Q2 2024 Axsome Therapeutics Inc Earnings Call

Speaker Change: [music].

Operator: Hello and welcome to the Axsome Therapeutics second quarter 2024 financial results conference call and webcast. At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may place the question queue at any time by pressing star 1 on your telephone keypad. We ask that you please limit yourselves to one question and then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead, Darren. Good morning.

Hello, and welcome to the Axon Therapeutics second quarter 'twenty 'twenty four financial results conference call and webcast. At this time all participants are in a listen only mode. If anyone should require operator assistance. Please press star zero on your telephone keypad.

Unknown Attendee: Hello and welcome to the Axon Therapeutics' second quarter, 2024 financial results conference call and webcast. At this time, all participants are in newly listened-only mode. If anyone would require operator or assistance, please press star zero on your telephone keypad.

Unknown Attendee: A question and answer session will follow the formal presentation. You may be placed in the question queue anytime by pressing star one on your telephone keypad. We ask you please limit yourselves to one question and then return to the queue. As a reminder, this conference is being recorded.

A question and answer session will follow the formal presentation.

You may be placed in the question queue at any time by pressing star one on your telephone keypad. We ask you. Please limit yourselves to one question and then return to the queue.

As a reminder, this conference is being recorded its now my pleasure to turn the call over to Darren Open director of corporate Communications at Axon Therapeutics. Please go ahead Darren.

Darren Opland: It's now my pleasure to turn the call over to Darren Opland, Director of Corporate Communications at Axon Therapeutics.

Darren Opland: Please go ahead, Darren. Good morning, and thank you all for joining us on today's conference call. This morning we issued our earnings press release, providing a corporate update and details of the company's financial results for the second quarter of 2024.

Darren Opland: Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a corporate update and details of the company's financial results for the second quarter of 2024. The release crossed the wire a short time ago and is available on our website at Axsome.com.

Darren Open: Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release, providing a corporate update and details of the company's financial results for the second quarter of 'twenty 'twenty four.

Darren Opland: The release crossed the wire a short time ago and is available on our website at axom.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended use utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding CINOSI, Avality, and our pipeline products, revenue projections, and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

Darren Open: The release crossed the wire a short time ago and is available on our website at <unk> Dot com.

Darren Open: During today's call, we will be making certain forward looking statements. These statements may include statements regarding among other things the efficacy.

Darren Opland: During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding CENOSI, Avality, and our pipeline products, revenue projections, and possible intended use of cash and investments.

Darren Open: D and intend to abuse utilization of our investigational agents, our clinical and non clinical plans.

Darren Open: Plans to present or report additional data the anticipated conduct and the source of future clinical trials regulatory plans future research and development plans, our commercial plans regarding sanofi ability and our pipeline products revenue projections and possible intended use of cash and investments.

Darren Open: These forward looking statements are based on current information assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.

Darren Opland: These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements.

Darren Opland: These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your caution is not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligations to update such statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.

Darren Open: You are cautioned not to place undue reliance on these forward looking statements, which are only made as of today's date and the company disclaims any obligation to update such statements.

Darren Opland: Joining me on the call today are Dr. Ario Tabuto, Chief Executive Officer; Nick Peasy, Chief Financial Officer; Mark Jacobson, Chief Operating Officer; and Ari Maisel, Executive Vice President and Head of Commercial.

Darren Opland: Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, Mark Jacobson, Chief Operating Officer, and Ari Maizel, Executive Vice President and Head of Commercial. Ariel will comment on the progress we made in the second quarter of 2024 and review key upcoming milestones. Following Ari, Nick will review our financial results, and then Ari will provide a commercial update. We will then open the line for questions. Questions will be taken in the order that they are received. And with that, I will turn the call over to Herriot.

Darren Open: Joining me on the call today are doctor areas have your toe Chief Executive Officer, Nick Peasy, Chief Financial Officer.

already myself: Mark Jacobson, Chief operating officer, and already myself executive Vice President and head of commercial.

Ario Tabuto: Ario will comment on the progress we made in the second quarter of 2024 and review key upcoming milestones.

area: Area will comment on the progress we made in the second quarter of 'twenty 'twenty, four and review key upcoming milestones.

Nick Peasy: Following Ario, Nick will review our financial results, and then Ari will provide a commercial update.

area: Following area, Nick will review, our financial results and then already will provide a commercial update.

Darren Opland: We will then open the line for questions. Questions will be taken in the order that they are received, and with that, I will turn the call over to Ario.

Speaker Change: We will then open the line for questions.

Speaker Change: Questions will be taken in the order that they are received.

area: And with that I will turn the call over to area.

Ario Tabuto: Thank you, Darren.

area: Thank you Darron and good morning, everyone and thank you for joining axon Therapeutics second quarter 2024 financial results and business update conference call.

Herriot Tabuteau: Thank you, Darren. Good morning, everyone, and thank you for joining Axsome Therapeutics' second quarter 2024 financial results and business update conference call. We had a very productive second quarter, with all elements of our business advancing across our singular CNS-focused portfolio as we continue to build a leading neuroscience company. We delivered strong commercial performance with continued momentum for the launch of Available. In particular, we secured important improvements in both the quality and quantity of payer coverage, and we are clearly seeing the impact of our expanded sales representative team. We remain pleased with CENOSI and remain excited by the opportunities we see in the currently improved indications alone. Nick and Ari will provide additional color on both products shortly.

Ario Tabuto: Good morning, everyone, and thank you for joining Axel and Therapeutics' second quarter 2024 financial results and business update conference call. We had a very productive second quarter with all elements of our business advancing across our singular CNS-focused portfolio as we continue to build a leading neuroscience company. We delivered strong commercial performance with continued momentum for the launch of availability. In particular, we secured important improvements in both the quality and quantity of pay or coverage, and we are clearly seeing the impact of our expanded sales representative team. We remain pleased with Sonozzi; we remain excited by the opportunities we see in the currently improved indication alone.

Speaker Change: We had a very productive second quarter with all elements of our business advancing across our singular CNS focused portfolio as we continue to build a leading neuroscience company.

Speaker Change: We delivered strong commercial performance with continued momentum for the launch of ability.

Speaker Change: In particular, we secured important improvements in both the quality and quantity of payer coverage and we are clearly seeing the impact of our expanded sales representative team.

Speaker Change: We remain pleased with some nosy remain excited by the opportunities we see in the currently approved indications alone.

Ario Tabuto: Mick and Ari will provide additional color on both products shortly. A adjacent to our commercial products, we made important progress on both our NDA stage product candidates. The NDA for Ex-SO7 for the acute treatment of migraine has been resubmitted to the FDA, and we look forward to providing updates on the FDA review. We believe that Ex-SO7 has approved would be an important new treatment option that could provide different sheeted outcomes for patients. With respect to Ex-SO14 for the management of fibromyalgia, we made important progress now in the package, taking a steady approach to ensure a quality submission, and we expect to complete this in the submission shortly in the third quarter.

Ari: Making ari will provide additional color on both products shortly.

Speaker Change: Adjacent to our commercial products, we made important progress on both our NDA stage product candidates.

Herriot Tabuteau: Adjacent to our commercial products, we made important progress on both our NDA stage product candidates. The NDA for XSO7 for the acute treatment of migraine has been resubmitted to the FDA. And we look forward to providing updates on the FTE review. We believe that AXS07, if approved, would be an important new treatment option that could provide differentiated outcomes for patients. With respect to AXS 14 for the management of fibromyalgia, we made important progress in our NDE package, taking a steady approach to ensure a quality submission, and we expect to complete this NDE submission shortly in the third quarter. Fibromyalgia is a debilitating chronic CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment.

Speaker Change: The NDA for excess so seven for the acute treatment of migraine has been resubmitted to the FDA.

Speaker Change: And we look forward to providing updates on the FTE review.

Speaker Change: We believe that access so seven if approved would be an important new treatment option that could provide differentiated outcomes for patients.

Speaker Change: With respect to excess 14 for the management of Fibromyalgia, we made important progress in our NDA package, taking a steady approach to ensure a quality submission.

Speaker Change: And we expect to complete this NDA submission shortly in the third quarter.

Speaker Change: Fibromyalgia is a debilitating chronic CNS disorder characterized by widespread pain fatigue, disturbed sleep depression and cognitive impairment.

Ario Tabuto: Fibromyalgia is a debilitating chronic CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment. With limited treatment options available, Ex-SO14 has the potential to deliver much needed innovation to patients and HCVs alike.

Herriot Tabuteau: With limited treatment options available, AXS 14 has the potential to deliver much needed innovation to patients and HCPs alike. Moving on to the rest of our robust late stage development pipeline. We are making excellent progress on our numerous important clinical programs, a number of which have pivotal trial readouts later this year and next. AXS05 is Axsome's novel oral investigational NMDA receptor antagonist and SIGN1 receptor agonist that we are developing for Alzheimer's disease agitation.

Speaker Change: With limited treatment options available.

Speaker Change: 14 has the potential to deliver much needed innovation to patients and hcp's alike.

Ario Tabuto: Moving on to the rest of our robust late-stage development pipeline. We are making excellent progress on our numerous important clinical programs, the number of which have pivotal trial readouts later this year and next. Ex-SO5 is Axomes, a novel oral investigational NMBA receptor antagonist and single one receptor agonist that we are developing for Alzheimer's disease agitation. We continue to anticipate top line results for the pivotal advanced two Phase Three trial in the second half of the year. Additionally, the enrollment target in the pivotal Accord to phase three trial has been reached. As a result, we now expect top line results for both of these studies in the second half of 2024.

Speaker Change: Moving on to the rest of our robust late stage development pipeline.

Speaker Change: We are making excellent progress not where numerous important clinical programs a number of which have pivotal trial Readouts later this year and next.

Speaker Change: Extra so five as axon is a novel oral investigational NMDA receptor antagonist and Sigma one receptor agonist that we are developing all timers disease agitation.

Herriot Tabuteau: We continue to anticipate top-line results for the Pivotal Advanced II Phase III trial in the second half of the year. Additionally, the enrollment target for the Pivotal Accord 2 Phase 3 trial has been reached. As a result, we now expect top-line results for both of these studies in the second half of 2024. Solvay-Ampetol, our dopamine and norepinephrine reuptake inhibitor and TAR1 agonist, is now in phase 3 trials and 4 new indications.

Speaker Change: We continue to anticipate topline results from the pivotal advance to phase III trial in the second half of the year.

Additionally, the enrollment target in the pivotal cohort two phase III trials has been reached as a result, we now expect top line results for both of these studies in the second half of 2024.

Speaker Change: Solid reinstall, our dopamine and norepinephrine reuptake inhibitor in Taiwan agonist is now in phase III trials for new indications.

Ario Tabuto: Solaryanthotol, our dopamine and norepinephrine optic inhibitor and colin agonist, is now in phase three trials in four new indications. The focus phase three trial in adults with 80 HD remains on track for top line results in the second half of the year. In addition, the paradigm phase three trial in major depressive disorder in the Engage phase three trial in benzene disorder also ongoing with results from both trials anticipated in 2025. We also recently launched the sustained phase three trial and shift work disorder, for which we anticipate results in 2026. Each of these programs, if successful, has the potential to represent a significant commercial expansion opportunity for Solaryanthotol.

Herriot Tabuteau: The FOCUS Phase III trial in adults with ADHD remains on track for top-line results in the second half of the year. In addition, the Paradigm Phase III trial in Major Depressive Disorder and the Engage Phase III trial in Binge Eating Disorder are also ongoing, with results from both trials anticipated in 2024. We have also recently launched...

Speaker Change: The focus phase III trial in adults with ADHD remains on track for top line results in the second half of the year.

Speaker Change: In addition, the paradigm phase three trial in major depressive disorder in the engage phase three trial and binge eating disorder also ongoing with results from both trials anticipated in 2025.

Speaker Change: We also recently launched.

Herriot Tabuteau: The Sustained Phase 3 Trial and Shift Work Disorder, to which we anticipate results in 2020. Each of these programs, if successful, has the potential to represent a significant commercial expansion opportunity for soil re-infertile. Finally, we continue to anticipate results this year from the eMERGE Phase 3 trial of AXS07 in patients with an inadequate response to oral CGRP therapy, as well as results from the Phase 3 Open Label Safety Extension Trial of AXS12 in narcolepsy.

Speaker Change: The sustained phase III trial and shift work disorder for which we anticipate results in 2026.

Speaker Change: Each of these programs if successful has the potential to represent a significant commercial expansion opportunity for soybean in for Tal.

Ario Tabuto: Finally, we continue to anticipate results this year from the Emerge phase three trial of XS07 in patients with an inadequate response to oral CGRP therapy, as well as results from the phase three open-label safety extension trial of XS12 in knockout. C. In total, we have five product candidates in late-space development for nine important indications, each of which has key, potentially valued driving milestones on the horizon.

Speaker Change: Finally, we continue to anticipate results this year for the emerge phase III trial of excess so seven in patients with an inadequate response to oral C. G. Europe's therapy as well as results from the Phase three open label safety extension trial of excess 12 in narcolepsy.

Speaker Change: In total we have five product candidates in late stage development for nine important indications each of which is key potentially value driving milestones on the horizon.

Herriot Tabuteau: In total, we have five product candidates in Late Space Development for nine important indications, each of which has key, potentially value-driving milestones on the horizon. We are incredibly excited by our work and the potential Axsome has to contribute to differentiated patient outcomes and to the advancement of medical practice in neuropsychiatry. Stay tuned for updates on our progress as we continue to work every day to make a difference in the lives of the millions of people in the U.S. affected by Central Nervous System Disorders. I will now turn the call over to Nick, who will provide details of our financial performance.

Ario Tabuto: We are incredibly excited by our work and the potential Axsome has to contribute to differentiated patient outcomes and to the advancement of medical practice in neuropsychiatry. Stay tuned for updates on our advancements as we continue to work every day to make a difference in the lives of the millions of people in the US affected by central nervous system disorders.

Speaker Change: We are incredibly excited by our work and the potential axon has to contribute to differentiated patient outcomes and to the events of medical practice and neuropsychiatry.

Speaker Change: Stay tuned for updates on our advancements as we continue to work every day to make a difference in the lives of the millions of people in the U S affected by central nervous system disorders.

Nick Peasy: I will now turn the call to Nick, who will provide details of our financial performance. Thank you, Ariel, and good morning. Today, I will discuss our second quarter results and provide some financial guidance. Total net product revenue for the second quarter of 2024 was 87.2 million, representing 87% year-over-year growth. Total net product revenue for the comparable period in 2023 was $46.7 million. Avalody net product sales were 65 million for the second quarter of 2024, representing 135% year-over-year growth. Avalody net product sales for the comparable period in 2023 were 27.6 million. Avalody net product revenue was 22.1 million for the second quarter of 2024, consisting of 21.5 million in net product sales and 600,000 in royalty revenue associated with sales and outlicence territories, representing 16% year-over-year growth.

Speaker Change: I will now turn the call to Nick who will provide details of our financial performance.

Nick Peasy: Thank you Ariel and good morning today, I'll discuss our second quarter results and provide some financial guidance.

Nick Pizzie: Thank you, Ariel, and good morning. Today, I will discuss our second quarter results and provide some financial guidance. Total net product revenue for the second quarter of 2024 was $87.2 million, representing 87% year-over-year growth. Total net product revenue for the comparable period in 2023 was $46.7 million. Availability net product sales were 65 million for the second quarter of 2024, representing 135% year over year. L&D Net Product Sales for the comparable period in 2023 were 27.6. The NOSI net product revenue was $22.1 million for the second quarter of 2024, consisting of $21.5 million in net product sales and $600,000 in royalty revenue associated with sales in outlicensed territories, representing 16% year-over-year growth. Zanossi net product revenue for the comparable period in 2023 was $19.1 million, consisting of $18.4 million in net product sales and $700,000 in royalty revenue.

Nick Peasy: Total net product revenue for the second quarter of 2024 was $87 2 million, representing 87% year over year growth.

Nick Peasy: Total net product revenue for the comparable period in 2023 was $46 7 million.

Nick Peasy: <unk> net product sales were $65 million for the second quarter of 2024, representing 135% year over year growth.

Nick Peasy: <unk> net product sales for the comparable period in 2023 or $27 6 million.

Nick Peasy: The nursing net product revenue was $22 1 million for the second quarter of 2024, consisting of $21 5 million in net product sales of 600000 in royalty revenue associated with failed an out license territories, representing 16% year over year growth.

Nick Peasy: Avalody net product revenue for the comparable period in 2023 was 19.1 million, consisting of 18.4 million in net product sales and 700,000 in royalty revenue. Total cost of revenue was 8.1 million for the second quarter of 2024, versus 4.6 million for the comparable period in 2023. Research and development expenses were 49.9 million for the second quarter of 2024, compared to 20.6 million for the comparable period in 2023. The increase was primarily related to the initiation and continuation of sorry capital-based three trials in major depressive disorder, ADHD, and binge eating disorder, ongoing trials of AXS-5 and AXS-12, manufacturing costs associated with AXS-7 and AXS-14, postmarketing commitments for Avalody and Sinose, and higher personnel costs, including non-cash stock-based compensation due to organizational growth.

Nick Peasy: <unk> net product revenue for the comparable period in 2023 was $19 1 million consisting of $18 4 million in net product sales at 700000 in royalty revenue.

Nick Pizzie: Total cost of revenue was $8.1 million for the second quarter of 2024 versus $4.6 million for the comparable period in 2023. Research and development expenses were $49.9 million for the second quarter of 2024, compared to $20.6 million for the comparable period in 2023. The increase was primarily related to the initiation and continuation of psoriatic adult phase 3 trials in major depressive disorder, ADHD, and binge eating disorder, ongoing trials of AXS05 and AXS12, manufacturing costs associated with AXS07 and AXS14, post-marketing commitments for Aveliti and Sanosi, and higher personnel costs, including non-cash stock-based compensation due to organizational growth.

Nick Peasy: Total cost of revenue was $8 1 million for the second quarter of 2024 versus $4 6 million for the comparable period in 2023.

Nick Peasy: Research and development expenses were $49 9 million for the second quarter of 2024 compared to $20 6 million for the comparable period in 2023.

Nick Peasy: The increase was primarily related to the initiation and continuation of sorry. After the phase III trials in major depressive disorder, ADHD and binge eating disorder.

Speaker Change: In trials of <unk>. So, it's 12 manufacturing costs associated with excess of seven and except for 14.

Speaker Change: Marketing commitments for ability and Sanofi and higher personnel costs, including noncash stock based compensation due to organizational growth.

Nick Peasy: Selling, general and administrative expenses were 103.6 million for the second quarter of 2024, compared to 78.9 million for the comparable period in 2023. The increase was primarily related to commercialization expenses, largely driven by field force expansion and higher personnel costs, including non-cash stock-based compensation due to organizational growth. Net loss for the second quarter of 2024 was 79.3 million, or $1.67 per share, compared to a net loss of 67.2 million, or $1.54 per share for the comparable period in 2023. The net loss in the second quarter of 2024 reflects $26 million in non-cash stock. Rages, gross from that discount for Q2 was in the low to mid-50s for both Avality and Sinose.

Nick Pizzie: Selling general and administrative expenses were $103.6 million for the second quarter of 2024 compared to $78.9 million for the comparable period in 2023. The increase was primarily related to commercialization expenses largely driven by field force expansion and higher personnel costs, including non-cash stock-based compensation due to organizational growth.

Speaker Change: Selling general and administrative expenses were $103 6 million for the second quarter of 2024 compared to $78 9 million for the comparable period in 2023.

Speaker Change: The increase was primarily related to commercialization expenses, largely driven by field force expansion and higher personnel costs, including noncash stock based compensation due to organizational growth.

Speaker Change: Net loss for the second quarter of 2024 was $79 3 million or $1 67 per share compared to a net loss of $67 2 million or $1 54 per share for the comparable period in 2023.

Nick Pizzie: The net loss for the second quarter of 2024 was $79.3 million, or $1.67 per share, compared to a net loss of $67.2 million, or $1.54 per share for the comparable period in 2023. The net loss for the second quarter of 2024 reflects $26 million in non-cash charges. Gross net discount for Q2 was in the low to mid-50s for both Aveliti and Synose. We ended the second quarter of 2024 with $315.7 million in cash and cash equivalents compared to $386.2 million as of December 31, 2023.

Speaker Change: Net loss in the second quarter of 2024 reflects $26 million in noncash charges.

Gross to net discount for Q2 was in the low to mid fifties for both ability and Sanofi.

Nick Peasy: We ended the second quarter of 2024 with $315.7 million in cash and cash equivalents, compared to $386.2 million as of December 31, 2023. We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

Speaker Change: We ended the second quarter of 2024 with $315 $7 million in cash and cash equivalents compared to $386 $2 million as of December 31, 2023.

Speaker Change: We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on our current operating plan.

Nick Pizzie: We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating. I will now like to turn the call over to Ari who will provide a commercial update.

Ari Maisel: I will now like to turn the call over to Ari, who will provide a commercial update. Thank you, Nick. Axsome drove significant demand growth for Ability and Sinose in the second quarter of 2024, reflecting strong market acceptance of our sales and marketing efforts and positive experiences with our products. Our optimization of commercial execution and operations powered by our digital-centric commercialization platform, combined with improved market-access dynamics beginning in Q3, positioned Axsome well for the second half of the year. Starting with Avality, the second quarter of 2024 saw Avality outperform the market in branded competitors with approximately 123,000 prescriptions, representing 29% quarter-over-quarter growth and 131% growth compared to the second quarter of 2023.

Speaker Change: I will now like to turn the call over to Ari, who will provide a commercial update.

Ari: Thank you Nick axon drove significant demand growth for our ability and so nosy and the second quarter of 2024, reflecting strong market acceptance of our sales and marketing efforts and positive experiences with our products.

Ari Maizel: Axsome drove significant demand growth for Ability and Synosy in the second quarter of 2024, reflecting strong market acceptance of our sales and marketing efforts and positive experiences with our product. Our optimization of commercial execution and operations, powered by our digital-centric commercialization platform, combined with improved market access dynamics beginning in Q3, positioned Axsome well for the second half of the year. Starting with aubelity.

Ari: Our optimization of commercial execution and operations powered by our digital centric commercialization platform combined with improved market access dynamics, beginning in Q3 positioning us well for the second half of the year.

Ari: Starting with <unk> the.

Ari Maizel: The second quarter of 2024 saw Aveliti outperform the market for branded competitors with approximately 123,000 prescriptions. Representing 29% quarter over quarter growth and 131% growth compared to the second quarter of 2023. By comparison, the antidepressant market grew 1% sequentially and declined 1% compared to the second quarter of 2023.

Ari: The second quarter of 2024 saw ability outperformed the market and branded competitors with approximately 123000 prescription.

Ari: Representing 29% quarter over quarter growth and 131% growth compared to the second quarter of 2023.

Ari Maisel: By comparison, the antidepressant market grew 1% sequentially and declined 1% compared to the second quarter of 2023. More than 24,000 new patients were prescribed Avality in the quarter, and we successfully activated 4,300 new prescribers in Q2, underscoring strong underlying demand for the product as we continue to expand use among depression traders in both psychiatry and primary care offices. Our efforts to improve market access for Avality recently resulted in a significant commercial coverage decision, which added more than 22 million new covered lives effective August 1st. This increases the percentage of covered commercial lives from 48% to 60%, and the percentage of total covered lives across all payer channels from approximately 70% to 76%.

Ari: By comparison, the antidepressant market grew 1% sequentially and declined 1% compared to the second quarter of 2023.

Ari Maizel: More than 24,000 new patients were prescribed Alvelity in the quarter, and we successfully activated 4,300 new prescribers in Q2, underscoring strong underlying demand for the product as we continue to expand use among depression treaters in both psychiatry and primary care offices. Our efforts to improve market access for Audality recently resulted in a significant commercial coverage decision, which added more than 22 million new covered lives effective August 1st. This increases the percentage of covered commercial lives from 48% to 60%, and the percentage of total covered lives across all payer channels from approximately 70% to 76%.

Ari: More than 24000, new patients were prescribed our ability in the quarter and we successfully activated 4300, new prescribers in Q2, underscoring strong underlying demand for the product as we continue to expand use among depression treaters in both psychiatry and primary care offices.

Ari: Our efforts to improve market access for our ability recently resulted in a significant commercial coverage decision, which added more than 22 million new covered lives effective August 1st.

Ari: This increases the percentage of covered commercial lives from 48% to 60% and the percentage of total covered lives across all payer channels for approximately 70% to 76%.

Ari Maisel: We anticipate continued progress on coverage dynamics as we strive to improve access for the millions of patients living with major depressive disorder.

Ari Maizel: We anticipate continued progress on coverage dynamics as we strive to improve access for the millions of patients living with major depressive disorders. Turning to CENOSI, total prescriptions were approximately 45,000 in the quarter, representing 8% sequential growth and 15% growth versus Q2 2023. By comparison, the waste-promoting agent market grew 4% sequentially and declined 1% compared to the second quarter of 2023.

Ari: We anticipate continued progress on coverage dynamics as we strive to improve access for the millions of patients living with major depressive disorder.

Ari Maisel: Turning to Sinozie, total prescriptions were approximately 45,000 in the quarter, representing 8% sequential growth and 15% growth versus Q2 2023. By comparison, the waste promoting agent market grew 4% sequentially and declined 1% compared to the second quarter of 2023. Of note, Sinozie had strong performance with new patient prescriptions in Q2, with more than 4,200 new patients initiating Sinozie treatment during the quarter. In addition, approximately 400 new writers were activated in Q2, as Sinozie continues to grow adoption across the universe of sleep specialists in the United States. Pay or coverage for Sinozie in Q2 was stable, with 83% of lives covered across channels.

Ari: Turning to the nosy.

Ari: Total prescriptions were approximately 45000 in the quarter, representing 8% sequential growth and 15% growth versus Q2 2023.

Ari: By comparison, the wake promoting agent market grew 4% sequentially and declined 1% compared to the second quarter of 2023.

Ari Maizel: Of note, CINOZI had strong performance with new patient prescriptions in Q2, with more than 4,200 new patients initiating CINOZI treatment during the quarter. In addition, approximately 400 new riders were activated in Q2, as Zanossi continues to grow adoption across the universe of sleep specialists in the United States. Payer coverage for CENOSI in Q2 was stable, with 83% of lives covered across channels.

Ari: Of note the nosy had strong performance with new patient prescriptions in Q2 with more than 4200, new patients initiating <unk> treatment during the quarter.

Ari: In addition, approximately 400, new writers were activated in Q2 as the nosy continues to grow adoption across the universe of sleep specialists in the United States.

Speaker Change: Payer coverage first day, nosy and Q2 was stable with 83% of lives covered across channels.

Ari Maizel: Efforts to improve patient access for synosis are ongoing. In closing, we are very pleased with our commercial performance in Q2 for both Aubelity and Cynosa. This is evidenced by key metrics including new patient starts, new writer activation, and improved market access dynamics. In addition, we continue to receive outstanding real-world feedback on the impact our products are having on the lives of millions of adult patients suffering from major depressive disorder and excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy. Our success in 2024 provides compelling evidence of the promise and potential of Axsome's commercialization capabilities in support of future product launches in the CNS space. I will now turn the call back to Darren for Q&A.

Ari Maisel: Efforts to improve patient access for Sinozie are ongoing.

Speaker Change: <unk> to improve patient access first to nosy are ongoing.

Ari Maisel: In closing, we are very pleased with our commercial performance in Q2 for both Ability and Sinozie. Lucy, evidence by key metrics, including new patient starts, new writer activation, and improved market access dynamics. In addition, we continue to receive outstanding real-world feedback on the impact our products are having on the lives of millions of adult patients suffering from major depressive disorder and excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy. Our success in 2024 provides compelling evidence of the promise and potential of Axom's commercialization and keeping abilities in support of future product launches in the CNS space.

Speaker Change: In closing we are very pleased with our commercial performance in Q2 for both ability and so nosy.

Speaker Change: Evidenced by key metrics, including new patient starts new rider activation and improved market access dynamics.

Speaker Change: In addition, we continued to receive outstanding real World feedback on the impact our products are having on the lives of millions of adult patients suffering from major depressive disorder, and excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy.

Speaker Change: Our success in 2024 provides compelling evidence of the promise and potential of exxon's commercialization capabilities and support our future product launches in the CNS space.

Darren Opland: I will now turn the call back to Darren for Q&A. Thank you, Ari. Operator, may we please have our first question?

Speaker Change: I will now turn the call back to Darrin for Q&A.

Darrin: Thank you Ari operator may we please have our first question.

Darren Opland: Thank you, Ari. Operator, may we please have our first question? Sure. We'll now be conducting a question and answer session. As a reminder, if you'd like to be placed in the question queue, please press star one on your telephone keypad. And in the interest of time, we ask that you please ask one question and return to the

Unknown Attendee: Certainly. When I'll be keeping up with your question and answer session, as a reminder, if you'd like to be placed in the question queue, please press star one on your telephone keypad. And in the interest of time, we ask you, please ask one question in the return to the queue.

Speaker Change: Certainly, we'll now be conducting a question and answer session. As a reminder, if you'd like to be placed in the question queue. Please press star one on your telephone keypad and the interest of time. We ask you. Please ask one question and return to the queue. Our first question is coming from Vikram <unk> from Morgan Stanley. Your line is now live.

Operator: Certainly. We'll now be conducting a question and answer session. As a reminder, if you'd like to be placed in the question queue, please press star 1 on your telephone keypad. In the interest of time, we ask that you please ask one question and return to the queue. Our first question is coming from Vikram Purohit from Morgan Stanley. Your line is now live. Hi, good morning. Thanks for taking

Vikram Purohit: Our first question is coming from Vikram Proto from Morgan Stanley. Your line is a lot.

Ari Maisel: Hi, good morning. Thanks for taking our question. Our one question is on availability commercialization. So you mentioned that the Salesforce expansion was having a benefit that you saw in the quarter, which would just be curious to get some more context on the specific kinds of prescribers and kind of the techniques that you could quantify what sort of benefit you saw from the Salesforce expansion would be helpful. Thank you. Yes.

Vikram <unk>: Hi, good morning, Thanks for taking our question or one question is on our ability commercialization.

Mentioned that the sales force expansion was having a benefit that you saw in the quarter would just be curious to get some more context on our.

Speaker Change: The specific kinds of prescribers and.

Speaker Change: Kind of the.

Speaker Change: To any extent you can quantify what sort of benefit you saw from the sales force expansion. It would be helpful. Thank you.

Speaker Change: Yeah, Thanks, Doug Drummond as Ari.

Unknown Attendee: Yeah, thanks Vikram and Ari. Obviously, we're really pleased with how the quarter ended up, and the impact of the sales force is being seen in a couple different areas. One, we saw a clear inflection in weekly new patient starts that began at the end of March and continued through the quarter. Secondly, we're seeing nice growth in the primary care segment. So, although psychiatrists, MDs, and NPPAs are still the lion's share of our volume, we are seeing primary care utilization increase, and we saw it do so over the course of the quarter.

Ari Maisel: Thanks, Secretary. I'm sorry. Obviously, we're really pleased with how the quarter ended up, and the impact of the Salesforce is being seen in a couple different areas. One, we saw a clear reflection in weekly new patient starts that began at the end of March and continued through the quarter. Secondly, we're seeing a nice growth in the primary care segment. So although psychiatrists, MDs, and MPPAs are still the line share of our volume, we are seeing primary care utilization increase and solid do so over the course of the quarter. So those are two things that I would point to you in terms of Salesforce expansion impact.

Doug Drummond: Obviously, we're really pleased with how the quarter ended up and the impact of the sales force is being seen in a couple of different areas. One we.

Doug Drummond: We saw a clear inflection in weekly new patient starts that.

Doug Drummond: That began at the end of March and continued through the quarter Secondly.

Doug Drummond: Secondly, we're seeing.

Doug Drummond: A nice growth in the primary care segment, so although psychiatrist and do you use an M. P. P. A's are still the lion's share of our volume we are seeing primary care utilization increase and solid do so over the course of the quarter. So those are two things that I would point to you in terms of sales force expansion impact.

Unknown Attendee: Thank you.

Liana <unk>: Thank you next question is coming from Liana <unk> from RBC capital markets. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from Leonid Timashev from RBC Capital Markets. Your line is now live. Hey, guys. Thanks.

Unknown Attendee: So, those are two things that I would point to in terms of sales force expansion impact. Thank you. Next question is coming from Leonid Timashev from RBC Capital Markets. Your line is now live. Hey guys, thanks for taking my question, and congratulations on another

Leonid Timashev: Next question is coming from Leonid Timichep from RBC Capital Market. Your line is now live. Hey guys, thanks for taking my question, and congrats on another quarter. I just want to ask on the progress for advance to I guess. Can you talk about what you're seeing with respect to the dynamics, you know, in particular with the fact that there's now an approved agent there? I guess what's driving your confidence that you can complete recruitment in the second half of the 2024, and I guess read that trial out. So any kind of color on the recruitment for advance should be appreciated.

Liana <unk>: Hey, guys. Thanks for taking my question and congrats on another quarter I just wanted to ask on the progress for advance two I guess can you talk about what you're seeing with respect to the dynamics and particular with the fact that there's now an approved agent there I guess, what's driving your confidence that you can complete recruitment and second half of.

Speaker Change: 'twenty 'twenty, four and I got to read that trial out so any.

Speaker Change: Any kind of color on the recruitment fragrance totally appreciate it. Thank you.

Ario Tabuto: Thank you.

Ario Tabuto: Thanks for the question. What's driving our confidence is simply the enrollment progress. The study is progressing in terms of enrollment that very steadily, and it's putting us on track to record results in the second half. So we're pretty confident in the progress to that. And as it relates to the market of Exalty, which is an approved agent in the syndication, the impact that we anticipated was that it could provide patients with an alternative treatment. So patients were considering to enroll in a trial and all type of these agitation. They will now be presented with another approved agent.

Speaker Change: Sure. Thanks for the question what's driving.

Unknown Attendee: Sure, thanks for the question. What's driving our confidence is simply the enrollment progress. The study is progressing very steadily, and it's putting us on track to report results in the second half. So we're pretty confident with regard to that. And as it relates to the launch of Rexalti, which is an approved agent in this indication, the impact that we anticipated was that it could provide patients with an alternative treatment.

Speaker Change: This is simply the enrollment progress study is progressing in terms of enrollment the very steadily and putting us on track to report results in the second half. So we're pretty confident with regards to that and as it relates to the launch of our exalt D, which is an approved agent in this indication the impact.

Speaker Change: We anticipate it was that good.

Speaker Change: Provide patients with an alternative treatment so patients who are working with it ran war considering to enroll trials overseas agitation. They will now be presented with another daycare.

Unknown Attendee: So patients who were considering or are considering enrolling in a clinical trial in Alzheimer's disease agitation will now be presented with another approved agent. So that could have an impact, and that's an impact that we had anticipated and built into our modeling.

So that could have an impact.

Ario Tabuto: So that could have an impact, and that's an impact that we had anticipated and built into our modeling. And we're very comfortable with the patient's progress of the trial and are read out in a second. Thank you.

Speaker Change: And in fact that we had.

Speaker Change: Dissipated and built into our modeling.

Speaker Change: And we're very comfortable with the pace of progress on the trial readout in the second half.

Speaker Change: Yeah.

Speaker Change: Thank you. Our next question today is coming from Marc Goodman from Leerink Partners. Your line is now live.

Unknown Attendee: Thank you. Our next question today is coming from Mark Goodman from Lear Inc. Partners. Your line is now live.

Unknown Attendee: And we're very comfortable with the pace of progress of the trial and the readout in the second half. Thank you. Our next question today is coming from Mark Goodman from Leering Partners. Your line is now live. Hey, good morning. Is the plan still to do a DTC?

Marc Goodman: Your next mission today is coming from Marc Goodman, from Learning Partners. Your line is now live. Good morning.

Marc Goodman: Hey, Good morning is the plan still to do DTC advertising campaign in the second half.

Nick Peasy: It's the plan still to do a DTC advertising campaign in the second half of the day. And then also just update us on the marketing, like plans to spend, like just give us a sense of what we'll have next year considering maybe launching multiple products. Thank you. Yeah, thanks, Mark. You broke up a little bit, but I believe the first question was plans on direct-to-consumer. You know, we obviously have direct-to-consumer in market right now. It's primarily focused on digital media. We continue to evaluate the potential for a broad-based media campaign, and we'll share updates as things progress.

Speaker Change: Mhm serves like.

Speaker Change: Yeah.

Speaker Change: And then also just update us on the marketing.

Speaker Change: <unk> plans to spend like just give us a sense of what.

Speaker Change: Next year, considering you may be launching multiple products. Thank you.

Speaker Change: Yeah. Thanks, Mark you broke up a little bit, but I believe the first question was Ah plans on direct to consumer.

Unknown Attendee: Yeah, thanks, Mark. We broke up a little bit, but I believe the first question was about plans for direct-to-consumer. You know, we obviously have direct-to-consumer in the market right now, but it's primarily focused on digital media. We continue to evaluate the potential for a broad-based media campaign, and we'll share updates as things progress. Part of the decision criteria, just with the anticipated noise level during the election season, is one of the factors that we're evaluating. Secondly, your comments about spend as it relates to ongoing launches. Maybe, Nick, you want to take that? Sure, yeah. So, currently, we're

Speaker Change: You know, we obviously have direct to consumer end market right now is primarily focused on digital media.

Speaker Change: You need to evaluate the potential for a broad based media campaign, and we'll share updates as.

Speaker Change: Things progressed, a part of the decision criteria just with the anticipated noise level with the.

Nick Peasy: Yes, part of the decision criteria just with the anticipated noise level with the election season is one of the factors that we're evaluating. Secondly, your comments about spend as it relates to ongoing launches.

Speaker Change: The election season as one of the factors that we're evaluating.

Lee: Lee your your comments about spend as it relates to ongoing launches do you want to take that.

Nick Peasy: Nick, do you want to take that? Sure. Yeah, so we're currently evaluating planning for the spend for those launches. And as we get closer to those launches, we'll be able to share more information with you. Thank you.

Lee: Sure Yeah. So so.

Unknown Attendee: We're currently evaluating and planning for the spend for those launches, and as we get closer to those launches, we'll be able to share more information with you.

Lee: We're currently evaluating.

Lee: Planning for the spend for those launches.

Lee: And as we get closer to two to those launches will will be able to share more information with you.

Speaker Change: Thank you. Your next question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from Charles Duncan from Cancer Pit Shuttle. Your line is now live.

Charles Duncan: Next question is coming from Charles Duncan from Canterbury. Charlotte, your line is now live. Yes. Good morning, Aeroan Team. Congratulations on a good quarter. I had a two-part question on AXS-05 or Ovality. One is with regard to ovality. Are you seeing persistence that perhaps exceeds expectations relative to other anti-depressant medicines?

Speaker Change: Yes, good morning area and team congratulations on a good quarter I had a two part question on access so fine our ability one is with regard to obesity are you seeing persistence.

Unknown Attendee: Yes. Good morning, Ariel and team. Congratulations on a good quarter. I had a two-part question on AXS05 or ovality. One is with regard to ovality; are you seeing persistence that perhaps exceeds expectations relative to other antidepressant medicines? And for AXS05, relative to the two readouts, congrats on finishing a cord. I guess the question is, what is the rate-limiting step to filing an NDA, and when would you anticipate that if those two studies are positive? Thanks.

Speaker Change: Perhaps exceeds expectations relative to other anti depressant medicines and for accent. So five relative to the two readouts congrats on finishing a cord.

Ario Tabuto: And for AXS-05 relative to the two readouts, congrats on finishing a court that enrollment. I guess the question is, what is the rate-limiting step to filing an MBA? And one would you anticipate that if those two studies are positive? Thanks.

Speaker Change: That enrollment I guess the question is what is the rate limiting step to filing an NDA and when would you anticipate that and those two studies are positive.

Ari Maisel: Sure. So I'll take the second question, and then I'll turn it over to Ari to talk about our persistence. With regards to AXS-05, the gaining factor, the major gaining factor is completion of the ongoing studies, including the long-term open-label portion. So once those studies are completed, then we'll be in a very good position to put together an MBA filing. Typically, that takes about six months.

Speaker Change: So.

Unknown Attendee: I'll take the second question and then I'll turn it over to Ari to talk about persistence. With regard to XSO5, the gaining factor, the major gaining factor is completion of the ongoing studies, including the long-term open-label portion. So once those studies are completed, then we'll be in a very good position to put together an MDE filing. Ard, do you want to comment on persistence? Yeah, Charles.

I'll take the second question and then I'll turn it over to talk about our persistence with regards to excess so five the gating factor a major gating factor is a completion of the ongoing studies, including long term open label portion. So once those studies are.

Speaker Change: Completed then we'll be in a very good position to put together an NDA filing typically that takes about.

Six months.

Ari Maisel: Are you in common on persistence? Yeah. Charles, you may remember in the past we talked about some of the anecdotal feedback we've received that suggested persistency on Ovality is greater than that observed with SSRIs. We recently conducted a cohort analysis using claims data that is validate. There's a numerical advantage for Ovality relative to the most widely used SSRI. So we were really pleased to see that, and it does support overhearing from providers in their practice. Thank you.

Speaker Change: Argument comment on persistence, Yeah. Charles you May remember in the past we talked about some of the anecdotal feedback. We've received that suggested persistency on ability is greater than that observed with ssris. We recently conducted a cohort analysis you can claim that.

Unknown Attendee: Yeah, Charles, you may remember in the past we talked about some of the anecdotal feedback we've received that suggested persistency on aubility is greater than that observed with SSRIs. We recently conducted a cohort analysis using claims data that did validate there's a numerical advantage for aubility relative to the most widely used SSRIs. So we were really pleased to see that, and it does support what we're hearing from providers. Thank you. Our next question today is coming from Joon Lee from Truist Security. Your line is now live. All right, congratulations on a strong quarter and thanks for taking our questions.

Speaker Change: Did validate there's a numerical advantage for our ability relative to the most widely used ssris. So we were really pleased to see that and it does support what we're hearing from providers in their practices.

Speaker Change: Thank you. Our next question today is coming from Joon Lee from <unk> Securities. Your line is now live.

Unknown Attendee: Thank you. Our next question today is coming from Joon Lee from Truist Security. Your line is now live. All right, congratulations on the show.

Joon Lee: Your next question today is coming from Joon Lee, from Trua Security. Your life is now live. I can wrap up the strong quarter and thanks for taking our questions. Or a core two, can you remind us the duration of open label running period and what the typical time to relapse was in a core one using the a core two definition.

Speaker Change: Congrats on the strong quarter and thanks for taking our question.

Joon Lee: Or a court to can you remind us the duration of open label run in period and what the typical time to relapse was and of course one.

I think the core two definition thank you.

Ario Tabuto: Thank you. So, with regards to the running period, what we've disclosed is that it is long enough to enable patients to respond. So if you think back to the advanced studies, those are five weeks of duration, and we're able to see patients respond fairly quickly. And then you would add on to that period of time to judge whether or not the response is stable. And as soon as that judgment can be made, then patients will be able to randomize.

Joon Lee: So.

Unknown Attendee: So, with regard to the running period, what we've disclosed is that it is long enough to enable patients to respond. So, if you think back to the advanced studies, those were five weeks in duration, and we were able to see patients respond fairly quickly. And then you would add to that a period of time to judge whether or not the response is stable. And as soon as that judgment can be made, then patients will be able to respond.

Speaker Change: With regards to the running period, what we've disclosed is that it is long enough to enable patients to respond so.

Speaker Change: Think back to the fans.

Speaker Change: Studies those over five weeks in duration, and we're able to see patients respond fairly quickly and then you would add to that period of time to judge whether or not the response is stable and as soon as that that judgment nave.

Speaker Change: Patients will be able to.

Speaker Change: To wrap up.

Ario Tabuto: Thank you. Next question. And then the other, I'm sorry, I think the other part of your question was how long did it take for patients to relapse. So we definitely have that information based on the result of a court one study. And those definitely my clients. Here we've shown, so we definitely get back to you with regards to some qualitative way of looking at that. In that study, there was no. Estimal immediately in time to relapse because the patients aren't successful five at such low relapse rates. But obviously, the results were highly significantly significant in a core one.

Speaker Change: Thank goodness.

Unknown Attendee: I think the other part of your question was how long did it take for patients to relapse. So we definitely have that information based on the results of the ACCORD-1 study. And those definitely might occur here, we've shown.

Speaker Change: I'm sorry, the other I'm sorry.

Speaker Change: On the part of your question was around Hum.

Speaker Change: Did it take to relapse. So we definitely have that information based on the results.

Speaker Change: Cohort one.

Speaker Change: One study.

Speaker Change: Kaplan Meier curves here soon so we can definitely get back to you with regards to Oh, some qualitative way of looking at that the.

Unknown Attendee: So we can definitely get back to you with regard to some qualitative ways of looking. There was no estimable median time to relapse because the patients on AXS05 had such low relapse rates, but obviously, the results were highly statistically significant after a quarter of a month. Thank you. Next question is coming from Raghuram Selvaraju from H.C. Wainwright. Your line is now live.

Speaker Change: In that study.

Speaker Change: There was no.

Speaker Change: Ethanol more medium time to relax because the pieces on five at such low relapse rates, but obviously.

Speaker Change: The results were highly statistically significant.

Speaker Change: Okay.

Unknown Attendee: Thank you.

Robert <unk>: Thank you next question is coming from Robert <unk> from H C. Wainwright. Your line is now live.

Ram Sabaraju: Next question is coming from Ram Sabaraju from H.C. Wayne, right? Your line is our line.

Ario Tabuto: Thank you very much for taking my question. Ario, you mentioned the various indications potentially commercializable for Sol-Ram Fatal. And I was wondering if you could provide additional color on which of those you expect to present the most attractive competitive landscape, competitive opportunity for Sol-Ram Fatal and what the peak market opportunity might look like on an annualized basis for Sol-Ram Fatal in that indication. Of those four that are currently the basis of ongoing clinical investigation. Thanks. Thanks for the question. What's nice about all the four what's nice about the four indications which we are studying for new indications ADHD and V.D.

Robert <unk>: Thank you very much for taking my question.

Unknown Attendee: Thanks very much for taking my question. Ariel, you mentioned the various indications potentially commercializable for sole re-amphitol. And I was wondering if you could provide additional color on which of those you expect to present the most attractive competitive landscape, competitive opportunity for sole re-amphitol, and what the peak market opportunity might look like on an annualized basis for sole re-amphitol in that indication, among those four that are currently the basis of ongoing clinical investigation. Thank you.

Robert <unk>: <unk> you mentioned the various indications potentially commercialize the ball for salary Amphenol and I was wondering if you could provide additional color on which of those you expect to present the most attractive.

Speaker Change: <unk> landscape competitive opportunity for solar and for call and what the peak market opportunity might look like on an annualized basis of course, all ramp at all in that indication of those four that are currently are the basis of ongoing clinical investigation.

Unknown Attendee: Thanks for the question. What's nice about the four indications which we are studying, four new indications, ADHD, MDD, binge eating disorder, and chipped throat disorder, is that these are all very large patient populations. And we think that's all we have at all based on the mechanism of action and the efficacy that's been seen in the current indications does potentially provide added benefit which can be superior to what is seen with the current agents in certainly in ADHD and also in binge eating disorder.

Speaker Change: Thanks for the question.

Speaker Change: What's nice about all the.

Speaker Change: Look Michael at the four indications, which we are studying for new indications ADHD and binge eating disorder and chip work. This water is.

Ario Tabuto: Vengeance disorder and check road disorder is that these are all very large patient populations. And we think that Sol-Ram Fatal, based on the mechanism of action and the efficacy that's been seen in the current indications, does potentially provide added benefit on which can be superior to what is seen with the current agents in certainly in ADHD and also in Vengeance disorder. So it remains, you know, it remains to be seen what the full clinical profile is, which is why we are conducting the current studies. We're looking forward to the result of the ADHD study first that's in the second half of this year.

Speaker Change: A very large patient populations.

We think that's oriented at all based on this mechanism of action.

Speaker Change: Yes.

Speaker Change: And the current indications does essentially provide added benefit.

Speaker Change: Can be superior to what is the current agents is.

Speaker Change: Certainly.

Speaker Change: ADHD.

Speaker Change: All sorts of binge eating disorder. So it remains it remains to be seen.

Unknown Attendee: So, it remains to be seen what the full clinical profile is, which is why we are conducting the current studies. We're looking forward to the results of the ADHD study first, that is, in the second half of this year, and then we'll be looking forward to the results for the other indications thereafter. Chipped throat disorder is an interesting indication. So, as a reminder, the indication there is excessive daytime sleepiness in patients with chipped throat disorder.

Speaker Change: What the full clinical profile is which is why we are conducting.

Speaker Change: Conducting the.

Speaker Change: The current studies.

Speaker Change: We're looking forward to the results of the Eastern States first that's in the second half of this year and and then we'll be looking for towards the results for the other indications thereafter.

Ario Tabuto: And then we'll be looking forward towards the results for the other indications thereafter.

Unknown Attendee: That's very akin to the currently approved indications, which are excessive daytime sleepiness in OSA and narcolepsy. So, that will round out the currently approved indications. And then ADHD and binge eating disorder, obviously, those are... Very new indications, and then NDD would be another new indication, an entirely new indication for scoliatral.

Ario Tabuto: Ship flow disorder is an interesting indication. So, as a reminder, the indication there is accessibility times in patients with ship flow disorder. That's very akin to the currently approved indications, which is because of the kinds of events in OSA and in narcolepsy. So that's been ground out the currently approved indications. And then ADHD and vengeance disorder obviously those are...

Speaker Change: Shift work disorder.

Speaker Change: Interesting indications so as a reminder, the indication there is excessive daytime sleepiness in patients with shift work disorder, that's very cute.

Speaker Change: To.

Speaker Change: The currently approved indications, which is because of the policy.

Speaker Change: And in normal biopsy. So that's that will round out the currently approved indications and.

Speaker Change: Before obviously those are.

Ario Tabuto: David Amsellem, Mary New Indicators, and then MDV, would be also a New Indication, entirely New Indication, Force, Julian Pedal. Thank you.

Very new indications and then it would be also communication.

Speaker Change: Entirely new indications.

Speaker Change: Thank you. Our next question today is coming from Jason <unk> from Bank of America. Your line is now live.

Unknown Attendee: Thank you. Our next question today is coming from Jason Gerberry from Bank of America. Your line is now live.

Jason Gerberry: Our next question today is coming from Jason Gerberry for Bank of America. Your line is now live. Good morning, guys. Thanks for taking my question.

Unknown Attendee: Hey, good morning, guys. Thanks for taking my question. Mine is just I wanted to get your latest thinking on AXSO FHIR for ADA, assuming you're able to file your thoughts on something like a unique NDA versus supplemental to the ability NDA. Specifically, given the differences in the payer mix, what are your thoughts on tactical considerations for approaching this more highly Medicare Medicaid indication in lieu of Part D redesign implications for next year, and how a unique pricing strategy may be important for AXSO5 adoption? So anything you can do just at a high level to frame some of these tactical considerations would be helpful as we think about monitoring kind of large comps.

Jason: Hey, good morning, guys. Thanks for taking my question mine is just I wanted to get your latest thinking on a excess of fire for 80, a assuming youre able to file your thoughts on like a unique NDA versus supplemental to the ability NDA specifically like given the differences in the payer mix just what are your thoughts.

Nick Peasy: Mine is just, I wanted to get your latest thinking on AXS-O-Fire for ADA, assuming you're able to file your thoughts on a unique NDA versus supplemental to the Ovality NDA, specifically given the differences in the payermix. Just what are your kind of thoughts on tactical considerations for approaching like this more highly Medicare Medicaid indication and lieu of Part D redesign implications for next year, how like a unique pricing strategy may be important for AXS-O-5 adoption. So anything you can do to set a high level to frame some of these tactical considerations would be helpful as we think about monitoring kind of large comps.

Jason: Tactical considerations for approaching like this more highly Medicare Medicaid indication and in lieu of part D redesign implications for next year, how like a unique pricing strategy, maybe important for axi cel five adoption. So anything you can do this at a high level to frame some of the tactical considerations would be helpful.

Speaker Change: As we think about monitoring kind of large comps. Thanks.

Nick Peasy: Thanks.

Nick Peasy: Okay, so those are great questions that we obviously are giving a lot of thought to. What's nice is we do have optionality, so we want to make sure that we make the right decision and I'm going to make it hastily. It does require a lot of work. We like to be very quantitative in our assessments, and as soon as you know, as soon as there's something definitive, we will let you know. Typically, that would be closer to the time of the filing and then the approval. Having said that, you know, you already provide you some some some guardrails around how we're thinking about things.

Speaker Change: Yes, so it's.

Unknown Attendee: So those are great questions that we obviously are giving a lot of thought to. What's nice is that we do have options.

Speaker Change: Those are great questions bad.

Obviously, you are giving a lot of thought to what's nice is we do have optionality. So we want to make sure that we make the right decision, making hastily and it does require them.

Unknown Attendee: So we want to make sure that we make the right decision. We're not going to make it hastily, and it does require a lot of work. We like to be very quantitative in our assessments. And as soon as there's something definitive, we will let you know. Typically, that would be closer to the time of the filing and then approval.

Speaker Change: A lot of work, we'd like to be a very quantitative in our assessments.

Speaker Change: And as soon as soon as there's something definitive we will.

Speaker Change: Let you know.

Speaker Change: That would be closer to.

Speaker Change: At the time of the filing and then the approval having said that maybe he can provide you. Some some some guardrails around how we're thinking about it yes.

Unknown Attendee: Having said that, maybe Ari could provide you with some guardrails around how we're thinking about it. Yeah, thanks for the question, Jason. So there are a bunch of considerations that we're working through right now. There are obviously marketing elements as it relates to the halo that may be associated with the drug, with single or separate brand names. There are patient safety considerations. When you look at other drugs that have the same molecule, different brand names, generally speaking, there may be a difference in the route of administration or dosages.

Nick Peasy: Yeah, thanks for the question, Jason. So there are a bunch of considerations that we're working through right now, is obviously marketing elements, you know, as it relates to the halo that may be associated with the drug with single or separate brand names. There are patient safety considerations. When you look at other drugs, that same molecule, different brand names, generally speaking, there may be a difference in route of administration or dosages. So there are a number of different factors that were still in the process of evaluating.

Speaker Change: Yeah. Thanks for the question Jason So there are a bunch of considerations that we're working through right now is obviously marketing.

Speaker Change: Elements as it relates to the Halo that may be associated with the drug.

Speaker Change: Single or separate brand names are there are patient safety considerations. When you look at other drugs that same molecule different brand names generally speaking there may be a difference and route of administration or dosages.

Speaker Change: So there are a number of different factors that were still in the process of evaluating and as <unk> mentioned, we'll provide further updates as we get a little bit more certainty around our decision.

Nick Peasy: And as Ariel mentioned, we'll provide further updates as we get a little bit more certainty around our decision. Thank you.

Speaker Change: Thank you. Our next question today is coming from Amy <unk> from Needham <unk> Company. Your line is now live.

Unknown Attendee: Thank you. Our next question today is coming from Amy Fadia from Dieterman & Company. Your line is now live.

Unknown Attendee: So there are a number of different factors that we're still in the process of evaluating. And as Herriot mentioned, we'll provide further updates as we get a little bit more certainty around our decision. Thank you. Our next question today is coming from Amy Fadia from Niedermann Company. Your line is now live.

Ami Fadia: Next question today is coming from Amy Faudia from Deedman Company. Your line is now live. Good morning. Thanks for taking my question.

Amy: Good morning, Thanks for taking my question.

Ari Maisel: Can you talk about the pull through that you've started to see falling the expansion of the commercial coverage and how you anticipate roasted to evolve from the remainder of the year. Thank you.

Amy: Can you talk about the pull through that you're starting to see funding the expansion of the commercial coverage.

Paul: And how you anticipate question actually Paul.

Speaker Change: Thank you.

Nick Peasy: Yeah, so thanks on me for the question. The 22 million additional lives, which increased our commercial coverage from 48 to 60% and overall coverage from 70 to 76%, just started on August 1st. So it is premature to talk about pull through at this point, but obviously we will share additional updates as time goes on.

Speaker Change: Yeah. So thanks, Amit for the question does the 22 million additional lives, which increased our commercial coverage from 48% to 60% and overall coverage from 70% to 76% I just started on August 1st So it is premature to talk about.

Unknown Attendee: Yeah, so thanks Ami for the question. The 22 million additional lives, which increased our commercial coverage from 48 to 60% and overall coverage from 70 to 76% just started on August 1st. So it is premature to talk about a pull-through at this point, but obviously, we will share additional updates as time goes on. And then, in terms of growth and that dynamic, I'll hand it to Nick.

Our pull through at this point, but obviously, we will share additional updates as time goes on and then in terms of gross to net dynamics I'll hand, it to Nick.

Nick Peasy: And then, in terms of growth in that dynamics, I'll hand it to Nick. Yeah, for the GTN, as I said, in my remarks, GTN for Ability was in the low to mid 50s. We do expect it to remain in this range for the second half of the year.

Unknown Attendee: Yeah, for the GTN, as I said in my opening remarks, GTN for Ability was in the low to mid 50s, and we do expect it to remain in this range for the second half of the year as well. I guess let me just alter the question. What I meant to ask was how long do you expect that pull-through to come starting August. We expect it to be dynamic, you know, over the coming months. The impact is not felt immediately; it sort of builds over time, so we would expect that to build in the weeks and months ahead.

Nick Peasy: Yeah for the GTS as I said in my opening remarks, GTA for ability wasn't a low to mid fifties, we do expect it to remain in this range for the second half of the year I saw them.

Nick Peasy: David Amsellem. Great, I guess let me just alter the question, but I meant to ask with how long do you expect that's put through to come starting August 1st? We expect it to be dynamic, you know, over the coming months. You know, the impact is not felt immediately; it sort of builds over time, so we would expect that to build in the weeks and months ahead.

Nick Peasy: And Greg I guess, let me just answer the question what I meant to ask was how long do you expect that's supposed to come starting August one.

Greg: We expect it to be dynamic you know over the coming months. The impact is not felt immediately and it sort of builds over time. So we would expect that to build in the weeks and months ahead.

Yatin Suneja: Thank you, and the next question is coming from Yatin Suneja from Guggenheim Partners. Your line is now live. Hey guys, thank you for taking the question. Could you maybe help us clarify or maybe set the stage for the ADHD study? What exactly are you looking for on the AI, by SRS endpoint? How should we think about placebo? What would be meaningful here? So that's one.

Speaker Change: Thank you. Our next question is coming from your teams from Asia from Guggenheim Partners. Your line is now live.

Unknown Attendee: Thank you. Our next question is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.

Speaker Change: Hey, guys.

Unknown Attendee: Hey guys, thank you for taking my question. Could you maybe help us clarify or maybe set the stage for the ADHD study? What exactly are you looking for on the AI SRS endpoint?

Speaker Change: For taking my question could you maybe help us a lot.

Speaker Change: Refi or maybe set the stage for the 80 S. D studying what exactly you're looking for on the AI F.

Unknown Attendee: How should we think about placebo? What would be meaningful here? So that's one. The second is on the ADA side. Could you maybe also help us articulate or maybe re-familiarize us with your filing strategy?

Speaker Change: Srs endpoint, how should we think about placebo would be meaningful there. So that's one.

Ario Tabuto: The second is on the ADHD. Could you maybe also help us articulate, maybe re familiarize us with your filing strategy? So you have advanced one, which was more of a component contribution study. You have a code one, which was a randomized withdrawal study. Which one is the primary study from an efficacy standpoint? How are you going to utilize the advanced to study all of the chords to study in that package?

Speaker Change: Second is on the ADR side could you maybe also help us articulate or maybe.

Unknown Attendee: So you have advanced one, which was more of a component contribution study. You have code one, which was a randomized withdrawal study. Which one is the primary study from an efficacy standpoint? How are you going to utilize the advanced two study or the accords to study in that package? Thank you.

Speaker Change: Re familiarize us with your filing strategy. So you'll have that belongs one which was more of a component contribution study you have the cord, one which was a randomized withdrawal study, which one is the primary study from an efficacy standpoint, how are you going to utilize the advance two study or the a corkscrew study in that package.

Ario Tabuto: Thank you. Sure, with regards to the first question around ADHD, this is for salt reanfor tall, which is the study in the phase three trial, the Focus trial for ADHD. This study is 90% powered to what detect a treatment difference. So we're very comfortable with the powering of the study. As a reminder, it's a rolling well, and it's on track for our readout in the second half of this year.

Speaker Change: Sure.

Unknown Attendee: Sure. With regard to the first question around ADHD, this is for sulforampetol, which is being studied in the phase three trial, the focus trial for ADHD. The study is 90% powered to detect a treatment difference, so we're very comfortable with the powering of the study. As a reminder, it's enrolling well, and it's on track for a readout in the second half of this year. With regard to the Alzheimer's Disease Agitation Program, we now currently have a total of four different phase three trials. And so we really like the way that that positions us.

Speaker Change: With regards to the first question around ADHD.

Speaker Change: For Salt remember toll, which is being studied in the phase III.

Speaker Change: But focused trial for ADHD study is 90% powered to detect a treatment difference so very comfortable with the powering of the study.

Speaker Change: A reminder, it's enrolling well and is on track for a readout in the second half of this year.

Ario Tabuto: With regards to the Alzheimer's disease agitation program, we now currently have a total of more different phase three trials. And so we really like the way that that positioned us. The Advanced One trial was a parallel group study. It did also have a program on the arm. So not only did it provide a pivotal evidence of efficacy, but it also did satisfy the component contribution aspect. The advanced two trials designed exactly like the advanced one trial for the most part. And except that it's only it's a two orange study. So it's an excess of five versus placebo.

Speaker Change: With regards to the.

Speaker Change: All of our risk disease agitation program. So we now currently have a pool of more different.

Speaker Change: Different phase III trials, and so we really like the winter that positions us the advance one trial.

Unknown Attendee: The advanced one trial was a parallel group study, and it did also have AB4 gram-only arms. So not only did it provide pivotal evidence of efficacy, but it also did satisfy the component contribution aspect. The ADVANCE-2 trial is designed exactly like the ADVANCE-1 trial for the most part, except that it's only a two-arm study. So it's AXS05 versus placebo. The ACCORD-1 trial is a randomizer for all studies. And the Accord 2 study is also a randomized withdrawal study. So, as a reminder, typically, for regulatory considerations, one needs two positive trials. So we really like the way that the development program has been structured, which should provide us with a very robust dataset.

Speaker Change: With a parallel group study.

Speaker Change: It also have bought before.

Speaker Change: So not only did it provide a.

Speaker Change: Pivotal evidenced.

Speaker Change: Although efficacy, but it also.

Speaker Change: Satisfied contribution aspect.

Speaker Change: Two trials designed Oh exactly like the advance one trial for the most part.

Speaker Change: And.

Speaker Change: It's only it's a two arm study so accessible behind versus placebo.

Ario Tabuto: The Accord One trials are randomized for all study. And the Accord two studies also randomized for all study. So, as a reminder, typically for regulatory considerations, one needs two positive trials. So we're really like the way that the development program has been structured, which provides us, which should provide us a very robust data set for the Indian submission.

Speaker Change: The accord one trials are randomized withdrawal study.

Speaker Change: And the accord study is also a randomized withdrawal study so as a reminder, typically for regulatory considerations.

Speaker Change: Two positive trials.

Speaker Change: We're really like.

Speaker Change: The way that.

Speaker Change: The development program has been structured which provides this should provide us a very robust dataset.

Speaker Change: Michelle.

Speaker Change: Yeah.

Unknown Attendee: Thank you.

Speaker Change: Thank you. Your next question is coming from David and some of them from Piper Sandler. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from David Amsellem from Piper Family. Your line is now live.

David Amsellem: Next question is coming from David, and tell him from Piper Sammler. Your line is now live. Yeah, on AXS-07, I appreciate that the color earlier in the call, but wondering if you could elaborate more on your go-to-market strategy and acute migraines, just bearing in mind that there have been some product launches that in that space that are fail to gain traction and just given that the payer landscape is not particularly generous. So how do you think about that? How do you think about pricing and the payer landscape and just overall thoughts there? Thanks. Yeah, thanks for the question, David.

David: Yeah on excess Oh, seven I appreciate the color earlier.

Unknown Attendee: Yeah, on AXS07, appreciate the color earlier in the call, but wondering if you could elaborate more on your go-to-market strategy for acute migraine, just bearing in mind that there have been some product launches in that space that have failed to gain traction, and just given that the payer landscape is not particularly generous. So how do you think about that? How do you think about pricing and the payer landscape and just overall thoughts there? Thanks.

David: In the call, but I'm wondering if you could elaborate more on your go to market strategy.

Speaker Change: In acute migraine just bearing in mind that there've been some product launches that in that space that have failed to gain traction and just given that the payer landscape is not particularly.

Speaker Change: Generous so how do you think about that how are you thinking about pricing in the payer landscape and just overall thoughts there. Thanks.

Speaker Change: Yeah. Thanks for the question, David Obviously, we're doing a ton of work on our launch readiness for in excess of seven I think the important thing to remember is that.

Unknown Attendee: Yeah, thanks for the question, David. Obviously, we're doing a ton of work on our launch readiness for AXS07. I think the important thing to remember is that the oral CGRP space is crowded. There are many triptans available.

David Amsellem: Obviously, we're doing a ton of work on our launch readiness for AXS07. I think the important thing to remember is that the oral CGR's piece space is crowded. There are many trip times available. However, there are still 70% of the 6 million or so migrant patients on therapy who are dissatisfied. We're not getting the efficacy or safety results. That they're looking for, and so we do think that there is a meaningful opportunity for AXS07. Obviously, market access and pair dynamics is top of mind. We're going through the work right now to understand what the pricing strategy should be, but we do feel confident based on the clinical trials that we've designed and the potential impact on patients with or without prior CGRP utilization is very high.

Speaker Change: The oral <unk> space.

Speaker Change: As crowded there aren't many triptans available. However, there are still 70% of the $6 million or so in migraine patients on therapy, who are dissatisfied who are not getting the.

Unknown Attendee: However, there are still 70% of the 6 million or so migraine patients on therapy who are dissatisfied, who are not getting the efficacy or safety results that they're looking for. And so we do think that there is a meaningful opportunity for AXS07. Obviously, market access and payer dynamics are top of mind. We're going through the work right now to understand what the pricing strategy should be, but we do feel confident based on the clinical trials that we've designed and the potential impact on patients with or without prior CGRP utilization is very high.

Speaker Change: Efficacy or safety results that they're looking for and so we do think that there is a meaningful opportunity for accessories have been obviously market access and payer dynamics is top of mind, we're going through the work right now to understand what the pricing strategy should be but we do feel confident based on.

Speaker Change: On the clinical trials that we've designed and the potential impact on patients.

With or without prior <unk> ERP utilization is very high. So we will provide additional updates as we get a bit closer to launch, but we feel that there's a meaningful opportunity for us.

David Amsellem: So we'll provide additional updates as we get a bit closer to launch, but we feel that there's a meaningful opportunity for AXS07. Thank you.

Unknown Attendee: So we'll provide additional updates as we get a bit closer to launch, but we feel that there's a meaningful opportunity for AXS07. Thank you. Next question today is coming from Joel Beatty from Baird. Your line is live. Hi, thanks for taking the question for availability.

Speaker Change: Thank you. Our next question today is coming from Joel Beatty from Baird. Your line is now live.

Unknown Attendee: Thank you. The next question today is coming from Joel Beatty from Baird. Your line is now live.

Joel Beatty: Next question, today is coming from Joe Beatty from Badger Line. Is that live? Thanks for taking the question.

Joel Beatty: Alright, Thanks for taking the question for all of the the press release mentions that actually might start coverage to continue to expand and evolve what do you mean by evolves and then a question on access so seven for migraine, but where you'll be.

Ari Maisel: For availability, the press release mentions that actually much less coverage to continue to expand and evolve. What do you mean by evolve?

Ari Maisel: And then a question on AXS07 for migraine. What will you be looking for in the results of the single group phase 3 emergency study reading out in the second half of this year? And could those results make it into the NBA that was just recently submitted?

Speaker Change: Are you looking for in the results of the single group Phase III study reading out in the second half of this year and cause those results to make it into the NDA and I was just recently resubmitted.

Joel Beatty: Okay.

Ari Maisel: Yeah, I'll take the first question, which is around expanded evolve. So obviously, we're very focused on our negotiations with payers. The expand is what you just saw, which was the addition of 22 million lives. So increasing the percent of cover lives is the expand part. The evolve is our strategy is to secure access that is first line or first switch. And in instances where we have existing coverage, where that first line for switch is not accessible, we work with payers to try to improve the access over time. And so that's sort of a two-pronged approach to our market access engagement.

Unknown Attendee: Yeah, I'll take the first question, which is about Expand and Evolve. So obviously, we're very focused on our negotiations with payers.

Speaker Change: Yeah, I'll take the first question, which was around expanding evolve.

Speaker Change: Obviously, we're very focused on our negotiations with payers. The expand is what you just saw which was the addition of 22 million lives so increasing the percent of covered lives.

Unknown Attendee: The Expand is what you just saw, which was the addition of 22 million lives. So increasing the percent of covered lives is the Expand part. The Evolve is, you know, our strategy is to secure access that is first line or first switch. And in instances where we have existing coverage, where that first line or first switch is not accessible, we work with payers to try to improve that access over time. And so that's sort of a two-pronged approach to our market access engagement.

Speaker Change: The expand part the evolved is we are our strategy is to secure access that is first line or first switch.

Speaker Change: In instances, where we have existing coverage.

Speaker Change: Or did that first line first which is not accessible and we work with payers to try to improve the access overtime.

Speaker Change: So that's sort of a two pronged approach to our market access engagement right.

Ari Maisel: Right.

Unknown Attendee: And with regard to the question about the migraine study with XSO7, this is the study in patients, the eMERGE trial in patients with a history of inadequate response to oral CGRPs. The way that that study is designed is that it is enrolling patients who are not responding to oral CGRPs, and we monitor their treatment once they've been switched over to AXS 07. And what we'd be looking for there is what the response rates are with patients who are taking AXS 07 versus what the response rates were prior to when they were on AXS 07.

Ari Maisel: And with regards to the question on the Migraine study with AXS07, this is the study in patients Emerge trial in patients with a history of inadequate response to oral CTRPs. The way that that study is designed is it is overwhelming patients who are not responding to oral CTRPs. And we monitor their treatment once they've been switched over to AXS-07. And what would be looked into when there is what the response rates are with patients who are taking AXS-07 versus what the response rates were prior to when they were on AXS-07. In other words, response rates on all CTRPs versus the response rates on AXS-07.

Speaker Change: And with regards to the question on the migraine.

Speaker Change: Migraine study with the Exosomes that Oh. This is the study in patients emerge trial in patients with <unk>.

Speaker Change: A history of inadequate response to or some trp's.

Speaker Change: The winner that study's design it is enrolling patients.

Speaker Change: Not responding to oral <unk>.

Speaker Change: We monitor.

Speaker Change #100: They are treatment once they've been switched over to access those seven.

Speaker Change #100: And what would be looking for there is what.

Speaker Change #100: Response rates or with patients who are taking in excess of seven versus what the response rates were prior to when they were all in excess of seven.

Unknown Attendee: In other words, response rates on oral CGRPs versus the response rates on AXS 07. And in terms of... whether or not that would make it into the filing, by definition, that would not be the case, right? Because that study has not yet been read out. However, we do think that it will provide very good information, should it be positive from a marketing perspective, and certainly from NHCP education.

Speaker Change #100:

Speaker Change #100: Response rates on all Europeans versus.

Speaker Change #100: Response rates.

Ari Maisel: And in terms of what we're not, that would make it into the filing, if by definition that we're not through the case rate, because that study has not yet read out. However, we do think that it will provide very good information, should it be positive from a marketing perspective, and certainly from NACP education perspective.

Speaker Change #100: Kevin.

Speaker Change #100: And in terms of.

Speaker Change #100: Of whether or not that we're making into the E filing.

Speaker Change #100: By definition it will not.

Speaker Change #100: In the case rate because the density is not yet read out.

Speaker Change #100: However, we do think that it will provide a very good information or should it be positive from a marketing perspective.

Speaker Change #100: And certainly from from an HCP education perspective.

Speaker Change #100: Yeah.

Unknown Attendee: Thank you.

Speaker Change #101: Thank you. Your next question is coming from Joseph told me from TD calendar. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from Joseph Comey from TD Calendar. Your line is now live.

Joseph John: Next question is coming from Joseph. Tell me from KD calendar line is that live.

Unknown Attendee: Hi there, good morning, and thank you for taking our question. Maybe on the commercial side for CINOZI, you are seeing growth, obviously, but maybe a little bit slowly. So can you talk a little bit about maybe what you can do or your plans to increase prescribing for narcolepsy in an OSA market? Is there still more room here, or are you getting to a place where you might be a little bit tapped out?

Ari Maisel: Hi there. Good morning, and thank you for taking our question. Maybe on the commercial side for Sinozi, you are seeing growth, obviously, but it may be a little bit slowly. So a keen talk a little bit about maybe what you can do or your plans to increase prescribing in the narcolepsy in an OSA market. Is there still more room here, or are you getting to a place where you might be a little bit tapped out. And then second, can you just remind us on the access 12 in narcolepsy? What are sort of the next steps there?

Speaker Change #102: Hi, there good morning, and thank you for taking my question maybe on the commercial side for synergy you are seeing growth, obviously, but maybe a little bit slowly. So can you talk a little bit about maybe what you can do your plans to increase prescribing in the narcolepsy and OSA market is there still more room here or.

Speaker Change #103: Are you getting to a place where you might be a little bit tapped out and then second can you just remind us on the excess 12 and narcolepsy what are sort of the next steps. There do you have to meet with the FDA for a pre NDA meeting or are you waiting for the safety database I'm just sort of some timeline updates would be would be helpful.

Unknown Attendee: And then second, can you just remind us about AXS-12 and narcolepsy? What are the next steps there? Do you have to meet with the FDA for a pre-NDA meeting? Are you waiting for the safety database? Just some timeline updates would be helpful.

Ari Maisel: Do you have to meet with the FDA for a pre-andee meeting? Are you waiting for the safety database? Just sort of some timeline updates would be helpful.

Ari Maisel: Yes, so I'll take the first question. Obviously, we're very pleased with how Sinozi has performed. It was a good quarter, and we saw a really nice uptake in terms of new patients started on treatment. And this is overall a smaller market opportunity relative to major depression. That said, we do look at the entire commercial mix of activities and investments. You know, everything from our marketing plans, our sales force effort, market access dynamics, as well as our marketing to consumers. And so all those things are levers that we're evaluating to try to support the brand growth, but we're really pleased with how it's performed since we acquired the product from Jess.

Speaker Change #104: Yeah. So I'll take the first question obviously, we're very pleased with how Sanofi has performed it was a good quarter and we saw a really nice uptake in terms of new patients started on treatment and this is overall a smaller market opportunity relative to our major depression.

Unknown Attendee: Yeah, so I'll take the first question. Obviously, we're very pleased with how Cenosia has performed. It was a good quarter, and we saw a really nice uptake in terms of new patients starting treatment. And this is overall a smaller market opportunity relative to major depression. That said, we do look at the entire commercial mix of activities and investments, everything from our marketing plans, our salesforce efforts, market access dynamics, as well as our marketing to consumers. And so all those things are levers that we're evaluating to try to support brand growth. But we're really pleased with how it's performed since we acquired the product from Jets.

Speaker Change #104: That said, we do look at the entire commercial mix of activities and investments you know everything from our marketing plans, our salesforce effort, our market access dynamics as well as our marketing to consumers and so all of those things are levers that were valued.

Speaker Change #104: <unk> to try to support the brand growth, but we're really pleased with how it's performed since we acquired the product from jazz.

Speaker Change #104: Sure.

Ari Maisel: Great, and it relates to X-12 and the next steps there. So the next steps are completion of the non-promote and legal safety extension trial. And then it is typical to meet with the FDA and have a pre-andee meeting, so we look to do that. Thank you.

Unknown Attendee: Great, and as it relates to XS12 and the next steps there, so the next steps are completion of the Long-Term Open Label Safety Extension Trial, and then it is typical to meet with the FDA and have a pre-emptive meeting, so we'd love to do that.

Speaker Change #104: Great and as it relates to.

Speaker Change #104: <unk> 12.

Speaker Change #105: And the next steps there. So next steps are completion of the long term open label safety extension trial and Thats and then it is typical to meet with the FDA and have a premium E meeting. So we look to do that.

Speaker Change #106: Thank you next question is coming from David home from Citigroup. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from David Hoang from Citigroup. Your line is now live.

David Hoang: Next question is coming from David Home from City Group. Your line is not live. Hi there. Good morning. Thanks for taking my questions. So I just wanted to ask about first or second line usage of X-105 in MDD. Have you seen any increase early line usage, you know, this quarter. And then also want to ask about X-105 versus Thorium Fatal in MDD. Obviously, you have a trial for Thorium Fatal now going on there. How do you think about these two products fitting into the MDD competitive landscape? Thank you. Yeah, thanks, David. So we have seen continued progress in terms of versus second line use.

Unknown Attendee: Hi there. Good morning. Thanks for taking my questions. So I just wanted to ask about first or second line usage of AXS05 in MDD. Have you seen any increased early line usage this quarter?

David home: Hi, there good morning, Thanks for taking my questions. So I just wanted to ask about.

Speaker Change #108: First or second line usage of excess sort of five and M. D. D have you seen any increase early line usage.

Unknown Attendee: And then I also want to ask about AXS05 versus Solarium Fetol in MDD. Obviously, you have a trial for Solarium Fetol going on there. How do you think about these two products fitting into the MDD competitive landscape? Thank you.

Speaker Change #109: And then also wanted to ask about access of five versus full ramp at all in M. D. D. Obviously, you have a trial for sole reemphasize now going on there how do you think about these two products fitting into the.

Speaker Change #110: Competitive landscape. Thank you.

Speaker Change #111: Yeah. Thanks, David So we have seen continued progress in terms of versus second line use it's roughly 50% of all utilization for all ability now is first or second line and then we've seen that.

Unknown Attendee: Yeah, thanks, David. So we have seen continued progress in terms of first and second line use; it's roughly 50% of all utilization for all validity now as first or second line. And we've seen that progress, you know, over the past year or so. So we're really pleased with the direction that's heading.

Ari Maisel: It's roughly 50% of all utilization for availability now is first or second line. And then we've seen that progress, you know, for the past year or so. So we're really pleased with the direction that it takes.

Speaker Change #111: That progress over the past year or so so we're really pleased with the direction of that tenant.

Ario Tabuto: And as it relates to the profile and MDD for X-105 or ability and Thorium Fatal, what we want to do is wait to see what the profile is the sorium called MDD. We're currently conducting that study. So once we see that profile, we'll know more. There are some things, though, that we can say right now, which is that if you look at patients who have MDD, a very large percentage of them also have access at the time sweetness. So remember, that is an education, which is currently approved for Thorium fatal. So there is a tremendous amount of overlap in terms of symptomatology between the MDD and EDS associated with OSA.

Unknown Attendee: And as it relates to the profile in MDD for XSO5, mobility, and solar EM for tall. What we want to do is wait to see what the profile is of solarium called MDD. We're currently conducting that study. So once we see that profile, we'll know more.

Speaker Change #111: And as it relates to.

Speaker Change #112: The profile and MTV for Oh, five or ability and sold me on for Paul What we want to do is wait to see what the profile of <unk>. We are currently conducting that study. So once we see that profile. We will know more there are some things though that that.

Unknown Attendee: There are some things, though, that we can't say right now, which is that if you look at patients who have MDD, a very large percentage of them also have excessive daytime sleep. So, remember, that is an indication that is currently approved for solar re-emphatol. So there is a tremendous amount of overlap in terms of symptomatology between the MED and EDS associated with OSA. So you can imagine that if solar re-emphatol were to be positive in major depressive disorder, that might be helpful for clinicians who are trying to treat a patient who is both depressed and also has excessively high sleep. So, this is a recurring theme if you look at our entire portfolio, the overlap in terms of symptomatology and disease states for the various products that we indicate.

Speaker Change #112: What I can say right now.

Speaker Change #112: Which is that if you look at <unk>.

Speaker Change #113: Patients who have MTBE.

Speaker Change #113: A very large percentage of them also have excessive daytime sleepiness. So remember that is an indication which is currently approved for soybeans. If at all so there is tremendous amount of overlap in terms of symptomatology between <unk> and eds associated with OSA.

Ario Tabuto: So if you can imagine that if the sorium were to be positive in major depression disorder, that might be helpful for clinicians who are trying to treat a patient who is both depressed and will also have access to these high sleep deaths. This is a recurring theme; if you look at our entire portfolio, the overlap in terms of symptomatology and the disease states, coronavariate products, and the indications.

Speaker Change #113: No.

Speaker Change #114: You can imagine that.

Speaker Change #115: So I mean proposal were to be positive in major depressive disorder that might be helpful. For clinicians who are trying to treat a.

Speaker Change #115: A patient who is both depressed and we also have successfully.

Speaker Change #115: So.

Speaker Change #116: This is a recurring theme if you look at our entire portfolio.

Speaker Change #117: Overlap in terms of symptomatology and disease states for various products and new indications.

Speaker Change #116: Yeah.

Speaker Change #116: Okay.

Unknown Attendee: Thank you. Next question today.

Speaker Change #116: Thank you next question today is coming from Greg <unk> from Mizuho Securities. Your line is now live.

Unknown Attendee: Thank you. The next question today is coming from Graig Suvannavejh from Missoula Security. Your line is now live.

Graig Suvannavejh: Can we move on to Graig Suvannajhs from Missouri Security. Your line is out live. Good morning. Thanks so much, and congrats on the quarter. Just a clarification just around your big phase three data readouts, focus, and also, you know, you were advanced two studies. I know the guidance is a second half of this year. Any comments on when or if you plan on providing more refined guidance around those timelines, and then just a follow-up question, commercial question, just on a Velities performance in the second quarter? Congrats there. But any comments on stocking, destocking in the quarter that might have impacted the performance.

Unknown Attendee: Good morning. Thanks so much. And congrats on the quarter. Just a clarification around your big phase three data readouts focus and also, you know, your advanced two studies. I know the guidance is for the second half of this year. Any comment on when or if you plan on providing more refined guidance around those timelines?

Greg: Good morning, Thanks, so much and congrats on the quarter I just a clarification just around your big Phase III data Readouts are focus and also.

Greg: You are advanced two studies I know the guidance in the second half of this year any comment on when or if you plan on providing more refined guidance around those timelines and then just a follow up question. A commercial question just on a validate its performance in the second quarter Congrats.

Speaker Change #118: There, but any.

Speaker Change #119: Any comment on stocking.

Speaker Change #120: Stocking destocking in the quarter that might have impacted the performance. Thanks.

Nick Peasy: Thanks. Yeah, is it related to the first question in terms of providing more granularity as it relates to global trial readouts. So we said the second half of what these studies were very comfortable with that, and we definitely will consider providing additional guidance.

Unknown Attendee: Yeah, as it relates to the first question, in terms of providing more granularity. As it relates to clinical trial readouts, so we've set the second half for these studies.

Speaker Change #121: Yeah it.

Speaker Change #122: As it relates to the first question in terms of providing.

Speaker Change #122: More granularity.

Speaker Change #122: As it relates to our corporate trial Readouts. So we've set the second half when these studies were very comfortable with that and we definitely will consider.

Unknown Attendee: We're very comfortable with that, and we definitely will consider providing additional guidance. Typically, you know, we do that around the time that we announce our quarterly results. So stay tuned. Yeah, it's great.

Speaker Change #122: Riding additional guidance typically we do that around the time that we announced.

Nick Peasy: Typically, you know, we do that around the time that we announce our quarterly results, so stay tuned. Yeah, Greg, Nick, as it relates to stocking or destocking, there was no impact specifically around stocking or destocking in channel remaining at two weeks, as we have pretty much since launched for availability. Thank you.

Speaker Change #122: Quarterly results so stay tuned.

Unknown Attendee: Yeah, hey Craig, it's Nick. As it relates to stocking or destocking, there was no impact specifically around stocking or destocking in the channel. We remain at two weeks, as we have pretty much since launch for availability.

Speaker Change #122: Hey, Craig it's Nick as it relates to stocking or Destocking, there was no impact specifically around stocking or Destocking in China will remain at two weeks as we as we have pretty much since launch for <unk>.

Speaker Change #122: Yeah.

Unknown Attendee: Thank you. The next question today is coming from Ash Verma from UBS. Your line is now live.

Speaker Change #122: Thank you next question today is coming from Ash Verma from UBS. Your line is now live.

Ash Burma: Next question today is coming from Ash Burma from UBS. Your line is now live. Thanks. Thanks for taking our questions.

Ash Verma: Hi, Thanks, Thanks for taking our questions I had two questions on agitation. So I'm trying to figure. It out then you can file there's so few definitely need the OLED to file what does that mean that you also need events to the company for us because the Orleans joining patient from acquired one in advance too.

Unknown Attendee: Thanks for taking our questions. I had questions on area agitation.

Ario Tabuto: I had the questions on area agitation, so I'm trying to figure out when you can file this. So if you definitely need the OLE to file, what does that mean that you also need advanced to complete course because the OLE is drawing in patients from a called one and advanced two. And they're not advanced to, are there any specific hurdles that you're facing in terms of getting or excel deny patients. Thanks. Sure. So, with regards to the timing for advanced doing in the open label, so the extension trial. So, so you, you, you are correct that there is a relationship because the open label.

Unknown Attendee: So I'm trying to figure out when you can file this. So if you definitely need the OLE to file, wouldn't that mean that you also need Advance 2 to complete first because the OLE is drawing in patients from Accord 1 and Advance 2? And then on Advance 2, are there any specific hurdles that you're facing in terms of getting RIC-SALT into IE patients? Thanks.

Speaker Change #124: And then on advanced two are there any specific hurdles that you are facing in terms of getting <unk> naive patients.

Speaker Change #124: <unk>.

Speaker Change #124: Sure.

Speaker Change #125: So with regards to the timing for advanced doing in the open label safety extension trial.

Unknown Attendee: So, with regard to the timing of Advanced 2 in the Open Label Safety Extension Trial. You are correct that there is a relationship because the Open Label Safety Extension Trial is enrolling patients who are coming out of the ADVANCE II trial. However, the guiding factor for the Open Label Safety Extension Trial is the number of patients who are exposed. So we need 300 patients who have been treated with XSO5 in this patient population for six months, and 100 who have been treated for one year.

Speaker Change #125: So.

Speaker Change #126: So you you are correct that there is a relationship because the open label safety extension trial is enrolling patients who are coming out of the bounds to trial. However, the guiding factor for.

Ario Tabuto: So safety extension trial is enrollment patients who are coming out of the advanced to trial. However, the guiding factor for the open label safety extension trial is the number of patients who are exposed. So, so we need 300 patients who have been treated with the excess on five in the space of population for six months and a hundred who have been treated for one year. So we are very much on track to hit those numbers. And, and so that was on track for potentially completing not only the advanced to trial and the accord to trial.

Speaker Change #126: The open label safety extension trial is the number of patients who are exposed. So so we need 300 patients who've been treated.

Speaker Change #126: With our emphasis on five and the speaking population for six months and 100, who have been treated for one year. So we are very much on track to hit those numbers.

Unknown Attendee: So we are very much on track to hit those numbers. And so that puts us on track for potentially completing not only the Advance 2 trial and the Accord 2 trial but also the Open Label Safety Extension trial, all in the second half of this year, and then that will put us on the glide path toward submitting an NDA or SMP filing.

Speaker Change #126: And so that put us on track for.

Speaker Change #126: Essentially completing not only the advanced through trial and error.

The accord two trial, but also the open label safety extension trial all in the second half of this year and then that will put us on the glide path towards submitting.

Ario Tabuto: But also the open label safety extension file, all in the second half of this year.

Ario Tabuto: And then that will put us on the live path towards submitting an NDA or SMD filing. Thank you.

Speaker Change #126: In EMEA worsened E filing.

Speaker Change #127: Thank you next question is coming from Myles Minter from William Blair. Your line is now live.

Unknown Attendee: Thank you. The next question is coming from Myles Minter on behalf of William Blair. Your line is now live.

Myles Minter: Next question is coming from Myles Minter from William Blair; your line is now live. Hey, thanks for taking the question. Just on the accord to read out, I know that that trial has the opportunity for patients to have up to 26 weeks of treatment post-randomization, and you got into the second half of the year for top one data. You know, wondering why that guidance is there, like you've seen on a blinded basis similar to what you saw in a court one, which was the majority of relapse events are happening by 12 weeks. And that's what's giving you the confidence you can read it out as early as the second half here, rather than, you know, pushing year-end if you do require that full 26 weeks of treatment for these patients.

Unknown Attendee: Hey, thanks for taking the question. Just on the Accord 2 readout, I know that that trial has the opportunity for patients to have up to 26 weeks of treatment post-randomization, and you got into the second half of the year here for top-line data. You know, wondering why that guidance is there, like are you seeing on a blinded basis similar to what you saw in Accord 1, which was that the majority of relapse events are happening by 12 weeks, and that's what's giving you the confidence. You can read it out as early as the second half here rather than, you know, pushing year-end if you do require that full 26 weeks of treatment for these.

Myles Minter: Oh, Hey, thanks for taking the question just on the a code to write out I know that that trial.

Speaker Change #129: The opportunity for patients to have up to 26 weeks of treatment post randomization and you got into the second half of the year here for top line data.

Speaker Change #130: You know what.

Speaker Change #131: Wondering why that guidance is there like he's saying on a blinded basis similar to what you saw in a cold one which was.

Speaker Change #132: The majority of relapsed events are happening by 12 weeks and that's what's giving you the confidence you can ride it out as early as the second half here rather than pushing here and if you do require that full 26 waits a fragrance for these patients.

Ario Tabuto: Thanks. So the way that the study is designed, so once the patients have been randomized, then they're treated for their treated eye until two things occur. Either one may relapse, or two that are treated for six months. So given the timing of completion of randomization of tard randomization, then it just flows that the study should be able to read out in the second half of the year.

Uh huh.

Speaker Change #132: So the.

Unknown Attendee: So the way that the study is designed, so once patients have been randomized, then they're treated for six months. Either one, they relapse, or two, they've been treated for six months. So, given the timing of the completion of randomization, of target randomization, then it just flows that the study should be able to read out in the second half of the year. Thank you. The next question today is coming from Matt Kaplan from Landenburg-Baumann. Your line is now live.

Speaker Change #132: The way that the study is designed some once patients have been.

Speaker Change #132: Randomize then they are treated.

Speaker Change #132: Warren.

Speaker Change #132: They're treated.

Speaker Change #132: Until two things occur either one they relapse or two they've been treated for six months.

Speaker Change #132: So given the timing of completion of.

Speaker Change #132: Randomization of target Randomization then.

Speaker Change #132: It just flows that are.

You should be able to read out in the second half of the year.

Unknown Attendee: Thank you.

Speaker Change #132: Thank you next question today is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.

Unknown Attendee: Thank you. The next question today is coming from Matt Kaplan from Lattinburg-Culmin. Your line is now live.

Matthew Kaplan: Next question today is coming from Matt Kaplan from Latin Berkthalman. Your line is now live. Hi. Good morning, guys. We're at the court of the results. Just with the near-term filing for AXS-14, can you give us a little bit more sense in terms of the opportunity there in five of an hour? And how are you thinking about it? Yeah. Thanks for the question, Matt.

Matt Kaplan: Hi, good morning, guys.

Matt Kaplan: That's on the quarterly results just with the near term filing a free access 14 can.

Matt Kaplan: Can you give us a little bit more sense in terms of the opportunity there in fibromyalgia and how youre thinking about it.

Matt Kaplan: Yes.

Unknown Attendee: Thanks for the question, Matt. So I'll just give maybe just some epidemiological data, and then I'll turn it over to Ari to talk about the opportunity. The best and highest quality epidemiological studies that have been conducted in the U.S. show that the prevalence of fibromyalgia is 6.4% of U.S. adults. So if you do the math, that equates to a very large patient population, about 17 million in

Speaker Change #134: Thanks for the question, Matt So I'll just keep maybe just some epidemiological data and then I'll turn it over to Oregon to talk about the opportunity.

Nick Peasy: I'll just give maybe just some epidemiological data, and then I'll turn over to Ari and talk about the opportunity. The best, you know, the highest quality of epidemiological studies that have been conducted in the U.S. show that the prevalence is a five or myology 6.4% of U.S. adults. So if you do the math, that equates the very large patient population of about 17 million. Yeah. We're really excited about AXS-14. As you may know, there are only three treatments that are approved in fibromyalgia, and there have been no new treatments in the last 15 years.

Matt Kaplan:

The.

Oregon: The best highest quality epidemiological studies that have been conducted in the U S showed up a private lines is a fibromyalgia is six 4% of U S. Adults. So if you do the math that equates to a very large patient population about 17 million.

Unknown Attendee: Yeah, we're really excited about AXS14. As you may know, there are only three treatments that are approved for fibromyalgia, and there have been no new treatments in the last 15 years. So we believe that AXS14 has the real potential to become a new standard of care based on its robust clinical profile, and we're looking forward to bringing it to market sometime in the future.

Speaker Change #136: Yeah, we're really excited about <unk> 14.

Speaker Change #137: As you May know there are only three treatments that are approved in fibromyalgia and there have been no new treatments in the last 15 years.

Ari Maisel: So we believe that AXS-14 has a real potential to become a new standard of care based on the robust clinical profile, and we're looking forward to bringing it to market sometime in the future. Thank you.

Speaker Change #138: So we believe that <unk> has a real potential to become.

Speaker Change #138: A new standard of care based on the robust clinical profile.

Speaker Change #138: Looking forward to bringing it to market sometime in the future.

Thank you we reached end of our question and answer session I'd like to turn the floor back over to management for any further closing comments.

Unknown Attendee: Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to management for any further closing comments.

Darren Opland: We reached out to our question-and-answer session.

Ario Tabuto: I'd like to turn the floor back over to management for any further closing comments. Thank you for taking the time to join us for today's quarterly update. We delivered another robust quarter during by focused commercial execution and continued pipeline advancement. In the second half of the year, we expect similar progress, including top line results, from the Phase III Advanced II and Phase III Accord to Trials of AXS-05 and AED agitation, and the Phase III Vokus trial of AXS of solarium at all in AED.

Speaker Change #138: Sure.

Speaker Change #139: Thank you for taking the time to join us for todays quarterly update we delivered another robust quarter driven by focused commercial execution and continued pipeline advancement.

Unknown Attendee: Thank you for taking the time to join us for today's quarterly update. We delivered another robust quarter driven by focused commercial execution and continued pipeline advancement. In the second half of the year, we expect similar progress, including top-line results from the Phase 3 Advanced II and Phase 3 Accord II trials of XSO5 in AD agitation and the Phase 3 Focus trial of XSO5 in ADHD. All told, we expect to make substantial progress across our unparalleled CNS portfolio this year, and we look forward to continuing to deliver innovation and value to patients, healthcare professionals, and investors alike. Thank you, and have a great rest of your day.

Speaker Change #140: In the second half of the year, we expect similar progress, including top line results from the phase III advance to phase III trials are in excess of five and EDI agitation in the phase III <unk> trial. It makes us a story of a tall in each D.

Ario Tabuto: R&D. All told, we expect to make substantial progress across our room parallel CNS portfolio this year, and we look forward to continuing to deliver innovation in value to patients, healthcare professionals, and investors alike.

Speaker Change #140: All told we expect to make substantial progress across our group paralleled CNS portfolio. This year and we look forward to continuing to deliver innovation and value to patients health care professionals and investors alike.

Unknown Attendee: Thank you, and have a great rest of your day.

Speaker Change #141: We have a great rest of your day.

Unknown Attendee: Thank you. That does include today's teleconference webcast.

Speaker Change #142: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.

Operator: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Unknown Attendee: You would just connect your line at this time and have a wonderful day. We thank you for your participation.