Company Strategy - Axsome Therapeutics aims for differentiated outcomes by avoiding conventional approaches [1] Leadership - Herriot Tabuteau, 57, CEO of Axsome Therapeutics, gave his first interview about the company [1]

Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biopharmaceutical company focused on developing therapies for central nervous system disorders. The company is known for its innovative approach to treating conditions like depression and migraines. In the competitive healthcare sector, Axsome stands out with its commitment to addressing unmet medical needs.On December 4, 2025, Herriot Tabuteau, the CEO and a significant shareholder of Axsome, sold 10,558 shares of the company's common stock at $148.18 each. This ...

PresentationJohn-Paul DavidsHead of Investor Relations Good afternoon, everyone, and good morning to those joining from the U.S. My name is JP Davids, I look after Investor Relations for the Vodacom Group. Thank you for joining this call to discuss the acquisition of a strategic stake in Safaricom. As a reminder, we have put out an announcement this morning on the Johannesburg Stock Exchange alongside Safaricom. We've also published a presentation to our website, which is available at www.vodacom.com. And ...

Core Insights - The company is currently awaiting an important decision regarding the filing for Auvelity and its application for AD agitation, which is a significant topic for stakeholders [1] - The company confirmed that a supplemental New Drug Application (sNDA) was submitted, and they are now waiting to provide further updates on this matter [1] - The expectation is that if the sNDA is accepted, it will undergo a standard review due to the current resource constraints and bandwidth considerations at the FDA, which are independent of the submitted package [2]

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference on December 03, 2025 Key Points Industry and Product Updates - **Auvelity and Alzheimer's Disease (AD) Agitation**: - Axsome is awaiting an acceptance decision for the supplemental new drug application (SNDA) for Auvelity in AD agitation, which was submitted in early November [3][5][10] - The expectation is for a standard review due to FDA resource constraints, despite having three positive trials and breakthrough therapy designation [10][11] - The company believes the trial package is robust, consisting of one randomized parallel group study and two randomized withdrawal studies [10][12][22] Commercialization Strategy - **Sales Force Expansion**: - Currently, Axsome has approximately 300 sales representatives detailing for Major Depressive Disorder (MDD) and plans to expand the team upon approval for AD agitation [24][26] - The peak sales opportunity for AD agitation is estimated between $1.5 billion and $3 billion, while MDD is estimated at $1 billion to $3 billion, totaling $2.5 billion to $6 billion [30][32] - A discrete field force team will be established for long-term care facilities, recognizing the comorbidity between MDD and AD agitation [32][34] Market Access and Coverage - **Access to Auvelity**: - Currently, there is 100% access in the government channel and 75% in the commercial channel, leading to an overall 85% total covered lives [47][47] - The majority of prescriptions are expected to come from the government channel, with high-quality access anticipated for the AD agitation indication [47][123] Direct-to-Consumer (DTC) Campaign - **DTC Campaign for Auvelity**: - A national TV DTC campaign launched in September has shown positive results, with new prescriptions (NBRXs) increasing from 2,000 to over 2,800 per week [75][78] - The campaign is expected to continue through 2026, with adjustments made based on market conditions [79][100] Product Performance and Market Position - **Auvelity in MDD**: - Over 50% of prescriptions are now for monotherapy, with 15% first-line and 35% second-line usage [103][108] - The gross-to-net (GTN) improved from mid-50s% in Q1 and Q2 to high 40s% in Q3, with expectations for a slight uptick in Q4 [122][123] Pipeline Developments - **Solriamfetol**: - Axsome is excited about the potential of Solriamfetol in various CNS settings, with studies underway for ADHD, MDD with excessive daytime sleepiness, and binge eating disorder [159][161][186] - The company anticipates starting a pediatric ADHD study this quarter and expects top-line results for binge eating disorder next year [174][190] New Product Development - **GABA-A Alpha 2/3 Modulator**: - Axsome is exploring the value proposition of a new GABA-A modulator for epilepsy and psychiatric indications, with preclinical work already underway [200][206] - The company is taking an opportunistic approach to expand its early-stage pipeline [211][220] Conclusion - Axsome Therapeutics is strategically positioned with a robust pipeline and commercialization plans, focusing on expanding its market presence in both existing and new indications while maintaining a strong emphasis on data-driven decision-making and market access strategies.

Core Viewpoint - Axsome Therapeutics reported a wider-than-expected loss in Q3 2025, but revenues surged significantly due to strong sales of its drug Auvelity, raising questions about the sustainability of this positive trend leading up to the next earnings release [2][3][12]. Financial Performance - Axsome incurred a loss of $0.94 per share in Q3 2025, which was wider than the Zacks Consensus Estimate of a loss of $0.82, compared to a loss of $1.34 per share in the same quarter last year [2]. - Total revenues increased by 63% year-over-year to $171 million, surpassing the Zacks Consensus Estimate of $164 million, primarily driven by strong Auvelity sales [3][4]. - Net product revenues reached $169.8 million, reflecting a 63.7% year-over-year increase, while royalty revenues totaled $1.2 million [4]. Product Sales Breakdown - Auvelity sales amounted to $136.1 million, marking a 69% year-over-year increase and a 14% sequential increase, with approximately 209,000 prescriptions recorded, a 46% increase year-over-year [5]. - Sunosi's net product sales were $32.8 million, up 35% from the previous year, with total prescriptions growing 12% year-over-year [6]. - Symbravo generated $2.1 million in sales in its first full quarter since launch [6]. Expenses and Cash Position - Research and development expenses decreased by 11.5% year-over-year to $40.2 million, attributed to the completion of label expansion studies for Sunosi [7]. - Selling, general, and administrative expenses rose by 57.1% year-over-year to $150.2 million due to increased commercial activities for Auvelity and ongoing launch activities for Symbravo [7]. - As of September 30, 2025, Axsome had cash and cash equivalents of $325.3 million, up from $303 million as of June 30, 2025 [8]. Market Sentiment and Estimates - Recent estimates for Axsome have trended downward, with a consensus estimate shift of -23.81% [9]. - The stock has a Growth Score of A but lags in Momentum with an F, resulting in an aggregate VGM Score of C [11]. - Axsome holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [12]. Industry Comparison - Axsome operates within the Zacks Medical - Biomedical and Genetics industry, where Gilead Sciences reported revenues of $7.77 billion, reflecting a 3% year-over-year increase [13]. - Gilead's expected earnings for the current quarter indicate a -2.1% change from the previous year, with a Zacks Rank 3 (Hold) and a VGM Score of A [14].

Group 1: Axsome Therapeutics - Axsome Therapeutics has shown strong clinical and regulatory progress, with a 63% year-over-year revenue increase to $171 million in Q3 [3][6] - The company’s main growth driver is Auvelity, approved for major depressive disorder, and it has received approval for Symbravo, a migraine medication [4][3] - Axsome estimates a potential of over $16 billion in peak sales across all its targeted indications, indicating a large addressable market [6][7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy, which could further enhance its growth prospects [6][8] Group 2: Exelixis - Exelixis specializes in cancer medicine, with Cabometyx as its primary product, approved for multiple indications, contributing to a 10.8% year-over-year revenue increase to $597.8 million in Q3 [9][10] - The company successfully won a lawsuit to keep generic competition for Cabometyx off the market until 2030, boosting its medium-term outlook [10] - Exelixis is developing new cancer therapies, including zanzalintinib for metastatic colorectal cancer, which has shown promise in clinical trials [12][13] - The ongoing development of new treatments and the upward sales trajectory of Cabometyx could enhance Exelixis's stock performance in the coming years [13]

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 - The article emphasizes the potential of investing in smaller, lesser-known biotech companies alongside established market leaders, highlighting Viking Therapeutics and Axsome Therapeutics as promising candidates for growth in the biotech sector [1][2]. Viking Therapeutics - The weight loss market is projected to grow from $15 billion last year to $150 billion by 2035, driven by breakthroughs and increasing demand for obesity-related treatments [3]. - Viking Therapeutics is developing VK2735, a dual GLP-1/GIP agonist, currently in phase 3 trials for subcutaneous use, with promising efficacy observed in mid-stage trials for an oral formulation [4]. - The company is also working on another weight-loss candidate in preclinical studies and plans to initiate human clinical trials next year, alongside VK2809, which has completed phase 2 studies for metabolic dysfunction-associated steatohepatitis [7]. Axsome Therapeutics - Axsome Therapeutics has achieved significant clinical and regulatory advancements, with third-quarter revenue reaching $171 million, a 63% year-over-year increase, primarily due to its depression medication, Auvelity [9]. - Auvelity, launched in 2022, is expected to achieve blockbuster status in treating depression and is awaiting approval for use in Alzheimer's disease agitation, with potential peak sales estimated between $1.5 billion to $3 billion [10][11]. - The company has a robust pipeline with other approved products and ongoing late-stage trials, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which are expected to enhance financial performance [12][13].

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]