Q1 2026 Axsome Therapeutics Inc Earnings Call

May 4, 2026

Operator: Good morning. Welcome to the Axsome Therapeutics Q1 2026 Earnings Conference Call. My name is Kevin, I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, there'll be a question-and-answer session. Instructions will be given at that time. Please note, this call is being recorded. I will now turn the call over to Ashley Gong, Senior Director of Investor Relations. Ashley, please go ahead.

Speaker #2: At this time, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. Please note this call is being recorded.

Speaker #2: I will now turn the call over to Ashley Dong, Senior Director of Investor Relations. Ashley, please go ahead.

Speaker #3: Thank you. Good morning, and thank you for joining Axsome's first quarter 2026 earnings conference call. With us today are Dr. Herriot Tabuteau, our Chief Executive Officer; Nick Pizzie, our Chief Financial Officer; and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks.

Ashley Gong: Thank you. Good morning, and thank you for joining Axsome's first quarter 2026 earnings conference call. With us today are Dr. Herriot Tabuteau, our Chief Executive Officer, Nick Pizzie, our Chief Financial Officer, and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, our General Counsel, will also be available for Q&A. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to defer materially. Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks.

Speaker #3: Mark Jacobson, our Chief Operating Officer, and Hunter Murdoch, our General Counsel, will also be available for Q&A. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities.

Speaker #3: These statements are based on current expectations and assumptions, and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for descriptions of these and other risks.

Speaker #3: You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements.

Ashley Gong: You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. With that, I'll hand it over to Herriot Tabuteau.

Speaker #3: And with that, I'll hand it over to Ari.

Speaker #2: Thank you, Ashley, and good morning, everyone. In the first quarter of 2026, Axsome delivered strong year-over-year growth and execution across the business. This performance was driven by our commercial products and the advancement and expansion of our R&D pipeline, which is now composed of six innovative, potentially first-in-class or best-in-class product candidates.

Herriot Tabuteau: Thank you, Ashley, and good morning, everyone. In Q1 2026, Axsome delivered strong year-over-year growth and execution across the business. This performance was driven by our commercial products and the advancement and expansion of our R&D pipeline, which is now composed of six innovative, potentially first-in-class or best-in-class product candidates. Starting with our commercial business, total revenue for our three marketed products was $191 billion, representing year-over-year growth of 57%, driven by Auvelity and Sunosi with contribution from Symbravo. Building on the strong clinical profile of our marketed products, in the quarter, we substantially expanded the sales force for Auvelity, finalized plans for the expansion of the Symbravo sales force, and increased covered lives and quality of coverage for all of our marketed products. These initiatives will support continued strong revenue growth of the base business this year and beyond.

Speaker #2: Starting with our commercial business, total revenue for our three marketed products was $191 billion. Representing year-over-year growth of 57%, driven by fidelity and synopsy with contribution from Simbravo.

Speaker #2: Building on the strong clinical profile of our marketed products, in the quarter we substantially expanded the sales force for Fidelity. We finalized plans for the expansion of the Simbravo sales force and increased covered lives and quality of coverage for all of our marketed products.

Speaker #2: These initiatives will support continued strong revenue growth of the base business this year and beyond. Last week, we received FDA approval of Fidelity for the treatment of agitation associated with Alzheimer's disease.

Herriot Tabuteau: Last week, we received FDA approval of Auvelity for the treatment of agitation associated with Alzheimer's disease, an indication which received FDA breakthrough therapy designation and priority review. This approval introduces a first-in-class treatment option for this highly prevalent, debilitating, and critically underserved neuropsychiatric condition. As such, it marks an important milestone for the millions of patients living with Alzheimer's disease, their families, and their caregivers. Auvelity has now been approved in two indications that received FDA breakthrough therapy designation and were granted FDA priority review. The approval in Alzheimer's disease agitation, combined with the health of the MDD business and the recent augmentation of the Auvelity commercial infrastructure, provide us with a clear line of sight to Auvelity's market potential. Ari will provide an update to our peak sales estimate for the Auvelity franchise based on these developments.

Speaker #2: An indication which received FDA Breakthrough Therapy designation and Priority Review. This approval introduces a first-in-class treatment option for this highly prevalent, debilitating, and critically underserved neuropsychiatric condition.

Speaker #2: As such, it marks an important milestone for the millions of patients living with Alzheimer's disease, their families, and their caregivers. Fidelity has now been approved in two indications that received FDA breakthrough therapy designation.

Speaker #2: And were granted FDA priority review. The approval in Alzheimer's disease agitation, combined with the health of the MDD business and the recent augmentation of the Fidelity commercial infrastructure, provide us with a clear line of sight to Fidelity's market potential.

Speaker #2: Ari will provide an update to our peak sales estimate for the fidelity franchise based on these developments. The approval in Alzheimer's disease agitation is a testament to our research and development productivity.

Herriot Tabuteau: The approval in Alzheimer's disease agitation is a testament to our research and development productivity. Since the start of this year, we have continued to advance and expand the rest of our industry-leading pipeline with a focus on developing first-in-class and best-in-class products. On the regulatory front, following the FDA approval of Auvelity last week, we are pleased to share that we have submitted our NDA for AXS-12 for the treatment of cataplexy and narcolepsy. Clinically, our ongoing trials continue to progress, and we will be starting multiple Phase 3 trials within the next few months. Finally, we recently expanded our pipeline further with the addition of AXS-20, a potentially first-in-class pre-Phase 3 PDE10A inhibitor for schizophrenia and Tourette syndrome. I will discuss each of these developments in detail later in the call.

Speaker #2: Since the start of this year, we have continued to advance and expand the rest of our industry-leading pipeline, with a focus on developing first-in-class and best-in-class products.

Speaker #2: On the regulatory front, following the FDA approval of Fidelity last week, we are pleased to share that we have submitted our NDA for AXS-12 for the treatment of cataplexy and narcolepsy.

Speaker #2: Clinically, our ongoing trials continue to progress, and we will be starting multiple Phase 3 trials within the next few months. Finally, we recently expanded our pipeline further with the addition of AXS-20.

Speaker #2: A potentially first-in-class, pre–Phase 3 PDE10A inhibitor for schizophrenia and Tourette syndrome. I will discuss each of these developments in detail later in the call.

Speaker #2: All in all, Axsome is advancing the commercialization of three differentiated, marketed medicines across four highly prevalent indications, as well as an innovative pipeline of potentially first-in-class and best-in-class medicines that includes six product candidates targeting 10 different highly burdensome conditions in psychiatry and neurology.

Herriot Tabuteau: All in all, Axsome is advancing the commercialization of three differentiated marketed medicines across four highly prevalent indications, as well as an innovative pipeline of potentially first-in-class and best-in-class medicines that includes six product candidates targeting ten different highly burdensome conditions in psychiatry and neurology. Looking ahead, Axsome is well-positioned to realize robust growth driven by execution across our commercial portfolio, the long-term availability in Alzheimer's disease agitation, and the advancement of the rest of our neuroscience pipeline. With that, I'll hand the call over to Nick to review our financial results for the quarter.

Speaker #2: Looking ahead, Axsome is well positioned to realize robust growth driven by execution across our commercial portfolio, the launch of Fidelity in Alzheimer's disease agitation, and the advancement of the rest of our neuroscience pipeline.

Speaker #2: With that, I'll hand the call over to Nick to review our financial results for the quarter.

Speaker #4: Thanks, Ario. And good morning, everyone. Our financial performance in the first quarter was strong, with our three commercial products delivering continued double-digit revenue growth.

Nick Pizzie: Thanks, Herriot Tabuteau, good morning, everyone. Our financial performance in Q1 was strong, with our three commercial products delivering continued double-digit revenue growth. Total revenue for Q1 was $191.2 million, a 57% increase compared to Q1 2025. We expect revenue growth to continue in 2026. Auvelity achieved net product revenue of $153.2 million in Q1, up 59% compared to Q1 2025. Sunosi net product revenue for Q1 was $33.9 million, a 34% increase compared to Q1 2025. Sunosi revenue consisted of $32.6 million in net product sales and $1.3 million in royalty revenue associated with Sunosi sales in out licensed territories.

Speaker #4: Total revenue for the quarter was $191.2 million, a 57% increase compared to the first quarter of '25. We expect revenue growth to continue in 2026.

Speaker #4: Fidelity achieved net product revenue of $153.2 million in the quarter, up 59% compared to the first quarter of 2025. Synopsy net product revenue for the quarter was $33.9 million, a 34% increase compared to the first quarter of 2025.

Speaker #4: Synopsy revenue consisted of $32.6 million in net product sales, and $1.3 million in royalty revenue associated with Synopsy sales in out-licensed territories. Net sales for Simbravo were $4.1 million in the quarter.

Nick Pizzie: Net sales for Symbravo were $4.1 million in the quarter. Auvelity and Sunosi gross and net discounts for Q1 2026 were both in the low to mid-50s range. We anticipate the gross and net discounts for both products to improve throughout the year, consistent with prior year trends. Symbravo gross and net discount for the quarter was in the high 70% range. We continue to expect it to remain elevated over the near term as access continues to evolve and awareness continues to build. Turning now to expenses. Total cost of revenue were $14.7 million compared to $9.8 million for Q1 2025. Our research and development expenses were $52.7 million in the quarter, compared to $44.8 million for Q1 2025.

Speaker #4: Fidelity and Synopsy gross-to-net discounts for the first quarter of 2026 were both in the low- to mid-50s range. We anticipate the gross-to-net discounts for both products to improve throughout the year, consistent with prior year trends.

Speaker #4: Simbrava gross-to-net discount for the quarter was in the high 70% range, and we continue to expect it to remain elevated over the near term as Axsome continues to evolve and awareness continues to build.

Speaker #4: Turning now to expenses, total cost of revenue was $14.7 million, compared to $9.8 million for the first quarter of 2025. Our research and development expenses were $52.7 million in the quarter, compared to $44.8 million for the first quarter of 2025.

Speaker #4: The increase in R&D spend primarily reflects a one-time acquisition-related expense booked in the quarter. Our selling, general, and administrative expenses were $185 million for the quarter, compared to $120.8 million for the first quarter of 2025.

Nick Pizzie: The increase in R&D spend primarily reflects a one-time acquisition-related expense booked in the quarter. Our selling, general and administrative expenses were $185 million for the quarter, compared to $120.8 million for Q1 2025. The increase was primarily driven by the acceleration of pre-launch activities for Auvelity in Alzheimer's disease agitation and commercialization activities for Auvelity, which included the national direct-to-consumer advertising campaign and sales force expansion, along with commercial activities for Symbravo. Net loss for the quarter was $64.5 million or $1.26 per share, compared to a net loss of $59.4 million or $1.22 per share for Q1 2025.

Speaker #4: The increase was primarily driven by the acceleration of pre-launch activities for Fidelity in Alzheimer's disease agitation, and commercialization activities for Fidelity, which included the national direct-to-consumer advertising campaign and Salesforce expansion, along with commercial activities for Simbravo.

Speaker #4: Net loss for the quarter was $64.5 million, or $1.26 per share, compared to a net loss of $59.4 million, or $1.22 per share, for the first quarter of 2025.

Speaker #4: The $64.5 million net loss in the quarter includes $23.4 million in stock-based compensation expense. Our balance sheet remained strong. We ended the first quarter with $305 million in cash and cash equivalents, compared to $323 million as of the end of last year.

Nick Pizzie: The $64.5 million net loss in the quarter includes $23.4 million in stock-based compensation expense. Our balance sheet remained strong. We ended Q1 with $305 million in cash and cash equivalents, compared to $323 million as of the end of last year. Our overall financial performance reflects continued top-line revenue growth and improving operating leverage driven by disciplined commercial execution. We anticipate that our current cash balance is sufficient to fund our operations into cash flow positivity based on our current operating plan. With that, I'd like to turn the call over now to Ari, who will provide additional details on the key drivers behind our medicines and the broader commercial performance of the business.

Speaker #4: Our overall financial performance reflects continued top-line revenue growth and improving operating leverage, driven by disciplined commercial execution. We anticipate that our current cash balance is sufficient to fund our operations into cash flow positivity based on our current operating plan.

Speaker #4: And with that, I'd like to turn the call over now to Ari, who will provide additional details on the key drivers behind our medicines and the broader commercial performance of the business.

Speaker #2: Thank you, Nick. The first quarter of 2026 was a pivotal period for Axsome’s brand, reflected in ongoing demand for our medicines, meaningful improvements in payer coverage, and Salesforce expansion activities.

Ari Maizel: Thank you, Nick. The first quarter of 2026 was a pivotal period for Axsome's brands, reflected in ongoing demand for our medicines, meaningful improvements in payer coverage, and sales force expansion activities. Our promotional efforts across HCP and patient audiences, combined with a broadening commercial infrastructure, will support Axsome sales objectives throughout 2026. Starting with Auvelity, more than 223,000 prescriptions were written in the quarter, representing 35% year-over-year growth and remaining consistent with the prior quarter. By comparison, the antidepressant market grew 1% year-over-year and declined by 1% compared to Q4 2025. Auvelity performance in the quarter was highlighted by a continued shift toward earlier line use, with first line, first switch prescriptions increasing to 56% of overall demand. Primary care adoption also expanded in the quarter, now representing 35% of total Auvelity prescribers.

Speaker #2: Our promotional efforts across HCP and patient audiences, combined with a broadening commercial infrastructure, will support Axsome's sales objectives throughout 2026. Starting with Fidelity, more than 223,000 prescriptions were written in the quarter, representing 35% year-over-year growth and remaining consistent with the prior quarter.

Speaker #2: By comparison, the antidepressant market grew 1% year-over-year and declined by 1% compared to Q4 2025. Fidelity performance in the quarter was highlighted by a continued shift toward earlier-line use.

Speaker #2: With first-line, first-switch prescriptions increasing to 56% of overall demand, primary care adoption also expanded in the quarter, now representing 35% of total fidelity prescribers.

Speaker #2: These trends reflect meaningful improvements in market access over the last two years, broadened awareness of the brand driven by our national direct-to-consumer campaign, and our concentrated effort in expanding use among primary care providers, a key driver of earlier-line utilization and an important foundation to support early trial in connection with the upcoming Alzheimer's disease agitation launch.

Ari Maizel: These trends reflect meaningful improvements in market access over the last 2 years, broadened awareness of the brand driven by our national direct-to-consumer campaign and our concentrated effort in expanding use among primary care providers, a key driver of earlier line utilization and an important foundation to support early trial in connection with the upcoming Alzheimer's disease agitation launch. More than 5,500 new prescribers were activated in the quarter, bringing the total number of unique prescribers for Auvelity since launch to approximately 60,000. We continue to make important progress with formulary access for Auvelity. Commercial coverage is at 78% and alongside Medicare and Medicaid coverage at 100%, total coverage is now at 86% of all lives across channels, establishing a strong foundation of access for Auvelity in advance of the launch in Alzheimer's disease agitation.

Speaker #2: Additionally, more than 5,500 new prescribers were activated in the quarter, bringing the total number of unique prescribers for Fidelity since launch to approximately 60,000.

Speaker #2: We continue to make important progress with formulary access for Fidelity. Commercial coverage is at 78%, and alongside Medicare and Medicaid coverage at 100%, total coverage is now at 86% of all lives across channels, establishing a strong foundation of access for Fidelity in advance of the launch in Alzheimer's disease agitation.

Speaker #2: We expect both the quantity and quality of coverage to continue to expand and improve. Fidelity’s growth to date in the depression market continues to reflect its compelling clinical profile, highlighted by rapid and durable symptom improvement and a distinctly favorable safety and tolerability profile.

Ari Maizel: We expect both the quantity and quality of coverage to continue to expand and improve. Auvelity's growth to date in the depression market continues to reflect its compelling clinical profile, highlighted by rapid and durable symptom improvement and a distinctly favorable safety and tolerability profile. Last week's FDA approval of Auvelity as a treatment for agitation associated with dementia due to Alzheimer's disease is a significant advancement for patients and a major milestone for the brand. We are very pleased with the product label, which provides compelling clinical information regarding Auvelity's impact on agitation for Alzheimer's patients. Auvelity is a first-in-class treatment for this patient population, demonstrating rapid and durable symptom improvement with a favorable safety and tolerability profile. Auvelity is the only approved treatment for Alzheimer's disease agitation with efficacy on symptom relapse demonstrated in long-term trials.

Speaker #2: Last week's FDA approval of Fidelity as a treatment for agitation associated with dementia due to Alzheimer's disease is a significant advancement for patients and a major milestone for the brand.

Speaker #2: We are very pleased with the product label, which provides compelling clinical information regarding Fidelity's impact on agitation for Alzheimer's patients. Fidelity is a first-in-class treatment for this patient population, demonstrating rapid and durable symptom improvement with a favorable safety and tolerability profile.

Speaker #2: Fidelity is the only approved treatment for Alzheimer's disease agitation, with efficacy on symptom relapse demonstrated in long-term trials. In a short-term study, the most common adverse reactions were dizziness and dyspepsia, and only 1.3% of patients discontinued treatment due to an adverse reaction—the same rate as placebo.

Ari Maizel: In a short-term study, the most common adverse reactions were dizziness and dyspepsia. Only 1.3% of patients discontinued treatment due to an adverse reaction, the same rate as placebo. In market research, HCPs rate Auvelity's clinical profile in Alzheimer's disease agitation as highly compelling from both an efficacy and safety perspective, with clear potential for first-line use in appropriate patients. We are expanding the Auvelity sales team to approximately 630 representatives, enabling Axsome to reach 68,000 HCP targets across primary care, psychiatry, neurology, and geriatric specialists who treat both MDD and Alzheimer's agitation patients across community and long-term care settings. Our expansion efforts are substantially complete, positioning us well for the commercial launch in June.

Speaker #2: In market research, HCPs' rate of Fidelity's clinical profile in Alzheimer's disease agitation is highly compelling from both an efficacy and safety perspective, with clear potential for first-line use in appropriate patients.

Speaker #2: We are expanding the Fidelity sales team to approximately 630 representatives, enabling Axsome to reach 68,000 HCP targets across primary care, psychiatry, neurology, and geriatric specialists who treat both MDD and Alzheimer's agitation patients, across community and long-term care settings.

Speaker #2: Our expansion efforts are substantially complete, positioning us well for the commercial launch in June. We believe Fidelity has the potential to play a significant role in the treatment of Alzheimer's agitation, and together with the MDD indication, further broadens its use across serious neuropsychiatric conditions.

Ari Maizel: We believe Auvelity has the potential to play a significant role in the treatment of Alzheimer's agitation, and together with the MDD indication, further broadens its use across serious neuropsychiatric conditions. Auvelity's expanded sales force and strong foundation of coverage position the brand to drive growth across both indications throughout H2 2026. Taking into account the recent label expansion in Alzheimer's disease agitation, the clinical profile in this indication, the health and trajectory of the MDD business, and recent investments in our sales infrastructure, we are now able to update our peak sales outlook for the product. We now believe Auvelity has the potential to generate at least $8 billion in annual revenue at peak, with approximately equal contribution from each indication.

Speaker #2: Fidelity's expanded sales force and strong foundation of coverage position the brand to drive growth across both indications throughout the second half of 2026. Taking into account the recent label expansion in Alzheimer's disease agitation, the clinical profile in this indication, the health and trajectory of the MDD business, and recent investments in our sales infrastructure, we are now able to update our peak sales outlook for the product.

Speaker #2: We now believe Fidelity has the potential to generate at least $8 billion in annual revenue at peak, with approximately equal contribution from each indication.

Speaker #2: Over the extended life of the product, we see a clear path to achieving this growth potential, supported by the underlying fundamentals of the business as we continue to scale.

Ari Maizel: Over the extended life of the product, we see a clear path to achieving this growth potential, supported by the underlying fundamentals of the business as we continue to scale. Turning now to Symbravo. More than 17,000 total prescriptions were written in the quarter, representing 36% growth versus Q4 2025. More than 5,000 new patients started Symbravo treatment in the quarter. Neurology specialists accounted for approximately 60% of total writers in the quarter, with primary care representing approximately 32%, an increase from 20% in the Q1 of launch. While headache specialists will remain a critical prescriber segment for Symbravo, the increase in primary care prescribing is an encouraging signal of Symbravo's potential and reinforces the early experience with Symbravo as a safe and tolerable acute migraine treatment that provides fast migraine pain improvement sustained through 24 and 48 hours.

Speaker #2: Turning now to Simbravo, more than 17,000 total prescriptions were written in the quarter, representing 36% growth versus Q4 2025. More than 5,000 new patients started Simbravo treatment in the quarter. Neurology specialists accounted for approximately 60% of total writers in the quarter, with primary care representing approximately 32%, an increase from 20% in the first quarter of launch.

Speaker #2: While headache specialists will remain a critical prescriber segment for Simbravo, the increase in primary care prescribing is an encouraging signal of Simbravo's potential and reinforces the early experience with Simbravo as a safe and tolerable acute migraine treatment that provides fast migraine pain improvement, sustained through 24 and 48 hours.

Speaker #2: Based on Simbravo's growth within its launch year and increasing demand for education for the only branded multi-mechanistic acute migraine treatment in the market, we are increasing the Simbravo sales team by approximately 50 representatives.

Ari Maizel: Based on Symbravo's growth within its launch year and increasing demand for education of the only branded multi-mechanistic acute migraine treatment in the market, we are increasing the Symbravo sales team by approximately 50 representatives. Our expanded Symbravo sales force of 150 representatives will support broader reach in the primary care market while deepening engagement with headache specialists and neurologists throughout the country. We are also pleased to announce a major commercial payer contract for Symbravo effective this month, securing coverage for approximately 17 million lives. The agreement reflects Symbravo's compelling clinical profile and its potential to address the needs of patients with inadequate response to triptans. Overall payer coverage for Symbravo is approximately 57%, representing 56% in the commercial channel and 57% in government channels. We expect coverage for Symbravo to expand and evolve throughout 2026.

Speaker #2: Our expanded Simbravo sales force of 150 representatives will support broader reach in the primary care market, while deepening engagement with headache specialists and neurologists throughout the country.

Speaker #2: We are also pleased to announce a major commercial payer contract for Simbravo effective this month, securing coverage for approximately 17 million lives. The agreement reflects Simbravo's compelling clinical profile and its potential to address the needs of patients with inadequate response to triptans.

Speaker #2: Overall payer coverage for Simbravo is approximately 57%, representing 56% in the commercial channel and 57% in government channels. We expect coverage for Simbravo to expand and evolve throughout 2026.

Speaker #2: And finally, in Q1, approximately 54,000 Sinozi prescriptions were written, representing 16% year-over-year growth and a 3% decline sequentially. By comparison, the weight-promoting agent market grew 1% year-over-year and declined by 5% versus Q4 2025.

Ari Maizel: Finally, in Q1, approximately 54,000 Sunosi prescriptions were written, representing 16% year-over-year growth and a 3% decline sequentially. By comparison, the wake-promoting agent market grew 1% year-over-year and declined by 5% versus Q4 2025. Nearly 500 new clinicians prescribed Sunosi in the quarter, bringing the total cumulative prescriber base to more than 16,500 since launch. Payer coverage for Sunosi remains steady at approximately 83% of lives covered across channels. Overall, Q1 2026 was marked by significant progress across Axsome's commercial business, including strong demand for our products, key advancements in market access, launch preparations for Auvelity in Alzheimer's disease agitation, and disciplined organizational growth designed to maximize the potential of our singular CNS portfolio.

Speaker #2: Nearly 500 new clinicians prescribed Sinozi in the quarter, bringing the total cumulative prescriber base to more than 16,500 since launch. Payer coverage for Sinozi remains steady at approximately 83% of lives covered across channels.

Speaker #2: Overall, the first quarter of 2026 was marked by significant progress across Axsome's commercial business, including strong demand for our products, key advancements in market access, launch preparations for fidelity and Alzheimer's disease agitation, and disciplined organizational growth designed to maximize the potential of our singular CNS portfolio.

Speaker #2: Looking ahead, Axsome is well-positioned to deliver on our commercial objectives across our innovative portfolio through the balance of the year. We look forward to sharing our continued progress with you over the coming months.

Ari Maizel: Looking ahead, Axsome is well positioned to deliver on our commercial objectives across our innovative portfolio through the balance of the year. We look forward to sharing our continued progress with you over the coming months. I will now turn the call back to Ari to discuss our singular CNS pipeline.

Speaker #2: I will now turn the call back to Ari to discuss our singular CNS pipeline.

Speaker #1: Thank you, Ari. I will now touch on recent developments and upcoming milestones for the rest of our pipeline. Starting with AXS-12, as I mentioned, we recently submitted our NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy.

Herriot Tabuteau: Thank you, Ari. I will now touch on recent developments and upcoming milestones for the rest of our pipeline. Starting with AXS-12, as I mentioned, we recently submitted our NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy. Narcolepsy is a rare and debilitating neurological condition that affects approximately 185,000 people in the US. We are excited by the potential of AXS-12 to provide a new and differentiated treatment option to patients living with narcolepsy. We look forward to announcing the FDA's decision on the acceptance of the filing. Beyond AXS-12 and narcolepsy, we are also developing the full suite of clinical programs in our leading neuroscience pipeline. Starting with AXS-05, we are on track to initiate a pivotal Phase 2/3 trial in smoking cessation this quarter. Moving on to solriamfetol. Our Phase 3 programs for this molecule continue to progress.

Speaker #1: Narcolepsy is a rare and debilitating neurological condition that affects approximately 185,000 people in the US. We are excited by the potential of AXS-12 to provide a new and differentiated treatment option to patients living with narcolepsy.

Speaker #1: We look forward to announcing the FDA's decision on the acceptance of the filing. Beyond AXS-12 and narcolepsy, we are also developing the full suite of clinical programs in our leading neuroscience pipeline.

Speaker #1: Starting with AXS-05, we are on track to initiate a pivotal Phase 2/3 trial in smoking cessation this quarter. Moving on to solriamfetol, our Phase 3 programs for this molecule continue to progress.

Speaker #1: These include ADHD, binge eating disorder, MDD with symptoms of excessive daytime sleepiness, and excessive sleepiness in shift work disorder. For ADHD, we are on track to initiate two pediatric Phase 3 trials—one in children and one in adolescents—this quarter.

Herriot Tabuteau: These include ADHD, binge eating disorder, MDD with symptoms of excessive daytime sleepiness, and excessive sleepiness in shift work disorder. For ADHD, we are on track to initiate 2 pediatric phase 3 trials, one in children and one in adolescents this quarter. For MDD, we recently initiated the CLARITY study, a phase 3 double-blind, placebo-controlled, randomized withdrawal trial. In the trial, patients who achieve a sustained response during the open label period will be randomized to continue solriamfetol or switch to placebo. The primary endpoint of that trial is time to relapse of depressive symptoms. For binge eating disorder, our ENGAGE phase 3 double-blind randomized controlled trial is progressing, and we anticipate top-line results in H2 of this year. Finally, for shift work disorder, the phase 3 trial continues to enroll, with top-line results anticipated in 2027.

Speaker #1: For MDD, we recently initiated the Clarity study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal trial. In the trial, patients who achieve a sustained response during the open-label period will be randomized to continue solriamfetol or switch to placebo.

Speaker #1: The primary endpoint of that trial is time to relapse of depressive symptoms. For binge eating disorder, our engaged Phase 3 double-blind randomized controlled trial is progressing, and we anticipate top-line results in the second half of this year.

Speaker #1: Finally, for shift work disorder, the Phase 3 trial continues to enroll, with top-line results anticipated in 2027. Turning now to AXS-14, our novel, highly selective, and potent norepinephrine reuptake inhibitor for fibromyalgia.

Herriot Tabuteau: Turning now to AXS-14, our novel, highly selective and potent norepinephrine reuptake inhibitor for fibromyalgia. Enrollment is ongoing in the FORWARD Phase 3 trials. We look forward to sharing updates on this program as the study progresses. For AXS-17, our novel oral selective GABA PAM for epilepsy, PET transfer and Phase 2 trial enabling activities are well underway. Lastly, we recently acquired AXS-20, or Balipodect, a potentially first-in-class oral potent selective PDE10 inhibitor. We plan to develop AXS-20 for the treatment of schizophrenia and for Tourette syndrome. We plan to initiate Phase 3 trial enabling activities for AXS-20 in schizophrenia later this year. I will now turn the call back to Ashley for Q&A.

Speaker #1: Enrollment is ongoing in the FORWARD Phase 3 trials. We look forward to sharing updates on this program as the study progresses. For AXS-17, our novel oral selective gabapamin for epilepsy, PEP transfer and Phase 2 trial-enabling activities are well underway.

Speaker #1: Lastly, we recently acquired AXS-20, orbalipidec, a potentially first-in-class oral, potent, selective PDE10A inhibitor. We plan to develop AXS-20 for the treatment of schizophrenia and for Tourette's syndrome.

Speaker #1: We plan to initiate Phase 3 trial-enabling activities for AXS-20 in schizophrenia later this year. I will now turn the call back to Ashley for

Speaker #2: Thank you, Ario. Operator, please open the line for

Ashley Gong: Thank you, Ari. Operator, please open the line for Q&A.

Speaker #3: Certainly. Without conducting a question-and-answer session, if you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Operator: Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove yourself from the queue. In the interest of time, we ask you please ask one question and one follow-up, then return to the queue. Our first question today is coming from Ashish Verma from UBS. Your line is now live.

Speaker #3: You may press star 2 if you'd like to remove yourself from the queue. In the interest of time, we ask that you please ask one question and one follow-up, then return to the queue.

Speaker #3: Our first question today is coming from Ash Verma from UBS. Your line is now live.

Ashish Verma: Hey, guys. Congratulations again on all the progress. Thanks for taking our question. I know it's the second day of Q&A, but maybe just on ADA, are you thinking about the LTC market in the long run? I mean, clearly right now, 40% of these patients reside in LTC, but the current prescriber mix is heavily PCP. When you think about the long run, For this, for you to completely extract value out of this market, how much of a focus does LTC need to become in the long run? Thanks.

Speaker #4: Guys, congratulations again on all the progress. Thanks for taking our question. So, I know it's the second day of Q&A, but maybe just on ADA, are you thinking about the LTC market in the long run?

Speaker #4: I mean, clearly, right now, 40% of these patients reside in LTC. But the current prescriber mix is heavily PCP. But when you think about the long run, how much— for you to completely extract value out of this market, how much of a focus does LTC need to become in the long run?

Speaker #4: Thanks.

Speaker #5: Hi, Ash. Thanks for the question. As Ari, our sales team of approximately 630 representatives will call on both community and long-term care facilities. And so for us, it's important to be present and to educate prescribers and care partners within both facilities, or both settings of care.

Ari Maizel: Hi, Ash. Thanks for the question. It's Ari. Our sales team of approximately 630 representatives will call on both community and long-term care facilities. For us, it's important to be present and to educate prescribers and care partners within both facilities or both settings of care. Ultimately, it's a concentrated market that allows for efficient promotional activities. We expect that it will grow over time as the brand ramps.

Speaker #5: Ultimately, it's a concentrated market that allows for efficient promotional activities, and we expect that it will grow over time as the brand ramps up.

Speaker #5: But we believe that community and long-term care are both very important for this market, and look forward to sharing some updates as we get going with the launch.

Ashish Verma: Okay.

Ari Maizel: We believe that community and long-term care are both very important for this market and look forward to sharing some updates as we get going with the launch.

Speaker #4: Got it. Can I ask a quick follow-up?

Ashish Verma: Got it. Can I ask a quick follow-up?

Speaker #5: Sure.

Ari Maizel: Sure.

Ashish Verma: Just on the ADA indication, I know that you're using this unique 30 mg dextromethorphan dose in the titration pack, which you haven't used before for this launch. Is this supplied in the channels already, or does this in any way become like a bottleneck for the full launch at this point? Thanks.

Speaker #4: So just on the ADA indication, I know that you're using this unique 30 mg dextromethorphan dose in the titration pack, which you haven't used before.

Speaker #4: For this launch, is this supplied in the channels already, or does this in any way become a bottleneck for the full launch? At this point, thanks.

Speaker #5: Hi, Ash. As a reminder, we'll be launching next month. And Ari touched on the items that are being finalized right now for the launch.

Herriot Tabuteau: Hi, Ash. As a reminder, we'll be launching next month. Ari touched on the items that are being finalized right now for launch. Do you wanna recap those again one more time, Ari?

Speaker #5: Do you want to recap those again one more time, Ari?

Speaker #6: Yeah, I mean, we're finalizing our sales and marketing resources and training our salesforce on the new indication. The titration dose will be available at the time of commercial launch.

Ari Maizel: Yeah. I mean, we're finalizing our sales and marketing resources and training our sales force on the new indication. The titration dose will be available at the time of commercial launch.

Speaker #4: Thanks.

Ashish Verma: Thanks.

Speaker #3: Thank you. Next question is coming from Mark Goodman from Lyric. Your line is now live.

Operator: Thank you. Next question is coming from Marc Goodman from Leerink Partners. Your line is now live.

Marc Goodman: Those are pretty big peak sales numbers. Can you help us just understand, like, why did you feel like you had to raise them today? Secondly, just talk about what went into the forecasting there and, $4 billion in each indication. Thank you.

Speaker #7: Those are pretty big peak sales numbers. Can you help us just understand why you felt like you had to raise them today? And secondly, just talk about what went into the forecasting there—and $4 billion in each indication.

Speaker #7: Thank you.

Speaker #5: Yeah, thanks, Mark. Well, the FDA approval of Auvelity and Alzheimer's disease education provides greater certainty regarding the long-term sales potential of the product. And, as you know, Alzheimer's disease is a large and growing market.

Ari Maizel: Yeah. Thanks, Marc. Well, the FDA approval of Auvelity in Alzheimer's disease agitation provides greater certainty regarding the long-term sales potential of the product. As you know, Alzheimer's disease is a large and growing market. 7 million patients, of which 76% are impacted by agitation symptoms. Of course, there are only 2 approved agents on the market. When we review our proprietary market research on HCP perceptions, potential use of the product, taken together with the clarity around the final label, it really provides confidence that Auvelity will be used as a frontline treatment in Alzheimer's agitation, and we've seen growing use as frontline treatment in MDD. Our the foundation market access that we built, along with growing adoption in primary care, which of course is a critical provider segment in the Alzheimer's space.

Speaker #5: Seven million patients, of which 76% are impacted by agitation symptoms. And of course, there are only two approved agents on the market. So, when we review our proprietary market research on HCP perceptions, potential use of the product, together with the clarity around the final label, it really provides confidence that Auvelity will be used as a frontline treatment in Alzheimer's agitation.

Speaker #5: And we've seen growing uses of frontline treatment in MDD. Our foundational market access that we built, along with growing adoption in primary care—which, of course, is a critical provider segment in the Alzheimer's space—I think these things taken together with our MDD penetration and growth trajectory, and the increased Salesforce to support both indications, give us confidence in the potential to achieve our updated peak sales estimate for Auvelity.

Ari Maizel: I think these things, taken together with our MDD penetration, growth trajectory, and the increased sales force to support both indications, give us confidence in the potential to achieve our updated peak sales estimate for Auvelity.

Speaker #3: Thanks. Thank you. Next question is coming from Andrew Sy from Jefferies. Your line is now live.

Marc Goodman: Thanks.

Operator: Thank you. Next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Speaker #8: Hi. Good morning. Thanks for taking our questions. I have a bigger picture question. Now, with Auvelity approved in Alzheimer's agitation, how does that embolden you guys to pursue even more indications?

Andrew Tsai: Hi, good morning. Thanks for taking our questions. I have a bigger picture question. You know, now with Auvelity approved in Alzheimer's agitation, how does that embolden you guys to pursue even more indications? I'd imagine you can directly go to Phase 3 with Auvelity for other indications. This drug has a long tail, too. Maybe talk about when we might learn more about indication expansion of opportunities, or is that it with Auvelity? Thanks.

Speaker #8: I'd imagine you can directly go to phase three with Auvelity for other indications. And this drug has a long tail, too. So maybe talk about when we might learn more about indication expansion opportunities.

Speaker #8: Or is that it with Auvelity? Thanks.

Speaker #5: Hey, Andrew. Good morning. We did touch on the next indication that we've been working on for some time, that's smoking cessation. So stay tuned for updates there.

Herriot Tabuteau: Hey, Andrew. Good morning. The We did touch on the next indication that we've been working on for some, that smoking cessation. Stay tuned for updates there. You know, the next step with that program is initiating the phase 2/3 pivot trial. We'll have updates there soon. You know, the product is very interesting given that it targets NMDA and sigma-1 receptors. High potential applicability to other neuropsychiatric conditions. You know, that's something that the team is obviously exploring. Right now, next formal step is smoking cessation trial initiation.

Speaker #5: And the next step with that program is initiating the Phase 2/3 pivotal trial, so we'll have updates there soon. And the product is very interesting.

Speaker #5: Given that it targets MDA and sigma-1 receptors, there's high potential applicability to other neuropsychiatric conditions, and that's something that the team is obviously exploring.

Speaker #5: But right now, the next formal step is smoking cessation trial initiation.

Speaker #8: Great. And then as a follow-up, with your new PDE-10 asset that's starting Phase 3 enabling studies, can you talk about the efficacy and safety profile?

Andrew Tsai: Great. Then as a follow-up, with your new PDE ten asset that's starting Phase 3 enabling studies this year, can you talk about the efficacy safety profile, why it did not necessarily hit stat sig in Phase 2, and why you think you can produce a different outcome in Phase 3? Correct me if I'm wrong, but I think schizophrenia studies could be relatively fast. Could it be possible we get data maybe 2028? Thanks.

Speaker #8: Why did it not necessarily hit stat sig in phase two, and why do you think you can produce a different outcome in phase three? And correct me if I'm wrong, but I think schizophrenia studies could be relatively fast.

Speaker #8: So, could it be possible we get data maybe 2028? Thanks.

Speaker #5: Sure, thanks for the question on Belipidect. With regards to the efficacy, there was a Phase 2 trial, which you mentioned, which was done in schizophrenia.

Herriot Tabuteau: Sure. Thanks, Andrew, for the question on Balipodect. With regards to the efficacy, there was a phase 2 trial, which you mentioned, which was done in schizophrenia. This was a randomized double-blind, placebo-controlled trial. When we looked at the data, there was clear separation. The magnitude of treatment effect for Balipodect was on the high end when you look at historical treatments for schizophrenia. Now, because of the size of the study, obviously it was not powered for statistical significance. Despite that, there was a very clear trend, there was statistical significance on various measures, including, for example, global measures. Clinicians were able to see highly statistically significant improvements in schizophrenia. There were also other measures which were positive.

Speaker #5: This was a randomized, double-blind, single-controlled trial. And when we looked at the data, there was clear separation. The magnitude of treatment effect for Belipidect was on the high end when you look at historical treatments for schizophrenia.

Speaker #5: Now, because of the size of the study, obviously, it was not powered for statistical significance. But despite that, there was a very clear trend.

Speaker #5: And there was statistical significance on various measures, including, for example, global measures. So clinicians were able to see highly statistically significant improvements in schizophrenia, and there were also other measures which were positive.

Herriot Tabuteau: For example, the rates of discontinuations due to lack of efficacy, wide gap with, you know, half of the patients who were on placebo discontinuing for lack of efficacy versus in the low double digits for Balipodect. Clearly, there was a very strong signal there. When you look at the safety profile, it is very distinct, obviously, from atypical antipsychotics. We're very excited about this potentially first-in-class treatment. As it relates to timing of starting a Phase 3 trial, this is a Phase 3-ready asset. What we need to do is to restart manufacturing of clinical supplies.

Speaker #5: For example, the rates of discontinuations due to lack of efficacy. There's a wide gap, with half of the patients who weren't on placebo discontinuing due to lack of efficacy.

Speaker #5: Versus in the low double digits for Belipidect. So clearly, there was a very strong signal there. And when you look at the safety profile, it is very distinct, obviously, from atypical antipsychotics.

Speaker #5: So we're very excited about this potentially first-in-class treatment. And as it relates to timing of starting a Phase 3 trial, this is a Phase 3-ready asset.

Speaker #5: What we need to do is to restart manufacturing of clinical supplies. So the phase 3 enabling activities are ongoing this year. And we would anticipate, and we are targeting, potentially starting a phase 3 trial around the end of the year.

Herriot Tabuteau: While the phase 3 enabling activities are ongoing this year, and we would anticipate we are targeting potentially starting a phase 3 trial around the end of the year.

Speaker #8: Thank you again. Big congratulations.

Andrew Tsai: Thank you again. Big congratulations.

Speaker #3: Thank you. Next question is coming from Ami Fadia from Adeyemin Company. Your line is now live.

Operator: Thank you. Next question is coming from Ami Fadia from Needham & Company. Your line is now live.

Speaker #9: Hi, good morning. Thanks for taking my question. Firstly, on Simbravo, can you give us some more details around where you're seeing utilization and how you see the drug evolve with sort of this expanding payer coverage?

Ami Fadia: Hi. Good morning. Thanks for taking my question. firstly, on Symbravo, can you give us some more details around where you're seeing utilization and how you see the drug evolve, you know, with sort of this expanding payer coverage? How do you see the evolution of, you know, gross net and also utilization as the year progresses? Then with regards to Auvelity, just to follow up to a previous comment, as you think about the IP runway you have, how are you thinking about sort of really expanding the number of indications where you explore this product, you know, ahead of the IP runway and the IRA? You know, could we expect to see you look at multiple other indications, or will it be sort of more sequential? Thank you.

Speaker #9: How do you see the evolution of growth genetics and also utilization as the year progresses? And then with regards to Auvelity, just to follow up to a previous comment, as you think about the IP runway you have, how are you thinking about sort of really expanding the number of indications where you explore this product ahead of the IP runway and the IRA?

Speaker #9: So, could we expect to see you look at multiple other indications, or will it be sort of more sequential? Thank you.

Speaker #5: Thanks, Ami. I'll start with the Simbravo question. We've been really pleased that Simbravo has found its way into the treatment paradigm for many headache specialists.

Ari Maizel: Thanks, Ami Fadia. I'll start with the Symbravo question. You know, we've been really pleased that Symbravo has found its way into the treatment paradigm for many headache specialists. What we're seeing is, you know, approximately 60% of use is in the first and second-line setting. The feedback that we get from HCPs is that Symbravo has been particularly effective for patients with inadequate or partial response to triptans. We expect those patients to be the primary focus moving forward. Obviously the market access win that we're announcing today is an important step for long-term patient access. We think it will have a positive impact on GTN in the future.

Speaker #5: And what we're seeing is approximately 60% of use is in the first- and second-line settings. The feedback that we get from HCPs is that Simbravo has been particularly effective for patients with inadequate or partial response to triptans.

Speaker #5: And we expect those patients to be the primary focus moving forward. Obviously, the market access win that we're announcing today is an important step for long-term patient access.

Speaker #5: We think it will have a positive impact on GTN in the future. But the focus of the team is to continue to expand access for patients, which will help to drive reductions in GTN over time.

Ari Maizel: The focus of the team is to continue to expand access for patients, which will help to drive reductions in GTN over time. For the short term, we expect GTN to continue to be elevated as we build our access.

Speaker #5: Before the short term, we expect GTN to continue to be elevated as we build our— And as it relates to the question on new indications, or additional indications for Auvelity, given the IP runway, you are correct.

Herriot Tabuteau: Great. As it relates to the question on new indications or additional indications for Auvelity, given the IP runway, you know, you are correct. We're in a very favorable position given that there is a very long exclusivity runway for Auvelity and also the fact that the product is commercialized. We are not resource-constrained as it relates to potentially developing it for other indications. The other interesting thing about the product, which Herriot Tabuteau touched upon, is its unique pharmacology, which is applicable to a number of potential CNS indications. We have very clear ideas, as you can imagine, internally around what these additional indications are, and we want to make sure that they move in a very measured way.

Speaker #5: We're in a very favorable position given that there is a very long exclusivity runway for Auvelity. And also, the fact that the product is commercialized, we are not resource-constrained as it relates to potentially developing it for other indications.

Speaker #5: The other interesting thing about the product, which Mark touched upon, is its unique pharmacology, which is applicable to a number of potential CNS indications.

Speaker #5: So we have very clear ideas, as you can imagine, internally, around what these additional indications are. And we want to make sure that we move in a very measured way.

Herriot Tabuteau: If there is something that is worth doing, you know, we think it's worth doing quickly. Stay tuned as it relates to other potential indications which could further increase the value of the product long term.

Speaker #5: And if there is something that is worth doing, we think it's worth doing quickly. And so stay tuned as it relates to other potential indications.

Speaker #5: Which could further increase the value of the product long-term.

Speaker #9: Thank you.

Ami Fadia: Thank you.

Speaker #3: Thank you. Next question is coming from Jason Gruber from Bank of America. Your line is now live.

Operator: Thank you. Next question is coming from Jason Gerberry from Bank of America. Your line is now live.

Speaker #10: Hey, guys. Thanks for taking my question. Another follow-up question on the PDE10. My understanding was that I think Axsome, in acquiring this asset, plans to push the dose relative to what was studied by Takeda to get better receptor occupancy.

Jason Gerberry: Hey, guys. Thanks for taking my question. Another follow-up question on the PDE10. My understanding was that I think Axsome in acquiring this asset planned to push dose relative to what was studied by Takeda to get better receptor occupancy. So wondering if you can speak to that dynamic, how high you'd be looking to push dose and confidence that the supportive data give you a safe dose strength to interrogate. Then as my follow-up, are there any signs or indications that, you know, antipsychotic use in nursing homes is coming down at all in the wake of the March OIG report that was dubbed, I think, inappropriate use of antipsychotics in nursing homes?

Speaker #10: So, wondering if you can speak to that dynamic—how high you'd be looking to push the dose, and your confidence that the supportive data give you a safe dose strength to interrogate?

Speaker #10: And then as my follow-up, are there any signs or indications that antipsychotic use in nursing homes is coming down at all in the wake of the March OIG report that was dubbed I think inappropriate use of antipsychotics in nursing homes?

Speaker #10: So just kind of curious if you have any insights as you gear up for your own ADA launch. Thanks.

Jason Gerberry: Just kind of curious if you have any insights, as you gear up for your own, ADA launch. Thanks.

Speaker #5: Yeah, thanks for the question. With regards to the PDE10A inhibitor, we have not discussed dosing. As it relates to the product, however, the dose that was studied was effective.

Herriot Tabuteau: Yeah. Thanks for the question. With regards to the PDE10A inhibitor, we have not discussed dosing as it relates to the product. However, the dose that was studied was effective. You know, had the number of subjects per arm than what you would have seen in a normal phase 3 trial in schizophrenia. Clearly it would have reached statistical significance.

Speaker #5: Had the number of subjects per arm been what you would have seen in a normal phase 3 trial in schizophrenia, clearly it would have reached a significance.

Speaker #10: Yeah. And regarding your question on antipsychotic use, there hasn't been an immediate drop in antipsychotics in an overall substantial But what I will say is that the awareness of that report and the sensitivity on using antipsychotics with this patient population is very high among providers and family members.

Ari Maizel: Yeah. Regarding your question on antipsychotic use, there hasn't been an immediate drop in antipsychotics in an overall substantial way. I think the news is still relatively new. What I will say is that the awareness of that report and the sensitivity on using antipsychotics with this patient population is very high among providers and family members. We think that provides a good foundation for the Auvelity launch in the Alzheimer's disease agitation space, and expect there to be, you know, continued focus on antipsychotic use moving forward.

Speaker #10: So, we think that provides a good foundation for the Auvelity launch in the Alzheimer's disease agitation space, and expect there to be continued focus on antipsychotic use moving forward.

Speaker #10: Thank you.

Herriot Tabuteau: Thank you.

Speaker #3: Thank you. Next question today is coming from Rob Silverado from HC Rainway. Your line is now live.

Operator: Thank you. Next question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.

Speaker #11: Thanks so much for taking my questions. Firstly, on the commercial side, I was wondering if you could provide us with some additional details regarding the deployment of the field sales force.

Ram Selvaraju: Thanks so much for taking our questions. Firstly, on the commercial side, I was wondering if you could provide us with some additional details regarding the deployment of the field sales force, the degree to which sales reps currently promote more than one product or are dedicated to promoting a single product within your commercial product range, and how you expect this to evolve going forward. In other words, to what extent do you expect to deploy sales representatives dedicated to a specific product and a specific indication, versus having them promote more than one product at a time? To what extent, you know, this strategy will be reflected going forward, in the deployment of the commercial sales force.

Speaker #11: The degree to which sales reps currently promote more than one product or are dedicated to promoting a single product within your commercial product range.

Speaker #11: And how do you expect this to evolve going forward? In other words, to what extent do you expect to deploy sales representatives dedicated to a specific product in a specific indication, versus having them promote more than one product at a time?

Speaker #11: And to what extent will this strategy be reflected going forward in the deployment of the commercial sales force? And then, with respect to clinical development directions, I was wondering if you could comment generally, perhaps, on your interest in muscarinic receptor modulation, particularly as this pertains to both the neuropsychiatric and cognitive dysfunction dementia fields.

Ram Selvaraju: With respect to clinical development directions, I was wondering if you could comment generally perhaps on your interest in muscarinic receptor modulation, particularly as this pertains to both the neuropsychiatric and cognitive dysfunction dementia fields. If you could also give us a sense with respect to Balipodect, you know, where you expect the specific safety advantages of this, of this product to lie within the neuropsychiatric indications that you expect to target. Thank you.

Speaker #11: And if you could also give us a sense, with respect to balapodect, where you expect the specific safety advantages of this product to lie within the neuropsychiatric indications that you expect to target.

Speaker #11: Thank you.

Speaker #10: Yeah. I'll start with the deployment of sales force question. So up to this point, we've largely had our sales teams focused on one specific brand part of that is related to the unique specialist audiences that are particularly important in the launch phase.

Ari Maizel: I will start with the deployment of sales force question. Part of that is related to the unique specialist audiences that are particularly important in the launch phase. For Auvelity, that is psychiatry, for Symbravo, headache specialists and neurologists, and for Sunosi, sleep specialists. With the Alzheimer's agitation launch, because of the high degree of overlap in call points for MDD and ADA, that team will be supporting and promoting both indications. But in terms of long-term potential or vision for the team, as you know, our portfolio and our pipeline is unique in that there are many shared call points for certain therapeutic areas.

Speaker #10: And so for Auvelity, that's psychiatry, for Simbravo, headache specialists, and neurologists. And for Sinozi, sleep specialists. With the Alzheimer's Agitation launch, because of the high degree of overlap in call points for NDD and ADA, that team will be supporting and promoting both indications.

Speaker #10: But in terms of long-term potential or vision for the team, as you know, our portfolio and our pipeline are unique in that there are many shared call points for certain therapeutic areas.

Speaker #10: And so that's something we'll continue to evaluate, and we'll share as we make some progress moving forward.

Ari Maizel: That's something we'll continue to evaluate, and we'll share as we make some progress moving forward.

Speaker #5: Great. As it relates to the pipeline questions, with regards to your question on muscarinic receptor modulation, that mechanism of action does not fall into our current pipeline.

Herriot Tabuteau: Great. As it relates to the pipeline questions, with regards to your question on muscarinic receptor modulation, that mechanism of action does not fall into our current pipeline, so we don't have much to add there. As it relates to Balipodect and the potential safety advantages, just as a reminder, this is a PDE10A inhibitor, so it works by regulating cyclic AMP and cyclic GMP levels downstream from D one and D two receptors. The potential safety advantage, and this has been shown in pre-clinical studies as well as in clinical studies, is one of the advantages is that what has not been seen or changes in glucose levels or prolactin levels.

Speaker #5: So we don't have much to add there. And as it relates to balapodect and the potential safety advantages, just as a reminder, this is a PDE10A inhibitor.

Speaker #5: And so it works by regulating cyclic AMP and cyclic GMP levels downstream from D1 and D2 receptors. So, the potential safety advantage—and this has been shown in preclinical studies as well as in clinical studies—is that one of the advantages is that what has not been seen are changes in glucose levels or prolactin levels.

Speaker #5: So, as you know, with atypical antipsychotics, one of the major side effects has to do with metabolic side effects. And so we have seen, preclinically as well as clinically, that this could be a major benefit with balapodect.

Herriot Tabuteau: As you know, with atypical antipsychotics, one of the major side effects has to do with metabolic side effects. We have seen pre-clinically as well as clinically that this could be a major benefit with Balipodect.

Speaker #10: Thank you.

Ram Selvaraju: Thank you.

Speaker #3: Thank you. Next question is coming from David Amselem from Piper Sandler. Your line is now live.

Operator: Thank you. Next question is coming from David Amsellem from Piper Sandler. Your line is now live.

David Amsellem: Thanks. Just two for me. With the significant expansion of the commercial infrastructure, what's your appetite for the acquisition of a market-ready or commercial stage asset? I know you focused on expanding the pipeline, but you have a lot of infrastructure now that you can leverage. Maybe talk to that. Secondly, a question on reboxetine and how you're thinking about the underlying commercial opportunity in a landscape where you're going to have orexin 2 receptor agonists as options in this population. Thanks.

Speaker #12: Thanks. So just two for me. With the significant expansion of the commercial infrastructure, what's your appetite for the acquisition of a market-ready or commercial-stage asset?

Speaker #12: I know you focused on expanding the pipeline, but you have a lot of infrastructure now that you can leverage. So maybe talk to that.

Speaker #12: And then secondly, a question on reboxetine. How are you thinking about the underlying commercial opportunity in a landscape where you're going to have orexin 2 receptor agonists as options in this population?

Speaker #12: Thanks.

Herriot Tabuteau: Great. In terms of being able to acquire a marketed product, you know, we have done that in the past, and we did that with Sunosi, which was our first acquisition. Having said that, we have such a rich portfolio of marketed assets, new indications and also a very late-stage pipeline that we, you know, we have enough to focus on to drive long-term as well as near-term value. Short-term and near-term value inflections and, you know, long-term sustainable value creation. With regards to the orexin 2 agonists. If you look at narcolepsy, this is an orphan indication, but a large orphan, 185,000 patients.

Speaker #5: Great. So in terms of being able to acquire a marketed product, we have done that in the past. And we did that with Sinozi.

Speaker #5: Which was our first acquisition. Having said that, we have such a rich portfolio of marketed assets, new indications, and also a very late-stage pipeline that we have enough to focus on to drive long-term, as well as near-term, value.

Speaker #5: So short-term and near-term value inflections and long-term sustainable value creation. With regards to the Rex and 2 agonists, so if you look at if you look at narcolepsy, this is an orphan indication but a large orphan, 185,000 patients.

Speaker #5: And what we see is that there is a lot of heterogeneity in this patient population. There is a lot of polypharmacy, not every drug works.

Herriot Tabuteau: What we see is that there is a lot of heterogeneity in this patient population. There's a lot of polypharmacy. Not every drug works. Also there is a lot of side effect liability with the current treatments. You know, each treatment will have different side effect profiles. What we like about our product, about AXS-12, couple of things. One, it works very quickly. We have an onset of action, which is at 1 week. Currently, all the other products on the market take a lot longer, about a month to work. Secondly, the efficacy that we've seen is durable. We have data out to 6 months.

Speaker #5: And also, there is a lot of side effect liability with the current treatments. And each treatment will have a different side effect profile. So, what we like about our product, about AXS-12, is a couple of things.

Speaker #5: One, it works very quickly. So we have an onset of action, which is at one week. And currently, all the other products on the market take a lot longer—about a month—to work.

Speaker #5: Secondly, the efficacy that we've seen is durable. So, we have data out to six months, and all of that efficacy comes with a very favorable side effect profile and a first-in-class mechanism of action for narcolepsy.

Herriot Tabuteau: All of that efficacy comes with a very favorable side effect profile and a first-in-class mechanism of action for narcolepsy. Lastly, with regards to some of the other ancillary symptoms of narcolepsy, the data does show that AXS-12 has the potential to also beneficially affect EDS as well as cognition. We're very excited by the potential to provide a new treatment option to patients.

Speaker #5: Lastly, with regards to some of the other ancillary symptoms of narcolepsy, the data does show that AXS-12 has the potential to also beneficially affect EDS as well as cognition.

Speaker #5: So, we're very excited by the potential to provide a new treatment option to patients.

Speaker #12: Thank you.

Ari Maizel: Thank you.

Speaker #3: Thank you. Next question today is coming from Jonathan Sinozia from Guggenheim Partners. Your line is now live.

Operator: Thank you. Next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.

Speaker #13: Hey, guys. Thank you for taking my questions, and congrats on all the success and progress. Just a question on ADA—actually, two questions. So, one is, how should we think about sort of guidance?

Yatin Suneja: Hey, guys. Thank you for taking my questions, and congrats on all the success and progress. Just a question on ADA. Actually two questions. One is, you know, how should we think about sort of guidance? You know, at what point do you think you might be able to establish guidance if that's even possible? Two, you know, if we, you know, we are all trying to model the ADA ramp curve. Obviously, when you launch Auvelity in MDD, I think the awareness was not there. Like, how should we think about the early launch in MDD, and how do we sort of model it for ADA? Any guidance there will be really helpful. Thank you.

Speaker #13: At what point do you think you might be able to establish guidance, if that's even possible? Two, if we are all trying to model the ADA ramp curve—obviously, when you launch a Velatine MDD, I think the awareness was not there.

Speaker #13: So, how much more should we think about the early launch in MDD, and how do we sort of model it for ADA? Any guidance there would be really helpful.

Speaker #13: Thank you.

Speaker #5: Sure. Hey, Aden. This is Nick. As it relates to guidance, first of all, we gave guidance, right? We have peak sales guidance out there of at least 8 billion for Velatine, 300 to 500 million for Sinozie, and 500 million to a billion for Sembravo.

Nick Pizzie: Sure. Hey, Yatin. This is Nick. As it relates to guidance, first off, we gave guidance, right? We have peak sales guidance out there of at least $8 billion for Auvelity, $300 to 500 million for Sunosi, and $500 million to 1 billion for Symbravo. That's our peak sales guidance. You know, obviously a lot of fluidity now with the expansion, with the approval, with market access continuing to grow and evolve. At this point, there's many variables out there from a short-term perspective. We wanna see how they evolve, and then we can take a look at potential guidance down the road.

Speaker #5: So that's our peak sales guidance. And obviously, a lot of fluidity now with the expansion, with the approval, with market access continuing to grow and evolve.

Speaker #5: So at this point, there's many variables out there from a short-term perspective. So we want to see how they evolve. And then we can take a look at potential guidance down the road.

Ari Maizel: Regarding the ADA ramp, obviously it's very challenging to predict exactly how any new launch will ramp over time. As you mentioned, you know, the Auvelity MDD in one hand is an analog, even though different marketplace and same product. you know, obviously we're optimistic because there's greater awareness, better market access, larger sales team. On the other hand, there's a one analog in this market with Rexulti, and although the clinical profiles are very different, it does give some sense of uptake in the settings of care which we'll be entering. I think we'll learn more as we get into the launch, and we'll be able to share those details of what we're observing.

Speaker #13: And regarding the ADA ramp, obviously it's very challenging to predict exactly how any new launch will ramp over time. As you mentioned, the Velatine MDD, on one hand, is an analog, even though it's a different marketplace and the same product.

Speaker #13: And obviously, we're optimistic because there's greater awareness, better market access, and a larger sales team. On the other hand, there's one analog in this market with Rexulti, and although the clinical profiles are very different, it does give some sense of uptake in the settings of care which we will be entering.

Speaker #13: So, I think we'll learn more as we get into the launch, and we'll be able to share those details of what we're observing. Thank you.

Yatin Suneja: Thank you.

Speaker #3: Thank you. Next question is coming from Sean Marmon from Morgan Stanley, your line is now live.

Operator: Thank you. Next question is coming from Sean Laaman from Morgan Stanley. Your line is now live.

Sean Laaman: Thank you. Good morning, everyone. Hope everyone's well. Back on AXS-12, I'm just wondering what you sort of price and payer discussions, if any, have been like. What's the kind of investment you think you need to make to ensure that this drug has a success, you know, given there is, you know, such hot debate on the receptor agonist and the large market potential there?

Speaker #14: Thank you. Good morning, everyone, and hope everyone's well. Back on AXS-12, I'm just wondering, what the sort of price and payer discussions, if any, have been like?

Speaker #14: And what's the kind of investment you think you need to make to ensure that this drug has success, given there is such hot debate on the Rex and 2 agonists and the large market potential there?

Speaker #13: Yeah, thanks, Sean, for the question. Obviously, we've been engaged with payers on early education around the clinical trial programs, and the data. We have not specifically engaged in pricing discussions.

Ari Maizel: Thanks, Sean, for the question. You know, obviously, we've been engaged with payers on early education around the clinical trial programs in the data. We have not specifically engaged in pricing discussions, so I'll have to defer to a later time to share some of those details. There is genuine interest in new narcolepsy products for the reasons Ari stated earlier, which is that there's significant inadequate response, treatment switching, and polypharmacy. Payers are very mindful of ensuring that treatment options that are available have strong efficacy, safety, tolerability. In terms of the investment required, you know, we'll have more to share as we get closer to a potential approval.

Speaker #13: So I'll have to defer to a later time to share some of those details. But there is genuine interest in new narcolepsy products for the reasons Ari stated earlier, which is that there's significant inadequate response, treatment switching, and polypharmacy, and so payers are very mindful of ensuring that treatment options that are available have strong efficacy, safety, and tolerability.

Speaker #13: In terms of the investment required, we'll have more to share as we get closer to a potential approval. But as we've mentioned previously, we have established a sleep team for Sinozie.

Ari Maizel: As we've mentioned previously, you know, we have established a sleep team for Sunosi that is in market today. Obviously there is near perfect overlap in terms of HCP targets for Sunosi and AXS-12, if approved.

Speaker #13: That is in market today. And obviously, there is near-perfect overlap in terms of HCP targets for Sinozie and AXS12 if approved.

Speaker #5: Yeah. Maybe just a little bit furthering onto Ari's comments from a financial perspective, you would consider—you would think of orphan drug pricing. From a top line, as Ari shared, we already have the infrastructure set up with the sleep team.

Nick Pizzie: Yeah. Maybe just a little bit furthering on to Ari's comments from a financial perspective. You would think of orphan drug pricing from a top line. As Ari shared, we already have the infrastructure set up with the sleep team and the marketing team from sleep. You know, what we would anticipate that a lot of synergies with AXS-12 into the current infrastructure and continued improved operating leverage within the P&L.

Speaker #5: And the marketing team from sleep. So what we would anticipate that a lot of synergies with AXS12 into the current infrastructure and continuing to improve the operating leverage within the P&L.

Speaker #13: Cool. Thank you. How excited are you about that product? It doesn't seem to get a whole heap of airplay amongst investor discussions. So, how excited are you about it?

Sean Laaman: Well, thank you. How excited are you about that product? It doesn't seem to get a whole heap of airplay amongst investor discussions, so how excited are you about it?

Speaker #5: Very. Oh, I'm sorry. Go ahead. Very excited. We are very excited. The feedback we're getting from KOLs and early market research is really strong.

Ari Maizel: Very-

Herriot Tabuteau: Go ahead.

Ari Maizel: Oh, I'm sorry. Go ahead. Very excited. We are very excited. The feedback we're getting from KOLs and early market research is really strong. You know, because these patients are very difficult to treat and are frankly dissatisfied with existing treatment options, we believe there will be significant room for AXS-12 to make a significant impact in this marketplace.

Speaker #5: And because these patients are very difficult to treat and are, frankly, dissatisfied with existing treatment options, we believe there will be significant room for AXS-12 to make a significant impact in this marketplace.

Speaker #14: Wonderful. Thank you. That's all I have.

Sean Laaman: Wonderful. Thank you. That's all I have.

Speaker #3: Thank you. Next question today is coming from David Hong from Deutsche Bank. Your line is now live.

Operator: Thank you. Next question today is coming from David Hoang from Deutsche Bank. Your line is now live.

Speaker #15: Hi there, thanks for taking my question. And congrats on all the recent progress. So, first, I wanted to come back to the peak sales number that you put out there for Velatine.

David Hoang: Hi there. Thanks for taking my question. Congrats on all the recent progress. First, I wanted to come back to the peak sales number that you put out there for Auvelity. If I heard you correctly, I think you said 50/50 for the, you know, MDD versus ADA indications. The MDD number, you know, strikes me as a large one, and I'm just wondering if you looked at other, kind of other antidepressants or comparable products in the market to help you get to that number. Maybe a follow-up there is, does that contemplate, you know, evolving competition in the field over the next few years, let's say? For example, do you see psychedelic therapies as competitors to Auvelity? Thanks a lot.

Speaker #15: If I heard you correctly, I think you said 50/50 for the MDD versus ADA indications. And so the MDD number, it strikes me as a large one.

Speaker #15: And I'm just wondering if you looked at other, kind of, other antidepressants or comparable products in the market to help you get to that number.

Speaker #15: And then maybe a follow-up there is, does that contemplate evolving competition in the field over the next few years, let's say? And, for example, do you see psychedelic therapies as competitors to Velatine?

Speaker #15: Thanks a lot.

Speaker #13: Yeah, thanks, David. I think, obviously, we take a look at market analogs, but they don't fully drive our decisions, which are largely based on our internal research and analysis.

Ari Maizel: Yeah. Thanks, David. Yeah, I think, obviously we take a look at market analogs, but they don't fully drive our decisions, which is largely based on our internal research and analysis. You know, what we're seeing in terms of adoption rates, penetration, the improvements in our commercial infrastructure related to sales force and market access, and now the additional data in Alzheimer's disease agitation. In some ways, Auvelity stands on its own in this marketplace because of its novelty in terms of mechanism of action as well as the clinical profile that it delivers when compared to other treatment options. We're confident in the potential that we shared earlier today.

Speaker #13: And what we're seeing in terms of adoption rates, penetration, the improvements in our commercial infrastructure related to Salesforce and market access, and now the additional data in Alzheimer's disease agitation—in some ways, Velatine stands on its own in this marketplace because of its novelty in terms of mechanism of action as well as the clinical profile that it delivers when compared to other treatment options.

Speaker #13: And so we're confident in the potential that we shared earlier today, and look forward to sharing some additional updates as we grow the brand, and particularly as we get into the Alzheimer's disease agitation launch, which is a really important milestone for the brand.

Ari Maizel: You know, look forward to sharing some additional updates as we grow the brand, you know, particularly, as we get into the Alzheimer's Disease Agitation launch, which is a really important milestone for the brand.

Speaker #3: Thank you. Next question is coming from Miles Minter from William Larry. Your line is now live.

Operator: Thank you. Next question is coming from Myles Minter from William Blair. Your line is now live.

Speaker #16: Oh, hey. Thanks, everyone. Congrats on the quota. First, I want to touch on the ENGAGE study of soriamphatol and Binjadine disorder. How are you thinking about what you'd like to see from an efficacy standpoint there?

Myles Minter: Thanks everyone. Congrats on the quarter. First one's just on the ENGAGE study of solriamfetol in binge eating disorder. How are you thinking about what you'd like to see from an efficacy standpoint there? Should we be looking at the Vyvanse data set of about 1 and a half day reduction in binge eating days over that week period, so that it'd be about 18 to 20 days over your 12 weeks in ENGAGE? That's the first one. On AXS-14, very curious as to the randomized withdrawal nature of the trial that you're conducting in fibromyalgia. That seems great from a probability of success standpoint. Just reading some recent guidance from the FDA, I think that they make a statement that it's not necessarily a robust comparative from the safety aspects of that drug.

Speaker #16: Should we be looking at the Vyvanse dataset of about a 1.5-day reduction in binge eating days over that week period, so that it'd be about 18 to 20 days over your 12 weeks in ENGAGE?

Speaker #16: That's the first one. And then on AXS-14, very curious as to the randomized withdrawal nature of the trial that you conducted in fibromyalgia. That seems great from a probability of success standpoint.

Speaker #16: Just reading some recent guidance from the FDA, I think that they make a statement that it's not necessarily a robust comparative from the safety aspects of that drug.

Speaker #16: Was there any sort of conversations that you're already over the hurdle, per se, on the safety data requirements for AXS-14, with the previous data from Pfizer, and that you don't have to do any additional studies beyond this one?

Myles Minter: Was there any sort of conversations that you're already over the, you know, over the hurdle per se, on the safety data requirements for AXS-14 with the previous data from Pfizer that you don't have to do any additional studies beyond this one? Thanks very much.

Speaker #16: Thanks very much.

Herriot Tabuteau: Thanks for the questions. As it relates to the binge eating disorder study, it's hard to say what we're looking for. Obviously, we powered the study to detect a treatment difference. One of the limitations of making predictions is that currently there's only one product that's approved, so not very many studies have been done in binge eating disorder. That's exciting. We look forward to the data readout to see what we see. Obviously, what we're looking for is a positive study. We're looking for a statistically significant improvement with our drug versus placebo. As it relates to AXS-14, we are very excited about the clinical trial which we've launched.

Speaker #5: Thanks for the questions. As it relates to the Binjadine disorder study, it's hard to say what we're looking for. Obviously, we powered the study.

Speaker #5: To detect a treatment difference, one of the limitations of making predictions is that currently, there's only one product that's approved, so not very many studies have been done.

Speaker #5: In binge eating disorder, so that's exciting, and we look forward to the data readout to see what we see. Obviously, what we're looking for is a positive study.

Speaker #5: So we're looking for a specifically significant improvement with our drug versus placebo. As it relates to AXS-14, we are very excited about the clinical trial, which we've launched.

Herriot Tabuteau: As with regards to the safety data, just as a reminder, two randomized double-blind placebo-controlled trials have been conducted and both of those were positive. These were very large studies. Also, there were two long-term safety trials with hundreds of patients treated out to at least a year. Plenty of randomized as well as long-term safety data with AXS-14.

Speaker #5: With regards to the safety data, just as a reminder, two randomized, double-blind, placebo-controlled trials have been conducted. And both of those were positive. These were very large studies.

Speaker #5: And also, there were two long-term safety trials with hundreds of patients treated out to at least a year. So, plenty of randomized as well as long-term safety data.

Speaker #5: With AXS14.

Speaker #3: Thank you. Next question is coming from Matthew Herschelhorn from Oppenheimer. Your line is now live.

Operator: Thank you. Next question is coming from Matthew Hershenhorn from Oppenheimer. Your line is now live.

Speaker #17: Hey, guys. Congrats again on the ADA approval, and thanks for taking our question. We were wondering just about your overall BD strategy following the recent deals for AXS-17 and Beliepidact, especially in terms of additional capacity in other areas you'd like to add to.

Matthew Hershenhorn: Hey, guys. Congrats again on the ADA approval, and thanks for taking our question. We were wondering just about your overall BD strategy following the recent deals for AXS-17 and Balipodect, especially in terms of additional capacity in other areas you'd like to add to. Do you consider psychedelics or neuroplastogens as a potential complement to your psychiatry portfolio? If the recent policy and regulatory dynamics as well as some strategic interest for those inform your thinking there at all? I really appreciate it.

Speaker #17: Do you consider psychedelics or neuroplastigens as a potential complement to your psychiatry portfolio? And do the recent policy and regulatory dynamics, as well as some strategic interests for those, inform your thinking there at all?

Speaker #17: I really appreciate it.

Speaker #18: Thanks for the question. We don't, as you know, comment specifically on business development. But what we can share is that we think very carefully, and we're very selective as to what we add.

Herriot Tabuteau: Thanks for the question. We don't, as you know, comment specifically on business development, but what we can share is that we think very carefully and we're very selective as to what we add. Now, we don't really need to add anything more. We have a pipeline right now, which is very deep and very broad, and late stage. You know, we did announce these two recent business development transactions, which provide us two new NCEs with novel first-in-class mechanisms of actions. That complements the rest of our pipeline. You know, we've demonstrated our ability to generate what we believe will be an inflection in the base business already.

Speaker #18: Now, we don't really need to add anything more. We have a pipeline right now, which is very deep and very broad, and late-stage. And so, we did announce these two recent business development transactions, which provide us two new NCEs with novel, first-in-class mechanisms of action.

Speaker #18: And then that complements the rest of our pipeline. So we've demonstrated our ability to generate what we believe will be an inflection in the base business already.

Speaker #18: And then also, we are ensuring that that inflection will be sustained with the current pipeline that we have.

Herriot Tabuteau: Also we are ensuring that that inflection will be sustained with the current pipeline that we have.

Speaker #3: Thank you. Next question is coming from Ben Burnett from Wells Fargo. Your line is now live.

Operator: Thank you. Next question is coming from Benjamin Burnett from Wells Fargo. Your line is now live.

Speaker #19: Hey, thanks very much. I want to ask just a question about the CLARITY Soriamphatol study. Is that so it's a randomized withdrawal study? Maybe give a little color as to why that design was chosen.

Benjamin Burnett: Hey, thanks very much. I wanna ask just a question about the CLARITY solriamfetol study. It's a randomized withdrawal study. Maybe give a little color as to why that design was chosen. I guess if it's positive, would you expect to have to do a parallel study after that?

Speaker #19: And I guess if it's positive, would you expect to have to do a parallel study after that?

Herriot Tabuteau: Thanks for the question. We, we do anticipate that we would need 2 positive trials. That's the standard for any approval for any indication at the FDA. In terms of the reason for the randomized withdrawal design, one of the challenges with neuropsych, psychiatric indications and depression in particular is the high placebo response. How do you deal with that? In the prior studies, in the prior study which we conducted with solriamfetol in this indication, what we saw in the active arm was clearly a very pronounced antidepressant effect. What we wanted to make sure is that we're able to tease out and really demonstrate that this is a drug effect and while minimizing the impact of the placebo response.

Speaker #18: Thanks for the question. So, we do anticipate that we would need two positive trials. That's the standard for any approval for any indication at the FDA.

Speaker #18: And in terms of the reason for the randomized withdrawal design, one of the challenges with neuropsychiatric indications, and depression in particular, is the high placebo response.

Speaker #18: So, how do you deal with that? So in the prior studies—in the prior study, which we conducted with Soriamphatol in this indication—what we saw in the active arm was clearly a very pronounced antidepressant effect.

Speaker #18: So what we wanted to make sure is that we're able to tease out and really demonstrate that this is a drug effect, while minimizing the impact of the placebo response.

Speaker #18: So that's the rationale behind the selection of that study design.

Herriot Tabuteau: That's the rationale behind the selection of that study design.

Speaker #19: Okay. Thank you very much. And can I also ask, just long-term, how are you thinking about profitability? And does the increased conviction and novelty—and what that could do from a sales perspective—does, I guess, does profitability start to become a goal for the company?

Benjamin Burnett: Okay. Thank you very much. Can I also ask, long term, how are you thinking about profitability? Does the increased conviction in Auvelity and what that could do from a sales perspective, I guess, does profitability start to become a goal for the company or is the focus kind of more on revenue growth?

Speaker #19: Or is the focus kind of more on, sort of, revenue growth?

Speaker #18: Right now, our focus continues to be on revenue growth. So, I think if you had to put things in priority order, revenue growth is number one.

Nick Pizzie: Right now our focus continues to be on revenue growth. I think if you had to put things in priority order, revenue growth is number 1, then getting the cash flow positivity is 2, and then profitability shortly thereafter.

Speaker #18: Then getting to cash flow positivity is two, and then profitability shortly thereafter.

Speaker #19: Great. Thank you.

Benjamin Burnett: Great. Thank you.

Speaker #3: Thank you. Next question is coming from Greg Sublavez from Mizuho. Your line is now live.

Operator: Thank you. Next question is coming from Graig Suvannavejh from Mizuho. Your line is now live.

Speaker #20: Good morning, guys. Congrats on all of the progress, and especially the AD education approval. And thanks for taking my questions. I've got questions on Auvelity and I'm curious if you could provide some color around how we should think about this year's quarterly sequential growth, given seasonality dynamics. Given that while Auvelity is still growing year over year in MDD, as you get to bigger numbers, it starts slowing down.

Graig Suvannavejh: Good morning, guys. Congrats on all of the progress and especially the AD agitation approval, and thanks for taking my questions. I've got questions on Auvelity, and I'm curious if you could provide some color around how we should think about this year's quarterly sequential growth given seasonality dynamics. Given that, you know, while Auvelity is still growing year over year in MDD, as you get to bigger numbers, it starts slowing down, but then you've got the ADA launch. I guess, do you anticipate year over year growth in 2026 to be perhaps bigger than you saw in 2025?

Speaker #20: But then you've got the ADA launch. So I guess, do you anticipate year-over-year growth in 2026 to be perhaps bigger than you saw in 2025?

Graig Suvannavejh: Just a follow-up on Auvelity, just given the ADA approval, can you tell us how you're thinking about IRA implications and how we should think about as you add more Medicare patients, how we should think about including that in our models or not in terms of any impact there? Thanks.

Speaker #20: And then just a follow-up on availability—just given the ADA approval, can you tell us how you're thinking about IRA implications, and how we should think about it as you add more Medicare patients?

Speaker #20: How should we think about including that in our models, or not, in terms of any impact there? Thanks.

Ari Maizel: Great. Yeah. I'll start with the first question around quarterly sequencing. You know, we haven't guided specifically on sales ramp over the course of the year, but as you know, Q1 is a quarter in which market seasonality comes into effect, but we believe is transitory in nature, as evidenced by the early demand trends that we're seeing in Q2.

Speaker #18: Great, yeah, I'll start with the first question around quarterly sequencing. We haven't guided specifically on sales ramp over the course of the year, but as you know, Q1 is a quarter in which market seasonality comes into effect.

Speaker #18: But we believe it's transitory in nature, as evidenced by the early demand trends that we're seeing in Q2. Yeah. And then maybe just a little bit on the IRA, Greg.

Herriot Tabuteau: Maybe just a little bit on the IRA, Graig. You know, at the earliest, IRA negotiations will not impact Auvelity until 2031, obviously assuming Auvelity meets the requirements for negotiation of being a top spend Medicare Part D product. It is important to note that the $8 billion that we shared today contemplates any type of IRA impact.

Speaker #18: At the earliest IRA negotiations, this will not impact availability until 2031. Obviously, assuming availability meets the requirements for negotiation of being a top spend Part D product.

Speaker #18: And it is important to note that the $8 billion that we shared today contemplates any type of IRA impact.

Graig Suvannavejh: Okay. Thank you.

Speaker #19: Okay. Thank you.

Speaker #3: Thank you. Next question is coming from Brian Scorni from Baird. Your line is now live.

Operator: Thank you. Next question is coming from Brian Skorney from Baird. Your line is now live.

Speaker #21: Hi, thanks for taking our question. This is Charlie on for Brian. So just kind of following up on an earlier question—curious how you're thinking about positioning Sunosi ahead of the potential rexinagonist launch later this year.

[Analyst] (Baird): Hi. Thanks for taking our question. This is Charlie on for Brian. Just kind of following up on an earlier question, curious how you're thinking about positioning Sunosi ahead of potential orexin agonist launch later this year, as well as with your expansion of the sales force there and wrapping up the expansion of the Auvelity sales force, how should we think about kind of the ramp of SG&A spend throughout 2026? Thank you.

Speaker #21: As well as with your expansion of the Salesforce there. And wrapping up the expansion of the availability of Salesforce. How should we think about kind of the ramp of SG&A spend throughout 2026?

Speaker #21: Thank you.

Speaker #18: So maybe I'll take the SG&A question first. So, SG&A increased this quarter primarily for four reasons. First off, we typically do see a bit of phasing of higher spend in SG&A in Q1 versus the rest of the year, just on the underlying business.

Nick Pizzie: Maybe I'll take the SG&A question first. SG&A increased this quarter primarily for four reasons. First off, we typically do see a bit of phasing of higher spend in SG&A in Q1 versus the rest of the year just on the underlying business. Secondly, we accelerated the marketing spend in preparation of approval of Auvelity to ensure the infrastructure was established and ready to launch in June. We're moving along there very nicely. Thirdly, the field force expansion was actually faster than we anticipated. We're pleased with where we are in preparation for a June launch. Fourth, we actually continue to have DTC spend for Auvelity in MDD.

Speaker #18: Secondly, we accelerated the marketing spend in preparation for approval of ADA, to ensure the infrastructure was established and ready to launch in June. So we're moving along there very nicely.

Speaker #18: Thirdly, the field force expansion was actually faster than we anticipated. So we're pleased with where we are in preparation for a June launch. And fourth, we actually continue to have DTC spend for availability in MDD.

Speaker #18: So, as we think about the rest of the year, we would anticipate SG&A will likely increase in Q2, but at a slower rate than what we've seen from Q4 to Q1.

Nick Pizzie: As we think about the rest of the year, we would anticipate SG&A will likely increase in Q2, but at a slower rate than what we've seen from Q4 to Q1 and likely level out shortly thereafter. It's importantly, we should note that we expect to see continued operating leverage in the P&L as top line revenue growth is anticipated to outpace the growth that we expect to see in operating expenses.

Speaker #18: And likely level out shortly thereafter. But importantly, we should note that we expect to see continued operating leverage in the P&L, as top-line revenue growth is anticipated to outpace the growth that we expect to see in operating expenses.

Speaker #20: Yeah. And regarding your question on AXS-12, obviously it's a great time for treatment developments in the narcolepsy space. And we're very excited about the potential for AXS-12 to enter this marketplace.

Ari Maizel: Yeah. Regarding your question on AXS-12, obviously it's a great time for treatment developments in the narcolepsy space. We're very excited about the potential for AXS-12 to enter this marketplace. You know, without sharing specifics around the orexins, I would just say that we're very pleased with the phase 3 clinical trial results. Herriot mentioned earlier, you know, significant reduction in weekly cataplexy attacks, as early as week 1, very safe and tolerable, and demonstrated benefits across a variety of secondary endpoints, including excessive daytime sleepiness and cognition. We think there's a real opportunity for AXS-12 to make a difference for patients. We'll look forward to news regarding the submission.

Speaker #20: Without sharing specifics around the Rexins, I would just say that we're very pleased with the Phase 3 clinical trial results. Ariel mentioned earlier, significant reduction in weekly cataplexy attacks.

Speaker #20: As early as week one, very safe and tolerable. And demonstrated benefits across a variety of secondary endpoints, including excessive daytime sleepiness and cognition. So we think there's a real opportunity for AXS-12 to make a difference for patients.

Speaker #20: And we'll look forward to news regarding the

Speaker #19: Great. Thank you very much.

Madison El-Saadi: Great. Thank you very much.

Speaker #3: Thank you. Next question today is coming from Madison Al-Saadi from B-Riley Securities. Your line is now live.

Operator: Thank you. Next question today is coming from Madison El-Saadi from B. Riley Securities. Your line is now live.

Speaker #21: Hey, congrats on the progress. And thanks for taking our question. A couple related to availability. Our understanding is that long-term care formulary additions are gated by these quarterly reviews.

Madison El-Saadi: Hey, congrats on the progress, and thanks for taking our question. A couple related to Vyleesi. Our understanding is that long-term care formulary additions are gated by these quarterly reviews that facilities have. Just given everything we know in terms of payer coverage, sales force expansion, the general profile, the landscape, curious if there could be a bolus of AD agitation patients. Just as a follow-up, I guess over the next, say, call it 12 months, how many prescribers do you expect may prescribe B-Vyleesi for both depression and for AD agitation? Thanks.

Speaker #21: That facilities have. And so just given everything we know, in terms of payer coverage, Salesforce expansion, the general profile, the landscape—curious if there could be a bolus of AD agitation patients?

Speaker #21: And then, just as a follow-up, I guess over the next, say, call it 12 months, how many prescribers do you expect may prescribe Auvelity for both depression and for AD agitation?

Speaker #21: Thanks.

Speaker #20: Yeah, thanks for the question, Madison. Regarding LTC bolus, I think it's difficult to predict exactly. But our team has been actively engaged with payers and LTC organizations to ensure patient access and availability.

Ari Maizel: Thanks for the question, Madison El-Saadi. Regarding LTC bolus, I think it's difficult to predict exactly. You know, our team has been actively engaged with, you know, payers and LTC organizations to ensure patient access for all Auvelity. You know, we'll have more to share once we get into the commercial launch. In terms of MDD and ADA prescribing, I think it's important to note, we shared this on our call last Friday, that we'll be calling on roughly 68,000 HCPs with our expanded sales team. Approximately half of those targets are considered high volume treaters of both Alzheimer's disease agitation and Major Depressive Disorder.

Speaker #20: So we'll have more to share once we get into the commercial launch. And in terms of MDD and ADA prescribing, I think it's important to note—and we shared this on our call last Friday—that we'll be calling on roughly 68,000 HCPs with our expanded sales team.

Speaker #20: And approximately half of those targets are considered high-volume treaters of both Alzheimer's disease agitation and major depressive disorder. So I think that gives you some sense of the potential for availability to be used across both indications within a single prescriber's or clinician's practice.

Ari Maizel: I think that gives you some sense of the potential for Vyleesi being used across both indications, within a single prescriber or clinician's practice.

Speaker #19: Understood. Congrats again. And thanks.

Madison El-Saadi: Understood. Congrats again, and thanks.

Speaker #3: Thank you. Next question is coming from Rudy Lee from Wolf Research. Your line is now live.

Operator: Thank you. Next question is coming from Rudy Li from Wolfe Research. Your line is now live.

Speaker #22: Hi, thanks for taking my question. Just a quick follow-up to your long-term guidance of AB and availability sales. How should we think about the uptake, maybe for the relatively near term, maybe in the next two to three years?

Rudy Li: Thanks for taking my question. Just a quick follow-up to your long-term guidance of Auvelity and Vyleesi sales. How should we think about the uptake maybe for the relatively near term, maybe in the next two, three years? Just additional color, like, on your key assumptions and what's gonna give you confidence with the trajectory to Auvelity peak sales. Secondly, just can you talk about your OUS development plan for Vyleesi since now we already secured two indications in the US. Thanks.

Speaker #22: Just additional color on your key instructions on what kind of gives you confidence with the trajectory to AB and peak sales. And secondly, can you talk about your OUS development plan for availability?

Speaker #22: Since now we already secured two indications in the US. Thanks.

Speaker #20: Yeah, and thanks for the question. When you think about uptake in the next two to three years, obviously there will be a lot to learn over the next several months as we see our expanded Salesforce in the market for both indications.

Ari Maizel: Yeah. Thanks for the question. You know, when you think about uptake in the next 2 to 3 years, obviously, there will be a lot to learn over the next several months as we see our expanded sales force in the market for both indications. Obviously, the Alzheimer's agitation indication will be new. This is a new launch. It is hard to share specifics on what we expect the uptake to be, but we have seen strong growth in new patient starts and new writer activation within MDD, which we expect to continue.

Speaker #20: And obviously the Alzheimer's agitation indication will be new. So this is a new launch, and so it's hard to share specifics on what we expect the uptake to be.

Speaker #20: But we have seen strong growth in new patient starts and new writer activation. Within MDD, which we expect to continue, and there will be another increase relative to the Alzheimer's agitation market, which shares some common targets with MDD, but there are some distinct targets that we're adding to the call plan for this year.

Ari Maizel: There will be another increase relative to the Alzheimer's agitation market, which shares some common targets with MDD, but there are some distinct targets that we're adding to the call plan for this year. I think we'll have more to share as we get into the Alzheimer's agitation launch. You know, the update to peak sales estimate was guided by our internal analysis and ultimately the final label for agitation, which gives us confidence that in both indications there will be increasing frontline use of the product.

Speaker #20: So I think we'll have more to share as we get into the Alzheimer's agitation launch. But the update to the peak sales estimate was guided by our internal analysis and ultimately the final label for agitation, which gives us confidence that in both indications, there will be increasing first frontline use of the product.

Speaker #19: Yeah. And Rudy, as it relates to OUS, our primary focus is on executing a launch in ADA and successful commercialization in the US while identifying the ideal partner XUS.

Nick Pizzie: Yeah. Rudy, as it relates to OUS, our primary focus is on executing, you know, a launch in ADA and successful commercialization in the US while identifying the ideal partner, ex US. As we said in the past, our plans are to partner ex US, and our primary focus is to ensure that we find a partner that shares our vision for the drug in the future.

Speaker #19: So, as we said in the past, our plans are to partner XUS, and our primary focus is to ensure that we find a partner that shares our vision for the drug and its future.

Speaker #22: Got it. Congrats on the progress.

Rudy Li: Got it. Congrats on the progress.

Speaker #3: Thank you. We reached the end of our question and answer session. I'd like to turn the floor back over for any further closing comments.

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

Speaker #20: Thank you, operator. Axsome today represents a singular CNS platform. With differentiated marketed products and a broad pipeline of potentially first-in-class and best-in-class treatments targeting unmet medical needs in psychiatry and neurology, we are well positioned to deliver substantial long-term value for patients and shareholders.

Herriot Tabuteau: Thank you, operator. Axsome today represents a singular CNS platform. With our differentiated marketed products and a broad pipeline of potentially first-in-class and best-in-class treatments targeting unmet medical needs in psychiatry and neurology, we are well-positioned to deliver substantial long-term value for patients and shareholders. We look forward to providing updates on our progress throughout the balance of the year. Thank you, everyone, for joining us this morning. Have a great day.

Speaker #20: We look forward to providing updates on our progress throughout the balance of the year. Thank you, everyone, for joining us this morning. Have a great day.

Speaker #3: Thank you. That does conclude today's teleconference webcast. You may disconnect from lines at this time and have a wonderful day. We thank you for your participation today.

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