Axsome Therapeutics Conference Call Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Industry**: Biopharmaceuticals, focusing on central nervous system (CNS) disorders - **Mission**: Develop transformative medicines for CNS conditions affecting hundreds of millions globally [6][7] Key Financial Highlights - **2025 Performance**: - Auvelity generated over **$500 million** in revenue, marking its third year since launch - Total sales for the company approached **$640 million** [7][8] - **2026 Expectations**: - Anticipation of a PDUFA date for Auvelity in Alzheimer's disease agitation on **April 30, 2026** [7][8] - **Team Expansion**: Plans to increase the workforce from **300 to 600** employees [8] Product Portfolio - **Current Products**: - Three on-market products: Auvelity, Sunosi, and SYMBRAVO - Peak sales potential for these products estimated between **$2 billion to $5 billion** [10][18] - **Pipeline**: - Five differentiated product candidates with **seven late-stage clinical trials** [10][11] - Total peak sales potential for pipeline conditions exceeds **$16 billion**, affecting over **150 million patients** [11][12] Product-Specific Insights - **Auvelity**: - Approved for major depressive disorder; expected peak sales for Alzheimer's agitation between **$1.5 billion to $3 billion** [14][34] - Currently holds **86%** market access coverage, with plans to enhance primary care market penetration [22][23] - **Sunosi**: - Revenue growth of **40% year-over-year**; currently generating **$300 million to $500 million** [27][28] - **SYMBRAVO**: - Launched in June 2025; initial growth observed with plans to improve payer coverage [19][30] Clinical Trials and Future Developments - **AXS-05**: - Undergoing review for Alzheimer's disease agitation; three positive trials supporting the application [34][36] - **AXS-12**: - NDA submission for cataplexy in narcolepsy imminent [41] - **Solriamfetol**: - Involved in multiple phase 3 trials for ADHD, major depressive disorder with excessive daytime sleepiness, binge eating disorder, and shift work disorder [37][39][40] Financial Position - **Cash Position**: - **$323 million** on the balance sheet, with a small debt of around **$190 million** [45] - **Revenue Growth**: - Revenues grew three times faster than operating expenses in 2025, with expectations for continued operating leverage in 2026 [45][46] Strategic Focus for 2026 - **Growth Initiatives**: - Focus on commercial performance, R&D advancement, and team expansion to support business growth [17][18] - **Market Access**: - Continued efforts to improve formulary access and expand into primary care markets [22][23] Conclusion - Axsome Therapeutics is well-positioned for growth in 2026, with a strong product pipeline, significant revenue potential, and strategic initiatives aimed at expanding market access and enhancing operational efficiency [45][46]

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]

Core Insights - Axsome Therapeutics reported a revenue of $196 million for the quarter ended December 2025, marking a 65% increase year-over-year and exceeding the Zacks Consensus Estimate of $193.01 million by 1.55% [1] - The company's earnings per share (EPS) was -$0.71, an improvement from -$0.96 in the same quarter last year, although it fell short of the consensus estimate of -$0.70 by 1% [1] Revenue Breakdown - Product sales, net reached $194.7 million, surpassing the average analyst estimate of $191.25 million, reflecting a 66% increase compared to the previous year [4] - Royalty and milestone revenue was reported at $1.3 million, slightly above the average estimate of $1.18 million, but this represented a year-over-year decline of 9.5% [4] - Specific product sales included SYMBRAVO at $4.1 million (below the estimate of $5.27 million), Auvelity at $155.1 million (above the estimate of $151.25 million), and Sunosi at $36.7 million (exceeding the estimate of $33.86 million) [4] Stock Performance - Over the past month, Axsome's shares have returned -1.2%, contrasting with a +1.8% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

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 ...

Core Insights - Axsome Therapeutics reported strong financial results for Q4 and full year 2025, with total net product revenue of $196.0 million and $638.5 million, reflecting year-over-year growth of 65% and 66% respectively [4][2][3] Financial Performance - AUVELITY generated net product sales of $155.1 million in Q4 2025 and $507.1 million for the full year, marking year-over-year growth of 68% and 74% [4][3] - SUNOSI achieved net product revenue of $36.7 million in Q4 2025 and $124.8 million for the full year, representing growth of 40% and 32% year-over-year [4][3] - SYMBRAVO's net product sales were $4.1 million in Q4 2025 and $6.6 million for the full year [4][3] - The total cost of revenue was $12.3 million for Q4 2025 and $47.5 million for the full year, compared to $10.5 million and $33.3 million for the same periods in 2024 [8] - Research and development expenses were $48.8 million for Q4 2025 and $183.3 million for the full year, down from $55.0 million and $187.1 million in 2024 [8] - Selling, general, and administrative expenses rose to $169.3 million for Q4 2025 and $570.6 million for the full year, compared to $113.3 million and $411.4 million in 2024 [8] - The net loss was $28.6 million, or $(0.56) per share, for Q4 2025, and $183.2 million, or $(3.68) per share, for the full year [8] Commercial Highlights - AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for major depressive disorder [6] - SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy, with approximately 54,000 prescriptions written in Q4 2025, an 11% increase from Q4 2024 [7][10] - SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic COX-2 preferential inhibitor and 5-HT1B/1D agonist approved for acute migraine treatment, with 13,000 prescriptions written in Q4 2025, a 147% increase from Q3 2025 [11][15] Development Pipeline - Axsome's pipeline includes five differentiated product candidates, with significant upcoming milestones including the sNDA for AXS-05 for Alzheimer's disease agitation, which has a PDUFA target action date of April 30, 2026 [3][16] - AXS-12 for narcolepsy is on track for NDA submission in Q1 2026 [18] - Clinical trials for solriamfetol in various conditions, including ADHD and binge eating disorder, are set to initiate in 2026 [17] Corporate Updates - Axsome resolved patent litigation with Alkem Laboratories regarding a generic version of SUNOSI, allowing Alkem to sell its version under specific conditions starting in 2040 [21] - The company has sufficient cash to fund operations into cash flow positivity based on its current operating plan [5]

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. 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]