Q1 2023 Intra-Cellular Therapies Inc Earnings Call
Good morning, and welcome to interest cellular therapies first quarter financial results Conference call.
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Relations. Please go ahead.
Good morning, and thank you all for being here today.
<unk>, Chairman and Chief Executive Officer, Mark Nina ship commissioned officer, Dr. Dotcom to medical officer on long Island.
Financial Officer.
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Thanks, one good morning, everyone and welcome to today's call.
Following a strong performance last year 2023 is off to a great start.
During the first quarter our team delivered strong grounds for kept later and made important progress clinical development Frank.
Just a few weeks ago, we announced robust positive topline results from study 403 evaluating limit in patients with major depressive disorder or M. D day exhibiting next features and in patients with bipolar depression exhibiting next features.
We'll talk more about this in a moment.
Let's start with outperformance with kept lyda 821.
Demand for capital Ida in prescriber adoption has been strong.
Total prescription increased by 159% compared to first quarter of 2022 and increased 16% sequentially in Q1 2023.
Compared to 242022.
First quarter total revenues increased to $95.3 million are strong prescription growth drove kept light of net revenues of $94.7 million 173 per cent growth versus the same period in 2022.
We are very pleased with our performance in Q1 and reiterate our prior guidance for full year kept light and that sales between 430 and $455 million. We are confident and continued growth in the future potential of capital Ida.
We continued to received very positive feedback from both prescribers and patience.
Physicians site kept light is critical profile and efficacy for a broad range of patients with bipolar depression and schizophrenia.
<unk> patients often highlight improvements in their symptoms and kept light is favorable side effect profile.
This positive feedback further reinforces Arab belief that kept lyda is helping to change the lives of patients.
On the political front, we continue to expand our kept light of development programs in advance or other type line programs.
Let's start with our most recent news.
March we announced robust positive top line results from study 403. These strong resolves further validate the potential for <unk> to treat a broad spectrum of mood disorders.
In this study we evaluated limit kept around 42 milligrams is mono therapy for the treatment of major depressive episode impatience with M. D day exhibiting like features and in patients with bipolar depression exhibiting next features.
<unk> demonstrated a statistically significant clinically meaningful reduction on the magic total score compared to placebo at week sick. The primary endpoint of this study.
Result was demonstrated in the combined patient population of major depressive disorder with mixed features and bipolar depression with next features the drug placebo L. S. Main difference with 5.7 point with a P value of less than 0.0001, and the effect size with 26 for this.
Strong results were consistent for the individual patient populations as well.
The M D D patient population with mixed features the effect size with 0.67 and for the bipolar depression patient population with mixed features the effect size with 0.64.
Value for each of these individual populations with less than 0.0001.
<unk> 42 milligrams also met the key secondary end points by demonstrating a statistically significant and clinically meaningful reduction and the clinicians global impressions scale or C. G I compared to placebo at week, six and all populations evaluated.
Consistent with prior trials limit <unk> wrong, with generally safe and well tolerated.
Patients experiencing depressive episodes with mixed features have more severe illness with higher returns right <unk> and rates of suicide and suicidal ideation.
In addition patients with M D D and mixed features respond poorly to antidepressants. These.
These study results provide important data about the efficacy tolerability and safety profile of <unk> for these difficult to treat conditions.
These results built on the day that we reported in our post hoc analysis of study 404 on the <unk>.
<unk> set of patients with bipolar depression exhibiting next features.
We are pleased to announce that this analysis has just been published in April and the journal of clinical psychiatry.
We plan to meet with the F. D. A later this year to discuss our study results and determine the next steps for the program.
Are a little tougher on program extends across several major neuropsychiatric conditions, including M. D D.
We have an ongoing registration program evaluating limit <unk> as adjunctive treatment for major depressive disorder impatience with partially respond to antidepressants subject to the results of our ongoing studies, we expect to file.
S N D. A N 2024.
We have continued also continued to invest in argument TERP wrong long acting injectable program, having completed a phase one study evaluating one formulation and completed preclinical studies evaluating several formulations, which can deliver drugs for one month or longer.
All of this program is to develop formulations that are effective safe and well tolerated with treatment duration of one month for longer we plan on progressing Reformulations this year and next year.
Beyond human <unk>, we continue to make progress with our other pipeline programs, including ITI 12, 84 or five.
<unk>, one or P D, one inhibitors and ITI triple three.
With our lunar Tepper on program. These innovative pipeline programs focus on therapeutic areas with significant unmet patient need.
Starting with ITI, 12, 84, or do the right form of limit <unk> and.
2023, we plan to begin phase two clinical studies in patients with agitation in Alzheimer's disease patients with psychosis, and Alzheimer's disease, and patience generalized anxiety disorder, all highly prevalent condition.
I'll repeat it you want inhibitor program.
Patient enrollment has been initiated and our phase two proof of concept study for lenders potent which is being developed for the treatment of motor symptoms in patients with Parkinson's disease.
Changes in cognitive measures and inflammatory Biomarkers will also be assessed.
Since you're the evidence supports the involvement of neurons formation and the development of Parkinson's disease. We.
We have shown that line was supposed to reduce narrow information directly modulating into cellular signaling pathways in the brain called micro glia.
A similar pathway may be involved in controlling the new cell function, particularly macrophages and Nancy N S tissue, including certain solid tumors.
An active I N D for our newest P D. One inhibitor.
10, 20, which is being developed as a novel immunotherapy for oncology indications clinic.
Political conduct has begun and a single a sending dose study in normal healthy volunteers to establish a safe and tolerable range of doses for further study.
The potential of safe and well tolerated small molecule as part of the treatment on <unk> for cancer indications is an exciting prospect and we look forward to advancing this program.
Finally, we continue to develop ITI triple three or five H T. Two a receptor antagonists and new opioid receptor partial agonist for the treatment of opioid use disorder in pain and.
Q1, we began clinical conduct and a multiple I, sending those study and healthy volunteers evaluating pharmacokinetics safety and tolerability of the molecule.
Imaging studies ongoing.
Our company is in a strong financial position ending the quarter with $548.5 million in cash cash equivalents and investment securities. Additionally, we have no debt.
As a company we remain deeply committed to our goal of developing effective and innovative treatment that improves the lives of patients.
We continue to take steps forward to achieve this goal. We believe we have significant growth potential in capital Ida and the rest of our pipeline and we look forward to continuing our progress.
I will now turn the call over to Mark to further discuss kept lightest performance and commercial opportunity Mark.
Thanks, Sharon and good morning, everyone is Sharon noted kept light is off to a great start in 2023 registering sequential quarterly growth in total prescriptions of 16% versus Q4 of 2022 and year over year growth of 159% versus the same period law.
Last year.
Step ladder generated this impressive performance despite facing typical first quarter headwinds and an overall anti psychotic market that group total prescriptions only modestly.
Additionally weekly new patient starts a capital items are now five to six times higher than they were prior to our label expansion of bipolar depression.
This growth is being driven by continued strong underlying demand then prescriber adoption of capital items.
As we saw a consistently strong monthly increases in Q1.
Both the breath of our prescriber base as well as the depth of prescribing.
By the end of the first quarter kept lightest prescriber base had grown to more than 25000 unique prescribers, adding.
Adding close to 4000, new first time prescribers in Q1, including over 1400 in March alone as we continue to penetrate the prescriber adoption curve.
We believe the fundamentals of a healthy larger evidence and were highly confident that couple Ida will continue to experience strong growth throughout this year and beyond.
The market opportunity for capital Ida as large and we believe this is just the beginning with plenty of room for long term growth there.
There are several reasons for this.
First and kept light is approved and large patient populations, including bipolar depression, a highly prevalent mood disorder affecting more than 11 million American.
There's a significant remaining unmet medical need and bipolar depression with frequent medications switching in the class as prescribed research for the optimal balance of efficacy and tolerability for each patient.
Apply that has a compelling product profile and it's proven effective and bipolar depression and schizophrenia with a favorable safety and tolerability profile with weight metabolic changes EPS and akathisia all similar to placebo in our clinical trials. These are powerful reasons to prescribed.
Or bipolar depression label, which includes the use of capital Ida as both mono therapy, and his adjunctive treatment and bipolar one and bipolar two depression.
Puts us in a strong competitive position in this marketplace.
While the prevalence of bipolar one and bipolar two disorders or similar bipolar two patient population remains under diagnosed.
This patient population represents an important opportunity for capital Ida is there is only one other drug approved for bipolar two depression.
As part of our marketing efforts were increasing awareness and the importance of treating bipolar two disorder.
Secondly, the prescriber base for anti Psychotics as large with tens of thousands of prescribers as I mentioned before we have been consistently increasing both the breath and the depth of this space, adding significant numbers of unique prescribers and expanding the average number of prescriptions per prescriber.
The recent increase in the size of our sales organization allows us to connect more frequently with our highest volume prescribers as well as continuing to expand our reach thereby increasing our market share and penetration.
We are investing behind the brand to optimize the growth of capital items and have a comprehensive commercial plan complementing our sales efforts with peer to peer medical education program digital promotion and are let in the light direct to consumer national advertising campaign.
Together. These efforts are raising awareness amongst prescribers and patients about the unmet need in bipolar one and bipolar depression.
And educating physicians and potential new patients about the benefits of capital items.
Finally, our extensive market access coverage across all three pair channels and our comprehensive lightly patient support offerings complement our promotional efforts.
And Q1, we strengthened our market access position to now cover approximately 90% of commercially insured lives and have continued to maintain greater than 98% coverage in the Medicare part B and Medicaid channels.
Our experienced commercial team is proud of our progress to date and.
And we remain focused on supporting the needs of our physicians and patients and delivering sustain prescription and revenue growth throughout the year.
Now I'll hand, the call over to Larry to detail our financial performance.
Thank you Mark I will provide highlights of our financial results.
Total revenues were $95.3 million for the first quarter of 2023 compared to $35 million for the same period in 2022.
Net product sales, a calculator, where $94.7 million in the first quarter of 2023 compared to $34.8 million for the same period of 2022, representing a year over year increase of 173 per cent.
And the first quarter calculated net sales increased 8% over the fourth quarter of 2022 in total prescriptions grew 16% sequentially.
Gross Tonight percentage was in the low thirties reflect the more favorable than anticipated pay your dynamics, including lower than anticipated co pays systems cost due to a more favorable formulary placement and lower managed care rebates.
We expect our gross to note percentage to increase towards the mid thirties for the remainder of the year.
During the quarter there was a modest decrease in days on hand of calculated at the wholesale level as.
As we expect underlying demand for calculated to remain strong we are reiterating our prior full year 2000, twenty-three capitalize the net sales guidance of $430 million to $455 million.
Selling general and administrative SG&A expenses were $98.9 million for the first quarter of 2023 compared to $75.5 million for the same period in 2022.
This increases due to increases in marketing and advertising costs.
Research and development R&D expenses.
The first quarter of 2023 $38 million compared to $29 million for the same period in 2022.
This increase was primarily due to higher luman chaperone project cost and to a lesser extent Magnum a temporary project cost.
Cash cash equivalents an investment securities.
Total $545 million at March 31, 2023.
Compared to $593.7 million of December 31st 2022.
For 2023, we continued to estimate full year SG&A expenses to range between 420, and $450 million and full year R&D expenses to range between 195 and $220 million <unk>.
This concludes our prepared remarks, operator, please open the line for questions.
Currently.
A reminder to ask a question you will need to press star one one on your telephone.
The time constraints and to give everyone a chance to ask a question. We ask that you. Please limit yourself to one question.
One moment please.
No first question comes from the line of Jessica <unk> with J P. Morgan.
Hi, Good morning, this is where the mine on for Jessica. Thank you for taking our questions you talked about <unk> being in a load 30% range can you talk about how do you see it going a little Q is it likely to improve sequentially and.
Secondly, <unk> M. D D. The study <unk> would you be able to provide us with anytime lunch on <unk>. Thank you.
Thanks for your question I think I got both of them I think the beginning the first question and stomach last night and I'll ask Larry to take that one and then if I have it right. Your second question is on starting spot studies type.
Oh, five I might ask you to repeat that one but first let's do the cross to net so Larry do you want to take the asking that question. Please.
Yeah, I do I think.
You ask why is the gross that percentage going to increase or decrease as we go forward I didn't quite hear that.
Yeah, I think he's.
<unk>, Yeah right yeah.
Yeah sure well as I mentioned in our prepared remarks, there's and our gross to net was lower in the first quarter, Alright, and we do expect diversity of that the increase in the.
Towards the mid thirties from the low thirties that was experienced in the first quarter and this is primarily due to increased volume going through the commercial channel as well as increased commercial coverage.
Okay and could you repeat the second part of the question on 505. Please.
Yeah sure just thinking about the timeline for the $30 from did the <unk>.
Okay. So for the first two M. D. D trials, we've said that we expect that should they be successful we would be filing in 2024. So obviously read out his earlier than that 4505, which said that that that would take.
More time clinical conduct has started.
And obviously it would take longer it would probably take another year.
Expect that we would be concluding that study and be ready to <unk> to do our filing in 2025.
Mmm.
Next question operator please.
Thank you and our next question comes from the line of Brian a rooms with RBC capital markets.
Hi, Yeah, it's landed on for a Brian . Thanks for taking my question. Congratulations on the strong quarter I wanted to ask dawn. The mixed features indication just how much more education do you think that.
There needs to be done to get some of the kols up to speed on how to best treat these patients.
Are you finding that there are any differences in the familiarity with next features across geographies or treatment centers and it's I guess, what's the best way to position kept later in the next features population across lines of therapy or you know first switch.
Yeah. Thanks <unk>.
Great questions and I'll start and I'll have to get some restaurants to add anything I think that with the publication of the D. S. M five which now is.
Some years ago, I think there's been an increasing awareness and then increased desire to be able to treat these patients.
Uhm bipolar depression with next features was included in the D. S. M. Four but it was a looser definition I mean, that's not a technical term, but I'll lose their definition and then in the D. S. M. Five and there wasn't there wasn't any specifier are clear definition.
And the D. S. M. Four for next features and M. D. D. So again with the D. S M. Five I think that.
That has allowed the.
The clear desk clearer definition and that there has been an increase in physician.
Awareness and and wishes to be able to treat this patient population. These are not small patient population about on average about a third of each of these patient populations have mixed features they're difficult to treat patients they have higher rates of suicide and.
Tidal ideation.
So these are these are important patient populations to treat.
As to whether or not there are differences.
<unk> geographical regions I I I am not aware of that but maybe I'll ask the rash and he has anything he wants to add to that.
In terms of the geographical distribution no I don't think.
I don't think that it's any different assess it is seen.
This is as you said it is about a third of the patient population little bit on the lower side for the <unk> site on the.
Pushing such space and since 2030 and since it's been officially a specified within the <unk> five.
Describe with have been getting more and more.
Used to this.
And we're going to need to educate educate the prescribes.
So also I think it's important to note that our data was extremely robust and health care providers are very interested in these results and and to that end of course, we're working on a publication as well as all the other measures at we've described to you.
Got it thanks, so much.
Okay.
Q.
And our next question comes from the line of Andrew Cy with Jeffries.
So I will dot com I'll ask Suresh to fill in uhm. So first what we're expecting.
On all of these mood disorders.
Or using the Mac address.
As our measure.
Primary end point the change from baseline on the mattress score and as you know.
Optimally. So you look towards the lower end for for the change in my address.
In a chunk of studies.
I need a little bit before the other one so I think well, we'll see when they conclude if there if they conclude.
Separately and will report them out separately, if there's a long time or any period period of time between the two and if they're close together then will report them out together I think it's it we're not prepared to give any.
Further.
You're already on that yet.
And I think that covers it unless I missed something slash did I Miss anything.
No I think.
<unk>.
Oh yeah.
Yeah. Thank you guys for that makes perfect sense Richardson.
Thank you.
Next question comes from the lineup Charles Duncan with cancer Fitzgerald.
Say this schizophrenia population and if the guidance include any change him pricing assumed later on this year.
<unk>, Yeah sure Yep sure Hi, Charles Yeah. So the we continue to see a very strong compliance and persistence profile with capital Ida.
Okay.
Operator and that any questions. Thank you and our next question comes from the lineup, Jeff home with Morgan Stanley .
Thanks for taking my question for.
For your P. D. One inhibitor portfolio talk about the differences between 214, and 10 20, and how those differences Linda candidates to be better suited for different indications. Thanks.
Okay. So the the two molecules your testing to 14 and 10 20 are are different molecular entities that both new molecular entities, but they differ from each other we have several different skyphos within the P. D. One inhibitor.
<unk> and that affects the potency of these molecules and they have been purposely designed to.
Have different potencies, and too and in their ability to penetrate the blood brain barrier.
And some other.
Aspects as well, but I think this is what we've said publicly today. So we're very excited about these both of these molecules and as we go forward I think we'll be talking more and more about them.
Alright, thank you.
Thank you.
[laughter].
Good Thanks for taking my question the nice to see all the progress of the company. So on mixed features is it any way to proactively gauge how D of doctors and physicians and patients might be but.
Feeding the high quality data that you have on hand already and on that note. When you meet the F. D. I know you're going into seek feedback what'd you proactively expect to.
Request, a potential put an S N D assumption on the back of very high quality data.
Yeah, I'm, not quite sure who to who to address that to the rash do you Wanna start.
Yes.
Ah yes, the data we have seen with our.
Hold on to the next week to study as strong both in the combined populations of bipolar Depression makes me just as well as the <unk>.
<unk> <unk> and also the individual patient population with mbd with mixed we just.
An interview with population bipolar depression with mixed features as we have indicated earlier we are.
Putting a package to get that to go to the F D a and discuss.
And we will update you on our next steps.
What steps would be from from there be it.
And we are.
Also planning to the grid data there'll be published in an obligation.
Obligation right now so probably pretty S. As soon as possible.
The physician community.
With the data.
About that and we'll get a great a great reception to it as well.
Thanks.
Our next question comes from the lineup Mark Goodman with SBB Larry.
Good morning, Mark can you talk about your share voice for capital I at a relative to a very large percentage terms of and if you feel like you've got it right and whether there's potential that you might need to take it higher or just curious how you were thinking about things relative to probably the other major competitor the smithy.
Noise out there.
Mmm.
Yeah. Thanks bark, we think pretty much since the beginning we have maintained a comparable share a voice out there across the different.
Elements of the promotional mix and we feel that.
With the quality of the profile the clinical profile of capital Ida.
If we can maintain a comparable share of boys and have comparable access from a payer perspective, then that's a situation that we like a lot because we think we can win in that situation. So I think as I mentioned in my prepared remarks, we are investing behind the brand.
To optimize the growth of capital Ida as you are aware mark at the beginning of the year we.
Expanded our salesforce by an additional 50 representatives that has allowed us to more frequently interact with our highest volume prescribers, but also increase our reach <unk>.
Still early days with that but we're seeing a very nice progress with those representatives and we expect that impact build over the course of the year. We've been airing are revised Ah and new DTC campaign that let in the light campaign and <unk>.
Getting the metrics that we're following there so I think across the board we feel good about the level of promotion and our ability to compete.
With the others in the in the brand new category.
Six.
And our next question comes from the lineup.
Jason <unk> Berry.
One moment please.
Our next question comes from the line of Michael <unk> with Evercore ISI.
[noise] Hi, guys. This is Omar working for Mike I have [laughter] I have two here if I may 1st as we think about sort of the like the bigger picture as we think about your expansion into mixed features as well as M. D. D. Can you lay out for US what are the market chairs because there may be.
Getting used off label and mix features right now can you speak to what your commercial diligence is on that like the key players, but even more importantly on the M. D decide and perhaps if you could also give us an added layer of mono therapy versus the junk to use and then separately would you at any point consider or possibly even exploring a mono therapy trial and error.
D D as well thank you very much.
I don't know Mark do you want to start or do you want me to start.
I mean, I can I can address the market share portion of the question that that Omer has and then turn it over to you I think.
There's only a handful of products approved for M. B D as you're aware, including Rexall fee more recently for Alar Abilify previously.
Well I will first say that as you know there is nothing approved and.
Mixed features for either bipolar depression or N D D.
With next features having said that I will first turn it over to thrash to tell you a little bit more about beyond that.
Yeah in terms of the mix. We just you know if this is what we are studying his patients who have a major depressive episode.
<unk> R M D D.
Some of the matic symptoms that don't read the clinical pressure a full blown mania.
<unk> or.
Mixed sweetest patients who have a great rest of you <unk> <unk> <unk>.
So that's why we studied this.
Implications in a broad range of <unk> spectrum.
Treated such that they go into remission. So we know that there is a very broad need for.
What what are the counter arguments to why you shouldn't be able to get approved with a single study.
Stay tuned we there's a lot more to come including a lot more data on on our programs that are in the clinical studies. So we'll get back to you as soon as we have more information.
Open enrollment.
Yeah, I can tell you that good news.
Mostly made up of psychiatrist and nurse practitioners that support those psychiatrist, but also a segment of primary care as well now.
Growth through the remainder of this year and into the future as well.
<unk> seven studies Withdrawl ready for first one being the agitation.
And <unk>. This is spacious and regarding the studies itself as we come close up to the.
Starting to study, which we are planning to do this year and we will let you know the designs and the details of the study once we come closer to that study.
So I can add to that end and you commented on the <unk> add calm and we were very pleased to see the endorsement by the panel first for for the use of anti Psychotics in this patient population we.
Do think that are product profile for 12 84.
Would benefit patients with agitation, we are currently tweaking the protocols.
I think that one always tries to learn from those that uhm present data and we think that.
We.
We are currently based on what we heard at that AD com.
Tweaking our protocol.
To reflect both what we heard by the committee and Ivy Agency as well as making sure. We're maximizing what we think it can be a benefit to patients.
So.
Well update Ya.
Soon as possible.
Okay. Thanks Shan.
Thank you I would not like to hand, the call back over to C. E O Sharon mates for any closing remarks.
Thank you up right and thank you everybody for joining US today I think we're very pleased with a strong performance that we saw in Q1 as Mark mentioned to you. We look forward to increasing the depth and breadth of the prescribing of kept lighter as well as the <unk> moving.
Our pipeline programs, so with that we look forward to speaking with you next quarter and with that upgrade or you can disconnect.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating and you may now disconnect.
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