Axsome Therapeutics, Inc. (AXSM) Bundle
A Brief History of Axsome Therapeutics, Inc. (AXSM)
Company Formation
Company Formation
Axsome Therapeutics, Inc. was founded in 2012 in New York City. The company was established to develop novel therapies for central nervous system disorders.
IPO and Initial Financing
In 2015, Axsome Therapeutics raised approximately $10 million in its initial public offering (IPO), trading under the ticker symbol AXSM.
Key Product Development Milestones
- In 2017, Axsome announced positive results for its lead product candidate, AXS-05, in a Phase 2 trial for treatment-resistant depression.
- By 2018, the company initiated Phase 3 clinical trials for AXS-05 for major depressive disorder (MDD).
- In 2019, Axsome announced successful completion of Phase 3 trials for AXS-05 in MDD and launched additional studies on the drug.
Acquisitions and Expansions
In 2020, Axsome expanded its portfolio through the acquisition of VTV Therapeutics' product candidate, AXS-07, targeting migraine treatment.
Regulatory Approvals
AXS-05 received FDA approval on August 19, 2021, for treating MDD, followed by a second approval for AXS-07 on September 30, 2021, for the acute treatment of migraine.
Financial Performance and Market Cap
| Year | Revenue ($ million) | Net Loss ($ million) | Market Capitalization ($ billion) |
|---|---|---|---|
| 2020 | 0.00 | (60.52) | 0.305 |
| 2021 | 26.30 | (49.14) | 1.70 |
| 2022 | 66.40 | (62.10) | 1.10 |
Recent Developments
As of 2023, Axsome is focused on expanding the indications for its product candidates. The company recently announced partnerships aimed at enhancing its pipeline for additional CNS disorders.
Stock Performance
As of October 2023, the stock price of AXSM has shown significant fluctuations, with prices ranging from $20.00 to $50.00 throughout the year.
Clinical Trials and Pipeline
- AXS-05: Currently in trials for Alzheimer's disease agitation and smoking cessation.
- AXS-07: Investigating efficacy in cluster headaches and other related conditions.
Strategic Vision and Future Outlook
Axsome Therapeutics aims to leverage its proprietary technology and clinical data to innovate treatment options, focusing on CNS disorders, with projected revenues estimated at $100 million by 2024.
A Who Owns Axsome Therapeutics, Inc. (AXSM)
Current Ownership Structure
As of October 2023, Axsome Therapeutics, Inc. (AXSM) has an ownership structure comprised of institutional investors, retail investors, and company insiders. The distribution of shares is critical when assessing the power dynamics within the company.
| Ownership Type | Percentage Owned | Number of Shares |
|---|---|---|
| Institutional Investors | 85.2% | 24,000,000 |
| Company Insiders | 5.5% | 1,500,000 |
| Retail Investors | 9.3% | 2,700,000 |
Top Institutional Shareholders
The involvement of institutional investors significantly impacts Axsome Therapeutics' strategic direction and shareholder value. The following are the top institutional shareholders:
| Institution | Percentage of Total Shares | Shares Held |
|---|---|---|
| The Vanguard Group, Inc. | 11.2% | 3,200,000 |
| BlackRock, Inc. | 10.8% | 3,000,000 |
| FMR LLC (Fidelity) | 9.6% | 2,700,000 |
| State Street Corporation | 8.5% | 2,400,000 |
Insider Ownership
Insider ownership in Axsome Therapeutics is a critical component in aligning management interests with those of shareholders. The following table illustrates key insiders and their ownership stakes:
| Insider Name | Position | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| Dr. Herriot Tabuteau | CEO | 1,000,000 | 3.5% |
| Dr. Robert McCarthy | President | 300,000 | 1.1% |
| Jane Doe | CFO | 200,000 | 0.7% |
Recent Changes in Ownership
Monitoring changes in the ownership of Axsome Therapeutics can provide insight into investor sentiment and future performance potential. Recent SEC filings reveal:
- In September 2023, FMR LLC increased its stake by 1.2 million shares.
- The Vanguard Group reduced its holdings by 500,000 shares in August 2023.
- BlackRock, Inc. maintained its position, showing confidence in the company's future.
Stock Performance and Market Capitalization
Axsome Therapeutics has seen fluctuations in its stock performance, impacting ownership value. As of the latest trading session:
- Current Stock Price: $45.50
- Market Capitalization: $1.5 billion
- 52-Week High: $68.00
- 52-Week Low: $32.50
Conclusion on Ownership Trends
Ownership dynamics at Axsome Therapeutics reflect significant institutional commitment along with moderate insider investment. The current overall distribution suggests a strong level of institutional confidence in the company’s strategy and future prospects.
Axsome Therapeutics, Inc. (AXSM) Mission Statement
Company Overview
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapies for the management of central nervous system (CNS) disorders. The company aims to provide novel treatment options for patients suffering from debilitating conditions.
Mission Statement
Axsome Therapeutics’ mission is to deliver innovative, safe, and effective therapies for patients with CNS disorders, thereby enhancing their quality of life. The company is committed to advancing science through rigorous research and development.
Core Values
- Innovation: Continuously pushing the boundaries of science to discover new treatments.
- Integrity: Upholding high ethical standards in all business practices.
- Patient Focus: Prioritizing the needs of patients in product development.
- Collaboration: Partnering with stakeholders to enhance therapeutic options.
Strategic Goals
Axsome aims to achieve the following strategic goals:
- Advance clinical development of its lead product candidates.
- Facilitate regulatory approval and market access for innovative therapies.
- Broaden the pipeline with new candidates in CNS disorders.
Recent Financial Performance
For the fiscal year 2022, Axsome Therapeutics reported:
| Financial Metric | 2022 Amount | 2021 Amount |
|---|---|---|
| Total Revenue | $6.2 million | $1.9 million |
| Net Loss | $(64.4) million | $(39.4) million |
| Total Assets | $162.1 million | $109.9 million |
| Total Liabilities | $46.2 million | $36.1 million |
Product Pipeline
Axsome Therapeutics focuses on several key product candidates:
| Product Candidate | Indication | Development Stage |
|---|---|---|
| Axsine (AXS-05) | Major Depressive Disorder | FDA Approved |
| AXS-07 | Acute Migraine | FDA Approved |
| AXS-12 | Narcolepsy | Phase 3 |
| AXS-14 | Neuropathic Pain | Phase 2 |
Recent Developments
As of October 2023, Axsome Therapeutics has made significant strides in its mission:
- Expansion of its commercial team to enhance market presence.
- Initiation of new clinical trials for emerging candidates in its pipeline.
- Engagement with healthcare providers to increase awareness of its approved products.
Market Opportunities
The increasing prevalence of CNS disorders presents a substantial market opportunity for Axsome:
- Major depressive disorder affects approximately 7% of the U.S. adult population.
- Acute migraine prevalence ranges from 10% to 15% globally.
- The narcolepsy treatment market is projected to reach $2.3 billion by 2026.
Commitment to Research and Development
Axsome allocates a significant portion of its budget to R&D:
| Year | R&D Expense |
|---|---|
| 2022 | $50.1 million |
| 2021 | $27.3 million |
Conclusion
Through its commitment to innovation and patient-centric approaches, Axsome Therapeutics strives to meet the unmet needs in the CNS landscape and improve outcomes for patients. The company’s ongoing efforts reflect its mission to reshape treatment paradigms in the field.
How Axsome Therapeutics, Inc. (AXSM) Works
Company Overview
Axsome Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative therapies for the treatment of central nervous system (CNS) disorders. Founded in 2012, Axsome is headquartered in New York City.
Pipeline Development
As of October 2023, Axsome's pipeline includes several key products:
- AXS-05: Approved for the treatment of depression.
- AXS-07: Undergoing evaluation for acute migraine treatment.
- AXS-12: In Phase 3 trials for narcolepsy.
Financial Performance
For the fiscal year ended December 31, 2022, Axsome reported the following financial metrics:
| Financial Metric | 2022 Amount (in millions) |
|---|---|
| Total Revenue | $25.4 |
| Net Income (Loss) | ($130.6) |
| Research and Development Expenses | $75.3 |
| General and Administrative Expenses | $30.2 |
| Cash and Cash Equivalents | $184.4 |
Market Position
Axsome Therapeutics operates in a competitive landscape focusing on neurologic and psychiatric disorders, which represents a significant market potential. The company reported a market capitalization of approximately $1.5 billion as of October 2023.
Partnerships and Collaborations
Axsome Therapeutics has engaged in various collaborations to enhance its research efforts:
- Collaboration with the National Institute of Health (NIH): To explore AXS-05 in treating Alzheimer's-related agitation.
- Pursued partnerships: With academic institutions for clinical trials and development initiatives.
Stock Performance
As of mid-October 2023, Axsome Therapeutics' stock is trading at approximately $40.15 per share, with a 52-week range of $18.45 - $55.60. The stock has seen an increase of over 150% year-to-date.
Regulatory Approvals
Axsome has achieved significant regulatory milestones:
- AXS-05: Received FDA approval in August 2021 for major depressive disorder.
- AXS-07: Accepted for review by the FDA with a PDUFA date set for January 2024.
Research and Development Focus
Axsome’s R&D efforts are primarily directed towards:
- Neuropathic Pain
- Depression
- Migraine
- Narcolepsy
Future Outlook
Axsome Therapeutics aims to expand its product offerings and advance its clinical trials, targeting significant CNS disorders with high unmet medical needs, anticipating sustained growth and potential profitability.
How Axsome Therapeutics, Inc. (AXSM) Makes Money
Product Portfolio
Axsome Therapeutics, Inc. operates with a focus on innovative therapies for central nervous system (CNS) disorders. The company’s flagship product is Axsine (formerly known as AXS-05), which is approved for the treatment of major depressive disorder (MDD) and has a potential market size exceeding $17 billion annually in the U.S.
In addition to AXS-05, Axsome is developing AXS-07 for migraine treatment and AXS-12 for narcolepsy, each targeting market segments worth billions.
Revenue Streams
- Product Sales
- Collaborations and Partnerships
- Licensing Agreements
- Government Grants
Financial Performance
As of the fourth quarter of 2022, Axsome reported total revenue of $68.1 million, primarily driven by product sales from AXS-05. The company’s revenue for fiscal year 2022 was $200.5 million, a significant increase from $73.6 million in 2021.
Axsome's operating expenses for 2022 were approximately $151.7 million, resulting in a net loss of $103.5 million for the year. Research and development expenses were $88.9 million, accounting for nearly 59% of total expenses.
Market Dynamics
According to Statista, the global CNS market is projected to reach $115.5 billion by 2026, driven by increasing prevalence of mental health disorders. Axsome aims to capture a share of this growing market.
Table of Financial Data
| Year | Total Revenue ($ millions) | Net Loss ($ millions) | Operating Expenses ($ millions) | R&D Expenses ($ millions) |
|---|---|---|---|---|
| 2022 | 200.5 | (103.5) | 151.7 | 88.9 |
| 2021 | 73.6 | (35.2) | 66.5 | 35.0 |
| 2020 | 12.1 | (50.2) | 52.4 | 37.8 |
Strategic Partnerships
Axsome has entered collaborations with major pharmaceutical companies, enhancing development capabilities and market reach. Notable partnerships include agreements with Sunovion Pharmaceuticals and Upsher-Smith Laboratories, significantly impacting distribution and market penetration.
Future Prospects
Axsome is projected to launch AXS-07 in the migraine market, anticipated to have an annual market potential of over $4 billion. The company also plans to expand its product line, diversifying revenue sources.
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