Axsome Therapeutics (AXSM) incurred an adjusted loss of $1.22 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.26. The company had incurred a loss of $1.44 per share in the year-ago quarter.Axsome’s total revenues surged 62% year over year to $121.5 million in the first quarter, beating the Zacks Consensus Estimate of $119 million. The year-over-year increase in revenues can be attributed to strong sales of Auvelity (AXS-05). (Find the latest EPS estimates a ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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. (State or other jurisdiction of incorporation or organization) (I.R.S. ...

Axsome Therapeutics (AXSM) reported $121.46 million in revenue for the quarter ended March 2025, representing a year-over-year increase of 62%. EPS of -$0.80 for the same period compares to -$1.09 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $119.49 million, representing a surprise of +1.66%. The company delivered an EPS surprise of +36.51%, with the consensus EPS estimate being -$1.26.While investors scrutinize revenue and earnings changes year-over-year and how they compare ...

Axsome Therapeutics (AXSM) came out with a quarterly loss of $0.80 per share versus the Zacks Consensus Estimate of a loss of $1.26. This compares to loss of $1.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 36.51%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1 per share when it actually produced a loss of $0.96, delivering a surprise of 4%.Over the last four quarters, the compa ...

axsome Corporate Presentation 4 May 5, 2025 Forward Looking Statements & Safe Harbor Certain matters discussed in this presentation are "forward-looking statements". The Company may, in some cosses, use terms such as "predicts," "boleves," "potential," "co "estimates," "anticipates," "expects, ""plans," "intends," "might, " will, " should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements reqarding trends ...

Financial Data and Key Metrics Changes - Total product revenues for Q1 2025 were $121.5 million, representing a year-over-year growth of 62% compared to $75 million in Q1 2024 [16][17] - Net loss for Q1 2025 was $59.4 million or $1.22 per share, an improvement from a net loss of $68.4 million or $1.44 per share in Q1 2024 [20] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [20] Business Line Data and Key Metrics Changes - Avelity net product sales were $96.2 million for Q1 2025, representing 80% year-over-year growth from $53.4 million in Q1 2024 [17] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year increase from $21.6 million in Q1 2024 [17][18] - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [21] Market Data and Key Metrics Changes - Avelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% in the commercial segment [22] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [23] - Payer coverage for Sunosi was stable with 83% of lives covered across channels [25] Company Strategy and Development Direction - The company aims to advance three novel NDA stage product candidates: AXS-fourteen for fibromyalgia, AXS-five for Alzheimer's disease agitation, and AXS-twelve for narcolepsy [6][10] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [6] - The company anticipates a strong launch for Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate trade policy developments, stating that any potential impact would be immaterial [13] - The company expects 2025 to be a catalyst-rich year with potentially five marketed products across six indications by 2026 [15] - Management remains optimistic about achieving cash flow positivity based on the current operating plan [20][96] Other Important Information - The company has submitted an NDA for AXS-fourteen and anticipates a decision in Q2 2025 [7] - AXS-five has been granted breakthrough therapy designation by the FDA, with an sNDA submission planned for Q3 2025 [9] - The company is closely monitoring the competitive landscape, particularly regarding new entrants in the narcolepsy treatment space [35] Q&A Session Summary Question: Recent interactions with the FDA regarding developmental agents - Management indicated that dialogue with the FDA remains status quo and no changes have been noted regarding review teams or agency responsiveness [30] Question: DTC advertising plans for Avelity - A national campaign is expected to launch later this year, with a focus on engaging patients [34] Question: Coverage expectations for Avelity - Management aims to increase the number of covered lives and reduce utilization management barriers [68] Question: Expected cadence of coverage for Cymbravo - Management is focused on securing access quickly, acknowledging the competitive market [48] Question: Sales potential for AXS-fourteen in fibromyalgia - Management is enthusiastic about the market opportunity, with approximately 17 million people diagnosed in the U.S. [63] Question: Profitability outlook for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on timing for profitability [96]

Revenue Growth - Total net product revenue for Q1 2025 was $121.5 million, representing 62% year-over-year growth from $75.0 million in Q1 2024[5] - AUVELITY net product sales reached $96.2 million in Q1 2025, an 80% increase from $53.4 million in Q1 2024[5] - SUNOSI net product revenue was $25.2 million for Q1 2025, reflecting a 17% growth from $21.6 million in Q1 2024[8] - Total revenues for Q1 2025 reached $121.463 million, a 62% increase compared to $74.999 million in Q1 2024[31] - Product sales, net for Q1 2025 were $120.358 million, up from $74.096 million in the same period last year, reflecting a significant growth[31] Prescription and Payer Coverage - Approximately 167,000 prescriptions were written for AUVELITY in Q1 2025, a 76% increase compared to the same period in 2024[9] - Payer coverage for AUVELITY is approximately 78% across all channels, with 63% in commercial and 100% in government channels[9] Regulatory Developments - SYMBRAVO received FDA approval for acute migraine treatment, with commercial launch expected in June 2025[10] - NDA for AXS-14 for fibromyalgia has been submitted, with FDA decision anticipated in Q2 2025[18] - Supplemental NDA for AXS-05 in Alzheimer's disease agitation is on track for submission in Q3 2025[18] Financial Performance - Net loss for Q1 2025 was $59.4 million, or $(1.22) per share, compared to a net loss of $68.4 million, or $(1.44) per share, in Q1 2024[5] - Operating expenses totaled $178.445 million in Q1 2025, compared to $142.274 million in Q1 2024, indicating a 25% increase[31] - The net loss for Q1 2025 was $59.413 million, an improvement from a net loss of $68.357 million in Q1 2024[31] - The company reported a basic and diluted net loss per common share of $1.22 for Q1 2025, an improvement from $1.44 in Q1 2024[31] Cash and Assets - Cash and cash equivalents totaled $300.9 million as of March 31, 2025, down from $315.4 million at the end of 2024[5] - Cash and cash equivalents as of March 31, 2025, were $300.910 million, slightly down from $315.353 million at the end of 2024[29] - Total assets increased to $596.671 million as of March 31, 2025, compared to $568.498 million at the end of 2024[29] - The company’s accounts receivable increased to $161.398 million as of March 31, 2025, from $142.001 million at the end of 2024[29] Research and Development - Research and development expenses rose to $44.785 million in Q1 2025, compared to $36.830 million in Q1 2024, reflecting ongoing investment in product development[31] - Axsome Therapeutics is focused on expanding payer coverage and advancing clinical trials for its product candidates, including SUNOSI, AUVELITY, and SYMBRAVO[26]

NEW YORK, May 01, 2025 (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 it is joining with Mental Health America (MHA) and the broader mental health advocacy community in a consolidated effort to raise awareness and promote action during May’s Mental Health Month. On May 1, as part of Mental Health America’s “Light Up Green” initiative, Axsome’s New York City headquarters, t ...

Company Overview - Axsome Therapeutics (AXSM) shares increased by 4.2% to close at $101.67, following a broader market rally after President Trump's announcement of a 90-day pause on tariffs against non-retaliating countries [1] - The stock had previously experienced an 18.4% loss over the past four weeks [1] Financial Performance - Axsome is expected to report a quarterly loss of $1.25 per share, reflecting a year-over-year decline of 14.7% [2] - Revenue projections for the upcoming quarter are $119.74 million, which is a significant increase of 59.7% compared to the same quarter last year [2] Earnings Estimates and Trends - The consensus EPS estimate for Axsome has been revised 6.8% higher in the last 30 days, indicating a positive trend that typically correlates with price appreciation [3] - Empirical research suggests a strong correlation between earnings estimate revisions and near-term stock price movements, highlighting the importance of monitoring these trends [2][3] Industry Context - Axsome operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies such as Emergent Biosolutions (EBS) [3] - Emergent Biosolutions' consensus EPS estimate remains unchanged at $0.71, representing a year-over-year increase of 20.3% [4]

NEW YORK, April 08, 2025 (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 it will report its financial results for the first quarter of 2025 on Monday, May 5, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live con ...