Core Insights - Axsome Therapeutics reported a loss of $0.94 per share in Q3 2025, which was wider than the expected loss of $0.82, but an improvement from the loss of $1.34 per share in the same quarter last year [1][6] - Total revenues increased by 63% year over year to $171 million, surpassing the consensus estimate of $164 million, driven by strong sales of Auvelity [2][6] Financial Performance - Product revenues reached $169.8 million in Q3, reflecting a 63.7% year-over-year increase, while royalty revenues were $1.2 million [4] - Auvelity sales amounted to $136.1 million, up 69% year over year, with approximately 209,000 prescriptions recorded, marking a 46% increase from the previous year [5][6] - Sunosi generated net product sales of $32.8 million, a 35% increase from the prior year, with total prescriptions growing 12% year over year [7] Expenses and Cash Position - Research and development expenses were $40.2 million, down 11.5% from the previous year, while selling, general, and administrative expenses rose 57.1% to $150.2 million [9] - As of September 30, 2025, the company had cash and cash equivalents of $325.3 million, up from $303 million as of June 30, 2025 [10] Pipeline Developments - Axsome is conducting label expansion studies for Auvelity and has filed a supplemental new drug application for AXS-05 for Alzheimer's agitation [11] - The company plans to initiate pivotal studies for AXS-05 in smoking cessation and has multiple candidates in development for various CNS disorders, including AXS-12 and AXS-14 [12][13] - Solriamfetol is being evaluated in phase III studies for ADHD and MDD, with top-line data expected in 2026 for binge eating disorder and shift work disorder [14][15] Market Performance - Year to date, Axsome's shares have increased by 60.5%, significantly outperforming the industry average rise of 12.1% [2]

Financial Performance - Total revenues for Q3 2025 reached $170.992 million, a 63.2% increase from $104.762 million in Q3 2024[15] - Product sales, net for the nine months ended September 30, 2025, were $439.101 million, up 66.1% from $264.352 million in the same period of 2024[15] - For the nine months ended September 30, 2025, total revenues were $442.5 million, a 65.7% increase from $266.9 million in the same period of 2024[148] - Total revenues for the three months ended September 30, 2025, were $171.0 million, up 63.5% from $104.8 million in the same period of 2024[148] - The company reported a net loss per common share of $0.94 for Q3 2025, an improvement from $1.34 in Q3 2024[12] - For the three months ended September 30, 2025, the net loss was $47.2 million, compared to a net loss of $64.6 million for the same period in 2024, representing a 26.5% improvement[12] - The segment net loss for the nine months ended September 30, 2025, was $154.615 million, down 27.2% from $212.304 million in the same period of 2024[169] Expenses - Operating expenses for Q3 2025 totaled $217.101 million, compared to $167.386 million in Q3 2024, reflecting a 29.7% increase[15] - Research and development expenses for the nine months ended September 30, 2025, were $134.488 million, slightly up from $132.071 million in the same period of 2024[15] - Research and development expenses totaled $40.2 million for the three months ended September 30, 2025, down from $45.4 million in 2024, and $134.5 million for the nine months ended September 30, 2025, slightly up from $132.1 million in 2024[202] - Selling, general and administrative expenses increased to $150.2 million for the three months ended September 30, 2025, compared to $95.6 million in 2024, and $401.3 million for the nine months ended September 30, 2025, up from $298.1 million in 2024[198] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $325.272 million, up from $315.353 million at the end of 2024[13] - Total assets increased to $669.250 million as of September 30, 2025, compared to $568.498 million at the end of 2024, representing an 18% growth[13] - The accumulated deficit increased to $1.277 billion as of September 30, 2025, from $1.123 billion at the end of 2024[13] - Cash flows from operating activities resulted in a net cash used of $74.752 million, compared to $102.208 million in the prior year, indicating a 27% improvement[21] Product Sales and Revenue Sources - Product sales for Auvelity reached $136.1 million in Q3 2025, a 69.5% increase from $80.4 million in Q3 2024[148] - The company reported a royalty revenue of $1.2 million for Sunosi sales in Q3 2025, compared to $1.0 million in Q3 2024, reflecting a 20% increase[151] - The primary sources of cash included proceeds from the sales of Auvelity, Sunosi, and Symbravo, as well as the issuance of common stock and debt[30] - The company generated revenue from license agreements and product sales, with sales recorded net of reserves for variable consideration[41] Debt and Financing - The Company entered into a loan agreement with Blackstone for up to $570 million, including a first lien senior secured term loan of $120 million funded on May 8, 2025[109] - The effective interest rate on the Term Loans was 9.58% for the nine months ended September 30, 2025[110] - The Company recorded a loss on debt extinguishment of approximately $10.4 million upon repaying its obligations under the Hercules Loan Agreement[116] - The Company has a minimum liquidity covenant of $30 million, tested quarterly under the Blackstone Loan Agreement[112] Research and Development - Research and development costs are expensed as incurred, with significant expenses related to employee-related costs and third-party services[80] - AXS-05 has received FDA Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation[178] - The Company has submitted a supplemental NDA for AXS-05 in Alzheimer's disease agitation, supported by four completed Phase 3 trials[178] - The company anticipates moderate increases in research and development costs through the end of 2025 and into 2026 as new development programs commence[203] Inventory and Receivables - As of September 30, 2025, accounts receivable, net increased to $196.5 million from $142.0 million as of December 31, 2024, representing a 38.3% increase[97] - Total inventory as of September 30, 2025, was $35.6 million, up from $26.3 million as of December 31, 2024, reflecting a 35.5% increase[98] Customer and Market Information - The company has three largest customers representing approximately 34%, 30%, and 26% of gross product sales for the nine months ended September 30, 2025[146] - The company expects fluctuations in revenues from Auvelity, Sunosi, and Symbravo based on demand quarter to quarter, and future revenue generation is contingent on successful product development and regulatory approval[186] Stock and Compensation - Total stock-based compensation expense for the nine months ended September 30, 2025, was $71.0 million, compared to $63.2 million for the same period in 2024[140] - The intrinsic value of restricted stock units (RSUs) that lapsed during the nine months ended September 30, 2025, was $17.2 million[134] - The Company granted 64,281 performance stock units (PSUs) in February 2025, with a grant date fair value of $94.39 per share[136]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $171 million, representing a 63% increase year over year [4][11] - Net product sales for Auvelity were $136.1 million, up 69% compared to the previous year [11] - Sunosi net product revenues were $32.8 million, reflecting a 35% increase year over year [11] - The net loss for the quarter was $47.2 million, or $0.94 per share, an improvement from a net loss of $64.6 million, or $1.34 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - Auvelity showed strong prescription growth with approximately 209,000 prescriptions written, a 46% year-over-year increase [15] - Sunosi had approximately 53,000 prescriptions, representing a 12% year-over-year growth [18] - Sembravo generated $2.1 million in net sales during its first full quarter on the market [11] Market Data and Key Metrics Changes - Commercial coverage for Auvelity increased from 73% to 75%, bringing total coverage to 85% of all lives across channels [15] - Payer coverage for Sunosi remains at approximately 83% of lives covered across channels [18] - Sembravo's overall payer coverage was approximately 52% of all lives as of October 1st [17] Company Strategy and Development Direction - The company aims to broaden patient access and drive awareness with clinicians for its products [5] - Axsome is advancing a robust pipeline with late-stage programs targeting Alzheimer's disease agitation, narcolepsy, and ADHD [5][10] - The company plans to initiate a phase 2/3 trial for AXS-05 in smoking cessation and target NDA submission for AXS-12 for cataplexy in narcolepsy [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth potential of Axsome, highlighting strong performance across its commercial portfolio [19] - The company anticipates meaningful activity across its late-stage programs in the coming months [5] - Management noted that the fundamentals of the business have never been stronger, positioning Axsome for substantial near and long-term value [10] Other Important Information - The company ended Q3 2025 with $325.3 million in cash and cash equivalents, an increase from $315.4 million at the end of 2024 [14] - Gross-to-net discounts for Auvelity and Sunosi were in the high 40% range, expected to increase to the low 50% range in Q4 [12] Q&A Session Summary Question: Insights on Sembravo's launch and prescribing depth - Management noted early positive responses from healthcare providers and patients, with a targeted approach focusing on top headache centers [22][23] Question: Growth driver for Auvelity in primary care - Management emphasized the importance of primary care as a growth driver, supported by sales force expansion and direct-to-consumer campaigns [26][27] Question: Expectations for AXS-05 adoption in Alzheimer's agitation - Management is optimistic about AXS-05's impact, planning to cover various specialties and settings of care [31][32] Question: Sales force expansion and cash flow positivity - Management confirmed plans for sales force expansion if AXS-05 is approved, with costs already included in cash flow positivity guidance [35][76] Question: Impact of DTC campaign on Auvelity prescriptions - Management indicated that significant impacts from the DTC campaign may be observed in 8-12 weeks, with early positive trends noted [77] Question: Regulatory interactions for AXS-05 - Management stated that interactions are ordinary course and that they are prepared for standard review by the FDA [87]

Financial Performance - Total net product revenue reached $171.0 million, a 63% year-over-year increase[12, 27] - AUVELITY net product sales were $136.1 million, representing a 69% year-over-year growth[12, 27, 46] - SUNOSI net product revenue amounted to $32.8 million, a 35% year-over-year increase[12, 27, 56] - SYMBRAVO net product sales were $2.1 million[12, 27] - Cash and cash equivalents stood at $325.3 million as of September 30, 2025[12] Pipeline Development & Regulatory Milestones - An sNDA for AXS-05 in Alzheimer's disease agitation has been submitted to the FDA[12, 25, 74] - An NDA submission for AXS-12 for cataplexy in narcolepsy is anticipated in 4Q 2025[12, 25, 109] - A Phase 3 trial of solriamfetol in children and adolescents with ADHD is anticipated in 4Q 2025[12, 25, 82] Strategic Focus & Market Potential - The company is targeting therapeutic areas with high unmet needs, with potential approvals through 2028[11] - The company estimates a combined peak sales potential of >$16 billion across its pipeline[21]

Revenue Performance - Total net product revenue for Q3 2025 was $171.0 million, representing 63% year-over-year growth and 14% sequential growth from Q2 2025[4] - AUVELITY net product sales reached $136.1 million in Q3 2025, reflecting a 69% year-over-year growth and 14% sequential growth from Q2 2025[4] - SUNOSI generated $32.8 million in net product revenue for Q3 2025, marking a 35% year-over-year growth and 9% sequential growth from Q2 2025[4] - Total revenues for Q3 2025 reached $170.992 million, a 63.2% increase from $104.762 million in Q3 2024[28] - Product sales, net, amounted to $169.784 million in Q3 2025, compared to $103.736 million in Q3 2024, reflecting a 63.5% year-over-year growth[28] Prescription and Payer Coverage - Approximately 209,000 prescriptions were written for AUVELITY in Q3 2025, a 46% increase compared to Q3 2024[9] - Payer coverage for AUVELITY is approximately 85%, with 75% in commercial and 100% in government channels[9] Research and Development - Axsome submitted a supplemental NDA for AXS-05 for Alzheimer's disease agitation to the FDA[4] - Research and development expenses were $40.2 million in Q3 2025, down from $45.4 million in Q3 2024[4] - Research and development expenses were $40.162 million in Q3 2025, down from $45.388 million in Q3 2024, indicating a 5.4% decrease[28] Financial Loss and Cash Position - The net loss for Q3 2025 was $47.2 million, or $(0.94) per share, an improvement from a net loss of $64.6 million, or $(1.34) per share, in Q3 2024[8] - The net loss for Q3 2025 was $47.229 million, an improvement from a net loss of $64.602 million in Q3 2024[28] - Cash and cash equivalents totaled $325.3 million as of September 30, 2025, compared to $315.4 million at December 31, 2024[8] - Cash and cash equivalents as of September 30, 2025, were $325.272 million, up from $315.353 million at the end of 2024[26] Assets and Liabilities - Total assets increased to $669.250 million as of September 30, 2025, compared to $568.498 million at the end of 2024[26] - Total liabilities rose to $595.523 million as of September 30, 2025, compared to $511.483 million at the end of 2024[26] Shareholder Information - The company reported a weighted average of 50,021,851 common shares outstanding for Q3 2025, compared to 48,140,519 for Q3 2024[28] Future Outlook - The company anticipates continued growth in product sales and is focused on expanding payer coverage for its products[24] Commercialization - SYMBRAVO achieved net product sales of $2.1 million in its first full quarter of commercialization[4] Expenses - Selling, general and administrative expenses increased to $150.235 million in Q3 2025, up from $95.564 million in Q3 2024, representing a 57.3% rise[28]

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Core Insights - Axsome Therapeutics reported a total net product revenue of $171.0 million for Q3 2025, reflecting a 63% year-over-year growth and a 14% sequential growth from Q2 2025 [3] - The company has submitted a supplemental NDA for AXS-05 for the treatment of Alzheimer's disease agitation, addressing a significant unmet medical need [2][11] Financial Highlights - Total net product revenue for Q3 2025 was $171.0 million, up from $104.8 million in Q3 2024, marking a 63% increase year-over-year [3] - AUVELITY sales reached $136.1 million in Q3 2025, a 69% increase from $80.4 million in Q3 2024 [3] - SUNOSI generated $32.8 million in revenue for Q3 2025, representing a 35% year-over-year growth [3] - SYMBRAVO achieved $2.1 million in sales during its first full quarter of commercialization [3] - The net loss for Q3 2025 was $47.2 million, or $(0.94) per share, an improvement from a net loss of $64.6 million, or $(1.34) per share, in Q3 2024 [3] Commercial Highlights - AUVELITY prescriptions increased by 46% year-over-year, totaling approximately 209,000 in Q3 2025 [9] - Payer coverage for AUVELITY is approximately 85%, with 75% in commercial channels and 100% in government channels [9] - SUNOSI prescriptions rose by 12% year-over-year, with approximately 53,000 prescriptions written in Q3 2025 [9] - SYMBRAVO had approximately 5,000 prescriptions written in its first full quarter [9] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [11] - Axsome plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in Q4 2025 [12] - AXS-12 is set for NDA submission for the treatment of cataplexy in narcolepsy in Q4 2025 [13] - A Phase 3 trial of AXS-14 in fibromyalgia is also planned for Q4 2025 [17] Cash Position - Cash and cash equivalents totaled $325.3 million as of September 30, 2025, compared to $315.4 million at the end of 2024 [8]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Axsome Therapeutics, Inc. (NASDAQ: AXSM), urging shareholders to contact the firm to discuss their rights [1][2]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Axsome may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2][3]. - Shareholder involvement is emphasized as a means to improve company policies and enhance shareholder value through better management and accountability [3]. Group 2: Firm's Background and Services - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].

Herriot Tabuteau combined his Yale medical degree and two decades in finance to start Axsome Therapeutics. Now the company has three drugs on the market and five more in the pipeline. https://t.co/U5nnQb1nbE ...

Core Insights - Axsome Therapeutics is transitioning from a development-stage company to a neuroscience-focused entity, with three drugs currently marketed and a robust late-stage pipeline [1] Company Overview - Axsome Therapeutics has successfully moved into the commercialization phase with three marketed drugs [1] - The company is developing a rich late-stage pipeline, indicating potential for future growth and revenue generation [1] Financial Analyst Background - Gamu Dave Innocent Pasi, a financial professional, has extensive experience in financial analysis and investment research, contributing to reputable publications [1] - He holds advanced qualifications in investments and portfolio management, emphasizing his expertise in the field [1] Investment Focus - The analyst is currently focused on building an international investment portfolio, aiming to share insights and strategies with the global investing community [1]