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    AXSM
    Earnings call· Mar 2026(Q1 FY26)

    Axsome Therapeutics Q1 FY26 earnings call AXSM

    May 4, 2026 Source

    Executive summary

    Axsome Therapeutics Q1 FY26 — AUVELITY Peak Sales Outlook Raised to $8B Following ADA Approval

    Axsome Therapeutics delivered strong Q1 FY26 results, driven by robust commercial performance of AUVELITY and SUNOSI, and a significant FDA approval for AUVELITY in Alzheimer's disease agitation. This approval led to a substantial increase in the product's peak sales outlook and prompted sales force expansion. The company continues to advance a broad, late-stage neuroscience pipeline, with several key regulatory submissions and clinical trial initiations planned, positioning it for sustained long-term growth.

    Highlights

    5

    • Total revenue grew 57% year-over-year to $191.2 million in Q1 FY26, driven by commercial products.

    • AUVELITY net product revenue increased 59% year-over-year to $153.2 million in Q1 FY26.

    • FDA approved AUVELITY for agitation associated with Alzheimer's disease, a first-in-class treatment.

    • AUVELITY peak annual revenue outlook was raised to at least $8 billion, with equal contribution from MDD and ADA indications.

    • AXS-12 NDA for cataplexy in narcolepsy was submitted to the FDA.

    Concerns

    3

    • Net loss for the quarter was $64.5 million, or $1.26 per share, compared to $59.4 million or $1.22 per share in Q1 FY25.

    • Selling, general and administrative expenses increased to $185 million from $120.8 million in Q1 FY25, primarily due to AUVELITY launch activities and sales force expansion.

    • SYMBRAVO gross-to-net discount remained elevated in the high 70% range, expected to continue in the near term.

    Guidance & targets

    10
    CategoryTargetConfidence
    AUVELITY Annual Peak Revenue
    at least $8 billion
    high materiality
    High
    SUNOSI Annual Peak Revenue
    $300 million to $500 million
    medium materiality
    High
    SYMBRAVO Annual Peak Revenue
    $500 million to $1 billion
    medium materiality
    High
    AUVELITY ADA Commercial Launch
    June
    high materiality
    High
    AXS-05 Smoking Cessation Phase II/III Trial Initiation
    this quarter
    medium materiality
    High
    Solriamfetol ADHD Pediatric Phase III Trials Initiation
    this quarter
    medium materiality
    High
    Solriamfetol Binge-eating Disorder (ENGAGE Phase III) Top-line Results
    second half of this year
    medium materiality
    High
    Solriamfetol Shift Work Disorder Phase III Top-line Results
    2027
    medium materiality
    High
    AXS-20 Schizophrenia Phase III Trial Initiation
    around the end of the year
    medium materiality
    Medium
    Cash runway
    into cash flow positivity
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    AUVELITY
    Strong growth driven by increased market access, awareness, and expanded primary care adoption. FDA approval for Alzheimer's disease agitation significantly expands market potential.
    Prescriptions: >223,000Prescription growth YoY: 35%First-line, first-switch prescriptions: 56% of overall demandPrimary care adoption: 35% of total prescribersNew prescribers activated in quarter: >5,500Total unique prescribers since launch: ~60,000Commercial coverage: 78%Medicare and Medicaid coverage: 100%Total lives covered: 86%Gross-to-net discounts: low to mid-50s range
    		$153.2 million59%——
    SUNOSI
    Continued double-digit revenue growth year-over-year, despite a sequential decline in prescriptions. Payer coverage remains steady.
    Prescriptions: ~54,000Prescription growth YoY: 16%New clinicians prescribed in quarter: ~500Total cumulative prescriber base since launch: >16,500Payer coverage: ~83% of lives coveredGross-to-net discounts: low to mid-50s range
    		$33.9 million34%-3%—
    SYMBRAVO
    Significant sequential growth in prescriptions and new patients. Increasing primary care adoption and a new major payer contract are positive indicators, though gross-to-net remains elevated.
    Total prescriptions: >17,000New patients started treatment in quarter: >5,000Neurology specialists prescribing: ~60% of totalPrimary care prescribing: ~32% (up from 20% in Q1 launch)Commercial coverage: 56%Government channels coverage: 57%Total payer coverage: ~57%Major commercial payer contract: 17 million lives securedGross-to-net discount: high 70% range
    		$4.1 million—36%—

    Operational metrics

    15
    Total Revenue
    $191.2 million57% increase compared to Q1 FY25
    Q1 FY26

    Driven by commercial products AUVELITY and SUNOSI with contribution from SYMBRAVO.

    Cost of Revenue
    $14.7 millioncompared to $9.8 million for Q1 FY25
    Q1 FY26
    Research and Development Expenses
    $52.7 millioncompared to $44.8 million for Q1 FY25
    Q1 FY26

    Increase primarily reflects a one-time acquisition-related expense.

    Selling, General and Administrative Expenses
    $185 millioncompared to $120.8 million for Q1 FY25
    Q1 FY26

    Increase driven by pre-launch activities for AUVELITY ADA, commercialization activities for AUVELITY MDD (DTC campaign, sales force expansion), and SYMBRAVO commercial activities.

    Net Loss
    $64.5 millioncompared to $59.4 million for Q1 FY25
    Q1 FY26

    Includes $23.4 million in stock-based compensation expense.

    Stock-based Compensation Expense
    $23.4 million
    Q1 FY26

    Included in net loss for the quarter.

    Cash and Cash Equivalents
    $305 millioncompared to $323 million as of end of FY25
    Q1 FY26 end

    Balance sheet remains strong.

    AUVELITY Sales Force Size
    ~630
    Q2 FY26

    Expanded to reach 68,000 HCP targets across primary care, psychiatry, neurology, and geriatric specialists for both MDD and ADA. Expansion substantially complete for June launch.

    SYMBRAVO Sales Force Size
    150increased by ~50 representatives
    Q2 FY26

    Expanded to support broader reach in primary care and deepen engagement with headache specialists and neurologists.

    AUVELITY Gross-to-Net Discounts
    low to mid-50s range
    Q1 FY26

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

    SUNOSI Gross-to-Net Discounts
    low to mid-50s range
    Q1 FY26

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

    SYMBRAVO Gross-to-Net Discount
    high 70% range
    Q1 FY26

    Expected to remain elevated over the near term as access continues to evolve and awareness builds.

    Antidepressant Market Growth
    1%year-over-year
    Q1 FY26

    Antidepressant market declined by 1% compared to Q4 FY25.

    Wake-promoting Agent Market Growth
    1%year-over-year
    Q1 FY26

    Wake-promoting agent market declined by 5% versus Q4 FY25.

    AUVELITY ADA Titration Dose Availability
    available
    Commercial launch

    The unique 30 mg dextromethorphan dose in the titration pack will be available at the time of commercial launch in June.

    Industry KPIs

    6
    MetricValueDetails
    Peak sales guidanceat least $8 billionUSD
    Pricing policy impactIRA negotiations will not impact AUVELITY until 2031
    Pipeline clinical milestones6 product candidates
    Regulatory approvals filingsAUVELITY
    Clinical trial efficacy safety dataAUVELITY in ADA
    Business development capacity deal appetiteVery selective

    Product announcements

    1
    ProductTypeDetails
    AUVELITYlaunch

    Deals & partnerships

    1
    UndisclosedAcquisition of AXS-20 (balipodect), a PDE10A inhibitor

    Recently expanded pipeline with the addition of AXS-20, a potentially first-in-class oral potent selective PDE10A inhibitor for Schizophrenia and Tourette syndrome. This provides a new NCE with a novel first-in-class mechanism of action.

    Risks & headwinds

    3
    Elevated SYMBRAVO Gross-to-Net Discountsnear term

    high 70% range

    Mitigation: Expects gross-to-net discounts to improve over time as access expands and awareness builds, with a major commercial payer contract recently secured.

    Increased Operating ExpensesQ1 FY26, expected to increase in Q2 FY26

    SG&A increased to $185 million in Q1 FY26 from $120.8 million in Q1 FY25

    Mitigation: Expects continued operating leverage as top-line revenue growth is anticipated to outpace the growth in operating expenses. SG&A growth rate expected to slow after Q2.

    Market Seasonality Impact on SalesQ1 FY26

    Q1 is a quarter in which market seasonality comes into effect

    Mitigation: Believes seasonality is transitory in nature, as evidenced by early demand trends in Q2.

    What to watch in Q2 FY26

    5

    AUVELITY ADA Commercial Launch

    Q2 FY26
    CurrentFDA approved, sales force expanded
    TargetSuccessful launch and initial uptake in June

    Why it matters

    This is a major new indication and a key driver for the updated $8 billion peak sales outlook, critical for long-term revenue growth.

    Our expansion efforts are substantially complete, positioning us well for the commercial launch in June.

    Q&A highlights

    7

    How will Axsome extract value from the LTC market for AUVELITY ADA, given 40% of patients reside there but current prescriber mix is PCP-heavy?

    Axsome's expanded sales team of ~630 representatives will call on both community and LTC facilities. This is a concentrated market allowing for efficient promotion, and both settings are important for market penetration. The company expects LTC engagement to grow over time.

    “Our sales team of approximately 630 representatives, we'll call them 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.”

    asked by Ashwani Verma · answered by Ari Maizel

    2 min read5 chapters

    Detailed Narrative

    01

    AUVELITY's Expanded Market Potential and Commercial Strategy

    The recent FDA approval of AUVELITY for agitation associated with Alzheimer's disease (ADA) significantly broadens its market. This first-in-class treatment, which received breakthrough therapy designation, is expected to contribute equally to the updated peak sales outlook of at least $8 billion annually, alongside the MDD indication. The company has expanded its AUVELITY sales force to approximately 630 representatives to target 68,000 HCPs across primary care, psychiatry, neurology, and geriatric specialists, supporting both MDD and ADA patients in community and long-term care settings. Commercial launch for ADA is set for June.

    02

    SYMBRAVO's Growth Trajectory and Payer Access

    SYMBRAVO demonstrated strong sequential growth with over 17,000 total prescriptions in Q1 FY26, up 36% from Q4 FY25, and over 5,000 new patients. Primary care prescribing increased to 32% of total, indicating broader adoption beyond headache specialists. A major commercial payer contract was secured, covering approximately 17 million lives, bringing overall payer coverage to 57%. The SYMBRAVO sales team is being expanded by 50 representatives to a total of 150 to further penetrate the primary care market and deepen engagement with specialists.

    03

    Pipeline Advancement and Expansion

    Axsome's pipeline now includes six product candidates targeting ten conditions. The company submitted an NDA for AXS-12 for cataplexy in narcolepsy. Several Phase III trials are progressing or initiating, including Solriamfetol programs for ADHD, MDD with excessive daytime sleepiness, binge-eating disorder (top-line results H2 FY26), and shift work disorder (top-line results 2027). The company also acquired AXS-20 (balipodect), a PDE10A inhibitor for schizophrenia and Tourette syndrome, with Phase III enabling activities underway and a target to initiate a Phase III trial by year-end.

    04

    Financial Performance and Operating Leverage

    Q1 FY26 saw total revenue of $191.2 million, a 57% increase year-over-year. AUVELITY and SUNOSI revenues grew 59% and 34% respectively. While SG&A expenses increased to $185 million due to pre-launch activities and sales force expansion, the company expects continued operating leverage as top-line revenue growth is anticipated to outpace operating expense growth. The cash balance of $305 million is projected to fund operations into cash flow positivity.

    05

    AUVELITY's Clinical Profile and Market Positioning

    AUVELITY's growth in MDD is driven by its rapid and durable symptom improvement and favorable safety profile, with first-line/first-switch prescriptions increasing to 56% and primary care adoption reaching 35%. The ADA approval label provides compelling clinical information, positioning AUVELITY as a first-line treatment for Alzheimer's agitation, demonstrating rapid and durable efficacy with a favorable safety profile, and being the only approved treatment with efficacy on symptom relapse shown in long-term trials.

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