ACADIA Pharmaceuticals Inc. Q1 2023 Earnings Call
Okay.
Yeah.
Good day, ladies and gentlemen, thank you for standing by welcome to Acadia Pharmaceuticals first quarter 2023 financial results.
My name is Cory and I will be your coordinator for today at this time all participants are in a listen only mode. We will be facilitating a question and answer session towards the end of today's call.
Ask your question during the session you will need to press star one one on your telephone.
Here, an automated message advising you that your hand is raised to withdraw your question. Please press star. One again. Please be advised today's conference call is being recorded I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please.
Please proceed.
Thank you good afternoon, and thank you for joining us on today's call to discuss the caveats first quarter 2023 financial results.
Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our performance and a review of our business, Brian <unk>, Our Chief operating officer head of commercial who will provide updates on our recent launch of debut for the treatment of breast syndrome, followed by commercial updates on our deposit franchise, Doug Williamson our head of R&D will provide an update of our pipeline programs.
Mark Shire, our Chief Financial Officer will discuss our financial results before turning it back to Steve for final remarks, and opening the call up for your questions and.
In addition, kathie Bishop our Chief Scientific officer, and head of rare disease will be on the call and available for the Q&A session.
I would also like to point out that we were using supplemental slides, which are available on the events and presentations section of our website.
Before we proceed I would first like to remind you that during our call today, we will be making a number of forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995. These forward looking statements, including goals expectations plans prospects growth potential timing of events or future results are based on current information assumptions and expectations that are inherently subject to change.
If all of a number of risks and uncertainties that may cause actual results to differ materially. These.
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 and thank you for joining us today.
Please turn to slide five.
2023 is off to a great start with strong progress across our four strategic priorities.
First in March <unk> received FDA approval as the first and only treatment for Ret syndrome.
Our team moved quickly to Mike gave you a commercially available by mid April and we will be sharing updates on our launch execution with you today.
Second we continued to deliver steady volumes in our NUPLAZID franchise in Parkinson's disease psychosis.
Our PDP business is generating increasing cash flows year over year every year, so turning profitable in 2019.
Third we expect to complete enrollment for our phase III study advance to evaluating <unk> as a treatment for the negative symptoms of schizophrenia around mid year, and we will have top line results early in 2024.
And fourth we've completed phase one development of ACP tool for part of our next generation <unk> program.
Our next steps are to meet with FDA to discuss the clinical development plan to evaluate ACB tier four as a treatment for Alzheimer's disease psychosis.
Let's begin with a quick recap of our <unk> approval and subsequent launch on slide six.
Since the approval of debut on March 10, we have been working round the clock to deliver the first ever treatment for ret syndrome to the patient community.
Ret syndrome is extremely debilitating rare genetic neurodevelopmental disorder that severely impacts the lives of patients and their families.
We are beyond excited to be launching as first in class first to market drug for a disease with such a high unmet need.
The treating community is also excited.
They've been extremely receptive in Hcp's are moving quickly to prescribed debut having waited a very long time for an FD approved therapy.
In parallel we are engaged with payers in our first post approval discussion.
As is typical with rare disease launches, we anticipate it will take some time for payers to adjudicate initial prescription request as you would expect we are working diligently with plans to obtain insurance coverage.
Patients, who have prescriptions submitted to our hub.
Although we are only three weeks into the launch we are highly encouraged with the response, we've seen so far and Brendan will provide additional color on our launch execution today.
Now, let's turn to NUPLAZID on slide seven.
Our NUPLAZID franchise continues to deliver steady volumes and gain market share in a contracted PDP market.
In parallel we've optimized and reduced our NUPLAZID commercial expense base, which has resulted in a significant increase in profitability for the franchise.
Adding a meaningful contribution to our overall business.
Our first quarter performance of $118 5 million in net sales was driven by year over year increase in demand bottles of 2%.
<unk> volumes were down slightly year over year as a result of quarterly inventory fluctuations, which mark will describe further in his section.
We are beginning to see early indicators that our discussions with health care providers on the real World evidence publications are gaining initial traction this.
This is evidenced by an increase in our market share of new to therapy patients for PDP.
So far the initial feedback has been very positive on these datasets.
And two is it returned to growth for Parkinson's medication prescriptions as well as in person patient visits returning to pre pandemic levels, which we've not yet observed.
And now let's briefly review our clinical programs on slide eight.
Doug will provide more detail in his section, but beyond our two commercial programs NUPLAZID and debut we're developing multiple programs all focused on treating significant needs in.
CNS.
A couple of quick updates one as we've noted before the negative symptoms of schizophrenia has been.
Fleetingly difficult area.
With lots of industry failures over multiple decades, and still no drug approved to treat this condition.
But the answer and we've achieved something very rare in this population are positive pivotal study advance one.
So if our ongoing against two phase III study results are positive we would be in a position to submit a supplemental new drug application shortly thereafter.
Again, we expect to have results of this study in early 2024.
And two as I mentioned, we've completed our phase one development work for ACP tool or the lead molecule in our next generation <unk> program.
The key takeaway here is that the phase one work continues to support our target product profile and we plan to initiate phase II studies in Alzheimer's disease psychosis later this year.
I'll now turn it over to Brendan to provide additional insights on our debut launch execution and requires its commercial performance.
Thank you Steve Please turn to slide 10.
We are thrilled to have launched our second commercial product debut the first and only medicine ever approved for the treatment of Ret syndrome.
As we've discussed throughout the development program Ret syndrome is a highly debilitating disease with patients requiring lifelong continuous care and assistance with all aspects of daily living.
Debut and patient enrollment forms became available on April 17th ahead of our initial expectations.
As we are only three weeks into the launch we will not provide any specific metrics today, but we will share initial insights and color on our launch execution and the positive feedback we've received from the broader community.
Let's turn to slide 11.
First our launch execution is going very much according to plan as.
As expected we are receiving enrollment forms representative of the broad FDA approved label debut has received for the treatment of Ret syndrome.
With the broad label received back in March we are pleased to see patient enrollment forms for both male and female rep patients both clinical trial participants and de Novo patients.
Patients from all ages above two to well above 20 years of age pace.
Patients from both clinical trial sites centers of excellence high volume institutions and from Standalone neurology practices.
Of the identified 4500 diagnosed untreated patients.
Today, our outreach proactively spans physicians treating well over 50% of the diagnosed population.
This includes engagement with 100% of Ret centers of excellence and clinical trial sites, which treat about 25% of the total rep population.
In fact over 90% of our patients remaining from our open label extension studies have started the process of becoming paid patients.
We also have engaged a large number of the 300 high volume institutions, which represents 60% of the patient population.
And we're starting to engage the over 2700, Standalone neurology offices in the community setting.
In addition, our launch execution includes development of key marketing materials, both print and digital.
Standing up and activating our speakers Bureau to further educate the treating community.
Engaging the community at medical Congresses, including branded debut boots.
Since approval, we've been actively engaging in a robust and productive dialogue with the payer community and as the process takes time, it's too early to comment further today.
In addition to these payer engagement activities are Acadia connect support services hub, along with our field based family access managers are already providing meaningful support to both HCP and families to provide the best financial assistance options given the patients coverage to ensure timely access to debut.
And finally, following our approval we hosted our first ret community caregiver focused live webinar sharing information about the product how to enroll a loved one and obtained a prescription the path to access and all of the caveats robust support services. The webinar was a big success with over 900 caregiver.
Kennedy's well above our internal targets.
I'd like to reiterate that while we are only three weeks into the launch we are highly encouraged with the response, we've seen so far we look forward to sharing more on our next quarterly call Netflix.
Now, let's discuss our NUPLAZID performance on slide 12.
In the first quarter of 2023, we grew demand bottles, 2% compared to first quarter last year.
Our performance was driven by an increase in new to brand prescription share and new patient starts across both the office space at long term care channels.
Beginning in fourth quarter and continuing now into the first we have observed early indicators of growth in new patient starts for NUPLAZID.
As you May recall, new patient growth was negatively impacted during the pandemic as a direct result of the reduction in the overall patient population fewer patients coming into the office or being admitted to our long term care facility at the decrease in prescriptions as foundational PD treatments like carpet opah in levodopa.
Thus by maintaining steady volumes for NUPLAZID, we are actually continuing to grow share in an otherwise contracted PDP market.
Furthermore, we are encouraged by the high level of engagement, we're seeing from Hcp's when presented with the real world evidence data highlighting the potential differences in treatment with NUPLAZID compared to off label anti Psychotics.
These datasets on mortality safety and health care resource utilization and create an important ongoing dialogue with physicians to further differentiate NUPLAZID as the first and only treatment option for their PDP patients.
We are pleased that our teams have grown market share and achieved early indicators of growth in new patient starts all while continuing to optimize and reduce our NUPLAZID commercial expense base.
With a focus on both top and bottom line I'm proud to say that the NUPLAZID franchise has continued to grow profitability each year since turning cash flow positive in 2019.
And with that I'll turn it over to Doug Williamson to provide an update on our clinical programs.
Thank you Brendan please turn to slide 14.
Firstly to support the debut launch efforts, we continue to set up important opportunities for scientific exchange and sharing of medical information, while also generating important new data for the <unk> community.
Our medical affairs team is up and running including our medical science liaison team, who have already delivered important scientific information and clinical education about debut to the REIT community.
We continue to have a meaningful presence at key medical Congresses that are central to the rec community, including the American Academy of Neurology Congress or AAN.
In April and the upcoming International Ret Syndrome Foundation conference in June .
And we presented several posters, which included important clinical presentations and data as well as surveys on disease education.
In addition, we're excited for two very important clinical publications, which should be available in the coming months.
One is the publication of the phase III <unk> results and the other is a white paper on the best approaches to Gi management associated with Refranchising.
Finally in the next month or so we will be initiating a large scale prospective naturalistic study to learn more about how debut is best used in a real world setting.
Let's move on to our clinical programs, starting with <unk> as a potential treatment for the negative symptoms of schizophrenia on slide 15.
Persistent negative symptoms remain one of the largest unmet needs in schizophrenia and as of today. There is still no approved treatments for these symptoms the.
The negative symptoms of schizophrenia are characterized by social withdrawal lack of emotion or flat affect our adjunctive <unk> program is designed to treat the approximately 700000 patients in the U S who have positive symptoms the hallucinations delusions and other psychosis are adequately controlled but.
We still suffer from persistent and uncontrolled negative symptoms inhibiting their ability to lead a normal productive life.
Our second pivotal study advance two is almost identical to our positive advance one study, but with two key differences.
First a clear learning from the advance one trial was the optimal therapeutic dose for further evaluation of <unk> and negative symptoms of schizophrenia was the 34 milligram dose and this is indeed the dose we are evaluating in advance too.
And second it's well understood in our industry as well as by the FDA that placebo responses have become less reliable in U S. Schizophrenia trials over the past couple of decades. We also observed in our U S sites of our advance one trial and so now that we have the U S exposures, we need advanced two is being conducted solely.
Ian sites outside the U S.
Advanced two is close to completing enrollment which should occur around mid year with top line results in early 2024.
Please turn to slide 16.
I'd like to provide an update on our next generation <unk> program and specifically the lead molecule ACP tool for which we are developing as a potential treatment for alzheimers disease psychosis.
Similar to Pentagon strain ACP till fall works, primarily by blocking <unk>.
We believe this mechanism is ideally suited for elderly populations and with ACP 204 are seeking to build on our learnings from timberland strength.
As Steve mentioned, we have completed our phase one wax for ACP to oncor and.
In these studies and both healthy adults and elderly volunteers, we focused on characterizing receptor occupancy and exposure and optimizing the doses we plan to evaluate in phase III development.
ACP <unk> continues to demonstrate a very favorable safety and tolerability profile.
In addition, we have confirmed that ACP till fall reaches steady state in less than half the time, so roughly five days compared to around 12 12 days of apparent answering.
This could potentially translate into a faster onset of action.
Our work completed to date also appears to support our target product profile of minimizing the risk of Qt prolongation.
Our next steps to meet with the FDA and discuss the future clinical development plan for ACP tool for.
Now I'll turn it over to Mark for a financial update.
Thank you Doug.
Let's review our quarterly performance on slide 18.
In the first quarter, we recorded $118 5 million and net sales up 3% from the first quarter of last year.
Our gross to net adjustment for the quarter was 29, 3%.
Year over year demand growth was up approximately 2% in the quarter driven by an increase in new patient starts across both channels.
As Steve mentioned sell in volume declined approximately 2% year over year as in channel inventory declined in the first quarter of 2023 compared to an increase in channel inventory in the first quarter of 2022.
R&D expenses decreased to $69 1 million in Q1, 2023 from $128 9 million.
In Q1 of 2020 to the.
The decrease is related to a $60 million upfront payment for our Stoke collaboration which we recorded in Q1 2022.
SG&A expenses increased slightly to $101 2 million in Q1, 2023 from $96 $7 million in Q1 2022.
We continue to expect SG&A expenses to be essentially flat for 2023 versus 2022.
This is a result of one the optimization and reduction of our NUPLAZID commercial expense base and to making the right investments to execute a successful launch update yet.
We ended the quarter with a cash balance of $402 9 million.
Compared to $416 8 million at the end of 2022.
Our balance sheet remains strong and we are confident in our ability to execute on our current business plan with our existing cash resources.
As you can see on slide 19, we are reiterating all guidance measures for 2023, including net sales gross to net and expense ranges.
And now I'd like to turn the call over to Steve for closing remarks.
Thanks, Mark Please turn to slide 21.
Locked in today's prepared remarks focused on our execution across our four strategic priorities.
First debut was recently approved and launched only three weeks ago.
We look forward to providing our first quarter net sales for debut in appropriate performance metrics on the next earnings call.
Second in our PDP commercial franchise, we look forward to continuing to driving share growth and profitability of NUPLAZID.
Third we plan to complete enrollment in our phase three advanced II study for the negative symptoms of schizophrenia mid year with top line results expected in early 2024.
And finally, we plan to meet soon with the FDA to discuss the clinical development plan for ACP to award.
As always I'd like to thank our employees for their accomplishments and their ongoing commitment and passion as we continue our mission to elevate line.
Yes.
Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced.
Your question. Please press Star one again, please limit yourself yourself to one question I repeat one question. Please standby, while we compile the Q&A roster.
Our first call comes from Richard <unk> of TD Cohen Retool Your line is open.
Good afternoon, guys. Thanks for taking the question.
I will just ask one.
On your.
New payer discussions for a debut.
Can you give us any more color on what those are focusing on specifically are you.
Hello.
Unexpected preauthorization preauthorization requirements.
Or I guess.
So to the phase III requirements or are they open to prescribing per label. Thanks.
Thanks, So much for the question Ritu, Brendan you want to take that sure.
Sure.
For the question.
And yes, we have been engaging payers ever since we got our final label they've been.
Very good and constructive encouraging.
Discussions with payers I think that they've largely demonstrated that they are following the process, we would've expected for rare disease.
Rare disease products.
We are working with them logistically to get early patients access through what would be considered a medical exception or letter of medical necessity process that is precisely what we expected and is going according to plan, we have not yet seen.
Policy decisions those do happen it can happen in a relatively short period of time as you know some can take 30 to 60 days more will take in the 60 to 90 day range and some can take up to 180 days, but as of now.
We are really working in that interim period to get those first identified patients put.
Put on therapy, while those policy decisions are being made.
Im sorry inclusion criteria.
Yeah. Thanks. Thanks again for the question. We are I guess I'll say, we're very pleased by first of all the breadth of the label that we received we are encouraged by the breadth of.
Enrollment forms that we've gotten from clinicians.
From the youngest of patients to patients well over the age of 20.
And we've also seen enrollment forms that have come from each of the different types of treatment settings from clinical trial sites, all the way through to Standalone neurology practices.
And thus far I think payers are working closely with us to.
Okay very helpful. Thanks.
Please standby for our next question.
Yes.
Our next question. Our next question comes from the line of Charles Duncan at Cantor Fitzgerald, Charles Your line is open.
Sure.
Can you hear me.
Charles Youre bearing no sir.
Okay.
Okay.
Okay.
Sure.
And I'm wondering.
Okay.
Okay.
Thank you.
Thank you.
Okay.
Communications.
Thank you.
<unk>.
Thank you.
Okay Charles.
Sorry, we got.
Got here, yes, we can hear you talking where we can make out your question.
Okay.
Yeah.
Can you imagine maybe Scott.
Yes.
Much better yes, Yes go ahead Joseph.
Okay, sorry about that sorry for taking time from the call.
In terms of the registry, how will that help you to drive adoption for debut.
As well with the two upcoming publications has there been pushback on the use of debut.
And management of diarrhea. Thank you.
Thanks, So much for the question Charles we've already this is Dan Brennan I'll, let you.
I'll take that.
Sure Charles Thanks, So much for the question so in the real world setting we've been in the <unk>.
<unk> position of being able to proactively communicate the benefits and Tolerability profile of debut we've been able to do that with clinicians and we've been able to do that with families as well. So I would say with the appropriate Gi management plan. It's been very well received in fact, I would say that the feedback has been very pause.
<unk>, especially when we can reference the label itself that shows the clarity on discontinuing anti constipation medicines.
The FDA saw fit to put to put in the label and then I guess beyond that we learned so much from the phase III program that we're able to surround both clinicians and families with the type of support they need we have our field based family access managers 18 of them that are paired specifically with the caregivers and patients.
<unk> and HCP to make sure that we've set the right expectations for.
For the best of treatment plans and I don't know, if Doug or Cathy wanted to speak about the real world evidence piece.
Real World study.
Kathy you want to.
Yes, I'll take this and Doug can chime in if I Miss something.
So Charles is as I've mentioned on the call.
As we rollout the launch in parallel with that we're offering patients the option and it's just the option if they want to.
Caregivers can she is doing well.
Patient into a real world evidence study.
As Brendan mentioned that we have learned a great great job here conducting the clinical trials.
We are launching that society.
Additional information about how <unk> would be used in the real world.
In terms of what the efficacy overall.
Long term.
Well, how clinicians and caregivers is to manage the diarrhea, and the railroad, which I think is a lot easier to do outside the confines of the clinical trial.
Maybe on the table.
Combined to study medicine things like that so that's really the purpose of the study.
It's sort of an optional add on.
Patient Halo guard commercial Jack.
Very good thanks for taking the question and congrats on the recent progress.
Thank you for your question. Please standby, while we bring to the stage. Your next question.
Our next.
It comes from Tessa Romero of J P. Morgan Test your line is open.
Good afternoon, Stephen Thanks for taking our question.
Net revenues from sales of <unk>, what are the key metrics you will be providing the street.
The health of the launch and if you cannot provide those metrics to ask today qualitatively how should we think about kind of what the key buckets or areas that you see as the most valuable thanks so much.
Yes. Thanks, so much for the question Mark you with Zika, yes, Thanks tests as we mentioned.
Only three weeks into launch and at this stage, we just don't think its constructive too to share mattress today or even are just too.
Specifically, what we will share on the next call we can commit to you.
And the investment community is that not only will provide net revenue on our next call, but we will provide a reasonable set of metrics that we find will be meaningful at the time and going forward too.
To give you insight in our progress on lunch.
Okay. Thank you.
Thank you very much please stand by for your next question.
Yeah.
Yes.
Our next question comes from <unk> Ahmad Bank of America to Zane Your line is open.
Hey, guys can you hear me.
Just wanted to ask you about ECP kilo for as far as the phase one data when exactly should we be expecting to see that and what level of data should we expect to see.
Great. Thanks, so much for the question, Doug you want to take that.
Explored and characterize the receptor occupancy and exposure.
And basically use that data internally to optimize the doses that we plan to evaluate in phase III. So we don't plan to share details of the phase one data and it's really a more important for those internal decisions.
<unk>.
And probably issue a press release.
After that meeting.
Have you requested a meeting.
We have now.
Okay, great. Thank you.
Thank you very much standby for our next question.
Okay.
Our next question comes from Nina.
<unk> of Citi. Your line is open.
Hey, guys. Thanks for taking my question.
The trophy type launch.
Drug can you just walk us through that extra 10% why they haven't been initiated yet and then what's the overall timeline is now four.
The completion of rollover of the open label extension patients.
Dan do you want to take that sure.
Sure. Thanks.
So much for the question and just to clarify we have over I would say over 90% of eligible open label extension patients have begun the process to become paid patients. So we're talking about a handful of additional patients that are also completing end of study visits with their trial investigators.
At that point the families engage with their insurance plans of course, with Acadia support where needed and we'll help them with the completion of the adjudication process and converting to paid patients as soon as reasonably possible and for those handful of families where they are still in that process.
I'm sure some of them just want to spend a little bit of time with their clinicians take a look at the benefits that they're seeing and then decide how best to proceed all in all we will be pursuing.
<unk> of 100% of those patients eligible for four.
From for moving over and we expect that that process will take on average two to three months.
Got it that's helpful. Thank you.
Thank you standby for our next question.
Okay.
Our next question comes from the line of Marc Goodman, Sbb's SBB Securities Mark here.
Okay.
Thanks for taking my question, Mr. Rudy online for Mark.
Final question for NUPLAZID, maybe talk about Tam.
Penetration of this product in the PDP population.
Your current expectation for peak penetration.
Thanks.
Sure Brendan let me take the first part of that market the second.
Sure. So thanks for the question.
We reported in our in our prepared remarks.
<unk> that we have increased our share of new patient starts in the first quarter that was in both the long term care setting and in the community setting and.
And we also increased our new patient starts overall year over year in both of those populations.
We don't provide guidance necessarily on where ultimately we believe penetration will be but we do know that on the in the community based setting we're well over 20% and continuing to move that north as you know we started in long term care. After after we started in the community.
Setting so that is.
Growing and growing more rapidly, but is still kind of making up that space and overall, where we are over a 20% share for the entire NUPLAZID business across both channels. So mark I don't know if you want to add.
Thank you covered both parts of the question. Thanks.
Thanks very helpful.
Thank you please standby for our next question.
Let's see.
Sure.
Our next question comes from the line of Gregory rents at RBC capital markets. Gregory Your line is open.
Great. Thanks, Good afternoon, Steve and team congrats on the progress and thanks for taking my question.
Steve maybe just a quick one for me is you have acknowledged the award of the priority review voucher on debuts approval. Just wondering if you could update us on your latest thinking there.
As far as extracting the value and harnessing the value of the voucher either for you or for external parties clearly are shared.
With with Marin, but also sponsors out there who are looking to accelerate their own programs before the FDA any color you have there would be great. Thanks, so much.
Yes. Thanks, so much for the question, Greg I'll, just take a little bit of a running start I'd remind you that we share the value with neuron.
But the decision in terms of how to utilize that vouchers entirely.
But rest with us and so we haven't determined yet whether we will sell it or use it in one of our own internal programs. If we use it we have to be nearing their share based upon some good value. There is an established market value for these things.
Or sell it will be.
That it was determined down the road.
Got it thanks, Steve.
Yes.
Thank you please standby for our next question.
Yes.
Okay.
Our next question comes from the line of Paul Matteis at Stifle Paul Your line is open.
Hi, This is James on for Paul Thanks for taking our question.
Maybe just a quick one on ACP too far.
I guess as you're thinking about subsequent clinical development plans.
I guess, one do you expect to be able to move right into pivotal studies.
And two are you thinking about running relapse prevention studies are in acute studies I guess, just any color on your clinical development plans would be great. Thanks.
Yes, thanks, so much for the question.
Based upon the profile of this drug which is as we've said closely enough related to <unk>.
To answer and to be in a space that we know what we know the chemical space well, we know the biochemical space well.
That puts us in a position where we have the opportunity to move aggressively with the program.
As Doug mentioned in his prepared remarks, we're not quite ready to describe exactly what.
These two and beyond program it looks like I'll simply say that once we have met with the FDA will be in a position to go into that in much greater detail.
And as Doug mentioned on the call at this point now having completed phase one the target product profile that we.
That we said is our goal and this continues to look extremely attractive drug.
<unk> is in phase one was very well behaved very well tolerated.
No safety issues.
Clearly appears to get to a steady state and therefore potentially faster onset of action that <unk> answering.
We've seen no indications of Qt issues at this point.
Our next question comes from Jason Butler at JMP, Jason Your line is open.
Alright, thanks for taking my questions.
Just one on the PDP market dynamics, you've said now for a couple of quarters that you are seeing early signs of growth in new patient starts can you, maybe just give us a little bit more context, there where you think yes.
In the office space setting, we stand today versus pre pandemic or where you think.
<unk>.
Future normalized level would stand thanks.
Yes. Thanks for the question, Jason Brendan you want to take that sure. Thanks for the question.
And yes, if we're if we look at it in context too I'll say mid pandemic I think that there is a market dynamic in the community setting that is relatively consistent at this point, we still see fewer in office in person patient visits and we see.
Flat.
The PD market in terms of use of carbon <unk>, so essentially zero percent growth year over year.
As we've stated on previous calls we're focused on the real world evidence data that exists to help us differentiate NUPLAZID from other atypical anti psychotics in terms of outcomes. Those three datasets have been important additions to I think the whole clinical.
Discussion of this category and I think they've been very well received by our audiences both in the community and in the long term care setting so for us from a midpoint of the pandemic, where new patient starts had slowed down I think along with the market were incurred.
<unk> to see that we're able to increased new patient starts and increased share in what is otherwise a contracted PD market.
That for me is the best way to describe this encouraging results on the NUPLAZID and for new starts in a market that has been a little bit sluggish in the early part of 'twenty three.
Thank you.
Okay.
Thank you very much.
<unk>.
Standby as we queued up.
And our next question comes from Jason <unk> of Morgan Stanley Jason Your line is open.
Hey, Thanks for taking my question. This is Jeff can you can you talk about your updated thoughts on business development. How important is it to you to be cash flow positive versus further expanding your mid to late stage pipeline say with M&A. Thanks.
Yes, thanks, so much for the question.
So as we've stated previously business development continues to be a very important part of our business.
We have now established franchise, both in neurology and psychiatry established franchises in rare disease and broad applications and we have an opportunity to leverage those capabilities will continue to do that.
Sure.
The question in terms of.
Priority prioritization of profitability versus continuing to build the company for the future is.
The answer is we're going to do but we're going to continue.
Executing on business development, particularly in an environment that is much more attractive today than it has been in any time in recent.
History.
But we will continue to also be very judicious about the investments, we're making and as Mark mentioned in his prepared remarks, and as you've heard us say before with PDP franchise as an example.
We that franchise became profitable and begin throwing off cash in 2019 has become more profitable every year. Since then and will continue to have that as a as a top priority. So as we move forward you'll continue to see us.
No.
Exercising discretion as well as investment opportunities on both fronts.
Great. Thank you.
Thank you very much standby for our next question.
Our next question comes from South being Richter Goldman Sachs <unk>. Your line is open.
Hey, Thanks, guys. This is Matt on for solving.
We were just interested is there a specific patient group, where docs are more keen on using debut.
Some of our checks with doctors suggested a preference to use the drug and stable early stage patients versus late stage ones.
So just wanted to see if that was in line of what Youre seeing and then could you share what you view as the most important takeaways from that.
<unk>, Thanks, a lot.
Yeah, I'm, sorry, we didn't hear the second part of the question.
Just what you view as the most important takeaways from your AAN presentations.
Got it okay.
You want to take this question sure Matt. Thanks, Thanks for the question.
Obviously, we're three weeks in and have been watching with keen interest to see what patient populations. Our audience would look to address I'd go back to the prepared remarks. However to show you that with a broad label, we've been very encouraged by the breadth of enrollment.
Enrollment forms that we're seeing.
And it's indicative I think of what we saw in the 11 to study which demonstrated that.
Regardless of age or severity of disease across the HL means of.
RSP Q, we've seen improvements and that means that both clinicians and caregivers are going to look at their individual patients and say I think there is an opportunity to help improve this individual patients situation. So as I've said I wish I could point to.
To a particular patient type, but we're very encouraged that there is a broad range of patients that are being considered for for debut both in terms of age as young as two and well above 20%, we've seen male and female patients we've seen.
Patients that are.
Across the disease severity spectrum, some clinicians looking to start with patients that are maybe on the sicker end of the scale and others looking to intervene as early as they can.
Patient population. So it's still very very early days to see but in terms of the feedback that we've gotten from clinicians were not seeing a particular interest in <unk>.
A subset for example of renovations.
Okay.
Talk about and so on the clinical side, we had.
Two main presentations.
From a clinical trial data one with an additional data from our <unk> phase III study on the <unk>.
Benefits of tariff to date view on communication, especially nonverbal communication and client.
As <unk> talked about communication is wanted a key aspects of the disease that caregivers and Paris really wed like to see them goodness Loews.
Most patients with ret syndrome lays the ability to speak and cannot even communique non durability with things like eye gaze are pointing out what they want so in the phase III <unk> trial. We included a key secondary endpoint to attach non verbal communication.
The Sds and then we actually had an additional.
Functional task asking them to you.
Indicate preferences as a surrogate for now.
Communication and then we saw benefit with JBL for both of these nonverbal communication endpoints compared to placebo.
Yes.
<unk> and focused on that we actually have a publication, our putting together on that data.
Second clinical.
The presentation and what in.
<unk> study, which is the younger girls aged two to four.
<unk> been on open label debuted for all for over a year now.
And with that we saw very consistent safety and tolerability profile compared to the phase III data no safety or tolerability outcomes in that study.
And we even had a lower discontinuation rate due to diarrhea with only one patient discontinuing of any year.
And then in addition, we included some initial exploratory endpoints looking at efficacy.
Underground, they're harder to study efficacy because they are in a period regression, that's very variable where they ability.
Ability, but there's a lot of inter individual variability in that but we are seeing steady.
Outcomes as far as efficacy in some handset net R&D. In addition to those two we did have a couple of other presentations on health economics outcome.
It's showing the burden of disease that ret syndrome causes in these patients and these families.
Got it thanks a lot.
Please standby for our next question.
Okay.
Our next question comes from <unk> <unk> of Guggenheim Teen Your line is open.
Yes.
Okay.
Thank you for taking my question two quick ones.
To the debut could you comment on how should we model duration of therapy.
That's one.
The second one on NUPLAZID second quarter generally is a stronger quarter.
As Pos.
Should we look at the cost or the last couple of years and predict how the second quarter is going to look like or are there any key.
The changes this year.
Let's say last year.
Yeah. Thanks. Thanks for the question Brendan you want to take the first question in March 2nd one sure.
Sure and thanks.
Thank you so much for your question.
We're not really providing internal estimates on this concept of duration and persistency because there is of course going to be a range, but I'll give as much color as I can as to what were thinking first and foremost as we said we've learned an awful lot from the phase III study lavender and is a function of that we've known what to expect.
Specced, you've heard in the last couple of last couple of calls where we've talked about all of the support systems. We've put in place and obviously, we want nothing more than for patients and families to see the long term benefit that debut stands to offer.
From the work that's been done in <unk>. The additional work Thats been done in the open label extension and hopefully beyond so where there are a couple of things that lead us to believe that we can be supportive in the real world setting to get to those outcomes. The first we were obviously very pleased with the label the label allows us to.
Speak to discontinuation of anti constipation medications from the outset, that's very important.
Setup, the right treatment expectation with both clinician and family. The second is that we have proactively been able to work with the HCP audience and families to discuss educational efforts on GI management, both of those set those audiences up for the appropriate expectations as they move into <unk>.
Treatment with debut and then we support them in the field with the family access manager team, which I said these folks are paired specifically with each patient and family. So that we can be well positioned to hold their hands from the outset on the beginning of this treatment journey, both for the patients and caregivers. So for US we believe that sets up.
Best of all.
Patient experiences again looking to get to the long term benefit for debut and while we're in the very early days.
The.
The feedback we've gotten both from clinicians and families has been very positive about setting the appropriate treatment course, but more importantly, having the support necessary.
For them to begin and stay on that journey.
Thanks, So much Brendan Mark you want to take NUPLAZID seasonality.
No.
Thanks for the question as you know, we don't provide quarterly guidance, but let me just share some additional color, which I think will be helpful.
As we discussed on this quarter.
There tends to be some seasonality as patients for patients one as they go through the Medicare reauthorization process.
It happens for all patients in Q1, it's just that process just happens for new patients as we move on later in the year, so you'll have that.
That dynamic is tends to be more positive.
Going forward Q2 through Q4, we also have the higher gross to net.
In the first quarter, primarily due to the reauthorization process and our obligation for that for all patients that will be lower again in the second quarter and third quarter little higher in the fourth quarter typical with the seasonality that <unk> seen.
In past years I, just remind you. This year, we do have the impact of the inflation reduction act. So our gross to net will be higher year over year on a quarterly basis and consistent with our overall annual guidance.
And then as far as just seasonality between quarters, Obviously will report results as we go through.
Our revenues are obviously impacted by volumes patient volumes so how.
The results of patient volumes throughout the rest of the year will impact our sales on a quarterly basis.
Thank you.
Thank you everyone. This is all the time, we have for today I'll now turn it over to Steve Davis CEO for closing remarks.
Great. Thank you operator, thanks again, everyone for joining US today, we look forward to updating you on our progress next quarter.
Thank you for your participation in today's conference call. This concludes the presentation you may now disconnect good day.
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