Core Insights - Axsome Therapeutics has shown significant market performance over the past five years, driven by clinical and regulatory advancements, and is approaching large-cap status [1] - There remains potential for further investment in Axsome Therapeutics due to ongoing growth and new product developments [1] Group 1: Sales Growth - Axsome's revenue for the third quarter reached $171 million, reflecting a 63% increase compared to the same period last year [2] - The company's current product lineup includes Auvelity for depression, Sunosi for narcolepsy-related daytime sleepiness, and Symbravo for migraines, all contributing to strong sales growth [2][3] Group 2: Future Approvals - Axsome is pursuing new approvals and label expansions, including a new indication for Auvelity in treating Alzheimer's disease agitation, which has shown positive results in phase 3 studies and is under FDA consideration [4] - Sunosi has completed a phase 3 study for ADHD in adults, with plans for additional late-stage trials in related markets [5] Group 3: New Product Pipeline - The company is developing several other products, such as AXS-12 for cataplexy in narcolepsy and AXS-14 for fibromyalgia, which could significantly enhance sales potential [6] - The addressable market for Alzheimer's agitation is substantial, with over 5 million patients in the U.S. and currently only one FDA-approved treatment available [7]

Core Insights - Axsome Therapeutics is experiencing significant sales growth for its lead drug, Auvelity, which is approved for major depressive disorder, contributing substantially to the company's revenue since its U.S. launch in 2022 [1][11] Sales Performance - Auvelity generated sales of $352 million in the first nine months of 2025, marking a 77% increase year-over-year, primarily due to higher unit sales volume [2][11] - Total product revenues are projected to be approximately $196 million for Q4 2025 and around $638.5 million for the full year, reflecting year-over-year increases of 65% and 66%, respectively [3] - Auvelity's net product sales are expected to reach about $155.1 million for Q4 2025 and $507.1 million for the full year [4] Product Development and Regulatory Updates - The FDA has accepted a supplemental new drug application (sNDA) for AXS-05 to treat agitation in Alzheimer's disease, with a decision expected by April 30, 2026 [5][11] - Auvelity is also being studied for label expansions in other CNS disorders, which could broaden its market reach and enhance future sales [4][5] Additional Products and Market Position - Axsome's narcolepsy drug, Sunosi, is contributing to revenue growth, with sales increasing by 29.1% year-over-year in the first nine months of 2025 [6][7] - Sunosi's net product revenues are anticipated to be around $36.7 million for Q4 2025 and $124.8 million for the full year [7] - The newly launched Symbravo, approved for migraine treatment, is expected to generate net product sales of approximately $4.1 million for Q4 2025 and $6.6 million for the full year [8] Competitive Landscape - The competitive environment remains challenging, with companies like Acadia Pharmaceuticals marketing therapies for CNS disorders, including its drug Nuplazid, which recorded sales of $505.7 million in the first nine months of 2025 [9][10] - Symbravo is likely to face competition from established migraine treatments from Pfizer and AbbVie, which may hinder its market adoption [12]

Core Insights - The healthcare sector underperformed in 2025, but there are still solid investment opportunities in smaller biotech companies [1] - Axsome Therapeutics and Exelixis are highlighted as promising investment options for 2026 and beyond [2] Axsome Therapeutics - Axsome Therapeutics has made steady clinical and regulatory progress, with approved products including Auvelity for depression, Symbravo for migraines, and Sunosi for narcolepsy [3] - The company is close to earning approval for Auvelity in treating Alzheimer's disease agitation, which could address a significant unmet need, as approximately 5 million patients in the U.S. experience this condition [4] - Axsome's revenue for the first nine months of 2025 reached $442.5 million, marking a 65.8% increase year-over-year [7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which could further boost revenue [6][8] Exelixis - Exelixis specializes in oncology, primarily generating revenue from Cabometyx, which is approved for various cancers, including liver and kidney cancer [9] - The company reported $1.7 billion in revenue for the first nine months of 2025, a 7.5% increase compared to the same period in 2024 [10] - Exelixis has successfully defended its patent rights, delaying generic competition until the next decade [10] - The company is developing new products, including Zanzalintinib for metastatic colorectal cancer, which has shown strong phase 3 results and could significantly impact sales [12][14] - Exelixis is expected to submit regulatory applications soon, which will help diversify its portfolio beyond Cabometyx [13]

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]

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 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]

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]

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.