Q1 2021 Intra-Cellular Therapies Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to intracellular therapies first quarter 2021 financial results Conference call.
As a reminder, today's conference call is being recorded.
I'd now like to turn the conference over to Dr. Juan Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.
Good morning on thank you all for joining us for today's conference call.
Our earnings press release provided provides a corporate update on details of the company's financial results for the first quarter ended March 31 2021.
This press release Crazy, where on a short time ago and he is available on our website at intracellular therapies Dot com.
Joining me on the call today on Dr. Sharon mates, Chairman and Chief Executive Officer, Mark Newman Executive Vice President and Chief Commercial Officer Doctor, So that Paragon Senior Vice President and Chief Medical Officer, and very high net senior Vice President and Chief Financial Officer.
As a reminder, during today's call we will be making certain forward looking statements. These statements may include statements regarding among other things.
Cause these safety on.
We intend to use on the company's product development candidates, our clinical and non clinical plans our plans to present or report additional data the.
The anticipated conduct and results before going on future clinical trials.
Regarding regulatory filings future.
Research and development, our planet and expectations regarding the commercialization of cup data potential impact of the COVID-19 pandemic our business on possible uses of existing cash on investment resources.
These forward looking statements are based on current information assumptions and expectations that are.
Subject to change on in both on a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.
These and other risks on this guy.
Made with the Securities and Exchange Commission, including our quarterly and annual reports.
<unk> net.
Play on your reliance on these forward looking statements on the company disclaims any obligations to update such statements.
I will now turn the call over to Sharon.
Thanks, Juan it's a pleasure to be here.
And welcome to today's call every line.
We are very excited to share our progress during the first quarter of this year.
First and foremost last week, we announced the acceptance by the FDA of our supplemental new drug application for Luna Tempur on for the treatment of bipolar depression with the produce the action date of December 17th of this year.
This marks an important milestone towards offering this important medicine for a broad group of patients living with bipolar depression, a complex and highly prevalent on a condition with significant unmet medical needs.
As many of you heard from our K O L call last week from the tap Ron given its efficacy and safety profile if approved will be a promising new medicines for these patients.
We are very excited about this opportunity and our commercial team is actively preparing to launch immediately upon approval.
I will now provide additional highlights of the first quarter, starting with our commercial progress.
Total revenues grew to $15 $9 million in Q1, 'twenty 'twenty. One we are pleased with couple items quarter over quarter prescription growth of 23% despite challenging market conditions due to COVID-19 continuing.
Kept lightest net product revenues for the first quarter were $15 $6 million versus $12 $4 million in Q4, 2020 and point $9 million in Q1 'twenty 'twenty.
Larry High line in Mark Newman will provide further details shortly.
I'd like now to summarize our pipeline progress.
I'll begin with our late stage programs. We recently made several presentations at the American Psychiatric Association annual meeting.
These presentations were discussed last week during our webcast with Dr. Roger Mcintyre Professor of Psychiatry, and pharmacology at the University of Toronto.
Dr. Mcintyre provided an overview of the mood disorders spectrum. He described the complexity of bipolar disorder, and the severity of bipolar depression, which represents the most common until attaining manifestation of this disease.
He underscored the unmet medical needs in bipolar depression, and major depressive disorder or M. D D and discussed how luma tapper on maybe an important option for these broad patient populations, given its efficacy and favorable safety profile.
In addition, he provided highlights of our poster presentations, which included results from our two phase III Studies study four O two and study four O four which form the basis of our S. N D as for the treatment of bipolar depression.
The efficacy of women wrong has been demonstrated in two positive phase three clinical trials, one evaluating limit tepper on as monotherapy and the second one is an adjunctive therapy with lithium or valproate.
The benefit of the woman around as a treatment for a broad patient population suffering from bipolar depression is further enhanced by its favorable safety and Tolerability profile.
Rates of Akathisia, restlessness, extrapyramidal symptoms and changes in weight and metabolic parameters and our bipolar studies were similar to placebo and consistent with the safety profile demonstrated in all other type of on studies.
Studies.
Expanding on the strong data, we have ongoing programs and other depressive disorders, including adjunctive treatment of major depressive disorder and treatment of depression in patients with bipolar depression or major depressive disorder exhibiting ex features.
There is a significant need for effective safe and well tolerated medicine for these highly prevalent psychiatric disorders.
We expect clinical conduct in our M. D. D. Adjunctive studies to begin later this year and clinical conduct in our mixed features program is ongoing and we expect top line results in the second half of 2022.
Our phase one safety and pharmacokinetic study with a long acting formulation of alumina kept around for the treatment of schizophrenia is ongoing we anticipate initial results from this study in the second half of 2021.
I also want to call your attention to some of our other pipeline programs first I'd like to highlight the important progress that we've made in our PDE one inhibitor platform.
As you have heard us discuss on previous calls this platform is focused on diseases in which the PDE. One enzyme is over expressed with a focus on diseases, where there's also abnormal.
Immune cell function that contributes to a diseases pathology.
This focus provides multiple therapeutic opportunities for our PD, one inhibitors across a variety of diseases, including Parkinson's disease heart failure and certain cancers.
As previously reported the benefits of PD, one inhibition in Parkinson's disease were demonstrated in our proof of concept.
Phase one two a study study ITI 214, one O five.
In this study our lead PD, one inhibitor languished Poten formally ITI 214 was shown to improve motor function reduce dyskinesia and lower biomarkers associated with inflammation when added to optimize therapies for Parkinson's patients.
We have published preclinical data showing that anti inflammatory effect of PD one inhibitors in the brain are mediated by controlling microglia brain resident macrophage like cells.
It may be important for altering disease progression in Parkinson's disease.
Based on these findings on this potent is advancing into a phase two clinical study in Parkinson's disease in the second half of this year.
Our goal for the Parkinsons program is to study the drug's ability to improve motor symptoms without causing troublesome dyskinesia improved cognition and preserve and restore neuronal function, which may lead to disease modification.
We recently shared with your preclinical data we presented at the American Association for cancer research on the potential anti tumor effect of PD one inhibitors.
We presented preclinical data supporting the potential of PD, one inhibition to enhance the anti tumor effect of other immuno therapies by altering the tumor microenvironment.
Hypothesize that PD, one inhibition would act by a similar mechanism in tumors in the periphery as they do in the brain to control aberrant immune cell function.
Our preclinical data presented at ACR showed that when our PD, one inhibitors and anti PD. One checkpoint inhibitor are combined tumor volumes were significantly reduced and tumor free survival, what significantly increased in a mouse model with colon carcinoma.
Our PD one inhibitors could represent a novel and broadly applicable approach to the treatment of immune responsive cancers.
We are also advancing a new molecular entity called ITI 12, 84 O D. T. S. L. A generated form of Luna Tapper on delivered sublingual <unk> as an orally disintegrating tablet.
This is the result of our efforts to evaluate different molecules and formulations for different patient populations with neuropsychiatric disorders.
Our phase one program showed ITI 12, 84 O D. T. S. L was rapidly absorbed into the systemic circulation with metabolically stable and resulted in high systemic exposure, making it suitable for study and the elderly population.
We plan to evaluate ITI 12, 84 O D. T S. L. In the treatment of behavioral disturbances in patients with dementia dementia related psychosis as well as in certain depressive disorders in the elderly.
These are conditions with large unmet medical needs and there are few effective treatments.
We are presently planning these studies and expect to begin. These studies later this year and in 2022.
We will provide further information about our plans as the year progresses.
We continue to develop I T I triple three or ITI 333, our novel oral modulator of serotonin and Mu opioid receptors for the treatment of opioid use disorder.
A phase one single ascending dose study evaluating the safety Tolerability and pharmacokinetics of ITI 333 in healthy volunteers is ongoing and we anticipate data from this study in the second half of this year.
Our expanding portfolio, including the recent editions of ITI, 12, 84, and I T. I Triple three demonstrates the strength of our Companys pipeline and our continued long term commitment to developing innovative therapeutics for central nervous system disorders.
I will now turn the call over to Mark following his remarks, Larry will provide details on our financial performance.
Thanks, Sharon and good morning, everyone. It's a pleasure to be here today with all of you.
We made steady progress with the launch of kept lighter for schizophrenia. During the first quarter of the year registering a 23% increase in total prescriptions versus the fourth quarter of 2020.
This performance came at a time of intensified COVID-19 impact during the winter months that limited psychiatry patient visits overall and increase the proportion of visits conducted through tele psychiatry.
Psychiatrists have generally been more conservative in their treatment approach and a tele psychiatry setting versus an in person visit, thereby reducing the frequency of treatment changes, including switches from other anti psychotics. This.
This has been particularly true for patients with more complex conditions like schizophrenia.
In personal sales representative access to physicians also continued to be impacted during the quarter as clinics and offices maintained visitation restrictions for industry Representatives.
More recently, we've seen incremental improvements in market conditions and remain optimistic that this should continue with more favorable dynamics emerging in the second half of the year, including increases in schizophrenia patient visits and greater physician access for our sales force efforts.
We continued to successfully execute our hybrid commercialization model of combined in person and virtual engagements and drove significant prescription growth during a time when the overall antipsychotic market declined slightly.
Importantly kept lighter has been very well received in the market by our target physicians.
We are very pleased with what we are hearing from doctors and seeing in our market research surveys regarding the use of cap line up for the treatment of schizophrenia.
Psychiatrists highly rate the performance of capital items efficacy and also point to kept light as favorable weight EPS and metabolic profile there.
They also appreciate the lack of titration and convenient single 42 milligram dose.
Couple of items market access position continues to be strong with coverage standing at more than 95% of covered lives in both Medicare part D and state Medicaid.
These are the major payer channels in schizophrenia, representing approximately 70% to 85% of all prescriptions for the treatment of schizophrenia.
Additionally, our Lydall, Inc. Patient support program continues to be highly effective and assisting prescribing physicians and eligible patients to gain access to capital items.
So in summary, we continue to be pleased with the commercial launch execution and performance of capital either in the market for the treatment of schizophrenia.
I'd like to now transition to our preparations for the potential approval of cap line out for the treatment of bipolar depression later this year.
As a commercial organization. We are extremely excited about this potential label expansion as it represents a significantly larger opportunity compared to schizophrenia.
There are about 11 million adults in the U S, who are living with bipolar one or bipolar II disorder.
These patients have few approved treatment options for the depressive episodes associated with the disorder.
These depressive episodes last longer and recur more often and manic or hypomanic episodes and they can be severely debilitating highlighting the urgent need for new therapies.
<unk> has the potential to be approved across the broadest range of patients with bipolar depression.
With indications encompassing both bipolar one and bipolar too.
And for both monotherapy and as an adjunctive treatment to lithium or valproate.
We've conducted extensive market research on bipolar depression, and believe that low <unk> clinical profile will be highly competitive for the treatment of this disorder.
Psychiatrists site efficacy and safety, particularly lack of weight gain and motor and metabolic disturbances as key drivers for their treatment selection for their bipolar depressed patients.
Given these treatment dynamics. It is not surprising that psychiatrists reacted positively to lumens helper on efficacy and a broad patient population and safety profile in our market research.
We know health care providers believe the distinction between bipolar one and bipolar two is clinically meaningful.
Given there is only one drug currently approved for use in bipolar depression. We believe this will be a strong differentiator for Loopnet heparin.
We are well advanced in our commercialization planning and are confident that we will be ready to launch as soon as we receive FDA approval for the treatment of bipolar depression.
Our market access team is actively working to engage payers on bipolar one and bipolar II.
And to increase access to cap lighter in the commercial channel.
Our target prescriber paying all will expand significantly from approximately 23000 for schizophrenia to approximately 44000 prescribers for the combined indications.
There is a large overlap between schizophrenia and bipolar prescribers. So we will be able to leverage our existing infrastructure, but will also incrementally add to our sales team prior to approval. So that it is appropriately sized to cover this large opportunity.
Our sales team will be trained and will be able to move quickly and reach a large prescriber base soon after launch.
Again, we are proud of the continuous strong commercial execution of capital items, and we are excited and ready to build on that success for additional indications to reach patients with bipolar depression.
With that I will turn the call over to Larry.
Gary.
Thank you Mark I will review our financial results from the first quarter ending March 31 2021.
In the first quarter, we recorded total revenues of $15 $9 million and net capital items revenues of $15 $6 million.
In the same period in 2020, we recorded $1 $1 million on total revenues and $9 million in product revenue was a couple items.
Cost of product sales were $1 $5 million on the first quarter of 2021 compared to $69000 for the first quarter of 2020.
Research and development expenses for the first quarter of 2021 were $15 $1 million compared to $16 million for the first quarter of 2020.
This decrease is due primarily to a decrease in manufacturing expense and offset by an increase of lumia temporary on clinical and non clinical expenses.
Selling general and administrative expenses were $52 $6 million from the first quarter of 2021 compared to $34 $1 million from the same period in 2020.
This increase is primarily due to an increase in sales related labor costs and commercialization costs.
Net loss for the first quarter of 2021 was $52 $7 million compared to a net loss of $47 $4 million from the quarter ended March 31 2020.
Cash cash equivalents restricted cash and investment securities totaled $613 $4 million at March 31, 2021, compared to $658 $8 million at December 31, 2020.
This concludes our prepared remarks, operator could you. Please open the line for questions.
It gets on to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
To withdraw your question press the pound key.
Again that is star then one if you'd like to ask a question at this time.
Our first question comes from Brian Abrams from RBC capital markets.
Oh, Hey, guys. Thanks, so much for taking my questions and congratulations on all the progress.
I guess, maybe starting with.
The our existing indications schizophrenia.
Hugh you mentioned that you're seeing some incremental improvements in market conditions. I was wondering if you could expand on that a little bit I guess I'm curious to what degree are you seeing any very recent changes in the delivery of psychiatric care with the pandemic waning now and I.
I guess, how much persistence do you expect telehealth to hat on as you sort of thinking about navigating any longer term.
Fundamental changes to the overall environment sort of how you manage through physician behaviors and potential switching.
Hi, Brian Thanks for the question I'll ask Mark to address that please.
Yeah, sure Sharon Hi, Brian Good question, Yes.
I would say the two main areas when we see when we say that we've seen incremental improvements in market conditions more recently.
On January and February were very challenging.
As cases of COVID-19 Roes as we moved into March and then into April caseload began to come down the country starting to open back up.
And we are starting to see.
Some improvements in the number of patient visits for schizophrenia patients coming back for their appointments. We are seeing our sales force incrementally be able to gain access in physician offices and clinics.
But we're still not back to pre COVID-19 levels in both of those we think that.
We're optimistic that we're going to continue to see these incremental improvements for a while and then in the second half of the year. We think that's when we're going to see the greatest advances.
In market conditions.
The one area that has persisted has been to use of Telus psychiatry. So this is an area that psychiatrists are adopted quickly.
And throughout the pandemic they've been maintaining the percent of visits through tele psychiatry at about the same level about 50% of the visits.
We do expect as conditions improve that the degree to which telemedicine is used in psychiatry will begin to come down.
But there will probably be some persistence that remains with telemedicine.
It's difficult to know what's going to happen with COVID-19 and difficult to know what's going to happen with.
Reimbursement for telemedicine.
But we would expect that that would begin to come down back more towards baseline in.
In the second half of the year.
Got it that's really helpful. Thanks, Mark and then on.
On the generated limit chaperone program.
Talked a little bit about the PK profile there.
Can you also talk about how maybe any differences there on the receptor profile such as on day, one of them you might have might be guiding.
Your decision to move that into dementia related behavioral disorders, and then maybe just quickly remind us on the IP for that and I'll hop back in the queue. Thanks.
Yeah. Thanks, Brian I think 12 84 the receptor profile.
And the PK.
We are going to present that data at a medical meeting so I think I'll leave it for right now suffice it to say that we believe that it is.
Advantageous for the indications that we're pursuing just to remind you on.
We have said that.
12, 84 quickly is absorbed in.
And his presence in the circulatory system and that we have good PK.
Hum.
In the normal healthy volunteers and then Lee Allen.
Totally population.
I would not look at there isn't new activity here, So I think you're confusing that with ITI triple three.
So.
And then you asked one more question on all of the IP on the eye.
The Pea is on and we certainly don't have the entire.
Patent prosecution portfolio, yet, but the patents that have issued them go into the 2000 and forties.
Got it that's super helpful. Thanks, Sharon.
Our next question comes from Jessica Fye with J P. Morgan.
Hey.
Thanks, so much for taking my question.
You said that youre working on increasing access or calculator in the commercial channel. What's your current commercial coverage and what's your goal for commercial coverage either.
You know to get to before or shortly after the approval in bipolar depression.
And also what the payer mix in bipolar depression.
Mark.
Yeah sure Sharon Thanks, Jessica for the question I'll start with your second part of your question first the <unk>.
Payer mix in bipolar depression is different than it is from schizophrenia as we've been communicating.
In the past in schizophrenia, or roughly 70% to 85% of all schizophrenia prescriptions flow through the government channels, either Medicaid or Medicare part D.
With bipolar depression being a different condition.
You see a lot more.
Of those prescriptions coming through the commercial channel that doesn't mean that there aren't cigna.
Significant prescription levels coming through Medicaid and Medicare for bipolar depression, but we will see an increase in in commercial.
As far as our access our focus because of that dynamic.
Dynamic for schizophrenia has really been to prioritize the Medicare part D and state Medicaid channels, where we have over 95% access to capitalize on both of those channels with commercial it's in the between 50 and 60% and we've made really good progress there.
We will be focusing during the course of this year, leading up to bipolar depression and shortly thereafter to get the commercial access up to the same levels that we currently have for Medicaid and Medicare as that becomes more important in bipolar depression.
Okay, Great and you also talked about expanding the sales team for live bipolar depression launch can you elaborate on that a little bit.
Yeah sure. So the the prevalence of bipolar depression is much greater than it is for schizophrenia. So that means there are more patients and therefore more physicians who care for those patients. So we expect to see in.
An expansion of our target audience size from about 23000 today with schizophrenia.
About doubling to about 44000, once we have the bipolar depression indication now.
There is a good degree of overlap in the prescribers of schizophrenia. So the good news is virtually all of the 23000 prescribers that we currently target for schizophrenia also treat high levels of bipolar depression, So we'll be able to leverage our existing footprint in our existing infrastructure to reach those.
Physicians, but the additional 20000 or so.
<unk>, who treat high levels of bipolar depression patients, but don't treat schizophrenia is for those physicians that we'll be expanding our sales force prior to the approval.
We don't anticipate.
Expanding the sales force by two times, which you might expect with a doubling of the size of the target audience, but it will be a significant expansion and we don't feel we'll need to double the size of the sales force because we do believe some of the changes in the commercialization model that we've seen during the pandemic where physicians.
Like to receive their information and be educated in a mix of ways. Both in person, which will continue but also now even more to a greater extent virtually and through digital means we think we'll be able to have a more efficient sales force with a greater number of targets and therefore, we won't have to double the size of the sales force, but there will be a significant.
Expansion and will be highly competitive at those levels with the existing companies that have products indicated for bipolar depression.
Okay, Great and maybe just the last one and apologies if I missed this and put back on line because I think in the past you've indicated a comfort with.
On a consensus which I look at Bloomberg right now Alex.
Slightly over $100 million core Cup lighter. This year are you still comfortable with consensus estimates.
So I'll start on that and then I'll ask if mark has anything.
To add to it to do so.
On.
What we we believe we have a great product a great team and we're confident continent kept of kept lightest commercial success and our ability to execute and our execution.
We are comfortable with current consensus for the year.
Of course it does.
On the rate of COVID-19 recovery, and particularly as it relates to the return of schizophrenia patients two office visits so as Mark mentioned the offices are opening up the community mental health centers or are seeing more patients are there start.
Going to allow people and and.
And of course, we're dependent upon.
The patient population that we treat.
Schizophrenics, which is a fragile patient population, they're returning to doctors' offices.
With that we are comfortable with the current consensus for the year.
Got it thank you.
Okay.
Our next question comes from Charles Duncan with Cantor Fitzgerald.
Hi, Sharon and team thanks for taking the question and congrats on a good quarter progress wanted to ask you first of all Mark a quick question regarding cash.
The survey work that you've done in.
In terms of the importance of black of waking in extra pyramidal side effects et cetera, being more important for be PD, one and two versus say schizophrenia in terms of prescriber.
Decision, making I guess I'm wondering are you are.
Are you specifically asking those questions of current prescribers or of prescribers.
Prescribers that have not yet prescribed capsulate on and what is the awareness of capsulate of for in terms of its profile for those you.
You know not current prescribers.
Yeah. Thanks, Charles Good question. So when we do our market research for new indications like bipolar depression.
We go out to physicians, who are high prescribers within that condition, whether their current prescribers of capitalize that or not so our market research would include a mix of both of those types of.
Prescribers and and you're absolutely right when we do that and we talk about what are the most important treatment drivers.
For them when considering what anti psychotic that choose to treat a patient with bipolar depression, obviously efficacy is very important to them. That's something that comes up right away, but very quickly safety and tolerability in particular weight gain but also metabolic disturbances movement disorders et cetera.
Are also very important.
In their treatment decisions and win in a market research setting. We then put the clinical data from Zuma Tempur, one in front of them and ask them to rate the performance of cap line and their likelihood to prescribe.
For that patient type.
Future they rate the product very highly they see the strong efficacy in the two clinical trials. They see the differentiated safety and Tolerability profile. If they are familiar with kept lighter already they see that the safety and tolerability in the bipolar depression trials was essentially replicated from what.
We saw on the schizophrenia trials and.
And that all leads to a very high intent to prescribe in bipolar depression for these prescribers.
That's that's helpful. Mark and then just sticking with prescriber dynamics in the first quarter versus what you're seeing in the second quarter. Thus far how do you feel about qualitatively about breadth versus depth in terms of prescribers within a practice versus broad gang.
The number of prescribers.
Yeah. Good question, Charles and we continued to be pleased with what we're seeing in both breadth of prescribing.
As well as depth of prescribing and we continue our marketing efforts.
Against both of those dynamics. So we continue to add significantly new prescribers each week.
And the existing prescribers, we continue to see the depth and increasing so I'd characterize it is at this stage of the launch.
We feel very good about what we're seeing there and we're going to continue our efforts in both of those areas.
Okay last question for Sharon in terms of the pipeline.
I'm really intrigued with broadening pipeline, particularly wanted to ask you today about $2 14, although interest in the rest of the pipeline as well, but in terms of 214 are in line rich who dying.
I'm wondering in terms of the P D indication.
Are you are you thinking about trying that first in early stage patients or in patients that are on already on dopamine therapy and given the mechanism. It would seem to me that theres potential use be on P. D. I'm wondering if you could provide some thoughts on that.
Sure. Thanks, a question Charles.
In our phase one two study these were patients who were on what day and their physicians believed were optimized treatment. So these are these are not very early stage patients because of course, they're not on these.
Yet when they're very early stage, so I think that while we do believe that our PD one inhibitors.
May in fact have potential to be disease modifying we are first testing on.
In helping patients with motor disturbances and the dyskinesia, which just to remind you. These dyskinesia is a caused by the medicines that they're taking.
So on.
We also do believe if you remember back to our preclinical data.
With our PD one inhibitors.
We we very.
Very effectively treated.
Their cognitive deficits either early or late either.
Recall our retained so.
So we believe that there is a potential for treating.
Cognitive deficits as well in this patient population.
Lastly, as as we've shown now both on.
In brain.
Ability to.
Yes.
Prevent on.
Neuro inflammation by preventing on Maclagan wheel activation in the brain and in the periphery.
Bye.
Bending the recruitment of macrophages to tumors that we can have an effect.
On on lease.
Appellations Upsells as well so and we think all of that comes together in Parkinson's disease in fact, the neuro inflammatory effects progression of disease.
The cognitive deficits you see in this patient population and of course their motive motor deficits and their dyskinesia.
Okay. Thank you.
Thanks for taking my questions.
Net income.
Our next question comes from Omar revert with Evercore ISI.
Hi. This is both of them are thank you for taking our questions.
First could you remind us.
Do you expect for the duration of therapy, Inc. As a free tier and bipolar monotherapy and bipolar adjunct therapy, we understand that our doctor of mercantile.
Event.
Mentioned that study for them to have very low dropout rate. If you could give us some color on that really appreciate it and second is on your ex U S. Commercial strategy are you waiting for the bipolar S. NDA approval to consider ex U S partnership or.
You already in discussion thank you.
Thanks.
I'm not sure I understand your question on duration of therapy.
For this class of drugs all studies are done.
On a short term studies on.
Both schizophrenia and bipolar depression patients.
We remain on their drugs.
On for very long periods of time.
Our compliance and if they don't drop out due to side effects.
If that doesn't answer your question I would ask.
Maybe you could.
We face it or say it again.
And then.
I'm now forgetting your second question can you ask that one again, please yeah sure.
The second question is on the ex U S partnership how Reits Orange Yeah.
Right.
Hmm.
We'll partner ex U S. I think we are.
First focused on on.
Our approval in the U S a for bipolar.
Polar depression, but you will see us partnering in other parts of the world.
Thank you very much and could you give us some color on the dropout rate in this study for it too.
Ooh I can't remember it off the top of my head on I don't know Suresh if you remember it or we can look it up and get back to you.
Later in this call or after the call.
Thank you very much and it was low yeah. Okay.
Our next question comes from Marc Goodman with SBB Leerink.
Hey.
Thanks for taking my question. This is Rudy on the line Hallmark. So I have two quick questions.
First can you provide some color on a growth tonight and the inventory changes in the quarter.
And secondly regarding the long acting injectable study.
Just curious with data from these background ongoing study and what next steps to move into a pivotal trial.
Yes.
So I'll take the long acting injectable question, but I'll wake for Larry to tell you about the gross to nets first.
Yeah.
Okay. Thank you thanks for the question.
As you know we've got several quarters of experience with gross to net for cap line up and.
Going forward for the balance of 2021.
We expect our gross to net to be in the range of the mid twenty's to the low thirties.
Hopefully that's helpful.
Yeah that works thanks.
And then I'll I'll take I'll take the long acting injectable question. So right now we are in the single life, sending dose study.
And what we hope to get to that is of course safety and tolerability as well as the PK.
Meaning that we have a sustained PK value in the range that what you're seeing for the oral therapy.
Following this study we would be doing a multiple ascending dose study. So we expect this data on the single ascending dose study later this year, we would then.
Begin the multiple ascending dose study.
On followed by we have an agreement with the FDA for one efficacy study.
Prior to.
Application for approval.
Got it that's very helpful. Thanks for the color.
Our next question comes from Andrew Tsai with Jefferies.
Hey, Thanks, good morning, and congrats on all the progress on my first question is just on the filing for bipolar depression did that after you happened to mention anything perhaps on your day 74 letter about their thoughts on whether to hosted on our comment on I understand that after you can do whatever it wants but would it be.
Usable for investors to rule out that scenario.
Hi, Andrew.
I think as we've seen over time.
I would never rule out anything about anything.
When it comes to drug development on approval.
On our day 74 letter did not address and outcome.
Okay. Thanks.
And my second question is on the ongoing.
Sales of capital I don't I mean, a competitor recently reported sales for their branded antipsychotic that missed consensus by a good amount. So do you have any thoughts what is going on in the overall marketplace and why cap lighter seemingly isn't being affected as much as the other competing on trucks.
Okay.
Mark do you want to take that and then I'll add.
Any day.
Yeah, absolutely. Thanks, Andrew for the question Yeah, we have as I said in my.
Proactive remarks, we have been very pleased with the steady progress that we're making the 23%.
Puerto over quarter total prescription growth.
Came at a time, a very challenging market conditions. When you look at the overall anti psychotic market during that same time period that we grew 23%.
That market actually declined slightly in the branded market declined even even more than that.
And as I think youre.
You're well aware there are some seasonality.
<unk> associated with that but I think the majority of that was.
Due to the challenging COVID-19 conditions that we saw especially in January and February win.
The case load really rose to a very high level now we have seen.
Recent incremental improvements in those market conditions, we are seeing higher level of patient visits we are seeing.
Some better access for our sales representatives.
But that's that's coming slowly during this quarter, we do think as the country continues to open that we'll see greater advancements in the second half of the year.
But the first quarter was a challenging one from a COVID-19 perspective, and I think thats, what youre seeing reflected in the overall prescription.
The market for the anti Psychotics. So we were pleased we think we executed well on this environment. We think we have a great product on the product continues to be very.
Very well received we're getting great feedback from physicians in our market research surveys and anecdotally through our sales force.
So we do expect to see that continued quarter over quarter prescription growth and revenue growth.
And the magnitude of that depends on on the rate of the COVID-19 recovery, how schizophrenia patients come back the access of our sales representatives.
But we feel good about.
How were executing in this environment. So I hope that's helpful.
I'd like to just return to Andrew's question before we go on to the next one because I'm not sure I gave you a complete answer on the real answers, but at the present time, we have no indication that we will have an ad com.
And we do believe that our application is straightforward and having said that as I said before on.
Our leather didn't have.
Any information required in that.
Perfect. Thank you.
Okay.
Ladies and gentlemen on the interest of time, we ask that you limit yourself to one question.
Our next question comes from Greg <unk> with Goldman Sachs.
Yeah.
Hi, this is not yet okay.
Yeah.
So on GE.
Okay, I guess all day.
Good day.
But the idea is just that.
Okay from that try it it's been a benchmark Bachelor Lake.
Okay.
I'm, sorry, you blanked out right at the important part of the question I know it was something about triple three but I don't know what you are you then went fuzzy can you repeat it.
Yeah sure so what could the idea of just how it look likes on the face when Tri Ed on our ITI <unk> in open I guess, all I know is that a benchmark that you are looking from.
Well, yes, so obviously.
It's extremely important that you demonstrate safety and tolerability so that.
That is overall.
Extremely important.
And then of course the PK. So that this is a single sending dose study.
And we started very low in dose.
And we have been escalating the dose to the different cohorts and we've now completed several cohorts and obviously looking to continue seeing safety and Tolerability, we've been seeing on to measure the pharmacokinetics.
And then we expect the results from this study by.
By year end.
And then we would go into a multiple ascending dose study.
Okay Gotcha.
Yeah.
Our next question comes from Nish, Mani <unk> with Bank of America.
Hi, Thanks for taking my question congrats on the on the progress Hum COO I have just one quick one I wanted to ask about the kept light has slipped a little thin.
Well that any extraneous factors impacting the <unk> side from COVID-19.
I ask that because the sequential growth went from 74% in <unk> to 22% didn't want to and do you think this kind of growth will bounce back from on two levels as I realize that though you need at least 20% growth for the remainder of the year to hit the consensus.
So mark maybe you could take that and you can talk about the anti psychotics in general.
What we've seen.
Yeah. Good good question Ash and.
Yes, I think in the in the overall anti psychotic market. The first quarter of this year versus the fourth quarter of last year.
There was actually a slight decline in the number of prescriptions and when you look at the oral branded market.
It was a more significant decline overall, so during that time cap lighter was able to grow.
At 23% I think what you see in the first quarter is a combination of.
Some seasonal effect where.
Patients are required to get reauthorization on on prior authorizations, you see some impact on revenues of Inc.
Increased gross to net for certain products because.
There is more out of pocket.
Raymond assistance provided to patients now what I would say with capped lighter is we are affected to a lesser degree.
By those things because our predominant patient type is the dual eligible.
Medicare patients that is not.
Exposed to high deductible insurance plans or to a little bit later going into the donut hole or exempt from that so we're not hit.
On the on the revenue side from that on the prescription side kept light is subject to some of the same reauthorization seasonal impact that you see in the first quarter that will begin to go away in the second quarter and get better as the year goes on.
And so we do expect to see continued quarter over quarter growth in prescriptions and revenues for cap line.
And as I mentioned, we have seen some ring incremental improvements recently in March and April to the market conditions due to COVID-19, we expect that to continue but.
But we expect to see the greatest advancements there in the second half of the year and that's when we believe we will see further prescription acceleration.
But again, we feel good about the product.
How well it's being received we feel good about how well the team is executing even during challenging market conditions, and we look forward to that.
As conditions improving in.
And really having the opportunity to drive prescription growth for cap line of uneven even greater expense.
Yeah got it thank you.
That concludes today's question and answer session I'd like to turn the call back to Dr. Knight for closing remarks.
Thank you everyone for participating on today's call, we look forward to updating.
Updating you on as.
As we get updated and we look forward to.
On bringing new medicines to patients and to them.
On Paducah date, or bipolar depression, we're very excited about that here at intracellular therapies.
Operator, you can now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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