AXSM
Axsome Therapeutics, INC
NASDAQ
10-Q: Axsome Therapeutics Reports Q1 2025 Financial Results, Revenue Jumps to $121.5 Million
Sentiment:
Quarterly Report
5 May 2025 4:47 PM
Axsome Therapeutics announces strong Q1 2025 financial results, with total revenue increasing to $121.5 million driven by product sales and royalty revenue.
Better than expected
Revenue increased significantly year over year.
Net loss decreased year over year.
Delay expected
If Subtenant is delayed in completing the New Premises Subtenant Work and vacate the Original Premises within four (4) months of the New Premises Commencement Date, subject to Force Majeure, then, notwithstanding anything to the contrary contained herein, Subtenant shall not be required to pay holdover rent as set forth in Section 3 above for the amount of time that Prime Landlords actions delayed Subtenant in completing the New Premises Subtenant Work (such amount of time, the Prime Landlord Delay) and the Original Premises Termination Date shall be extended by such period of Prime Landlord Delay; provided however that maximum amount of time for the delay in Subtenant paying holdover rent pursuant to Section 3 hereof shall be an additional thirty (30) days so that if Subtenant has not vacated the Original Premises and delivered possession of the Original Premises to Sublandlord due to Prime Landlord Delay within five (5) months of the New Premises Commencement Date, for whatever reason whatsoever, Subtenant shall pay such holdover rent pursuant to Section 3 hereof.
Capital raise
The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Summary
- Axsome Therapeutics reported a net loss of $59.4 million for the three months ended March 31, 2025, compared to a net loss of $68.4 million for the same period in 2024.
- Total revenue for Q1 2025 was $121.5 million, up from $75.0 million in Q1 2024, driven by increased product sales and royalty revenue.
- Auvelity U.S. net sales were $96.2 million, compared to $53.4 million for the three months ended March 31, 2024.
- Sunosi net sales were $24.1 million, compared to $20.7 million for the three months ended March 31, 2024.
- Research and development expenses increased to $44.8 million from $36.8 million year-over-year.
- Selling, general, and administrative expenses increased to $120.8 million from $99.0 million year-over-year.
- The company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing.
- As of March 31, 2025, Axsome had $300.9 million in cash and cash equivalents.
- The company has $180 million outstanding and $150 million remaining under its 2020 Term Loan with Hercules Capital.
Sentiment
Score: 7
Explanation: The document presents a mixed sentiment. While revenue growth is positive, the ongoing net losses and increasing expenses temper the overall outlook. The FDA approval of Symbravo is a positive development, but the company faces significant challenges in a competitive market.
Positives
- Significant revenue growth driven by Auvelity and Sunosi sales.
- FDA approval of Symbravo for migraine treatment.
- Existing cash is expected to fund operations for at least the next twelve months.
- The company has $150 million remaining under its 2020 Term Loan with Hercules Capital.
Negatives
- The company continues to operate at a net loss, with a $59.4 million loss reported for Q1 2025.
- Operating expenses, including research and development and selling, general, and administrative costs, have increased.
Risks
- The company's ability to achieve profitability depends on obtaining regulatory approval for product candidates and successful commercialization.
- The company faces competition from other pharmaceutical and biotechnology companies.
- The company relies on third-party manufacturers and service providers, and their failure to perform could negatively impact the business.
- The company is subject to various healthcare laws and regulations, and failure to comply could result in penalties and liabilities.
- The company is involved in ongoing patent litigation regarding Auvelity and Sunosi, which could be costly and time-consuming.
Future Outlook
The company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. The company expects that its expenses will increase primarily due to the commercialization of Auvelity, Sunosi, and Symbravo while continuing to further develop the company's pipeline assets.
Management Comments
- Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements.
- Management must apply significant judgment in this process.
Industry Context
The biopharmaceutical industry is highly competitive, with numerous companies developing or marketing therapies for CNS disorders. Axsome faces competition from major pharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations.
Comparison to Industry Standards
- It is difficult to compare Axsome's results directly to industry standards without detailed competitor data.
- However, the company's revenue growth suggests a strong commercial performance compared to other emerging biopharmaceutical companies.
- The net loss is typical for a company investing heavily in research and development and commercialization activities.
- Comparisons to companies like Jazz Pharmaceuticals (from whom Sunosi was acquired) and other CNS-focused biotechs would provide a more granular benchmark.
Stakeholder Impact
- Shareholders: The company's financial performance and stock price are influenced by the success of its products and clinical trials.
- Employees: The company's ability to attract and retain key personnel is crucial for its success.
- Patients: The company's development of new therapies aims to address unmet medical needs for CNS disorders.
- Customers: The company's commercialization efforts focus on providing effective treatments to healthcare providers and patients.
- Creditors: The company's ability to repay its debt obligations depends on its financial performance and cash flow.
Next Steps
- Continue commercialization of Auvelity, Sunosi, and Symbravo.
- Advance clinical trials for AXS-05, solriamfetol, AXS-12, and AXS-14.
- Seek regulatory approval for additional product candidates.
- Manage expenses and maintain sufficient cash reserves.
Legal Proceedings
- The company is involved in ongoing patent litigation regarding Auvelity and Sunosi.
- A securities class action lawsuit against the company and certain officers is ongoing.
- A shareholder derivative action is stayed pending further proceedings in the Securities Class Action.
Related Party Transactions
- The company recorded royalty expense of $2.9 million and $1.6 million for the three months ended March 31, 2025 and 2024, respectively, for royalty due to Antecip, which is equal to 3.0 % of net sales of Auvelity.
Key Dates
- January 2012: Company issued shares to Antecip Bioventures II LLC
- November 2015: 2015 Omnibus Incentive Compensation Plan adopted by stockholders
- December 2019: Company entered into a sales agreement with SVB Securities LLC
- January 2020: Company entered into an exclusive license agreement with Pfizer Inc.
- September 25, 2020: Company entered into a Loan and Security Agreement with Hercules Capital, Inc.
- September 16, 2011: Leahy-Smith America Invents Act signed into law
- March 25, 2022: Company entered into an Asset Purchase Agreement with Jazz
- May 9, 2022: Initial Closing of Asset Purchase Agreement with Jazz
- August 2022: Auvelity approved by the FDA for the treatment of major depressive disorder in adults
- October 2022: Commercial availability of Auvelity in the U.S.
- November 14, 2022: Final Closing of Asset Purchase Agreement with Jazz
- December 2, 2022: Company filed an automatic shelf registration statement with the SEC
- February 2023: Company entered into a licensing transaction with Atnahs Pharma UK Limited (Pharmanovia)
- January 9, 2023: Company entered into a Third Amendment to the Loan Agreement with Hercules
- May 8, 2023: Company entered into the Waiver and Fourth Amendment to the Loan Agreement with Hercules
- June 2023: Company completed an underwritten public offering of its common stock
- September 30, 2024: Company entered into a Fifth Amendment to its Loan and Security Agreement with Hercules Capital, Inc.
- January 2025: Symbravo approved by the FDA for the acute treatment of migraine with or without aura in adults
- January 17, 2025: Company entered into an amended sublease agreement
- January 1, 2025: Medicare Part D coverage gap program was replaced with a redesigned program under the Inflation Reduction Act of 2022
- March 31, 2025: SDNY District Court entered an order granting in part and denying in part defendants motions to dismiss
- April 28, 2025: Date of share information
Keywords
Axsome Therapeutics, financial results, revenue, Auvelity, Sunosi, Symbravo, clinical trials, FDA approval, net loss, pharmaceutical, CNS disorders, stock options, restricted stock units, loan agreement, intellectual property, legal proceedings
AXSM
Axsome Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
Delay expected
9 June 2025 7:05 AM
Regulatory Update
- The Refusal to File (RTF) letter from the FDA necessitates an additional controlled trial for AXS-14.
- This new trial is anticipated to be initiated in the fourth quarter of 2025, indicating a delay in the regulatory pathway and potential market entry for AXS-14.
Worse than expected
9 June 2025 7:05 AM
Regulatory Update
- The FDA issued a Refusal to File (RTF) letter for the AXS-14 NDA, indicating the application was not sufficiently complete for substantive review.
- This requires Axsome to conduct an additional controlled trial, delaying the potential approval and commercialization of AXS-14.
Capital raise
13 May 2025 7:06 AM
8-K Filing
- Axsome conducted a private placement of 140,000 shares of common stock to Blackstone at a price of $107.14 per share.
- The gross proceeds from the private placement were approximately $15 million.
- Purchasers agreed to a lock-up period of 120 days from the closing date, restricting the sale or transfer of the securities.
Capital raise
5 May 2025 4:47 PM
Quarterly Report
- The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Delay expected
5 May 2025 4:47 PM
Quarterly Report
- If Subtenant is delayed in completing the New Premises Subtenant Work and vacate the Original Premises within four (4) months of the New Premises Commencement Date, subject to Force Majeure, then, notwithstanding anything to the contrary contained herein, Subtenant shall not be required to pay holdover rent as set forth in Section 3 above for the amount of time that Prime Landlords actions delayed Subtenant in completing the New Premises Subtenant Work (such amount of time, the Prime Landlord Delay) and the Original Premises Termination Date shall be extended by such period of Prime Landlord Delay; provided however that maximum amount of time for the delay in Subtenant paying holdover rent pursuant to Section 3 hereof shall be an additional thirty (30) days so that if Subtenant has not vacated the Original Premises and delivered possession of the Original Premises to Sublandlord due to Prime Landlord Delay within five (5) months of the New Premises Commencement Date, for whatever reason whatsoever, Subtenant shall pay such holdover rent pursuant to Section 3 hereof.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
Better than expected
5 May 2025 7:33 AM
Quarterly Report
- The company's revenue growth exceeded expectations, driven by strong sales of AUVELITY and SUNOSI.
- The approval of SYMBRAVO and positive clinical trial results for solriamfetol in ADHD and SYMBRAVO in migraine patients were better than expected.
Worse than expected
1 April 2025 7:06 AM
Press Release
- The PARADIGM Phase 3 trial did not meet its primary endpoint in the overall patient population, indicating worse than expected results.
Better than expected
25 March 2025 7:06 AM
Clinical Trial Results
- The FOCUS Phase 3 trial achieved both its primary and key secondary endpoints, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
Capital raise
18 February 2025 5:10 PM
Annual Results
- The company may need to raise additional financing to support its continuing operations.
- The company may seek to fund its operations through public or private equity, debt financings, or other sources.
Worse than expected
18 February 2025 5:10 PM
Annual Results
- The company's net loss increased from 2023 to 2024.
- Research and development expenses increased from 2023 to 2024.
- Selling, general, and administrative expenses increased from 2023 to 2024.
Delay expected
18 February 2025 7:06 AM
Annual Results
- Topline results from the ENGAGE Phase 3 trial of solriamfetol in BED are now anticipated in 2026.
Better than expected
18 February 2025 7:06 AM
Annual Results
- The company's revenue growth exceeded expectations, driven by strong sales of Auvelity and Sunosi.
- The FDA approval of Symbravo was a positive development, expanding the company's commercial portfolio.
- The successful completion of Phase 3 trials for AXS-05 and AXS-12 positions the company for potential NDA submissions and future product launches.
Better than expected
30 January 2025 5:55 PM
Press Release
- SYMBRAVO demonstrated statistically significant superiority compared to rizatriptan on sustained pain freedom from 2 to 24 hours.
Better than expected
30 December 2024 7:56 AM
Clinical Trial Results
- The ACCORD-2 trial met its primary endpoint with a statistically significant result, demonstrating a 3.6-fold lower risk of relapse compared to placebo, which is better than expected.
- The ACCORD-2 trial also met its key secondary endpoint, showing statistically significant prevention of relapse of agitation, which is better than expected.
- AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to placebo in the ACCORD-2 trial, which is better than expected.
Better than expected
26 November 2024 7:05 AM
Clinical Trial Results
- The trial met its primary endpoint with statistically significant results, showing a reduction in cataplexy attacks compared to placebo.
- The drug also demonstrated statistically significant improvements in cognition and overall narcolepsy symptoms, exceeding expectations.
Worse than expected
12 November 2024 9:43 AM
Quarterly Report
- The company's net loss increased compared to the same period last year, indicating worse than expected results.
Capital raise
12 November 2024 9:43 AM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Better than expected
12 November 2024 7:07 AM
Quarterly Report
- The company's revenue growth significantly exceeded expectations, with Auvelity sales growing by 113% year-over-year.
- The company is progressing its pipeline faster than expected with multiple topline results expected in the near term.
- The company has sufficient cash to fund operations into cash flow positivity, which is better than expected.
Better than expected
1 October 2024 5:24 PM
Loan Agreement Amendment
- The loan amendment provides better terms for Axsome, including an increased tranche commitment, extended availability periods, and more flexible performance covenants.
Worse than expected
5 August 2024 4:30 PM
Quarterly Report
- The company reported a net loss of $79.3 million for the quarter, which is worse than the net loss of $67.2 million reported for the same period in the previous year.
Capital raise
5 August 2024 4:30 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Better than expected
5 August 2024 7:05 AM
Quarterly Report
- The company's revenue growth of 87% year-over-year and Auvelity sales growth of 135% year-over-year significantly exceeded expectations.
Delay expected
5 June 2024 7:38 AM
Settlement Announcement
- The settlement delays the entry of a generic version of Sunosi until at least June 30, 2042.
Worse than expected
6 May 2024 5:20 PM
Quarterly Report
- The company's net loss increased significantly compared to the same period last year, indicating worse than expected financial performance.
Capital raise
6 May 2024 5:20 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Worse than expected
6 May 2024 7:05 AM
Quarterly Report
- The company's net loss of $68.4 million for the quarter was significantly worse than the $11.2 million loss in the same period of 2023.
Worse than expected
25 March 2024 9:06 AM
Patient Survey Results Announcement
- The survey results show that a high percentage of patients continue to experience symptoms despite being on treatment, indicating that current treatments are not as effective as expected.
Better than expected
25 March 2024 9:02 AM
Clinical Trial Results
- The results of the SYMPHONY trial were better than expected, as AXS-12 demonstrated statistically significant improvements across multiple endpoints compared to placebo.
Better than expected
20 February 2024 7:05 AM
Annual Results
- The company's revenue growth of 309% year-over-year significantly exceeded expectations.
- Auvelity's sales of $130.1 million in its first full year of launch surpassed initial projections.
- Sunosi's 67% year-over-year revenue growth was also better than anticipated.
Delay expected
20 February 2024 7:05 AM
Annual Results
- The completion of the ADVANCE-2 trial for Alzheimer's disease agitation is now anticipated in the second half of 2024, due to enrollment trends and market dynamics, which is a delay from previous expectations.
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