growth, Virginia, as we continued to transform the standard of care for patients with Parkinson's disease psychosis.

Since launching in 2016 implies it with this breakthrough selective serotonin inverse agonist profile has been helping patients caregivers and families with very high burden caused Parkinson's disease psychosis.

We continue to drive growth would be fine.

In PDP.

And achieved $98.3 million and net sales in the fourth quarter 2019.

65% increase over the same period in 2008.

Net sales for the full year to date, and Nike Rthree hundred $39.1 million, which represents a 52% increase year over year.

Stephen R. Davis: This growth was fueled by our commercial and medical initiatives, including the inclusion of Duplazid in the Movement Disorders Society Guidelines, completing our transition to the 34 milligram capsule, and continuing our education efforts to help encourage much-needed and appropriate dialogue between physicians and patients regarding the signs and symptoms of PDP.

This growth was gilbarco commercial and medical initiatives, including the inclusion of new bias it in a little bit its worst society guidelines.

Completing our transition to the 34 milligram capsule.

And continuing education efforts to help encourage much needed and a corporate dialogue between physicians and patients regarding the signs and symptoms of PD.

Stephen R. Davis: 2019 was also a year of strong execution for patients in research and development. We announced positive results from two pivotal studies, one in dementia-related psychosis, or DRP, and one for the negative symptoms of schizophrenia. In addition, in 2019, we advanced our Phase III programs and two other indications. We initiated two new studies for the adjunctive treatment of MDD based on our positive pivotal study from 2018, and we initiated our Phase III program for Terpenatides and RETs. On slide six.

2019 was also a year of strong execution brick each on the research and development.

We announced positive results from two pivotal studies, one in dimension related psychosis, or GRP and one for the negative symptoms of schizophrenia.

In addition in 2000, Nike, we advanced our phase three programs in two other indications.

We needed to do studies for their jumped to treatment of MDD based on our awesome pivotal study from 2018.

And we initiated our phase three program under tight and rent.

On slide six we highlight the breadth and depth of our pipeline.

What you're generating a multiyear contains a pivotal study readout and potential regulatory approvals deposition Acadia are significant and attractive long term growth.

Stephen R. Davis: We highlight the breadth and depth of our pipeline, which is generating a multi-year cadence of typical study readouts and potential regulatory approvals that position ACADIA for significant and attractive long-term growth. In 2020, we are driving toward a potential approval for DRP by year end, and three additional approvals over the next three years. In the 2021-22 timeframe, we could see approvals for adjunctive treatment of MDD. Trufenatak for Rett Syndrome could get approval in 2022. And in 2023, we could see approval for the negative symptoms of schizophrenia, which could be the fourth indication for PIMIVANS.

In 2020, we're driving toward a potential approval in the RP by yearend.

In three additional approvals over the next three years in.

In the 2021 22 timeframe, we can see approvals and jumped three but I've been D.

Tryphena tied for Rett syndrome is getting approval in 2022.

And in 2023, we can see approval for the negative symptoms of schizophrenia.

Which could be the fourth indication for Pimavanserin.

Let's turn now to our strategic focus for 2020, beginning on slide seven.

The momentum we have going into 2020 sets up for a transformational year.

It's transformational on two fronts.

First the investments, we're making for the continued growth in GDP as long as for the potential approval and launch of GRP.

Stephen R. Davis: Let's turn now to our strategic focus for 2020, beginning on slide seven. The momentum we have going into 2020 sets us up for a transformational year that is transformational on two fronts. First, the investments we are making for the continued growth of PDP, as well as for the potential approval and launch of DRP, will transform the new plasmid opportunity in the very near term. And second, in 2020, we'll also be making foundational investments in our future with our late-stage clinical development programs in MDD, Rett syndrome, and negative symptoms of schizophrenia. These investments will continue to further drive our mid- and long-term growth. In 2020, look for us to continue to execute on these three strategic pillars. And as we turn to slide eight, I'll highlight priorities within each of these areas. First, we will drive the continued growth of new plants. Based on our growth in 2019, we are providing New Flags of Net Sales guidance of $440 to $470 million for the full year 2020. At the midpoint of the range, this represents net sales growth of 34% year-over-year.

Well transformed the new placid opportunity in the very near term.

And second in 2020 will also be making foundational investments and our future with our late stage clinical development programs in M.D. Rett syndrome, and negative symptoms of schizophrenia.

These investments will continue to further drive our mid and longer term growth.

2020 look for us to continue to execute on these three strategic pillars.

And as we turn to slide eight Oh, how I've already spoken to each of these periods.

First we will drive the continued growth of new class.

And our growth in 2019, we're providing new buys a net sales guidance of 442 $470 billion for the full year 2020.

At the midpoint of the range. This represents net sales growth of 34% year over year.

Second we plan to meaningfully expand our commercial and medical footprint with the second indication for been of answering events related psychosis.

The market expansion opportunity 10 times larger in PDP today.

Here, we are on track with our regulatory timelines and Michael provide you with more color on our commercial investments as we prepare for potential approval and launch.

Third well also set the stage for potential third indication for Pimavanserin as an injunction treatment for major depressive disorder.

The topline results from one of our ongoing phase three studies before the end of this year.

For the negative symptoms of schizophrenia, where we've recently announced positive results from our advanced study in this very difficult to treat patient population.

Well the initiating a second pivotal study advanced.

This summer.

Stephen R. Davis: Over to you.

And we'll also continue to invest in our future through focused development and opportunities that shape, our long term growth strategy.

Stephen R. Davis: Second, we plan to meaningfully expand our commercial and medical footprint with a second indication, preventive intervention related psychosis.

I'm incredibly excited about your ahead as we prepare for new indications and progressed the clinical milestones in our pipeline.

Stephen R. Davis: a market expansion opportunity 10 times larger than GDP today. Here, we are on track with our regulatory timelines, and my goal is to provide you with more color on our commercial investments as we prepare for potential approval and launch. Third, we'll also set the stage for our potential third indication for Pimivantarin as an adjunctive treatment for major depressive disorder based on the top-bound results from one of our ongoing Phase III studies before the end of this year. For the negative symptoms of schizophrenia, where we've recently announced positive results from our advanced study in this very difficult-to-treat patient population, we will be initiating a second pivotal study, ADVANCE II, this summer. We will also continue to invest in our future through focused business development and opportunities that shape our long-term growth strategy. I'm incredibly excited about the year ahead as we prepare for new indications and progress to clinical milestones in our pipeline. With that, I will now turn it over to Michael to discuss our commercial performance and highlight some of our recent accomplishments. Thank you, Steve.

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

Thank you Steve.

Please turn to slide 10.

Had a very successful 2019 from a commercial execution standpoint.

Our underlying growth dynamics remain strong we look forward to continuing momentum throughout 2020.

We have plenty of opportunity for continued growth in PDP for our current market share in the high teens, our new patient share continues to exceed our overall market share and additional growth will be driven by the following the initiatives including.

Our ongoing focus to elevate deposit as the standard of care.

Highlighting new and relevant information.

Medical inpatient care giver community.

Increasing awareness of the inclusion of deposited in the M.D. as evidenced based guidelines.

Jerry New long term patient safety data.

Highlighting data on the positive impact of new closet therapy on the caregiver burden scale.

Continued investment in our integrated Asian, caregiver consumer campaigns, which helped drive awareness of deposit and connect the dots between patients caregivers and their physicians with the need to treat.

We also expect to leverage the benefits of the 34 milligram capsule as we continue to observe high compliance and long term adherence rates would be plaza.

The leading indicators such as new patient starts at new prescribers remain strong for new plaza across both.

Michael Yang: Please turn to slide 10. We had a very successful 2019 from a commercial execution standpoint. Our underlying growth dynamics remain strong, and we look forward to continuing this momentum throughout 2020. We have plenty of opportunity for continued growth in PDP from our current market share in the high teams.

Specialty pharmacy, and especially distribution channels.

Dynamics support our 2020 net sales guidance, which reflects approximately 25% volume growth at the midpoint of the range.

Looking ahead, we are excited about being a first and only sta approved therapy for dementia related psychosis and the difference we can make for patients and caregivers on slide 11.

Michael Yang: Our new patient share continues to exceed our overall market share, and additional growth will be driven by the following key initiatives, including: Our ongoing focus to elevate New Ploset as the standard of care by highlighting new and relevant information with the medical and patient caregiver community; and increasing awareness of the inclusion of Duplazid in the MDS evidence-based guidelines. Sharing new long-term patient safety data andhighlighting data on the positive impact of nuclosive therapy on the caregiver burden scale. Continued investment in our integrated patient, caregiver, and consumer campaigns, which helped drive awareness of Nuplazid and connect the dots between patients, caregivers, and their physicians with the need to treat. We also expect to leverage the benefits of the 34 milligram capsule.

As we prepare for eight ERP launch what are the most important aspects. We can focus on now is to educate the medical community on the high burden of disease.

Our HCP website, more then cognition dot com.

Physician better understanding I understand the important aspects of dementia related psychosis.

Dementia related hallucinations, and delusions represent a high burden and significant unmet need.

Psychosis is one of the most common reasons why patients end up in a long term care facility.

The burden on caregivers, who are most often close family members is especially challenging when dealing with a loved one already struggling with dementia with a difficult addition of all those nations and delusions.

Michael Yang: As we continue to observe high compliance and long-term adherence rates with Neplasma, the leading indicators, such as new patient starts and new prescribers, remain strong for new plots across both Specialty Pharmacy and Specialty Distribution Channels. These dynamics support our 2020 Net Sales Guidance, which reflects approximately 25% volume growth at the midpoint of the range.

In Harmony study did that answer and demonstrated clinically significant reductions in a loose nations and delusions and the maintenance to that effect when continued on therapy.

Patients, who continued on therapy, demonstrating almost eight threefold reduction in the risk of relapse other psychosis, when compared to placebo over six months.

Furthermore.

To answer it did not show negative impacts on cognition motor function or sedation.

As we evaluate the ERP market I'd like to discuss some of the keys similarities and differences on slide 12 highlight how it'll be leveraging expanding commercially.

Michael Yang: Looking ahead, we are excited about being the first and only FDA-approved therapy for dementia-related psychosis, and The Difference We Can Make for Patients and Caregivers on Slide 11. As we prepare for a DRP launch, one of the most important aspects we can focus on now is to educate the medical community on the high burden of disease. Our ACP website, morethancognition.com, will help physicians better understand the important aspects of dementia-related psychosis. Dementia-related hallucinations and delusions represent a high burden and significant unmet need. Psychosis is one of the most common reasons why patients end up in a long-term care facility. The burden on caregivers, who are most often close family members, is especially challenging when dealing with a loved one already struggling with dementia and the difficult addition of hallucinations and delusions.

In both PDP and dealer E. There is unfortunately, a high used off label don't mean blocking anti psychotics.

Exacerbate the poor symptoms of disease.

In PDP blocking doesn't mean, it's the last thing you want to do for Parkinsons patients and is associated with a worsening of your motor symptoms.

For GRP the negative impact on cognition is particularly worrisome in patients with dementia.

Importantly, a key difference and significant opportunity into your E is that for physicians treating dimension patients.

Association between cognition and narrow psychiatric symptoms such as the loose nations collisions is dramatically greater than it is for physicians treating PDP are typically more focused on motor symptoms.

And the answer is unique profile when its high selectivity and the robust clinical study results. We observed to date would be a welcome new treatment option for GRP in a market.

Nothing else is a prudent.

Michael Yang: In the Harmony Study, Pena Vansorin demonstrated clinically significant reductions in hallucinations and delusions and the maintenance of that effect when continued on therapy. Furthermore, patients who continued on therapy demonstrated almost a three-fold reduction in the risk of relapse of their psychosis when compared to placebo over six months. Furthermore, Pimivansir did not show a negative impact on cognition, motor function, or sedation. As we evaluate the DRP market, I'd like to discuss some of the key similarities and differences on slide 12 to highlight how it will be leveraging and expanding commercial. In both PDP and DRP, there is, unfortunately, a high use of off-label dopamine-blocking antipsychotics that could exacerbate the In PDP, blocking dopamine is the last thing you want to do for a Parkinson's patient and is associated with a worsening of their motor system.

Our preparations to deliver the DRD opportunity to the market are well underway and the commercial team is excited about transformational year ahead.

That I'd like to turn it over to surged to discuss our R&D pipeline.

Thank you Michael.

I'm very pleased with the R&D progress in 2019, and our ongoing and planned development for Twentytwenty.

Please turn to pipeline chart on slide 14.

Last year, we made significant advancements in R&D pipeline, we initiated a phase three clarity program.

M.D.D. and the phase three lavender study for Rett syndrome, we announced positive results from the people what they'll harmony study, India B and the people tell advanced study for the negative symptoms of schizophrenia.

Starting with them did the program on slide 15.

There remains significant unmet need in depression with millions of patients, having an inadequate response to their sri or S and the right there.

Please turn to slide 16 for a review of our clinical development program.

Michael Yang: For DRP, the negative impact on cognition is particularly worrisome in patients with dementia. Importantly, a key difference and significant opportunity in DRP is that for physicians treating dementia patients, the association between cognition and neuropsychiatric symptoms such as hallucinations and delusions is dramatically greater than it is for physicians treating PDP, particularly more focused on motor symptoms. Tim Abamson's unique profile, with its high selectivity and the robust clinical study results we have observed to date, would be a welcome new treatment option for DRP in a market where nothing else is approved. Our preparations to deliver the DRT opportunity to the market are well underway, and the commercial team is excited about the transformational year ahead. With that said, I'd like to turn it over to Serge to discuss our R&D pipeline.

The first Claritas study evaluated they immediately patients using pimavanserin.

As a John Demeritt, before which we achieved robust efficacy results.

In addition, we observed a broad range or meaningful secondary outcomes.

Due to enthusiasm among investigators the phase three studies have continued to enroll well and we expect to announce topline results from one study by the end of this year with our second study reporting doubts or shortly thereafter.

If we're successful our phase two clarity study combined with at least one of the phase three trials would be the bases over supplemental in D.A. submission.

Turning to negative symptoms of schizophrenia on slide 17.

About 40% to 50% of schizophrenia patients experienced predominant negative symptoms.

These symptoms are prominent residual symptoms often observed with anti psychotic therapy in spite of adequate control of hallucinations and delusions agitation in other so called positive symptoms.

Serge Stankovich: Thank you, Michael. I'm very pleased with the R&D progress in 2019 and our ongoing and planned development for 2020. Please turn to the pipeline chart on slide 14. Last year, we made significant advancements in our R&D pipeline. We initiated the Phase III Clarity Program for MDD and the Phase III Lavender Study for Retsin. We announce positive results from the Pivotal Harmony Study in DRP and the Pivotal Advance Study for the Negative Symptoms of Schizophrenia, starting with the MDD program on slide 15. There remains significant unmet need in depression, with millions of patients having an inadequate response to their SSRI or SNRI therapy.

Unlike positive symptoms the negative symptoms of schizophrenia are characterized by the degradation and loss will be important psychological and functionally deal. It is resulting in blunted effect in the lack of emotions loss of interest cognitive symptoms and ultimately CV or social withdrawal.

In many cases this results in a profound deficits syndrome, where these symptoms become for a dominant clinical presentation very difficult to threed and very challenging for patients and their caregivers.

On slide 18.

Serge Stankovich: Please turn to slide 16 for a review of our Clinical Development Program. The first CLARITY study evaluated MNDD patients using Pimavansirin as adjunctive therapy for which we achieved robust efficacy results. In addition, we observed a broad range of meaningful secondary outcomes. Due to enthusiasm among investigators, the Phase III studies have continued to enroll well, and we expect to announce top-line results from one study by the end of this year, with our second study reporting out shortly thereafter. If we are successful, our Phase 2 clarity study combined with at least one of the Phase 3 trials would be the basis of a supplemental NDA submission.

We reviewed the positive advanced data and our next steps.

As a reminder, yeah. It's been study was a 26 week phase two study evaluating pimavanserin as a treatment for schizophrenia patients with the predominant negative symptoms, while controlling for their positive symptoms on a stable anti psychotic background therapy.

All patients started on 20 milligram dose of Pimavanserin and could die three top to 34 milligrams or down to 10 milligrams. We didn't the first eight weeks.

We're extremely pleased to have observed positive results in the primary endpoint improvement in negative symptoms assessments 16 item scale in this very difficult to treat the population importantly at the 34 milligram dose we saw robust efficacy, we the P value of zero.

Serge Stankovich: Turning to negative symptoms of schizophrenia, on slide 17. About 40-50% of schizophrenia patients experience predominant negative symptoms. These symptoms are prominent residual symptoms often observed with antipsychotic therapy in spite of adequate control of hallucinations, delusions, agitation, and other so-called positive symptoms. Unlike positive symptoms, the negative symptoms of schizophrenia are characterized by the degradation and loss of important psychological and functional abilities, resulting in blunted affect and lack of emotions, loss of interest, cognitive symptoms, and ultimately severe social withdrawal. In many cases, this results in a profound deficit syndrome where these symptoms become the predominant clinical presentation, very difficult to treat, and very challenging for patients and their caregivers.

<unk> 0.0065 as shown in the graph on the right.

The second pivotal study advance to will commence in December of this year utilizing a fixed dose of 34 milligram and it will be conducted exclusively sites outside of the United States.

Rett syndrome is a debilitating disorder with the unmet need highlighted here on slide 19.

There are about 6002 9000 patients in the United States.

As young girls start like we had a normal development and then at about six months to a year begin to experience neurocognitive decline they often lose their independence and Ken experienced the law suit <unk> purposeful EM movement and spoken communication.

Serge Stankovich: We reviewed the positive advance data in our next step. As a reminder, the ADVANCE study was a 26-week Phase 2 study evaluating pimavanserine as a treatment for schizophrenia patients with predominant negative symptoms while controlling for their positive symptoms on a stable antipsychotic background therapy. All patients started on a 20mg dose of Pimavansirin and could titrate up to 34mg or down to 10mg within the first 8 weeks.

We initiated a phase three program, we'd love under in the fall of last year and expect topline results next year.

Slide 21 highlights why Twentytwenty will get transformational year for our team.

We will be submitting a supplemental in D.A. for D. R. P.

Second indication for Pimavanserin this summer.

Before the end of the year, we expect to announce topline results from a phase three M.D. study a potential third indication for Pimavanserin.

Serge Stankovich: We are extremely pleased to have observed positive results in the Primary Endpoint Improvement in Negative Symptoms Assessment, 16-item scale, in this very difficult-to-treat population. Importantly, at the 34 mg dose, we saw robust efficacy with a p-value of 0.0065, as shown in the graph on the right. The second pivotal study, ADVANCE2, will commence in the summer of this year, utilizing a fixed dose of 34mg and will be conducted exclusively in sites outside of the United States. Rett syndrome is a debilitating disorder with the unmet need highlighted here on slide 19. There are about 6,000 to 9,000 patients in the United States. These young girls start life with normal development and then, at about six months to a year, begin to experience neurocognitive decline. They often lose their independence and can experience the loss of purposeful hand movement and spoken communication.

In addition.

We will initiate this summer a second pivotal study for the negative symptoms of schizophrenia.

Potentially pimavanserin ports indication.

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

Thank you Eric there all the [laughter] Blair and full year, that's nice myself and our 2020 finance.

Please turn to slide 23.

The fourth quarter 2019.

$93 million now.

We have approximately 85% compared to $9 million <unk> now in Q4 20 team is driven by 40% buying right no here.

Right that adjustment he forney that 19 was 15.1%.

Yeah. So that's why he's on hand channel inventory increased about it you are Twitter increase Q4, 2019 about new that like <unk> million dollars.

Yes, I am breathlessly, whatever 9% without.

Serge Stankovich: We initiated a Phase III program with Lavender in the fall of last year and expect top-line results next year. Slide 21 highlights why 2020 will be a transformational year for our team. We will be submitting a supplemental NDA for DRP, the second indication for Pimavansirin, this summer. Before the end of the year, we expect to announce top-line results from a Phase 3 MDD study, a potential third indication for Primavanza. In addition, we will initiate this summer a second pivotal study for the negative symptoms of schizophrenia, potentially Pimavansirin's fourth indication. I will now turn the call over to Elena to discuss our financial performance.

Channel inventory.

Hi, sometime in Q4 would've been approximately.

Moving down the P. now that R&D.

[laughter] $7.5 million.

That's a 19 $42 million.

Anthony.

<unk> $99.9 million.

It doesn't 1970 $523 million.

Last year.

Non cash compensation expense during the winter was $19.8 million compared to $20.4 million. The theme here he doesn't need.

Cash used in operations during the winter and $29.7 million compared to $39.1 million teach Anthony.

Alaina Riboff: Thank you, Serge. Today, I'll discuss our fourth quarter and full year 2019 results and our 2020 financial outlook. Please turn to slide 23. In the fourth quarter of 2019, we recorded $98.3 million in net sales, an increase of approximately 65% compared to $59.6 million in net sales in Q4 2018. This was driven by 42% volume growth year-over-year. The growth net adjustment for Q4 2019 was 15.4%. At the end of the fourth quarter, phase-on-hand channel inventory increased relative to the third quarter, and this increased Q4 2019 revenue by approximately $2.5 million. Sequential volume growth in the fourth quarter was 9%.

Please turn to bite anymore.

The full year 2019, there are quite in $339.1 million no doubt an increase of 50% compared to $223.8 million out Anthony just driven by 34% year over year buying.

Right and that adjustment for the full year 2019 with his team we are Stan.

R&D expense increased.

$44 million, she that 19 from 187.99 Kathy.

Increase is primarily it's not clinical study inquiry I think you can you didn't bat and additional pipeline programs and answering it.

Got a teenager [laughter] $325.6 million for 2019 $65.8 million she doesn't eat.

The increase is primarily due to general and administrative [laughter], including charitable contribution right now.

Alaina Riboff: Without this increase in channel inventory, sequential volume growth in Q4 would have been approximately... Moving down the P&L, GAAP R&D expenses increased to $57.5 million in Q4 2019 and $48.2 million in Q4 2018. Staff SG&A expenses increased to $91.9 million in Q4 2019 and $74.3 million in the fourth quarter of last year. Non-cash, stock-based compensation expense during the quarter was $19.8 million compared to $20.4 million for the same period in 2018. Kath, she's in operations during this quarter with $29.7 million compared to $39.1 million for 4Q 2018. Please turn to slide 24.

Non cash stock based compensation expense for 2019 $80.3 million parenting.

$9 as he.

Cash used in operations during the year with $151.1 million compared to $175 million.

I see.

We ended the year with $697.4 million in cash investments on our balance sheet compared to 473.5 million.

When he increase your flat actually [laughter] equity offering with net from $271.5 million and proceeds from employee option exercise. It 91.9 dollars feature to our financial guidance on slide 25.

[laughter] fully or 2020, we expect continued strong growth pretty flat.

So guidance of $440 million to $470 million.

Alaina Riboff: For the full year 2019, we recorded $339.1 million in net sales, an increase of 52% compared to $223.8 million in net sales in 2018. This was driven by 34% year-over-year volume per. Gross net adjustment for the full year 2019 was 15.6 percent. Staff R&D expenses increased to $240.4 million in 2019 from $187.2 million in 2018, primarily due to additional clinical study costs incurred as we continue to invest in additional pipeline programs for Pneumothorax and Intravenous. GAAP FG&A expenses increased to $325.6 million for 2019 from $265.8 million in 2018. The increase was primarily due to increased general and administrative expenses, including charitable contributions and personnel costs. Non-cash stock-based compensation expense for 2019 was $82.3 million compared to $81.6 million for 2018. Cash used in operations during the year was $151.1 million compared to $167.5 million in 2018. We ended the year with $697.4 million in cash and investments on our balance sheet, compared to $473.5 million at year-end in 2018.

Next we have this guidance range. This represents 34% growth rabid year over here and 25% signed but youre right here.

[laughter] westernized adjustment in the range of 17, 18%.

Thank you.

He is projected to be higher then well your 2019 adjustment and the results of the manufacturers obligation.

And on each one.

And he model plenty plenty there are two considerations for the first were first as a reminder, tonight typically highest in the first quarter in the annual we said this on an all manufacturer allocation Medicare part D.

In addition, as I just mentioned the manufacture allegation increasing 25.

As a result, [laughter] I suppose that increased from 15.4% in the fourth quarter two approximately 30% in Q1.

Second we [laughter] million dollar increase in channel inventory any thought the engine for winter. When do you read you start historical average inventory levels in Q1, and then it will impact potential revenue in time.

As a result with a higher gross to net and the reduction of time between Q1, <unk> first quarter net sounds to me down <unk>.

And Michael mentioned with our leading indicators such as mutation all right and you first fiber strom.

Rather than a south resuming a second player and continued throughout the year.

Any sense I for 2020 back at R&D can you be between 270 and $285 million.

Increased compared to 29, you know, we're just not as a result would be asking for pivotal study in 2020.

He's got a teenage maybe between 440 $450 million well here.

Alaina Riboff: This increase reflects our successful equity offering with net proceeds of $271.5 million and proceeds from employee option exercises of $91.6 million. Please turn to our financial guidance on slide 25. For the full year of 2020, we expect continued strong growth for new classes, with net sales guidance of $440 to $470 million. At the midpoint of this guidance range, this represents 34% growth in revenue year-over-year and 25% volume growth year-over-year. We expect growth to net an adjustment in a range of 17 to 18 percent for 2020. We project this to be higher than the full year 2019 adjustment as a result of the manufacturer's obligation for the donor haul increasing in 2020. As we model 2020, there are two considerations for the first quarter.

Increase compared to last year reflect similar level of investment in PDP.

Oh, gosh strategic investments, you're making a pair of for the GRP launch, including Denise eat education, any faster than ever our commercial and medical affairs team.

For 2020, we expect non cash stock based compensation expense he between 90 and $100 million.

The answer to the ending 2020 with strong balance sheet, our cash balance.

To be between 470 500 million dollar yen 20 funny.

That's kind of thought I mean.

And your line now please turn to slide 27.

In closing, we expect 2020 to be another great year for Acadia as we drive continued growth and the net sales of new plans. It in PDP deliver the New York the opportunity to the market or the potential approval around year end.

And develop new and innovative treatments with our ongoing and planned pivotal studies.

Well look forward to keeping you updated on our transformational year ahead, as we drive towards future, where the breadth and depth of our pipeline.

Alaina Riboff: First, as a reminder, growth to net is typically highest in the first quarter due to the annual reset of the zone and all manufacturer obligations for Medicare Part D patients. In addition, as I just mentioned, the manufacturer obligation is increasing in 2020. As a result, we expect substantial growth in net income to increase from 15.4% in the fourth quarter to approximately 30% in Q1. Additionally, we expect the $2.5 million increase in channel inventory we saw at the end of the fourth quarter will be reduced to our historical average inventory levels in Q1, and this will impact sequential revenue and volume. As a result of the higher growth to net and the reduction of channel inventory in Q1, we expect first quarter net sales to be down substantially.

Generating a multiyear paintings.

Study readout soon potential approvals that positions Acadia for long term growth.

As always we appreciate the dedication and hard work of all of our employees, who may 2019, such a success.

You are committed to our 2020 goals and improving the lives of those CNS disorders.

I'll now open up the call for questions operator.

Ladies and gentlemen, if you wish to ask a question. Please press star followed by one on your touched on telephone.

If your question has been answered or you wish to withdraw your question press the pound.

Please limit yourself to one question.

Press Star one to begin.

Standby for your first question.

Your first question comes from Reid Huber <unk> with Cowen Your line is now open.

Yeah can you guys. Thanks for taking my question and congratulations on nice continued growth through 19, and 2020 I want ask about sort of the evolving who shot in the <unk> dark patient in 2020 looking good.

Alaina Riboff: As Michael mentioned, with our leading indicators such as new patient starts and new prescribers strong, we expect growth in NetDell to resume in the second quarter and continue throughout the year. On the expense side, for 2020, we expect GAAP R&D expenses to be between $270 and $285 million. The increase compared to 2019 is a result of advancing four pivotal studies in 2020. We expect GAAP at Q&A to be between $440 and $460 million for the full year. The increase compared to last year reflects a similar level of investment in PDP, as well as strategic investments we are making to prepare for the DRP launch, including disease state education and expansion of our commercial and medical affairs team.

And then it was two years ago that profile changing at all is that a soft is that a result of some of these refinements up that commercial strategy my called that you outlined.

<unk>.

Thanks for the question Michael is one of your question, Yeah, Hi, Ritu. Thanks for the question I think that I would ticket and kind of two parts thinking long term care I don't think the profile that patient has changed and that's as you know because we're getting a more severe and later stage Asian.

I don't know that we have exact statistics, but my impression is that we are starting to get a younger more front functioning patient in the context of Parkinson's in the community that has to say, we still get a world where psychosis occurs in a in the later stages, but golf in Arsene examples anecdotally Oh.

Alaina Riboff: For 2020, we expect non-cash, stock-based compensation expense to be between $90 and $100 million. We anticipate ending 2020 with a strong balance sheet. Our cash balance is expected to be between $470 and $500 million at the end of 2020. And with that, I'll turn the call back over to Steve.

Younger patient in the profile of GDP, Parkinson's and they're more function on apps will have a longer period of time and time period of time on the driving more to come on that later.

Great very quick follow up the I think like Brickyard, what's left to do for what the summer submission.

A surgeon you want a good question, yes, I agree too we have all of the data.

Stephen R. Davis: Thank you, Elena. Please turn to slide 27.

Stephen R. Davis: In closing, we expect 2020 to be another great year for ACADIA as we drive continued growth in net sales of nucleic acid and PDP, deliver the DRP opportunity to the market with a potential approval around year-end, and develop new and innovative treatments with our ongoing and planned federal study. We look forward to keeping you updated on our transformational year ahead as we drive towards a future where the breadth and depth of our pipeline are generating a multi-year cycle of pivotal study readouts and potential approvals that position ACADIA for long-term growth. As always, we appreciate the dedication and hard work of all of our employees who made 2019 such a success and who are committed to our 2020 goals of improving the lives of those with CNS disorders. I'll now open up the call for questions. Operator.

That will cause to do it though or supplement to lay in D.A. The people tell harmonies study results will be the basis of Datsun da submission, which was previously agreed upon at the end of Phase two meeting and in addition, we will have supportive efficacy results from our previous.

Oh short term studies, which provided evidence of acute Africa sort of pimavanserin in Alzheimer's disease, any Parkinson's disease psychosis, where patients.

The patients with dementia.

And finally, we plan to submit our extensive safety data from completed an ongoing studies. So what is left for US is to essentially put that all together he and format.

Required for the supplemental India oldest study reports in summary documents and once we have a agree we'd have D.A. on that to submit.

Operator: Ladies and gentlemen, if you wish to ask a question, please press star followed by one on your touchtone telephone. If your question has been answered, or you wish to withdraw your question, press the pound key. Please limit yourself to one question. Press star 1 to begin. Your first question comes from Ritu Baral on Macallan. Your line is now open.

So I'm quite you've generated all that safety data and safety analysis news for that anymore.

Oh, sorry.

Yes, we generated all the at both efficacy and safety data that we will be some meeting with Doug supplement <unk>.

Ritu Subhalaksmi Baral: Good afternoon, guys. Thanks for taking the time to answer the question. And

Ritu Subhalaksmi Baral: Congratulations on the continued growth through 19 into 2020.

Great. Thanks for taking the question.

Your next question comes from to see them up with Bank of America. Your line is open.

Ritu Subhalaksmi Baral: I wanted to ask about sort of the evolving patient.

Ritu Subhalaksmi Baral: Is the new Stark patient in 2020 looking different than it was two years ago? Is that profile changing at all? And is that a result of some of these refinements of the commercial strategy, Michael, that you outlined?

Hi, Good evening guys. Thanks for taking my questions, maybe a commercial one on dare P. I think in the prepared remarks, he talks about upsizing the a the size of your marketing team.

Ritu Subhalaksmi Baral: Thanks for the question, Ritu. Michael, do you want to take a question?

Its current roughly 200, so lets say roughly 500.

Michael Yang: Yeah, hi Ritu. Thanks for the question. I think that I would take it in kind of two parts.

Have you already commenced on adding those new folks to your marketing team I guess, that's the first part of the question.

Michael Yang: In long-term care, I don't think the profile of that patient has changed, and that's, as you know, because we're getting a more severe and later stage patient. I don't know that we have exact statistics, but my impression is that we are starting to get younger, more functioning patients in the context of Parkinson's in the community. That is to say, where psychosis occurs, it's in the later stages, but we often are seeing examples anecdotally of a younger patient in the profile of PDP of Parkinson's, and they're more functional and perhaps will have a longer period of time on the drug, but more to come on that later.

Then secondly, how much overlap is there based on your market analysis of the doctors, who are treating PDP patients versus those that you're going to be detailing for de RP. Thanks.

Michael you when it becomes a great hey, great question and I, just want to be frame, where we're not hiring or planning to hire those as marketing people what I'm, referring to the 200 commercial roles. They include a variety of rolls or patient services, our field sales team or long term care et cetera, So it's not that not mark.

<unk> in that context, and we are you know appropriately planning for the expansion to be aided in times too.

Ritu Subhalaksmi Baral: Great, very quick follow-up on the SNDA for DRP. What's left to do before the summer?

Serge Stankovich: Uh, Serge, do you want to take that call?

Serge Stankovich: Do you want to take a question? Yes.

The regulatory milestones so at this juncture, Oh, we're well prepared to execute perpetual launch at the end of the year, but for the meant for the most part we are possibly going after say leadership positions. So that they can be prepared to cascade or the variety of different roles that we have to hire so that has.

Serge Stankovich: We have all of the data that will constitute our Supplemental NDA. The Pivotal Harmony Study results will be the basis of the SNDA submission, which was previously agreed upon at the end of the Phase 2 meeting, and in addition, we will have supportive efficacy results from our previous short-term studies, which provided evidence of acute efficacy of Pimavansirine in Alzheimer's disease and in Parkinson's disease psychosis for patients And finally, we plan to submit our extensive safety data from completed and ongoing studies. So, what is left for us is to essentially put that all together in the format required for the supplemental NDA, all the study reports and summary documents, and once we agree with FDA on that, to submit it.

From a hiring perspective, not starting from a PDP the de are being perspective, obviously, the physicians in neurology and psychiatry.

Physician base, we'll have an overlap of detour he will be going into a much broader audience psychiatry.

And Additionally, D. What we're calling dementia care specialists or geriatric easy Pease, who are acting as like suit, especially so we'll be expanding a into an audience. So it's kind of a boat and it's a current footprint or penetration, but also an expansion of our journey.

Ritu Subhalaksmi Baral: So you've generated all the safety data.

Transcripts by Transcription Outsourcing, LLC.: Transcripts by Transcription Outsourcing, LLC.

Okay, and just as a quick follow up as it relates to how we should think about S. DNA throughout the year, if we assume that a good percentage of the increase in S. DNA. This year is going towards prepping for CRP should we assume that it's evenly spread throughout the year or maybe is that more back half.

Ritu Subhalaksmi Baral: Sorry

Serge Stankovich: Yes, we generated all the efficacy and safety data that we will be submitting with that supplemental input.

Ritu Subhalaksmi Baral: Great, thanks for taking the questions.

Tazeen Ahmad: Your next question comes from Tazeen Ahmad with Bank of America. Your line is now open. Hi, good evening, guys.

<unk> for laid out and maybe it up in Atlanta question. Thanks.

Yeah.

Once again certainty. So are you doing well be relatively consistent breath here, but it won't be high net worth water and ramp up I'm a little further.

Tazeen Ahmad: Thanks for taking my questions. Maybe a commercial one on DRP? I think in your prepared remarks, you talked about upsizing the size of your marketing team from its current roughly 200 to, let's say, roughly 500. Have you already begun adding those new folks to your marketing team? I guess that's the first part of the question. And then, secondly, how much overlap is there based on your market analysis of the doctors who are treating PDP patients versus those that you're going to be detailing for DRP? Thanks.

In here.

Okay. Thank you.

Your next question comes from Marc Goodman with SPD Leerink. Your line is now open.

Well they maybe just to continue on what the spending just give us a sense of of when you're thinking about adding the additional reps in into your when should we put that in the <unk> in the year how much of the are we going to have that half the year full year. I'm also can you give a sense of for direct to consumer advertising.

Michael Yang: Great question, and I just want to reframe it. We're not hiring, or planning to hire, those as marketing people when I'm referring to the 200 commercial roles. They include a variety of roles, such as patient services, our field sales team, our long-term care, etc. So it's not marketing in that context.

Will you be spending an equal amount of money in 2020. She didn't 2019, what are the other push pulls I mean, obviously, it's a pretty significant step up we can all figure out you know if you're adding 200 sales reps, we know what that cost. We you know what else is going on and just give us a sense of when the reps are covenants, we understand the run rate for the following here. Thanks.

Michael Yang: And we are appropriately planning for the expansion to be dated in time for the regulatory milestones. So at this juncture, we're well prepared to execute for a potential launch at the end of the year, but for the most part, we are thoughtfully going after, say, leadership positions so that they can be prepared to cascade the variety of different roles that we have to hire. So we'll be expanding into an audience. So it's kind of both a current footprint penetration, but also an expansion of our opportunity.

Sure So few questions in there.

So first with regard to DRTV then for the year a portion of the spend is related to your expansion.

He also means that men and medical affairs advanced disease awareness initiatives. So increased spend just really didn't more broadly to our preparation for here and not the field team a woman with regards to T. He right that is there anything.

Tazeen Ahmad: Okay.

Transcripts provided by Transcription Outsourcing, LLC.: And just as a quick follow-up, as it relates to how we should think about SG&A throughout the year, if we assume that a good percentage of the increase in SG&A this year is going towards prepping for DRP, should we assume that it's evenly spread throughout the year, or maybe is that more back half related, and maybe that's an Elena question?

Pretty flat year over year, you don't typically comment on our E band that overall, even though [laughter] similar year over year.

Hi, Mark I think you also asked about the timing of.

Mark Goodman: Transcripts provided by Transcription Outsourcing, LLC.

I understand as Michael mentioned, that's mostly in the second half as we get closer to launch.

Unknown Attendee: Okay, thank you. Your next question comes from Mark Goodman with SVB Lear Inc. Your line is now open.

Our next question comes from the line of your denominator with Guggenheim. Your line is now open.

Elena: Elena, maybe just to continue on with the spending, just give us a sense of when you're thinking about adding the additional reps in during the year. When should we put that in during the year? How much of the year are we going to have that? Half the year? Full year? Also, can you give us a sense of for direct-to-consumer advertising, will you be spending an equal amount of money in 2020 as you did in 2019? What are the other push-pulls? I mean, obviously, it's a pretty significant step up. We can all figure out, you know, if you're adding 200 sales reps, we know what that costs, you know, but what else is going on? Just give us a sense.

Hey, guys. This is Derek on the line for yacht and I was hoping we could just have a couple about MTD can you just maybe talk a little bit about that confidence study design and maybe once you've done to avoid that professional patient problem.

The U.S. sites and then.

Many changes that you may have done just true enrolling patients actually respond.

Certainly want to take that question, yes, Yeah, let me start first by by saying that where we are doing a or phase to be with total.

Trials two trials for essentially one positive trial a the design of bought trials are identical and they are very similar to the design of stage one of the phase two clarity study which showed.

Transcribed by https://otter.ai: Transcript by Rev.com Page 1 of 11.

Elena: Sure, so a few questions. So first, with regard to DRP spend for the year, a portion of the spend is related to the expansion of the field team, but we're also making investments in medical affairs, as well as disease awareness initiatives. So, the increase in spend is related more broadly to our preparations for DRP and not the field team alone. With regard to PDP, our investments are going to be pretty flat year over year. We don't specifically comment on our PDP spend, but overall, from a PDP investment perspective, we're having similar year over year spend.

Sizable effect size of a of <unk> 0.63 N P value of 0.0003, so we feel quite good about the design of the study is and in this study is we are applying those.

A a variety of quality and compliance measures.

That that we utilized in all of our trials and that's served us very very well.

Elena: And Mark, I think you also asked about the timing. Reps. And as Michael mentioned, that's mostly in the second half as we get closer to it.

Until now in the execution of all while clinical trials.

The most importantly, I would say when you talk about Oh professional patients we are quite careful about applying a independent blinded interviews.

Yatin Suneja: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.

Derek: Hey guys, this is Derek on the line for Yatin. I was hoping we could just have a couple about MDD. Can you just maybe talk a little bit about the confidence of the study design and maybe what you've done to avoid the professional patient problem at US sites and then any changes that you may have done just to enroll patients likely to respond?

Oh, we have to pay a every subject potentially to be enrolled in our trial.

So that there is a in addition to investigators assessment there is an independent assessment on the.

Suitability of the patients in terms of their diagnoses in terms of the sufficiency of duration of a inadequacy dose of the underlying.

Serge Stankovich: Sir, do you want to take that question?

Serge Stankovich: Yes, yeah. Let me start first by saying that we're doing our phase two pivotal trials, two trials for essentially one positive trial. The design of both trials are identical and they are very similar to the design of stage one of the phase two clarity study where we showed sizable effect size of 0.63 and p-value of 0.0003. So we feel quite good about the design of the studies and in these studies we are applying a variety of quality and compliance measures, uh... that uh... that we utilized in all of our trials and that served us very very well uh... until now in the execution of of uh... clinical trials uh... the most importantly i would say when you talk about uh... uh... professional patients we are uh... quite careful about uh... applying uh... independent blinded interviews uh... with every subject potentially to be enrolled in our trial uh...

Since our IPO Ness, and all right. So we are quite careful about making sure that a appropriate patients are enrolled into thrive.

We also from the compliance perspective have a a unique opportunity in the adjunctive trial to actually measure levels.

All of the background Sri on SNL right.

During the screening period, which gives us a quite a good view on the patients compliance with the medication even before they are randomizing. The trial and we are doing that's where a in this trial as well and finally, we monitor very carefully.

Ratings throughout the trials.

You know with Oh opportunity to enter weaned. When there are a you know when we observed a rate or is are not either spending goodness sufficient timing evaluating patients for depression symptoms or and or or there are some conflicting grading seemed a so we are really.

Serge Stankovich: So that, in addition to the investigators' assessment, there is an independent assessment of the suitability of the patients in terms of their diagnosis, and the sufficiency of the duration of inadequacy of the dose of the underlying SSRI or SNRI. So we are quite careful about making sure that the appropriate patients are enrolled. We also, from the compliance perspective, have a unique opportunity in the adjunctive trial to actually measure levels of the background SSRI and SNRI during the screening period, which gives us quite a good view of the patient's compliance with the medication, even before they are randomized in the trial. And we are doing that in this trial as well. And finally, we monitor the ratings very carefully throughout the trials with an opportunity to intervene when we observe that the raters are not either spending sufficient time evaluating patients for their depression symptoms or there are some conflicting ratings. So we are really putting quite a bit of energy into trying to make sure that we have the right patients in the trial, that they are appropriately evaluated, and then continuously in really close contact with our collaborators and research sites.

We are putting quite a bit of energy in trying to make sure that we have a proper patients into the trial did their appropriately evaluating and then continues we have really a close contact with our collaborators and research sites.

That's very helpful. Maybe just quick clarity on that part of that process is also.

I assume it's looking at baselines and the existing therapy and that compliance you're able to kinda tease out patients who are not so severe that their refractory does sort of all new therapies, yeah, we're applying the independent or devaluation, it's called Oh say forever.

Relation where do you assessment is done.

Not only on the proper it appropriate diagnosis, but appropriate severity of depression as well as appropriateness of the treatment background treatment. There on in terms of our day sufficiently long and that a appropriate a therapeutic dose on death medication and still experiencing adequate.

Derek: That's very helpful. Maybe just quick clarification on that. Part of that process is also, I assume, looking at baselines and existing therapy and compliance. You're able to kind of tease out patients who are not so severe that they're refractoried as sort of all new therapies.

Films and as I said unique feature is that we also measure plasma levels of those background medications and of course, the people that are not comply and within medication to not they can get our north randomized into the trial.

Serge Stankovich: Yeah, we are applying the independent evaluation; it's called a SAFER evaluation where the assessment is done not only on the appropriate diagnosis but the appropriate severity of depression as well as the appropriateness of the treatment, background treatment they are on in terms of whether they have been on it for sufficiently long and at an appropriate therapeutic dose on that medication and still. And, as I said, a unique feature is that we also measure plasma levels of those background medications. And, of course, the people that are not compliant with that medication and are not taking it are not randomized into the trial.

Okay. That's very helpful. Thank you for taking the questions and congrats on the good quarter and the progress going forward.

Thank you.

[music].

Your next question comes from Cory Kasimov with JP Morgan Your line is open.

Thank you. This is gathering on for Corey Thanks for taking my questions, maybe a one on commercial the commercial metrics.

You mentioned that it's the penetrations in the high teens seems like it's been that for now maybe the last couple of quarters or any color on on moving the needle there and then secondly on it here and any reasons why we should think that compliance rate and a D. P label expert.

Derek: Okay, that's very helpful. Thank you for taking the questions and congrats on a good quarter and the progress going forward.

Corey Kazimoff: Thank you.

Gavin: Your next question comes from Corey Kazimoff with J.P. Morgan. Your line is now open.

And should differ from PDP. Thank you.

Two questions, Mike you want to take both of them sure. So the second question from a compliance perspective with ERP and PDP, we think that will be a very similar dynamics. Obviously, there is a little bit more long term care in the.

Gavin: Thank you, this is Gavin on behalf of Corey. Thanks for taking our questions. Maybe one on commercial, the commercial metrics, you know, you mentioned that it's the penetrations in the high teens, seems like it's been there for, you know, maybe the last couple quarters, any color on moving the needle there? And then secondly, on adherence, any reasons why we should think that the compliance rate in a DRP label expansion should differ from PDP. Thank you.

Do you pay patient population so they tend to take a little less because of their they're medical condition. So we've got into the whole denominators of the of the patients that we get both from the community and for long term care.

Michael Yang: I have two questions, Michael. Do you want to take both of them?

In regards to PDP market penetration.

Michael Yang: So the second question, from a compliance perspective with DRP and PDP, we think that will be a very similar dynamic. Obviously, there is a little bit more long-term care in the DRP patient population, so they tend to take a little less because of their medical conditions. So we'll weave that into the whole denominator of the patients that we get both from the community and for long-term care. Regarding the PDP market penetration, you know, as I mentioned before, the thing that we're focused on is winning the dynamic patient population, and in that case, our market share, our numbers are higher than our overall share, so as we continue to drive greater acquisition of both the new and the switch patients, that will then begin It may be just me, but

I mentioned before the thing that we're focused on is winning the dynamic patient population and in that case, our market share or our numbers are higher than our overall share since we continue to drive.

Greater acquisition of both new and a switch patients that will then begin to.

Add to our our total patient penetration.

Maybe just the.

And today I don't think.

It may seem like a couple of quarters, because we mentioned high teens with JP Morgan, but a quarter ago was 19.

We actually have continued to gain share throughout for the last two or three quarters.

Great. Thank you.

Your next question comes from Charles Duncan with Cantor Fitzgerald. Your line is now open.

[noise] like eyesight. Thanks for taking the question and congrats on a good a year in 19 had a quick question, perhaps from Michael If you think about that guidance of a you know call it 25% volume growth.

Michael Yang: And maybe just to add to that, I don't think... It may seem like a couple of quarters because we mentioned high teams at J.P. Morgan, but a quarter ago, it was mid to high team, a quarter ago, it was mid team, so we actually have continued to gain share throughout the last two or three quarters.

I'm wondering if you could identify one key library that would you know make it under lower end versus the upper end to bat and then I have to follow up on a couple of earlier questions regarding the sales footprint that you're talking about going forward just kind of wondering what the increased.

Charles Cliff Duncan: Great, thank you.

Charles Cliff Duncan: Your next question comes from Charles Duncan with Cantor Fitzgerald. Your line is now open.

Michael Yang: Hi guys, thanks for taking the question and congrats on a good year in 19. Had a quick question perhaps for Michael, if you think about the guidance of, you know, call it 25% volume growth, I'm wondering if you could identify one key lever that would, you know, make it on the lower end versus the upper end of that. And then I have to follow up on a couple of earlier questions regarding the sales footprint that you're talking about going forward. I was just kind of wondering what the increased number of field roles would pick up for you. What is the key goal, you know, of that expansion?

Number of field roles will pick up for you. What is what is the key or you know goal of that have that expansion.

Sure. Thanks, Thanks for the question and and be in regards to where we sit on on PDP and you can hear enthusiasm that I have four more data. We are now executing on some somebody some expanded datasets I would call that more evidence based.

Communication, we launched with a lot of awareness and we had a pivotal study, but now showing no long term or long term extension data were well over 300, and well over a year worth of patient exposure on the drug and caregiver burden data. The MBS guidelines all that starts to build a mountain and evidence to I wouldn't say.

Michael Yang: Sure, thanks for the question. And in regards to where we sit on PDP, I think you can hear, you know, the enthusiasm that I have for more data. We are now executing on some expanded data sets. I would call that more evidence-based communication. We launched with a lot of awareness, and we had our pivotal study, but now showing, you know, long-term, our long-term extension data, we're well over 300, well over a year worth of patient exposure on the drug, and we have caregiver burden data, the MDS guidelines. All that starts to build a mountain of evidence for the lagging adopter to try a new closet.

The lagging a doctor or two to try to be positive and I just would remind folks out there that we're competing here with you know historical generic products that are kind of hadn't Mitch will in the doctor's practice, so that takes quite a bit more effort to extract their habits and so I think were.

That that to me would be the bulk of higher or lower.

Volume guidance.

The second question just regards to personal footprint. So the roles that we have today, our multi factorial you become much more sophisticated in our approach to the market meeting the physicians in the customers where they are.

Michael Yang: And, you know, I just would remind folks out there that we're competing here with, you know, historical generic products that are kind of habitual in the doctor's practice. So that takes quite a bit more effort to extract their habits, and so I think that, to me, would be the fulcrum of, you know, higher or lower volume guidance. The second question just regards the commercial footprint. So, the roles that we have today are multifactorial. We've become much more sophisticated in our approach to the market, meeting the physicians and the customers where they are. And so, many of the roles, the bulk of those roles are what I would call traditional blocking and tackling, demand-generating, you know, sales representatives, both in long-term care and in the community.

And so many of the roll the bulk of those roles are what I would call traditional blocking and tackling demand generating no sales representatives. Both in long term care in the community, but we do have a very sophisticated group of people that help with patient pulled through how they work with the opposite is to make sure. They can get on product we have.

A center of excellence team that works with the academic teaching hospitals.

New business development supposed to work into the market not in terms of new products, but in terms of merging a emerging business partnerships in models. So that we can stay you know and at the forefront of how medicine is evolving and so all of those roles, but I just described our wells.

It in onto the expanded what I'd call commercial field roll footprint.

Okay, and if I may Steve I ask one question of surge and that is for a asset that I'm sure you won't get any other questions on bets trofim to tighten the and the Lavender study I'm wondering if you could characterize in your ability to identify those patients and im roll them in this.

Michael Yang: But we do have a very sophisticated group of people that help with patient pull through. They work with the offices to make sure that patients can get on product. We have a center of excellence team that works with academic teaching hospitals. We have new business development folks that work in the market, not in terms of new products but in terms of emerging business partnerships and models so that we can stay, you know, at the forefront of how medicine is evolving. And so, all of those roles that I just described are woven into the expanded, what I would call commercial field role footprint.

Study and if it if it's run long enough. So any of them has actually come off and gone out into the open label expansion and and what is converting their timing you. I think you mentioned data in 2021, but that's you know full 12 months, so any granularity on that would be great.

Charles Cliff Duncan: Okay, and if I may, Steve, ask Serge one question about Serge, and that is for Asset, which I'm sure you won't get any other questions on, that is, Trophinatide and the Lavender Study. I'm wondering if you could characterize your ability to identify those patients and enroll them in the study, and if it's run long enough so any of them have actually come off and gone on to the Open Label expansion, and what is governing the timing. I think you mentioned data for 2021, but that's, you know, a full 12 months, so any granularity on that would be great.

Thanks for that question Charles <unk>, It's a very important study to us. So sorry, do you want to think that yeah.

Yes, first a you know the important.

Factor in the level of enthusiasm that we're seeing he out there in the Red community for does that is for that for 11. Their study is the fact that the phase two study was conducted in the United States and so that rats community.

Serge Stankovich: Thanks for the question, Charles. It's a very important subject to us. So, sir, do you want to take that question? Yes.

Already has an experience with through phenotype and so even before we started with the study.

Serge Stankovich: Yes, first, you know, the important... A factor in the level of enthusiasm that we are seeing out there in the Rett community for the Lavender study is the fact that the Phase II study was conducted in the United States. And so the Rett community already has experience with drophenotide, and so even before we started with the study, we had from the very beginning a good involvement with both the Rett community as well as key opinion leaders in the area, people that actually were instrumental both in the conduct of the Phase II study as well as in our Phase III Lavender program. And that was extremely helpful.

We have from very beginning have a good involvement with the boat to de Red community as soon as well as a key opinion leaders in the area people death, we actually were instrumental boat in.

The phone docs over the phase two study as well instrumental for our phase three love and their program and and that's was you keep extremely helpful. So interest for the study enthusiasm for this study is very high and we are enrolling exactly.

As planned you know there are there is a.

I.

Serge Stankovich: So the interest in the study, and enthusiasm for the study, is very high, and we are enrolling exactly as planned. You know, there are, there is. We have a definite number of centers of excellence in terms of the treatment of Rett disease. We are involved with all of them. They are participating in our program, and, you know, these are primarily academic centers, so they are doing a really, extremely careful job of enrolling the patients. So studies are going very well, exactly as planned, and to your sub-question, yes, there have been patients that have completed and rolled over into our extension trial, an open-label extension trial. So, you know, we usually don't, you know, we are still at the beginning of the enrollment, and until we have a better sense of the pace and cadence of the enrollment, probably sometimes by mid-year or later in the year, we will be more precisely defining the timeline for the completion of the trial in our NDA submission.

Definitely its number of centers of excellence in terms of the treatment of Red disease. We are in wall, we'd all of them. They are participating in our program.

And a you know deserve a primarily academic centers. So they are Ah you are doing a really extremely.

Capital job being in a enrolling patients so studies going very well exactly as planned and to to your sub question. Yes. There has been a patients that have completed and rolled over into.

Our extension a extension trial open label extension trial.

So are you know we as usually.

We don't.

You know, we're still at the beginning of the enrollment and until we have Oh, well I've better sense of the pace and cadence of the enrollment.

Probably sometimes by mid year or or later in the year, we will be pretty some more precisely defining or the timeline for the completion of the trial in our and da submission.

Charles Cliff Duncan: Sounds good. Thanks. Thanks, Serge. Progress in the Year.

Sounds good thanks, Thank search congrats on the.

Progress in there.

Yeah.

Unknown Attendee: Your next question comes from Salveen Richter of Goldman Sachs.

Your next question comes from Salveen Richter with Goldman Sachs. Your line is now open.

Andrea: Thanks for taking our questions. This is Andrea on for shelving. Maybe just to follow up on the DTC campaign, just any insights if there's been any new learnings gained from the second one compared to the first, and then

No question, Andrew or something maybe I'll up on the <unk>.

HM if there's any line seems from the second one.

<unk>.

Andrea: And then, if you have a sense here, which channels are being most impacted by this effort? Thank you.

And then weird you had a something out which can also thing.

Okay.

I'm sorry, Andrew could you were a little bit Karma could you repeat the question.

unknown: I'm sorry, Andrew, you were a little bit garbled. Could you repeat the question?

www.academia.ac.uk: www.academia.ac.uk

Sure just a with respect to that to the DTC campaign or any new findings are observation.

unknown: Here, just with respect to the DTC campaign, if there are any new learnings or observations that you've seen in the second line.

I think one compared to the first.

Transcribed by https://otter.ai: Transcribed by https://otter.ai

None of which channels you're seeing the most impact.

Got it okay. Thank you very much I believe on its again, great. So we have though and we continue to learn campaign to campaign I think the first thing I would say is the he need has not subsided in regards to the education and awareness and predominately that's because from a dynamic point of view new Parkinson's.

Michael Yang: Yeah, great. So we have learned, and we continue to learn, from campaign to campaign. I think the first thing I would say is the need has not subsided in regards to education and awareness. And predominantly, that's because, from a dynamic point of view, new Parkinson's patients, when they're diagnosed, are still not necessarily told, as part of their disease spectrum, that there's a 50% chance over the course of their disease that they're going to have hallucinations and delusions.

Patients when they are diagnosed are still not necessarily told as part of their you know disease spectrum that you know, there's a 50% chance over the course of their Z, they're going to get loosen nations and delusions and so consequently, we have to have this campaign and we post the TV campaign to broaden the awareness so that when those.

Michael Yang: And so, consequently, we have to have this campaign, and we pulse the TB campaign to broaden awareness so that when those symptoms do occur, both with the patient and the caregiver, they're appropriately primed to have those appropriate conversations and treatment conversations with their doctor. We support those campaigns on a pulsing strategy with TB. We support those campaigns with digital and other tactics. The learnings that we've The types of programs that we're running, the rhythms of them, and I think we are more efficient in capturing greater value with less money or less. We're more efficient with our capital applications from a media buy perspective, and I think that's some of the things that we continue to look at in our ROI assessment.

Sometimes do occur both with the patient and caregiver their appropriately prime to have those propylene conversations and treating conversations with their doctor. We support those campaigns are not pulsing strategy with TV, we support those campaigns with digital and and other tactics the learnings that we've gotten.

No I think are more in regards to how we posted the mix. The types of programs are running the rhythms of them and I think we are more efficient.

ER and capturing greater value with less money or less or more efficient with our capital allocation from a media buying perspective, and I think that's submitting that were we continue to look at in our ROI assessments.

Michael Yang: Great. And then just, I guess, maybe if you're seeing impacts on any particular channel.

And then just maybe if you're seeing impact and right now.

Yeah.

Oh, you are you referring to say do we see an impact in.

Andrea: Are you referring to, say, do we see an impact on, like, our long-term care channel? Right, right.

Like our long term care channel.

Right right versus yeah, we see impact or I would say the overwhelming impact we see is in our specialty pharmacy, which is basically reflecting the office based environment. We do see an impact in in long term care. When we run the commercials caregivers are seen at their staff has seen it there.

Michael Yang: Yeah, um, no, we see impact. I would say the overwhelming impact we see is in our specialty pharmacy, which is basically reflecting the office-based environment. We do see an impact in long-term care when we run the commercials because caregivers are seeing it there. Staff is seeing it there. Maybe the patients aren't able to articulate it, but it does help us with our initiatives there in long-term care.

Maybe the patients aren't able to articulated but that's helping us with our initiatives there in long term care.

Andrea: Got it. Thanks so much.

Hi, Thanks, so much.

Jason Nicholas Butler: Thanks so much. Your next question comes from Jason Butler with J&P Securities. Your line is now open.

Your next question comes from Jason Butler with JMP Securities. Your line is now open.

Niravan: Hey, thanks for taking the question. Steve, I just wanted to come back to a comment you made in the prepared comments about business development. Can you maybe give us a sense of how you view new business development opportunities as a priority for 2020 versus 2019? And then maybe touch on how you think you could best leverage R&D?

Hi, Thanks for taking my question, Steve just wanted to come back to a comment you made on my prepared comments about our business development can you maybe give us a sense to how you viewed new business development opportunities as a priority for 2020 versus 2019, and then maybe touch on how you think you could be.

Last leverage R&D versus commercial capacity. Thanks.

Stephen R. Davis: [inaudible] Yeah, thanks for the question. I'll just start by reiterating that it is a key component, one of our pillars of our business strategy to grow the company through transactions and business development. You've heard me say before that we started early. We did a survey to determine when companies typically do this, and we started way before most companies. And we did that for a reason. We wanted to be in a position where we could assess more opportunities over a longer period of time to be more strategic and more judicious, and that's what we did. As you know, we completed a deal in 2018 to acquire the North American rights to Trufenetide. And that deal, we said at the time and would say again today, represents kind of an ideal strategic fit, seeing as how it leverages both our development and commercial expertise. So I would simply say we will be doing more transactions. You'll see that coming. It remains a high priority for us, but doing the right deals also remains an equally high priority.

Thanks for the question Jason.

Oh I'll just start by reiterating that you just wanted to key.

Component one of our pillars of our business strategy to grow the company through transactions in through business development.

Hi, you've heard me say before that we.

Started early we did a survey just German when companies typically do this and we started way before well it's confusing we did it for a reason we wanted to in a position where we could assess more opportunities over a longer period of time be more strategic more judicious and that's what we've done.

As you know we completed a deal in 2018 to farther North American Rovs efforts were been inside.

And then deal we.

So to the time and let's say yesterday.

Or just kind of an ideal strategic fit.

Cienas and then it leverages, both our development and commercial expertise. So I was just simply say, we will be doing more transactions, you'll see that upcoming.

Remains a high priority for us, but doing dry deals remains an equally on power.

Jason Nicholas Butler: Okay, great. Thanks for taking the question.

Okay, great. Thanks for taking the question.

Danielle Brill: Your next question comes from Danielle Brill with Piper Sandler. Your line is now open.

Your next question comes from Daniel Brims with Piper Sadler. Your line is now open.

Niravan: Hey everyone, thanks for taking my question. This is Niravan on behalf of Danielle. Just a quick question from me: if you could provide us with just some color on the trends that you saw in 4Q and 2019 in the growth between various channels and how you expect that to sort of evolve going forward.

Everyone. Thanks for taking my question [noise] This and arrive on for Danielle I. Just a quick question for me if you could provide us with just some color on the trends that you saw over Fourq, you and 2019 in the growth between various channels and how you expect that to sort of.

<unk> going forward.

Thanks for the question Michael Yeah, Great. Thanks, Thank you throughout 2019 and and in the fourth quarter.

Michael Yang: Throughout 2019 and in the fourth quarter, both channels, and as I say, specialty pharmacy and specialty distribution channels, continued to grow, and we would anticipate that to be the same throughout 2020.

Channels, and that's just say specialty pharmacy in specialty distribution channels.

Continued to grow and we would anticipate that Ah D. The same throughout 2020.

Niravan: Great, thank you.

Yeah.

Great. Thank you.

Paul Matisse: Our next question comes from the line of Paul Matisse with Stiefel. Your line is now open.

Our next question comes from the line up comedies Stifel. Your line is now open.

Alex: Hey, thanks. This is Alex. I'm on behalf of Paul.

Hey, Thanks. This is Alex on for Paul just a quick question on your upcoming Sn D.A. meeting just wondering if you could sort of give us a sense of what your goals are for the meeting or what you expect to discuss the FDA just generally and if you will provide us with an update once that the card great. Thank you.

Alex: Just a quick question on your upcoming SMDA meeting. Just wondering if you could sort of give us a sense of what your goals are for the meeting, what you expect to discuss with the FDA just generally, and if you'll provide us with an update once that's occurred. Great. Thank you.

Transcribed by https://otter.ai: Transcribed by https://otter.ai

Sure you want to pick them, yes happy too.

Serge Stankovich: Sir, do you want to take this? Yes, I'd be happy to.

So I mentioned earlier.

Serge Stankovich: As I mentioned earlier, we're meeting with FDA primarily to review the content and format of our application. Meaning, you know, we will be discussing with them the totality of the data we're bringing, both efficacy and safety data we're bringing to the SNDA, as well as the different ways of analysis and pooling of the data in order to present it better and enable reviewers to do their review, both on the efficacy and the safety side. So, discussing that content and the format of that data presentation are our main objectives in the discussion with FDA.

Yeah, we're meeting we'd have the a permit early to review the content in form of two of our application meaning.

You know we knew we will be discussing with a D. Totality of the data we are bringing both efficacy and safety data, we're bringing to the S.

San Diego as well as the different ways of analyses and pooling of the data in order to present a.

Bad or any enabled reviewers to to do their review vote on the efficacy and safety side. So discussing then that content and the form at all that data presentation. These are our main objectives into discussion with FDA.

Alex: Great. And do you expect to update us once it's done?

Great and do you expect to update us once that's a occurred.

Oh, I'm, sorry, I think that.

I I guess branches or yeah, we typically don't.

Serge Stankovich: I'll line them up again.

Talk about our interactions with FDA.

Stephen R. Davis: We typically don't talk about our interactions with FDA, and I think provided we continue to stay on track to submit the SNDA in the summer of this year, there's probably not going to be a lot to talk about from this meeting. Again, just to reiterate, our plan is to submit this summer, and having breakthrough therapy designation, we think there's a very high likelihood we'll get priority review and should be looking at a PDUFA date by the end of the year.

And I think provided we continue to stay on track to Oh submitted.

It's an da's in summer of this year with you're probably not maybe a lots to talk about from this meeting or and again just to reiterate our plans to submit this summer.

And every breakthrough therapy designation, we think there's a very high likelihood well get priority review and and ER should be looking at it would do for Dave.

Gregory James Renza: Great, thanks.

Great. Thanks.

Stephen R. Davis: Your next question comes from Gregory Renza with RBC Capital Markets. Your line is now open.

Your next question comes from Gregory rents I with RBC capital markets. Your line is now open.

Gregory James Renza: Hey guys, thanks for taking my question and congratulations on 2019 as well as the path forward. Steve, I may be able to start with a broader question. Generally, when years ago you pointed to, and recently pointed to, just looking at years ago the risk and perhaps unconventionalism of launching several pivotal trials, maybe something unique to the industry at the time and really yielding kind of the growth that it has.

Hi, guys. Thanks for taking my question and congratulations on a 2019 as well as the path forward.

Steve maybe I'll just start with that.

With a broader question certainly when.

Years ago, you pointed to and then recently appointed you're still looking at a years ago, the risk and perhaps on conventionalism of launching several pivotal trials, maybe something unique to to the industry at at the time at the time and and really yielding kind of the growth that that it has and that growth forward I'm I'm. Just curious if if you could perhaps point to where you are now any.

Stephen R. Davis: I'm just curious if you could perhaps point to where you are now, any analogous strategic steps or decisions that you're taking in this new phase of the company that perhaps would be similar to those decisions in the past about launching trials, whether it's in the context of really execution that you have over 2020 or something more broadly.

Analogous strategic steps or decisions that you're taking in this new phase of the company that perhaps would be similar to those decisions in the past about launching troughs, whether it's in the context of really execution that you have over 2020 or something more broadly. Thank you very much.

Stephen R. Davis: Yeah, thanks so much for the question. I'll take a little bit of a running start on it. You know, when we got an approval for nucleic acid in PDP, we immediately turned toward a life cycle management program that we'd commenced about nine months earlier to really explore where we should go with this drug. And we picked indications that we pursued, and we said at the time, you know, this is the kind of investment we'd love to make. We know a lot about this drug. We know the drug-drug interactions. We know the safety profile.

Yeah, Yeah. Thanks, much for the question and I'll take a little bit of running started it.

When we.

Ah gotten approval for a new buyer has been in PDP.

We immediately turn towards a lifecycle management program that we commenced about nine months earlier to really explore where should we go with this trial.

And Ah we picked indications that we pursued and we said at the time. This is kind of investment we bumped Tonight.

We know a lot about this right we know the drug drug interactions. We know the safety profile. One thing we don't really have a full I do sit on yet is the full extent of utility molecule. So fast forwarding today, what we see today as we see in multiple clinical studies.

Stephen R. Davis: One thing we don't really have a full data set on yet is the full extent of utility. So fast forwarding today, what we see in multiple clinical studies is a molecule with very strong pharmacology and a very favorable safety and tolerability profile. What we see on the efficacy side is that in multiple patient populations, we see a robust antipsychotic effect, and we see a robust effect on mood as manifested in depression or in negative symptoms of schizophrenia. So we really filled in a lot of the blanks, and throughout all of this, which doesn't always happen, we've continued to see a very consistent clinical profile. Usually, when you go to more and more patients, broader and broader populations, people when you get on the market, things emerge, and what we've seen is this very consistent profile.

Molecule was a very strong pharmacology and a very favorable.

Safety Tolerability profile and what we've done the former on the efficacy side, because we see in multiple patient populations robust anti psychotic effect.

And we see a robust effect on mood is as manifestation depression or negative symptoms of schizophrenia. So we've really filled in a lot of the bikes and throughout all of his this doesn't always happen.

We've continued to see a very consistent clinical profile, usually when you go to more and more patients brought about a population even when you get on the market things emerging what we've seen this is very consistent profile. So as a consequence of all of that what we have today is a molecule that has a very different profiles in Peru.

Stephen R. Davis: So as a consequence of all of that, what we have today is a molecule that has a very different profile than previous generation antipsychotics that work primarily by blocking dopamine. So as we look forward to where we stand today, we now see these opportunities ripening, and what we need to deliver on is the same kind of execution that we've had in R&D on the commercial front, to deliver on these opportunities. You know, look, I know we all look at these things through other people's eyes. I can't tell you how excited we are to do that. We've got very high confidence that this is going to be an extremely important drug. It is a game-changing drug, and I think when we all look back and look back at the history books in a decade or two, we'll all agree that this was a real turning point from a medical perspective in terms of opportunities for these patients.

Your next generation and that's I talked to them that work primarily about walking don't me.

So as we look forward to where we stand today, we now see these opportunities ripening and what we need to deliver on is the same kind of execution. We've had an R&D on the commercial front end to deliver these opportunities.

You know look I know we all are these things are both sides I can't tell you how excited we ought to do that we've got very high confidence that this is going to be an extremely important drug.

It is a game changing drug and I think when we'll look back and look back of history books in a decade or too well all agree that this was a real turning point from a medical perspective in terms of opportunities for these patients.

Gregory James Renza: That's great. Thank you very much, and congratulations again. Thank you very much.

That's great. Thank you very much and congratulations again.

Thank you and <unk>.

Jay Olson: Your next question comes from Jay Olson with Oppenheimer. Your line is now open.

Your next question comes from Jay Olson with Oppenheimer. Your line is now open.

Jay Olson: Oh, hey, congratulations on all the progress, and thank you for taking my questions. I wanted to follow up on the SNDA for DRP, and I think you mentioned PDUFA by the end of the year, so I apologize if I missed this, but I was wondering if we should expect a priority review, and then also if you think there will be an advisory committee meeting. And then, separately, with regard to MDD, I was wondering if maybe you could just talk about where Pima-Vancouver might fit into the evolving landscape of both existing and new MDD treatments currently in development. Thank you.

Oh, Hey, congrats on all the progress and thank you for taking my questions I wanted to follow up on the Sndk for de RP and I think you mentioned that produced by the end of the year. So I apologize if I missed this but I was wondering if we should expect a priority review and then also if you think there'll be an advisory Committee meeting and then.

Separately with regards to MDD I was wondering if maybe you could just talk about where pimavanserin might fit into the evolving landscape of both existing and new MDD treatments currently in development. Thank you.

[noise] certain you want to take the first question.

Oh, I'm, sorry, I missed a I didn't quite key or can you repeat it was.

Serge Stankovich: Sir, do you want to take the first question?

Yeah, I thought I heard you mentioned that there could be a producer for the S.N.D.A. for de RP by the end of the here and I was wondering if we should expect a priority review and whether or not your it's probably advisory Committee, yes, a you know a historically a all of the drugs with.

Serge Stankovich: I'm sorry, I missed it, I didn't quite hear it, can you repeat it?

Jay Olson: Yeah, I thought I heard you mention that there could be a PDUFA for the SNDA for DRP by the end of the year, and I was wondering if we should expect a priority review and whether or not you're expecting an advisory committee.

Serge Stankovich: Yes, you know, historically, all of the drugs with the breakthrough designation or, to our knowledge, almost all of the drugs have received a priority review once the NDA is filed. So we do expect, considering that Pimavansirin has a breakthrough therapy designation for dementia-related psychosis, we will be receiving a priority review as well. Having said that, obviously, FDA will inform us about that and make that decision once we file. So we fully expect that that will happen, but we will confirm once after we file.

Breakthrough designation Oh or to the.

Almost all of the drugs to our knowledge have received a priority review was a India is filed so we do expect a considering that the pimavanserin has a a breakthrough therapy designation for dementia related say goes is that we will.

Be receiving the priority review as well.

Having said that obviously F.D.A. will inform us about that didn't make that decision. Once we filed so or you know we fully expect that that will happen, but we'll confirm ones. After we file.

Jay Olson: Okay, great. And do you expect an advisory committee meeting?

Okay, Great and do you expect in Advisory Committee meeting.

Because this there is nothing approved for dementia related say closes.

Serge Stankovich: Because there is nothing approved for dementia-related psychosis, we think there is a high likelihood that we will have an advisory committee. Again, the FDA will let us know about that during the review process, so again, we cannot say for sure, but we are preparing and expecting that there will be an advisory committee.

We think that is a high likelihood that we will have advisory committee again.

You know the F.D.A. will let us know about that enduring review process. So we again, we cannot say for sure, but we are preparing and expecting that there will be advisory committee.

Okay, great and.

Jay Olson: Okay, great.

Stephen R. Davis: I think your other question related to where does Simvansurn potentially fit in the MDD landscape. Yeah, let me take a look at that.

I think your other question related to where does that answer and potentially that indeed in d. landscape.

Let me take a look let me let me take that.

Stephen R. Davis: I think Today, there are 17 million patients in the United States that have depression, and a majority of them do not respond adequately to standard SSRI or SNRI therapy. It is a consequence that a majority of the not adequately responding 2.4 million patients take adjunctive therapy on top of those baseline therapies, and of those patients. The adjunctive therapies that are approved today are the same dopaminergic antipsychotics that are also approved for adjunctive depression that we see used in schizophrenia, bipolar disorder, etc. As a result, those treatments and the side effect profile that those drugs have present, we think, a very ripe opportunity for a different kind of drug. And so, with Pimavansirin, what we've seen so far in the clinical work that we've done is a very robust antidepressant effect.

I think.

Today, either 17 million patients United States that depression.

Majority of them do not respond adequately to standard SSR Iris and alright therapy.

And as a consequence of a majority do not adequately responding 2.4 million patients take adjunctive therapy on top of those based left there.

And of those patients the jumped therapies that are approved today are the same dopaminergic antipsychotics that are also for brand jumped a depression that that we see used in schizophrenia and bipolar disorder et cetera. So.

As a as a result, those therapies and the side effect profile. Those drugs have presented we think a very ripe opportunity for a different kind of drug and so within that answer in what we what we've seen so far in the clinical work that we've done.

He is a very robust and that depressive effect.

Stephen R. Davis: We saw a rapid onset of action results within a week. Additionally, we do not see weight gain, which is a significant issue with available therapies today. We do not see sedation. In fact, we saw an increase in daytime wakefulness. We do not see impairment in motor function in those patients. And importantly, where depression patients often have sexual dysfunction which can be exacerbated by the therapies they're on. Not only did we not see an exacerbation of sexual function, but we actually saw an improvement in sexual function. So, our view is that PIMA Advancing, based on the profile we've observed so far in the clinic, is ideally situated to move right to the head of the class of adjunctive therapy. And so we're very excited about getting results from the first of the two pivotal studies that we're running currently by the end of this year, and if one of these studies is positive, that'll serve as the basis, when combined with the one pivotal study, the positive pivotal study we already have, for an SNDA next year.

We saw a rapid onset of action or results within a week.

We do not see weight gain which is a significant issue with available therapies today.

We do not see sedation in fact, we saw a increase in daytime wastefulness.

We do not see impairment on motor function in those patients and importantly.

Where.

Depression patients are many times of sexual dysfunction, which can be exacerbated by their piece there on.

Not only did we don't see and exacerbations central functional interest on improvement in central functions.

So our view is we think thing with answering based upon the profile when certain so far the clinic is ideally situated to right to the head of the class a bed jumped to therapy.

And so we're very excited about getting results Oh, our first of the two pivotal studies that were running currently about later this year or any one of these studies as Bob said that will serve as a basis when combined with the one pivotal study to autobytel, starting already have certain bases for as Cindy.

Jay Olson: Great, thanks so much for taking the question.

Next year.

Great. Thanks, so much taking the questions.

This concludes the Q1 I fashion Mr. Davis. Please proceed to closing remarks.

Operator: This concludes the Q&A session. Mr. Davis, please proceed with your closing remarks.

[noise] right [laughter].

Thank you so much for joining us today.

Its always be appreciation appreciate.

Stephen R. Davis: Thank you.

Stephen R. Davis: Great. Thank you so much for joining us today. As always, we appreciate the hard work of our employees, and we look forward to updating you on our progress next quarter.

The hard work for our employees and we look forward to updating you on our next progress on our progress next quarter.

Thank you for your participation in today's conference call. This concludes the presentation you may now disconnect.

[noise].

Operator: Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.

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