Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on November 10, 2025 Key Points Industry and Market Performance - Axsome Therapeutics operates in the biotechnology sector, focusing on treatments for mental health and neurological disorders [1] - The company reported a strong Q3 performance with total net sales of **$171 million**, driven by their leading product for Major Depressive Disorder (MDD) which generated **$136 million**, reflecting a **69% year-over-year growth** and **14% quarter-over-quarter growth** [4][5] Product Pipeline and Development - Axsome has several products in various stages of development: - **AXS-05** for MDD - **AXS-12** for narcolepsy - Ongoing Phase III programs for other indications [3] - The company is expanding its earlier stage pipeline and has launched a direct-to-consumer (DTC) campaign to enhance product visibility [3][5] Direct-to-Consumer Campaign - The DTC campaign launched in early September has already shown positive early metrics, including increased Google searches and new prescriptions (NBRxs) [8][10] - NBRxs increased from **2,000 per week** to **2,800**, attributed largely to the DTC efforts [9][10] - The company is taking a disciplined approach to DTC spending, ensuring that sales in Q4 will meet or exceed the additional DTC expenditures [11][12] Market Access and Sales Force Expansion - Axsome has improved its gross-to-net dynamics, achieving a discount in the high **40s%** and covering **85% of total lives** [18][19] - The sales force currently consists of **300 representatives**, with plans for expansion upon receiving approval for additional indications [20][21] Regulatory and Approval Process - Axsome is preparing for an NDA submission for Alzheimer's Disease Agitation (ADA), with a robust package that includes three positive controlled trials and a standalone safety database [24][25] - The company has received breakthrough therapy designation and is eligible for priority review, although they are modeling a standard review timeline [32][33] Competitive Landscape - The market for Alzheimer's Disease treatments is evolving, with competitors like Rexulti showing growth rates of **20% to 25%** [39][40] - Despite the presence of approved products, a significant portion of patients are still treated off-label, indicating room for growth in formalized treatment protocols [42][43] Financial Outlook - Axsome achieved cash flow positivity for the first time, with approximately **$1 million** positive cash flow from operations in Q3 [60] - The company anticipates operating leverage moving into Q4 and next year, with revenue growth of **14%** and operating expenses growing at **5.5%** [61] Future Projections - Axsome projects peak sales for its products, including **$500 million to $1 billion** for Cymbravo and **$300 million to $500 million** for Sunosi [51][57] - The company is focused on maintaining a disciplined approach to its investments while preparing for potential growth in the ADA market [58][61] Conclusion - Axsome Therapeutics is positioned for significant growth with a strong product pipeline, effective marketing strategies, and a disciplined financial approach. The upcoming regulatory submissions and market expansions are critical to the company's future success.

Core Insights - Axsome Therapeutics reported a loss of $0.94 per share in Q3 2025, which was wider than the expected loss of $0.82, but an improvement from the loss of $1.34 per share in the same quarter last year [1][6] - Total revenues increased by 63% year over year to $171 million, surpassing the consensus estimate of $164 million, driven by strong sales of Auvelity [2][6] Financial Performance - Product revenues reached $169.8 million in Q3, reflecting a 63.7% year-over-year increase, while royalty revenues were $1.2 million [4] - Auvelity sales amounted to $136.1 million, up 69% year over year, with approximately 209,000 prescriptions recorded, marking a 46% increase from the previous year [5][6] - Sunosi generated net product sales of $32.8 million, a 35% increase from the prior year, with total prescriptions growing 12% year over year [7] Expenses and Cash Position - Research and development expenses were $40.2 million, down 11.5% from the previous year, while selling, general, and administrative expenses rose 57.1% to $150.2 million [9] - As of September 30, 2025, the company had cash and cash equivalents of $325.3 million, up from $303 million as of June 30, 2025 [10] Pipeline Developments - Axsome is conducting label expansion studies for Auvelity and has filed a supplemental new drug application for AXS-05 for Alzheimer's agitation [11] - The company plans to initiate pivotal studies for AXS-05 in smoking cessation and has multiple candidates in development for various CNS disorders, including AXS-12 and AXS-14 [12][13] - Solriamfetol is being evaluated in phase III studies for ADHD and MDD, with top-line data expected in 2026 for binge eating disorder and shift work disorder [14][15] Market Performance - Year to date, Axsome's shares have increased by 60.5%, significantly outperforming the industry average rise of 12.1% [2]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $171 million, representing a 63% increase year over year [4][11] - Net product sales for Auvelity were $136.1 million, up 69% compared to the previous year [11] - Sunosi net product revenues were $32.8 million, reflecting a 35% increase year over year [11] - The net loss for the quarter 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 the same period last year [13] Business Line Data and Key Metrics Changes - Auvelity showed strong prescription growth with approximately 209,000 prescriptions written, a 46% year-over-year increase [15] - Sunosi had approximately 53,000 prescriptions, representing a 12% year-over-year growth [18] - Sembravo generated $2.1 million in net sales during its first full quarter on the market [11] Market Data and Key Metrics Changes - Commercial coverage for Auvelity increased from 73% to 75%, bringing total coverage to 85% of all lives across channels [15] - Payer coverage for Sunosi remains at approximately 83% of lives covered across channels [18] - Sembravo's overall payer coverage was approximately 52% of all lives as of October 1st [17] Company Strategy and Development Direction - The company aims to broaden patient access and drive awareness with clinicians for its products [5] - Axsome is advancing a robust pipeline with late-stage programs targeting Alzheimer's disease agitation, narcolepsy, and ADHD [5][10] - The company plans to initiate a phase 2/3 trial for AXS-05 in smoking cessation and target NDA submission for AXS-12 for cataplexy in narcolepsy [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth potential of Axsome, highlighting strong performance across its commercial portfolio [19] - The company anticipates meaningful activity across its late-stage programs in the coming months [5] - Management noted that the fundamentals of the business have never been stronger, positioning Axsome for substantial near and long-term value [10] Other Important Information - The company ended Q3 2025 with $325.3 million in cash and cash equivalents, an increase from $315.4 million at the end of 2024 [14] - Gross-to-net discounts for Auvelity and Sunosi were in the high 40% range, expected to increase to the low 50% range in Q4 [12] Q&A Session Summary Question: Insights on Sembravo's launch and prescribing depth - Management noted early positive responses from healthcare providers and patients, with a targeted approach focusing on top headache centers [22][23] Question: Growth driver for Auvelity in primary care - Management emphasized the importance of primary care as a growth driver, supported by sales force expansion and direct-to-consumer campaigns [26][27] Question: Expectations for AXS-05 adoption in Alzheimer's agitation - Management is optimistic about AXS-05's impact, planning to cover various specialties and settings of care [31][32] Question: Sales force expansion and cash flow positivity - Management confirmed plans for sales force expansion if AXS-05 is approved, with costs already included in cash flow positivity guidance [35][76] Question: Impact of DTC campaign on Auvelity prescriptions - Management indicated that significant impacts from the DTC campaign may be observed in 8-12 weeks, with early positive trends noted [77] Question: Regulatory interactions for AXS-05 - Management stated that interactions are ordinary course and that they are prepared for standard review by the FDA [87]

Core Insights - Axsome Therapeutics focuses on developing treatments for brain disorders, with three drugs currently on the market and five in the pipeline, potentially addressing the needs of 150 million Americans suffering from such conditions [1][3][4] - The company reported a revenue of $495 million for the 12 months ending in June, marking a 70% increase from the previous year, although it remains unprofitable with a net loss of $247 million [3][4] - Axsome's market capitalization stands at $6.1 billion, and the company aims for peak sales of $16.5 billion from its current drug portfolio, contingent on successfully navigating FDA approvals for five new drugs by 2028 [4][13] Company Overview - Founded in 2012 by Herriot Tabuteau, Axsome Therapeutics was established with a unique approach to drug development, focusing on brain disorders and self-funding rather than relying on venture capital [1][2][5] - The company has evolved from humble beginnings in a small office to a significant player in the biotech sector, with a notable drug portfolio and innovative strategies for clinical trials [3][7] Financial Performance - Axsome's revenue growth of 70% year-over-year highlights its increasing market presence, although the company has yet to achieve profitability [3][4] - The stock price has increased by 35% over the past year, outperforming the Nasdaq Biotech Index, which only rose by 1% during the same period [12] Drug Development and Pipeline - The approval of Auvelity for major depressive disorder in August 2022 significantly boosted Axsome's market valuation, with shares rising 65% in a week [9] - Auvelity is projected to generate $500 million in sales this year and is expected to become a blockbuster drug, with potential annual revenues exceeding $1 billion [10][13] - Axsome is also working on a drug for Alzheimer's agitation, which could provide a safer alternative to current antipsychotic treatments, despite mixed results in Phase III trials [12][13] Strategic Acquisitions - In 2022, Axsome acquired Sunosi for $53 million, which treats excessive daytime sleepiness, and later sold its rights for $66 million, demonstrating effective financial management [11]

Core Insights - Axsome Therapeutics' lead drug, Auvelity, has shown strong sales performance since its approval for major depressive disorder, contributing significantly to the company's revenue [1] Sales Performance - Auvelity recorded sales of $215.9 million in the first half of 2025, marking an 82.3% increase year-over-year, driven by higher unit sales volume [2][9] - The company anticipates a compound annual growth rate (CAGR) of approximately 42.7% for Auvelity sales over the next three years [2] Product Development and Expansion - Auvelity is undergoing label expansion studies for other CNS disorders, including Alzheimer's disease agitation and smoking cessation, with an sNDA expected to be filed in Q3 2025 [3] - A pivotal phase II/III study for smoking cessation is planned to commence in Q4 2025 [3] - The approval of Auvelity for additional indications is expected to further enhance sales and growth prospects [4] Additional Products - Axsome's narcolepsy drug, Sunosi, has also contributed to revenue, with sales increasing by 25.6% year-over-year in H1 2025 [5][9] - The recent launch of Symbravo for migraine treatment, approved in January 2025, is expected to strengthen Axsome's market presence [5] Competitive Landscape - Axsome faces significant competition in the CNS disorder market, particularly from Acadia Pharmaceuticals' Nuplazid, which generated $328.2 million in sales, a 14% increase year-over-year [6][7] - Sunosi may encounter competition from Jazz Pharmaceuticals' sleep disorder drugs, while Symbravo will face established migraine treatments from Pfizer and AbbVie [8]

Group 1: Axsome Therapeutics - Axsome Therapeutics is a mid-cap biotech company with three products on the market: Auvelity, Symbravo, and Sunosi, driving strong revenue growth, with a 72% year-over-year increase to $150 million in Q2 [3][4] - The launch of Symbravo in June presents a significant growth opportunity, targeting a market of 39 million migraine patients in the U.S., where over 70% have inadequate responses to current treatments [4][5] - Auvelity shows promise in treating agitation associated with Alzheimer's disease, with a potential market of 7 million patients, and is on track to achieve blockbuster status [5][6] - The company is advancing its pipeline with AXS-12 for narcolepsy and other late-stage trials, positioning itself for continued revenue growth and market outperformance [6] Group 2: Exelixis - Exelixis specializes in oncology, known for its drug Cabometyx, which treats liver and kidney cancers and continues to drive revenue growth despite a reported 11% drop in total revenue to $568.3 million due to lower collaboration revenue [7][8] - Net product revenue for Exelixis increased by 19% year-over-year to $520 million, with Cabometyx expected to maintain strong sales through early 2030, fending off generic competition [8][9] - The company is focused on developing cancer therapies for high unmet needs, with its candidate zanzalintinib showing promise in metastatic colorectal cancer, which could address a significant treatment gap [9][10] - Exelixis has additional candidates in its pipeline, and strong clinical progress alongside Cabometyx's revenue growth is expected to yield strong returns through the end of the decade [10]

Group 1 - The event is the Fifth Annual TD Cowen Novel Mechanisms in Neuropsychiatry and Epilepsy Summit, featuring Axsome Therapeutics [1] - Axsome Therapeutics has made significant progress in both commercial and development aspects over the past year [2] - The company is expected to provide insights into future expectations for investors, particularly looking towards the end of 2025 and early 2026 [2] Group 2 - In Q2, Axsome Therapeutics reported net sales of $150 million, with Auvelity contributing $120 million and Sunosi $30 million [4] - The recent launch of SYMBRAVO generated approximately $400,000 in its first 2.5 weeks [4]

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: Fifth Annual TD Cowen Novel Mechanisms in Neuropsychiatry and Epilepsy Summit - **Date**: September 17, 2025 Key Points Commercial Performance - **Q2 Net Sales**: $150 million, with Auvelity contributing $120 million and Sanofi $30 million [3][4] - **Symbravo Launch**: Generated approximately $400,000 in revenue within two and a half weeks of launch [3] - **MBRXs Growth**: Increased from 2,000 to 2,500 per week due to the expansion of the sales force [4][15] - **Coverage Expansion**: Added 28 million additional lives covered, enhancing patient access and maintaining net pricing [4][21] - **Direct-to-Consumer Campaign**: Launched a national TV advertising campaign for Auvelity, expected to boost awareness and prescriptions [5][19] Product Utilization - **Auvelity Utilization**: Approximately 50% of prescriptions are for first-line or first-switch patients, indicating strong market penetration [11] - **Monotherapy Use**: Over 50% of Auvelity prescriptions are for monotherapy, suggesting a reduction in polypharmacy [12] Research and Development - **AXS-05 for Alzheimer's**: sNDA filing expected in Q3 2025, with ongoing trials and a focus on agitation in Alzheimer's patients [7][24] - **Upcoming NDA Submission**: AXS-12 for narcolepsy planned for Q4 2025 [8] - **Clinical Trials**: Multiple ongoing trials for various conditions, including ADHD, major depressive disorder, and fibromyalgia [9] Market Potential - **Alzheimer's Market Size**: Estimated at 7 million patients, with around 5 million experiencing agitation, presenting a significant market opportunity [32] - **Peak Sales Estimates**: Projected peak sales for AXS-05 in the range of $1.5 to $3 billion [32] Strategic Outlook - **Sales Force Expansion**: Plans to increase the sales force significantly in 2026, focusing on primary care and long-term care centers [15][16] - **Market Dynamics**: Anticipated growth in prescriptions post-Labor Day as patient compliance improves [20] - **Business Development**: While monitoring market opportunities, the company is currently satisfied with its existing pipeline and acquisitions [39] Additional Insights - **KOL Feedback**: Positive feedback from Key Opinion Leaders regarding the safety and tolerability profile of AXS-05, especially in elderly patients [29] - **Regulatory Engagement**: Consistent dialogue with the FDA regarding trial requirements and product development strategies [24][25] Conclusion Axsome Therapeutics is positioned for growth with strong commercial performance, a robust pipeline, and strategic plans for market expansion. The company is optimistic about its future prospects, particularly in the Alzheimer's market and ongoing product launches.

Axsome Therapeutics (AXSM) Conference Call Summary Company Overview - Axsome Therapeutics is a CNS-focused company specializing in brain health with three in-market products and a deep pipeline of novel product candidates [3][4] Financial Performance - Q2 total net sales reached $150 million, with $120 million from Auvelity, indicating a trajectory towards a half a billion annual run rate [4] - Cash on hand exceeds $300 million, positioning the company towards cash flow positivity [4] - Auvelity's market access expanded by 28 million lives as of July 1, enhancing growth potential [5] Product Pipeline and Development - Axsome V for Alzheimer's disease agitation is on track for sNDA submission in Q3, supported by three positive trials and additional safety data [6][8] - NDA submission for Axsome 12 (reboxetine for narcolepsy) is anticipated in Q4, with positive trial results across multiple endpoints [20][21] - Four Phase 3 programs for Sunosi are underway, with trials for Axsome V in smoking cessation and Axsome 14 in fibromyalgia planned [6] Commercial Strategy - Continued growth is expected for Auvelity and Symbravo, with a focus on expanding the sales force and targeting long-term care settings [6][10] - The company plans to invest in direct-to-consumer (DTC) marketing to drive new prescriptions [27] - Auvelity has a peak sales estimate of $1 billion to $3 billion, with current annualized sales at $500 million, representing only 0.16% of the total antidepressant market [26][30] Product Differentiation - Auvelity is positioned as an oral NMDA receptor antagonist, distinct from atypical antipsychotics, with a favorable safety and tolerability profile [18][19] - Axsome 12 is differentiated by its efficacy in treating cataplexy and improvements in sleepiness and cognition, with a distinct tolerability profile compared to existing therapies [20][21] - Symbravo is designed to address efficacy gaps in acute migraine treatment, with early feedback indicating robust efficacy and tolerability [33][34] Market Access and Pricing - Gross net pricing remains stable in the mid-50% range, with potential for improvement as market access increases [32] - The company anticipates higher gross and net discounts in the migraine treatment space, aligning with industry norms [43] Future Outlook - Axsome Therapeutics is optimistic about its growth trajectory, with significant developments expected in the coming quarters, including product launches and market expansions [6][46]

Financial Data and Key Metrics Changes - In Q2, the company achieved a milestone of $150 million in net sales for the first time, with $120 million from Avelity, indicating a trajectory towards $500 million in annualized sales [5] - The company reported a strong balance sheet with over $300 million in cash, positioning it for cash flow positivity [5][6] - The gross-to-net discount for Q2 was in the mid-50s range, showing slight improvement from Q1, and is expected to remain stable for the second half of the year [46][47] Business Line Data and Key Metrics Changes - Avelity for major depressive disorder (MDD) is tracking close to $500 million in sales, with peak sales potential estimated between $1 billion to $3 billion [30][31] - Sunosi generated $30 million in sales, with two-thirds of scripts coming from obstructive sleep apnea (OSA) [62] - The newly launched product, Symbravo, recognized approximately $400,000 in sales during its initial weeks [5] Market Data and Key Metrics Changes - The company has expanded its covered lives for Avelity to 83%, with a national direct-to-consumer campaign planned to further increase brand awareness [31][32] - The Medicare channel has shown significant growth, with Rexulti scripts growing over 40% year-over-year, indicating a robust market for Alzheimer's disease agitation treatments [14][15] Company Strategy and Development Direction - The company is focused on expanding its product portfolio with a robust pipeline, including potential indications for Alzheimer's disease agitation, smoking cessation, ADHD, and binge eating disorder [4][63] - The strategy includes optimizing the sales force by integrating Alzheimer's disease agitation into the existing MDD sales team and potentially expanding into long-term care [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the fundamentals of the company, stating that the current environment is favorable for growth [4] - The company is focused on top-line growth while also improving cash flow, with a significant reduction in losses year-over-year [84][85] Other Important Information - The company is in dialogue with the FDA regarding the submission package for Avelity in Alzheimer's disease agitation, with a focus on providing robust clinical data [18][19] - The patent for Symbravo extends to 2041, providing a strong competitive position in the market [60][61] Q&A Session Summary Question: Are you still on track to file an sNDA for Alzheimer's disease agitation in Q3? - Yes, the company is on track to file [6] Question: What is the commercial opportunity in Alzheimer's disease agitation? - There is a substantial unmet need, with potential peak sales estimated between $1 billion to $3 billion [8][9] Question: How is the sales force structured for Avelity and Alzheimer's disease agitation? - The sales force has expanded to approximately 300 reps, with plans to integrate Alzheimer's disease agitation into the existing MDD team [27][28] Question: What is the expected gross-to-net discount at steady state? - The company expects to maintain a mid-50s gross-to-net discount for the remainder of the year [46][47] Question: What are the goals for the launch of Symbravo? - The focus is on gathering clinician feedback and improving access for patients [49][51] Question: What is the peak sales potential for ADHD indications? - The peak sales potential for ADHD is estimated between $1 billion to $3 billion [71]