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    AXSM
    Earnings call· Jun 2026(Q2 FY26)

    Axsome Therapeutics Q2 FY26 earnings call AXSM

    Aug 10, 2026 Source

    Executive summary

    Axsome Therapeutics Q2 FY26 — Robust Commercial Growth and Pipeline Advancement

    Axsome Therapeutics delivered strong Q2 FY26 results, driven by robust commercial performance of Auvelity and Sunosi, alongside significant pipeline progress. The launch of Auvelity for Alzheimer's disease agitation shows promising early uptake, supported by an expanded sales force. The company remains focused on advancing its neuroscience pipeline with multiple late-stage candidates and maintaining a strong financial position to fund future growth.

    Highlights

    5
    • Net product revenue increased to $218 million, representing a 46% year-over-year growth.

    • Auvelity net product sales grew 51% year-over-year to $180.3 million and 18% quarter-over-quarter.

    • Auvelity new-to-brand prescriptions (NBRx) in patients 65 years and older increased 126% in the first 8 weeks post-Alzheimer's disease agitation launch.

    • Overall Auvelity NBRx increased 26% quarter-over-quarter, with total prescriptions up 12% sequentially.

    • SYMBRAVO demand grew 30% quarter-over-quarter to approximately 23,500 total prescriptions.

    Concerns

    3
    • SYMBRAVO gross-to-net discount deviated into the high 80% range in the quarter due to a prior period adjustment and increased patient service program utilization.

    • Net loss for the quarter was $51.3 million, or $0.99 per share.

    • Cash and cash equivalents decreased slightly to $320 million as of quarter-end, compared to $323 million at the end of 2025.

    Guidance & targets

    8
    CategoryTargetConfidence
    Cash balance sufficiency
    Sufficient to fund anticipated operations into cash flow positivity
    high materiality
    High
    SYMBRAVO Gross-to-Net (GTN) discount
    Return to prior levels
    medium materiality
    High
    Auvelity and Sunosi Gross-to-Net (GTN) discount
    Improve throughout the year
    medium materiality
    High
    New NDA filings
    On average one new NDA each year
    high materiality
    High
    AXS-05 Phase II/III trial initiation
    Initiate planned Phase II/III trial
    medium materiality
    High
    Solriamfetol ENGAGE Phase III trial top-line results
    Anticipate top line results
    high materiality
    High
    AXS-20 Phase III trial initiation
    Goal of initiating a Phase III trial
    medium materiality
    Medium
    SG&A expenses
    Anticipated to essentially plateau to where we are this quarter in Q2 of $208 million
    medium materiality
    High

    Segment performance

    4
    SegmentRevenueYoYQoQMargin
    Commercial Portfolio (Total)
    Driven by strong performance across Auvelity, Sunosi, and SYMBRAVO.
    Net product revenue: $218MYear-over-year growth: 46%
    $218M46%
    Auvelity
    Strong growth driven by MDD and early uptake in Alzheimer's disease agitation, supported by sales force expansion. Outpacing the antidepressant market.
    Net product sales: $180.3MYear-over-year growth: 51%Quarter-over-quarter growth: 18%Total prescriptions: 266,000Total prescriptions YoY growth: 34%Total prescriptions sequential growth: 12%New-to-brand prescriptions QoQ growth: 26%New-to-brand prescriptions (65+ patients) post-launch increase: 126%New prescribers activated: 6,800New prescribers activated QoQ growth: 21%Total unique prescribers since launch: 69,000Market access coverage: 89% of total livesCommercial lives coverage: 82%Government channel coverage: 100%
    $180.3M51%18%
    Sunosi
    Delivered durable growth, outpacing the wake-promoting agent market. Maintained broad payer coverage.
    Net product revenue: $35.8MYear-over-year growth: 20%Net product sales: $33.8MRoyalty revenue: $1.5MMilestone revenue: $0.5MTotal prescriptions: 61,000Total prescriptions YoY growth: 14%Total prescriptions sequential growth: 8%Clinicians prescribed since launch: 17,000+Payer coverage: 82% of lives
    $35.8M20%
    SYMBRAVO
    Strong underlying demand and positive feedback. Sales force expansion substantially complete to support continued growth and market penetration.
    Net product sales: $2.3MTotal prescriptions: 23,500Total prescriptions QoQ growth: 30%Sales force expansion: 150 representativesPayer coverage: 57% of livesCommercial lives coverage: 56%Government lives coverage: 57%
    $2.3M

    Operational metrics

    12
    Cost of revenue
    $13.6M
    Q2 FY26

    Compared to $13.4 million in Q2 FY25.

    Research and development expenses
    $46.2Mdecreased from $49.5M in Q2 FY25
    Q2 FY26

    Primarily reflects lower costs associated with AXS-05 and AXS-14.

    Selling, general and administrative expenses
    $208.1Mincreased from $130.3M in Q2 FY25
    Q2 FY26

    Primarily driven by commercialization activities for Auvelity and SYMBRAVO.

    EPS
    $0.99 losscompared to $0.97 loss per share in Q2 FY25
    Q2 FY26

    Net loss for the quarter was $51.3 million, including $27.1 million in stock-based compensation expense.

    Stock-based compensation expense
    $27.1M
    Q2 FY26

    Included in net loss for the quarter.

    Cash and cash equivalents
    $320Mcompared to $323M as of end of 2025
    Q2 FY26

    Sufficient to fund anticipated operations into cash flow positivity.

    SYMBRAVO gross-to-net discount
    high 80%deviated from trend
    Q2 FY26

    Due to a prior period adjustment and increased utilization of patient service program. Anticipated to return to prior levels for the remainder of the year.

    Auvelity gross-to-net discount
    approximately 50%
    Q2 FY26

    Anticipated to improve throughout the year, consistent with prior year trends.

    Sunosi gross-to-net discount
    approximately 50%
    Q2 FY26

    Anticipated to improve throughout the year, consistent with prior year trends.

    Operating leverage
    Revenues growing at 14%, OpEx growing at 7%
    Q2 FY26

    Continued improvement in operating leverage observed.

    Antidepressant market growth
    1%YoY
    Q2 FY26

    Auvelity substantially outpaced the market.

    Wake-promoting agent market growth
    1% declineYoY
    Q2 FY26

    Sunosi outpaced the market.

    Industry KPIs

    5
    MetricValueDetails
    Prescription volume266,000prescriptions
    Pipeline clinical milestones6 innovative product candidatescandidates
    Regulatory approvals filingsNDA accepted
    Therapeutic drug market sharegains
    Clinical trial efficacy safety datasignificant treatment effect

    Risks & headwinds

    2
    SYMBRAVO gross-to-net discount deviationQ2 FY26

    High 80% range

    Mitigation: Anticipate SYMBRAVO-GTN to return to prior levels for the remainder of the year.

    Net lossQ2 FY26

    $51.3 million or $0.99 per share

    Mitigation: Continued improvement in operating leverage; current cash balance sufficient to fund operations into cash flow positivity.

    What to watch in Q3 FY26

    5

    Auvelity NBRx growth in ADA (65+ patients)

    Next quarter (Q3 FY26)
    Current126% increase in first 8 weeks post-launch
    TargetContinued strong growth/acceleration

    Why it matters

    Key indicator of successful market penetration and adoption in a new, significant indication.

    Regarding Alzheimer's disease agitation, during the first 8 weeks following the launch in this indication, new-to-brand prescriptions among patients 65 years of age and older increased 126% compared to the same period in the prior quarter.

    Q&A highlights

    6

    Can you discuss trends and enthusiasm in long-term care settings for Auvelity's ADA launch, including any successes or challenges?

    Early data is encouraging, with strong new-to-brand prescription growth in patients aged 65 and older. Positive feedback is consistent across both community and long-term care settings, though it's too early to provide specific details on care settings.

    we're really encouraged by some of the early data we're seeing, the early patient experience has been very promising. We're seeing strong growth in new-to-brand prescriptions in patients aged 65 and older. And that feedback is consistent from both the community and long-term care settings.

    asked by Leonid Timashev · answered by Ari Maizel

    2 min read6 chapters

    Detailed Narrative

    01

    Commercial Portfolio Performance

    Axsome's commercial portfolio generated $218 million in net product revenue for Q2 FY26, marking a 46% year-over-year increase. This growth was primarily driven by Auvelity, which saw net product sales of $180.3 million (up 51% YoY), alongside steady contributions from Sunosi ($35.8 million, up 20% YoY) and SYMBRAVO ($2.3 million). The company highlighted continued improvement in operating leverage, with revenues growing faster than operating expenses, while still investing in key commercial and pipeline priorities.

    02

    Auvelity Alzheimer's Disease Agitation Launch

    The recent launch of Auvelity for Alzheimer's disease agitation (ADA) is showing promising early indicators. In the first 8 weeks post-launch, new-to-brand prescriptions (NBRx) among patients 65 years and older increased by 126% compared to the prior quarter. This early adoption is supported by positive anecdotal feedback from prescribers regarding Auvelity's differentiated clinical profile, including rapid reduction in agitation symptoms and a favorable safety/tolerability profile. The expanded Auvelity sales force activated over 6,800 new prescribers, contributing to a 26% sequential increase in overall NBRx.

    03

    SYMBRAVO and Sunosi Momentum

    SYMBRAVO demonstrated strong underlying demand, with total prescriptions growing 30% quarter-over-quarter to approximately 23,500. Positive feedback from patients and providers supports the commercial strategy to drive prescription volume and improve market access. Payer coverage for SYMBRAVO has expanded to approximately 57% of lives. Sunosi continued its durable growth, with approximately 61,000 total prescriptions written, representing a 14% year-over-year and 8% sequential increase, outpacing the broader wake-promoting agent market. Sunosi maintains broad payer coverage at 82% of lives.

    04

    Pipeline Advancement and Regulatory Milestones

    Axsome's neuroscience pipeline achieved several key milestones. The FDA accepted the NDA submission for AXS-12 for cataplexy in narcolepsy, setting a PDUFA target action date of May 1, 2027. The company is on track to initiate a Phase II/III trial for AXS-05 in smoking cessation this quarter. Additionally, top-line results for the Solriamfetol ENGAGE Phase III trial in binge-eating disorder are anticipated in the fourth quarter of this year. Enrollment is also progressing for AXS-14 in fibromyalgia.

    05

    Strategic Pipeline Expansion

    The company is advancing a broad late-stage neuroscience pipeline comprising 6 innovative product candidates targeting 10 serious conditions. This strategy aims to file, on average, one new NDA each year between now and 2030, leveraging novel mechanisms of action and differentiated clinical profiles to create significant value. This includes ongoing Phase III trials for Solriamfetol across four new indications (ADHD, binge-eating disorder, MDD with EDS, EDS with shift work disorder), and advancing AXS-20 (schizophrenia) and AXS-17 (epilepsy).

    06

    Financial Position and Operating Leverage

    Axsome ended Q2 FY26 with approximately $320 million in cash and cash equivalents, which management expects to be sufficient to fund operations into cash flow positivity. While selling, general and administrative (SG&A) expenses increased to $208.1 million due to commercialization activities for Auvelity and SYMBRAVO, the company noted continued improvement in operating leverage. R&D expenses decreased to $46.2 million, primarily due to lower costs associated with AXS-05 and AXS-14.

    AI-generated summary of the company’s earnings call. Not investment advice.