Q1 2022 Intra-Cellular Therapies Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the intra cellular therapies.
First quarter earnings call at this time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press Star then one on your telephone keypad.
As a reminder, today's conference call is being recorded I would now like to turn the conference over to Dr. Juan Sanchez, Vice President corporate Communications and Investor Relations y.
Good morning, and thank you all for joining us on the call today.
Our earnings press release provides a corporate update and details of the company's financial results for the first quarter ended March 31st 2022.
This press release is available on our website.
The cellular therapies dotcom.
Joining me on the call today, a doctor Sharon mates.
Chairman and Chief Executive Officer, Mark Allen Executive Vice President and Chief Commercial Officer.
Doctor So that store, then executive Vice President and Chief Medical Officer, and Lori Hyland.
Senior Vice President and Chief Financial Officer.
As a reminder during.
During today's call, we will be making certain forward looking statements. These statements may include statements regarding among other things the efficacy safety and intend to use the company's product development candidates, our clinical and non clinical plans our plans to present or report additional data.
The anticipated conduct countries talk ongoing and future clinical trials plans regarding regulatory filings future research and development, our plan and expectations regarding the commercialization of Cup later potential impact of the Covid pandemic on our business and possible uses of existing cash.
Cash and investment resources.
These forward looking statements are based on current information.
Since then expectations.
Those are subject to change and even pull 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 described in our filings made with the Securities and Exchange Commission, including our quarterly and annual reports.
<unk> not.
And not to place undue reliance on these forward looking statements and the company disclaims any obligation to obey such thing.
I will now turn the call over to Sharon.
Thanks, Juan good morning, everyone and welcome to today's call.
I'm pleased to present, our first quarter 2022 results and to provide an overview of our strong launch of kept lighter in bipolar depression.
Additionally, I will share our progress with our clinical development programs and other pipeline programs.
We launched kept light in bipolar depression immediately following FDA approval in late December of last year, and we're off to a great start.
Following this important label expansion kept lightest prescription growth has accelerated significantly.
In the first quarter kept light and new prescriptions increased by 63% and total prescriptions increased by 45% compared to the fourth quarter of 2021.
Compared to the first quarter of 2021 in Q1 2022, new prescriptions increased by 154% and total prescriptions increased by 134%.
Consistent with this strong demand has been highly positive feedback we are receiving from physicians regarding kept lightest clinical profile in a broad range of patients with bipolar depression as well as their early experience with patient care.
Right. It is an important treatment option to help individuals living with bipolar disorder. We are confident in Capsulitis continued growth for several reasons.
First kept light it is a novel anti psychotic.
With its strong clinical profile, which is clearly reflected in its broad label.
There are only a few approved treatments for bipolar depression, which affects more than 11 million U S. Adults.
Kept light it is the first and only treatment approved for both bipolar one and bipolar depression in adult.
<unk> as monotherapy and as adjunctive therapy with with the inland Valproate.
Depressive episodes in patients with bipolar one or bipolar two disorder are significantly more common in mania or hypomania in our link to worst prognosis greater impairment decreased quality of life.
And increased suicide rates.
The prevalence of bipolar one and bipolar two disorder are similar.
Bipolar two is often characterized by a higher frequency of depressive episodes that last longer with lower overall functioning then bipolar one.
I heard you kept lightest approval only one drug was approved for bipolar depression.
Second physicians and patients are looking for effective treatment with favorable side effect profile and kept lighter has shown consistent efficacy across a broad patient population with a favorable safety and tolerability profile.
Bipolar patients consistently identify wait and acres seizure of side effects of great concern.
Importantly across our clinical trials weight gain was similar to placebo and in fact.
In our longer term open label study patients with bipolar depression, and no weight gain from baseline for six months, while patients with schizophrenia lost an average of 77 pounds in one year.
Additionally, fasting glucose total cholesterol triglycerides and EPS, including Akathisia were also similar to placebo.
In recent market research psychiatrist highly rate kept lightest performance on efficacy and safety measures.
Third kept light administration is simple and straightforward.
It is a once a day medication. It does not require dose titration, starting doses at therapeutic dose and can be taken with or without food.
To address special populations. We recently received FDA approval for the expansion of the capsule Ida label. This label provide dose adjustment recommendation for patients concomitantly, taking stronger moderate ship 384 inhibitors and for patients with moderate or severe hepatic impairment.
This label expansion allows an even greater patient populations have access to capital light.
Finally, our confidence about Capsulitis continued growth is further fueled by our strong commercial team their launch execution and the improving market conditions as Covid continues to subside.
Mark will provide more details on our launch in a few minutes.
We're pleased to report that total revenues were $35 million for the first quarter of 2022, representing a 120% increase over the same period of 'twenty, 'twenty, one and a 36% increase quarter over quarter.
Larry will provide additional details in our financial performance in his remarks.
In addition to our commercialization of kept lighter we have ongoing programs to expand our label to include the treatment of a broad range of mood disorders, including major depressive disorder or M. D. D and mixed features an M D D with bipolar and Paula bipolar depression.
These disorders, which affect millions of patients have important unmet medical needs.
Patient enrollment is ongoing in our Registrational M. D. D studies evaluating limit taproom Hasnt adjunctive treatment antidepressants.
We expect to file a supplemental new drug application with the FDA for approval of Lumia tap along as an adjunctive therapy to any depression for the treatment of M. D. D in 2024.
In addition study for all three are study evaluating the antidepressant effect of alumina tapped wrong in patients who exhibit mixed features with bipolar depression or M. D. D is ongoing.
We expect to complete clinical conduct of this study in the second half of this year.
We are also advancing our alumina tapper on long acting injectable program for the treatment of schizophrenia, which is currently in phase one clinical development addressing different formulations and additional sites of injection.
In addition to Luna Taproom, we continued to expand our robust pipeline with ITI 12, 84 O D. T. S. L. Our phosphodiesterase, one or PD, one inhibitors and a T. I D. Three three.
In 2022, we are advancing ITI 12, 84 for the treatment of agitation in patients with probable Alzheimer's disease, followed by studies in dementia related psychosis and certain depressive disorders in the elderly.
We also plan to begin patient enrollment in our phase two clinical study of our lead P. D E. One compound languished poses for the treatment.
Parkinson's disease shortly.
In addition, we have successfully completed a phase one single ace sending dose study for ITI 333, and plan to continue its development with neuro imaging studies to support dose selection for future studies, including a phase one multiple ascending dose study.
We ended the first quarter with $773 2 million in cash cash equivalents and investment securities and.
In January we received $433 7 million in net proceeds from a public offering of common stock we have no debt.
Across all our efforts our goal remains the same we're developing effective innovative treatments to improve the lives of patients with neuropsychiatric and neurologic disorders.
We're very proud of our team and the progress we've made towards our goals. We're encouraged by our performance to start off the year and look forward to bringing kept later to increasing numbers of patients in the months ahead.
I'll now turn the call over to Mark who will provide additional details about our successful launch.
Sure.
Thanks, Sharon and good morning, everyone. It's great to be here with all of you today.
Following the exciting approval of cap lighter for both bipolar one and bipolar two depression in late December Q1 marked the first full quarter of the launch of our expanded label and.
And as Sharon mentioned it has been a very successful initial launch.
Kept light or is seen a robust uptake and strong upward inflection in prescription trends growing new prescriptions by 63% and total prescriptions by 45% versus the prior quarter.
This strong performance is driven by a well differentiated product profile broad market access and successful sales and marketing execution.
Initial feedback from physicians is highly positive regarding the favorable efficacy and safety and Tolerability profile of Keppel Ida in bipolar depression.
We've seen utilization of cap lighter across a broad range of patients, including both bipolar one and bipolar depression and as both monotherapy and adjunctive use.
Newly diagnosed patients are being started on cap lighter as well as those switching from other anti psychotics.
Switches to cap light are coming from both branded and generic products.
New patient starts as reflected by new to brand prescriptions or N. B Rx have increased approximately 300% following capitalizes bipolar depression approval.
New to brand prescriptions reflect early adoption by prescribers and this metric is considered a key leading indicator of future prescription growth.
We expect the upward trajectory in new to brand prescriptions to continue throughout the launch phase of our bipolar depression indications and are confident in continued overall growth of the brand.
We continue to maintain broad formulary coverage for cap lineup, including greater than 98% of patients with Medicare part D and Medicaid and over 80% in the commercial channel.
We expect additional coverage gains in the commercial channel in the coming months.
Since the bipolar depression launch we have seen a rapid increase in the number of commercial patients being prescribed cap light up and expect to see additional growth in this channel through the remainder of the year.
Supporting this rapid uptake or lighter link program is effectively supporting patients through the prescription process as well as minimizing out of pocket costs for those with commercial insurance.
Our sales and marketing team is executing a comprehensive launch plan and our commercial efforts are sized to optimize the large market opportunity in both bipolar depression and schizophrenia.
During the first quarter, we saw improving market conditions relating to patient visits and physician access for our sales force.
Our sales force continues to seamlessly execute a hybrid commercialization model combining primarily in person presentations with supplemental virtual engagements.
These efforts are supported by extensive medical education programming and comprehensive digital initiatives to extend the reach to our target physician audience.
We're also proud to announce our new led in the light direct to consumer campaign, which we launched in early April .
Consisting of a national television ads, social media and other digital initiatives.
Let in the light campaign reaches out to people suffering from bipolar one and bipolar depression as well as extending awareness to prescribers.
We believe patients with bipolar disorder are particularly receptive to this type of campaign because they are typically well informed and vocal about their depressive symptoms and side effects with their existing antipsychotic medications and they are proactive in discussing these concerns with our physicians.
In summary, I'm very pleased with our current growth trends and the feedback we are hearing from health care providers and patients and I'm excited about our future growth.
We have a strong commercial plan in place and our team will continue to execute to drive results.
I'll now turn the call over to Larry.
Larry.
Thank you Mark I will now provide a summary of our financial results for the first quarter ending March 31 2022.
Total revenues in the first quarter grew to $35 million compared to $15 $9 million in the first quarter of 2021.
In the first quarter, we reported net product revenue of capital either a $34 $8 million compared to $15 6 million for the same period in 2021 and $25 $5 million in the fourth quarter of 2021.
The first quarter of 2022 gross to net percentage was in the low thirties consistent with our prior guidance as Mark mentioned, we had an increase in the number of patients in the commercial channel since the bipolar depression approval. This together with standard Q1 seasonal payer dynamics contributed to the gross to net increase for prior.
Quarters.
We expect cap line is gross to net percentage to remain consistently in the low thirties throughout 2022.
Cost of product sales were $3 $2 million in the first quarter of 2022 compared to $1 $5 million for the same period in 2021.
Research and development expenses for the first quarter of 'twenty, 'twenty, two or $29 million compared to $15 $1 million from the first quarter of 2021.
This increase was due to higher alumina tempur, one clinical trial and non clinical related costs and an increase in non lumi pepperoni project costs.
Selling general and administrative expenses were $75 $5 million for the first quarter 2022 compared to $52.6 million for the same period in 2020 one.
This increase is primarily due to an increase in commercialization marketing and labor related cost.
Net loss for the first quarter of 2022 was $72 $1 million compared to a net loss of $52 $7 million for the first quarter 2021.
Cash cash equivalents restricted cash and investment securities totaled $773 2 million at March 31, 2022, compared to $413 $7 million at December 31, 2021.
On January seven 2022, we completed a public offering of our common stock in which we sold approximately 10 point 95 million shares of common stock for aggregate pros gross proceeds of $460 million and net proceeds of approximately $433 $7 million.
This concludes our prepared remarks, operator could you. Please open the line for questions.
Yeah.
Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue simply press the pound key.
Again, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
Our first question or comment comes from the line of Andrew <unk> from Jefferies. Your line is open.
Okay. Thanks, and good morning, Thanks for taking my question Congrats on the great quarter. So last quarter, you all as well as this quarter you mentioned there.
Set of leading indicators that we're looking favorable which helped drive our costs. So can you kind of remind us one more time at what these leading indicators or if any of them have slowed down this quarter or are all of them still trending in the right direction or even accelerating so I'm just trying to gauge your confidence there.
You know momentum should indeed continue to accelerate throughout 2022.
Good morning.
Andrew and thanks for the question.
I'll ask mark to address that.
Yeah, sure Sharon and thanks, Andrew for the question Yeah, There's there's really three leading indicators that we look at it first and foremost we look at our new to brand prescriptions, which really represents.
The adoption of a new medicine or new indication for that medicine by.
By prescribers and is really considered to be the key leading indicator of future prescription growth and with new to brand prescriptions. Since we launched the bipolar depression, we've seen about a 300% increase in that metric and that continues to trend.
In a very positive direction. So we're very pleased with what we're seeing in the Newport New to brand prescriptions. Another thing we look at is a sample demand samples of the product.
And since the launch of the bipolar indication.
We have been getting seeing a very high level of demand for samples and that demand is continuing.
Physicians are identifying new patients to put on cap light up and looking to start them on a sample to assess the effectiveness and the safety and Tolerability and.
And that sample demand as is continuing and then finally, just the the feedback that we get from physicians about their current views and their expected future use of cap lighter.
And those trends are continuing to look very positive as well so to your point Andrew across the board when we look at the leading indicators are they're all pointing in the right direction and are suggesting continued future growth of the brand, especially in the new bipolar indication.
Okay very good and a very quick one is is it fair to assume.
There was indeed, no you know warehousing effect in Q1 that sales did grow organically through sales reps and marketing or even word of mouth.
Yeah, I'll stop there thanks.
Yeah sure Andrew that that that's our assessment and that's our belief that there wasn't a significant bolus of patients out there just waiting to be put on another.
Another antipsychotic. We believe this is true organic growth, there's a lot of excitement about the new indication for cap Lidar, there's a great deal of interest and support of the clinical profile and the feedback that we're getting from physicians of their early experience with their patients.
<unk> has also been very positive. So all signs are pointing to a very strong launch and that continuing.
Great. Thank you guys very much.
Thank you. Our next question or comment comes from the line of Jessica Fye from J P. Morgan Your line is open.
Hey, guys. Good morning, Thanks for taking my questions.
Mark You mentioned, you expect new to brand scripts to continue to grow throughout the launch phase in bipolar depression I'm curious how long is a launch phase in your mind.
Second question should we think of net price over the year improving as it is for some other companies.
<unk> often has the highest gross to net discount.
Or maybe because your gross to net.
Being driven by a payer mix shift is bipolar depression use grows.
We expect gross to net discounts to widen over the rest of the year.
For a little color there and lastly, I think you mentioned commercial coverage would continue to grow from around 80% now where do you see it leveling out and when could you get there.
Sure. Thanks, Jessica I'll I'll take the first part of the question and the last part of the question and then perhaps I'll turn it over to Larry to make some comments on.
Net price and gross to net so in in the launch phase of Jessica It varies depending on the category of the product a new indication new launch et cetera, but generally you can look at the first six to 12 months of a product indication as the launch phase in.
Given the strength that we've seen in the new to brand prescriptions, we would expect to see that continue during that timeframe and all signs are pointing to that happening.
In terms of the commercial coverage, yes, we are.
As we've said before we've taken the coverage in the commercial channel from about 55% last year up over 80% at the time of the launch and we do expect that to continue to climb in the coming weeks and months and we would expect to see that.
<unk> move up towards the 80, 590% range, perhaps even higher.
And we think that gives us a very broad coverage across all three of the channels and combined with our lighter link program really provides strong access to the product for patients. So that that's not a barrier.
In the marketplace are for the uptake of the product.
So with that maybe Larry I'll ask you to to comment on on net price and gross to nets.
Sure Jessica as you know that we've had a rapid uptake of cap light in the commercial channel in Q1.
As you know this is essential for successful launch, but what also.
The uptake and the child did result in higher utilization of our co pay assistance program, which impacts gross to net negatively.
And.
Secondly, the seasonal payer dynamics as you see with many other drugs the impact of co pay assistance programs is greater in the first quarter of the year due to the seasonal payer dynamics now what we see going.
For the rest of the year, we were in the low thirties and the first quarter, we see it staying in the low thirties for the rest of the year.
And.
One of the reasons is that there is less impact of seasonality and also the you know the impact of the mix of the Medicaid channel as that decreases. So there are pluses and minuses, but we expect to stay in that low thirty's range for the remainder of 2022.
Thank you. Our next question or comment comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.
Hey, good morning, Sharon.
Team congratulations on a great first quarter. Thanks for taking my question.
Did have a kind of a follow up to an earlier question for for Mark regarding the market feedback or if he could just really kind of provide us some color on the kind of feedback keeps getting from prescribers what is it about.
And its profile in terms of driving.
Adoption for PPD is it is it really on the efficacy side or safety and then can you provide us any color on that.
Patients regarding persistence in this particular population versus say is schizophrenic patient population.
Yeah sure Charles Thanks for the question and to answer the first part of the question. It really is all of the things you mentioned so what we're hearing back from physicians is that they are very impressed by the proven efficacy first and foremost in both bipolar one and bipolar two and the F D. A.
The approved indication in both of those disorders. So it all starts with safety our it all starts with efficacy.
But what they also are really highlight as a differentiation for capital item is the safety and Tolerability profile.
Sharon had mentioned in her.
Our initial comments that both weight gain and akathisia are two side effects of great concern to patients with bipolar disorder.
Based on some of the limitations of the existing anti psychotics that they had been using and in our clinical trial program changes in weight, where similar to placebo with cap lighter and.
And akathisia and other EPS measures were also similar to placebo and physicians are experiencing the same safety and tolerability profile in the bipolar depression patient population as they saw in the schizophrenia population. So that gives them a great deal of confidence that they can prescribe capital.
Later, they'll see the efficacy and.
And they're sure that there is a good and favorable safety and Tolerability and then in addition to that.
The dosing a single 42 milligram dose once a day without regard to food the physician can start the patient on the effective dose without having to titrate over multiple weeks to get to that point and then maintain the patient on that same dose and that's being viewed very much as a benefit as well.
The second part of your question regarding persistency, what we have seen historically.
Is that patients with bipolar disorder tend to persist with their medication their antipsychotic.
A bit longer than patients with schizophrenia, do and while it's still too early for us to gauge that with cap later.
We do believe that we will see a similar dynamic in patients with bipolar.
Those with schizophrenia, and as we get that data.
In the coming months, we'll share that with you.
Thank you. Our next question or comment comes from the line of Brian Abrahams from RBC capital markets. Your line is open.
Hey, good morning, Thanks for taking my questions Congrats on the launch.
I'm just curious if you could expand a little bit more on access for cap lighter now that you've expanded the commercial channels and with regards to just any potential barriers or step edits, what's sort of the average time to get started on kept lighter and then I'm also curious if you could speak about what type of pull through you might expect from the April .
TTC campaign in and when we might see that start to manifest. Thanks.
Mark Yeah sure Yep sure. Thanks, Sharon Thanks, Brian Yeah. So we were very pleased with the broad access that we have across all three channels Medicaid Medicare part D and the commercial channel.
Depending on the payer.
Each one has a different utilization criteria a certain plans make kept light available unrestricted which means that the physician can write a prescription for cap lighter regardless of the indication if they feel that that kept light is right for that patient theres, others that employee and electronic step edit.
Which means that they first want to see the patient started on one sometimes two generic products.
The dynamic in bipolar is very similar to schizophrenia that the the vast majority of patients have already.
Cycled through a one to three different anti psychotics and this happens behind the scenes that the pharmacy. So it's not something that the physician or their office staff needs to do and.
And it is not a barrier at all to the patient being prescribed kept light up and then there are some that have a prior authorization in place and typically the prior authorization is the payer just wants to make sure that the patient is being prescribed cap light F or an on label indication either schizophrenia or bipolar.
Freshen and we have the the lighter link program to help physicians and their office staff to navigate that process.
And again it is not a significant barrier to to access to the medicine for.
For patients or for the physicians that are prescribing it.
In terms of the D. T C where we're we're very pleased with the early metrics that we're seeing in terms of interest that is being generated.
By looking at the increase in searches uncapped lyda increased traffic to our website and we would expect to see the impact of that and.
You know typically you see it in a four to eight week period of time. After you begin airing your television commercial and we're about a month into the airing as we started it in early April so we look forward to that as well.
Thank you. Our next question or comment comes from the line of Umar Rifat from Evercore. Your line is open.
Hi, guys. This is a mighty jewelry in for Omar. Thanks for taking my question and congrats on the quarter I have a two parter on the.
Mixed feature study if I may.
The design of study 403 is very similar to that of the adjunctive MTT trials in terms of the primary endpoint you have mattress at day 43, as well as in the number of patients enrolled so I guess my question is since patients with mixed features have greatest symptom severity and are harder to treat is the powering for a free adequate and if you can what are the powering.
Assumptions of that study.
Secondly, again since this population is historically harder to treat.
Is there any what gives you confidence that limit tap room would be efficacy in handling the mania aspects of these trials and is it maybe something that that we should.
Be more worried about and in this disease state. Thank you.
So good morning, Mike and Thanks for question I think.
I was going to start.
Comments, but maybe the rash do you want to start and first talk about what Nick's features is so that everyone on the call understands that and then talk about mania and how.
How we are you know.
We certainly monitor for ammonia.
Well as depression, and then just talk a little bit about our study design.
Yes.
Good morning.
In that.
In terms of the mix feature.
Patient.
Sure.
With both unipolar.
That has major depressive disorder and bipolar disorder.
Exhibit manic.
Hi, Paul.
Below the clinical threshold.
Of these symptoms during the course of the episode so that is the patient population we're studying.
It's a specified within the vehicle.
And this applies to patients.
<unk>.
And both in the.
Unipolar Department and also in bipolar.
Okay.
And they need to have something.
Hypo mania.
That is below the clinical threshold.
And the importance of this is because these symptoms are difficult.
Diagnose these.
These patients have greater.
Yes.
The how HIFU sideways.
I think currently.
Also the high Comorbidities.
And.
With antidepressant.
The only respond rounded it booked them.
But based on our studies.
In our bipolar.
The person in our programs that are complete that we looked at.
The subset of patients with.
And where we have seen.
And we just patient.
And that's what led us to design the study.
Our current credit.
Ah patients with vascular diagnostics really meet the criteria for a mixed picture.
In the current ongoing quarter to be steady.
And the primary endpoint for this.
At week six.
And then second.
Maybe.
Secondly.
And these patients we will include both patients coming in from major depressive disorder as well.
From bipolar one or two.
Yep.
And.
This study is not adequately powered.
And we are.
On target right now are completing the enrollment by end of this year.
So and then to address your question, Mike So first of all.
We have not.
Talked about the powering of the study, but obviously.
It is powered to do.
To look at efficacy appropriately.
A question about that.
Hum.
We do.
All of our bipolar studies.
L a monitor for ammonia and.
And we don't see patients.
Flipping to mania overall.
We have not seen that in any of the bipolar subsets either.
So I think were very good and knowing that we're not shifting patients.
Yeah.
Thank you. Our next question or comment comes from the line of Marc Goodman from S. B V Securities. Your line is open.
Mark.
Good morning, Mark or these patients these mixed patients.
Using anti Psychotics any way I mean, I guess, what I'm getting at is if they're using it anyway. How important is the new indication how much of a inflection point should we see when you get that indication hopefully when you do just trying to understand how much off label those already.
Usage there.
And then secondly can you just give us an update on the depression studies, how enrolments going some companies have had some trouble with enrollment obviously, it's not just COVID-19. It's also you know.
Because of the.
The Russia, Ukraine engagements. So can you talk about that a little bit and how the enrollments going thanks.
So mark do you want to take the first part of your question and then I'll comment on.
On the clinical trials yeah.
Yeah, maybe just to clarify mark when you're asking that question is that is that a follow on question to the mixed features patient population.
Or are you talking about the bipolar indication.
Okay. I think we are Mark may have may have hung up on that so sharron, maybe I can speak to the bipolar portion of that and then maybe you are Suresh could speak too mixed features if that's the focus of Mark's question.
For me as a as a commercial person theres really two big advantages to our product being a on label for a particular indication one when a physician sees that.
Product has passed the rigor of efficacy and safety and Tolerability and an indication for specific disorder. Like this it gives them a lot of confidence that they can use in four cap light in bipolar depression, when they see both bipolar one and bipolar two depression being on label.
This gives them a great degree of confidence that the patient in front of them.
Whether they have bipolar one or bipolar to Keppel Ida is an excellent choice for them. The second thing for US is that what this allows our commercial organization to do is to engage in promotional activities.
Around the on label promotion, which other companies with products that arent labeled for that cannot do so for me. There's there's those two big.
Advantages of having something on label as we do with bipolar one and bipolar depression. So.
So with that maybe I'll turn it over to Sharon and and Suresh to comment on the second part of the question.
Okay.
I'll start and I don't know.
<unk> was able to rejoin or not but I know it is an important question about what's happening.
Russia and the Ukraine.
Our enrollment.
The study and I.
I think as we've told you before.
For.
All of our studies are global studies and what we have done is put in place mitigation strategies.
Whereby we have been able.
To mitigate the effects of Russia and Ukraine.
Enrollment and so.
We can tell you that our studies are ongoing.
And what we have done is mitigate again.
For Russia, and the Ukraine, and we are still on track.
For our filing in 2024.
N D D as adjunctive treatment in <unk>.
Depression.
Thank you. Our next question or comment comes from the line of Sumit Kulkarni from Canaccord. Your line is open.
Good morning, Thanks for taking my question and nice to see all the progress I have a couple of quick ones first how important is the recent approval of the 10.5 Mg in 2021 mg strength and their ability to round out the currently approved indications and potentially target MTBC too.
Second on 12 84 is it fair to assume that your ascending dose study that's already baked the collection of optimized dosing spoke clinical studies in the elderly that are supposed to start later this year.
Yeah.
I'm, sorry, I have to tell you I missed that can you repeat the question. Please.
Oh sure. So the first one how important is the recent approval of the pinpoint by 'twenty, one big strength.
And the second was on 12 80 food.
Do you already have optimized doses selected for the clinical studies the elderly that are set to start later this year.
Great. Okay. Thank you, so I'll start and I'll ask Mark for Suresh.
Have any comments to add.
So.
The recent approvals of $10 five and in 'twenty. One milligram are for these special populations those with hepatic impairment.
And those 384 inhibition.
So that means they're taking.
Other drugs that.
Inhibits.
For so while these are especially for schizophrenia.
Because it's a smaller population overall it impacts a smaller number of people.
The larger we get and your indication obviously the more patients can be impacted so we think that it is an important option for.
That small percentage of people who.
Need dose adjustment.
That's the first answer.
And for 12 months 84, we are we are still.
Looking at certain things like we wanted to look at.
Occupancy of different receptor function of 12 84 to ensure that we that we have selected.
Yeah doses.
For our next studies.
I don't know Suresh did you want to add anything on the importance of $10 five and 21 milligrams.
Yes, I would say that it's important.
Actually for the special populations.
No.
And for both system that is.
Small percentage of patients.
Who will be on that.
Airport inhibitor, all export any severe hepatic impairment.
With us for a while.
Sure.
All right.
So in that sense it is important.
Right.
One thing I wanted to remind us.
These dose does not justify the special populations that have not.
Both the titration.
Titration.
Thank you. Our next question or comment comes from the line of Jason <unk> from Bank of America. Your line is open.
Hey, guys. Good morning, Thanks for taking my questions.
I guess first one just curious if you guys have seen any impact at all from the competitive blocks of alkermes the ball.
So you're schizophrenia business and then my my second question is just I'm looking at rail our gross to net sort of the person or the gross sales or net sales dynamic it looks like around 25% to 30% gross to net so just curious like directionally.
Their sales mix is probably similar to how both the street forecast kept lighter sales mix is that a good kind of medium term indicator again on a directional basis not looking for guidance. Thanks.
Mark do you want to take that.
Yeah, maybe I can take the first part and then I'll I'll have Larry comment on the on the gross to net so Jason Yeah. We were we were focused on on cap line that we're focused on.
Serving patients and driving cap line of business, what I would say about our schizophrenia business is we have seen in addition to very very strong growth in bipolar depression. We've also seen our schizophrenia business continued to increase and continue to grow and I think our expectation is that over time.
As physicians get more and more awareness of kept lighter and more and more experience with cap lighter in other indications like bipolar depression, there will be a positive halo on their prescribing in schizophrenia as well and we are seeing those increases in schizophrenia also so with the second part of the question with the gross and that's perhaps Larry you.
You could comment on that.
Yes, I mean, I really can't comment on another company's gross to net I I did mentioned that our gross to net in the first quarter was in the low thirties and that and that was impacted by a seasonal payer dynamics in that you know with.
Some adjustments up and down we should still see our gross to net going forward in 2022 and are in the low thirties.
I don't know if I can give you any more color than that.
Thank you. Our next question or comment comes from the line of Corinne Jenkins from Goldman Sachs. Your line is open.
Good morning, everyone. I'm curious if you have any visibility on the patients that are coming on to drug.
The bipolar indication and those are primarily bipolar one or bipolar too and how this compares to what you might expect given the more limited competitive auction for two in particular.
So I'll just yeah sure sure go.
Go ahead Sir.
Let me start with an overall statement ill turn it over to Mark we're very excited about the bipolar indication and we think there is.
A large number of patients.
Yeah, who.
Our either.
Misdiagnosed or underdiagnosed to.
Our candidate.
What may be candidates for cap lighter for bipolar to them and so we think we see the market continuing to grow with the bipolar two indications.
With that I'm going to turn it over to Mark to give further comment.
Yeah sure I can comment on characterizing sort of the source of a business of cap light in bipolar depression, and I guess the overarching statement is that we are seeing use across a broad range of patients consistent with the products labeling so we're seeing.
<unk> use in both bipolar one and bipolar depression, we're seeing use as both monotherapy and as adjunctive use.
In terms of the types of patients we are seeing an increase in the newly diagnosed patients being put on cap later as.
As well as continued strength in those switching from other anti psychotics and when we dig a little bit deeper into the switching we find that switches are coming to capital Ida from both generic anti psychotics as well as other branded anti Psychotics and so we view this as a very healthy sign.
Line of the launch and utilization across a broad range of patients suffering from bipolar depression.
Okay.
Thank you. Our next question or comment comes from the line of David <unk> from Piper Sandler Your line is open.
Hey, Thanks, So just have a couple of questions on.
The payer landscape just thinking longer term do you envision.
The loss of exclusivity of Latuda next year, as having any sort of impact on.
Access for cap lighter or at least in terms of.
Hassle free access I should say that's number one and then number two just with the overall utilization or they tip.
Pickles.
Growing considerably in recent years and continuing to grow.
Do you think there's going to be over time, a trend towards tighter control of the category, we haven't seen a ton of it over the last decade, or so but do you think that could happen in the next several years just given the sheer volumes here. Thank you.
Yes.
Great.
David and thanks for your question.
I will start with the loss of exclusivity of Latuda and will that have a big impact on us and then ask mark.
To comment on.
And strategies going forward and we don't believe that the loss of exclusivity of kept like Oh, sorry of Latuda will have a big effect on cap light up because first of all latuda has been around for a very long time.
Many patients have already cycled through Latuda.
We.
We don't imagine that could be.
A burden for us.
For patients who may have a step through.
They will already have skepticism latuda.
As one of the as a generic so I think that we're not concerned about that Mark do you want to add anything to that or do you want to go directly to the second question.
Yeah. The only thing I would add is it particularly in this category over the years as various brands went generic that that specific brand certainly was impacted by the loss of exclusivity, but the other and the other branded anti psychotics.
Not sudden academic significantly impacted so I think theres a historical precedent for it for that as well and then in terms of the trends moving forward with payer management of this category. We also don't expect there to be a significant shift in how payers manage this category, they're very comfortable managing the category.
The way that they have.
They they like to ensure access to a broad range of anti Psychotics for these conditions are they recognize there's an unmet need they recognize that there is a significant amount of churn whereby patients discontinue their existing anti psychotics and they need other effective it's safe and <unk>.
Herbal anti Psychotics to go to for their next line of therapy, and so we don't expect there to be a significant shift in how payers manage this category.
Thank you I'm showing no additional questions in the queue at this time I'd like to turn the conference back over to management for any closing remarks.
Great.
<unk>.
We're very excited about the progress that.
We have made for our launch.
For bipolar for the treatment of.
Bipolar depression, we look forward to continued progress and we look forward to updating you.
On this progress.
And on our pipeline as well as.
As we go forward with that operator, you can disconnect.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.
Yes.
Yes.