NEW YORK, June 20, 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 is joining with the Alzheimer’s disease advocacy community to raise awareness of the growing impact of Alzheimer’s disease in the United States and the importance of brain health during this year’s Alzheimer’s & Brain Awareness Month. “Alzheimer’s & Brain Awareness Month offers the perfect opportunity for all Ame ...

Axsome Therapeutics (AXSM) FY Conference Summary Company Overview - **Company**: Axsome Therapeutics - **Focus**: Development of innovative medicines for central nervous system (CNS) disorders, addressing significant unmet needs in psychiatry and neurology [2][3] Industry Context - **CNS Disorders**: Over 150 million people in the U.S. are affected by serious CNS conditions, which have been historically underserved by the biopharma industry [2][3] - **Key Conditions**: Major depressive disorder (MDD), Alzheimer's disease agitation, smoking cessation, ADHD, binge eating disorder, obstructive sleep apnea, migraine, narcolepsy, fibromyalgia, and shift work disorder [3][4] Core Strategies - **Five Pillars of Innovation**: 1. **Novel Mechanisms of Action**: Focus on distinct treatment outcomes in areas with multiple existing products [4] 2. **Multi-Mechanistic Modes of Treatment**: Examples include Ovelity and Cymbravo [5] 3. **Clinical Trial Innovation**: Designing trials to effectively detect signals from active molecules [5] 4. **Molecular Drug Delivery**: Innovative delivery methods for CNS-active molecules [6] 5. **Diversified Pipeline**: A singular neuroscience pipeline with three commercial products and multiple late-stage programs [6][7] Financial Highlights - **Potential Peak Sales**: Total potential peak sales across the pipeline estimated at $16.5 billion, with approved products like Avelity, Synoscience, and Bravo projected to reach $2 billion to $4.5 billion [8] - **Cash Position**: $300 million in cash resources as of the end of Q1, sufficient to reach cash flow positivity [39][40] Product Updates - **Ovelity**: Rapid growth with an annualized run rate of $400 million; over 50% of prescriptions are first-line treatments [11][14] - **Sunosi**: Steady growth with an annualized run rate of $100 million, focusing on potential label expansion [17] - **Simbravo**: Newly approved for acute migraine treatment, launching imminently [12][18] Clinical Trials and Regulatory Updates - **Cymbravo**: Approved earlier in the year, with positive Phase III clinical trial readouts [9] - **AXS-five**: NDA submission for Alzheimer's disease agitation on track for Q3; high unmet need with 7 million adults affected [21][22] - **Salriamfetol**: Exploring additional indications including ADHD and major depressive disorder, with ongoing trials [25][28] - **AXS-twelve**: NDA submission planned for narcolepsy in the second half of the year [33] - **AXS-fourteen**: Focused on fibromyalgia, with plans for a new 12-week fixed-dose trial following FDA feedback [35][36] Intellectual Property - **Patent Portfolio**: Broad coverage for pipeline programs, with settlements reached with multiple first filers [38] Conclusion - **Leadership and Future Outlook**: Strong leadership team and board, with a focus on providing updates throughout the year [40]

Alto Neuroscience (ANRO) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Okay, we're gonna get started with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies and it's my pleasure to have Amit Ekken by my side. Welcome. Speaker1 Thank you. Speaker0 I forgot to mention from Alto Neuroscience. So maybe give us spend two minutes, three minutes talking about the Alto story, what you're trying to achieve and what milestones we can expect over the next six to twelve months. You've got a lot ...

Group 1: Summit Therapeutics - Summit Therapeutics' shares have increased over 1,000% in the past three years, primarily due to the progress of ivonescimab, an investigational cancer medicine [2] - Ivonescimab has shown positive results in several phase 2 and phase 3 studies in China and is already approved there, contributing to Summit's market cap of $13.6 billion despite no revenue generation [2][6] - The drug has produced Phase 3 results comparable to Keytruda for non-small cell lung cancer, indicating significant market potential [4] - Ivonescimab is being tested for multiple cancer types, suggesting a robust pipeline for Summit Therapeutics [5] - The company anticipates U.S. approval for ivonescimab within three years, with potential for further approvals in the next decade [6] Group 2: Axsome Therapeutics - Axsome Therapeutics has seen stock market gains of nearly 350% over the past three years due to significant clinical and regulatory milestones [7] - The company’s revenue increased by 62% year over year to $121.5 million in the first quarter, driven by the approval of Auvelity for major depressive disorder and the acquisition of Sunosi for narcolepsy [8] - Axsome is expected to transform its product lineup with new approvals and label expansions in the next three years, including positive trial results for several candidates [9] - The company is conducting multiple clinical studies that could lead to further positive data and regulatory submissions, indicating a strong late-stage pipeline [10]

Axsome Therapeutics (AXSM) FY Conference June 03, 2025 11:40 AM ET Speaker0 To the the William Blair forty fifth Annual Growth Stock Conference. My name is Miles Minto. I'm a senior biotech analyst here at the firm. I cover the neurosciences and genetic medicines, and Axsome has been a day one coverage company for me. So early two thousand seventeen before before the Ascend data actually was when picked up coverage there. You know, obviously a bona fide growth story with a Vality well underway, launch of a ...

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 Insights - Teva Pharmaceutical Industries Ltd has initiated IND-enabling studies for BD9, a dual-specific multibody targeting TSLP and IL-13, aimed at treating TH2-driven inflammatory diseases like atopic dermatitis and asthma [1][2][3] - The development of BD9 is expected to improve patient outcomes in conditions where current treatments are inadequate [2] - Teva holds an exclusive license to develop BD9 globally, with Biolojic Design Ltd eligible for milestone payments based on various achievement criteria [3][4] Financial and Market Impact - Teva's stock has seen a positive response, increasing by 6.01% to $17.98 following the announcement of the IND-enabling studies [7] - The FDA's recent approval of Teva's ALVO Selarsdi as interchangeable with Johnson & Johnson's Stelara indicates a favorable regulatory environment for Teva's product pipeline [4] Legal and Regulatory Developments - Teva has resolved patent litigation with Axsome Therapeutics regarding the generic version of Auvelity, which is approved for major depressive disorder [6][7] - The FDA issued a warning about the risk of anaphylaxis associated with glatiramer acetate, a medication sold by Teva, highlighting ongoing regulatory scrutiny [5]

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].

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.

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]