Axsome Therapeutics(AXSM)
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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].
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]