AXSM
Axsome Therapeutics, INC
NASDAQ
10-K: Axsome Therapeutics Reports 2024 Financial Results, Highlights Pipeline Progress
Sentiment:
Annual Results
18 February 2025 5:10 PM
Axsome Therapeutics' 10-K filing summarizes the company's financial performance for 2024 and provides an overview of its commercial products and development programs.
Worse than expected
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.
Capital raise
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.
Summary
- Axsome Therapeutics, a biopharmaceutical company focused on CNS disorders, filed its Form 10-K for the fiscal year ended December 31, 2024.
- The company's pipeline includes three commercial products: Auvelity for major depressive disorder (MDD), Sunosi for excessive daytime sleepiness (EDS), and Symbravo for the acute treatment of migraine.
- Key development programs include AXS-05 for Alzheimer's disease (AD) agitation and smoking cessation, AXS-12 for narcolepsy, AXS-14 for fibromyalgia, and solriamfetol for ADHD, MDD, binge eating disorder (BED), and shift work disorder (SWD).
- The company reported net revenue from product sales of $381.7 million in 2024, compared to $202.5 million in 2023.
- Auvelity U.S. net sales were $291.4 million in 2024, while Sunosi net sales were $90.3 million.
- The company's net loss for 2024 was $287.2 million, compared to a net loss of $239.2 million in 2023.
- Research and development expenses increased to $187.1 million in 2024, driven by the advancement of clinical trials.
- Selling, general, and administrative expenses also increased to $411.4 million due to greater commercial activities and organizational growth.
- The company believes its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Sentiment
Score: 5
Explanation: The document presents a mixed picture. While revenue is increasing, losses are also growing, and the company is reliant on future financing. The outlook is uncertain.
Positives
- The company's pipeline includes three commercial products: Auvelity, Sunosi, and Symbravo.
- Net revenue from product sales increased to $381.7 million in 2024 from $202.5 million in 2023.
- Auvelity U.S. net sales reached $291.4 million in 2024.
- Sunosi net sales were $90.3 million in 2024.
- The company believes its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Negatives
- The company's net loss for 2024 was $287.2 million.
- Research and development expenses increased to $187.1 million in 2024.
- Selling, general, and administrative expenses increased to $411.4 million in 2024.
Risks
- The company has incurred significant losses since its inception and may never achieve or maintain profitability.
- The company may need additional funding to conduct future clinical trials and commercialize its product candidates.
- The company's operating activities may be restricted by covenants related to its loan agreement with Hercules.
- The company has a limited operating history of commercializing products.
- The company is substantially dependent on the success of its products and product candidates.
- The company faces significant competition from other pharmaceutical and biotechnology companies.
- The company relies on third parties to perform essential services, and their failure to perform satisfactorily could impact the company's ability to commercialize its products.
- The company's manufacturers may fail to produce products in the required volumes or comply with regulations.
- Patent reform legislation could increase uncertainties and costs surrounding the company's patents.
- The company may need to license intellectual property from third parties, which may not be available or may not be available on commercially reasonable terms.
- The company could face substantial penalties and liabilities if it fails to comply with healthcare laws.
- The government or third-party payors may fail to provide adequate coverage and payment rates for the company's products.
- The company may experience difficulties in managing growth.
- The company may fail to maintain an effective system of internal controls over financial reporting.
- The company's principal stockholders and management own a significant percentage of its stock and may be able to exert significant control over matters subject to stockholder approval.
- The use of the company's net operating loss carryforwards and research tax credits may be limited.
- The market price of the company's common stock may be highly volatile.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about the company, its stock price and trading volume could decline.
- The company's quarterly operating results may fluctuate significantly.
- Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict the company's operations or require it to relinquish proprietary rights.
- Provisions in the company's corporate charter documents and under Delaware law may prevent or frustrate attempts by its stockholders to change its management and hinder efforts to acquire a controlling interest in it, and the market price of its common stock may be lower as a result.
- The company's amended and restated certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by its stockholders, which could limit its stockholders ability to obtain a favorable judicial forum for disputes with it or its directors, officers or employees.
- The company is exposed to market risk from fluctuations in currency exchange rates and interest rates.
- Climate change or legal, regulatory or market measures to address climate change may negatively affect the company's business, results of operations, cash flows and prospects.
Future Outlook
The company expects to incur significant expenses and continuing operating losses as it continues the commercialization of its on-market products and the development and clinical trials of, and seek regulatory approval for, its current product candidates and any other product candidates that it develops or in-licenses and advances to clinical development.
Industry Context
The company operates in the highly competitive and rapidly changing CNS market, competing with major pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic institutions, and governmental agencies.
Stakeholder Impact
- The company's performance impacts shareholders through stock value and potential dividends (though none are currently anticipated).
- Employees are affected by the company's ability to provide competitive salaries, bonuses, and benefits.
- Patients benefit from the development and commercialization of new treatments for CNS disorders.
- The company's relationships with suppliers and creditors are important for maintaining stable operations.
Next Steps
- Continue commercialization of Auvelity and Sunosi.
- Prepare for the commercial launch of Symbravo.
- Advance clinical trials for AXS-05, AXS-12, AXS-14, and solriamfetol.
- Seek regulatory approval for additional product candidates.
- Evaluate strategic options for commercialization of other product candidates.
Legal Proceedings
- A securities class action lawsuit was filed against the company and certain officers and directors, alleging false statements and omissions concerning the company's Chemistry Manufacturing and Controls practices, and its NDA with the FDA, with respect to one of its product candidates, AXS-07.
- Shareholder derivative complaints were filed against the company's current directors, certain of the company's current and former officers, and the company (as nominal defendant).
- The company commenced a patent infringement action against Teva Pharmaceuticals, Inc., relating to Teva's ANDA for Auvelity.
- The company commenced a patent infringement action against Hikma and five other drug companies relating to each defendant's ANDA for Sunosi.
Related Party Transactions
- The company is required to pay to Antecip a royalty equal to 3.0% for AXS-05, of net sales of products containing the licensed technology by us, our affiliates, or permitted sublicensees.
Key Dates
- January 2012: Axsome Therapeutics incorporated in Delaware.
- 2012: Entered into exclusive license agreements with Antecip Bioventures II LLC.
- 2014: Jazz acquired worldwide rights to Sunosi excluding certain Asian markets from Aerial.
- November 2015: Initial public offering; 2015 Omnibus Incentive Compensation Plan adopted.
- September 25, 2020: Entered into Loan and Security Agreement with Hercules Capital, Inc.
- October 14, 2021: Entered into First Amendment to Loan and Security Agreement with Hercules Capital, Inc.
- March 25, 2022: Entered into Asset Purchase Agreement with Jazz Pharmaceuticals plc.
- May 9, 2022: Initial Closing of Sunosi acquisition from Jazz Pharmaceuticals plc.
- November 14, 2022: Final Closing of Sunosi acquisition from Jazz Pharmaceuticals plc.
- August 2022: FDA approved Auvelity for the treatment of MDD in adults.
- October 2022: Initiated commercial launch of Auvelity in the U.S.
- January 9, 2023: Entered into Third Amendment to Loan and Security Agreement with Hercules Capital, Inc.
- February 2023: Entered into licensing agreement with Pharmanovia to market Sunosi in Europe and certain countries in the Middle East / North Africa.
- April 7, 2023: Sublease for corporate offices at One World Trade Center commenced.
- May 8, 2023: Entered into Fourth Amendment to Loan and Security Agreement with Hercules Capital, Inc.
- June 2023: Completed underwritten public offering of common stock.
- September 30, 2024: Entered into Fifth Amendment to Loan and Security Agreement with Hercules Capital, Inc.
- January 17, 2025: Entered into an Amendment to our Sublease (the First Amendment), pursuant to which we will relinquish our existing space in One World Trade Center and commence occupancy of different space within the building.
- January 30, 2025: FDA approved Symbravo for the acute treatment of migraine with or without aura in adults.
- February 10, 2025: Entered into a settlement agreement with Teva to resolve all outstanding litigation between the parties relating to Auvelity.
- February 11, 2025: Date of employee count and share outstanding information.
Keywords
Axsome Therapeutics, financial results, 10-K, Auvelity, Sunosi, Symbravo, CNS disorders, clinical trials, product sales, net loss, research and development, regulatory approval, commercialization
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.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
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.
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.
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.
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.
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
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.
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.
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.
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.
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 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.
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.
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.
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.
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