Financial Data and Key Metrics Changes - Total product revenues for Q1 2025 were $121.5 million, representing a year-over-year growth of 62% compared to $75 million in Q1 2024 [16][17] - Net loss for Q1 2025 was $59.4 million or $1.22 per share, an improvement from a net loss of $68.4 million or $1.44 per share in Q1 2024 [20] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [20] Business Line Data and Key Metrics Changes - Avelity net product sales were $96.2 million for Q1 2025, representing 80% year-over-year growth from $53.4 million in Q1 2024 [17] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year increase from $21.6 million in Q1 2024 [17][18] - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [21] Market Data and Key Metrics Changes - Avelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% in the commercial segment [22] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [23] - Payer coverage for Sunosi was stable with 83% of lives covered across channels [25] Company Strategy and Development Direction - The company aims to advance three novel NDA stage product candidates: AXS-fourteen for fibromyalgia, AXS-five for Alzheimer's disease agitation, and AXS-twelve for narcolepsy [6][10] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [6] - The company anticipates a strong launch for Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate trade policy developments, stating that any potential impact would be immaterial [13] - The company expects 2025 to be a catalyst-rich year with potentially five marketed products across six indications by 2026 [15] - Management remains optimistic about achieving cash flow positivity based on the current operating plan [20][96] Other Important Information - The company has submitted an NDA for AXS-fourteen and anticipates a decision in Q2 2025 [7] - AXS-five has been granted breakthrough therapy designation by the FDA, with an sNDA submission planned for Q3 2025 [9] - The company is closely monitoring the competitive landscape, particularly regarding new entrants in the narcolepsy treatment space [35] Q&A Session Summary Question: Recent interactions with the FDA regarding developmental agents - Management indicated that dialogue with the FDA remains status quo and no changes have been noted regarding review teams or agency responsiveness [30] Question: DTC advertising plans for Avelity - A national campaign is expected to launch later this year, with a focus on engaging patients [34] Question: Coverage expectations for Avelity - Management aims to increase the number of covered lives and reduce utilization management barriers [68] Question: Expected cadence of coverage for Cymbravo - Management is focused on securing access quickly, acknowledging the competitive market [48] Question: Sales potential for AXS-fourteen in fibromyalgia - Management is enthusiastic about the market opportunity, with approximately 17 million people diagnosed in the U.S. [63] Question: Profitability outlook for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on timing for profitability [96]

Revenue Growth - Total net product revenue for Q1 2025 was $121.5 million, representing 62% year-over-year growth from $75.0 million in Q1 2024[5] - AUVELITY net product sales reached $96.2 million in Q1 2025, an 80% increase from $53.4 million in Q1 2024[5] - SUNOSI net product revenue was $25.2 million for Q1 2025, reflecting a 17% growth from $21.6 million in Q1 2024[8] - Total revenues for Q1 2025 reached $121.463 million, a 62% increase compared to $74.999 million in Q1 2024[31] - Product sales, net for Q1 2025 were $120.358 million, up from $74.096 million in the same period last year, reflecting a significant growth[31] Prescription and Payer Coverage - Approximately 167,000 prescriptions were written for AUVELITY in Q1 2025, a 76% increase compared to the same period in 2024[9] - Payer coverage for AUVELITY is approximately 78% across all channels, with 63% in commercial and 100% in government channels[9] Regulatory Developments - SYMBRAVO received FDA approval for acute migraine treatment, with commercial launch expected in June 2025[10] - NDA for AXS-14 for fibromyalgia has been submitted, with FDA decision anticipated in Q2 2025[18] - Supplemental NDA for AXS-05 in Alzheimer's disease agitation is on track for submission in Q3 2025[18] Financial Performance - Net loss for Q1 2025 was $59.4 million, or $(1.22) per share, compared to a net loss of $68.4 million, or $(1.44) per share, in Q1 2024[5] - Operating expenses totaled $178.445 million in Q1 2025, compared to $142.274 million in Q1 2024, indicating a 25% increase[31] - The net loss for Q1 2025 was $59.413 million, an improvement from a net loss of $68.357 million in Q1 2024[31] - The company reported a basic and diluted net loss per common share of $1.22 for Q1 2025, an improvement from $1.44 in Q1 2024[31] Cash and Assets - Cash and cash equivalents totaled $300.9 million as of March 31, 2025, down from $315.4 million at the end of 2024[5] - Cash and cash equivalents as of March 31, 2025, were $300.910 million, slightly down from $315.353 million at the end of 2024[29] - Total assets increased to $596.671 million as of March 31, 2025, compared to $568.498 million at the end of 2024[29] - The company’s accounts receivable increased to $161.398 million as of March 31, 2025, from $142.001 million at the end of 2024[29] Research and Development - Research and development expenses rose to $44.785 million in Q1 2025, compared to $36.830 million in Q1 2024, reflecting ongoing investment in product development[31] - Axsome Therapeutics is focused on expanding payer coverage and advancing clinical trials for its product candidates, including SUNOSI, AUVELITY, and SYMBRAVO[26]

Financial Performance - Total net product revenue for Q1 2025 was $121.5 million, reflecting a 62% increase year-over-year from $75.0 million in Q1 2024 [4] - AUVELITY® generated net product sales of $96.2 million in Q1 2025, an 80% increase from $53.4 million in Q1 2024 [4] - SUNOSI® reported net product revenue of $25.2 million in Q1 2025, a 17% increase from $21.6 million in Q1 2024 [4] - The net loss for Q1 2025 was $59.4 million, or $(1.22) per share, compared to a net loss of $68.4 million, or $(1.44) per share, in Q1 2024 [11] Product Developments - SYMBRAVO® received FDA approval for the acute treatment of migraine, with a commercial launch expected in June 2025 [3][8] - NDA for AXS-14 for fibromyalgia management has been submitted to the FDA, with a decision anticipated in Q2 2025 [3][19] - Supplemental NDA for AXS-05 in Alzheimer's disease agitation is on track for submission in Q3 2025 [3][16] - NDA submission for AXS-12 for cataplexy in narcolepsy patients is expected in the second half of 2025 [3][18] Clinical Trials and Pipeline - Positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD were announced, with plans to initiate a Phase 3 trial in pediatric patients in 2025 [13] - A Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness is also anticipated in 2025 [13] - The EMERGE Phase 3 trial of SYMBRAVO in migraine patients with inadequate response to oral CGRP inhibitors showed positive results [14] Market Position and Coverage - Approximately 167,000 prescriptions for AUVELITY were written in Q1 2025, a 76% increase year-over-year [12] - Payer coverage for AUVELITY is approximately 78% across all channels, with 63% in commercial and 100% in government channels [12] - SUNOSI had about 46,000 prescriptions written in Q1 2025, a 12% increase year-over-year [12] Financial Guidance and Cash Position - The company believes its current cash position of $300.9 million is sufficient to fund operations until reaching cash flow positivity [5] - Total cost of revenue for Q1 2025 was $9.8 million, up from $6.3 million in Q1 2024 [4]

Core Viewpoint - Axsome Therapeutics is collaborating with Mental Health America to raise awareness and promote action during Mental Health Month, highlighting the importance of mental health and the impact of mental health conditions in the U.S. [1][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) disorders, aiming to improve the lives of individuals with serious conditions that are difficult to treat [4][7]. - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [7] Mental Health Statistics - Nearly 1 in 4 adults in the U.S. live with a mental illness, and more than 1 in 8 individuals aged 12 or older reported feeling depressed in the past two weeks, indicating a significant prevalence of mental health issues [3]. - Approximately 90% of individuals living with depression experience difficulties in work, home, or social activities due to their symptoms, which complicates daily life [3] Advocacy and Resources - Axsome is promoting resources for individuals and communities to take action regarding mental health, including Mental Health America's Action Guide, online screening tools, youth leadership programs, and opportunities to become mental health advocates [4][6]. - The 988 Suicide & Crisis Lifeline is highlighted as a confidential support service available 24/7, connecting individuals in crisis with trained counselors [5].

Company Overview - Axsome Therapeutics (AXSM) shares increased by 4.2% to close at $101.67, following a broader market rally after President Trump's announcement of a 90-day pause on tariffs against non-retaliating countries [1] - The stock had previously experienced an 18.4% loss over the past four weeks [1] Financial Performance - Axsome is expected to report a quarterly loss of $1.25 per share, reflecting a year-over-year decline of 14.7% [2] - Revenue projections for the upcoming quarter are $119.74 million, which is a significant increase of 59.7% compared to the same quarter last year [2] Earnings Estimates and Trends - The consensus EPS estimate for Axsome has been revised 6.8% higher in the last 30 days, indicating a positive trend that typically correlates with price appreciation [3] - Empirical research suggests a strong correlation between earnings estimate revisions and near-term stock price movements, highlighting the importance of monitoring these trends [2][3] Industry Context - Axsome operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies such as Emergent Biosolutions (EBS) [3] - Emergent Biosolutions' consensus EPS estimate remains unchanged at $0.71, representing a year-over-year increase of 20.3% [4]

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of Axsome Therapeutics, Inc. related to misrepresentation of the company's practices and prospects [1] Group 1: Allegations of Misrepresentation - Insiders at Axsome allegedly caused the company to misrepresent or fail to disclose deficiencies in its chemistry, manufacturing, and control (CMC) practices concerning AXS-07 [2] - As a result of these deficiencies, Axsome was unlikely to submit the AXS-07 New Drug Application (NDA) on the initially represented timeline [2] - The unresolved CMC issues were present during the FDA's review of the AXS-07 NDA, leading to a low likelihood of FDA approval [2] - Consequently, Axsome overstated AXS-07's regulatory and commercial prospects, making the company's public statements materially false and misleading [2]

Core Viewpoint - Axsome Therapeutics, Inc. is set to report its financial results for Q1 2025 on May 5, 2025, and will host a conference call to discuss these results and provide a business update [1] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [3] - The company aims to address significant gaps in care by developing differentiated products with novel mechanisms of action, impacting over 150 million people in the United States [3] Conference Call Details - The conference call will take place at 8:00 a.m. Eastern Time on May 5, 2025, following the financial results announcement [1] - Participants can join the call by dialing (877) 405-1239 for domestic calls or +1 (201) 389-0851 for international calls, with a live webcast available on the company's website [2]

Core Insights - Axsome Therapeutics is presenting results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 for Alzheimer's disease agitation at the 2025 AAN Annual Meeting [1][2] - The company is also showcasing data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy and a network meta-analysis comparing SYMBRAVO® to oral CGRPs for migraine treatment [2] Alzheimer's Disease Agitation - Title of the presentation: "Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study" [3] - Oral presentation scheduled for April 7, 11:27 - 11:33 a.m. PT, with a poster presentation following from 12:09 - 12:45 p.m. PT [3] Narcolepsy - Title of the presentation: "AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial" [3] - Oral presentation scheduled for April 8, 10:45 - 11 a.m. PT [3] - Additional poster presentation titled "CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1" on April 8, 8 - 9 a.m. PT [3] Migraine - Title of the presentation: "Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis" [4] - Poster presentation scheduled for April 8, 5 - 6 p.m. PT [4] - SYMBRAVO is a novel oral medication approved for acute migraine treatment, combining MoSEIC™ meloxicam and rizatriptan [5][6] Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [35] - The company aims to address significant gaps in care and improve patient outcomes through novel mechanisms of action [35]

Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology po ...

Core Insights - Axsome Therapeutics is presenting results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 for Alzheimer's disease agitation at the 2025 AAN Annual Meeting [1][2] - The company is also showcasing data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy and a network meta-analysis comparing SYMBRAVO® to oral CGRPs for migraine treatment [2] Alzheimer's Disease Agitation - Title of the presentation: "Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study" [3] - Oral presentation scheduled for April 7, 2025, from 11:27 to 11:33 a.m. PT [3] - Poster presentation on the same day from 12:09 to 12:45 p.m. PT [3] Narcolepsy - Title of the presentation: "AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial" [3] - Oral presentation scheduled for April 8, 2025, from 10:45 to 11 a.m. PT [3] - Additional poster presentation titled "CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1" on April 8, 2025, from 8 to 9 a.m. PT [3] Migraine - Title of the presentation: "Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis" [4] - Poster presentation scheduled for April 8, 2025, from 5 to 6 p.m. PT [4] - SYMBRAVO is a novel oral medication approved for acute migraine treatment, combining MoSEIC™ meloxicam and rizatriptan [5][6] Company Overview - Axsome Therapeutics focuses on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine [34][35] - AXS-05 is an investigational drug for Alzheimer's disease agitation and smoking cessation, utilizing a proprietary formulation of dextromethorphan and bupropion [32] - AXS-12 is under development for narcolepsy and has received FDA Orphan Drug Designation [33]