It has been about a month since the last earnings report for Axsome Therapeutics (AXSM) . Shares have lost about 1.8% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is Axsome due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since Then?It ...

Axsome Therapeutics (AXSM) FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (AXSM) - **Industry**: Biotechnology, specifically focusing on Central Nervous System (CNS) conditions - **Conference Date**: June 03, 2025 Core Points and Arguments 1. **Growth Story**: Axsome is described as a bona fide growth story with a successful launch of a novel antidepressant, Avelity, and the product Sunosi gaining traction [2][3] 2. **Innovative Treatments**: The company aims to develop transformative medicines for CNS conditions, focusing on areas of unmet need such as Alzheimer's disease agitation and migraine [3][4] 3. **Pipeline Overview**: Axsome has a broad pipeline categorized into psychiatry (e.g., depression, ADHD) and neurology (e.g., migraine, narcolepsy), impacting over 50 million lives in the US [4][5] 4. **Potential Peak Sales**: The company anticipates a potential peak sales of $16.5 billion across its pipeline, with approved products like Avelity, Sunosi, and Simbravo projected to reach peak sales of $2 to $4.5 billion [10][11] 5. **Commercial Programs**: Axsome currently has three commercial programs, with Avelity for major depressive disorder showing rapid growth and a current annual run rate of approximately $400 million [19][20] 6. **Sales Team Expansion**: The sales team has expanded to 300 account managers to enhance market penetration, particularly in primary care [20][21] 7. **Simbravo Launch**: Simbravo, approved for acute migraine treatment, is expected to launch imminently, addressing significant dissatisfaction among migraine patients with current treatment options [23][24] 8. **Clinical Trial Success**: Positive results from multiple Phase III trials for products like AXS-five (Alzheimer's agitation) and AXS-fourteen (fibromyalgia) support ongoing development and upcoming NDA submissions [15][26][35] 9. **Financial Position**: The company is well-funded and on track for cash flow positivity, with a strong financial foundation and leadership team [38] Additional Important Content 1. **Market Access Strategy**: The company is focused on improving market access and coverage, with expectations for increased utilization management in commercial channels [44][45] 2. **Gross to Net Evolution**: Avelity's gross to net ratio is expected to stabilize in the mid-50s, influenced by evolving market access dynamics [46][47] 3. **Patient Profile for Simbravo**: The initial target patient profile for Simbravo includes those with mild to severe migraines, particularly those with inadequate responses to prior treatments [52][53] 4. **Regulatory Submissions**: Upcoming submissions include an sNDA for AXS-five in Alzheimer's agitation and an NDA for AXS-twelve in narcolepsy, with timelines set for the second half of the year [15][35][28] This summary encapsulates the key insights from the Axsome Therapeutics conference, highlighting the company's strategic direction, product pipeline, and market positioning within the biotechnology sector focused on CNS conditions.

Core Insights - Axsome Therapeutics, Inc. is presenting three innovative neuroscience programs at the ASCP 2025 Annual Meeting, focusing on treatments for central nervous system disorders [1][22] Group 1: AUVELITY - AUVELITY is an oral NMDA receptor antagonist approved for treating major depressive disorder (MDD) in adults, containing dextromethorphan (45 mg) and bupropion (105 mg) [3][4] - The mechanism of action for AUVELITY in treating depression is not fully understood, but it has received Breakthrough Therapy designation from the FDA for MDD [3][22] - AUVELITY is not approved for use in children and is specifically indicated for MDD [4][5] Group 2: AXS-05 - AXS-05 is being studied for its efficacy and safety in treating agitation associated with Alzheimer's disease through a Phase 3 randomized-withdrawal double-blind placebo-controlled study [2][22] - The lead author for this study is Dr. Jeffrey Cummings, Vice Chair of Research at UNLV [2] Group 3: Solriamfetol - Solriamfetol is being evaluated for excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, particularly those reporting anxiety and depression [2][22] - The lead author for this study is Dr. Ulf Kallweit, Assistant Professor of Neurology at Witten/Herdecke University, Germany [2]

Core Viewpoint - Axsome Therapeutics has reached a settlement with Hetero Labs regarding patent litigation over its product SUNOSI, allowing Hetero to market a generic version under specific conditions starting in 2040 [1][2]. 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, excessive daytime sleepiness, and migraines [3]. Settlement Details - The settlement permits Hetero to sell a generic version of SUNOSI starting on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, contingent upon FDA approval [1]. - The agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review [2]. Ongoing Litigation - Axsome continues to pursue similar patent litigation against other parties related to SUNOSI in the U.S. District Court for the District of New Jersey [2].

Axsome Therapeutics (AXSM) Conference Call Summary Company Overview - **Company**: Axsome Therapeutics - **Date**: May 20, 2025 - **Key Products**: AUVELITY, Sunosi, SINBRAVO Industry Context - **Market Focus**: Primarily operates in the U.S. market with products Ovelity and Sinbravo launching soon - **Regulatory Environment**: Discussed potential impacts from tariffs and IP redomiciling, but deemed minimal impact on operations [3][7] Core Business Insights - **Product Performance**: - AUVELITY has shown consistent growth since its launch in 2022, currently annualizing about $400 million in sales [9] - Expected peak sales for AUVELITY and MDD alone are projected between $1 billion to $3 billion [12] - **Market Access**: - Current coverage in the commercial channel is at 63%, with plans to improve both quantity and quality of coverage [10] - A national direct-to-consumer (DTC) campaign is being tested for potential rollout [11] Sales Strategy - **Sales Force Expansion**: - Expanded sales team to 300 account managers, allowing for increased reach into primary care [15] - Focus on both psychiatrists and primary care physicians for product promotion [14] Future Growth Potential - **Long-term Guidance**: - Confident in achieving peak sales due to ongoing market access improvements and potential prescribing behavior changes [18] - **Alzheimer's Agitation Studies**: - Three positive studies completed, with a submission to the FDA expected in Q3 [22][27] Upcoming Product Launches - **SINBRAVO Launch**: - Scheduled for next month, targeting headache specialists with a dedicated sales team [34] - **Sunosi Developments**: - Positive data from phase three trials for ADHD, with plans for pediatric studies [39][41] Financial Outlook - **Profitability Goals**: - Axsome is aiming for cash flow positivity, with resources in place to support this goal [46] Additional Considerations - **Regulatory Strategy**: - Emphasis on the importance of having two positive, well-controlled studies for FDA approval [25] - **Market Dynamics**: - Different strategies for migraine and depression products due to distinct payer requirements [36][37] This summary encapsulates the key points discussed during the Axsome Therapeutics conference call, highlighting the company's strategic direction, product performance, and future growth potential.

Group 1 - The article mentions that Anand Chokkavelu, CFA, Karl Thiel, and Keith Speights have no positions in any of the stocks mentioned [1] - The Motley Fool has positions in and recommends Axsome Therapeutics [1] - The Motley Fool has a disclosure policy regarding its investment positions [1]

Summary of Axsome Therapeutics (AXSM) 2025 Conference Call Company Overview - **Company**: Axsome Therapeutics (AXSM) - **Date of Conference**: May 13, 2025 - **Key Speakers**: Mark Jacobsen (COO), Nick Pizzi (CFO), Jason Gerber (Analyst) Key Points Industry and Product Launches - **Avelity (MDD)**: - The company is over two years into the launch and is experiencing a growth trajectory with ongoing initiatives to drive further growth [4][5] - Expansion of the field force to approximately 300 representatives was completed in Q1, expected to impact new prescriptions (NBRx) positively [5][8] - The company anticipates a national patient-provider program (PPP) campaign in the second half of the year to further catalyze growth [6] - **Symbravo (Migraine)**: - Launch is targeted for June 2025, with preparations underway and field force training in progress [36][37] - Peak sales expectations are between $500 million to $1 billion, compared to Avelity's $1 billion to $3 billion for MDD [35] Financial Performance and Projections - **Revenue Growth**: - Revenue growth is outpacing operating expense growth, with expectations for continued operating leverage into 2025 and 2026 [9] - The company is currently at 63% coverage in the commercial space, with a goal to exceed 80% [14][15] - Gross to net (GTN) in Q1 was in the mid-50s, expected to remain constant throughout the year despite seasonality [16] Market Dynamics and Competitive Landscape - **Payer Negotiations**: - The company is pleased with ongoing discussions with payers, aiming for long-term value rather than immediate coverage [13][14] - The efficacy of Avelity is a key factor in negotiations, with a strategy focused on maintaining net pricing [13] - **Market Access**: - Anticipated access in the Medicare Part D channel for Avelity, with expectations of around 70% coverage for total prescriptions [28] - The company is assessing potential targeting in long-term care facilities, which could enhance market penetration [31] Clinical Development and Regulatory Updates - **Alzheimer's Agitation Label Expansion**: - The company is preparing for a supplemental NDA (sNDA) submission in Q3 2025, with positive feedback from the FDA on the clinical program [22][24] - Three positive studies have been completed, supporting the filing [25] - **AXS-12 for Narcolepsy**: - The company plans to file for AXS-12 in the second half of 2025, with a robust clinical data package from multiple studies [47][48] Strategic Considerations - **Long-term Strategy**: - The company emphasizes a long-term approach to product value and market positioning, particularly in the context of evolving payer dynamics and competitive pressures [13][19] - The expansion of the field force is seen as a critical component for enhancing engagement with primary care clinicians [18] Additional Insights - **Market Segmentation**: - The company recognizes the distinct market dynamics for migraine treatments compared to MDD, with different refill patterns and prescribing behaviors [38][39] - There is a focus on ensuring that the product reaches patients effectively, with considerations for market access dynamics and clinician experiences [42][44] Conclusion - Axsome Therapeutics is positioned for growth with strategic initiatives in place for its key products, Avelity and Symbravo. The company is actively engaging with payers and preparing for significant product launches while maintaining a focus on long-term value and market access.

Previous term loan facility retired NEW YORK, May 13, 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 that it has entered into a $570 million term loan and revolving credit facility with funds managed by Blackstone Life Sciences and Blackstone Credit & Insurance ("Blackstone"). Concurrent with this new facility, Axsome has retired its previous term loan with Hercules C ...

Axsome Therapeutics (AXSM) Conference Call Summary Company Overview - Axsome Therapeutics is a commercial-stage company focused on Central Nervous System (CNS) indications with several approved products and a broad pipeline [1][2] Key Financial Performance - Q1 2025 net sales reached $120 million, with $96 million from OVALITY (for major depressive disorder) and $25 million from Sunosi [4][5] Product Launches and Pipeline - Symbravo, for acute treatment of migraine, is set to launch next month [5][6] - AXS-05 for Alzheimer's disease agitation is on track for an sNDA submission in Q3 2025 [6][18] - Positive data readouts for solriamfetol in ADHD and major depressive disorder with excessive daytime sleepiness [7][39] Market Adoption and Sales Strategy - OVALITY has over 50% adoption as a first or second-line treatment in major depressive disorder [9] - The sales team has expanded to approximately 300 account managers, with expectations for growth in the commercial channel [10][11] - The company aims for over 80-85% of lives covered in the antidepressant class [11][12] Competitive Advantages - OVALITY is noted for its rapid onset of action, durability, and favorable safety profile compared to traditional antidepressants [14][15] - AXS-05 is differentiated from atypical antipsychotics, which have a black box warning for elderly patients with dementia [23][24] Clinical Development Highlights - Three positive trials completed for AXS-05 in Alzheimer's agitation, with no safety signals for falls or mortality [17][18] - The company is preparing for NDA submissions for AXS-14 (fibromyalgia) and AXS-12 (cataplexy in narcolepsy) [45][46] Future Outlook - Axsome anticipates significant growth and attention as more products come into focus, particularly with ongoing regulatory filings and launches [47][48]

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]