Q1 2020 Earnings Call
Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals first quarter 2020 financial results Conference call.
Sarah: Good morning, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals first quarter 2020 financial results conference call. My name is Sarah, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will facilitate 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 the conference 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.
My name is there and I'll be your coordinator for today.
At this time, all participants are in listen only mode.
We will we facilitated the 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 the conference coordinator won't be happy with this year.
I would now like to turn the presentation over to Mark Johnson, Vice President Investor Relations at Acadia. Please proceed.
Mark C. Johnson: Thank you, Sarah.
Thank you Sarah good afternoon, and thank you for joining up on today's call because it's got the Kenya first quarter 2020 financial results.
Mark C. Johnson: Good afternoon, and thank you for joining us on today's call to discuss ACADIA's first quarter 2020 financial results.
Mark C. Johnson: Joining me on the call today from ACADIA is Steve Davis.
Joining me on the call today from Acadia or Steve Davis, Our Chief Executive Officer, who will provide an overview of our Q1 2020 financial performance and provide a review of our business operations and how we're addressing the ongoing cover 19 and.
Mark C. Johnson: Q1 2020 FINANCIAL PERFORMANCE & BUSINESS OPERATIONS
Mark C. Johnson: and how we are addressing the ongoing COVID-19 pandemic.
Mark C. Johnson: Also joining us today is Michael Yang, our Chief Commercial Officer, who will provide updates on our commercial initiatives, and Dr. Serge Sankovic, our President.
Also joining us today, it's Michael Yang our Chief commercial officer will provide updates on our commercial once initiatives.
Dr Search think of it our president who will discuss our pipeline progress our Chief Financial Officer, Elena Ridloff will then discuss our financial results in more detail before turning it back to see for final remarks, and opening the call up for your question.
Mark C. Johnson: We'll discuss our pipeline progress.
Mark C. Johnson: Our Chief Financial Officer
Mark C. Johnson: Alaina Ridloff. We'll then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call up to 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. Before we proceed, I would first like to remind you that during our call today, we'll be making a number of forward-looking statements.
I would also like to point out that where you think supplement flights, which are available on the events and presentations section of our website.
Before we proceed I'd first like to remind you that during our call today, well be making a number of forward looking statements within the meaning of the private Securities Litigation Reform Act like 95. These forward looking statements included goals expectations plans prospect growth potential timing of events or future results or based on current information assumptions and expectations pattern here.
Mark C. Johnson: www.academia.com These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. I'll now turn the call over to Steve. Thank you, Mark. Good afternoon, everyone.
We 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 yes. You see you are cautioned not to place undue reliance any forward looking statements, which are made only as of today thing I'll now turn the call over to Steve.
Thank you Mark.
Stephen R. Davis: Thank you for joining us today. Please turn to slide 5. Before we review our progress for the quarter, I'd like to take a moment and address the extraordinary circumstances we are all navigating with the COVID-19 pandemic. First, I hope all of you and your families are healthy and very, Second, I want to extend our gratitude to the health care workers on the front lines whose selfless care is helping so many who have been impacted by the virus. And third, I want to thank our employees. I'm grateful for their continued focus on the patients, caregivers, and the families we serve. Please turn to slide 6.
Good afternoon, everyone and thanks for joining us today.
Let's turn to slide ball.
Before we review our progress before I'm Lucky take a moment and address the extraordinary circumstances, where old navigating with the coke not team tendon.
First I hope I told you and your families are healthy right.
Second I want to exceed our gratitude to help your workers on the front lines himself carries helping so many who've been impacted by the borrowers.
And third I want to thank our employees.
I'm grateful for their continued focus on the patients caregivers in the families. We sir.
Please turn to slide six.
Stephen R. Davis: As the COVID-19 pandemic has evolved globally, ACADIA has made it a priority to support patients who rely on our current and developing medicine, protect the health and safety of our employees, and do our part to minimize the spread of the virus. As it relates to our business specifically, we view the challenges caused by the pandemic to be temporal. It does not change the underlying need for our medicine. Unfortunately, hallucinations and delusions associated with Parkinson's disease or dementia do not stop.
As a cope knocking parent Democrats, both locally Acadias major department to support patients who rely on our current developing medicines.
The health and safety, if our employees do our part to minimize spread of the bars.
As it relates to our business specifically.
We view the challenge is caused by the endemic to be temple. It has not changed the underlying data bar medicines.
Unfortunately, hallucinations and delusions associated with Parkinson's disease or dementia do not stop.
Stephen R. Davis: Patients with major depression or the negative symptoms of schizophrenia still suffer, and patients with Rett syndrome and their families still need an effective treatment option. We remain focused on our mission because patients are waiting. And we continue to move forward to deliver on a multi-year cadence of potential product approvals over the next few years. During this time, we've taken numerous proactive steps to adapt our business. All of our office and field-based employees continue to work from home to reduce the potential risk of the virus. We've embraced new ways of working. Let me describe just a few quick examples.
Patients with major depressive, what the negative symptoms of schizophrenia still suffer.
In patients with Rett syndrome, and their families still need an effective treatment option.
We remain focused on our mission because patients are way.
And we continue to report to deliver on a multiyear cadence of potential product approvals over the next few years.
During this time, we've taken numerous blockage steps to adapt our business.
All of our office would feel based employees continue to work from home to reduce the risk of the bars.
Embraced the ways of working.
Let me describe just a few quick examples.
Stephen R. Davis: Although we are not physically in doctors' offices, we quickly moved our promotional and educational materials to portals accessible by healthcare professionals, enabling them and our field employees to be looking at the same document at the same time when we engage virtually. Recognizing the significant shift to telemedicine, we've rapidly moved to support key Continuing Medical Education programs. On a related point, we also quickly expanded the ability for physicians to prescribe new clients using our online tools, an important advantage when they're treating patients virtually. Regarding our supply chain, we continue to maintain an uninterrupted supply of medicine and have more than sufficient inventory. On an important related note, I'd like to remind you that patients never have to travel to an outside pharmacy to fill a new Plazid prescription. We have always delivered new Pfizer directly to patient homes or directly to long-term care pharmacies and facilities.
Although we're not physically doctors' offices, we quickly moved our promotional and educational materials to portals accessible by health care professionals.
Enabling them in our field and poised to be looking at the same document at the same time when we engage virtually.
Recognizing the significant shifted telemedicine weve rapidly move to support key continuing medical education programs.
On a related point, we also quickly expanded the ability for physicians to prescribed replies that using our online tools and important vantage when they're treating patients virtually.
Regarding our supply chain, we continued to maintain an uninterrupted supply medicine at more than sufficient inventory.
On an important related note I'd like to remind you that patients never have to travel to an outside form to fill it implies a prescription.
We have always to liberty bison directly patient homes or directly to long term care pharmacy some facilities.
With respect to our clinical trials, we've made it a property protect the well begin study participants and research partners.
Stephen R. Davis: With respect to our clinical trials, we've made it a priority to protect the well-being of study participants and research partners. Like many others in our industry, we temporarily paused new patient enrollment in our study and have been working with our clinical trial statistics and study investigators to focus our efforts on current participants. We're also working with our sites and CRO partners to begin enrolling new patients as soon as possible. We entered 2020 in a position of strength, and the fundamentals of the company remain strong. As we turn to slide seven, I'd like to highlight the progress across our business during the quarter. We expect 2020 to be a transformational year for ACADIA, and we are focused on our three strategic pillars.
Like many others in our industry, we temporarily costly patient enrollment or studies and had been working with our clinical trial sites and study investigators to focus our efforts on current participants.
We're also working with our sites and zero partners to begin and well do patients as soon as possible.
We entered 2020 to position strengthened the fundamentals of the company remains strong.
As we turn slide seven Oclock hockey progress across our business during the quarter.
We expect 2020 to be a transformational year for Acadia and are focused on our three strategic pillars.
Stephen R. Davis: Drive growth of new classes, deliver on the DRP opportunity, and develop new treatment options for patients. This year, we are investing in the continued growth of PDP, as well as the potential approval and launch of DR, transforming the new class of opportunity in the very near term. We're also advancing our MDD, Red Syndrome, and Negative Symptoms of Schizophrenia development. If successful, we will have three additional approvals over the next three years that will drive our mid and long-term growth. We take a closer look at the plastic performance in Q1 as we turn to slide 8.
Transforming the new parts of the opportunity into very near term.
We're also advancing our MDD rett syndrome, and negative symptoms of schizophrenia development.
If successful we will have three additional approvals over the next three years that will drive our mid and long term growth.
We'll take a closer look at the plastic performance in Q once we turn slide eight.
For the first quarter 2020, why isn't achieved $90.1 billion net sales a 43% year over year increase driven by strong commercial execution.
Well, we quickly pivoted to what we believe this best in class virtual education engagement.
There are some limitations in the current environment that are having a short term impact on the rate of new patient.
Stephen R. Davis: For the first quarter of 2020, New Plymouth achieved $90.1 million in net sales, a 43% year over year increase driven by strong commercial execution. Well, we have quickly shifted to what we believe is best-in-class virtual education and engagement. There are some limitations in the current environment that are having a short-term impact on the rate of new patients. As a result, we are revising our net sales guidance to $420 to $450 million, representing a 28% growth year-over-year at the midpoint of the range.
As a result, we're revising our net sales guidance to $420 million to $450 million, representing a 28% growth year over year at the midpoint of the range.
Importantly, we see continued growth from new parts of this year and we remain confident you're driving the long term market opportunity in PDP.
Michael will provide additional insight into our commercial performance during his remarks.
As we turn to slide nine I'm very pleased to hear that we remain on track to deliver on the GRP opportunity.
Second indication for Pimavanserin.
During the quarter, we met with the FDA find submit our supplemental NDA this summer.
Breakthrough therapy designation, we expect a priority review and a potential approval around here.
Stephen R. Davis: Importantly, we see continued growth in New Plaza this year, and we remain confident in driving the long-term market opportunity in PDP. Michael will provide additional insight into our commercial performance during his remarks. As we turn to slide nine, I'm very pleased to share that we remain on track to deliver on the DRP opportunity, a potential second indication for Pimivan. During the quarter, we met with the FDA and plan to submit our supplemental NDA this summer. With Breakthrough Therapy designation, we expect a priority review and a potential approval around a year from now. You'll hear more from both Michael and Serge about our progress with U.S. Please turn to slide 10.
You'll hear more from both Mark Onesearch enough progress from TRP.
Please turn to slide.
We continue to make important investments in our clinical portfolio, while navigating the near term impact that dependent.
In our jumped to major depressive disorder program, where now prepared to read initiate new patient enrollment in certain sites.
And search will discuss given that both of these identical studies or just over 50% enrol. We're also pursuing a strategy to knock the role any additional patients and instead combined these studies into one study and a positive submitted nexidia you on the basis of this work and our previous positive signal clarity.
One study.
George will discuss further detail says its approach.
In addition, we plan to initiate our advanced to steady for the negative symptoms of schizophrenia in a second half of this year.
You know Rett syndrome program, where we are pursuing the first drug approval for the serious in merger neurological disorder.
The FDA granted rare pediatric disease designation to your friend.
Stephen R. Davis: We continue to make important investments in our clinical portfolio while navigating the near-term impact of the pandemic. For example, in our Adjunctive Major Depressive Disorder Program, we're now prepared to reinitiate new patient enrollment at certain sites. As Serge will discuss, given that both of these identical studies are just over 50% enrolled, we are also pursuing a strategy to not enroll any additional patients and instead combine these studies into one study and, if positive, submit an S&EA on the basis of this work and our previous positive physical clarity one study. Search will discuss further details of this approach.
We plan to re initiate enrollment in the latter Rett syndrome study as soon as possible.
Today, We also announced a new licensing collaboration agreement Vanderbilt University.
It is collaboration we've added a new bus clinic receptor program truck portfolio.
What exactly did we license the in one hand program is a portfolio of early stage clinical candidates that are complimentary to our development pipeline focused on new potential therapies for CNS disorders.
The lead compounds in phase one testing several additional preclinical compounds.
Finally, we continue to focus and invest in our future traditional business development opportunities that shape, our long term growth strategy.
I'll now turn it over to Mike will discuss our commercial performance and hot.
Thank you Steve.
Today I'd like to review, our first quarter performance, which highlights the strength of the fundamentals of our business.
Michael Yang: In addition, we plan to initiate our ADVANCE II study for the negative symptoms of schizophrenia in the second half of this year. In addition, we plan to initiate our Rett Syndrome Program, where we are pursuing the first drug approval for this serious and rare neurological disorder. The FDA granted rare pediatric disease designation to Trofenadol. We plan to re-initiate enrollment in the Lavender Rett Syndrome study as soon as possible. Today, we also announced a new licensing and collaboration agreement with Vanderbilt University. Through this collaboration, we've added a new vascarinic receptor program to our portfolio. What exactly did we license? The M1 PAN program is a portfolio of early stage clinical candidates that are complementary to our development pipeline focused on new potential therapies for CNS disorders. The lead compound is in Phase I testing with several additional preclinical compounds. Finally, we continue to focus on and invest in our future through additional business development opportunities that shape our long-term growth strategy. With that, I will now turn it over to Michael to discuss our commercial performance and highlights.
Gives us confidence in our long term expectations for new Plaza.
Parkinson's disease psychosis.
The strong base of PDP patients continuing on deposit.
And our focus on growth initiatives.
I will enable us to deliver double digit volume growth and 2020.
We're also on track and making good progress with our GRP launch plans.
Please turn to slide 12.
The plot it continues to transform the standard of care for patients with PDP.
First we have a strong base of patients continuing on new Plaza.
In the first quarter, we delivered net sales of $90.1 million driven.
Year over year volume growth of 32%.
Our commitment to programs to support patient access and continued leverage of the 34 milligram Council.
Helped to sustain consistently high monthly bottle fulfillment rates for patients established on therapy.
Second.
We continue to deliver new to brand patients consistent with previous quarters in both the specialty pharmacy and specialty distribution channels.
Reflecting positive customer engagement to our commitment to establish new plaza the standard of care for patients with PDP.
Michael Yang: Thank you, Steve. Today I'd like to review our first quarter performance, which highlights the strength of the fundamentals of our business and gives us confidence in our long-term expectations for new plazas. Parkinson's disease psychosis. A strong base of PDP patients continuing on Neplazid and our focus on growth initiatives will enable us to deliver double-digit volume growth in 2020. We're also on track and making good progress with our DRP launch plan. Please turn to slide 12.
As Steve mentioned earlier, we have quickly pivoted to what we believe is best in class virtual education and engagement.
However, at the end of the corner and into April we have seen reduce patient visits and delayed diagnosis.
According to our recent survey from a few via incursion physician visits remain down significantly.
When compared to the pre cobot time period.
Well neurologists have prior experience with Tele medicine and are leveraging this technology to manage patients at a distance.
Overall visits remains significantly lower.
Then pre pandemic levels.
Importantly, even during this time new positive new patient starts have outpaced the overall market new to brand trends.
Michael Yang: Plosid continues to transform the standard of care for patients with PDP. First, we have a strong base of patients continuing on Neuplaza. In the first quarter, we delivered net sales of $90.1 million, driven by year-over-year volume growth of 32%.
As such our revised 2020 revenue forecast reflects 28% year over year revenue growth at the midpoint of the range.
Let's review our growth initiatives further on slide 13.
Parkinson's disease hallucinations, and delusions are serious narrow psychiatric symptoms they could be very disruptive to the family and patience.
Michael Yang: Our commitment to programs to support patient access and continued leverage of the 34-milligram capsule helped to sustain consistently high monthly bottle fulfillment rates for patients established on therapy. Additionally, we continue to deliver new-to-brand patients consistent with previous quarters in both the specialty pharmacy and specialty distribution channels, reflecting positive customer engagement with our commitment to establish Neuplaza as the standard of care for patients with PDP. As Steve mentioned earlier, we have quickly shifted to what we believe is best-in-class virtual education and engagement.
As health care providers adjust to seeing patients with tele medicine. During the recent crisis PDP remains an important medical condition that needs to be addressed.
To support new patient identification, we've done a number of things to optimize our approach to sales marketing and medical education in a virtual environment. For example, leveraging technology to conduct peer to peer educational programs and product theaters.
Launched our online treatment form that is optimized for the tele medicine paradigm.
This is important.
Because patients can now be diagnosed and prescribing deposit remotely receive samples in the mail and upon reimbursement verification monthly prescriptions will be shipped to the patients home.
Michael Yang: However, at the end of the quarter and into April, we have seen reduced patient visits and delayed diagnosis. According to a recent survey from Acuvia, in-person physician visits remain down significantly when compared to the pre-COVID time period. While neurologists have prior experience with telemedicine and are leveraging this technology to manage patients at a distance, Overall, visits remain significantly lower than pre-pandemic levels. Importantly, even during this time, New Ploset New Patient Starts have outpaced the overall market new-to-brand trend. As such, our revised 2020 revenue forecast reflects 28% year-over-year revenue growth at the midpoint of the range. Let's review our growth initiatives further on slide 13. Parkinson's disease hallucinations and delusions are serious neuropsychiatric symptoms that can be very disruptive to the family and patients.
All of this keeping this vulnerable patient population safely sheltering at home.
And finally, we continue to use digital campaigns to further stimulate patient and caregiver conversations with your physicians about PD.
I was just and new Plaza.
Our commercial plan remains committed to increasing PDP awareness and establishing a positive standard of care.
Importantly, we continue to educate on the inclusion of new closet, and the movement disorder Society guidelines.
New long term patient safety data.
Data on the positive impact on new Plaza therapy on the caregiver burden scale.
Now, let's turn to our second potential indication for Pimavanserin.
Dementia related psychosis on slide 14.
We are excited about the opportunity to expand our label with another first and only F.D.A. improved indication.
I mentioned related psychosis is.
Michael Yang: As healthcare providers adjust to seeing patients with telemedicine during the recent crisis, PDP remains an important medical condition that needs to be addressed. To support new patient identification, we've done a number of things to optimize our approach to sales, marketing, and medical education in a virtual environment. For example, leveraging technology to conduct peer-to-peer educational programs and product theaters, we launched our online treatment form that is optimized for the telemedicine paradigm. This is important because patients can now be diagnosed and prescribed Neuplazid remotely. Receive samples in the mail, and upon reimbursement and verification, monthly prescriptions will be shipped to the patient's home.
He is a significant unmet need.
And bringing in the vans going forward as a treatment option could make a meaningful difference for patients and caregivers.
We continue to advance our readiness plan focused on market research disease awareness and education with the medical community on the high burden of disease.
Most of these efforts have temporarily pivoted to virtual programs for obvious reasons.
A few examples include advisory boards and payer engagements. In addition, we're seeing strong HCP interest and learning more about DMP for example, our disease education website more than cognition dot com as it had over 20000 visitors since launch in late 2019.
And we continue to see growth insight utilization month over month.
Since then plazas launch in 2016, we've built significant awareness for the need to appropriately treat PD psychosis.
Michael Yang: All of this keeps this vulnerable patient population safely sheltering at home. And finally, we continue to use digital campaigns to further stimulate patient and caregiver conversations with their physicians about PD psychosis and Neuplaza. Our commercial plan remains committed to increasing PDP awareness and establishing a positive standard of care. And most importantly, we continue to educate on the inclusion of Nuplazid in the Movement Disorder Society guidelines. New Long-Term Patient Safety Data and Data on the Positive Impact of Neuplaza Therapy on the Caregiver Burden Scale Now, let's turn to our second potential indication for Pimivanserin. Dementia-related psychosis on slide 14.
The D. R. P opportunity is approximately 10 times larger than PDP.
And we have previously outlined our field expansion expectations, but it should be recognized that we already have a significant base of engaged and experienced personnel to leverage.
Much of the additional preparation for the DCP launches scheduled to occur in the second half a 2020, mostly the hiring and training or feel based teams.
We made good progress in laying the groundwork and are well positioned to execute on our launch plans.
With that I'd like to turn it over to surge to discuss our R&D progress beginning on slide 15.
Thank you Michael and good afternoon I.
I would like to take this opportunity to shared with you. The important R&D update that have occurred since we last spoke in February.
Michael Yang: We are excited about the opportunity to expand our label with another first and only FDA-approved indication. Dementia Related Psychosis is a significant unmet need, and bringing PIM Advancement forward as a treatment option could make a meaningful difference for patients and caregivers. We continue to advance our readiness plans focused on market research, disease awareness, and education with the medical community on the high burden of disease. However, most of these efforts have temporarily shifted to virtual programs for obvious reasons. A few examples include advisory boards and payer engagements.
As Steve mentioned, we the ongoing pandemic, we have made it a priority to protect the wellbeing of our study participants and research partners as well as to minimize disruption to our clinical operations.
We have been working with our clinical trial sites and study investigators on their plans to continue appropriate assessment and safety monitoring of ongoing study participants as well as to ensure adequate conditions for future enrollment of new patients in our late stage clinical trial.
I'm pleased to report that our teams have been able to continued to collect data by implementing the remote monitoring and at home assessments.
Michael Yang: In addition, we are seeing strong HCP interest in learning more about DRP. For example, our disease education website, morethancognition.com, has had over 20,000 visitors since its launch in late 2019, and we continue to see growth in site utilization month over month. Since New Plaza's launch in 2016, we have built significant awareness for the need to appropriately treat PD psychosis. The DRP opportunity is approximately 10 times larger than PDP. We have previously outlined our field expansion expectations, but it should be recognized that we already have a significant base of engaged and experienced personnel to leverage. Much of the additional preparation for the DRP launch is scheduled to occur in the second half of 2020, mostly the hiring and training of our field-based teams. We made good progress in laying the groundwork and are well positioned to execute on our launch plan. With that, I'd like to turn it over to Serge to discuss our R&D progress, beginning on slide 15.
However, considering the rapid pandemic spread over the past couple of months, we have temporarily pause new patient enrollment in our clinical studies.
To read initiate enrollment we will use a phased approach, which will be boats study and site specific and reflect local health authorities and regulatory guidance.
Let's now turn to slide 16 for an update on the dealer Pete regulatory pod.
As planned we successfully completed a pre yes in D.A. meeting with FDA and confirmed that the pivotal data from our harmony study together with a confirmatory and supportive results from our Alzheimer disease psychosis phase two study.
And our Parkinson disease psychosis phase three study will all support the submission.
San Diego for Pimavanserin in dimension related say causes. In addition, we discuss the overall safety database and analysis plan.
Our Essen da preparation remains firmly on track.
As previously announced we blend to submit the S and D.A. this summer.
Unknown Attendee: Thank you, Michael, and good afternoon. I would like to take this opportunity to share with you the important R&D updates that have occurred since we last spoke in February. As Steve mentioned, with the ongoing pandemic, we have made it a priority to protect the well-being of our study participants and research partners, as well as to minimize disruption to our clinical operations. We have been working with our clinical trial sites and study investigators on their plans to continue appropriate assessment and safety monitoring of ongoing study participants, as well as to ensure adequate conditions for future enrollment of new patients in our late stage clinical trials. I am pleased to report that our teams have been able to continue to collect data by implementing remote monitoring and at-home assessment. However, considering the rapid spread of the pandemic over the past couple of months, we have temporarily paused new patient enrollment in our clinical studies. To re-initiate enrollment, we will use a phased approach that will be both study and site-specific and reflect local health authorities and regulatory guidance.
We expect a priority review with the potential approval for de RP around year end.
Turning to our major depressive disorder M.D. program on slide 17.
Both our ongoing clarity to and clarity three phase three studies have identical study designs with the same endpoints and analysis plan.
Please turn to slide 18.
Today, both our clarity phase three studies have been rose slightly over 50% of the total patients plan.
The pandemic has created many uncertainties in regards to maintaining appropriate experimental conditions for the execution of clinical trials and the timing go resolved.
As Steve mentioned earlier, we're now pursuing a strategy to move our depression program forward toward the timely and successful completion.
Given our progress with enrollment and the identical design of the two studies, we're pursuing a strategy do not enrolled in the additional patients into clarity to and clarity three and instead to combined these two studies into one study with a pre specified statistical analysis plan.
Unknown Attendee: Let's now turn to slide 16 for an update on the DRP regulatory path. As planned, we successfully completed a pre-SNDA meeting with the FDA and confirmed that the pivotal data from our Harmony study, together with the confirmatory and supportive results from our Alzheimer's disease psychosis phase two study and our Parkinson's disease psychosis phase three study, will all support the submission of an SNDA for pimavenserine in dementia In addition, we discussed the overall safety database and analysis plan. Our SNDA preparation remains firmly on track.
As a result.
Potential topline results of the combined study would be available in the third quarter of this year.
Positive.
Results with our previously announced positive clarity one study could serve as the basis of a supplemental India's submission.
These negative we would initiate another p. what they'll phase three M.D. These study in the second half of this year.
We plan to discuss our proposal with the F.D.A. in a meeting already scheduled for the second quarter.
We look forward to updating you further on our plans for DMD program.
Moving to the negative symptoms of schizophrenia on slide 19.
Unknown Attendee: As previously announced, we plan to submit the SNDA this summer, and we expect a priority review with a potential approval for DRP around year end. Turning to our major depressive disorder or MDD program, on slide 17. Both our ongoing CLARITY-2 and CLARITY-3 Phase III studies have identical study designs with the same endpoints and analysis plan. Please turn to slide 18.
We're continuing to prepare for the second pivotal study advance do which will utilize a fixed dose of 34 milligram and will be conducted exclusively insights outside of the United States.
We plan to initiate the study into second half of this year.
Rett syndrome is a rare and debilitating disorder with the unmet need highlighted here on slide 20.
Unknown Attendee: Today, both our Clarity Phase III studies have enrolled slightly over 50% of the total patients planned. The pandemic has created many uncertainties in regards to maintaining appropriate experimental conditions for the execution of clinical trials and the timing of results. As Steve mentioned earlier, we are now pursuing a strategy to move our depression program forward toward a timely and successful completion. Given our progress with enrollment and the identical design of the two studies, we are pursuing a strategy to not enroll any additional patients in Clarity 2 and Clarity 3 and instead to combine these two studies into one study with a pre-specified statistical analysis plan. As a result...
As I mentioned earlier.
While we are continuing morning during an assessment of ongoing study participants. We're currently initiating plans for gradual return to recruitment enrollment in our phase three lavender study.
At this time, we continue to anticipate the ability to complete and announced topline results next year.
Please turn to slide 21 to review our clinical stage pipeline.
Now includes the M. One Pam program.
We license Wonder bills, and one pain program, which is comprised of a highly selective positive allosteric modulators or pam's well. The M. One subtype of muscarinic I said, they will hauling receptor.
She is an exciting new program for our pipeline, which may represent a novel approach for improving cognitive function and I didn't know psychiatric symptoms in patients suffering from CNS disorders.
Unknown Attendee: Potential top-line results of the combined study would be available in the third quarter of this year. If positive, these results, along with our previously announced Positive Clarity I study, could serve as the basis of a supplemental NDA submission. If negative, we would initiate another Pivotal Phase III MDD study in the second half of this year. We plan to discuss our proposal with the FDA at a meeting already scheduled for the second quarter. We look forward to updating you further on our plans for the MDD program. Moving on to the negative symptoms of schizophrenia on slide 19.
The study of muscarinic modulators has been an area of high interest as there is an evidence of their ability to address cognitive and newer psychiatric symptoms associated with CNS diseases in schizophrenia.
Recent advances in the potential efficacy or was there any cagutis have only increases these interest in the industry.
And one Pam approach may achieve the efficacy recently observed lose muscarinic coghlan is while minimizing the potential side effects.
Unknown Attendee: We are continuing to prepare for the second pivotal study, ADVANCE-2, which will utilize a fixed dose of 34 mg and will be conducted exclusively in sites outside of the United States. We plan to initiate this study in the second half of this year. Rett syndrome is a rare and debilitating disorder with the unmet need highlighted here on slide 20. As I mentioned earlier, while we are continuing monitoring and assessment of ongoing study participants, we are currently initiating plans for a gradual return to recruitment and enrollment in our Phase III Lavender Study. At this time, we continue to anticipate the ability to complete and announce top-line results next.
Consistent with our strategy, we remained focus on developing innovative new treatments and that is reflected in our growing and advancing pipeline vote early and late stage.
With that.
I will now turn the call over to Atlanta to discuss our financial performance.
Thank you search today I'll discuss our first quarter 20, plenty results and our updated 2020 financial outlook. Please turn to slide 23.
In the first quarter 2020, their accorded $90.1 million nets out an increasing approximately 43% compared to $63 million of net sales in Q1 of 2019.
This was driven by approximately 32% volume growth year over year.
Unknown Attendee: Please turn to slide 21 to review our clinical stage pipeline, which now includes the M1 PAM program. We license Vanderbilt's M1-PAM program, which is comprised of highly selective positive allosteric modulators, or PAMs, of the M1 subtype of muscarinic acetylcholine receptor. This is an exciting new program for our pipeline, which may represent a novel approach for improving cognitive function and other neuropsychiatric symptoms in patients suffering from CNS disorders. The study of muscarinic modulators has been an area of high interest as there is evidence of their ability to address cognitive and neuropsychiatric symptoms associated with CNS diseases and schizophrenia. Recent advances in the potential efficacy of muscarinic agonists have only increased this interest in the industry. The M1-PAM approach may achieve the efficacy recently observed with muscarinic agonists while minimizing the potential side effects. Consistent with our strategy, we remain focused on developing innovative new treatments, and that is reflected in our growing and advancing pipeline, both early and late stage. I will now turn the call over to Elena to discuss our financial performance.
The gross cannot adjustment for Q1 2020 with 25.4%.
As a reminder growth Tonight, it's typically highest in the first quarter due to the annual reset the donut hole for Medicare part D piece it.
We couldn't entwined that cannot be ended the first quarter were consistent with year end 2019.
Moving down the piano GAAP R&D expenses increased to $72.6 million in Q1, 2020 from $52.9 million in Q1 29 Pete.
The increase is primarily due to an upfront payment a $10 million Vanderbilt University City I'm on Pant program and increased development costs associated with Tryphena type.
GAAP <unk> expenses increased $102 million for the first quarter from $93.1 million in the first quarter last year.
This is largely due to increased personnel and medical affairs.
Noncash stock based compensation expense during the quarter with $22.3 million compared to $19.9 million from the same period in 2019.
Cash used in operations during the quarter with $49 million compared to 64.2 million for Q1 2019.
Our cash balance at the ended the quarter with $651.4 million.
Tessa Thomas Romero: Thank you, Serge. Today, I'll discuss our first quarter 2020 results and our updated 2020 financial outlook. Please turn to slide 23. In the first quarter of 2020, we recorded $90.1 million in net sales, an increase of approximately 43% compared to $63 million in net sales in Q1 of 2019. This was driven by approximately 32% volume growth year over year. The GrowthConnect adjustment for Q1 2020 was 25.4%. As a reminder, growth to net is typically highest in the first quarter due to the annual reset of the donut holes for Medicare Part D patients. However, weeks of inventory in the channel at the end of the first quarter were consistent with year-end 2019.
Please turn to slide 24 for the full year 2020 mirror advising argue positive revenue guidance to $420 million to $450 million from a previous range of 440 to $479 to incorporate the short term impact cobot 19.
The revised revenue range reflects year over year revenue growth of approximately 20% at the midpoint of the range.
This guidance incorporates a range its scenarios, which reflect our currently anticipated impact its cobot 19 on our business.
Namely at the low end to me the film to delay to return a face to face physician visits resulting in recent mutation initiation trends persisting through the remainder of the year.
At the upper end, we've assumed that we start to see an increase in face to face physician visits and an increased rate of new patient growth starting in the third quarter.
Tessa Thomas Romero: Moving down the P&L, GAP R&D expenses increased to $72.6 million in Q1 2020 from $52.9 million in Q1 2019. The increase is primarily due to an upfront payment of $10 million to Vanderbilt University for the M1 PAM program and increased development costs associated with terfinitides. GAAP SG&A expenses increased to $102 million for the first quarter from $93.1 million in the first quarter of last year. This was largely due to increased personnel and medical affairs costs.
We continue to anticipate overall gross to net discounted 2023 in the range of 17% to 18%.
Forecast gross to net decreasing sequentially from 25.4% in the first quarter, two approximately 13% to 15% and second Claire.
On the expense side for 2020, we expect that R&D to be toward the low end up our previous range, a 270 $285 million.
Yeah, actually DNA to be between $425 million to $445 million from previous range of 440 to $469.
Tessa Thomas Romero: Non-cash stock-based compensation expense during the quarter was $22.3 million, compared to $19.9 million for the same period in 2019. Cash used in operations during the quarter was $49 million, compared to $64.2 million for Q1 2019. Our cash balance at the end of the quarter was $651.4 million. Please turn to slide 24.
It's reduction reflects cost that well be naturally lower you the current virtual engagement environment.
And you can use to reflect the important investments, we're making to prepare for hard ERP launch, including an expansion the field team towards the ended the year.
We continue to anticipate noncash stock based compensation expense.
Between 90 and $100 million 2020.
We will add 2020, as a strong balance sheets and expect our yearend cash balance to be approximately 470 $500 million unchanged from our previous guidance.
With that I'll turn the call back over to Steve.
Tessa Thomas Romero: For the full year 2020, we are revising our new Plaza revenue guidance to $420 to $450 million from a previous range of $440 to $470 million to incorporate the short-term impact of COVID-19. The revised revenue range reflects year-over-year revenue growth of approximately 28% at the midpoint of the range. This guidance incorporates a range of scenarios which reflect our currently anticipated impact of COVID-19 on our business. Namely, at the low end, we've assumed a delayed return of face-to-face physician visits, resulting in recent new patient initiation trends persisting through the remainder of the year. At the upper end, we've assumed that we will start to see an increase in face-to-face physician visits and an increased rate of new patient growth starting in the third quarter.
Thank you Alicia please turn to slide 26.
The Kt is proven the ability to quickly just an excel in the current environment.
An important work ahead of us and are focused on delivering on our commitments to our patients caregivers and positions.
As I stated earlier the challenges caused by the end then we'll pass but the underlying needs of our medicines remain.
I have great confidence in our future as we look forward to delivering on the multiyear cadence a pivotal trial readouts in potential improvements.
Finally, I'd like to acknowledge and again, thank our employees, who simplified true leadership and resiliency during these challenging times.
I'll now open the call up for questions operator.
As a reminder, you have a question at this time, please press star and the number one you touched on telecom.
Tessa Thomas Romero: We continue to anticipate an overall growth-to-net discount in 2020 to be in the range of 17 to 18 percent. We forecast growth-to-net decreasing sequentially from 25.4 percent in the first quarter to approximately 13 to 15 percent in the second quarter. On the expense side, for 2020, we expect GAAP R&D to be towards the low end of our previous range of $270 to $285 million. We expect GAAP SG&A to be between $425 to $445 million from a previous range of $440 to $460 million. This reduction reflects costs that will be naturally lower due to the current virtual engagement environment.
Tessa Thomas Romero: Our guidance continues to reflect the important investments we are making to prepare for our DRP launch, including an expansion of the field team towards the end of the year. We continue to anticipate non-cash stock-based compensation expense to be between $90-$100 million in 2020. We will end 2020 with a strong balance sheet and expect our year-end cash balance to be approximately $470 to $500 million, unchanged from our previous guidance. And with that, I'll turn the call back over to...
Stephen R. Davis: Thank you, Elena. Please turn to slide 26.
Stephen R. Davis: ACADIA has proven the ability to quickly adjust and excel in the current environment. We have important work ahead of us and are focused on delivering on our commitments to our patients, caregivers, and physicians. As I stated earlier, the challenges caused by the pandemic will pass, but the underlying needs of our medicines remain. I have great confidence in our future as we look forward to delivering on a multi-year cadence of pivotal trial readouts and potential approval. Finally, I'd like to acknowledge and again thank our employees who have demonstrated true leadership and resiliency during these challenging times. I will now open up the call to questions. Operator?
Operator: As a reminder, if you have a question at this time, please press star and the number 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from the line of Corey Kastamoff with J.P. Morgan.
Operator: Your line is open. Corey, your line may be on mute. Can you hear us? Can you hear me? Hello?
Operator: We can... Go ahead.
Corey Kastamoff: So I wanted to start by asking about the Clarity Program in MDD, starting
Corey Kastamoff: https://www.academia.com
Corey Kastamoff: If that is the case, are there nuances to combining these that kind of...
Corey Kastamoff: Add incremental risk to the readout in terms of underlying baseline characteristics or anything like that, are you confident in that front? And then the follow-up on this is just whether you – I know you're meeting with the FDA this quarter, but do you have any preliminary feedback from the agency that gives you the confidence to publicly announce this new strategy now? Yeah, thanks, Corey. I'm going to have Serge respond to both questions.
Unknown Attendee: Yeah, Corey. We are obviously combining these two studies into one study. Based on the variability we have observed in each of the studies, in terms of the baseline characteristics and the overall variability, and other differences, we have not seen any indication of an increase or substantial difference between the two clarity studies in that respect. So we feel fairly comfortable with that.
Corey Kastamoff: Okay, and then if the FDA agrees to your proposal this quarter, do you just lock the database at that?
Corey Kastamoff: Transcribed by https://otter.ai
Corey Kastamoff: Please join me in a moment to begin the process of scrubbing and analyzing the data.
Unknown Attendee: Yes, we're basically, as we mentioned, we paused enrollment in the studies. We are seeing the last few patients going through the studies. So following positive FDA interaction toward the end of this month, we will be moving forward, you know, cleaning the database, locking the database, and producing the results.
Fluctuations between which channel grows versus another one we would always anticipate I think these specially distribution channel to be one third of our of our franchise business. Obviously long term care is an important segments for us in one that has a lot of D.R.P. patients already sitting there and we'll be evaluating.
Corey Kastamoff: Okay, great. Appreciate you taking the questions. Thank you. Thanks, Corey.
The go to market principles as it relates to the office setting versus the long term care setting, but we expect we'll be able to operate in both settings going forward.
Operator: Thank you. And our next question comes from the line of Neena Bitritto with Citi. Your line is open.
Neena Marie Bitritto: Hey guys, thanks for taking my question. I just want to ask about the DRP launch. You know, just thinking about whether or not there's going to be kind of a resurgence of COVID-19 kind of around the time that you would be launching and, you know, dementia patients are, of course, going to be in that higher risk bucket. I mean, how are you thinking about that? Are you kind of making plans to assume that this is going to be a virtual launch?
Okay. Thank you.
Thank you in our next question comes in the line every tube overall with calendar year line or something.
Yeah.
If your phone is on <unk>.
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Please specify one once you can't we connected thank you.
Upper let's let's go to the next one questionable several by.
Next question will be from Alan Carr, we need them in company a line or something.
Hi, This is Ah Joey on for Alan Thanks for taking our questions or a few quick ones on new new closet sort of performance can you comment on.
Stephen R. Davis: Yeah, thanks a lot for the question. I'll just start by saying we've done a lot of alternative scenario planning, and I'll let Michael fill you in a little bit more on that.
Overall market share in P.D.P., you know previously you've you've given some metrics around that and how the sort of most recent quarter and looking forward effects that market share it if at all and.
Michael Yang: Thanks for the question. We have very thoughtful online plans to execute the expansion to support the launch that, number one, are tied to key regulatory milestones. As you've already alluded to, the environment is different than just a few months ago, and we're monitoring that environment very carefully. I just want to remind you that this is a significant expansion opportunity for ACADIA and for New Plaza, but we already have a very well-established team. We have ongoing support in our operations model on the ground supporting PDP, so we can leverage that to build upon and support our launch plans. But again, you've outlined it. This is a fluid situation. We'll continue to kind of monitor the situation as things evolve, and we're being prepared for multiple scenarios, and I think we'll be ready to go no matter what the environment.
Also I I, maybe I I Miss this but the quarter over a quarter volume growth could you.
Maybe they'd that and I have a quick question on the deer Pete launch.
Yeah I'm sure. So the sequential volume growth was a minus 1% or essentially flat Michael you want to take the other question.
Sure Yeah.
<unk> I you know I think for a brand like Neapolitan, where we see new to brand isn't it you know an important focus of our efforts were still in the in the growth in penetration phase of the life cycle. As I mentioned are share overall is in the high teams, but we have a higher share.
In the new to brand dynamic market and that's based on a a P.D.D. mark it 130000 patients.
Neena Marie Bitritto: Okay, great. And then in terms of just performance in the first quarter, you talked a little bit about specialty versus generic pharmacy versus specialty distribution channels. Could you just talk about whether you saw any impact in one channel more than the other due to COVID-19? And, in particular, the long-term care setting, and how you expect that to kind of play out moving forward? And as we think about the RP kind of
Okay. Thank you and I just quickly on the on me potential.
<unk> launch you you mentioned hiring a second half of this year, how much of the existing Salesforce would you be able to to leverage towards that thank you.
Right right <unk>.
Sure a and you know when I talked about forest, that's not yours reach in frequency represented is Ah delved includes our patients support and other other capabilities, but in general we've outlined our plans to to go to between 405 hundred and today, we have a round.
Michael Yang: Right, so, yeah, I'll speak. Sure. We anticipate growth in 2020 in both the specialty pharmacy and specialty distribution channel. As we've said in the past and as we saw in the first quarter, often there is quarter-by-quarter variability and fluctuations between which channel grows versus another one. But we would always anticipate, I think, the specialty distribution channel to be one-third of our franchise business. Obviously, long-term care is an important segment for us and one that has a lot of DRP patients. I'm Mark Schneyer, ACADIA Pharmaceuticals Inc., and I'm here to talk about the Go-To-Market Principles for the Office Setting and the Long-Term Care Setting. We expect to be able to operate in both settings going forward. Great, thank you.
180, 200 personnel to leverage.
Oh.
Great. Thanks for taking our questions.
And the next question that's in the line up to Dean Oh, My Bank of America airline Okay.
[noise] Hi, good afternoon in principle, you might question I haven't really guidance can you give us a little bit <unk> made some remarks on your prepared statement, but.
Award me for the area that you think is is not that rather cool just give us about that more color on that is it that it it's near policing.
Hum along for <unk> care facilities or is it <unk>, perhaps in general because at that scene from the strategy about your you know laid out that for continuing p. since it really should not.
Be much of an issue at all okay to stay on John just given all that sounds are just trying to get a better thing.
Oh, where most of you always want to call it is coming from Frank.
Michael you Olympic though.
Sure Yeah. Thanks, Thanks to the question and as it relates to you know the guidance I think the first thing to start with is that you know Parkinson's disease. Psychosis is is a very serious situation and it's quite bothersome in disruption disrupted to the family. So therefore, it elevates into a a neat it elevates on the ladder.
Operator: Thank you. And our next question comes from the line of Ritu Baral with Cowan. Your line is open.
Operator: ACADIA Pharmaceuticals Inc.
Operator: If your phone is on mute, please unmute it.
Need to tree, so without being said that's a good thing. Another good thing is we have a strong base of continued patients that we have continued to demonstrate a high and sustain fulfillment right. So that's also good with the franchise when you expect to grow new to brand patients both in the S.P.N.E.S.D. channel but.
Operator: Ritu, are you on mute?
Operator: Please press Star 1 once you get reconnected. Thank you.
Operator: Operator, let's go to the next question. We'll circle back. The next question.
Operator: Our next question will be from Allen Carr with Needham & Company. Your line is open. Hi, this is Joey on behalf of Alan.
The thing that I was trying to articulate it might prepared remarks is that physicians visits and and a diagnosis is are down in general and so it's really you know that final issue. While we may have a higher share the types of patients that are seeing overall visits her down. So once we're we're doing very well and engaging with.
Allen Carr: Thanks for taking our questions. A few quick ones on New Plazid sort of performance. Can you comment on overall market share and PDP. You know, previously, you've given some metrics around that and how this sort of most recent quarter and looking forward affects that market share, if at all, and Also, maybe I missed this, but the quarter-over-quarter volume growth, could you update that? And I have a quick question on the DRP launch.
Virtual tactics, but that's what is reflected really I think is in the new to brand area because it'd be the marketplace.
So when you want to just Oh for your.
Thoughts on the.
On the overall volume growth that were just putting in our gardens.
Yeah, so the midpoint of our guidance <unk> year over year volume growth and just as or a mind. There. Let me see you know the impact we've seen T.U.R.U.P.S.N. growth rate in that first part of the year.
Michael Yang: Yeah, I'm sure. So the sequential volume growth was minus one percent, or essentially flat. Michael, do you want to take the other question?
You know when you add patients to being in a year. They have the cumulative benefits definitely are so that's why I'm only look at the flea are bad and range.
Michael Yang: Sure, yeah. I think for a brand like NuPlaza and where we sit, NuDaBrand is an important focus of our efforts. We're still in the growth and penetration phase of the life cycle. As I mentioned, our share overall is in the high teens, but we have a higher share in the NuDaBrand dynamic market. And that's based on a PVP market of 130,000 patients.
Me reflected it reflected the change in our new dining.
Okay <unk> can you tell us what what percent of sales are coming currently from long term care.
[laughter], it's about 85%.
Okay.
About 25 minutes from long term care.
25%, Okay [laughter] thinking.
Thank you and the next question I'm from the line of Mark Goodman.
Michael Yang: Okay, thank you. And just quickly on the potential DRP launch, you mentioned hiring in the second half of this year. How much of the existing Salesforce would you be able to leverage towards that?
D Leerink airliners nothing.
Yes, I can you talk about the M. one Pam that you guys licensed in how's the products differentiated versus some of the others and development.
Michael Yang: Right. Well, in the.
Michael Yang: For more information, please visit www.fema.gov Capabilities, but in general, we've outlined our plans to go to between 400 and 500, and today we have around 180 to 200 personnel to leverage.
<unk> said to lead us it is in phase one what indication is that is it schizophrenia or Alzheimer's and then just back on new Placid can you talk about just.
What April has look like so far relative to March relative to February relative to maybe what you were expecting just so we get a sense of of what's happened so far thanks.
Allen Carr: Great, thanks for taking our questions. And our next question comes from a line called Tazeen Ahmad with Bank of America. Your line is open.
Yeah, what will take those one of them, let me offer a couple of thoughts on the.
Pam program personal allowance Michael to respond to certain question.
Tazeen Ahmad: Hi, good afternoon; thanks for taking my questions. As it relates to guidance, can you give us a little bit more detail? I know you've made some remarks in your prepared statements, but for the area that you think is most at risk, can you just give us a little bit more color on that? Is it that it's new patient ads from long-term care facilities, or is it new patient ads perhaps in general, because it does seem from the strategy that you laid out that for continuing patients, it really should not be much of an issue at all to stay on drugs, just given I'm just trying to get a better sense of where most of the exposure to COVID is coming from. Thanks.
So we really like this program I'm sure.
There's a lot of literature, describing the the potential it must bring it modulators. Both would you don't want them, one and m. poor sometimes in <unk>, mostly supportive potential utility and it's a <unk> cognition can dementia.
The challenge in this area has always been how to control the or mitigate the unwanted corner just five bucks. So there's some approach is that better and very country commerce by trying to <unk> when you spend bloxom of side effects.
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Busy signal you posted vandervelde taken in that we are cooperating with them on.
Is by module in one receptors sometime grew a positive alastair modular.
Michael Yang: Michael, do you want to take this?
Michael Yang: Sure, yeah, thanks for the question. And as it relates to, you know, the guidance, I think the first thing to start with is that Parkinson's disease psychosis is a very serious situation, and it's quite bothersome and disruptive to the family. So therefore, it ranks higher on the ladder of need to treat. So with that being said, that's a good thing. Another good thing is that we have a strong base of continuing patients that we have continued to demonstrate a high and sustained fulfillment rate. So that's also good for the franchise.
Everybody is Pam approach is designed to chief of similar level of Africa's.
Potentially without the side effects due to high school.
Exams. So we're very very excited about the approach we want the program a lot and <unk> you are.
Let's get it incorporate a good one.
Michael you Wanna take the other question.
Sure then you know thanks to the question I think that maybe as a chance to brag a little bit I I'm really proud of the commercial team for what they've been able to do quickly pivoting you know in in a time of a crisis.
Whereby we were able to do a lot of things that optimized the commercial approach you know I mentioned, the ability to diagnose tree and and get patients on therapy remotely. We've had product theaters that are very well attended our existing sales force.
Michael Yang: We do expect to grow new patients to brand both in the SP and the SD channel. But the thing that I was trying to articulate in my prepared remarks is that physician visits and diagnoses are down in general. And so it's really a funnel issue. While we may have a higher share of the types of patients that are coming in, overall visits are down. So once we're doing very well and engaging with our virtual tactics, but that's what is really reflected, I think, in the new brand.
Leveraging their relationships have had you know what I would call a a surprisingly good take in their effectiveness to reach customers engaging in meaningful conversations.
And you know obviously the first part of the state sheltered place I think was with you know a a pretty devastating thing for the country in the marketplace in general, but as physicians have come to get their feet under the ground I've been impressed with their response to tell a medicine medicine.
Tessa Thomas Romero: Alaina, you want to just... Alaina, you want to just...
Tessa Thomas Romero: and the overall volume growth that we're anticipating in our guidance.
As I mentioned earlier, the P.D.P. situation is one of serious need and therefore, we we have credible conversations and reasons to engage with with customers. So I think April is is is certainly seen better days then the ladder parts of the of Mar 20 pandemic was first raging and shelter and place was.
Tessa Thomas Romero: Yeah, so the midpoint of our guidance assumes high teen year-over-year volume growth. And just as a reminder, when we see, you know, the impact we've seen to our new patient growth rate in the first part of the year, you know, when you add patients at the beginning of the year, they have a cumulative benefit for the full year. So that's why when we look at the full year guidance range, we've reflected that change in our new guidance. Okay, thanks, Selena.
Kind of a new thing so or employees are really engaged the customers are really responding and you know I think qualitatively I would say that we've reached a a pretty good space to operate from in April.
And I was just confirm I'll just.
<unk> I'll, just echo Michael's comments I think.
Tazeen Ahmad: And can you tell us what percent of sales is coming currently from long term care? 25%? I'm sorry.
I I think I've been very very please some problem with the work that whose team is done in very quickly adapting to this very unusual and very different environment.
Michael Yang: About 25% is from long-term care. 25%. Okay, perfect. Thank you. Thank you. And our next question comes from the line of Mark Goodman with SVB Lee Rank. Your line is open.
What we've seen is is Michael mention while in person visits are down as you can see from our guidance in from the results of we've we published.
Mark Goodman: Yes, hi. Can you talk about the M1-PAM that you guys are licensed in? How is the product differentiated versus some of the others in development? You said the lead asset is in Phase 1. What indication is that? Is it schizophrenia or Alzheimer's? And then just back on New Plazid, can you talk about just what April has looked like so far relative to March, relative to February, relative to maybe what you were expecting, just so we get a sense of what's happened so far? Thanks.
Not had nearly a significant impact on our revenues in our in our projected revenues and and all <unk> early indicators that we look at so the business continues to be very strong and I think the the quick because it that we've done the worked at Michael's seems dominance.
Who's.
It is is is reflected in the fact that that we're runs gardens now only 5% I think I think we feel pretty good about where we stand of course, we have to well recognize it's a fairly good situation, but I think our team is a great job at work in virtually <unk>.
Stephen R. Davis: Yeah, we'll take those one at a time. Let me offer a couple of thoughts on the Pam program first, and I'll ask Michael to respond to the second question. So we really like this program. As many of you know, there's a lot of literature describing the potential of muscarinic modulators both with the M1 and the M4 subtypes. And the letter's mostly supportive of potential utility in schizophrenia and cognition and dementia. However, the challenge in this area has always been how to control or mitigate the unwanted cholinergic side effects. So there are some approaches that have shown very intriguing promise by trying to, when you can block some of those side effects, you can really, what's been observed is a very strong efficacy signal.
Entered the 90 million in the first quarter include any by N. because of Cove. It you know like we've seen it other companies that was pretty much demand driven.
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During the course.
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Thinking in N.X. question on some online child Dunkin with Cantor Fitzgerald Your mind is open.
Okay.
Thanks, guys, Steve and team for taking my questions congratulate a good a quarter I wanted to ask one commercial question and then probably too relatively simple pipeline questions of the commercial question.
For you is I know, there's been a fair amount of discussion about the components of guidance and appreciate a lane as.
Input there, but I'm, specifically wondering about that dynamics in the long term care facility setting I know there's been some discussion about that setting being hit hard by covert 19, and I guess I'm wondering if you're seeing continued persistence and or I guess.
Stephen R. Davis: The approach that Vanderbilt took and that we are collaborating with Avon is by modulating the M1 receptor subtype through a positive allosteric modulator. And we believe this PAM approach is designed to achieve a similar level of efficacy, but potentially without the side effects due to the high selectivity of these PAMs. So we're very excited about the approach. We like the program a lot and are eager to get it incorporated and get it going. Michael, do you want to take the other questions?
Improved or continued compliance in that setting in particular and what your assumptions are in the second half the year with regard to the <unk> 19, perhaps second wave.
Michael Yang: Sure. Thanks for the question.
Michael you want to pick up.
Yeah, Yeah. Thanks, Thanks to a a questionnaire and or our Hearts go out to the the pay.
Michael Yang: I think that maybe this is a chance to brag a little bit. I'm really proud of the commercial team for what they've been able to do, quickly pivoting in a time of crisis, whereby we were able to do a lot of things that optimized the commercial approach. You know, I mentioned the ability to diagnose, treat, and get patients on therapy remotely. We've had product theaters that are very well attended. Our existing sales force, leveraging their relationships, has had, you know, what I would call a surprisingly good success in their effectiveness to reach customers and engage in meaningful conversation. And, you know, obviously, the first part of the state shelter-in-place, I think, was a pretty devastating thing for the country and the marketplace in general, but as physicians have come to get their feet under the ground, I've been impressed with their response to telemedicine As I mentioned earlier, the PDP situation is one of serious need, and therefore, we have credible conversations and reasons to engage with customers. So I think April is certainly seeing better days than the latter parts of March when the pandemic was first raging, and shelter-in-place was kind of a new thing.
In the long term care sandwiches setting is you know a little bit more of an impact on on the <unk>.
You know are are we expect to continue to see the similar dynamics in our ability to kind of operate as I said on the S.P.N.E.S.D. side. The call that we have already well established a franchise pardon flow goes through there and continued patients have shown.
No we don't see general impact on the continuing patients as I mentioned earlier for both S.B.S.D.
The ability to get new patients, that's kind of where the where the <unk> focuses on on the guidance and we're speculating in that guidance some reduction in that ability to get new patients starts in both S.P.N.S.D., but.
That that at the fluid situation of we're continuing to monitor that and will continue to to evolve ours are are promotional and operational next to that category. When we see it it could be that we get back to state to state and market to market opportunities and then it's going to be in the evolution of how we get back into that market.
That makes sense to me however, we <unk>.
I'm sorry go ahead.
Just to be clear the the low into the guidance assumes that new patients starts they where they are what we've observed so far.
And we don't anticipate that to be the case the behind the bar guides assumes that we're able to get back into positions offices are not in the third quarter and and and receive more grows on nutrition store. So so it because the guys again is very well grounded and what we're seeing today recognizing again, it's a good situation recording.
Stephen R. Davis: I'll just, I'm sorry, I'll just echo Michael's comments. I think I've been very, very pleased and proud of the work that his team has done in very quickly adapting to this very unusual and very different environment. I think what we've seen is, as Michael mentioned, while in-person visits are down, as you can see from our guidance and from the results that we've published, it has not had nearly as significant an impact on our revenues and our projected revenues and all of the indicators that we look at. So the business continues to be very strong, and I think the quick pivot that we've done and the work that Michael's team has done is reflected in the fact I think we feel very good about where we stand. Of course, we have to, we all recognize it's a fairly fluid situation, but I think our team has done a great job of working virtually.
Okay very good that selfless, Steve and then perhaps if I could ask a couple of pipeline questions. One is related to D.R.P., you know pretty clear guidance that you'll be filing N.S.N.D.A. Soon you know I know that summer starts here in a manner.
Weeks, but I'm wondering if the search you could provide us any additional color on in a rate limiting steps or additional work that needs to be done to file a the P.R.P.S.N.D.A. and then on the M.D.D. program like that I think it's creative interesting, but I'm wondering if you could.
Would give us some color around the impact on powering if there's any penalties that you think from a statistical perspective, you would take and combining those two stuff.
Mark Goodman: And did the $90 million in the first quarter include any buy-in, be-all, be-all?
Yeah Stinks Charles.
On the first question really we are.
Mark Goodman: And because of COVID, you know, like we've seen in other companies, it was just pretty much demand driven.
I imagine.
Preparation of hours supplemental N.D.A., our discussions we'd have the a. didn't know dobrinja any.
Mark Goodman: No, it's the commander. Our inventory levels did not return to normal.
Charles Cliff Duncan: Thank you. And our next question comes from the line of Charles Duncan with Cancer Fitzgerald. Your line is open. Thanks guys, Stephen and the team for taking my questions. Congratulations on a good quarter.
Significant or meaningful of changes to that strategy. So we are continuing with the you know we'll finalization of the documents that are.
Components of the supplemental N.D.A. and we are is.
Charles Cliff Duncan: I wanted to ask one commercial question and then probably two relatively simple pipeline questions. The commercial question for you is, I know there's been a fair amount of discussion about the components of guidance, and I appreciate Elena's input there. But I'm specifically wondering about the dynamics in the long-term care facility setting. I know there's been some discussion about that setting being hit hard by COVID-19. And I guess I'm wondering if you're seeing continued persistence and, or I guess, improved or continued compliance in that setting in particular and what your assumptions are in the second half of the year with regard to the COVID-19, perhaps second wave.
As I mentioned earlier.
Completely on track for defamation into summer.
We we have six months or priority review we are.
Acting action date will be.
Yeah.
<unk> related to the second question in terms of the potential.
Statistical impact or penalties for combining the study all of this you know we.
Used on then we'll be done we had a alignment we D.F.D.A. and respectively. Prior to any of you know database lock or anything on that it is you know as a as a part of our discussion we're proposing statistical analysis plan and this is.
Michael Yang: Yeah, thanks Charles, thanks for the question, and our hearts go out to the patients. In the long-term care setting, which is a setting that has seen a little bit more of an impact on COVID, you know, we expect to continue to see similar dynamics in our ability to kind of operate, as I said, on the SP and the SP side. Recall that we already have a well-established franchise, the product flow goes through there, and continuing patients have shown no, we don't see a general impact on continuing patients. As I mentioned earlier, for both SP and SP, the ability to get new patients is kind of where the focus is on guidance and work. Speculating in that guidance, some reduction in the ability to get new patient starts in both SP and SD, but it's a fluid situation and we're continuing to monitor that, and we'll continue to evolve our promotional and operational mix to that category when we see it. It could be that we get back to state-to-state and market-to-market opportunities, and it's going to be an evolution of how we get back.
Something that precedents already exists for days.
And it has been done and we anticipate F.D.A., we'll be open for such a solution I do want to say is that starting.
In general, even though regulators and most of the sponsors are recognizing that there are certain risks involved and.
Ah Ah Ah, starting and stopping and starting the enrollment where a portion of patients will be assessed any role Bree called me to and <unk> boss call. It so.
That's solution or also bring certain risks in our assessment is that.
Ah proposal that we have a off or opportunity for us to still maintain our two shots on the goal strategy.
Stephen R. Davis: That makes sense to me. However, we... I'm sorry, go ahead. Just to be clear, the low end of the guidance assumes...
By already planning to.
Okay. So negative outcome starred second study, but also off their opportunity we feel very comfortable.
Stephen R. Davis: New patient starts stay where they are, as we've observed so far, and we don't anticipate that to be the case. The hindsight of our guidance assumes that we're able to get back into physicians' offices in the third quarter and receive more growth on new patient starts. So I think the guidance, again, is very well-founded in what we're seeing today, recognizing, again, it's a fluid situation that could change
Comfortable with.
Proposed statistical plans and analysis.
It's helpless I could sneak one more end up with regard to the Vanderbilt a deal that you did come Grad son that wondering if the current compound nets in phase one testing.
He's from an academic <unk> to say anything about that but would you see that as a pharmaceutically optimized compound or really a tool candidate to test hypothesis with regard to the <unk> to get to selectively.
Charles Cliff Duncan: Okay. Very good.
Charles Cliff Duncan: That's helpful, Steve. And then, perhaps, if I could ask a couple of pipeline questions. One is related to DRP. You know, pretty clear guidance that you'll be filing an SNDA soon. You know, I know that summer starts here in a matter of weeks, but I'm wondering if Sergio could provide us any additional color on any kind of rate-limiting steps or additional work that needs to be done to file the DRP SNDA. And then on the MDD program like that, I think it's creative and interesting, but I'm wondering if you could give us some color around the impact on powering, if there's any penalties that you think from a statistical perspective you would take in combining those two studies.
It's a great question Charles is something that we spent a lot of time in our diligence on.
Vanderbilt on something that is a little different than what typically see was academic institutions, but they they really a dedicated a lot of resources to building the same kind of capabilities.
Independent lab structure, they set up on the Dot com.
To do the same kinds of things at the same com prompted capabilities in house as you would have that pharmaceutical company or.
Well position Baltic company.
Unknown Attendee: Yes, thanks, Charles. On the first question, really, we are, as you can imagine, well-advanced in the preparation of our supplemental NDA. Our discussions with FDA did not bring any significant or meaningful changes to that strategy, so we are continuing with, you know, finalizing the documents that are components of the supplemental NDA, and we are, as you know.
So, but there was one of the real advantages we saw partnering with them is the only are they.
Gone through the same places there are where you and others would go through but they have the capability to continue doing that with other other compounds. So.
Yep <unk> Vanderbilt spend a lot of time in industry and they feel that really substantial platform there. So.
Unknown Attendee: For more information, please visit www.fema.gov Page PAGE of NUMPAGES www.verbalink.com Page PAGE of NUMPAGES
We're very excited about the the mechanism be programmed or potential.
Also because.
<unk>.
They were good things for the head color Steven <unk> [noise].
Unknown Attendee: It's related to the second question in terms of potential. Yeah, statistical impact or penalties for combining the study, all of this, you know, we are doing and will be done with alignment with the FDA and prospectively prior to any, you know, database lock or anything on that. As a part of our discussion, we are proposing a statistical analysis plan, and this is something that precedent has already existed for this, and it has been done, and we anticipate that the FDA will be open to such a solution. I do want to say that, in general, even the regulators and most of the sponsors are recognizing that there are certain risks involved in starting and stopping and starting enrollment where a portion of patients will be assessed and enrolled pre-COVID and a portion of patients will be assessed and enrolled post-COVID. So, that solution also brings certain risks, and our assessment is that the proposal that we have offers an opportunity for us to still maintain our two shots on the goal strategy by already planning to, Case of Negative Outcome starred the second study, but also offers an opportunity. We feel very comfortable with the proposed statistical plans and analysis.
Thank you. The next question number nine where the reruns Ah with capital markets or something.
Hey, guys. Thanks for taking my question Congrats on all the progress and also thank you for all the color. This afternoon and today really appreciate it.
Steve <unk> I, just wanted to ask a bit certainly more little on on Cove, It and as you discuss really settings, the company and a portfolio for for the longer term just curious you're discussing getting through some agree the coping 19 pressures now, but I'm just curious your thoughts on maybe more of the lingering negative.
<unk> that the pandemic could have on the market certainly setting up for a very important launched but then also with respect to the patient population. So the toll perhaps not mental health is there any read through to that market really being one that would be grilling lend itself to to the assets of of the Katie and certainly secondary.
Perhaps connected to to the clarity changes any additional F.T.A. or further amenability for them to work more flexible away with helping to get 'em products like 'cause answer through to these patient populations. Thank you very much.
Charles Cliff Duncan: That's helpful. If I could sneak one more in. With regard to the Vanderbilt deal that you did, congrats on that. I'm wondering if the current compound that's in phase one testing, you know, it's from an academic, and not to say anything about that, but would you see that as a pharmaceutically optimized compound or really just a tool candidate to test a hypothesis with regard to the strategy to get to select
Yeah. Thanks for the question I'll I'll start and then <unk> you guys have additional commentary Queen something but.
Look this is obviously really tragic situation that we're experiencing globally.
The impact that we're seeing Rickover 19 is yeah the short term.
As we mentioned, it's not going to change the fact that symptoms with Parkinson's dementia depression schizophrenia syndrome, they continue to suffer symptoms to spot depend on it.
Stephen R. Davis: It's a great question, Charles. It's something that we spend a lot of time and diligence on. Vanderbilt has done something that is a little different than what you typically see with academic institutions, but they've really done a lot.
I think in the in terms of longer term impact I think it will underscore.
Utility drugs that help treat the symptoms I do think we'll see some exacerbation a depression and anxiety induced depression I think we'll see some again.
Stephen R. Davis: ....
Stephen R. Davis: They dedicated a lot of resources to building the same kind of capabilities in an independent lab structure they set up under Jeff Hung to do the same kinds of things, and have the same types of capabilities in-house as you would have at a pharmaceutical company or at a well-positioned biotech company. And so that was one of the real advantages we saw in partnering with them: not only have they gone through the same paces that we and others would go through, but they have the capability to continue doing that with other compounds. So, and by the way, Jeff Kahn, who leads this effort at Vanderbilt, spent a lot of time in industry, and they've built up really a substantial platform there. So we're very excited about it. The mechanism, the program, the potential, but also the capabilities are great for our capability.
Impact on the on hallucinations, and delusions of Parkinson's and an entropy suffering and in some respects the the ability to actually treat the symptoms and possibly keep patients out of the nursing home longer.
Or any nursing home seven and to be able to treat the symptoms to make those patients have a higher quality block and be easier to manage et cetera will be things that will be higher value to <unk> have today.
So I think as we think about the potential reporting.
I I think they will just underscore the utility of <unk> the disease that we're pursuing and perhaps people were important treating them with.
<unk>. So far has some very robust advocacy very very horrible six intolerability profile. So so I think it will just simple underscored the value <unk> <unk>, <unk> <unk> or something.
Operator: Very good. Thanks for the added color, Steve and team. Thank you. Our next question comes from the line of Gregory Renza with RBC Capital Markets.
Michael or <unk>.
Yeah State I I would off her a couple more things I think that.
Gregory James Renza: Your line is open. Hey guys, thanks for taking my question. Congrats on all the progress and also thank you for all the color this afternoon and today. Really appreciate it. Steve, I just wanted to ask a bit, certainly more on COVID, and as you discuss really setting the company and the portfolio up for the longer term, I'm just curious, you've discussed in getting through some of the COVID-19 pressures now, but I'm just curious, your thoughts on maybe more of the lingering negative effects that the pandemic could have on the market, certainly setting up for a very important launch, but then also with respect to the patient populations, the toll perhaps on mental health, is there any read-through to that market really being one that would be growing and lend itself to the assets of ACADIA, and certainly secondarily, and perhaps connected to the clarity changes, any additional FDA or further amenability for them to be more flexible with helping to get products like COVID-19 through to these patient populations? Thank you very much.
One of the things that mental health has a attached to it is is a number one a stigma and number two and awareness and a lot of our medical and <unk> and consumer education as awareness.
And obviously folks being together in a longer period of time exposes that information or that situation and that can make that a lot more front and center as a as a problem to to solve second I would say that I think that we're fortunate in that psychiatry neurology.
Some of the two highest users of color medicine, and I think the tele medicine trend that has been established as that out of necessity. In this code that environment. I think is going to continue long. After this and I think that tele medicine is going to be here to stay companies that are optimized for that kind of environment in our product and company is.
Are going to you know continue to serve I think the physician customers extremely well and then the third I just want to anchor <unk> comments that in a product like new Plaza, whose overall positioning across the sequence indications is improvement without impairment in the case in a P.D.P. that was a.
Non improvement in psychosis without impacting motor in a case of dementia, it's potentially the impact on cognition say on falls and other safety benefits that you don't see with the dopaminergic side effects and then of course with depression and others we have benefits.
Stephen R. Davis: Yeah, thanks for the question. I'll start, and then Michael or Serge, if you guys have additional commentary, please jump in.
Stephen R. Davis: But look, this is obviously a really tragic situation that we're experiencing globally. The impact that we're seeing with COVID-19 is short-term. As we mentioned, it's not going to change the fact that symptoms with Parkinson's, dementia, depression, schizophrenia, and Rett syndrome, they continue to suffer symptoms despite the pandemic. I think in terms of longer term impact. I think it will underscore the utility of drugs that help treat these symptoms. I do think we'll see some exacerbation of depression and anxiety-induced depression. I think we'll see some, again, further impact on the hallucinations and delusions that Parkinson's and dementia patients suffer, and in some respects, the ability to actually treat those symptoms and possibly keep patients out of the nursing home longer, or in a nursing home setting to be able to treat those symptoms to make those patients have a higher quality of life and be easier to manage, etc., will be things that will be of an even higher value than the very high value they already have today.
We've shown in our in our studies if they were to be part of the claims you know in terms of sexual dysfunction weight gain metabolic. So the list goes on so a product like new closet in the future environment of the things that just disgusting, Steve anchored on I think or.
It's a really potentially good situation in that regard.
Yeah.
The likewise.
Side, we have been able to really.
Quickly and efficiently.
Move toward a remote assessments.
To properly Montador safety of the patients through you know remote manner.
Thing that regulators, who reacted really fostering providing.
Guideline food for a guide on the floor.
Spawns or how to do these.
One of all of these now we have actually essentially systems in place to operate.
Stephen R. Davis: So I think as we think about the potential rippling effects, I guess I'd say, I think they will just underscore the utility of treating the diseases that we're pursuing and, perhaps equally importantly, treating them with an agent that has so far shown very robust efficacy and a very, very tolerable safety and tolerability profile. So I think it will just simply underscore the value of Nuclizer in all of the indications. Michael or Sergio, do you have anything else to offer?
Whatever circumstances come up of course, we've been dynamic you never know if being sway.
<unk>, but in the circumstances as it is weekend really run both models boat on site.
Or a remote.
We are ready for any.
Circumstance.
Michael Yang: Yeah, Steve, I would offer a couple more things. I think that one of the things that mental health has attached to it is, number one, a stigma, and, number two, awareness, and a lot of our medical and consumer education is about awareness. And obviously, folks being together for a longer period of time exposes that information or that situation, and that can make that a lot more front and center as a problem to solve. Second, I would say that we're fortunate in that psychiatry and neurology are some of the two highest users of telemedicine. And I think the telemedicine trend that has been established as a necessity in this COVID environment is going to continue long after this. And I think that telemedicine is going to be here to stay. Companies that are optimized for that kind of environment, and our product and company are, are going to, you know, continue to serve, I think, physician customers extremely well.
Great operator.
Great operate I think we have time to to get back to <unk> from from talent and then we can take a couple more questions.
After that.
Oh, we to borrow from <unk> nothing.
Hey, guys. Thanks for hitting me back in really yeah, sorry about that my question is for syringe I know somebody are a little bit as previously, but like how how should we think about the activity of your one Pam from from Vanderbilt <unk> it's specific.
Really how do we think about that <unk> modulation in what sets. It apart activity wines from like was the Nomoline and <unk> like is it possible to separate the mix it must granted side effects from.
Psychotic affect the normally has shown you walk through that.
Well.
Steve do wanted me to address this.
Yeah, Yeah at least gorda.
Michael Yang: And then the third, and I just want to anchor this to Steve's comments, that in a product like Nuplazid, whose overall positioning across the sequence of indications is improvement without impairment. In the case of PDP, that was a non-improvement in psychosis without impacting motor. In the case of dementia, it's potentially the impact on cognition, say, on falls and other safety benefits that you don't see with the dopaminergic side effects. And then, of course, with depression and others, we have benefits that we've shown in our studies, if they were to be part of the claims, you know, in terms of sexual dysfunction, weight gain, metabolic, so the list goes on. So a product like Nuplazid in the future environment of the things I just discussed and Steve anchored on, I think it's a really potentially good situation in that regard.
The one of the really distinguishing feature.
Compounds the.
Is it's a high level of selectivity.
Really wouldn't impact.
The fact profile in terms of the advocacy.
You know that it shouldn't be any.
Distinguishing do for his but with the.
<unk> and I'll go news what happens often used today.
Activity is not exactly what what is proclaimed predominance, so activities and that often impacts.
Peripheral side effect profiles, particularly so.
Unknown Attendee: I'll just add that, likewise, on the R&D side, we have been able to really quickly and efficiently move toward remote assessments and the ability to properly monitor the safety of patients in a remote manner. Of course, with a pandemic, you never know if things may get to some catastrophic level, but in the circumstances as they are, we can really run both models, both on-site visits or remote visits, and we are ready for any circumstances.
What we.
Are impressed with the components is that it's hi selectivity.
And there.
<unk> producing the positive always started module either with you know a high precision. So we are really impressed with the than anticipated. We will we will ultimately C.D.F. you go see.
Operator: Great operator, I think we have time to get back to Ritu Baral from Calen, and then we can take it.
Observed already with.
Operator: I have a couple more questions. Thank you.
Operator: After that, Ritu Baral from Calum, your line is open. Hey guys, thanks for fitting me back in really. Sorry about that.
<unk>, but with the with a side effect profiles in some initial.
Data that we have also are indicating in that direction.
Ritu Subhalaksmi Baral: Um, my question is for Serge. I know somebody asked a little bit of this previously, but like, how should we think about the activity of your M1 PAM from Vanderbilt? Specifically, how do we think about that allosteric modulation and what sets it apart, um, activity-wise from Zanomalene? And, um, how are, like, is it possible to separate the anti-muscarinic side effects from the antipsychotic effects that Zanomalene has shown? Can you walk us through that?
Yeah, I would just so the last third mentioned I mean.
These early stage programs, you always have a biochemical hypothesis.
Do testing in vitro and then and Debo did you ultimately getting the clinic and <unk> in humans and all of the day that we've seen so far is supportive of the theory that we have that.
We that do this positive Alastair modulation that in one maybe been able to avoid the a colon district started like so so again, it's a it's an early stage program. It has the risk reward profiled in earnest each program, but we're very excited about it.
And one for <unk>.
Unknown Attendee: Well, um... Steve, do you want me to address this?
We're we have well did so the the lead compound is in page one now and hardly page one <unk> and I think as we progress or they will give them more updates on it but another thing we liked about the programs. The back then you wouldn't would be small molecule already speech programs.
Stephen R. Davis: Yeah, please, go right ahead.
Unknown Attendee: The one of the really distinguishing features of the compounds that we have in license is that they have a high level of selectivity which really would impact the entire side effect profile. In terms of efficacy, you know, there shouldn't be any distinguishing difference, but with muscarinic receptors and agonists, what happens often is that their selectivity is not exactly what is proclaimed or what their predominant selectivity is, and that often impacts the peripheral side effect profiles, particularly. So what we are impressed with Wunderbilt compounds is that they have high selectivity and their technology for producing the positive allosteric modulator with, you know, high precision. So we are really impressed with that and anticipate that we will ultimately see the efficacy that is observed already with M1 with muscarinic agonists, but with the side effect profiles and some initial data that we also have.
You always want to have multiple shots on goal and and we've got other compounds that are progressing rapidly as well. So so we feel good about the portfolio approach that Vanderbilt stick.
And last question apologizes that a repeat but in your conversations with.
S.T.A. about your European Yeah. He has the topic of the outcome come up now that AD com there.
Definitely virtual <unk>.
Surgeons yeah.
Continued to expect a there is oh, hi, likelihood that we will have advisory committee and we are preparing 40 Advisory Committee.
Stephen R. Davis: Yeah, I would just echo the last thing Serge mentioned. I mean, in these early stage programs, you always have a biochemical hypothesis. Do testing in vitro and then in vivo, then you ultimately get in the clinic and can test the hypothesis in humans. And all of the data that we've seen so far is supportive of the theory that we have that with this positive allosteric modulation, that M1, we may be able to avoid the colon esterase side effects. So again, it's an early stage program, The Risk Reward Profile of an Early Stage Program, but we're very excited about it.
Topic did not come up yet because it's not the time for that that's not something that.
Customarily discussed either the at any of the meetings or of the P.S.N.D.A. meeting, we expect that we will be ones, we file and.
File is accepted that we will at that point here.
It's on that I do want to remind everybody. It is typical for supplemental N.D.A. to have advisory committee, but because this is the first approval or want to say card. It can be syndication that we anticipated do these are like liquid we will have and we are behaving in that way.
Ritu Subhalaksmi Baral: And when's the fastest that can get into the clinic?
Stephen R. Davis: The lead compound is in phase one now. It's in early phase one.
Stephen R. Davis: And I think as we progress further, we'll give more updates on that, but another thing we liked about the program is the fact that, with these small molecule early stage programs, you always want to have multiple shots at goal, and we've got other compounds that are progressing rapidly as well, so we feel good about the portfolio approach that Vanderbilt has taken.
Great. Thank you personally for me back and think here.
And her next question has been line <unk> with Goldman Sachs Caroline Vulcan.
Yeah.
Good afternoon, what's it called Cupid clarity trials can comment on their bask in terms of differences previously seen with placebo response or other factors in the context of U.S.N.X.U.S. patients or U.S.M.F.C. website.
Ritu Subhalaksmi Baral: And last question, apologize if this is a repeat, but in your conversations with FDA about your DRPS NDA, has the topic of the adcom come up now that adcoms are definitely virtual for the foreseeable future? Jared, do you want to take that?
Unknown Attendee: Yes, we continue to expect that there is a high likelihood that we will have an advisory committee, and we are preparing for the advisory committee. That topic did not come up yet because it's not the time for that. That's not something that is generally customarily discussed at any of the meetings or at the pre-SNDA meeting. We expect that once we file and the file is accepted, we will at that point hear their thoughts on that. I do want to remind everybody that it's not typical for a supplemental NDA to have an advisory committee, but because this is the first approval of an antipsychotic in this indication, we anticipate that there is a likelihood that we will have one, and we are behaving in that way. Great. Thank you for taking the time to read this.
And then you know just just to clarify and then the screening <unk> what the rationale is behind targeting M., one and not so I'm wondering why.
Or you want to pick up.
Yes, if you're going to to clarity first of all let me just say that in terms of the placebo responds into depression trial. The difference is that we were seeing.
Generally see in schizophrenia are not replicated into depression trials.
Regional organisation all the studies.
Related to the potential control of the overall variability of this I mention the the data we have into what we observed so far does not indicate that there is significant concern in terms of differential variability.
Unknown Attendee: Great. Thank you for taking me back into the queue. And our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Thanks. Good afternoon. With regard to the clarity trials, could you just comment on the risk in terms of differences previously seen with placebo response or other factors in the context of U.S. and ex-U.S. patients or U.S. and ex-US sites? And then, you know, just to clarify on the muscarinic receptors, what the rationale is behind targeting M1 and not both M1 and M4?
We're observing and is two studies so from that perspective, we are reassured the risks are not.
Concerning nature, you know three garden obviously.
Unknown Attendee: Sir, do you want to take this?
You know combining to study is your combining the number of clinical sites, but as of you know we've.
Unknown Attendee: Yes. In terms of clarity, first of all, let me just say that in terms of the placebo response in the depression trial, the differences that we were seeing, which we generally see in schizophrenia, are not replicated in the depression trial. So from that perspective, we are reassured that the risks are not of a concerning nature in that regard. Obviously, when you combine the studies, you are combining the number of clinical sites, but with the observed variability between the two studies, we feel fairly comfortable in that respect, on the M1 versus M4. You know, it's a significant debate. What actually happens is that Cognitive slash neuropsychiatric symptoms are better addressed or more efficiently addressed with agonism at M1 versus M4. There is kind of a school of thought that M1 is more on the cognitive side, that M4 is more on the acute psychotic symptom side, but there is no, actually, looking historically through the studies, I think that there are arguments to be made that both cognition, cognitive symptoms, and more broader, Neuropsychiatric Symptoms in Schizophrenia, which would include both negative symptoms as well as positive symptoms, would be and can be But we are open-minded in that respect at this point.
<unk>.
Between two studies.
Fairly comfortable in that respect.
And.
And one versus same for you know, it's it's a significant debate.
What actually.
Magnitude slash, new or a psychiatric symptoms are better addressed or.
More efficiently address with the organism. It then one versus for there is there is.
Oh school of talk that M., one is more on a cognitive sided m. four is more on d. acute psychotic symptoms side, but there is no actually looking.
<unk> through the studies.
I think that there there are arguments to be made Ah Ah Ah boat cognition, cognitive symptoms and more broad or.
Neural psychiatric symptoms in schizophrenia, which would include vote a negative symptoms as a positive symptoms would be in can be addressed with.
I will simply say that we <unk>, we intend to do in developing these molecules is to simply leeson too.
And clinical generations and adjust our development programs as we are moving through the stages of development so that we.
Pursued most appropriate indication as we do is but we are open minded in that respect at this point.
Unknown Attendee: Great, thank you. Operator, I think we have time for one more question. Yes, sir. And our next question is from the line of Chris Howerton with Jeffries. Your line is open.
Great. Thank you.
Brenner I think we have time for one more question.
Yes, Sir nine next question is from the line of Chris How're 10, with Jeffrey airline nothing.
Great. Thank you so much for taking the question I'll try and make this quick so Steve we've had a you know some initial discussions about growing the company through B.D. and I just wanted to understand you know what the scope of the deals you're thinking about in the future just getting the pressing that these two relatively small.
Operator: Thank you so much for taking the time to answer the question. I'll try and make this quick.
Chris Howerton: So Steve, we've had, you know, some initial discussions about growing the company through BD. And I just wanted to understand the scope of the deals you're thinking about in the future, just given the precedent of these two relatively small deals that we've seen.
Deals that we've seen so far so thanks.
Stephen R. Davis: All the deals that we've seen so far. So Yeah, thanks for the question.
Yeah, Yeah. Thanks for the question.
Stephen R. Davis: As we've previously indicated, growing the company transactionally is a key pillar of our business plan. You'll see more transactions from us as we go forward. I think the two deals that we've done so far are good examples. I would characterize the kinds of deals we are doing, but I wouldn't, or shouldn't limit the scope of the deals or assume that our scope is limited to just those kinds of deals of those sizes. The course, as I mentioned, Trophinidide is a good example of a later stage opportunity that we are very excited about that Vanderbilt Yields has been discussing as an earlier stage opportunity. We have presences both in neurology and psychiatry. We've built a very, I would characterize it as a very, very large house.
As we previously indicated going to company Transactionally is the key pillar of our business plan.
You'll see more transactions grow Austin's we go forward.
The two deals that we've done so far are good examples I would characterize the kinds of deals we are doing but I wouldn't shouldn't limit.
The scope or assume that our scope is limited to just those kinds of deals with those signs appeals.
The of course as I mentioned [noise].
That is a good example of a later stage opportunity that are very excited about 'cause granted all deals with the discussing is an earlier stage opportunity.
We have presents both in neurology in psychiatry.
We've Belgrade very I would characterize as a very very formidable or indeed, India I think the results and you go seems produce.
Chris Howerton: Okay. All right. Very good. Thanks for taking the question. Thank you, and I'm not asking any more questions at this time.
The house and I think rebuilt a very very substantial presence commercially. So we've got capabilities that we can leverage and we will continue yeah.
Operator: Great. Thanks, Operator. Look, I know we've run a little bit long here.
Stephen R. Davis: I just want to say thanks to all of you for joining us today. We appreciate it. I look forward to updating you on our progress next quarter.
Okay, Alright Vegas, thanks for taking the question.
Thank you and I'm not showing any more questions at the time.
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Right. Thanks, operator look I know, we run a little bit longer just want to say thanks to all of you for joining US today, we appreciated her poor debating you on her own our progress next quarter.
Operator: Ladies and gentlemen, this does conclude the program. You may now disconnect. Everyone have a great day. Copyright Australian Broadcasting Corporation,
Ladies and gentlemen.
No Grand you May now does.
Everyone have a great.
[music].
Operator: BF-WATCH TV 2021