Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on February 25, 2026 Core Business and Product Performance - **Product**: Auvelity for Major Depressive Disorder (MDD) - **Sales Achievement**: Over $500 million in sales in 2025, three years post-launch [2] - **Salesforce Expansion**: Increased from 300 to 600 sales representatives to enhance market penetration, particularly in primary care [4] - **Market Access**: Improved access with 86% of covered lives, including 100% in the government channel [7][8] - **First Line Prescriptions**: 50% of total prescriptions are for first line or first switch patients [8] Market Dynamics and Growth Drivers - **Uptake Drivers**: Increased awareness, trial engagement, and a differentiated product profile leading to positive patient outcomes [9] - **Retention Rates**: Currently tracking in line with typical antidepressant persistence, with over 50% of patients being first line or first switch [11][12] - **Alzheimer's Disease Agitation (ADA) Opportunity**: Anticipation of FDA's PDUFA date on April 30, 2026, for Auvelity's indication in Alzheimer's agitation [15] Clinical Data and Regulatory Insights - **Clinical Trials**: Four controlled trials conducted, with three positive outcomes supporting efficacy and safety [22][23] - **Safety Profile**: No significant safety concerns noted, particularly regarding falls or mortality in the elderly population [24] - **Market Size for ADA**: Approximately 5 million Alzheimer's patients experience agitation, with 20 million scripts written annually, predominantly off-label [20] Go-to-Market Strategy - **Pre-launch Activities**: Non-branded campaigns to raise awareness about Alzheimer's agitation and education for healthcare providers [27] - **Reimbursement Strategy**: Full coverage anticipated for Medicare Part D, which constitutes over 70% of total scripts for Alzheimer's agitation [28] - **Expected GTN Improvement**: Anticipated better gross-to-net (GTN) for ADA scripts compared to MDD due to the nature of Medicare Part D [28] Future Catalysts and Pipeline - **Upcoming Trials**: Ongoing trials for binge eating disorder (BED) and shift work disorder, with top-line results expected in the second half of 2026 [35][36] - **New Product AXS-12**: NDA submission imminent, leveraging existing sales force for potential launch in narcolepsy [39] - **New Asset AXS-17**: Recently in-licensed for epilepsy, complementing the existing CNS pipeline [42] Financial Outlook - **Cash Flow Positivity**: Near-term expectations for cash flow positivity remain unchanged, with recent quarters showing close to cash flow positive results [53][54] - **Sales Projections**: Peak sales for Auvelity projected between $2.5 billion and $6 billion, viewed as achievable based on current market dynamics [34] Conclusion - Axsome Therapeutics is positioned for significant growth with its product Auvelity, particularly in the MDD and Alzheimer's agitation markets. The company is actively expanding its sales force, improving market access, and preparing for upcoming product launches and regulatory approvals. The financial outlook remains positive, with a focus on achieving cash flow positivity and leveraging its robust pipeline for future growth.

Key Takeaways AXSM reported a Q4 loss of 71 cents, missing estimates even as revenues rose 65% to $196M.Auvelity sales climbed 68% Y/Y to $155.1M, with prescriptions up 42% year over year in Q425.Axsome's Sunosi sales rose 40% Y/Y, while newly launched Symbravo generated $4.1M in Q4.Axsome Therapeutics (AXSM) incurred a loss of 71 cents per share in the fourth quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 70 cents. The company had incurred a loss of 96 cents per share in the year-ago ...

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.Considering buying THRM stock? Here’s what analysts think: Photo via Shutterstock ...

NEW YORK, Feb. 24, 2026 (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 that the first patient has been dosed in the CLARITY Phase 3 trial of solriamfetol in the treatment of major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms. CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-37635 AXSOME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or ot ...

Core Insights - Axsome Therapeutics reported an earnings per share (EPS) of -$0.56 for February 23, 2026, which was better than the expected -$0.70, indicating better-than-anticipated performance [1] - The company achieved a revenue of approximately $196 million, surpassing the estimated $193.3 million, suggesting successful sales growth [2] Financial Metrics - The price-to-sales ratio stands at 16.50, reflecting investor confidence in the company's future growth potential [2] - Axsome has a negative P/E ratio of -40.04 and an earnings yield of -2.50%, indicating a lack of profitability [3] - The current ratio of 1.57 suggests a reasonable level of short-term liquidity to cover current liabilities [3] Valuation and Debt - The enterprise value to sales ratio is 16.31, indicating that the company's valuation is closely tied to its revenue [4] - The enterprise value to operating cash flow ratio is significantly negative at -90.69, highlighting challenges in generating positive cash flow from operations [4] - The debt-to-equity ratio of 2.96 indicates a higher level of debt compared to equity, which could pose risks if the company cannot generate sufficient cash flow to service its debt [4]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston Bi ...

For the quarter ended December 2025, Axsome Therapeutics (AXSM) reported revenue of $196 million, up 65% over the same period last year. EPS came in at -$0.71, compared to -$0.96 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $193.01 million, representing a surprise of +1.55%. The company delivered an EPS surprise of -1%, with the consensus EPS estimate being -$0.70.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 increased 65% year-over-year to $196 million, and for the full year increased 66% to $639 million [6][12] - Net product sales of Auvelity for Q4 were $155.1 million, up 68% compared to the prior year, and total sales for Auvelity reached $507.1 million, representing a 74% year-over-year increase [12][13] - Net loss for Q4 was $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share for Q4 2024 [16] - Net loss for the full year was $183.2 million, or $3.68 per share, compared to a net loss of $287.2 million, or $5.99 per share for 2024 [17] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth in prescriptions [6][19] - Sunosi generated net product revenue of $36.7 million for Q4, a 40% increase compared to Q4 2024, and $124.8 million for the full year, representing a 32% increase [13] - Symbravo generated $4.1 million in net sales for Q4 and $6.6 million for the full year, following its second full quarter of launch [13] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [19] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [20] - Symbravo's overall payer coverage is approximately 52% at the start of the year [22] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications [6] - Plans to conduct two Phase 3 trials in ADHD, one in children and one in adolescents, are on track for initiation in the first half of the year [9] - The company aims to expand its sales force to approximately 600 representatives to support growth in MDD and potential launch in Alzheimer's disease agitation [21][59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver new treatment options for patients living with CNS disorders, supported by a scalable commercial platform [6][11] - The company anticipates that its current cash balance is sufficient to fund operations into cash flow positivity based on the current operating plan [17] - Management is optimistic about the potential impact of the upcoming launch for Alzheimer's disease agitation, with preparations underway [69] Other Important Information - The company has made significant progress with its NDA package for AXS-12 in narcolepsy and expects to submit that imminently [8] - The acquisition of AZD7325, a novel oral GABA A alpha-2/3 receptor positive allosteric modulator, is planned for evaluation in epilepsy [10] Q&A Session Summary Question: Implications of the new FDA publication on the one trial policy - Management is assessing the implications and will continue to vet clinical plans with the FDA [28] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the focus is currently on preparing for Phase II readiness [33] Question: Coverage evolution for Auvelity post-ADA label approval - Existing coverage should generally apply to the new indication, but there may be additional efforts needed for Medicare coverage [36] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access across OSA and narcolepsy markets [44] Question: Sales force expansion rationale - The expansion aims to accelerate growth in MDD and prepare for potential Alzheimer's agitation indication [59] Question: Coverage evolution for Symbravo - The secured contract with a third large GPO allows for active negotiation with payers, with optimism for increased coverage [63]

Axsome Therapeutics (NasdaqGM:AXSM) Q4 2025 Earnings call February 23, 2026 08:00 AM ET Company ParticipantsAndrew Tsai - Managing DirectorAri Maizel - Chief Commercial OfficerAshley Dong - Director of Investor RelationsDavid Hong - Senior Portfolio ManagerGraig Suvannavejh - Managing DirectorHerriot Tabuteau - CEOMark Jacobson - COOMatthew Harrison - Equity Research AssociateNick Pizzie - CFOPete Stavropoulos - Director of Biotech Equity ResearchSean Laaman - Executive DirectorConference Call ParticipantsA ...