Core Insights - Axsome Therapeutics reported an adjusted loss of $1.22 per share in Q1 2025, which is an improvement from the loss of $1.44 per share in the same quarter last year and better than the Zacks Consensus Estimate of a loss of $1.26 [1] - The company's total revenues increased by 62% year over year to $121.5 million in Q1 2025, surpassing the Zacks Consensus Estimate of $119 million, primarily driven by strong sales of Auvelity [2][5] - Year-to-date, Axsome's shares have increased by 37.7%, contrasting with a 2.2% decline in the industry [4] Financial Performance - Total revenues in Q1 2025 included product revenues from Auvelity and Sunosi, as well as royalty revenues, with net product revenues reaching $120.4 million compared to $74.1 million in the previous year [5] - Auvelity's sales were $96.2 million, reflecting an 80% year-over-year increase, with approximately 167,000 prescriptions recorded, marking a 76% increase from the previous year [6] - Sunosi's net product sales were $25.2 million, up 17% from the prior year, with total prescriptions growing 12% year over year to 46,000 [7] Expenses and Cash Position - Research and development expenses rose to $44.8 million, a 21.7% increase from the previous year, driven by higher costs related to clinical studies [9] - Selling, general, and administrative expenses totaled $120.8 million, up 22% year over year, attributed to increased commercial activities for Auvelity and pre-launch activities for Symbravo [10] - As of March 31, 2025, Axsome had cash and cash equivalents of $300.9 million, down from $315.4 million at the end of 2024 [11] Pipeline Developments - Axsome received positive feedback from the FDA regarding its plans to submit a supplemental new drug application for AXS-05 for agitation in Alzheimer's disease, expected in Q3 2025 [14] - The company plans to initiate a pivotal phase II/III study of Auvelity for smoking cessation later in 2025 and has submitted an NDA for AXS-14 for fibromyalgia treatment [15] - Axsome is also evaluating solriamfetol in phase III studies for ADHD and MDD, with plans to initiate additional studies later in 2025 [17][19] Market Position - Axsome currently holds a Zacks Rank of 3 (Hold), with better-ranked stocks in the biotech sector including ADMA Biologics and Immunocore Holdings, both carrying a Zacks Rank of 2 (Buy) [21]

Financial Performance - Total revenues for Q1 2025 were $121.463 million, a 62% increase from $74.999 million in Q1 2024[16] - Product sales, net for Q1 2025 reached $120.358 million, up from $74.096 million in the same period last year, representing a 62% growth[16] - The net loss for Q1 2025 was $59.413 million, compared to a net loss of $68.357 million in Q1 2024, reflecting a 13% improvement[16] - Operating expenses for Q1 2025 totaled $178.445 million, compared to $142.274 million in Q1 2024, marking a 25% increase[16] - The Company reported a consolidated net loss of $59.4 million for the three months ended March 31, 2025, an improvement from a net loss of $68.4 million in the same period of 2024[178] - The accumulated deficit as of March 31, 2025, was $1,182.2 million, highlighting the ongoing financial challenges faced by the company[194] Cash and Liquidity - Cash and cash equivalents as of March 31, 2025, were $300.910 million, down from $315.353 million at the end of 2024[14] - The Company expects its existing cash of $300.9 million will be sufficient to fund its operating cash requirements for at least twelve months[57] - The Company may utilize public and private equity offerings, debt financings, and strategic alliances to finance future cash needs if market conditions are favorable[32] - The Company must maintain Qualified Cash of at least $30.0 million plus the Qualified Cash A/P Amount, with conditional waivers if market capitalization exceeds $1.5 billion[115] Product Development and Sales - The company launched Symbravo® in January 2025, approved for the acute treatment of migraine, expanding its product portfolio[26] - Axsome Therapeutics has a diverse portfolio of FDA-approved treatments for CNS conditions, addressing over 150 million people in the U.S.[23] - The Company currently has three commercial products: Auvelity, Sunosi, and the recently FDA-approved Symbravo[34] - Product sales, net for Auvelity reached $96.231 million, up 80.0% from $53.395 million in the prior year, while Sunosi sales increased to $24.127 million from $20.701 million[157] - The company expects revenue fluctuations for Auvelity, Sunosi, and Symbravo based on demand, emphasizing the need for successful commercialization of its products[196] Research and Development - Research and development expenses for AXS-05 were $14.5 million for the three months ended March 31, 2025, compared to $13.5 million for the same period in 2024[178] - Research and development expenses for the three months ended March 31, 2025, were $44.8 million, an increase from $36.8 million in 2024, reflecting ongoing investment in product development[208] - The company expects moderate increases in research and development costs as it continues to develop current and future product candidates[212] Revenue Recognition and Accounting - Revenue is recognized when the customer obtains control of a promised good or service, reflecting the consideration expected to be received[36] - The Company generates revenue from license agreements, which may include non-refundable upfront fees and royalties on sales of products[38] - The Company recognizes revenue from product sales net of reserves for variable consideration, which reflects the best estimate of the amount entitled based on contract terms[42] - The Company estimates variable consideration for rebates, discounts, and other incentives based on expected patient usage and inventory levels[44] Debt and Financing - As of March 31, 2025, total outstanding debt was $180.0 million, with an accreted final payment fee of $4.5 million and unamortized debt discount of $3.1 million[122] - The Fifth Amendment to the Loan Agreement increased the Tranche 3 Commitment from $75.0 million to $80.0 million[109] - The aggregate principal amount under the Loan Agreement increased from $300.0 million to $350.0 million[110] Customer Concentration - The company’s three largest customers accounted for approximately 32%, 30%, and 27% of gross product sales for the three months ended March 31, 2025[155] Stock and Compensation - The company had 8,289,857 stock options outstanding with a weighted average exercise price of $48.97 and an intrinsic value of $565,499[140] - The total unrecognized compensation cost related to unvested stock options was $148.8 million, expected to be recognized over a weighted average period of 2.3 years[142] - The company recorded stock-based compensation expense of $23.308 million for the three months ended March 31, 2025, compared to $20.190 million in the same period of 2024[149] Miscellaneous - The Company has not recorded any allowances for doubtful accounts receivable as of March 31, 2025, indicating no significant credit losses historically[73] - The Company has a single operating segment focused on developing therapies for CNS disorders, with financial performance assessed based on consolidated net loss[175] - The Company did not record any income tax expense for the three months ended March 31, 2025 and 2024, maintaining an effective tax rate of 0%[170]

Core Insights - Axsome Therapeutics reported $121.46 million in revenue for Q1 2025, a 62% year-over-year increase, and an EPS of -$0.80, improving from -$1.09 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $119.49 million by 1.66%, and the EPS surpassed the consensus estimate of -$1.26 by 36.51% [1] Revenue Breakdown - Royalty revenue was $1.11 million, below the average estimate of $1.40 million from six analysts [4] - Product sales, net totaled $120.36 million, slightly above the average estimate of $117.91 million from six analysts [4] - Product sales for Auvelity reached $96.20 million, exceeding the two-analyst average estimate of $91.65 million [4] - Product sales for Sunosi were $25.20 million, also surpassing the two-analyst average estimate of $24.90 million [4] Stock Performance - Axsome's shares have returned +13.5% over the past month, compared to a +0.4% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Core Insights - Axsome Therapeutics reported a quarterly loss of $0.80 per share, which was better than the Zacks Consensus Estimate of a loss of $1.26, representing an earnings surprise of 36.51% [1] - The company achieved revenues of $121.46 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 1.66% and showing a significant increase from $75 million in the same quarter last year [2] - Axsome has consistently surpassed consensus EPS and revenue estimates over the last four quarters [2] Financial Performance - The company has shown a loss improvement from $1.09 per share a year ago to the current loss of $0.80 per share [1] - Axsome's stock has increased by approximately 32.6% since the beginning of the year, contrasting with a -3.3% decline in the S&P 500 [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$1 on revenues of $139.97 million, and for the current fiscal year, it is -$2.72 on revenues of $616.42 million [7] - The Zacks Rank for Axsome is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Axsome belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Apellis Pharmaceuticals, is expected to report a quarterly loss of $0.36 per share, reflecting a year-over-year change of +33.3% [9]

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 [18][21] - 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 [21] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [21] 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 [18] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year growth from $21.6 million in Q1 2024 [18] Market Data and Key Metrics Changes - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [23] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [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 [8][12] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [8][14] - The company anticipates a strong position with potentially five marketed products across six indications by 2026 [17] 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 [15] - The company expects 2025 to be a catalyst-rich year with significant updates on product launches and clinical trials [17] Other Important Information - The company is preparing for the launch of Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [26] - The company is actively negotiating to expand payer coverage for Avelity and Sunosi [68] Q&A Session Summary Question: FDA interactions 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 [32] Question: DTC advertising for Avelity - A national campaign is expected to launch later this year [35] Question: Coverage evolution for Avelity - Management is focused on increasing covered lives and reducing utilization management [68] Question: Expected cadence of coverage for Cymbravo - Management stated it is premature to specify the cadence but is focused on securing access quickly [48] Question: Sales opportunity for AXS-fourteen in fibromyalgia - Management is enthusiastic about the potential impact, given the large market size and lack of recent therapeutic innovation [62] Question: Profitability expectations for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on profitability [94]

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]

Core Viewpoint - Axsome Therapeutics is collaborating with Mental Health America to raise awareness and promote action during Mental Health Month, highlighting the importance of mental health and the impact of mental health conditions in the U.S. [1][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) disorders, aiming to improve the lives of individuals with serious conditions that are difficult to treat [4][7]. - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [7] Mental Health Statistics - Nearly 1 in 4 adults in the U.S. live with a mental illness, and more than 1 in 8 individuals aged 12 or older reported feeling depressed in the past two weeks, indicating a significant prevalence of mental health issues [3]. - Approximately 90% of individuals living with depression experience difficulties in work, home, or social activities due to their symptoms, which complicates daily life [3] Advocacy and Resources - Axsome is promoting resources for individuals and communities to take action regarding mental health, including Mental Health America's Action Guide, online screening tools, youth leadership programs, and opportunities to become mental health advocates [4][6]. - The 988 Suicide & Crisis Lifeline is highlighted as a confidential support service available 24/7, connecting individuals in crisis with trained counselors [5].

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]