Q3 2023 Intra-Cellular Therapies Inc Earnings Call

Okay.

Speaker 1: Thank you for standing by and welcome to the Interstellar Therapy's 3 Q2 023 Arnie's Conference call. At this time, all participants are listening only mode. After the speakers presentations, there will be a question and answer session. To answer the question, please press star one more.

Thank you for standing by and welcome to the intra cellular therapies three Q2023 earnings conference call. At this time, all participants are in a listen only mode.

After speakers' presentation, there'll be a question and answer session.

A question. Please press star one I'm wondering your telephone.

Speaker 1: Please be advised that today's call is being recorded. I would like to turn the call over to your host, Dr. Juan Sanchez, Head of Investor Relations at ITCI. Please go ahead, sir.

Please be advised today's call is being recorded.

I'd like to turn the call over to your host Dr. Juan Sanchez head of Investor Relations at I T. C. I. Please go ahead Sir.

Good morning, and thank you all for being here.

Speaker 2: Joining me on the call today are Dr. Jordan Naids, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Dorgan, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer.

Joining me on the call today, a doctor Sharon mates, Chairman and Chief Executive Officer.

Mark Newman Chief commercial officer Dr.

Doctors rescue program.

Chief Medical Officer.

Let me highlight two.

Financial Officer.

Speaker 2: As a reminder, during today's call, we will be making certain forward-looking statements.

As a reminder during.

During today's call, we will be making certain forward looking statements.

Speaker 2: These forward-looking statements are based on current information, assumptions, and expectations.

These forward looking statements are based on current information assumptions and expectations.

Speaker 2: Those are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement.

Those are subject to change I mean, both a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.

Speaker 2: These and other risks are describing our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.

These and other risk are described in our periodic filings made with the Securities and Exchange Commission.

Including our quarterly and that.

All reports.

Speaker 2: You are cautioned not to place on your reliance on these four-looking statements, and the company displains any obligations to obey such a statement.

You are cautioned not to place undue reliance on these forward looking statements.

And the company disclaims any obligations to update such statements.

Speaker 2: I will now turn the call over to Sean.

I will now turn the call over to sure.

Speaker 3: Thanks, Juan. Good morning, everyone. And pleased to report on our continued progress and the strong third quarter results we delivered. The positive trajectory for Keplido, we have seen over the past few quarters, continues, bolstered by positive reports from both prescribers and patients.

Sure.

Thanks, Warren good morning, everyone.

I'm pleased to report on our continued progress and the strong third quarter results we delivered.

Or is it a trajectory for kept light up we have seen over the past few quarters continues bolstered by positive reports from both prescribers and patients.

Speaker 3: In the third quarter, Kaplita total prescriptions increased by 71% compared to third quarter of 2022.

In the third quarter kept light of total prescriptions increased by 71% compared to third quarter of 2022.

Speaker 3: Third quarter total revenues increased to $126.2 million.

Third quarter total revenues increased to $126 $2 million.

Speaker 3: Keplite and net sales increased to $125.8 million, a 75% growth versus the same period in 2022.

<unk> net sales increased to $125 $8 million or 75% growth versus the same period in 2022.

Speaker 3: Demands for cap lighter has been strong and we expect to sustain this forward moment.

Sure.

Demand for kept like that has been strong and we expect to sustain this forward momentum.

Speaker 3: As such, we are increasing our cap light on net product sales guidance for the full year, 2023 to $460 to $470 million from our previous guidance of $445 to $465 million.

As such we are increasing our capital either debt.

<unk> sales guidance for the full year 2023 to $460 million to $470 million from our previous guidance of $445 million to $465 million.

Speaker 3: As caplighta use continues to expand and patient since physicians continue to gain positive experience, we remain confident in caplighta's growth.

As Kipp why do you use continues to expand and patients and physicians continue to gain positive experience, we remain confident in capsulitis growth potential.

Speaker 3: Looking ahead, strong fundamentals, fuel our confidence about cap light as growth prospects, including its clinical profile, its broad labor and schizophrenia and bipolar depression, as well as our proven commercial strategy.

Looking ahead strong fundamentals fuel our confidence about kept lightest growth prospects, including its clinical profile its broad label in schizophrenia, and bipolar depression as well as our proven commercial strategy.

Speaker 3: Both existing and new prescribers help to drive Keplite's growth.

Both existing and new prescribers helped to drive kept lightest growth.

Speaker 3: Since cap light is launched in bipolar depression, we've built a solid base of consistent prescribers allowing us to help an increasing number.

Since <unk> launch in bipolar depression, we've built a solid base of consistent prescribers, allowing us to help an increasing number of patients.

Speaker 3: Mark will share more details about our commercial performance.

Mark will share more details about our commercial performance.

Speaker 3: In addition to maximizing the existing market opportunity for Keplita, our strategy includes expanding Keplita beyond its current indication.

In addition to maximizing the existing market opportunity for kept later our strategy includes expanding capital light up beyond its current indication.

Speaker 3: To this end, we continue to generate clinical data to further establish Muteppron as an important treatment choice across broad patient populations with mood disorders.

To this end, we continue to generate clinical data to further establish <unk> as an important treatment choice across broad patient populations with mood disorders.

Speaker 3: This is exemplified by our programs including our Pivotal Program for Junctive Treatment of MDD and our recently announced positive results from study 403 into important move disorder patient populations. Those with MDD and mixed features and those with bipolar depression and

This is exemplified by our programs, including our pivotal program for adjunctive treatment of M D and our recently announced positive results from study four O rates at two important mood disorder patient population those with MD D and mixed features and those with bipolar depression on next features.

Speaker 3: These results are one of many clear signs of capillitis potential across broad patient populations with mood disorder.

These results are one of many clear signs of kept lightest potential across broad patient populations with mood disorders.

Speaker 3: We have submitted our meeting request to the FDA to discuss the results from study for us.

We have submitted our meeting request to the FDA to discuss the results from study 403, we expect this meeting to occur later this year or in Q1 2024.

Speaker 3: We expect this meeting to occur later this year or in Q1 2024.

Speaker 3: We have begun to share this important data at medical conferences, including psych congress and the European College of Neurocycle Pharmacology.

We have begun to share this important data at medical conferences, including site Congress and European College of Neuropsychopharmacology <unk>.

Speaker 3: We will continue to present our findings at other major medical meetings. We will also be submitting a manuscript for publications soon, which will help to further educate prescribers about caplida and mixed-

We will continue to present our findings at other major medical meetings. We will also be submitting manuscripts for publication soon which will help to further educate prescribers about cap lighter and mixed features.

Speaker 3: Let's now turn to our Lunar Tepperone, a junk to MDD clinical program. We continue to make progress in our phase three efficacy studies, 501, 502, and 505, as well as study 503, our open label safety studies.

Let's now turn to our lunar kept are on adjunctive <unk> clinical program.

We continue to make progress in our phase III efficacy studies by about one five years, two and 505 as well as study <unk> III, our open label safety study.

Speaker 3: We are on track to report type line results from Study 501 and Study 502 in the first and second quarter of 2024. Respect.

We are on track to report pipeline results from study <unk> hundred one and studied <unk> in the first and second quarter of 2024, respectively.

Speaker 3: Subject to those results, we expect to file a supplemental new drug application with the FDA in the second half of 2020.

Subject to those results, we expect to file a supplemental new drug application with the FDA in the second half of 2024.

Speaker 3: Turning to our Luma Teppu-Oh and Long Acting Injectible program, our goal is to develop long acting injectable formulations that are effective, safe, and well-tolerated with treatment durations of one month or long.

Turning to our lunar tap on long acting injectable program. Our goal is to develop a long acting injectable formulations that are effective safe and well tolerated with treatment durations of one month or longer.

Speaker 3: We conducted a Phase I single ascending those study with our initial LAI formulae.

Conducted a phase one single ascending dose study with our initial early I formulation.

Speaker 3: This study evaluated the pharmacopinetic safety and tolerability of lunges on L.A.I. in patients with stable symptoms of schizophrenia and lungiceparone with safe and generally well tolerated.

This study evaluated the pharmacokinetics safety and Tolerability of.

In patients with stable symptoms of schizophrenia, and Lula kept wrong with safe.

Speaker 3: We have been evaluating several additional LAI formulations with treatment durations of one month and long.

Generally well tolerated.

We have been evaluating several additional.

[noise] formulations with treatment duration of one months and longer.

Speaker 3: We have completed all non-clinical studies to support the initiation of phase one study with four formulations. We expect to commence clinical conduct in this study in the first half of 2024.

We have completed all non clinical studies to support the initiation of phase one study with four formulations, we expect to commence clinical conduct in this study in the first half of 2024.

Speaker 3: Given the encouraging tolerability data to date with oral luma teperon, we believe that an LAI option may provide a convenient treatment for appropriate patients. I'll now share up to

Given the encouraging tolerability data to date with oral limit tapped wrong, we believe that an LTI option may provide a convenient treatment for appropriate patients.

I will now share updates across the remainder of our pipeline.

Speaker 3: Starting with ITI-1284. ITI-1284 is a deuterated form of luma capron, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration.

Starting with ITI 12, 84, Ipi 12, 84 as it generated form of <unk>.

A new chemical entity formulated as an oral disintegrating tablet for Sublingual administration.

Speaker 3: We completed the toxicology studies requested by the FDA and have initiated our phase two programs evaluating ITI-1284 in generalized anxiety disorder, or GAD, psychosis in Alzheimer's disease and agitation in Alzheimer's disease. We expect clinical conduct in these ITI-1284 phase two studies to begin in the first half 2024.

We completed the toxicology studies requested by the FDA and have initiated our phase II programs evaluating ITI <unk> 84 in generalized anxiety disorder, or ghd, and psychosis and Alzheimers disease agitation in Alzheimer's disease, we expect clinical conduct in knees.

ITI 284 phase II studies to begin in the first half 2024.

Speaker 3: Our first study will be an adjunctive study to SSRIs and SNRIs approved for GAD.

Our first study will be an adjunctive study to SSRI and SNRI approved for J D.

Speaker 3: This is a condition with around 10 million diagnosed adults in the US with half of these patients not responding adequately to initial therapy.

This is a condition with around 10 million diagnosed adults in the U S with half of these patients not responding adequately to initial therapy.

Speaker 3: There are currently no approved anti-psychotics for GAD and only in minority of these patients are being treated off-label with anti-psychotics.

There are currently no approved anti Psychotics for Ghd and only a minority of these patients are being treated off label with anti Psychotics.

Speaker 3: We see a major opportunity for an effective, safe, and well-pollurated treatment for these.

See a major opportunity for an effective safe and well tolerated treatment for these patients.

Speaker 3: Our phosphodiesterase inhibitor clinical programs continue to advance. We are in low-end patients with Parkinson's disease and our LEN response phase to clinical trial, which will evaluate improvements in motor symptoms, changes in cognition, and inflammatory biomark.

Our phosphodiesterase inhibitor clinical programs continue to advance we are enrolling patients with Parkinson's disease, and our lenders potent phase II clinical trial, which will evaluate improvements in motor symptoms changes in cognition and inflammatory biomarkers.

Speaker 3: We expect a complete enrollment for this study in late 2024 with top line results anticipated in the first half of 2020.

We expect to complete enrollment for this study in late 2024 with top line results anticipated in the first half of 2025.

Speaker 3: ITI-1020 is our highly selective PDE1 inhibitor being developed for oncology indications. Our phase one single ascending dose study is ongoing, evaluating the pharmacokinetic safety and tolerability of different doses in healthy volunteers.

ITI <unk> 'twenty is our highly selective PDE, one inhibitor being developed for oncology indications our phase one single ascending dose studies ongoing evaluating pharmacokinetics safety and tolerability of different doses in healthy volunteers.

Speaker 3: Next, our novel product candidate by TI-TRIPLE-3 is being developed to treatment of opioid use disorder and pain. A multiple ascending dose study and the PET study looking at receptor occupancy are both currently ongoing.

Next our novel product candidate by Ti Triple three is being developed for the treatment of opioid use disorder and pain.

<unk> ascending dose study and the pet study looking at receptor occupancy are both currently ongoing.

Speaker 3: We anticipate completing our Mad Study in 2024 in the doses tested to date, IPI-333 is safe and generally well-toleried.

We anticipate completing our Mad study in 2024, and the doses tested to date ITI 333 is safe and generally well tolerated.

Speaker 3: Last quarter, we introduced ITI 1500, our new program focused on the development of novel, non-musinogenic psychedelics. This program is focused on treating mood, anxiety, and other neuropsychiatric disorders, notably without the liabilities of known psychedelics, such as positive. and risk for cardiac response virus.

Last quarter, we introduced ITI <unk> hundred our new program focused on the development of novel non hallucinogenic psychedelics.

This program is focused on treating mood anxiety and other neuropsychiatric disorders, notably without the liabilities of non psychedelics, such as hallucinogenic potential and risk for cardiac valvular pathologies.

Speaker 3: Our lead product candidate in this program, ITI 1549, continues to advance through IMD enabling studies and is expected to enter human testing in late 2024 or early 2025.

Our lead product candidate in this program ITI <unk> 49 continues to advance through IMD, enabling study and is expected to enter human testing in late 2024 or early 2025.

Speaker 3: We plan to present data on this preclinical program at a scientific conference later this year.

We plan to present data on this preclinical program at a scientific conference later this year.

Speaker 3: In summary, we are excited about the progress being made across our

In summary, we are excited about the progress being made across our company. We are confident about cap lightest commercial growth prospect and its potential to expand across different mood disorders. We are proud to continue building our company with our very novel pipeline.

Speaker 3: We are confident about capillitis, commercial growth prospect, and its potential to expand across different mood disorders. We are proud to continue building our company with our very novel pipe.

Speaker 3: All of our efforts underscore our continuous commitment to transforming the lives of patients with complex neurologic and neuropsychiatric diseases to effective, safe, and tolerable.

All of our efforts underscore our continuous commitment to transforming the lives of patients with complex neurologic and neuropsychiatric diseases to effective date.

Tolerable treatments.

Speaker 3: We are in a strong financial position and in the third quarter with approximately $495 million in cash, cash equivalent and investment securities and no debt. We look forward to continuing to share our progress with you.

We are in a strong financial position ending the third quarter with approximately $495 million in cash cash equivalents and investment securities and no debt, we look forward to continuing to share our progress with you.

I'll now turn the call over to Mark Mark.

Speaker 4: Thanks Sharon. Good morning everyone. It's really great to be with you.

Thanks, Sharon good morning, everyone, it's really great to be with you today.

Speaker 4: Keplite continues to establish itself as a major therapeutic option in the treatment of bipolar depression and schizophrenia.

<unk> continues to establish itself as a major therapeutic option in the treatment of bipolar depression and schizophrenia.

Speaker 4: In the third quarter, our commercial team drove strong growth, increasing total prescriptions 71% compared to the same quarter last year, and 7% sequentially compared to...

In the third quarter, our commercial team drove strong growth, increasing total prescription 71% compared to the same quarter last year, and 7% sequentially compared to Q2 of this year.

Speaker 4: We are pleased with capillitis prescription growth this quarter, considering the impact of the typical summer seasonality that saw the overall oral and a psychotic market register zero growth for the quarter.

We are pleased with capitalizes prescription growth this quarter, considering the impact of the typical summer seasonality that saw the overall oral antipsychotic market registered zero growth for the quarter.

Speaker 4: Looking more broadly, in the first nine months of 2023, capilloidate total prescriptions grew 100% compared to the same nine months in 2020.

Looking more broadly in the first nine months of 2023 <unk> of total prescriptions grew 100% compared to the same nine months in 2022.

Speaker 4: A growing number of physicians and patients continue to try capillighta and experience positive...

A growing number of physicians and patients continue to try cap lighter and experienced positive results.

Speaker 4: During the quarter, we continued to increase both the breadth of our prescriber base and their depth of prescription.

During the quarter, we continued to increase both the breadth of our prescriber base and their depth of prescribing.

Speaker 4: At the end of the third quarter, there were over 32,000 cumulative prescribers of capillitis in flight.

As of the end of the third quarter, there were over 32000 cumulative prescribers of capital items since launch.

Speaker 4: Importantly, we are also increasing their depth of prescribing every quarter as prescribers see the benefits that capillata provides.

Importantly, we are also increasing their depth of prescribing every quarter as prescribers see the benefit that kept light it provides for their patients.

Speaker 4: For Sharon mentioned, the strong performance in Q3 has led us to increase both the top end and bottom end of our full year cap lighter revenue guidance range to 460 to 460.

As Sharon mentioned the strong performance in Q3 has led us to increase both the top end and bottom end of our full year kept lighter revenue guidance range to $460 million to $470 million.

Speaker 4: And the strong performance also adds to our confidence that we will see continued long-term.

And the strong performance also adds to our confidence that we will see continued long term growth.

Speaker 4: On the market access run, we continue to benefit from broad coverage across all three payers.

On the market access front, we continue to benefit from broad coverage across all three payer channels.

Speaker 4: Our market access for capillighted covers approximately 90% of commercially insured lives and greater than 98% of the Medicare Part D and Medicaid lives. We also re-

Our market access for capital Ita covers approximately 90% of commercially insured lives and greater than 98% of the Medicare part D and Medicaid lives.

We also recently improved the quality of our coverage.

Speaker 4: Toward the end of the third quarter, two of the largest Medicare Part D plans changed their utilization criteria for CAPLITA from a prior authorization and two-step edit to unrestricted status.

Towards the end of the third quarter two of the largest Medicare part D plans change their utilization criteria for cap lighter from a prior authorization and two step at it too.

<unk> unrestricted status.

Speaker 4: Boosting capillight at 50% unrestricted coverage overall in the Medicare Part D channel, similar to established products in this.

Boosting capital light at 250% unrestricted coverage overall in the Medicare part D channel similar to established products in this category.

Speaker 4: Our sales force and broader commercial team continues to execute extremely well, maintaining high productivity with our 43,000 HCP targets.

Our sales force and broader commercial team continues to execute extremely well maintaining high productivity with our 43000, HCP targets and complementing that effort with well attended peer to peer medical education programs.

Speaker 4: complementing that effort with well-attended peer-to-peer medical education programs, comprehensive digital promotion.

Comprehensive digital promotion and on the consumer side, our lead in the life direct to consumer National advertising campaign continues to raise awareness of <unk>, among prescribers and to prompt more patients to ask their physicians about cap line.

Speaker 4: And on the consumer side, our Lead in the Light, direct-to-consumer national advertising campaign continues to raise awareness of.

Speaker 4: prompt more patients to ask their physicians about.

Speaker 4: Her brand messaging, approved in FSCATE, and FDA approved indications across schizophrenia and both bipolar one and bipolar two depression.

Our brand messaging are proven efficacy and FDA approved indications across schizophrenia in both bipolar one and bipolar depression.

Speaker 4: favorable safety and tolerability profile and a single once daily dose continues to resonate well and

Favorable safety and Tolerability profile and the single once daily dose continues to resonate well in the marketplace.

Speaker 4: Capelita has an extremely compelling product profile and we are well positioned for consistent growth in the coming-

Capital either has an extremely compelling product profile and we are well positioned for consistent growth in the coming years.

Speaker 4: I look forward to continuing to update you on the successful launch of Cap-

Look forward to continuing to update you on the successful launch of capital item.

Speaker 4: Now, I'll pass the call over to Larry to walk through our financial.

Now I'll pass the call over to Larry to walk through our financial performance Mark.

Speaker 5: Thank you, Mark. I will provide highlights of our third quarter financial result.

Thank you Mark I will provide highlights of our third quarter financial results.

Speaker 5: Total revenues were $126.2 million for the third quarter of 2023 compared to $71.9 million for the same period in 2020.

Total revenues were $126 2 million for the third quarter of 2023.

Compared to $71 9 million for the same period in 2022.

Speaker 5: The man for capillator remains strong. Net products sales of capillator were 125.8 million in the third quarter of 2023, compared to $71.9 million for the same period in 2022, representing a year over year, increase of 75%. In the third quarter, capillator.

Demand for capital either remained strong net product sales of capital either were $125 8 million in the third quarter of 2023 compared to $71 9 million for the same period in 2022, representing a year over year increase of 75%.

In the third quarter capitalizing net sales increased 14% sequentially over the second quarter of 2023.

Speaker 5: Our grossed and at percentage during the quarter remained in the low 30s as previously guided.

Gross to net percentage during the quarter remained in the low thirties as previously guided.

Speaker 5: We expect our gross to net percentage to increase modestly, but remain in the low 30s for the fourth quarter of 2020.

We expect our gross to net percentage to increase modestly but remain in the low <unk> for the fourth quarter of 2023.

Speaker 5: During the quarter, days on hand of caplata, at the wholesale level, remains stable, maintaining channel inventory at adequate levels to meet growing demand.

During the quarter days on hand, a calculator at the wholesale level remained stable.

Training channel inventory at adequate levels to meet growing demand.

Capital is strong uptake continues and as previously mentioned in this call. We are raising our capital at our full year 2023, net product sales guidance range to $460 to $470 million.

Speaker 5: And as previously mentioned in this call, we are raising our capillate of full year 2023 net product sales guidance range, the 460 to 400.

Speaker 5: Selling, Gen on Administrative Expenses, we're $105.2 million for the third-

Selling general and administrative expenses were $105 2 million for the third quarter of 2023 compared to $88 $4 million for the same period in 2022.

Speaker 5: Compared to $88.4 million for the same period.

Speaker 5: Research and Development Expenses for the third quarter of 2023 were $41.6 million compared to $33.3 million for the same period.

Research and development expenses for the third quarter of 2023 were $41 6 million.

Compared to $33 3 million for the same period in 2022.

Speaker 5: For 2023, we are lowering our estimated full-year FTNA expense range to $405 to $420 million.

For 2023, we are lowering our estimated full year SG&A expense range to $405 million to $420 million and we're lowering our estimated full year R&D expense range to a 185 million to $200 million.

Speaker 5: And we're lowering our estimated pool year R&D expense range to 185 million to 200 million.

Speaker 5: Our financial position remains strong. Cash, cash equivalents, invest in securities, and restrict the cash. Total's $494.8 million. At September 30th, 2012.

Our financial position remains strong.

Cash cash equivalents investment securities and restricted cash totaled $494 8 million at September 32023.

Speaker 5: This concludes our prepared remarks. Operator, please open the line.

This concludes our prepared remarks, operator, please open the line for questions.

Speaker 1: Thank you. Again, ladies and gentlemen, if you like to ask a question, please press star 11 on your telephone. Again, to ask a question, please press star 11. We do ask as you please limit yourself to two questions and then feel free to rejoin the queue. Thank you.

Thank you again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone again to ask a question. Please press star one one we do ask that you. Please limit yourself to two questions and then feel free to rejoin the queue. Thank you.

One moment for your first question.

Speaker 1: Our first question comes from the line of Jessica Faye, of Jake B. Mourney, a line is open. Okay.

Okay.

Our first question comes from the line of Jessica Fye of Jpmorgan. Your line is open.

Okay.

Hey, that's great you lie mining assets.

Speaker 6: Hey, good morning. This is Tanmeon for Jessica Fai. Thanks for taking a question. I have just one question. Assuming success in a joint MDD, can you talk about how much leverage there is with your existing commercial infrastructure? What is how much additional investment you might want to put behind that launch? Thanks.

Hey, Good morning, This is Don Maryland for Jessica Fye. Thanks.

Thanks for taking our question I have just one question.

Assuming success in adjunctive MTB can you talk about how much leverage there is with your existing commercial infrastructure.

How much additional investment you might want to put behind that launch thanks.

Speaker 3: Hi, thanks for the question. Mrs. Sharon calling, maybe Mark, would you like to take that?

Hi, Thanks for the question.

This is Sharon, calling maybe mark would you like to take that.

Speaker 4: Yeah, sure. Thanks for your question. We view the opportunity in MDD with successful trials of approval to be.

Yes sure. Thanks for your question.

We view the opportunity in MVD successful trials of approval to be.

Speaker 4: a really significant future event for us and we would look to resource that launch accordingly.

Really significant future event for us and we would look to resource that launch accordingly.

Speaker 4: Just to give you a little bit of background, our current target audience for schizophrenia and bipolar is about 43,000 prescribers, predominantly psychiatrists and nurse practitioners.

Just to give you a little bit of background, our current target audience for schizophrenia and bipolar.

It's about 43000 prescribers predominantly psychiatrist and nurse practitioners.

Speaker 4: and one segment of primary care physicians who treat by fuller depression or comfortable treating that and prescribe similarly to how psychiatrists prescribe. But the vast majority of primary care physicians are not included in that. As we think about and plan for an approval in MDD that prescriber target audience would increase.

One segment of primary care physicians, who treat bipolar depression are comfortable treating that and prescribe similarly to how psychiatrist prescribed but the vast majority of primary care physicians are not included in that as.

As we think about and plan for an approval in MTBE that prescriber target audience would increase.

Speaker 4: significantly from the 43,000. We believe we'd have a very strong existing leverage of the existing infrastructure, because virtually all of the 43,000 positions.

Significantly from the 43000.

We believe we have very strong existing leverage of the existing infrastructure because virtually all of the 43000 physicians who are high prescribers for schizophrenia and bipolar. We will also be high prescribers for mbd. So we will have a great deal of brand awareness, where those prescribers that we'll be able to leverage.

Speaker 4: who are high prescribers for schizophrenia and bipolar, will also be high prescribers for MDD. So we'll have a great deal of brand awareness with those prescribers that will be able to leverage our existing infrastructure there. But there is another segment of primary care physicians who do not see a lot of schizophrenia and bipolar patients, but they do see a lot of MDD patients. For those physicians, that's where we would look to increase our sales force side.

Our existing infrastructure there, but there is another segment of primary care physicians, who do not see a lot of schizophrenia or bipolar patients, but they do see a lot.

And the patients and for those physicians, that's where we would look to increase our sales force size.

Speaker 4: so that we can ensure that we have adequate coverage of those physicians and get the MDD launch off to a successful start. We've not quantified that at this point in time externally as we get a little bit closer to the time of a potential MDD approval. That's when we would come back and provide more details on that.

So that we can ensure that we have adequate coverage.

Of those physicians and get the MTB launch off to a successful start.

We've not quantified that at this point in time externally as we get a little bit closer to the time of a potential NDA approval. That's when we would come back and provide more details on that.

Speaker 3: Thank you. Just to be clear, the primary care physicians that we do call on now, they are high prescribers for bipolar depression. Primary care providers, however, don't typically prescribe for schizophrenia. Those are, that's prescribed by the psychiatrist primarily.

Okay.

Thank you this to be clear just to be clear the primary care physicians that we do call them now.

They are high prescribers for <unk>.

Bipolar depression.

Primary care providers, however, don't typically prescribed for schizophrenia.

Those are that's prescribed by the psychiatrist primarily.

Sure.

Thank you one moment please for our next question.

Speaker 1: Our next question comes from the line of Andrew Sive, Jeffries, Yelena Soh.

Our next question comes from the line of Andrew Tsai of Jefferies. Your line is open.

Speaker 7: A good morning guys. Congrats on another recorder and the consistent growth trajectory of papalitis. So it's really great to see a strong execution on your side. So for us, we wanted to kind of ask on another interesting development that happened earlier this quarter. One of your, I think, Orange Book Pants were extended. So can you talk about this a little bit more? Why did you choose to extend that patent specifically? Why not a later patent that lives exclusively for a later date? What is the significance of this patent particular? And then maybe talk about the overall strength of your IP portfolio. Do you think you can solidify your IP even further with more patents? Expect to be issued in the future date. Thank you.

Hey, good morning, guys. Congrats on another great quarter, and the consistent growth trajectory with top line. So it's really great to see a strong execution on your side.

For.

For us we wanted to kind of ask on another interesting development that happened earlier this quarter. One of your I think Orange book patents were extended so can you talk about this a little bit more why did you choose to extend that patent specifically why not later pattern.

That vuzix exclusively for a later date what is the significance of this patent particular, and then maybe talk about the overall strength of your IP portfolio.

Do you think you can solidify your IP, even further with more patents.

That could be issued in the future date. Thank you.

Speaker 3: Great. So, high Andrew and thanks for the congratulations. Yes, we're very excited. So we do, we have a very broad patent portfolio. And our portfolio is composed of both the Orange Book Listed patents, which goes through 2039.

Great.

Hi, Andrew and thanks.

Congratulations.

Yes, we're very excited.

So we do we have a very broad patent portfolio and our <unk>.

Portfolio is composed of both the Orange book listed patents.

Which goes through 2039 as well as what's called an entire set of defense such patents, which is outside of the scope of what's in your Orange book, but also have very important filings in them.

Speaker 3: as well as what's called an entire set of defensive patterns, which is outside of the scope of what's in your orange book, but also have very important filings in them, addressing cap light.

Okay.

Addressing kept light.

Speaker 3: So you might have to repeat some of the questions. I think that the main question was over the extension.

So you might have.

Repeat some of the questions I think the main question was over the extension.

Speaker 3: And what did we extend and why did we extend that?

And what did we extend and why did we extend that.

Speaker 3: and we selected to extend 839.

We selected to extend.

Speaker 3: And we did that, which now expires in the mid to late, uh, 2033. And then, of course, we expect to receive another six months extension for pediatric use. And so that would be into 2034.

839, and we did that which now.

Buyers.

In the mid to late 2033, and then of course, we expect to receive another six months extension for pediatric use so that would be into 2034.

Speaker 3: We chose A3-9 because it's very, very broad.

We chose <unk>, because it's very very broad and <unk> hundred nine covers the treatment of all cap light indications.

Speaker 3: and 839 covers the treatment of all cap-light indications.

Speaker 3: at all and at all of our dose.

At all and at all of our Bob <unk>.

Speaker 3: And it uses any form of lume teperon, anything containing lume teperon, any composition, including all the crystals, all the salts. So it would be extremely difficult to circumvent this cat.

Joseph.

And it uses any form of Luna tap anything containing luma tap around any composition, including all the crystals all the salt.

So it would be extremely difficult.

Speaker 3: And so I think we believe this is a very strong patent and we're very pleased to have extended that patent.

Up to circumvent this package.

And so I think we believe this is a very strong patent and we're very pleased.

To have extended that patent.

Speaker 3: You asked, have we, we do have other patents that upon approval of other indications or...

You asked have we do have other.

Patents.

That upon approval of other indications or.

Speaker 3: their issuance, if covering present indications, would be listed in the orange book as well.

Their issuance.

It's covering present indications would be listed in the Orange book as well so.

Speaker 3: I think that may cover all your questions. If not, you'll ask whatever it was. Okay, great. Thanks. Well, thank you very much.

I think that May cover all your questions.

If not it does.

Whatever it was okay, great. Thanks, a lot guys. Thank you very much.

Thank you one moment please.

Speaker 1: Our next question comes from the line of Brian Abrams, of RBC Capital Market, gelatis.

Our next question comes from the line of Brian Abrams of RBC capital markets. Your line is open.

Speaker 8: Hi, hello, this is Leo on for Brian . Thanks for taking our question. I just wanted to follow up on the mixed features.

Hi, Hello. This is Leo on for Brian Thanks for taking our question.

Wanted to follow up on the.

Speaker 8: regulatory discussions that you're going to have. I guess I'm curious what your strategy is going into the FDA meeting. So you're going to approach them specifically on mixed features. I guess how are you going to layer on the data you gathered and analyzed in anxious depression? And then curious if you're potentially going to discuss.

The mixed features.

Terry discussions is that youre going to have I guess I'm curious what your strategy is going into those FDA meetings or you're going to approach them specifically on mixed features.

How are you going to layer on the data.

<unk> analyzed it and anxious depression, and then curious if you are potentially going to discuss.

Speaker 8: You know, if mixed features can also be supportive of an MDD filing, just given the significant overlap between, you know, major depressive populations and mixed features.

If mixed features can also be supportive of an NDA filing just given the significant overlap between major depressive populations in VIX futures population. Thanks.

Speaker 3: highly in this sharing and I'll start and then I'll ask the rest to chime in. So, first, I think, yes.

Okay.

Hi, This is Sharon and I'll start and then I'll ask <unk> to chime in.

<unk>.

Sure I think.

Yes.

We have a very broad label.

Speaker 3: in bipolar disorder and we believe mixed features is encompassed within that label. As you know, we don't yet have a label for depression.

Bipolar.

The order and we.

We believe mixed features is encompassed within that label.

As you know, we don't yet have a label for depression and so.

Speaker 3: And so really front and center are the questions that we have about mixed features in major, in MDD, in major press web episodes, in MDD. So I think that while...

So really front and center part of the questions that we have about mixed features.

Major.

MDT and major depressive episodes.

D D.

So I think that one.

While.

Speaker 3: the way for us to have our discussions with the FDA to be very granular. I would tell you that's really where I would be, I would be looking forward.

You have to wait for us to have our discussions with the FDA.

To be very granular.

I would tell you, that's really where I would be.

I would be looking forward.

Speaker 3: to having a majority of the discussion.

Two having majority of the discussions.

Speaker 3: Anxious distress, we do think is extremely important. We think it's very prevalent in both bipolar patients as well as in MDD patients. We did...

Anxious distress when do you think is extremely important we think it's very prevalent.

And both bipolar patients as well as in.

MDT patients.

Speaker 3: Get that data a little bit later, and we are still looking at our strategy there, and we will let you know as that strategy evolves. I don't know, Sir Esch, did you have anything you want to add?

Yes, we did.

Get that data a little bit later, and we are still.

Looking at our strategy, there and we will let you know.

As that strategy evolves.

I don't know Suresh did you have anything you want to add.

Not at this time thank you.

Okay.

Okay. Thank you.

One moment please.

Okay.

Speaker 1: Our next question comes from a lot of Charles Duncan of Canterfist Jury, Lennas Ops.

Our next question comes from a lot of Charles Duncan of Cantor Fitzgerald. Your line is open.

Speaker 9: Yeah, hi. Good morning. I share it in team. Thanks for taking our questions. And let me add my congratulations on a really nice quarter and appreciate the guidance increase. I had a commercial question and then one R&D question aren't for the commercial question when you consider the

Yes.

Yes, hi, good morning, Sharon and team thanks for taking our questions and let me add my congratulations on a really nice quarter.

<unk> the guidance increase.

I had a commercial question and then one R&D question.

For the commercial question when you consider the guidance and contemplate next year I guess I'm wondering what would be the key thing that you would be looking for would it be new patients or are increasing persistence, perhaps see them within the bipolar community.

Speaker 4: and contemplate next year, I guess I'm wondering, what would be the key thing that you would be looking for? Would it be new patients or increasing persistence, perhaps even within the bipolar community? And that all is my pipeline push. Yeah, thanks Charles and GZ. The answer is both. And certainly we've been pleased with...

No no that's fine.

Hi.

Pipeline question.

Yes, thanks, Thanks Charles.

The answer is both and certainly we've been pleased with.

Speaker 4: the pace at which we've been adding new patients.

The pace at which we've been adding new patients.

Speaker 4: in bipolar depression, for cap light, and in fact, earlier this week, when we got our...

In bipolar depression for capitalized and in fact earlier this week when we got our NV Rx data, our new to brand prescription data, we hit a new all time high.

Speaker 4: NBRX data, new to brand, prescription data. We hit a new all time high.

Speaker 4: which is the best reflection of how many new patients are being added to your brand. We expected to see that following some of the typical summer seasonality that we see, and so that's a really good sign does that the fourth quarter is off to the good start, and we would see that continuing.

Which is the best reflection of how many new patients are being added to your brand.

We expected to see that following some of the typical summer seasonality that we see.

So that's a really good sign to us that the fourth quarter is off to a good start and we would see that continuing.

Speaker 4: in the next year as well and of course we

Into next year as well and of course, we.

Speaker 4: The new patients come with existing prescribers, but they also come with new prescribers that we've also been doing. I think a really good job of adding new first-time prescribers to our prescriber base. And as I mentioned in the prepared remarks.

New patients come with existing prescribers, but they also come with new prescribers that we've also been doing I think a really good job of adding new first time prescribers to our prescriber base and as I mentioned in the prepared remarks, we now have over 32000 unique.

Speaker 4: We now have over 32,000 unique prescribers of cap light up.

The unique prescribers of capital Ida.

And each quarter, we're adding significant numbers of new prescribers to that that base. So we would see all of that momentum continuing through the fourth quarter and into 2024 as well.

Speaker 3: that base. So we would see all of that momentum continuing through the fourth order and in the 2024 as well. Okay and that relative to the pipeline, I guess I'm wondering about Zootorage and the Mateperon quite intriguing target product profile there. Is it included in the IP that was recently extended? I guess it's for the H39 patent, Sharon and if not are there, you know, quote non-obvious observations on its PKPD that may be patentable, as you can imagine. Yes, the 1284 is a new, is an enemy, it's a new molecular entity with its own patent portfolio. So it has, it has a totally unique patent portfolio with a unique patent coverage. So you should look at that as a totally separate molecule. Okay. Okay.

Okay and that relative to the pipeline I guess I'm wondering about deteriorated lumen chaparral quite intriguing.

Target product profile. There is included and the IP that links recently extended I guess, it's for the <unk> nine patents sharron.

Sharon.

If not are there.

Call it non obvious observations on HP.

That may be applicable.

You can imagine.

Yes.

<unk> four is a new is an NME, it's a new molecular entity with its own patent portfolio.

It has.

Totally.

Unique patent portfolio with a unique patent coverage.

So you should look at that as a totally.

Speaker 3: The separate molecule.

The separate molecule.

Speaker 1: Okay, helpful. I mean, sometimes for a figure. I'll leave that. Yeah. Yeah, thanks. Thank you. One moment, please.

Okay.

Helpful.

Thank you.

I believe that yes.

Okay got it thanks.

Thank you one moment please.

Speaker 1: Our next question comes from an a lot of umar or fought of Everkori, a line is open.

Okay.

Our next question comes from the line of Omar <unk> of Evercore. Your line is open.

Speaker 10: Hi guys, thanks so much for taking my question and congrats on a great quarter. Two for me, number one, if you could clarify the reasons for your lowered outback to spend expectations this year.

Hi, guys. Thanks, so much for taking my question and congrats on a great quarter too for me number one.

If you could clarify the reasons for your lowered opex spend expectations this year.

And secondly.

Speaker 10: Kaplata PRX trends have been positive since Labor Day, showing positive week on week growth in three to last five weeks. And was just wondering if this was driven by any special promo activities and could we expect these trends to continue given the favorable change of coverage in...

Kept ladder Trs trends have been positive since labor day, showing positive week on week growth in three of the last five weeks and I was just wondering if this was driven by any special promo activities and could we expect these trends to continue given the.

A favorable change of coverage in two of those part D plans that you mentioned before thank you.

Speaker 3: Great, thanks, Mike. I'll ask Larry, do you want to take the first question on the WRAX experiment? And then Mark will take the next question. Okay, thanks.

Great. Thanks, Hi, Mike.

Ill ask Larry do you want to take the first question.

And then Martin for sure. The next question Okay. Thanks.

Speaker 5: right the uh... the decrease in r&d is uh... primarily driven by the

Alright.

<unk> and R&D is.

Primarily driven by the top.

Yes, I'm sorry.

Speaker 11: Okay, yeah, operating expenditures will start with R&D first. It's driven by the timing. I don't know if I can put it in the off-ex, which we've asked about.

Okay.

Operating expenditures will start with R&D first.

Driven by the <unk>.

Opex, which we asked about please.

Speaker 10: I asked about the reason behind the lower operating expenses, expensive guidance.

No.

It's about the reasons behind the lowered operating expenses expenses guidance.

What's driving right.

Speaker 5: Yeah, I'm trying, okay. Well, the reduction in the operating expenditures are in two areas, two primary areas, research and development, which is driven, the lower expectations are driven by the timing enrollment of clinical trials in our early stage program.

Thank you, yes, I am trying to okay well.

The reduction in the operating expenditures.

Two areas two primary areas research and development, Okay, which has driven the lower.

Expectations are driven by the timing enrollment of clinical trials and our early stage programs alright as far as SG&A is concerned we've we've been pretty disciplined with our opex spends there and while still achieving the strong results that we're seeing on topline revenue. So.

Speaker 5: All right. As far as SG&A is concerned, we've been pretty disciplined with our op-ex spends there. And while still achieving the strong results that we're seeing on top line revenues. So I think those are the explanations that...

I think those are the explanations that.

Speaker 5: especially STNA, we run a tight ship here and it's across the board sort of reduction.

Yes, especially the SG&A, we run a tight ship here and.

It's across the board sort of reduction so.

Hopefully that answers your question.

Speaker 4: Yeah, hi, Mike. It's Mark. I can take the second part of your question. And yes, we have been pleased, but not surprised at the at the re-acceleration of our growth in total prescriptions.

Thank you.

Yeah, Hi, Mike It's Marc I can take the second part of your question, Yes, we have been please.

Pleased but not surprised at the at the Reacceleration of our growth in total.

Speaker 4: Each year you see that summer seasonality in Q3 which suppresses some of the growth.

<unk>.

Each year, you see that summer seasonality in Q3, which suppresses some of the growth.

Speaker 4: As I mentioned in my prepared remarks, there was zero growth in the overall market. We were able to drive 7% growth and continue to penetrate the market.

As I mentioned in my prepared remarks, there were zero growth in the overall market, we were able to drive 7% growth and continue to penetrate the market and now as we got past labor day.

Speaker 4: And now as we got past Labor Day, we are seeing new all-time highs in TRX. We're seeing them in NBRX, and we believe that's reflective of the overall market recovering.

We are seeing new all time highs in <unk>, we're seeing them in <unk> and we believe that is reflective of the overall market recovering in the fourth quarter as it tends to do each year, but also I think you mentioned some of the activities certainly our salesforce execution has been very strong.

Speaker 4: in the fourth quarter as it tends to do each year, but also I think you mentioned some of the activities, certainly.

Speaker 4: Our Salesforce execution has been very strong.

Speaker 4: You're aware that at the beginning of the year towards the middle end of the first quarter we added 50 new sales representatives.

Youre aware that at the beginning of the year towards the middle end of the first quarter. We added 50, new sales representatives.

Speaker 4: It typically takes about six months for them to get fully up to speed and fully optimized. And those 50 are now really just hitting their strides. So we expect an even greater contribution from them this quarter. And as we go into 2024, our ongoing DTC efforts continue to be very effective bringing new patients into cap light up.

It takes about six months for them to get fully up to speed and fully optimized and those 50 are now really just hitting their stride. So.

We expect an even greater contribution from them this quarter and as we go into 2024, our ongoing DTC efforts continue to be very effective bringing new patients into cap lighter and then lastly, the two payer wins that I mentioned in my remarks.

Speaker 4: And then lastly, the two pair wins that I mentioned in my remarks.

Speaker 4: We do expect that to drive additional volume, but like other things, it does take a little while for that to be fully realized. We expect some of that benefit in the fourth quarter, but we'd really expect the full benefit of that in 2024. So, I guess to summarize, we are pleased in the re-exceleration and the growth. We expect that to continue this quarter, and then really expect to carry that momentum over into 2024. So, I hope that answers your question.

We do expect that to drive additional volume, but like other things. It does take a little while for that to be fully realized we expect some of that benefit in the fourth quarter, but we'd really expect the full benefit of that.

In 2024, so I guess to summarize we are pleased in the reacceleration in the growth we expect that to continue this quarter.

And then really expect to carry that momentum over into 2024, So I hope that answers your question.

Yes. It does thanks so much.

Thank you one moment please.

Yes.

Speaker 1: Our next question comes from an online of Jeffrey Heng of Morgan Stanley in line of open.

Our next question comes from the line of Jeffrey Hung of Morgan Stanley. Your line is open.

Speaker 12: Hi, this is Michael Riyad on for Jeff Hong. Thank you for taking our questions and congrats on all the progress. We have two. First, on the long acting injectable, the company is looking at four more formulations to begin single sending those for the past next year. How did the four formulations differ from the one you already took through that? And what criteria will you be evaluating beyond cream and duration to compare? Thanks another follow-up.

Hi, This is Michael or you add on for Jeff hung. Thank you for taking my questions and congrats on all the progress we have two first on the long acting injectable companies looking at far more formulations to begin single ascending dosing first half next year, how does the <unk> formulation differs from the one you already talked through that and what criteria will you be.

Anything beyond treatment duration to compare thanks, and I have a follow up.

Speaker 3: Yeah, I was sharing and I'll take that one. So the different formulations look at exactly that. You know, there are different vehicles and we're also looking at different sites of injection. So I think that and what we're looking at is a sustained PK profile of either one month or greater. Um.

Yes, Sharon.

I'll take that one so the different formulations look at.

Exactly that.

Theres different vehicles.

And we're also.

Looking at different sites of injection.

So I think that.

And what we're looking at is a sustained PK profile.

Of either one month or greater.

Speaker 3: in particular two months, as well as a clean safety and powerability profile.

In particular.

<unk> two months as well as a clean safety.

And Tolerability profile.

Speaker 12: Thank you. That's very helpful. And then on the second one, so you're seeing antidepressant effects with lumbicapurone across the broad spectrum of moudest orders, schizophrenia, bipolar depression, and MDD mixed features, and now anxious distress. But it's shared outcome for a lot of these patients is that they are either refractory or only partially respond. So in that context, what do you think is giving lumbicability to broadly deliver antidepressant effects specifically when traditional SSRIs sell? Thanks so much.

Thank you that's very helpful. And then on the second one so youre seeing antidepressant effects of lemon pepper on across a broad spectrum of mood disorders schizophrenia, bipolar depression, and redeeming features and now anxious distress, but assured outcome for a lot of these patients is that they are either refractory or only partially respond.

So in that context, what do you think is giving them the ability to broadly deliver antidepressant effect, specifically traditional ssris. So thanks so much.

Speaker 3: Yes, thanks for the question. I think that it's a, it's a, it's a confidence of many different factors. And in particular, it's the mechanism of action that we believe this drug is acting by. So unlike other anti-psychotics, this drug does have SSRI activity. But it's not, it's not.

Yes.

Thanks for the question I think that it fits.

It's a confluence of.

Many different factors and in particular its mechanism of action that we believe this drug is acting by.

So.

Unlike other anti Psychotics. This drug does have SSRI activity, but it is not.

Speaker 3: only the SSRI activity that is at work here. In fact, we have shown through our intercellular signaling pathway.

It's not.

Solely the SSRI activity that is at work here in fact, we have shown through our intracellular signaling pathways.

Speaker 3: work, which is what we really formed the company on, is to not only look at cell surface receptors, but to look downstream of the receptor. We show that through intercellular...

Work, which is what we really formed the company on is to not only look at cell surface receptors, but to look downstream.

<unk>.

Of the receptor.

We show that drew intracellular signaling through the <unk> one receptor. We believe that we are a partial agonist and we've shown how we proceed down the M Tor pathway and that we affect the glutamate system. So we think that that is very.

Speaker 3: through the D1 receptor, we believe that we are a partial agonist and we've shown how we proceed down the M-tore pathway and that we affect the glutamate system.

Speaker 3: So we think that that is very...

Speaker 3: exciting and very helpful in treating depression as well as we very rapidly saturate the 5-HT2A receptor, which we know boost.

Citing and very helpful.

In treating depression as well as we have we very rapidly saturate, the five Ht receptor, which we know boost the activity.

Speaker 3: the activity of other receptor biology. So in fact, we are boosting the activity that we see in...

Other receptor biology, so in fact, we are boosting.

The activity that we see and.

Speaker 3: in both D1 pathway as well as in the SSRI, which again, the unique opportunity here is the 5-HT2A and taggingism that we have, and then the CERT re-uptake inhibition, which allows for more serotonin to be in the cleft. So it's a very unique...

In both D. One pathway as well as in the SSRI, which again the unique opportunity here is the five Ht QA and <unk>.

Cognizant that we have and then the uptake inhibition, which allows for more serotonin debate in the class. So it's a very unique.

Speaker 3: profile of the molecule that we believe leads to the any depression effect. And not to forget about the D2 receptor activity which acts.

Profile.

The molecule that we believe leads to.

The anti depression effect and not to forget about the day two receptor activity.

Which.

Speaker 12: we believe as a partial agonist, presynaptically and post-anaptically as an antagonist. So that's important for bipolar, it's important for schizophrenia, it's important for several other psychiatric indications. Well. Thank you, that's really helpful. I appreciate the response. Thanks.

We believe as a partial agonist presynaptic late.

And post synaptic antagonist. So that's important for bipolar it's important for schizophrenia, it's important for <unk>.

Several other psychiatric indications as well.

Thank you that's really helpful. I appreciate the response thanks.

Thank you one moment please.

Speaker 1: Our next question comes from a line of Mark Goodman of Lee Rank, your line is open.

Our next question comes from the line of Marc Goodman of Leerink. Your line is open.

Speaker 12: Good morning Larry. The Acuraedadiac capture rate seems to have gone down. I was just curious if you've noticed that and that there was a reason for that. And you think you can help us with there because the prescription.

Okay.

Yes, good morning, Larry.

<unk> daily capture rates seems to have gone down I was just curious.

Is that in that there was a reason for that.

And you think you can help us with there because the prescriptions.

Speaker 12: just seem to be not not driving what we would think to be driving the sales on the quarter. You told us the gross planets didn't change much obviously, I'm in toward it didn't change much, so it's got to be this I cubic day that we were looking at. So just curious if you have any comment on that. And then secondly, you mentioned the ITI 1500. You talk about what data we're going to see and what meeting you're talking about. It's going to happen for the end of the year. Thanks.

You seem to be not.

Driving what we would think that would be driving the sales in the quarter.

But you told us the gross cadets didn't change much obviously inventory didn't change much. So it's got to be this <unk> that we're looking at so I'm. Just curious if you have any comment on that and then secondly, you mentioned.

500 can you talk about what data, we're going to see what meeting your youre talking about thats going to happen before the end of the year.

Speaker 3: Sure, so maybe to start, see you off, maybe I'll ask Mark to address, to start out on what we're seeing about the capture rates and then ask Larry to chime in if he has anything to add to that. And then if I remember by that time, he may need to remind me, come back through the 1500 series.

Sure. So maybe to start you off maybe I'll ask mark to address just start out on what.

What we're seeing about the capture rates and then.

Ask Larry to chime in if he has anything to add to that.

And then.

If I remember by that time, we may need to remind me.

I'll come back to the 1500 series.

Speaker 4: Yeah, sure Sharon and yes, thanks Mark for the question. Yeah, what I would say Mark is the, as with previous quarters, the primary driver of our revenue growth.

Yes, sure Sharon and.

Thanks, Marc for the question, Yeah, what I would say Mark is the as with previous quarters. The primary driver of our revenue growth.

Speaker 4: In the third quarter was driven by strong under-delying demand and the growth that we're seeing in prescriptions. As Larry mentioned in it.

In the third quarter was driven by strong underlying demand in the <unk>.

That we're seeing in prescriptions as Larry mentioned in his prepared.

Speaker 4: prepared remarks, gross net remained in the low 30s and it was comparable quarter over quarter.

Remarks gross to net remained in the low thirties, and it was comparable quarter over quarter and regarding the inventory the days on hand of capital either at the wholesale level remained stable during the cover and that maintain the channel inventory at adequate levels to meet the growing demand that we see.

Speaker 4: And regarding inventory, the days on hand of cop light at the wholesale level remain stable during the cover. And that's maintained the channel inventory at adequate levels to meet the growing demand that we see in the marketplace. So I think when you put all three of those factors together.

<unk>.

In the marketplace, So I think.

When you put all three of those factors together that helps to explain what we're seeing in terms of the overall revenue growth that we see for capitalized in the quarter.

Speaker 12: that helps to explain what we're seeing in terms of the overall revenue growth that we see for capitalite in the quarter. We've seen some of these up there mingles.

Sharon I'll turn it over to you for the second part of the question.

Speaker 3: So in a 1500 series, as you know, these are non-helucinogenic psychedelics.

So on a 2500 series as you know.

These are.

Non hallucinogenic psychedelics.

Speaker 3: that we've been developing. This is all in-house developed where there are new molecular entities, they're not modifications of the present psychedelics. The, I think,

That we've been developing this is all in house developed where there are new molecular entities theyre not modifications of the <unk>.

President Psychedelics.

The.

Speaker 3: There is only one medical meeting last year. I'm not sure they're not happy for people to announce things, but it is a CMT at the end of the year that will be presenting there.

<unk>.

There is only one medical meeting last this year.

I'm not sure they're not happy for people to announce.

Things, but it is AT&T at the end of the year.

We will be presenting there.

Yes.

Speaker 3: So, and we will, of course, make the information available to you after that.

So.

We will of course make the information available to you.

After ash.

After that.

Okay.

Thank you.

One moment please.

Speaker 1: Our next question comes from the line of Army Fadiya of Needham Company a lot of

Our next question comes from the line of Amit <unk> of Needham <unk> Company. Your line is open.

Speaker 13: Hi, good morning. Thanks for taking my question and congratulations on the strong quarter. I had a question about just where the demand of FOC applied is coming from and if you could throw some light into it, you talked about the total subscriber base now reaching about 32,000 of the 43,000 that you're targeting.

Okay.

Hi, Good morning, Thanks for taking my question and congratulations on the strong quarter.

I had a question about just where the demand of applied is coming from and if you could throw some light into what you talked about.

The total subscriber base, reaching about 32000 physicians after 43.

That youre targeting.

Speaker 13: Can you talk about the potential of expanding into the remaining 9,000 or so? And also, more importantly, the depth of describing, and maybe any commentary you can provide around what is the current average number of prescriptions, per physician, and where you see the potential for it to go to?

Can you talk about sort of the potential of expanding into the room mate.

The remaining <unk>.

9000, or so and also more importantly, the depth of prescribing and maybe any commentary you can provide on what is the current.

Average number of prescriptions per physician and waiting to see the potential for it to go to Brent.

Speaker 12: Yeah, sure. I mean, so thanks for your question. Yeah, so there's a lot of different ways to characterize where the demand is coming from and what we're pleased about.

Yes sure.

So thanks for your question yes.

So theres a lot of different ways to characterize where the demand is coming from and what we're pleased about.

Speaker 12: with the launch of Kapalida is that the product is not being nitched in any particular area. And by that, I mean we're seeing new patient starts as well as switches and add-ons. We're seeing switches come from branded products and generic products. We're seeing...

The launch of capital I'd add is that the product is not being niche in any particular area and by that I mean, we're seeing new patient starts as well as switches and add ons were seeing switches come from branded products and generic products we're seeing.

Speaker 12: use of capillight across all lines of therapy, as you know. In this category, there's a lot of switching of agents. So many of these patients have already been on one or two or three anti-psychotics, and capillight is getting used in each one of those situations. And in fact, what we hear from physicians is, as long as the patient...

Use of capital light.

All lines of therapy as you know in this in this category. There is a lot of switching of agents. So many of these patients have already been on one or two or three.

Psychotics and kept later.

He is getting used in each one of those situations and in fact, what we hear from physicians is as long as the patient.

Speaker 12: Insurance will allow first line use they would prefer to use it that way because of the favorable safety and polar ability Another way to characterize it is clearly the Strong growth that we've seen for the last 18 months is being driven by bipolar depression We continue to grow this gets a frenzy of business. It's an important business to us It's obviously important for patients and we continue to grow that business The real explosive growth that you've seen is coming from bipolar depression

Insurance will allow first line use they would prefer to use it that way because of the favorable safety and tolerability.

Another way to characterize it as is clearly the.

Strong growth that we've seen for the last 18 months is being driven by bipolar depression, we continue to grow the schizophrenia business. It's important business to us. It's obviously important for patients and we continue to grow that business, but the real explosive growth that you've seen that's coming from bipolar depression.

Speaker 4: And then a third wave in the characterizer, as you suggest.

And then a third way even to characterize it is as you suggest in.

Speaker 12: rest in depth and we have been very pleased that both of those metrics continue to

Breath and depth than we have been very pleased that both of those metrics continue to increase.

Speaker 12: with the pace not falling off at all as we go quarter over quarter. So we're now into our seventh quarter of the bipolar depression launch. We continue to add significant new numbers of first-time prescribers of Catalita, as you mentioned now over 32,000. And that's just a matter of working up the adoption curve of all positions.

With the pace not falling off at all as we go quarter over quarter. So we're now.

Into our seventh quarter of the bipolar depression launch we continue to add significant new numbers of first time prescribers of capital either as you mentioned now over 32000, and that's just a matter of working up the adoption curve all physicians.

Speaker 12: I'll fall somewhere on the adoption curve for new medicines. Some started very early. Some wait quite a bit longer to try a new medicine for the first time. And many of them fall within the middle. And it's really just the day-to-day effort in our promotional activities, communicating the message.

Fall somewhere on the adoption curve for new medicines. Some started very early some weight quite a bit longer to try a new medicine for the first time.

And many of them fall within the middle and it's really just the day to day effort.

And our promotional activities communicating the message.

Speaker 12: about the benefits of capillightum and continuing to get new prescribers. And in addition to that, each of those prescribers then finding additional appropriate patients for capillightum and increasing the depth. And what I would say about the depth is each quarter, quarter over quarter, that depth continues to increase at a similar pace. So overall, we're very... you try another. I Prim need all your beginner rehabilitationcm, please prepare ones of these original ones.?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????

About the benefits of capital item.

And continuing to get new prescribers and in addition to that.

Each of those prescribers than finding additional appropriate patients for capital Ida and increasing the depth and what I would say about the depth is each quarter quarter over quarter.

That depth continues to increase at a similar pace so.

Overall, we're very pleased with all of the metrics that we follow in terms of what it says about.

Speaker 12: with all of the metrics that we follow in terms of what it says about not only the current growth of capillighta, but what we see as continued robust growth into the futures.

Not only the current growth of capital light.

But what we see as continued robust growth into the future as well.

Speaker 13: Great, thank you. And if I may ask just another follow up on mixed features, you talked about mixed features, patients, exhibiting anxious distress. What percent of the population is that? And what, one of your avenues or discussion of the FDA, the two,

Okay.

Great. Thank you and if I may ask just another follow up on mix feature.

<unk> talked about mixed features patients exhibiting anxious distress.

What percent of the population is that and.

One of your.

Avenues of discussion with the FDA.

Speaker 13: perhaps focus on that subset of the population or will you still be looking for a label in next-teacher space?

Perhaps focus on that subset of the population or would you still be looking for a label in <unk> patients.

Speaker 3: Hi, I mean, maybe I'll ask Sarah to take that question. Yes.

Yes.

Hi, Amit maybe I'll ask Suresh to take that question.

Yes, so in terms of.

Speaker 6: Anxious distress, there is a lot of overlap between anxious distress and mixed features.

Anxious distress.

There is a lot of overlap between anxious just us on mixed feature.

Speaker 6: Patients with major depression disorder are bipolar depression.

Patients with major depressive disorder bipolar depression.

Speaker 6: have mixed features and also anxious distress. A larger person's age of patients have anxious distress and mixed features. And there's also an overlap between these two. Our focus right now at the FDA will be talking about mixed features. However, we're also looking at...

Sure.

Mixed feature and also anxious to assess a larger percentage of patients have access to a set that mixed features.

And there's also an overlap between these two our focus right now.

We'll be talking about mixed features however, we are also looking at.

Speaker 6: Thanks is Distress. Once we finish talking about mixed features, we will be evaluating the next steps for Anxious Distress.

Yes.

Once we finished up.

Talking about the mixed fleet.

Be evaluating.

The next steps for <unk> just us.

Got it thank you.

Speaker 1: Thank you. Thank you. We do ask that you please limit yourself to one question, one moment for the next question, please.

Thank you.

Thank you.

We do ask that you. Please limit yourself to one question one moment for the next question. Please.

Speaker 1: Our next question comes from the line of a Shwani Verma of UBS, and line is open.

Our next question comes from the line of.

Our Suwanee Verma of UBS Your line is open.

Speaker 14: Hi, this is Toyan on for Ash. Thanks for taking our questions. For our question, it's for PetLyda. What levels of contracting do you currently have? And in the long run, how much more can contracting play a part? Thank you.

Okay.

Hi, This is joey on for Ash, Thanks for taking our questions.

For our question is for Pat laid out what level of contracting do you currently have and the long run how much more akin contracting play a part thank you.

Mark you want me to take that sure, yes, I can take that Sharon so in terms of.

Speaker 12: Yeah, I can take that Sharon. So in terms of the breadth of our coverage and number of covered lives, our Medicare and Medicaid has very broad coverage at over 98% of covered lives.

The breadth of our coverage and number of covered lives.

Our Medicare and Medicaid.

It has very broad coverage.

Over 98% of covered lives.

Speaker 4: in the commercial channel, we have approximately 90%.

In the commercial channel, we have approximately 90% covered lives and so across all three channels. We're pleased with the coverage that we have which means that the vast majority of patients have access to capital light up.

Speaker 12: covered lives. And so across all three channels, we're pleased with...

Speaker 12: The coverage that we had, which means that the vast majority of patients have access to capillita. There's also what we call the quality of coverage, which is...

There is also the what we call the quality of coverage, which is weather.

Speaker 12: whether when these patients are covered, whether they're covered in an unrestricted way, whether there's a step at it or in some cases a prior authorization. And so as we looked forward, we'll always look at opportunities to take a look at the price and volume tradeoff.

Weather.

When these patients are covered whether they are covered in an unrestricted way whether there is a step edit or in some cases, the prior authorization and so as we look forward.

We will always look at opportunities to take a look at the price and volume trade off.

Speaker 12: If we see an opportunity with a particular payer where perhaps we want to move from a prior authorization situation to an unrestricted status and we believe that the rebate level is appropriate, then that's a decision that will take. So for example, at the end of the third quarter, as I mentioned in my preparatory remarks, there were two large part-de-payer.

If we see an opportunity with a particular payer where perhaps we want to move from a prior authorization situation to an unrestricted status and we believe that the rebate level is appropriate and then thats a decision that we'll take so for example at the end of the third quarter as I mentioned in my prepared remarks.

We're too large part D payers that we were able to move capital light up from a prior authorization to step edits.

Speaker 12: that we were able to move cap light up from a prior authorization and to step at it.

Speaker 12: to unrestricted status. And we believe that that will bring in significantly increased volume with those payers.

<unk> unrestricted status and we believe that that will bring in significantly increased volume with.

Speaker 12: and contribute to revenues as we head through the fourth quarter and into it in the next year. So while we are very pleased overall with where we stand with our market access situation, at the margins to continue to improve that. So I hope that answers your question, maybe a little bit more background than you were asking for in the question, but I thought it was important just to provide some of the details.

Those payers.

And contribute to revenues as we head through the fourth quarter and into the into next year. So while we are.

Very pleased overall with where we stand with our market access situation will continue to look at individual opportunities at the margin to continue to improve that so I hope that answers. Your question, maybe a little bit more background than you were asking for your question, but I thought it was important just to provide some of the details for you there.

Speaker 1: Thank you. Our next question comes from the line of Greg Savana of Mizzouho Security. Your line is open.

Thank you. Our next question comes from the line of Greg Savannah.

Mizuho Securities Your line is open.

Speaker 15: Good morning, thanks. It's Greg Savanovic and Mizzouho. Congrats on all the progress in the quarter. My question is regarding the mixed features opportunity. I think you would mention that you were hoping to get on the FDA calendar. This quarter, perhaps early next quarter, I was just curious as to.

Yes.

Good morning, Thanks, It's Greg Savannah venture Mizuho and congrats on all the progress in the quarter My question.

Regarding the mixed features opportunity.

Thank you had mentioned that you were hoping to get on the FDA calendar this quarter or perhaps early next quarter I was just curious as to.

Speaker 15: you know the time with which us since you have the data in hand which I

The time with which since you have the data in hand, which I believe if I recall correctly. It was late March and just.

Speaker 15: leaves I recall correctly was late March and just kind of the sequence and the timing as to

Kind of the sequence and the timing as to.

Speaker 15: I guess the time it's taking to be able to get in front of the FDA and whether that's related to...

I guess the time, its taking to be able to get in front of the FDA and whether thats related to additional analyses that you wanted to do in prep for that meeting.

Speaker 15: additional analyses that you wanted to do in prep-set meeting. It's just a little longer than perhaps I would have expected. And then maybe the corollary question is regarding us to, again, the strategy there, are you just to clarify, are you looking for a formal indication?

Just a little longer than perhaps I would have expected and then maybe the corollary question is regarding as to again. The strategy. There are you just to clarify are you looking for a formal indication and mixed features to put on the label or is it really more about getting the data from study 403.

Speaker 15: study 403, incorporate it perhaps, and reflect it in the label versus a formal indication. Thanks. All right.

Perhaps and reflected in the label versus.

A formal indication thanks.

Hi, Greg.

Speaker 3: Let me try and take that and then I'll ask if Suresh wants to add anything else. We did say in our prepared remarks that we do have a meeting. So we do have a meeting request in to the FDA and we do expect to meet with them at the end of this year, early next year. So that is done.

But so.

Let me try and take that and then I'll ask if restaurants to add anything else.

We did say in our prepared remarks that we do have and that we have requested.

Meeting so we do have a meeting request into the FDA.

And we but we do expect to meet with them.

At the end of this year.

Early next year.

So.

Speaker 3: We also said that

So that is done we all we also said that.

Speaker 3: We do believe that our label right now for bipolar is extremely broad.

We do believe that our labor right now for bipolar is extremely broad.

Speaker 3: and does include a broad patient population. And as you know, we don't have a label.

And does include a broad patient.

And as you know we don't have a label.

Speaker 3: today in MDD patients. So I think that the real focus of this discussion is going to go there and that we are presently looking further into the data that we have and anxious to stress.

Today.

In Mds.

<unk> patients. So I think that the real focus of this discussion is going to go there.

And that we are presently looking.

Further into the data that we have an anxious distress.

Speaker 3: And, you know, we will have more to say about that as we can.

And we will have more to say about that as we talk.

Speaker 3: as our position may revolve, and as the data directs us to.

Tom.

Our position there evolved.

And as the data directs us to <unk>.

Speaker 3: that describes the data. So.

Describes that describe.

The data.

Speaker 14: I think that answers your question. And I think in terms of what the next steps are, I think that now we've submitted the request, we'll have the meeting and we'll update you once we have that meeting. Okay. Bye.

<unk>.

I think that answers your question and I think in terms of.

What the next steps are I think that now.

We have submitted the request will have the meeting.

And well update you once we have that meeting.

Okay.

Yeah.

Thank you one moment please.

Speaker 1: Our next question comes from a line of Jason Gerber, a Bank of America in London.

Our next question comes from the line of Jason <unk> Bank of America. Your line is open.

Speaker 8: So hey guys, thanks for taking my question. So just on the earlier comment about MDD and sort of the target prescriber.

Oh, Hey, guys. Thanks for taking my question.

So just on the earlier comment about MTBE and sort of the target prescriber.

Speaker 8: footprint, if you will. I was taken by the comment about a significant increase. And I guess I would have thought that with a typical getting used, maybe in a later line patient, that this would have been the domain of the psychiatrist. And so, maybe, mindful, you're not going to specifically tell us how much that increases the...

Footprint. If you will I was cut I was taken by the comment about a significant increase in <unk>.

I would have thought that with atypical getting used maybe in the later line patients that this would have been the domain of the psychiatrist and so maybe Michael you are not going to specifically tell us how much that increases the prescriber footprint five but you did say significant so I just wanted to confirm that.

Speaker 12: Prescriber footprint buy, but you know, you did say significant. So I just wanted to confirm that that would be a pretty meaningful step change in terms of the number of prescribers that you'd have to reach for if MDD was added to the label. Thanks.

Would be a pretty meaningful step change.

In terms of the number of prescribers is you'd have to reach for <unk> was added to the label. Thanks.

Speaker 12: Yeah, thanks Jason. It's always difficult to get the right characterization of that because as I said, we're not at a point where we're providing the specific numbers of what that expansion might look like. But let me try to clarify again the 43,000 prescribers that we currently have.

Yeah. Thanks, Jason it's always it's always difficult to get the right characterization of that.

Because as I've said, we are not at a point, where we're providing the specific numbers.

What that expansion.

Might look like but let me, let me try to clarify.

Again, the 43000 prescribers that we currently have.

Speaker 12: are predominantly psychiatrists and nurse practitioners.

Predominantly psychiatrist and nurse practitioners, who treat the predominant number of schizophrenia and bipolar depression patients. There is a segment of primary care physicians that.

Speaker 12: who treat the predominant number of schizophrenia and bipolar depression patients. There is a segment of primary care physicians that we currently call on. Those primary care physicians are comfortable treating bipolar depression. They don't treat much schizophrenia, so we never really targeted them for schizophrenia. But they are comfortable treating bipolar depression.

We currently call on those primary care physicians are comfortable treating bipolar depression, they don't treat much schizophrenia. So we never really targeted them for schizophrenia, but they are comfortable treating bipolar depression and their prescribing habits look very similar to the psychiatrist in bipolar depression that is not the majority of prime.

Speaker 12: and their prescribing habits look very similar to the psychiatrist in bipolar depression.

Speaker 12: That's not the majority of primary care physicians, but there is a segment that is like that, and we currently target those primary care physicians.

Care physicians, but there is a segment that is like that and we currently target those primary care physicians.

Speaker 12: as we contemplate an approval in MDD, and we look at the prescribing habits of other segments of primary care physician.

As we contemplate an approval in MVD and we look at the prescribing habits of other segments that primary care physicians.

Speaker 12: That's where that segment expands.

That's where.

That segment expands and so any expansion in our target audience would be to go after.

Speaker 12: And so any expansion in our target audience would be to go after primary care physicians. And then the question just becomes how deep do you go into primary care? And that'll determine the number of prescribers that you add to the target list, and that will determine.

Primary care physicians and then the question just becomes how deep do you go into primary care and that will determine the number of prescribers that you added to the target list and that will determine.

Speaker 1: how much of a Salesforce expansion we would have in order to cover those primary care positions. And as we get closer to the MDV potential approval and launch, we'll come back to you with more details about that. Thank you. One moment, please.

How much of a sales force expansion, we would have in order to cover those primary care physicians and as we get closer to.

The MVD potential.

Potential approval and launch will come back to you with more details about that.

Thank you one moment please.

Our next question comes from the line of Corinne Jenkins.

Goldman Sachs. Your line is open.

Speaker 16: Yeah, good morning, everyone. Maybe one on the 1284 programs, just when should we anticipate kind of clinical data from those? And then are you thinking you'd pursue all of those programs if they showed activity or they're kind of criteria you're using to evaluate, go-no, go decisions, or any constraints on kind of the number that you could pursue into Phase III? Thanks.

Yes, good morning, everyone.

One on 12 months 84 programs just when should we anticipate kind of clinical data from those and then are you thinking you would pursue all of those programs. If they showed activity or are there kind of criteria you're using to evaluate go no go decisions.

Or any constraints on kind of the number that you could pursue into phase III.

<unk>.

Speaker 3: Hi, Clint. Thanks for the questions. So first on 1284, we will be going into, and we started the program and we expect clinical conduct to begin next year. As to whether, you know, we would pursue all three indications. I think that will be,

Hi, Chris Thanks for the question so first on $12 84.

We will be going into when we started the program and we expect clinical conduct to begin next year.

As to whether we would pursue all three indications I think.

That will be.

Speaker 3: dependent on what the data shows from these studies, right? I mean, if we have great data from all three, yes, we'll pursue all three. If we, if it looks like there's a better opportunity

Dependent on what the data shows from these studies right I mean, if we have great data from all three yes, well pursue all three its way.

It looks like there is a better opportunity in <unk>.

Speaker 3: two out of three, we would do that. So I think it's a little early to say how many of these will be pursuing full blown phase three programs on, but we're very encouraged by what we've seen today and very enthusiastic about these programs. And we've now outlined for you the GAD, what that program's gonna look like in terms of the first study who will be enrolled.

The three we would do we would do that so I think it's a little early to say how many of these will be pursuing full blown phase III programs on but we're very encouraged by what we've seen to date and we're very enthusiastic.

About these programs and we've now outlined for you.

On the J D.

What that program is going to look like in terms of the first study who will be enrolled.

Okay.

Speaker 1: We are out of time for questions for today. I'll turn the call back over to Sharon Mates for any closing remarks.

Okay.

We are out of time for questions for today I'd like to turn the call back over to Sharon mates for any closing remarks.

Speaker 3: So thank you everybody for participating today. As you can see, I think we've had a very strong quarter.

So thank you everybody for participating today.

As you can see I think.

Speaker 3: And we're very pleased with the progress we've been making on all fronts, both on Keplerta and on our pipeline. I think that we have demonstrated and we talked a little bit about.

Very strong quarter.

And we're very pleased with the progress we've been making on all fronts, both on capital and on our pipeline.

I think that we.

Have demonstrated and.

Speaker 3: the uniqueness of the way that we develop our drugs that we look not only at the self-service, but look downstream of the receptor as well, and how that has been driving our development programs, actually from the start of the company. And so we're very enthusiastic about our pipeline and about our research as well as continuing to advance Keplita.

A little bit about.

The uniqueness of the way that we develop are drugs that were not we look not only at the cell surface, but look downstream of the receptor as well and how that has been driving.

Our development programs.

Actually from the start of the company.

So were very enthusiastic.

About our pipeline and about our research as well as on continuing to advance kept blida, so with that I think operator.

Speaker 3: So with that, I think operator, we just say we look forward to updating you as we go forward. And with that operator, you can disconnect the call. Thanks.

Just to say, we look forward to updating you.

As we go forward and with that operator, you can disconnect the call.

Speaker 1: Thank you. Ladies and gentlemen, this is us Inclusively's Conference Call. Thank you for participating. You may now disconnect. Have a great day.

Ladies and gentlemen, this does conclude today's conference call. Thank you for participating you may now disconnect have a great day.

Okay.

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