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Axsome Therapeutics(AXSM) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:02
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $150 million, representing a 72% increase year over year and a 24% increase quarter over quarter [6][14] - Net loss for the quarter was $48 million, or $0.97 per share, compared to a net loss of $59.4 million, or $1.22 per share in the previous quarter [17] - Cash and cash equivalents at the end of Q2 2025 were $300 million, down from $315.4 million at the end of Q2 2024 [17] Business Line Data and Key Metrics Changes - Avelity generated net product sales of $119.6 million, up 84% year over year and 24% quarter over quarter [14] - Sunosi net product revenues were $30 million, up 35% year over year and 19% quarter over quarter [15] - Zimbravo, launched on June 10, generated net sales of $410,000 in its partial quarter [15] Market Data and Key Metrics Changes - Avelity led the market in total prescriptions (TRx) growth, generating approximately 192,000 prescriptions in Q2, representing a 15% quarter over quarter growth [19] - Sunosi prescriptions exceeded 50,000 for the first time, representing a 9% sequential growth [20] - Coverage for Avelity now stands at 83% of lives across all channels, with 73% of commercial lives covered [20] Company Strategy and Development Direction - The company is focused on expanding its commercial portfolio with three marketed products and advancing its late-stage neuroscience pipeline [6][12] - AXS-five for Alzheimer's disease agitation is a key priority, with an sNDA submission expected this quarter [8] - The company aims to leverage its existing sales force for AXS-twelve and Sunosi, anticipating synergistic opportunities [114] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong demand for its products and the potential for continued growth in the second half of the year [6][23] - The company is encouraged by the early feedback on Cymbravo and expects to expand its coverage throughout the year [21][22] - Management highlighted the importance of market access and the positive signals from pharmacy benefit managers [28] Other Important Information - The company is advancing multiple late-stage development programs targeting significant unmet needs in neuroscience [6][12] - The launch of Cymbravo represents a significant milestone for the company, providing new treatment options for migraine patients [7] Q&A Session Summary Question: Payer coverage expansion for Avelity - Management clarified that the coverage expansion represents pull-through from previously announced GPO contracts and expects some acceleration in volume [28][30] Question: Market positioning of AXS-twelve against competitors - Management expressed optimism about AXS-twelve's profile in narcolepsy, highlighting its rapid action and efficacy in addressing key symptoms [35][36] Question: Utilization of Cimbravo through sampling - Management reported positive early utilization of sampling programs and patient savings programs, indicating strong initial access [42][43] Question: Revenue recognition for Cimbravo - Management explained that Q2 revenue recognition was based on initial stocking orders, with expectations for improved gross to net assumptions in future quarters [47][48] Question: Strategy for AXS-five in Alzheimer's agitation - Management plans to leverage existing sales forces and expand promotional efforts to target geriatric psychiatry and long-term care facilities [56][90] Question: Pediatric ADHD study details - Management indicated that the pediatric study would be a standard parallel group design, with confidence based on adult data translating to pediatric efficacy [110][111]
Axsome Therapeutics(AXSM) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:00
Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $150 million, reflecting a 72% increase year over year and a 24% increase quarter over quarter, driven by strong performance from Ovelity and Sunosi [6][14] - Net loss for the quarter was $48 million, or $0.97 per share, compared to a net loss of $59.4 million, or $1.22 per share in the previous quarter, and $79.3 million, or $1.67 per share in Q2 2024 [17] Business Line Data and Key Metrics Changes - Ovelity generated net product sales of $119.6 million, up 84% year over year and 24% quarter over quarter [14] - Sunosi net product revenues were $30 million, up 35% year over year and 19% quarter over quarter [15] - Zimbravo, launched on June 10, generated net sales of $410,000 for the partial quarter [15] Market Data and Key Metrics Changes - Avelity led the market in total prescriptions (TRx) growth, generating approximately 192,000 prescriptions in Q2, representing 15% quarter over quarter growth and 56% year over year growth [20] - Sunosi prescriptions exceeded 50,000 for the first time, representing 9% sequential growth and approximately 13% growth versus Q2 of last year [21] Company Strategy and Development Direction - The company is focused on advancing its late-stage neuroscience pipeline, with key priorities including AXS-five for Alzheimer's disease agitation and AXS-twelve for narcolepsy [8][10] - The launch of Cymbravo represents a significant milestone, providing new treatment options for migraine patients [7] - The company aims to expand its commercial infrastructure and enhance patient access to its medicines through strategic market access initiatives [19][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the accelerating trajectory of the commercial portfolio and the potential for significant long-term value creation [13] - The company anticipates continued strong commercial execution to drive momentum across its product portfolio in the second half of the year [23] Other Important Information - The company ended Q2 2025 with $300 million in cash and cash equivalents, down from $315.4 million at the end of Q2 2024 [17] - The company is on track to submit the sNDA for AXS-five this quarter and expects to initiate a Phase III trial for AXS-twelve in Q4 [9][10] Q&A Session Summary Question: Payer coverage expansion for Avelity - Management indicated that the coverage expansion represents pull-through from previously announced GPO contracts and expects some acceleration in volume [28][30] Question: Market positioning of AXS-twelve against competitors - Management expressed optimism about AXS-twelve's profile in narcolepsy, highlighting its rapid-acting nature and potential to address significant unmet needs [34][36] Question: Utilization of Cimbravo through sampling - Management reported positive early utilization of sampling programs and patient savings programs, indicating strong initial access [41][43] Question: Revenue recognition for Cimbravo - Management clarified that Q2 revenue recognition was based on initial stocking orders and that they expect to see more data on new patient starts in the coming quarters [46][48] Question: Strategy for AXS-five in Alzheimer's agitation - Management plans to leverage existing sales forces and expand promotional efforts to target geriatric psychiatry and long-term care facilities [54][56] Question: Growth drivers for Avelity - Management noted that GTN remained stable, with growth driven by higher demand and a favorable change in estimates related to liabilities [58][60] Question: Coverage expectations for Sunosi - Management aims to continue expanding coverage for Sunosi, which currently stands at approximately 83% of lives covered across channels [125] Question: Pediatric ADHD study details - Management indicated that the pediatric study will be a standard parallel group design, with confidence based on the efficacy observed in adult trials [110][112]
Axsome Therapeutics(AXSM) - 2025 Q2 - Earnings Call Presentation
2025-08-04 12:00
axsome 2Q 2025 Corporate Presentation August 4, 2025 Forward looking statements & safe harbor Certain matters discussed in this presentation are "forward-looking statements". The Company may, in some coses, use terms such as "potential," "continue," "estimates," "anticipates;" "expects," "plans," "intends," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and po ...
Axsome Therapeutics(AXSM) - 2025 Q2 - Quarterly Results
2025-08-04 11:43
[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) This section provides an overview of Q2 2025 financial and operational achievements, including product performance and strategic pipeline advancements [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Axsome Therapeutics achieved robust financial and operational growth in Q2 2025, driven by significant product revenue increases and key pipeline advancements | Metric | 2Q 2025 Amount (Million USD) | YoY Growth | QoQ Growth | | :----------------------- | :--------------------------- | :--------- | :--------- | | Total Net Product Revenue | 150.0 | 72% | 24% | | AUVELITY Net Product Sales | 119.6 | 84% | 24% | | SUNOSI Net Product Revenue | 30.0 | 35% | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - AUVELITY market access expanded to an additional **28 million covered lives** in commercial channels[1](index=1&type=chunk) - SYMBRAVO secured its **first Group Purchasing Organization (GPO) contract**[1](index=1&type=chunk) - The supplemental New Drug Application (sNDA) for AXS-05 in Alzheimer's agitation is on track for submission in **Q3 2025**[1](index=1&type=chunk) - The New Drug Application (NDA) for AXS-12 for cataplexy in narcolepsy patients is anticipated for submission in **Q4 2025**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Dr. Herriot Tabuteau emphasized strong Q2 2025 performance driven by robust product demand, commercial execution, regulatory progress, and a promising neuroscience pipeline - The company demonstrated strong performance in Q2 2025, attributed to robust demand for life-changing medicines, precise commercial execution, solid regulatory progress, and continued advancement of a differentiated neuroscience pipeline[4](index=4&type=chunk) - SYMBRAVO has been approved and successfully launched, while AUVELITY and SUNOSI show accelerated performance[4](index=4&type=chunk) - The sNDA for AXS-05 in Alzheimer's agitation and the NDA for AXS-12 in narcolepsy are on schedule for submission in Q3 and Q4, respectively[4](index=4&type=chunk) - The company possesses a late-stage development pipeline, including ADHD, binge eating disorder, shift work disorder, depression with excessive sleepiness, fibromyalgia, and smoking cessation, with potential first-in-class or best-in-class medicines addressing serious conditions affecting over **150 million US patients**[4](index=4&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) This section details Axsome Therapeutics' Q2 2025 financial performance, including key metrics, guidance, and consolidated financial statements [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) Axsome Therapeutics reported significant Q2 2025 revenue growth and a narrower net loss, driven by increased product sales and commercial activities, with sufficient cash reserves Q2 2025 Key Financial Data | Metric | 2Q 2025 (Million USD) | 2Q 2024 (Million USD) | YoY Growth | 1Q 2025 (Million USD) | QoQ Growth | | :----------------------------------- | :-------------------- | :-------------------- | :--------- | :-------------------- | :--------- | | **Revenue** | | | | | | | Total Net Product Revenue | 150.0 | 87.2 | 72% | 121.0 | 24% | | AUVELITY Net Product Sales | 119.6 | 65.0 | 84% | 96.4 | 24% | | SUNOSI Net Product Revenue | 30.0 | 22.1 | 35% | 25.2 | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - | - | | **Expenses** | | | | | | | Cost of Revenue | 13.4 | 8.1 | 65.4% | - | - | | Research and Development Expenses | 49.5 | 49.9 | -0.8% | - | - | | Selling, General and Administrative Expenses | 130.3 | 103.6 | 25.8% | - | - | | **Net Loss** | | | | | | | Net Loss | (48.0) | (79.3) | 39.5% | - | - | | Net Loss Per Share | (0.97) | (1.67) | 41.9% | - | - | | **Assets** | | | | | | | Cash and Cash Equivalents (as of June 30) | 303.0 | - | - | 315.4 (as of Dec 31) | -3.9% | | Common Shares Outstanding (as of June 30) | 49,815,301 | - | - | 48,667,587 (as of Dec 31) | 2.36% | [Financial Guidance](index=2&type=section&id=Financial%20Guidance) The company anticipates existing cash reserves will fund operations to positive cash flow, assuming no major changes to current plans - The company believes its existing cash is sufficient to fund operations until achieving positive cash flow, based on current operating plans[8](index=8&type=chunk) [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets and liabilities increased, driven by receivables, inventory, and short-term borrowings, with a slight rise in shareholder equity Consolidated Balance Sheets (as of June 30) | Item | June 30, 2025 (Thousand USD) | December 31, 2024 (Thousand USD) | | :----------------------------------- | :----------------------------- | :----------------------------- | | **Assets** | | | | Cash and Cash Equivalents | 303,016 | 315,353 | | Accounts Receivable, Net | 198,825 | 142,001 | | Inventory, Net | 18,441 | 15,732 | | Total Current Assets | 536,620 | 485,064 | | Total Assets | 639,785 | 568,498 | | **Liabilities** | | | | Accounts Payable | 91,628 | 71,997 | | Accrued Expenses and Other Current Liabilities | 170,902 | 147,987 | | Short-Term Borrowings | 70,000 | — | | Total Current Liabilities | 342,099 | 230,104 | | Long-Term Debt | 117,540 | 180,710 | | Total Liabilities | 566,710 | 511,483 | | **Stockholders' Equity** | | | | Common Stock | 5 | 5 | | Additional Paid-in Capital | 1,303,243 | 1,179,797 | | Accumulated Deficit | (1,230,173) | (1,122,787) | | Total Stockholders' Equity | 73,075 | 57,015 | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Axsome Therapeutics reported substantial revenue growth in Q2 and H1 2025, narrowing net losses despite increased operating expenses, driven by product sales and royalty income Consolidated Statements of Operations (as of June 30) | Item | 2Q 2025 (Thousand USD) | 2Q 2024 (Thousand USD) | H1 2025 (Thousand USD) | H1 2024 (Thousand USD) | | :----------------------------------- | :--------------------- | :--------------------- | :--------------------- | :--------------------- | | **Revenue** | | | | | | Product Sales, Net | 148,959 | 86,520 | 269,317 | 160,616 | | Royalty Revenue | 1,083 | 646 | 2,188 | 1,549 | | **Total Revenue** | **150,042** | **87,166** | **271,505** | **162,165** | | **Operating Expenses** | | | | | | Cost of Revenue | 13,448 | 8,055 | 23,237 | 14,352 | | Research and Development Expenses | 49,541 | 49,853 | 94,326 | 86,683 | | Selling, General and Administrative Expenses | 130,280 | 103,554 | 251,067 | 202,524 | | **Total Operating Expenses** | **186,756** | **165,212** | **365,201** | **307,486** | | Loss from Operations | (36,714) | (78,046) | (93,696) | (145,321) | | Net Loss | (47,973) | (79,345) | (107,386) | (147,702) | | Net Loss Per Share, Basic and Diluted | (0.97) | (1.67) | (2.18) | (3.11) | [Commercial Updates](index=2&type=section&id=Commercial%20Updates) This section provides commercial updates on AUVELITY, SUNOSI, and the successful launch of SYMBRAVO, detailing prescription growth and market access [AUVELITY](index=2&type=section&id=AUVELITY) AUVELITY, a unique rapid-acting oral treatment for MDD, demonstrated significant prescription growth and expanded market coverage in Q2 2025 - AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the US for the treatment of major depressive disorder[9](index=9&type=chunk) AUVELITY Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~192,000 | - | 56% | - | 15% | - As of July 1, AUVELITY's payer coverage in commercial channels expanded to an additional **28 million covered lives**; overall payer coverage across all channels is approximately **83%**, with commercial at approximately **73%** and government channels (Medicare and Medicaid) at approximately **100%**[11](index=11&type=chunk) [SUNOSI](index=3&type=section&id=SUNOSI) SUNOSI, a unique treatment for excessive daytime sleepiness, sustained prescription growth and high payer coverage in Q2 2025 - SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea[12](index=12&type=chunk) SUNOSI Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~50,000 | - | 13% | - | 9% | - SUNOSI's payer coverage across all channels is approximately **83%**, with commercial coverage at approximately **95%** and government channels at approximately **60%**[16](index=16&type=chunk) [SYMBRAVO](index=3&type=section&id=SYMBRAVO) SYMBRAVO successfully launched on June 10, 2025, quickly advancing commercialization with GPO contracts, initial payer coverage, and patient support - SYMBRAVO became available in US pharmacies on **June 10, 2025**, and active engagement with healthcare providers has commenced[16](index=16&type=chunk) - As of July 1, Axsome has contracted with one of the top three GPOs for potential formulary coverage of SYMBRAVO[16](index=16&type=chunk) - SYMBRAVO's payer coverage across all channels is currently approximately **38%**, with commercial at approximately **26%** and government channels at approximately **56%**[16](index=16&type=chunk) - The SYMBRAVO On My Side patient support program is fully operational, offering savings cards, educational resources, and HCP samples[16](index=16&type=chunk) [Development Pipeline](index=3&type=section&id=Development%20Pipeline) This section details the progress of Axsome's development pipeline, including AXS-05, Solriamfetol, AXS-12, and AXS-14, with upcoming regulatory and clinical milestones [AXS-05](index=3&type=section&id=AXS-05) AXS-05 progressed in Alzheimer's agitation with sNDA submission on track, and a pivotal trial for smoking cessation is imminent - AXS-05 has received **FDA Breakthrough Therapy designation** for Alzheimer's agitation[15](index=15&type=chunk) - Alzheimer's Agitation: The company plans to submit a supplemental New Drug Application (sNDA) for AXS-05 to the FDA in **Q3 2025**[17](index=17&type=chunk) - Smoking Cessation: The company plans to initiate a pivotal Phase 2/3 trial for AXS-05 in **Q4 2025**[17](index=17&type=chunk) [Solriamfetol](index=4&type=section&id=Solriamfetol) Solriamfetol is progressing in its pipeline for ADHD, MDD with EDS, BED, and SWD, with multiple Phase 3 trials underway or planned - Attention-Deficit/Hyperactivity Disorder (ADHD): The company plans to initiate a Phase 3 trial of solriamfetol in pediatric and adolescent ADHD patients in **Q4 2025**, following positive top-line results from the FOCUS Phase 3 trial in adult ADHD[21](index=21&type=chunk) - Major Depressive Disorder (MDD) with Excessive Daytime Sleepiness (EDS): The company plans to initiate a Phase 3 trial of solriamfetol in MDD patients with EDS in **Q4 2025**, following numerically greater improvement in depressive symptoms in a severe EDS patient subgroup in the PARADIGM Phase 3 proof-of-concept trial[21](index=21&type=chunk) - Binge Eating Disorder (BED): The ENGAGE Phase 3 trial is ongoing, with top-line results expected in **2026**[21](index=21&type=chunk) - Shift Work Disorder (SWD): The SUSTAIN Phase 3 trial is ongoing, with top-line results expected in **2026**[21](index=21&type=chunk) [AXS-12](index=4&type=section&id=AXS-12) AXS-12, with FDA Orphan Drug designation for narcolepsy, plans Q4 2025 NDA submission after positive clinical trial outcomes - AXS-12 has received **FDA Orphan Drug designation** for narcolepsy[19](index=19&type=chunk) - Narcolepsy: The company plans to submit an NDA for AXS-12 for the treatment of cataplexy in narcolepsy to the FDA in **Q4 2025**[19](index=19&type=chunk) - AXS-12 met its primary endpoints in three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial, demonstrating rapid and significant reductions in cataplexy attacks, and improvements in excessive daytime sleepiness and cognitive function[19](index=19&type=chunk) [AXS-14](index=4&type=section&id=AXS-14) Axsome plans to initiate a new Phase 3 fixed-dose trial for AXS-14 in Q4 2025, addressing prior FDA feedback on its fibromyalgia NDA - Fibromyalgia: To address prior FDA Refusal to File (RTF) feedback for the AXS-14 NDA for the management of fibromyalgia, the company plans to initiate a Phase 3 fixed-dose 12-week trial in **Q4 2025**[20](index=20&type=chunk) [Corporate Information](index=5&type=section&id=Corporate%20Information) This section provides corporate updates, anticipated milestones, conference call details, company overview, forward-looking statements, and contact information [Corporate Updates](index=5&type=section&id=Corporate%20Updates) Axsome Therapeutics resolved SUNOSI patent litigation and hosted a successful "Brain Health R&D Day," highlighting its neuroscience leadership and innovative pipeline - In May 2025, Axsome resolved patent litigation with Hetero Labs Ltd. and its affiliates regarding generic versions of SUNOSI, allowing Hetero to begin selling its generic product after **September 1, 2040** (if pediatric exclusivity is obtained) or **March 1, 2040** (if pediatric exclusivity is not obtained)[26](index=26&type=chunk) - In July 2025, the company hosted a "Brain Health R&D Day" event, featuring six leading expert clinicians and key opinion leaders who discussed target indications for Axsome's late-stage pipeline and presented clinical data[26](index=26&type=chunk) [Anticipated Milestones](index=5&type=section&id=Anticipated%20Milestones) Axsome Therapeutics outlined key regulatory submissions, clinical trial results, and trial initiation plans for its product pipeline in upcoming quarters - Regulatory & Commercial: - AXS-05 sNDA submission for Alzheimer's agitation (**Q3 2025**) - AXS-12 NDA submission for narcolepsy (**Q4 2025**) - Clinical Trial Top-Line Results: - Solriamfetol Phase 3 ENGAGE trial for binge eating disorder (**2026**) - Solriamfetol Phase 3 SUSTAIN trial for shift work disorder (**2026**) - Clinical Trial Initiations & Progress: - AXS-05 pivotal Phase 2/3 trial initiation for smoking cessation (**Q4 2025**) - Solriamfetol Phase 3 trial initiation for pediatric and adolescent ADHD (**Q4 2025**) - Solriamfetol Phase 3 trial initiation for MDD with EDS (**Q4 2025**) - AXS-14 Phase 3 trial initiation for fibromyalgia (**Q4 2025**)[26](index=26&type=chunk) [Conference Call Information](index=5&type=section&id=Conference%20Call%20Information) Axsome Therapeutics provided details for its Q2 2025 financial results and business update conference call, including access information - The company is hosting a conference call and webcast today at **8:00 AM Eastern Time** to discuss its Q2 2025 financial results and business update[24](index=24&type=chunk) - To participate in the live conference call, dial **(877) 405-1239** (US Toll-Free) or **+1 (201) 389-0851** (International)[24](index=24&type=chunk) - A live webcast can be accessed on the "Investors" section of the company's website at axsome.com, under the "Webcasts & Presentations" page, with a replay available for approximately 30 days after the live event[24](index=24&type=chunk) [About Axsome Therapeutics](index=5&type=section&id=About%20Axsome%20Therapeutics) Axsome Therapeutics is a leading biopharmaceutical company focused on CNS disorders, developing differentiated products to improve patient outcomes and address severe neurological and psychiatric conditions - Axsome Therapeutics is a biopharmaceutical company dedicated to ushering in a new era of central nervous system (CNS) disorder treatment[25](index=25&type=chunk) - The company achieves scientific breakthroughs by identifying critical gaps in care and developing differentiated products with novel mechanisms of action to significantly improve patient outcomes[25](index=25&type=chunk) - Its neuroscience portfolio includes FDA-approved treatments for major depressive disorder, narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting a broad spectrum of serious neurological and psychiatric conditions affecting over **150 million people** in the US[25](index=25&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks and uncertainties regarding commercial success, clinical trials, regulatory approvals, and financial factors, with no obligation to update - Certain matters in this press release are "forward-looking statements," pertaining to the commercial success of the company's products (SUNOSI, AUVELITY, SYMBRAVO) and efforts to obtain additional indications for solriamfetol and/or AXS-05[27](index=27&type=chunk) - Forward-looking statements involve risks and uncertainties, including but not limited to the company's ability to maintain and expand payer coverage, the success, timing, and cost of ongoing and anticipated clinical trials, the timing and ability of regulatory agencies to grant approvals, the protection of intellectual property, capital requirements, and macroeconomic and regulatory developments[27](index=27&type=chunk) - The company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, and actual results and developments may differ materially from those expressed or implied in such statements[27](index=27&type=chunk) [Investor & Media Contacts](index=8&type=section&id=Investor%20%26%20Media%20Contacts) Contact information for Axsome Therapeutics' investor relations and media communications is provided - Investor Contact: Mark Jacobson, Chief Operating Officer, Phone: **(212) 332-3243**, Email: mjacobson@axsome.com[33](index=33&type=chunk) - Media Contact: Darren Opland, Director, Corporate Communications, Phone: **(929) 837-1065**, Email: dopland@axsome.com[33](index=33&type=chunk)
Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-08-04 11:00
Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% sequentially AUVELITY® 2Q 2025 net product sales of $119.6 million, representing growth of 84% year-over-year and 24% sequentially SUNOSI® 2Q 2025 net product revenue of $30.0 million, representing growth of 35% year-over-year and 19% sequentially SYMBRAVO® launched June 10th, with 2Q 2025 net product sales of $0.4 million AUVELITY® market access expanded by 28 million new covered lives in the commercial c ...
Axsome: Some Recent Setbacks, Some Recent Wins -- Still A Buy
Seeking Alpha· 2025-07-25 17:46
Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]
2 Top Stocks I Wouldn't Hesitate to Invest $1,000 in Right Now
The Motley Fool· 2025-07-24 09:51
Group 1: Investment Outlook - The stock market is viewed as a source of excellent long-term returns despite short-term volatility [1] - Investing in companies with strong financial results and long-term growth potential is emphasized [1] Group 2: Shopify - Shopify has outperformed the broader market since its IPO in 2015 and still has significant growth potential [4] - The company is a leader in the e-commerce market, providing a suite of valuable products for online merchants, including payment management, marketing tools, and analytics [5] - Shopify benefits from competitive advantages such as high switching costs and a network effect from its app store, holding over 12% market share in the U.S. e-commerce sector [6] - E-commerce growth potential is substantial, with only 16.2% of U.S. retail sales occurring online, and Shopify operates in over 175 countries with lower e-commerce penetration [7] - Despite facing competition and current unprofitability, Shopify's market share has increased from 10% at the end of 2023, and strategic changes are expected to lead to profitability in the coming years [8][9] Group 3: Axsome Therapeutics - Axsome Therapeutics has shown strong performance due to clinical and regulatory advancements, with approved products including Auvelity for major depressive disorder, Symbravo for migraines, and Sunosi for excessive daytime sleepiness [10] - The company anticipates submitting regulatory applications for AXS-12 for narcolepsy by year-end and is seeking label expansion for Auvelity in Alzheimer's disease agitation [11] - Recent phase 3 results for Sunosi in ADHD may lead to further label expansion, and late-stage studies in major depressive disorder are planned [12] - Axsome has faced regulatory challenges, including a recent FDA rejection for AXS-14 for fibromyalgia, but has successfully launched products despite previous delays [13][14] - The company's approved products are expected to drive solid revenue growth, and its late-stage pipeline may enhance financial performance [14] - Axsome is positioned to become a more prominent biotech company, making it a viable investment opportunity [15]
Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline
Globenewswire· 2025-07-21 11:30
Core Insights - Axsome Therapeutics is hosting its Frontiers in Brain Health R&D Day to showcase its CNS pipeline targeting various psychiatric and neurological conditions [1][2] - The event features presentations from six expert clinicians discussing clinical data from the company's pipeline programs [2] - Axsome Therapeutics focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS disorders [4][5] Company Overview - Axsome Therapeutics is a biopharmaceutical company specializing in the treatment of central nervous system (CNS) conditions [4] - The company has FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [5] - Axsome's pipeline addresses serious neurological and psychiatric conditions affecting over 150 million people in the United States [5] Event Details - The R&D Day is intended for institutional investors and sell-side analysts, with a live webcast available for broader access [3] - Presentations will cover conditions such as Alzheimer's disease, fibromyalgia, ADHD, and narcolepsy, with insights from leading experts in the field [2][4]
Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
Globenewswire· 2025-07-21 11:00
NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome's Chief Executive Officer, along with the rest of the management team, and other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Monday, July 21, 2025, in connection with its Frontiers in Brain Health R&D Day event being held today. For ...
Axsome Therapeutics to Report Second Quarter 2025 Financial Results on August 4
Globenewswire· 2025-07-09 11:00
Core Viewpoint - Axsome Therapeutics, Inc. is set to report its financial results for Q2 2025 on August 4, 2025, before U.S. market opening, followed by a conference call for discussion [1] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness related to narcolepsy and obstructive sleep apnea, and migraine [3] - The company aims to address significant gaps in care by developing differentiated products with novel mechanisms of action, impacting over 150 million people in the U.S. [3] Financial Communication - The conference call to discuss financial results will take place at 8:00 a.m. Eastern Time, and a live webcast will be available on the company's website [2] - A replay of the conference call will be accessible for approximately 30 days post-event [2]