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 ...

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 [4][11] - 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 for the full year, representing a 74% year-over-year increase [12][15] - 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 [15] - Net loss for the full year of 2025 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 [16] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth contributing to overall revenue [4] - 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 [12] - 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 [12] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [18] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [19] - Symbravo's overall payer coverage is approximately 52% at the start of the year, with 49% in commercial and 57% in government channels [21] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications, including a planned phase 2/3 trial of AXS-05 in smoking cessation [5][6] - AXS-12's NDA submission for narcolepsy is expected imminently, with significant progress made following positive FDA pre-NDA meeting minutes [6] - The company plans to expand its sales force to approximately 600 representatives to support growth in MDD and potential Alzheimer's disease agitation [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver upon vast opportunities for the growing portfolio of CNS medicines, supported by a scalable commercial platform [4][18] - The company anticipates continued momentum in its commercial business and expects to generate significant value through disciplined investment and performance across its CNS portfolios [104] Other Important Information - The company ended the year with $323 million in cash and cash equivalents, compared to $315 million at the end of 2024, indicating sufficient funds to support operations into cash flow positivity [17] - Gross and net discounts for Auvelity and Sunosi are expected to increase due to typical Q1 dynamics, with Symbravo's gross net discount remaining elevated during the launch phase [13] 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, indicating potential for supportive evidence in ongoing studies [26][27] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the company is closely assessing different types of epilepsy for potential clinical success [31][33] Question: Auvelity payer coverage evolution post-ADA label addition - Existing coverage is expected to apply to the new indication, with efforts ongoing to ensure sufficient coverage and utilization management [35][36] Question: Initial launch cadence for Alzheimer's agitation - The company is preparing for a launch within a quarter post-approval, with metrics to be shared regarding script percentages from the ADA space [39][69] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access, with steady performance in both OSA and narcolepsy markets [44] Question: DTC campaign progress for Auvelity - The national TV campaign launched in late 2025 has generated positive impacts on new patient starts, with ongoing optimization of media spend [46][48] Question: Coverage expectations for Auvelity at steady state - The goal is to secure access for as many patients as possible, with steady progress in increasing covered lives anticipated [50][52] Question: AXS-12 opportunity in narcolepsy - AXS-12 offers compelling treatment options for patients, with strong data in cataplexy and potential benefits in excessive daytime sleepiness [72][74]

4Q and Full Year 2025 Financial Results February 23, 2026 © Axsome Therapeutics, Inc. Forward looking statements & safe harbor Certain matters discussed in this presentation are "forward-looking statements" . The Company may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward- looking ...

Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively,representing 65% and 66% year-over-year growth AUVELITY® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively,representing 68% and 74% year-over-year growth SUNOSI® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively,representing 40% and 32% year-over-year growth SYMBRAVO® 4Q and full year 2025 net product sales of $4.1 million and $ ...

Core Insights - Axsome Therapeutics is gaining prominence in the biotech sector, outperforming broader equities over the past five years and showing potential for continued strong performance over the next decade [1][2] Company Overview - Axsome Therapeutics specializes in developing medicines for central nervous system conditions, with approved products like Auvelity for depression and Symbravo for migraines [4] - The company is also advancing AXS-12 for narcolepsy, which has completed phase 3 clinical trials, with regulatory submissions expected in Q4 [6] Market Opportunity - The market for Alzheimer's disease (AD) agitation, which affects over 5 million patients in the U.S., presents a significant commercial opportunity, especially as the aging population increases [5] - Auvelity is positioned to enter a growing market with high unmet needs and limited competition [5] Financial Potential - Axsome's late-stage pipeline has a peak sales potential exceeding $16 billion, while the current market cap stands at $9.3 billion [8] - The company enjoys a gross margin of 90.31% and has patent protection for its products until the 2040s, mitigating risks associated with patent cliffs [8]

The anticipated EPS of -$0.70 and revenue of $193.3 million for the quarter ending December 2025.Negative P/E ratio of -40.57 but potential growth indicated by revenue projections.Concerns over negative operating cash flow with an enterprise value to operating cash flow ratio of -91.91.Axsome Therapeutics, listed on NASDAQ:AXSM, is a biopharmaceutical company focused on developing therapies for central nervous system disorders. The company is set to release its quarterly earnings on February 23, 2026. Wall ...

Core Insights - Axsome Therapeutics, Inc. is set to present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026, at 2:00 p.m. ET, highlighting its role in CNS disorder treatments [1] - The company focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS conditions [3] Company Overview - Axsome Therapeutics is a biopharmaceutical company dedicated to addressing critical gaps in CNS care, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness, and migraine [3] - The company has multiple early and late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Investor Information - A live webcast of the upcoming presentation will be available on the company's website, with a replay accessible for approximately 30 days post-event [2]

Core Viewpoint - Axsome Therapeutics has reached a settlement with Alkem Laboratories regarding patent litigation over its product SUNOSI, allowing Alkem to market a generic version under specific conditions starting in 2040 [1][2]. Group 1: Settlement Agreement - Axsome will grant Alkem a license to sell a generic version of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not [1]. - The settlement is a result of Alkem's submission of an Abbreviated New Drug Application to the FDA for a generic version of SUNOSI [1]. Group 2: Regulatory Review - The settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review as required by law [2]. - Axsome is also involved in similar patent litigation against another party related to SUNOSI, which remains pending in the U.S. District Court for the District of New Jersey [2]. Group 3: Company Overview - Axsome Therapeutics focuses on treating central nervous system disorders and has a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness, and migraines [3]. - The company aims to address significant gaps in care and develop differentiated products to improve patient outcomes [3].