Q2 2023 Intra-Cellular Therapies Inc Earnings Call
Good morning, and welcome to answer a cellular therapy second quarter financial results Conference call.
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As a reminder, today's conference call is being recorded.
I would now like to turn the conference over to Dr. One Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.
Good morning, and thank you all for being here.
Joining me on the call today, I talked to a shuttle mate chairman and Chief Executive coffee Sir.
From your mind.
Commercial officer, doctors, who redfin dot Com Chief Medical Officer.
Hi, Lynn.
Financial Officer.
As a reminder.
Today's call, we will be making sir can forward looking statements.
These forward looking statements are based on current information I've come on expectations.
Forward looking screen.
Data another <unk> describe your <unk> filings made with a Securitas and exchange commission, including our quarterly connect and annual reports.
Your caution not to pay somebody reliance on this car payments.
And the company the screen any application such payments.
I will now turn the call over to share.
Thanks Man good morning, everyone and welcome to today's conference call.
Today I'm pleased to share our second quarter results, which consistent with past quarters continue to demonstrate high demand for cap light.
Thank you too kept light a total of prescriptions increased by 96% compared to second quarter of 2022 and increased 13% sequentially compared to 212023.
Second quarter total revenues increase to $110.8 million.
<unk> increase to $110.1 million and 100 per cent gross versus the same period 2022.
Kept light continues to be extremely well let.
Received by health care providers and patience.
In recognition of our robust performance to date and our confidence in the continued growth we are raising our kept light a full year 2023 net product sales guidance range to 445 $465 million from our previous guidance of 430 $455 million.
She just kept light is lost without a solid foundation with gross coming from increasing the breath dark prescriber base as well as increasing the depth of prescribing.
This is a reflection of the confidence that prescribers have gained in their real world use of kept light and the benefits their patients are experiencing during treatment with capital Ida.
Mark will further discuss our commercial efforts later on this call and will describe how we will continue to build on cap light is success.
We continue to develop <unk> for other disorders and advanced the rest of our pipeline.
Let's start with me with pepper on his breath of positioning and mood disorders.
Very pleased with the positive reception that I'm next feature study study 403 has received from leaders in the psychiatry community and equally excited about the drugs potential to help large numbers of patients.
As a reminder, in this study luma Tepper on 42 milligrams was statistically significant on the primary endpoint of symptom reduction on the Montgomery Aspirin depression rating scale or Madras, where the combined mixed feed your patient population of M D D and bipolar depression and the individual.
Patient populations of M. D D with mixed features and bipolar depression with next features.
The robust effect sizes range from 0.642 0.67.
Starting September we will be presenting results from this study 403 at major psychiatry meetings.
We also plan to submit a manuscript describing a 403 results in the second half of this year.
We've been analyzing study 403 results and refining our regulatory commercial strategy.
Lastly, we plan to meet with the F. D. A later this year and discuss this important program with the agency.
We continue to analyze study 403 data and today, we'd like to share with you an important post hoc analysis, we conducted of the pre specified patient population is this analysis, even further strengthen our confidence and kept light as potential as a treatment for M. D D and other mood disorders.
And entering into this study we documented the patient population presenting with anxious distress, commonly known as anxious depression using D. S M five criteria.
Anxious distress as a specify or in the D. S. M. Five and refers to the concomitant presses of anxiety symptoms during a current episodes of depression.
Our analysis showed that the anti depressant effect Blue <unk> patience with next features and anxious distress were robust.
In study 403.
Mmm <unk> significantly improved Madras total score <unk> compared with placebo.
Bind M D D and bipolar depression mixed features population with anxious distress with the main difference versus placebo of $6 1.8.
Bust effects is at 46, seven with a P value of less than 0.0001.
Additionally, each patient population of M D D and bipolar depression patients had robust result.
We plan to present, a detailed analysis of these data at a medical meeting later this year.
It is estimated that about 55% of patients with M. D D experienced anxious distress and a similar rate is estimated for bipolar depression the.
The presence of anxious distress is associated with treatment non response higher suicide risk and along the duration of illness.
This important analysis, showing robust anti depressant effect kept wrong patience with mixed features and anxious distress S.
Another line of evidence of kept light as potential across the spectrum of mood disorders.
In total we have shown limit <unk> has any depressive effects different patient populations with mood disorders, including those with schizophrenia with come Morbid Depression bipolar depression mixed features and both M D D and bipolar depression, and now and anxious distress and both M D D and bipolar.
Depression.
These patient populations are known to be difficult to treat and are more costly to the health care system.
Let's now turn to our Luma TERP wrong Adjunctive M D D clinical program.
We have three ongoing phase three study study 501502, and 505 and a registration.
Program evaluating <unk> after the jumped a treatment for M D D and patience with partially respond to any depresses.
It's just been our practice as we approach completion of clinical studies, we provide guidance on the expected time, finding a top line results in filing a R. S. N D. A with the F D a.
Now at this point that the conduct of our first two adjunctive M. D. V trials, we expect topline results from study 501 in the first quarter of 2024 and results from study 502 in the second quarter and 28 24.
Subject to the results of these studies, we anticipate filing R. S N D a and the second half of 2024.
As you can see we are excited about our adjunctive M. D. D program and kept light is broad potential across mood disorders are.
Optimism is based on multiple lines of evidence, including the mechanism of action via the interactions with the dopamine serotonin and glutamate systems and strong clinical evidence supporting the anti depressant effects kept light across different patient populations.
We also continue.
To study art <unk> long acting injectable form formulations.
We expect to initiate the eighth one single a sending dose studies with several new formulations of R. L. A I later this year and expect these studies to continue through next year.
This is a key step in developing long acting check both formulations that are effective safe and well tolerated with treatment duration of one month for longer.
Turning to our pipeline 12, 84 is an important program for the expansion of our neural psyche psychiatry franchise.
This year, we expect to initiate phase two programs evaluating ITI, 12, 84, and generalized anxiety disorder and psychosis in patients with Alzheimer's disease and agitation in patients with Alzheimer's disease.
We are committed to building are not neuropsychiatric franchise to ongoing R&D efforts.
Today I'm pleased to introduce our new program Iti's 1500 <unk>.
This program is focused on development of novel non hallucinogenic psychedelics.
As you are aware interest has reemerged in the potential.
Lucy <unk> psychedelics for the treatment of mood and anxiety disorders, however, adverse effects of these hallucinogenic psychedelics.
Safety issues, including abuse liability cardiac apology related to five H T to be receptor agonism hallucinations due to five H teach you a agonism and persistence of perceptual disorders that may limit <unk>.
Our chemists have developed novel compounds that allows us safe exploration of the full therapeutic potential of this new drug class.
Compounds in this program, which we call. The iced tea is 1500 series interact with the <unk> five H T. Two a receptor in a unique way and.
In animal models of neuropsychiatric disorders. These compounds retain the beneficial effects of psychedelics, while lacking liabilities of known psychedelics, including hallucinogenic potential and cardiac valvular apologies.
Our lead compound in this program Ipi's 15, 49th possesses this desirable pharmacologic profile and is currently being evaluated and I N D. A neighboring studies and expect it to enter human testing and light 24 or early 2025.
We plan to present data on this program at upcoming scientific conferences, and we look forward to sharing this data with Ya.
We also plan to discuss this program and an upcoming Orangy day, which we expect to hold later this year or early next year.
Turning to our P. D. One inhibitor platform patient enrollment is ongoing in art phase two clinical trial of <unk>, which evaluates improvements in motor symptoms changes in cognition and inflammatory biomarkers in patients with Parkinson's disease.
For I T. I, 10, 20 or cancer immunotherapy candidate our phase one single I, sending dose study is ongoing evaluating the pharmacokinetics safety and tolerability of different doses and healthy volunteers.
Lastly, we also have ongoing studies of ITI triple three for the treatment of opioid use disorder and pain. We have completed the single I, sending dose study and we are presently engaged in the multiple ice and you can go study and in the pet study looking at receptor occupancy.
Forward to sharing the results of the single eight sending dose study later this year and the multiple a sending dose study in 2024.
The company is in a strong financial position ending the second quarter with approximately $515 billion in cash cash equivalents and investment securities and know that we're.
We're very proud of our performance, which has enabled us to serve patients and expand our development programs. We are pleased to be deliberate transformative cancer patients with neuropsychiatric conditions, we look forward to continuing to share our progress with Ya.
I will now turn the call over to Mark to share additional details on Capsulitis performance this quarter Mark.
Thanks, Sharon good morning, everyone, it's great to be with you all today.
2023 continues to be an exceptional year for capital items.
We are successfully implementing our commercialization strategy and delivering robust growth as we further penetrate both of schizophrenia and bipolar depression markets.
During the second quarter or commercial team drove strong growth, increasing total prescriptions, 96% compared to the same quarter last year and 13% sequentially versus Q1 of this year.
We expect a strong performance to continue into the second half of 2023, providing the confidence to increase our full year net product sales guidance and importantly positioning kept light up for consistent growth in the coming years.
During the launch of a new indication, it's important to consistently add new prescribers as well as increasing the number of prescriptions for each prescriber.
During the second quarter, we continued to increase both the breath of our prescriber base and their depth of prescribing.
We again added nearly 4000, new first time prescribers of capital items during the quarter, increasing the cumulative total number of prescriber since launch to over 29000.
Weekly new patient starts with cap light it continue to be at a level five to six times higher than they were before we expanded our label into bipolar depression.
Earlier this year, we implemented two key initiatives designed to further expand both the breadth and depth of our prescriber base.
First we added 50, new neuroscience sales specialists to our team during the first quarter.
And this has enabled us to interact more frequently with our highest volume prescribers and reached even more new prescribers.
We are very pleased with the productivity in progress made thus far by this selling team and expect their contribution to the growth of cap light to further expand in the second half of the year.
Second we launched a new direct to consumer national advertising campaign to raise awareness of bipolar depression and to educate prescribers and patients about the potential benefits of cap light up.
The campaign is generating significant patient interest and requests for cap lighter as well as raising brand awareness among prescribers.
We are pleased with the impact that the campaign is having and will be continuing these efforts throughout the second half of the year.
We also continue to enjoy broad market access coverage across all three payer channels and will look to continue to execute our market access strategy with the objective of optimizing uptake and value creation.
These efforts are supported by our light a link patient and prescriber support program, which has been very effective in helping patients access kept light up.
In summary, the first half of 2023 has seen a continuation of the exceptional launch kept light as bipolar depression indication and we see strong momentum heading into the second half of the year.
We believe that kept light or has a compelling product profile and provide substantial benefits for patients schizophrenia and bipolar depression.
I'm very proud of the strong commercial execution of our sales force and the broader commercial team.
Look forward to continued success in the marketplace.
Now I'll pass the call over to Larry to walk through our second quarter financial performance Larry.
Thank you Mark.
Provide highlights of our financial results.
Total revenues were $110.8 million for the second quarter of 2023 compared to $55.6 million for the same period of 2022.
Net product sales of calculator, where $110.1 million in the second quarter of 2023 compared to $55.1 million for the same period in 2022.
Representing a year over year increase of 100 per cent.
And the second quarter capital either net sales increased 16% sequentially over the first quarter of 2023.
Strong growth was primarily driven by a 13% quarter over quarter increase in total prescription demand.
In the current quarter the increase in product sales was driven by strong demand for calculator with minimal impact some changes in days on hand, and gross Tonight.
We expect our gross Tonight percentage to nominally increase for the remainder of the year and remain in the low thirties for the full year 2023.
Due to increasing demand for calculator and strong operating performance debate, we're raising our cap right. A four year 2000, twenty-three net product sales guidance range to $445 million to $465 million from our prior guidance of $430 million to $455 million.
Selling general and administrative expenses were $101 million for the second quarter of 2023 compared to $100.3 million for the same period of 2022.
Research and development expenses for the second quarter of 2023 40.
$49.8 million compared to $38.5 million for the same period in 2022.
For 2023, we continued to estimate all year SG&A expenses to range between 420, and $450 million and full year R&D expenses to range between 195 and $220 million.
Our financial position remains strong cash cash equivalents investment securities and restrictive cash total $514.6 million of June 30th 2023.
This concludes our prepared remarks, operator, please open the line for questions.
As a reminder to ask a question you will need to press star one one on your telephone.
Please limit yourself to one question Venery Q.
Please stay on by while we compile the Q and a roster.
Our first question.
Comes from the line of Andrew Sigh of Jefferies.
Hey, good morning, and congrats on the recorder appreciate all the updates so maybe just to talk about the guidance raise what are the core assumptions that drove you to raise it.
For instance, does the top end of guidance apply more benefit on the volume or more benefit on the price side same question guys for the lower end of revenue got it and secondly, I think last year. You know there are some south summer seasonality for capital I'd.
It also apply to many Nero drugs in particular, so are you seeing that same phenomenon. This year, so far or is it is that going to be more or less pronounced in Q3. This time. Thank you.
Hi, Andrew.
Thanks for your questions, maybe Mark do you Wanna start and then Larry if you have anything to add.
Mmm.
Yeah, Yeah sure Andrew Thanks for the question, Yeah, I would say the.
A range of our guidance is based on the the trending that we see.
And the strength in the first half of the year the trajectory of our prescription volume and it's just some variation around those trends I think each end of the range indicates continued strong growth in the second half of the year as both Sharon and Larry said in their initial remarks the.
Second quarter improvement was definitely driven by.
Strong volume gains with middle no impact from from inventory days on hand and from from gross to net.
Regarding your your summer seasonality, yeah, each year, we do see some summer seasonality in the third quarter.
And then we tend to see a stronger fourth quarter.
So Larry I don't know if you have anything else that nah I think you've hit all the high points Mark.
Alright, very Clara congrats congrats again.
Great. Thank you et cetera.
Thank you.
Our next question.
Comes from the line of Mark Goodman of Leerink.
[noise] Hi, good morning can you talk about the <unk> program for one second it seemed like you were moving forward you had a formulation that you'd like to know you've gone back and you're working on a different formulations. So is this is this because you're working on a longer acting one. This time I was just kind of curious like just the big.
Sure.
Where we've been where are we moving.
And then just a quick question I'm 12, 84. This additional talk studies that you have to do are they going to slow you down from the rest of the work can you just do all of that work in parallel I'm. Just curious if the Fda's makes me do that before you move on.
Mm Okay. Let me let me start this thanks for your questions. Mark. This is Sharon and let me start with B L. A I and you got it <unk> absolutely correct. We did a study with one formulation I'm in L. A I, which would be.
A one month formulation, we do believe that we could tweak that I mean, that's that's still a contender, but we do believe we can tweak that formulation with other four and we've developed other formulations as well and those are what we're testing.
Because we do believe that.
We want to have a formulation that is also longer than a month and that in fact.
Maybe even better than the formulation that <unk>.
And that's why we have all of these other formulations that we've been that have been in development.
The top studies have been ongoing.
<unk> I guess.
What I would say is what we're doing other is other studies in the meantime, so that in total.
Program would not be slowed down it's just being done.
With different studies coming first and.
I mean, we're actually pretty excited that it is.
<unk> to be a new molecular entity, which has required us stealing.
The further tops package.
Thanks.
Thank you.
Our next question.
Comes from the line O'brien Abrahams of RBC capital markets. Please go ahead Brian .
Hi, This is leanne it on for Brian and Thanks for taking our question I guess I had a question on the anxious depression group from from the study you talked about can you talk about the rationale focusing on this subgroup of depressed patients rather than others, such as an actor and a donut depression for instance, and are you contemplating a potential opportunity for <unk>.
Light and and anxiety indications can you talk about any potential commercial work or future development past that could be interesting implications from the anxiety work you've done and I guess 12 84 is also being explored in general anxiety I guess any increase confidence in the success of that from the kept light at work. Thanks.
Great <unk>, maybe <unk> would you like to take that and I think maybe first if you would maybe remind.
Buddy what anxious distress is N y O important to look at.
Yes.
So anxious.
<unk> definition.
Having a presence of at least some anger to some of the symptoms.
Five symptoms one is.
<unk> tensed.
Feeling unusually restless.
[noise] difficulty concentration because of worry.
So you have that something awful may happen or <unk>.
Anything that an individual might lose control of these symptoms in the <unk> in the President's off a depressive episode.
That is considered patience meeting episode with anxious specify it.
So the reason why this is clinically important base.
<unk>, who have major depressive disorder and have some symptoms of anxiety.
We are calling based on the specify out anxious <unk>.
Or the <unk> <unk>.
Medications, especially the entered the <unk>.
And it has been shown in the <unk> study.
Study.
And also these patients that I mentioned this looks like name <unk> longest time for these patients too.
<unk> <unk>.
And that's why it's.
Clinically important.
<unk> 70 404.
We have studied.
Both bipolar.
The depression and major depressive disorder.
Four O J.
And then we have added <unk>.
Also looked at.
We have looked at.
<unk> will also <unk>.
<unk>. We are discussing today is looking at that club population, where you have shown strong.
Forget the boat in the <unk>.
Overall population of both combined populations and also an individual populations.
Answer you with regards to why did we do this it's because anxious distress is so highly prevalent among.
Amongst all patients who have have major depressive episodes. So we thought it very important to look at this tape population.
Mmm.
And I would add one more thing that there was a question about does it increase your confidence I would say that this also shows that <unk> have.
As demonstrated in a wide range of more <unk> more bizarre the space. So there's also ask for that product.
Alright.
Thank you.
Our next question.
It comes from the line of Charles Duncan of cancer Fitzgerald.
Please go ahead Charles.
Okay. Yeah. Thanks for taking my question and congratulations on a really nice quarter, Sharon 19 loss lots of updates as well. So many questions that out I, just lament mine really too commercial.
One is we know prescription volatility in the in the prescription trends change.
It seems to be lessening over time, and I guess I'm wondering if you can speak to dancing a function of.
More consistent.
New patient ads or persistence that you're saying so more retails over time and I guess a follow on to that question is when do you think about depression versus mania bipolar what kind of feedback are you getting from prescribers.
In terms of the relative important it would seem to me that the depression part is more important and therefore, the intent of new mechanisms that could be coming that treat <unk> focus more on mania or psychosis.
Maybe not so impactful can you can you speak to those two questions. Thanks.
Uhm, maybe they'll take the second question first because I think that's a very important point.
And maybe rash would want to expound upon this but yes, most patients with bipolar bipolar disorder to spend most of their time.
In a depressed episode so I don't know so rushed you want to go a little further into that as a psychiatrist.
Yes, <unk> <unk>.
Bipolar disorder, you have both paused a minute fall under the bus you Paul.
And.
About close to 80% of the time to spend as being depressed you have of course Monica seles into spread during that time period, yet, but most of the times out in different space. So that's why it becomes more important.
Two.
Look up medications and have patience and that's about it in that space.
And most of the anti psychotic so 90, I should say at the anti Psychotics do help in <unk>, but they did not.
Many of them have been shown to not have any effect in a depressive phase and that's why it. Another reason that's so important.
To have drugs that are are treating a depressive phase.
Now back to your first start which I hope Mark you you remember the question.
Alright [laughter].
I do and it's a good question Charles and yes, we have been very pleased with the how consistent and impressive the trajectory.
Of our volume growth has been ever since we launched the bipolar depression indication and I think that I know that both new patient starts the strength that we're seeing there as well as good persistently are contributing to the trajectory that we see and I think in terms of the.
Volatility, it's an interesting observation and I think it's probably due to the fact that we continue to add new prescribers were up over 29000 prescribers of cap light it now and on average each of those prescribers are prescribing more.
Each quarter over quarter, so that tends to take away some of the volatility that you see earlier on in the launch of a new product or a new indications and I think we should continue to see that in the future as well.
And grants and thanks for the guidance race.
Input.
Great. Thank you.
Thank you.
Our next question comes from a line of Jason <unk> of Bank of America.
Oh, Hi, good morning, and thank you for taking my questions.
For me just a question Sharon interesting B Benard hallucinogenic psychedelic program was curious if you can expand upon maybe what you guys do to strip out submit a hallucinogenic properties of.
That molecule, which seems like kind of a long standing unmet need.
With that approach.
Thanks, Jason and I'm, just gonna start and give you like a global overview in Alaska. The rash if he wants to contribute anything and then on our R&D day, we will have the scientists who actually develop these molecules and we've been developing a series of molecule and it started with.
Our deep knowledge of the five H T two a receptor and that space.
So we took.
Five H T. Two a core and we <unk> and when I say way, it's the royal weight, because I deserve no credit for this it's a really terrific chemists and biologists who.
Took the five H T. Two a it took a poor and they modified around that and then of course they wanted to build in other properties. They wanted to make sure. We didn't have to be agonism, so because of <unk> mm adverse event profile and.
So they have spent several years.
On the series of drugs modifying continuously going into animal models looking for things are very important proxy for hallucinations and a rat. So you can only in preclinical models, it's difficult to see this nation.
So you'll have foxy and head Twitch.
<unk> is the most common proxy so they would take these molecules puts them through this battery of behavioral tests, and then come back with the modified a molecule and that's how they've come up with a series of molecules now does that go.
Anywhere.
From molecules that do not have any head twitch and have either desirable properties all the way through the gamut.
Now where you can bring in a side effect profile and you can exclude a side effect profile. So that's that's been sort of that's about.
Couple of years worth or several years worth of preclinical studies, including <unk>, a lot of chemistry and as I said, we'll go further into it one way.
Well tell you more about 15 89 and about some of the other they have actually five molecules that they're looking at but 15 89 is the.
Is a lead molecule.
Thank you.
Our next question.
Comes from the line of.
Jeffrey hung up Morgan Stanley Your line is open Jeffrey.
Hi, This is Michael <unk>. Thank you for taking my question and congrats on the border I just want to follow up on a previous comment on how often do patience with a major depressive episode develop anxious distress and what is it per cent overlap between mix features and anxious. This dress I guess I'm wondering how many more.
Bipolar depression patience would be eligible to benefit from the therapy that also shows benefits I'm anxious to assess thanks so much.
<unk> do you want to tell you that.
Yes.
In terms of anxious discuss again the importance of anxious to assess as these patients have 40 responding to under the <unk>.
And that's why we we looked at this and if you're talking about the percentage of people approximately 55 per cent of major depressive disorder patients and bipolar depression patients have anxious to discuss on this number do you have a much higher numbers, but approximately able to pay per cent.
And then there is of course, an overlap between these two patients who have mixed we just can also have anxious.
Lapping.
And it is understood that.
There are some patients who just have one or the other and there's also a significant portion of all of them are between the slow patient populations.
Yeah, So it's very difficult to come up with a good number of the overlap because there haven't been all that many studies and just mix patience, we do know that a large percentage over and and the literature has a couple of different numbers, but we've used them.
Conservative numbers of 55% of patience with M. D D and bipolar depression have anxious distress. So we know your question is are there more patience with <unk>.
M D D.
Outside of mixed features that have anxious distress I think that's your question and the answer to that is yes.
Uhm. Additionally, there are patients with mixed features who don't have anxious distress and there are obviously a lot of patience with next features who also have anxious distress. So.
Maybe for our next call well, well well have a venn diagram, [laughter] Hum and well well map out exactly the overlap as we see it we have been working very hard to get I mean, it's a great question, we have been working very hard to get very clear numbers.
Again this is not a fee it feels that has been very well studied and I should tell you an anxious distress that the studies that have been done by and large has.
Not succeeded so so again it makes it even more difficult to relate cheese out exact numbers, but we do know from that we've given you. The published data on again the conservative numbers in the published data, which tell you that about 55% of patients with M D D and bipolar.
Depression have anxious distress.
And in fact, the other numbers are much higher even.
I see that that's really really helpful. Thank you for all your comments I appreciate it and could I have forgotten.
Thank you.
Thank you please stand by for our next question.
Our next question comes from the line of <unk> Kulkarni of Canaccord Genuity.
Nice to see all the progress and thanks for taking our questions.
But what is the latest in terms of your timeline on potential interactions with the F. D. On your mixed features and depression program, giving you have one where you could say that the pain or do you prefer to wait until you have the magenta cloud result, as well and do you expect to specifically discuss anxious depression you infections.
Yeah. So.
The simple answer for you is no we're not waiting.
Uhm for anything other than we have been waiting for the C. S are on on that report in other words. The clinical study report with all of the data on the mix feature study and we did say in our prepared remarks that we will be calling to the F. D. A later this year.
And discussing our program with them.
And that's spelled K.
Got it and do you expect to discuss anxious depression as part of that as well.
Well, we'll be discussing the whole study I think that we.
Again, we really don't comment prior to going to a meeting about the particulars in a meeting, but well well be discussing it. It's very as you can see it's a complex program and well well have discussions on the program.
Got it thanks.
Thank you.
Our next question.
Comes from the line of Corinne Jenkins of Goldman Sachs.
Yeah, maybe a quick follow up on portion of patients that have anxious depression. It would be helpful to understand what portion of the trial that was enrolled had these <unk> and the baseline patient characteristics and then I have a couple of follow up questions.
Fresh.
Part of the patients with in the whole study.
Had about close to 60% of patients who had anxious distress.
Okay. That's helpful.
Yeah and that matches the literature I told you. We've given you this very conservative number they range anywhere from about.
50% up to over 70, or 80% of patients M. M D D with and bipolar with anxious distress.
Okay, Great and then maybe separately how should we think about the cadence of R&D spend into next year, particularly as you wrap on some of these expansion studies and do you consider yourself sufficiently funded through the cap light or avenue to pursue those opportunities that you see at hand.
So I'll take the second part and add his gassy, we do consider ourselves sufficiently funded them too.
Progress every program that we've been mention to you on today's call.
And I think we haven't giving you guidance into next year.
But I'll ask Larry did you want to add anything to that.
No I I I think you know, we we're gonna we're gonna stay within the guidance that we gave you for this year and as you can see what the results of the first half that were on paced too.
To be within those that you know the guidance numbers, but again like Sharon said, we're not we're not in a position to be giving 2024 guidance at this point <unk>.
Okay.
Thank you.
Our next question.
Comes from a line of Ash Burma of UBS.
Hi, Thanks, Thanks for taking my question.
And congrats on <unk>.
So just on MTV.
Lighter fast onset of action <unk> do a similar.
Similar benefits in the MVD shedding and just for the study like the any media and then you'll be watching out for us when you combine it with the other anti depressants. Thanks.
So I.
I didn't he I couldn't hear the first part of your question I heard you're asking about any drug drug interactions that we would expect to see and have kept.
<unk> I'll I'll start with that and then I'll turn it over to Suresh and we might we may need to ask you to repeat the first part of your question but.
To date and all of the studies we've done we we have not had any issues on D. D. I. So.
But as I said I I could not really understand what you were asking I canceled Muslim.
Maybe would you repeat the whole question and then I'll asks the rush to tailor. Please.
So yeah, what what I was asking whether they can keep light as fast onset of action translate into.
Into a similar benefits in the MVD setting.
You're asking if the is there a fast onset of action right and again I'll I'll, just start and I'll turn it over to the rash in our bipolar studies. What we saw was an onset of action either in the first week or certainly by the second week.
And we don't measure in between.
<unk> points are at one weekend at two weeks.
No Thresh do you Wanna go into that any further or.
Yeah, No I think that I'd be able to imagine it's one weekend, we have seen in some studies <unk> two weeks, we didn't want to do because we have seen it because he's so far and.
In terms of the drug interactions you know you'll never.
The program again to study.
Ongoing so right now we have not seen any new safety issues and ongoing studies exactly the same no no issues with Judy.
Thank you.
Okay Bye for our next question.
Which comes from the line of David Emsellem of Piper Sandler.
Hey, thanks, so so it's coming back to the L. A I development program. My understanding is that L. A is are are mainly used in schizophrenia and and mania. So I'm just wondering how you see in L. A commercially.
In the context of a drug type room, where it's primarily used in depressives. How are you thinking about that and then and then secondly lots going on with the pipeline and I'm. Just wondering out loud are you exploring any potential out why some things are partnerships.
And and just how are you allocating resources in other words, just talk about prioritization.
Beyond Luma tempura. Thank you.
Okay I may need.
You have a few questions in there David So I may need to ask you to repeat some of them, but let me start with your first point cause that's where I got hung up where you said when the tap wrong is used mainly in Depressives I I don't believe that's a correct statement late Luma Teflon is very broad based.
And yes, we've been showing it to be effective.
In.
Patient populations within mood disorders mood disorders is a very large patients.
And catch her schizophrenia, where we also showed efficacy uhm.
We do have.
Robust sales it within the schizophrenia patient population as well, but the schizophrenia patient population is just a much smaller patient population.
And then a bipolar patient population cetera, we haven't done the studies in mania, but we do have patients who are on luma tap wrong for the treatment of bipolar depression and they are not.
Neither in our short term clinical trials, nor in our long term clinical trial, nor and we've measured everybody for the Y M. R. S. They haven't slipped into and they haven't become NAMIC. So they don't have mania. So I would tell you that as I've.
<unk> earlier remarks that.
Many of the drugs that.
Many of the anti Psychotics <unk>.
Work from manic episodes in these disorders.
Where they don't work as in the depressive episodes. So I just wanted to clarify that after the <unk> L. A I we are developing the L. A I.
Right now for the treatment of schizophrenia.
Uhm.
We may broaden that in the future, but the first indication is for that.
Treatment of schizophrenia, when we started the program.
We actually didn't have.
The database that we now have on the safety of <unk>. So we we do think that oral luma TERP wrong.
We'll continue and its trajectory we thank the injectable <unk> there are <unk> really a couple of different patient populations within schizophrenia, either those who for one reason or another don't Wanna taken oral drug or they won't comply with an oral <unk>.
And so they need to be on an injectable and that's really.
How that program is progressing we do think that it is.
Reasonable approach and we think that it's an important.
Approach for patients, we don't think it's gonna take over half the market, but we think it's an important option for patients to have.
Then I think your other questions were on B D is that right on in licensing and out licensing is that correct.
Yeah, and how you're prioritizing your earlier stage programs.
Well I think with the the programs. We've described to you so frankly.
We have other internal programs as well they I think we we describe programs to you typically in the past once they've been in the clinic. We've now told you about the non hallucinogenic psychedelics because they have been moving into the clinic and we're.
Very excited about the data that we're getting there.
I think you know, it's kind of like when I got this question.
It's for those have children, which child do you like best.
All our children and I think that.
I think we we are well capitalized and for every program that we've described to you we have sufficient funds to keep moving these programs forward. So I think that the answer I would give you is that each one of these programs is moving forward on its own.
Trajectory now of course.
As they move forward, they become more and more expensive and maybe at some 0.1 decides that you should be.
Either partner some of these are not and of course, depending upon the clinical data that you get.
You make those decisions and at some 0.1 will be <unk> you know.
Will be prioritized over others as they get into the later.
Stage of their development.
Right now I was summarized when you were moving them all forward [laughter].
Thanks.
Thank you.
Our next question.
Comes from the line of <unk> <unk> of Evercore.
[noise] Hi, guys. Thanks for taking my question. There's some construction next to my cube, so apologies for any noise and or salsa music.
212 questions real quick on the anxious distress do you think F. D label at any point may speak to someone that data is that your base case expectation and also what are there any endpoints evermore anxiety specific for example, anxious depressive attacks or the leibowitz scale et cetera that was evaluated for that subgroup. Thank you.
[noise], Okay hiring more thanks for your questions I was stuck on the south of music.
I'm kind of I'm not sure I got all the questions. However, maybe I'll <unk> the.
A rash speak to the anxious distress.
And.
Your other questions.
<unk>, yes in terms of this particular study we have looked at.
Three declined patient population, where we have looked at.
B S on five prospect your patients who have met the criteria for anxious distress and what we were looking bad was looking at the depressive symptoms and dispersion population.
And in terms of specifics scales put anxiety, we have not studied in this particular study.
And in terms of of F. D. A labour remember what what we're measuring in this study as those patients whose depression.
Scale was improved as a result.
<unk>.
They are diagnosis.
Of having anxious distress.
So they are <unk>.
<unk> scores were improved on within the Madras there are questions on anxiety and yes, we improve those but the so it's it's a.
This patient population, what you Wanna be doing is improving their depression scores.
Oh and that's what we were looking at in this study is in that patient population and where are they better off at the end when they were in the beginning and the answer is clearly yes.
Again, we'll have more to say about that is as we go forward.
Thank you guys.
Thank you.
Our next question.
It comes from the line of <unk> of Needham and company.
Hi, Good morning, Thanks for taking my question Uhm, maybe a fall upon anxious distress can you talk about the current.
<unk> practices around maybe diagnosing patients for anxious distress and if they treat.
These patients any differently from the <unk> the <unk> patient population.
Thank you.
Rash do you Wanna take that yes.
Yes.
I'm so anxious.
I would like to go before we go to the question of abuse and explain why this is important.
And the reason why this was even put in this this was introduced into the via some five.
Before I can relate to symptoms that recognition of this was coming mainly from the start of the trial.
Yeah.
Then they looked at patients with M. D D. They found that patients who also had just anxious depression anxious distrust.
Symptoms, but not responding to.
You ended the persons that episode I said, there's something that is so.
And this will do caution too.
Prescribed by some physicians prescribing.
Pay attention to that difficulty population.
Hawaii is that important it's important because then you can make great mendacious. Because these are the patients who don't respond to as I thought I thought of some advice and maybe give them a signal that we need to look for something else for the special populations right. Now there is no treatment specifically approved for this.
Population.
Any new medications that comes with that demonstrated value in this patient population.
He is welcome and that's what we have done in this particular case.
And in addition, these patients receive polypharmacy and often times with very poor responses and they.
Or a high burden on the health care system as well as nonresponders to be <unk>.
More traditional therapies.
So it is important to be able to identify a patient population and see.
What drugs can help them and that was what our aim was by adding that.
Patient population.
Description of that patient population and measuring how they do in the study that was the importance of putting putting that into the study.
Thank you that's helpful.
Thank you.
Our next question.
Comes from the line of Greg Savannah Bank of Mizuho Securities.
Thanks for taking my question Congrats on the progress also thanks for the guidance around the timing of the 575 or one in 502 I had a question on 70 505, which has to do just with study design.
On clinical trials Dot Gov. It does seem that the study design in the sample sizes.
Almost exactly the same as 30 501 and 502, so I just wanted to confirm that and also just from a timing.
Aspect of it does look like there might be a slight difference in terms of how long from start to end that study is gonna take relative to 501 and 502 I think 501 and 502 were about 25 months is listed from start to end I think 505 is 29 months from start to end and so I'm just trying to get a sense of where.
That is due to kind of where we are today and trying to win role MVD studies or if there's some other new one thanks so much.
So maybe I'll.
Maybe I'll just say <unk>. If you could just explain 30 505 I think for some people on the phone they may not even know what study 505 is so if you could identify what study 505 is and then take it from there.
Yes. This program is looking at.
Ah drink your treatment.
Major depressive disorder on patients with a partially respond to 100 per cent. So a program. Both 501502 studies are ongoing and then we have added probably will file.
Starting up this year.
And this is in design is very similar to the <unk>. It is six weeks a double blind placebo controlled study primary endpoint use modern sort of skull a secondary 0.2 C. G. I. So in that sense. It was very similar no difference.
And.
So this study was topic and he was going to be.
But the one other question was.
Yeah.
I think that I.
I I don't know <unk>, sorry, I don't mean to cut you off suffice. It's just say this study is ongoing I think everyone knows that M. C N S.
There are large placebo responses and studies, we started 505 S. A.
I know, we don't like this term, but as a backup study for 501 and 502.
It's ongoing and.
L.
It will read out I I, frankly don't remember how many months it says on on clinical trials Dot Gov.
But the important part is that it will it will read out later than 501 and 502, but it is ongoing and and it is it is progressing.
Sharon if I could ask just to follow up and I'm sure we best.
Just have a question before but in terms of risk mitigation strategies on high placebo responses that are typically seen in let us psychiatry studies can you just remind us what intracellular is doing to kind of minimize potential placebo responses.
Sure I'll start and I'll ask the rash if he wants to add anything so we certainly <unk>.
You know I think most studies have their own.
The risk mitigation and we we all hope that they're all successful and.
Usually they are.
Sometimes.
You get blindsided and something else happens, giving you a high placebo response, what we do is of course. The main thing is to try to ensure that you're getting in appropriate patients into your study. So we have.
A very rigorous screening for these patients when they come in and rigorous testing prior to enrollment in the study also you of course have a a large monitoring.
Program throughout the study.
I think.
We also adjudicate patients. So you don't have just one person making.
The decision.
Patients are communicated to make sure that you have appropriate patients coming into the study I think those are the few things that we do.
I don't know if that about covers it forced to rush. If you have anything you want to add.
I I think the other colors.
Broadly what are we doing again.
Use different scales to make sure that that is <unk> between what.
Patient is saying, what the English or you're just taking into account but.
That's all part of the reputation process.
Right.
Okay. Thank you.
It's a it's a great question and it's the Bane of all of our existence right [laughter] does how do you control or placebo response right.
Okay. I think we're we're out of time here.
Operator, so if I could wrap ups and I want to thank everybody for joining us today on the call I think it was a great discussion and some great questions.
We look forward to updating you on our progress as we go forward.
And.
We look forward to our next call Okay, great. Thank you everyone Bye bye.
This concludes today's conference call. Thank you for participating you may now disconnect.
Mmm.
[music].
Mhm.
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