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Axsome Therapeutics(AXSM) - 2025 Q3 - Earnings Call Presentation
2025-11-03 13:00
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]
Axsome Therapeutics(AXSM) - 2025 Q3 - Quarterly Results
2025-11-03 12:06
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]
Axsome Therapeutics GAAP EPS of -$0.94 misses by $0.07, revenue of $171M beats by $8.01M (NASDAQ:AXSM)
Seeking Alpha· 2025-11-03 12:04
Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if they have an ad-blocker enabled, indicating a need to disable it for proper access [1]
Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-03 12:00
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]
Halper Sadeh LLC Encourages Axsome Therapeutics, Inc. Shareholders to Contact the Firm to Discuss Their Rights
Businesswire· 2025-10-24 15:20
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].
X @Forbes
Forbes· 2025-10-15 23:00
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 ...
Axsome Stock's Strong Growth And Expanding Pipeline: Why I Assign A Buy (NASDAQ:AXSM)
Seeking Alpha· 2025-10-10 08:07
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]
Axsome Therapeutics' Strong Growth And Expanding Pipeline: Why I Assign A Buy Rating
Seeking Alpha· 2025-10-10 08:07
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, showcasing strong analytical skills [1] Investment Focus - The analyst is currently focused on building an international investment portfolio, emphasizing innovative solutions for financial inclusion and sustainability [1]
Perenti Limited (AUSDF) Shareholder/Analyst Call Transcript
Seeking Alpha· 2025-10-10 07:56
Group 1 - The Annual General Meeting (AGM) of Perenti for the year 2025 has commenced with a quorum present [2] - The meeting acknowledges the traditional owners of the land, specifically the Whadjuk people of the Nunga Nation, and pays respect to Aboriginal and Torres Strait Islander peoples [3] - Key members of the Perenti Board and Executive Committee are present at the meeting, including the Managing Director and CEO, Independent Non-Executive Directors, and various Presidents of divisions [4][5]
Axsome Therapeutics Recognizes Mental Illness Awareness Week Along with the National Advocacy Community
Globenewswire· 2025-10-09 11:00
Core Insights - Axsome Therapeutics is actively participating in Mental Illness Awareness Week (MIAW) to promote mental health awareness and community support [1][2] - The theme for this year's MIAW is "Building Community: Supporting Mental Well-being Together," emphasizing the importance of grassroots advocacy and local action [1][2] - Axsome is committed to supporting individuals with mental health conditions and collaborates with organizations like NAMI to provide resources and reduce stigma [3][4] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, narcolepsy, obstructive sleep apnea, and migraines [4] - The company aims to address critical gaps in care and develop innovative products that improve patient outcomes, impacting over 150 million people in the U.S. [4] - Axsome partners with national and global advocacy organizations to strengthen communities and provide support for those affected by mental health challenges [3][4] Mental Health Statistics - Over 1 in 5 adults in the U.S. experience mental illness each year, and more than 1 in 7 youth aged 6-17 also face mental health conditions annually [3] - Nearly 90% of individuals living with depression report difficulties in work, home, or social activities due to their symptoms, highlighting the significant impact of depression [3]