• AUVELITY: An oral, rapid-acting antidepressant approved for the treatment of major depressive disorder (MDD) in adults.
• SUNOSI (solriamfetol): A prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
• GEMTESA (vibegron): An oral beta-3 adrenergic agonist approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Axsome Therapeutics (AXSM), as a pharmaceutical company, primarily sells its products to major pharmaceutical wholesalers, which then distribute the medications to pharmacies, hospitals, and other healthcare providers. Therefore, Axsome's major customers are other companies, specifically the large drug distribution companies.

The primary customer companies are:

• McKesson Corporation (Symbol: MCK)
• Cencora, Inc. (formerly AmerisourceBergen Corporation) (Symbol: COR)
• Cardinal Health, Inc. (Symbol: CAH)

Herriot Tabuteau, MD, Chief Executive Officer

Dr. Tabuteau founded Axsome Therapeutics in January 2012 and has served as its Chief Executive Officer and Chairman of the board of directors since then. Prior to founding Axsome, he was a Senior Analyst and Partner at Healthco/S.A.C. Capital (now HealthCor), where he managed biotechnology, genomics, and instrumentation portfolios. His career also includes roles as a healthcare analyst at Kingdon Capital, a Senior Research Analyst at Banc of America Securities, and part of the healthcare investment banking group at Goldman Sachs. Dr. Tabuteau launched Axsome without venture capital.

Nick Pizzie, CPA, MBA, Chief Financial Officer

Mr. Pizzie has served as Chief Financial Officer of Axsome Therapeutics since May 2018. Before joining Axsome, he was the Vice President and Chief Financial Officer of Pierre Fabre USA. His previous experience includes serving as Senior Finance Director at Immucor, and holding various finance and accounting positions of increasing responsibility at Merck and Pfizer. Mr. Pizzie began his career as a staff auditor at Arthur Andersen.

Mark Jacobson, MA, Chief Operating Officer

Mr. Jacobson has been Axsome Therapeutics' Chief Operating Officer since March 2020 and has been a member of the team since April 2014. Before joining Axsome, he was the Director of Corporate Development at Stemline Therapeutics, Inc., where he was instrumental in the company's growth from a small team to a successful initial public offering and secondary public offering that raised approximately $100 million. He started his career in healthcare communications at Publicis Healthcare Communications Group.

Hunter Murdock, Esq., General Counsel

Mr. Murdock has served as General Counsel for Axsome Therapeutics since June 2022, having joined the company in December 2021. He began his legal career in private practice at White & Case LLP, and later became an associate and partner at Kirkland & Ellis LLP. Prior to Axsome, he held in-house counsel leadership roles within the pharmaceutical industry, including Vice President, General Counsel of Aurobindo Pharma USA, Inc. and Acrotech Biopharma LLC.

Ari Maizel, Chief Commercial Officer

Mr. Maizel assumed the role of Chief Commercial Officer at Axsome Therapeutics in October 2024, having joined the company in October 2023. Previously, he was the Vice President, US Psychiatry at AbbVie, where he managed sales and marketing for a multi-billion-dollar franchise. His career also includes sales and marketing leadership positions at AbbVie (formerly Allergan), Dendreon Corporation, and Johnson & Johnson. Mr. Maizel started his career at ArrowPath Venture Partners, an early-stage technology investment fund.

The key risks to Axsome Therapeutics (AXSM) are primarily centered around the inherent challenges of the biopharmaceutical industry, its financial performance, and the competitive landscape of the central nervous system (CNS) therapeutic area.

1. Regulatory and Development Risks: Axsome Therapeutics faces significant risks associated with the development and regulatory approval of its drug candidates. The biopharmaceutical industry is characterized by stringent regulatory requirements and the inherent uncertainty of clinical trial outcomes. Any adverse regulatory decisions, such as delays in approvals or outright rejections, or setbacks in clinical trials for its pipeline products (e.g., AXS-05 for Alzheimer's disease agitation, AXS-12 for narcolepsy, AXS-14 for PTSD/fibromyalgia), could significantly hinder product approvals and delay or prevent market entry. The approval process for CNS drugs, in particular, can be challenging due to the complexity of neurological disorders. The company's future success is contingent upon its ability to navigate this complex regulatory landscape and achieve positive clinical trial results.
2. Reliance on a Limited Number of Products and Achieving Profitability: Axsome's current financial success and revenue generation are heavily reliant on a limited number of approved products, primarily Auvelity and Sunosi. Despite increasing revenues, the company has consistently reported significant net losses and an accumulated deficit, indicating ongoing challenges in achieving and maintaining profitability. Sustained operating losses highlight the difficulties in managing its financial health over the long term. Any setbacks in the commercial performance or market acceptance of these key products could significantly impact its revenue streams and overall financial stability. The company's ability to achieve profitability depends on continued successful commercialization, market acceptance of its products, and effective management of high selling, general, and administrative (SG&A) expenses.
3. Intense Competition: The CNS therapeutic area, in which Axsome operates, is highly competitive, with numerous established pharmaceutical companies developing and marketing treatments. Axsome must continuously innovate and differentiate its products to maintain a competitive edge against existing therapies and emerging treatments, such as orexin-based therapies in the narcolepsy market. This competitive pressure can impact market share, pricing power, and the overall profitability of its products. While recent patent settlements have provided some protection against immediate generic competition for products like Auvelity and Sunosi, the broader competitive landscape remains a significant threat. Furthermore, changes in healthcare policies, including drug pricing reforms, could also negatively affect the company's profitability and market position.

Axsome Therapeutics (symbol: AXSM) focuses on developing novel therapies for central nervous system conditions. The addressable markets for their main products and pipeline candidates are detailed below:

• Auvelity (dextromethorphan and bupropion) for Major Depressive Disorder (MDD):
  • The major depressive disorder market across eight major markets (U.S., France, Germany, Italy, Spain, UK, Japan, and Canada) is projected to grow from $4.7 billion in 2019 to $9.6 billion in 2029.
  • The U.S. market is expected to maintain its dominance, increasing its proportion of global sales to 83.8% in 2029.
  • Auvelity is forecast to be the top-selling drug for MDD in the U.S., with estimated sales of approximately $1.53 billion in 2029.
• Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA):
  • The global narcolepsy therapeutics market size reached USD 3.3 billion in 2022 and is projected to surpass approximately USD 6.90 billion by 2032.
  • The global sleep disorders market is projected to reach USD 19.5 billion by 2027.
  • The U.S. sleep disorder market is estimated at USD 4.8 billion.
  • Sunosi is also being evaluated for other indications such as ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder.
• Symbravo (meloxicam and rizatriptan), also known as AXS-07 for the acute treatment of migraine:
  • The migraine market size is approximately $6 billion and is expected to nearly double by 2032.
  • Over 39 million patients in the U.S. alone are affected by migraine attacks.

For their pipeline products, the addressable markets are:

• AXS-05 for Alzheimer's disease agitation:
  • Axsome estimates there are approximately 7 million Alzheimer's patients in the U.S., and agitation can develop in about half of these patients. The treated addressable pool for drugs like AXS-05 is likely around 1 million patients.
  • Axsome models AXS-05 in Alzheimer's disease agitation as potentially generating between $1.5 billion and $3 billion in peak sales.
• AXS-12 for cataplexy in patients with narcolepsy:
  • The global narcolepsy therapeutics market size is projected to surpass USD 6.90 billion by 2032. North America held the maximum market share of 38% in 2022.
• AXS-14 for fibromyalgia:
  • Fibromyalgia is described as a large market in the U.S.

Here are 3-5 expected drivers of future revenue growth for Axsome Therapeutics (AXSM) over the next 2-3 years:

1. Continued Growth of AUVELITY: AUVELITY, approved for major depressive disorder, is a primary driver of Axsome's revenue growth, demonstrating a 69% year-over-year increase in net product sales to $136.1 million in Q3 2025. This growth is anticipated to continue due to expanding prescription volumes, broad payer coverage (approximately 85% of all lives covered), continued sales force expansion, and direct-to-consumer advertising campaigns.
2. Sustained Growth of SUNOSI: SUNOSI, indicated for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, also continues to be a significant revenue contributor. It achieved $32.8 million in net product revenue in Q3 2025, representing a 35% year-over-year increase. Increased prescription rates and stable payer coverage are expected to maintain its growth trajectory.
3. Commercialization Ramp-Up of SYMBRAVO: SYMBRAVO, launched in June 2025 for acute migraine treatment, generated $2.1 million in its first full quarter (Q3 2025). As Axsome expands its commercialization efforts for SYMBRAVO, including contracting with group purchasing organizations (GPOs) and increasing payer coverage (currently at approximately 52% of all lives), it is expected to contribute increasingly to revenue.
4. Potential Launch of AXS-05 for Alzheimer's Disease Agitation: Axsome has submitted a supplemental New Drug Application (sNDA) for AXS-05 for the treatment of Alzheimer's disease agitation. Regulatory approval and subsequent commercial launch of AXS-05 for this significant unmet medical need could unlock a substantial new revenue stream for the company.
5. Potential Launch of AXS-12 for Narcolepsy: Axsome anticipates submitting a New Drug Application (NDA) for AXS-12 for the treatment of narcolepsy in Q4 2025. If approved, AXS-12 would represent another new product launch, diversifying Axsome's portfolio and adding another source of revenue growth.

Share Issuance

• In June 2023, Axsome Therapeutics completed a public offering of 3,000,000 shares of common stock at $75.00 per share, generating aggregate gross proceeds of $225.0 million.
• As of September 30, 2025, the number of common shares outstanding increased to 50,307,834 from 48,667,587 at December 31, 2024.
• The company's additional paid-in capital increased from $0.706 billion in 2022 to $1.18 billion in 2024, and further to $1.303 billion for the quarter ending June 30, 2025, indicating equity issuance activity.

Inbound Investments

• In May 2025, Axsome Therapeutics entered into a $570 million term loan and revolving credit facility with Blackstone. Concurrent with this, Blackstone purchased $15 million of Axsome common stock.
• In September 2020, Axsome secured a $225 million term loan facility with Hercules Capital, Inc., drawing down $50 million at closing.

Outbound Investments

• In November 2025, Axsome acquired an epilepsy candidate (AZD7325) from AstraZeneca through the acquisition of Avenue Therapeutics' subsidiary, Baergic Bio, for an upfront payment of $0.3 million and potential milestone payments totaling approximately $82 million.
• Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals in May 2022.

Capital Expenditures

• Axsome Therapeutics reported capital expenditures of $0.05 million in 2020, $0.31 million in 2021, $0.70 million in 2022, $0.58 million in 2023, and $0.27 million in 2024.
• The company's last twelve months free cash flow of -$121.37 million reflects ongoing investment in its product pipeline.
• Axsome anticipates incurring capital expenditures to expand its research and development and manufacturing capabilities.