Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Date of Conference**: March 02, 2026 - **Key Personnel**: COO Mark Jacobson, CFO Nick Pizzie Core Business and Financial Performance - **AUVELITY Performance**: Generated $155 million in the last quarter, annualizing over $600 million after 13 quarters from launch [3][4] - **Sales Force Expansion**: Plans to increase field force from 300 to 600 representatives to enhance market penetration, particularly in anticipation of Alzheimer's disease agitation [3][4] - **Operating Leverage**: Revenues outpaced operating expenses by a ratio of 3:1 in 2025, with expectations for continued leverage in 2026 [4] Product Pipeline and Development - **Robust Pipeline**: Currently has 5 product candidates across 9 indications, with AXS-05 for Alzheimer's disease agitation being a key focus [5] - **PDUFA Date**: AXS-05 has a PDUFA date set for April 30, 2026, with pre-launch activities already underway [5][12] - **Clinical Trials**: Positive results from randomized withdrawal studies and head-to-head placebo-controlled studies for AXS-05, with significant safety data collected [15][16] Market Insights - **Market Penetration**: Currently at 0.2% of the total antidepressant market, indicating substantial growth potential [8] - **Patient Demographics**: Over 7 million Alzheimer's patients in the U.S., with an estimated 70% experiencing agitation, representing a significant treatment opportunity [20] - **Direct-to-Consumer Campaign**: Launched a national DTC campaign in September, with plans to continue through 2026, aiming to enhance product adoption [10][11] Competitive Landscape - **Comparison with Rexulti**: Acknowledged as the only approved product for Alzheimer's agitation, but differences in mechanism and sales strategy noted [31][32] - **Market Access**: Anticipated 100% coverage in government channels for Alzheimer's agitation, similar to MDD, which could facilitate script writing [34] Additional Products and Future Opportunities - **Simbravo Launch**: Targeted approach with a sales team focused on headache centers, showing early positive feedback [35][36] - **AXS-12 for Narcolepsy**: NDA submission expected soon, with peak sales potential estimated between $500 million to $1 billion [40][42] - **Sunosi Expansion**: Positive Phase 3 data in adult ADHD, with plans for pediatric studies, indicating a significant market opportunity [43][44] - **AXS-14 for Fibromyalgia**: Currently conducting a new study following an RTF from the FDA, with expectations for compelling data in an underserved market [51][53] Conclusion - Axsome Therapeutics is positioned for significant growth with a robust pipeline and strategic expansions in sales force and market access. The upcoming PDUFA date for AXS-05 and ongoing clinical trials for other products highlight the company's commitment to addressing unmet medical needs in various therapeutic areas.

Core Insights - Axsome Therapeutics has initiated the CLARITY Phase 3 trial for solriamfetol, targeting major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms [1][2] Group 1: Clinical Trial Details - The CLARITY trial is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal study [2] - It includes an open-label treatment period followed by a randomized double-blind period, where patients who respond to treatment will be randomized to either continue solriamfetol or switch to placebo [2] - The primary endpoint is the time from randomization to relapse of depressive symptoms [2] Group 2: Major Depressive Disorder and EDS - Major Depressive Disorder (MDD) affects over 21 million adults in the U.S. and is a leading cause of disability worldwide [3] - Approximately 50% of MDD patients experience excessive daytime sleepiness (EDS), which can lead to impaired daily functioning and increased safety risks [3] - There are currently no approved treatments specifically for MDD with EDS symptoms [3] Group 3: About Solriamfetol - Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI) and is being developed for multiple conditions, including MDD with EDS [4] Group 4: About Axsome Therapeutics - Axsome Therapeutics focuses on innovative treatments for central nervous system (CNS) disorders and has a portfolio that includes FDA-approved treatments for various conditions [5] - The company aims to address significant gaps in care and improve patient outcomes through novel mechanisms of action [5]

4Q and Full Year 2025 Financial Results February 23, 2026 © Axsome Therapeutics, Inc. Forward looking statements & safe harbor Certain matters discussed in this presentation are "forward-looking statements" . The Company may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward- looking ...

Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively,representing 65% and 66% year-over-year growth AUVELITY® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively,representing 68% and 74% year-over-year growth SUNOSI® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively,representing 40% and 32% year-over-year growth SYMBRAVO® 4Q and full year 2025 net product sales of $4.1 million and $ ...

Core Insights - Axsome Therapeutics, Inc. is set to present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026, at 2:00 p.m. ET, highlighting its role in CNS disorder treatments [1] - The company focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS conditions [3] Company Overview - Axsome Therapeutics is a biopharmaceutical company dedicated to addressing critical gaps in CNS care, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness, and migraine [3] - The company has multiple early and late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Investor Information - A live webcast of the upcoming presentation will be available on the company's website, with a replay accessible for approximately 30 days post-event [2]

Core Insights - Axsome Therapeutics Inc. (NASDAQ:AXSM) is recognized as a promising mid-cap stock by leading investors, with H.C. Wainwright raising its price target from $200 to $260 while maintaining a Buy rating [1] - The company reported interim unaudited financial results for Q4 2025, projecting total product revenue of approximately $196 million [1] Revenue Projections - Axsome anticipates overall product revenue of around $638.5 million for fiscal year 2025, representing a 66% increase compared to fiscal year 2024, surpassing H.C. Wainwright's estimate of $628.3 million [2] - The primary product, AUVELITY, is expected to generate net sales of about $155.1 million in Q4 and $507.1 million for the full year 2025, significantly exceeding the firm's annual sales estimate of $397 million [2] Performance of Other Products - Other products, such as SUNOSI, are also projected to perform well, with expected revenues of $36.7 million in Q4 and $124.8 million for the entire year [3] - Axsome Therapeutics focuses on developing novel therapies for central nervous system (CNS) disorders in the US [3]

Core Insights - Axsome Therapeutics, Inc. is set to report its financial results for Q4 and full year 2025 on February 23, 2026, before U.S. market opening [1] - A conference call will be held at 8:00 a.m. Eastern Time to discuss these results and provide a business update [1] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, aiming to deliver scientific breakthroughs and develop differentiated products [3] - 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 [3] - Axsome's development programs target serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3]

Core Insights - Axsome Therapeutics has initiated the FORWARD Phase 3 trial for AXS-14 (esreboxetine) aimed at managing fibromyalgia, marking a significant step in addressing this chronic condition [1][2] Group 1: Trial Details - The FORWARD trial is a Phase 3, double-blind, placebo-controlled, multicenter study involving a randomized withdrawal design [2] - Patients will undergo a 12-week open-label treatment period followed by a randomized phase where they will either continue AXS-14 (8 mg) or switch to a placebo [2] - The primary endpoint is the time from randomization to loss of therapeutic response [2] Group 2: Fibromyalgia Overview - Fibromyalgia affects approximately 17 million people in the U.S., characterized by widespread pain, fatigue, and cognitive impairment [3] - The condition has a significant impact on quality of life and is associated with a considerable economic burden [3] - Current treatment options are limited, with over 50% of patients discontinuing treatment within the first year due to inadequate symptom control or side effects [3] Group 3: AXS-14 Profile - AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being developed specifically for fibromyalgia management [4] - It is the SS-enantiomer of racemic reboxetine and is currently an investigational drug not yet approved by the FDA [4] Group 4: Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [5] - The company aims to address critical gaps in care and improve patient outcomes through differentiated products [5] - Axsome's mission is to tackle significant neurological and psychiatric challenges affecting over 150 million people in the U.S. [5]

Core Insights - Axsome Therapeutics has acquired exclusive global rights to AZD7325, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator, from AstraZeneca, enhancing its neuroscience portfolio and targeting epilepsy treatment [1][2][3] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine, as well as multiple late-stage development programs [5] Transaction Details - The acquisition was executed through Axsome's purchase of a 100% equity interest in Baergic Bio, Inc., which includes a $0.3 million upfront payment to Baergic Bio shareholders and potential milestone payments totaling up to $79 million [3] - AstraZeneca will receive a cash upfront payment in the single-digit millions and is eligible for additional milestone payments and royalties on global net sales of AZD7325 [3] Clinical Development - AZD7325 has shown anti-convulsant effects in preclinical models and has a favorable safety profile based on studies involving over 700 patients [2] - Axsome plans to initiate Phase 2 trial-enabling activities for AZD7325 in 2026 [1][2] Market Need - Epilepsy affects approximately 3.4 million people in the U.S., with about 150,000 new cases diagnosed annually, highlighting the urgent need for innovative treatment options [4]

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]