AXSM
Axsome Therapeutics, INC
NASDAQ
10-Q: Axsome Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Sentiment:
Quarterly Report
5 August 2024 4:30 PM
Axsome Therapeutics reports a net loss of $79.3 million for the second quarter of 2024, with product sales reaching $86.5 million.
Worse than expected
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
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 $79.3 million for the three months ended June 30, 2024, and a net loss of $147.7 million for the six months ended June 30, 2024.
- Product sales, net, totaled $86.5 million for the quarter and $160.6 million for the six-month period, driven by sales of Auvelity and Sunosi.
- The company's operating expenses were $165.2 million for the quarter and $307.5 million for the six-month period, including significant investments in research and development and selling, general, and administrative activities.
- Research and development expenses were $49.9 million for the quarter and $86.7 million for the six-month period, reflecting ongoing clinical trials and development programs.
- Selling, general, and administrative expenses were $103.6 million for the quarter and $202.5 million for the six-month period, primarily due to commercial activities for Auvelity and Sunosi.
- The company's cash and cash equivalents totaled $315.7 million as of June 30, 2024.
- 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.
Sentiment
Score: 5
Explanation: The document presents a mixed picture. While product sales are growing, the company is still incurring significant losses and faces numerous risks. The initiation of multiple Phase 3 trials is a positive sign, but the overall sentiment is neutral due to the financial challenges and uncertainties.
Positives
- Product sales increased significantly compared to the same period in the previous year, indicating strong commercial performance of Auvelity and Sunosi.
- The company has a substantial cash balance of $315.7 million, providing financial flexibility for ongoing operations and development programs.
- The company is actively advancing its pipeline with the initiation of multiple Phase 3 clinical trials for various product candidates.
- The company has a diverse portfolio of product candidates targeting significant and growing markets where current treatment options are limited or inadequate.
Negatives
- The company continues to incur significant operating losses, with a net loss of $79.3 million for the quarter and $147.7 million for the six-month period.
- Operating expenses, particularly in research and development and selling, general, and administrative, remain high.
- The company is dependent on the commercial success of Auvelity and Sunosi, and the successful development and commercialization of its product candidates.
- The company faces significant competition from other pharmaceutical and biotechnology companies.
Risks
- The company may need additional funding to conduct future clinical trials and complete the development and commercialization of its product candidates.
- The company's operating activities may be restricted by covenants related to its loan agreement with Hercules Capital.
- The company has a limited operating history of commercializing products, which may make it difficult to evaluate its business and prospects.
- The company is substantially dependent on the success of its products and cannot guarantee that any of its product candidates will successfully complete clinical trials, receive regulatory approval, or be successfully commercialized.
- The company faces significant competition from other pharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations.
- The company relies on third parties for essential services, including manufacturing, clinical trials, and distribution, and any failure by these third parties could negatively impact the company.
- The company may be subject to product liability claims, which could result in substantial liabilities.
- The company may be subject to intellectual property litigation, which could be costly and time-consuming.
- The company may be subject to new legislation, regulatory proposals, and healthcare payor initiatives that may increase costs of compliance and adversely affect the ability to market products, obtain collaborators, and raise capital.
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 Sunosi and Auvelity while continuing to further develop the company's pipeline assets. 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.
Management Comments
- 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.
Industry Context
The company operates in the competitive biopharmaceutical industry, focusing on central nervous system (CNS) conditions. The company's products and product candidates compete with those of major pharmaceutical and biotechnology companies, academic institutions, and other research organizations. The company's success depends on its ability to develop and commercialize differentiated therapies that address unmet medical needs in this space.
Comparison to Industry Standards
- Axsome's revenue growth from Auvelity and Sunosi is notable compared to other companies in the CNS space, but the company's high operating expenses and net losses are also typical for a company in its stage of development.
- Compared to companies like Jazz Pharmaceuticals, which previously owned Sunosi, Axsome is now responsible for the full commercialization and development costs, which impacts its financial results.
- The initiation of multiple Phase 3 trials for various product candidates is consistent with the development strategies of other companies in the biopharmaceutical industry, but the success of these trials is not guaranteed.
- The company's reliance on third-party manufacturers and service providers is a common practice in the industry, but it also introduces risks related to supply chain and quality control.
Stakeholder Impact
- Shareholders may be concerned about the company's continued losses and the potential need for additional capital raises.
- Employees may be affected by the company's growth and the need to manage increasing workloads.
- Customers (patients and healthcare providers) may benefit from the availability of new treatment options, but may also be affected by pricing and reimbursement decisions.
- Suppliers and creditors may be impacted by the company's financial performance and ability to meet its obligations.
Next Steps
- Continue the commercialization of Auvelity and Sunosi.
- Advance the ongoing Phase 3 clinical trials for AXS-05, AXS-12, and solriamfetol.
- Seek regulatory approval for AXS-07, AXS-12, and AXS-14.
- Evaluate other product candidates for CNS disorders.
- Explore potential strategic alliances and licensing arrangements.
Legal Proceedings
- The company is involved in a securities class action lawsuit and a shareholder derivative action, both related to allegations of false statements and omissions concerning the company's Chemistry Manufacturing and Controls practices and its NDA with the FDA for AXS-07.
- The company has commenced patent infringement actions against Teva relating to Teva's ANDA for Auvelity.
- The company has commenced patent infringement actions against Hikma and other drug companies relating to their ANDAs for Sunosi.
- The company entered into a settlement agreement with Unichem Laboratories Ltd. resolving patent litigation related to Sunosi that permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances.
Related Party Transactions
- The company recorded royalty expense of $2.0 million and $3.6 million for the three and six months ended June 30, 2024, respectively, for royalty due to Antecip Bioventures II LLC, an entity owned by the company's Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., which is equal to 3.0% of net sales of Auvelity.
Key Dates
- 2012-01-12: Axsome Therapeutics, Inc. was incorporated.
- 2020-01-09: Axsome entered into an exclusive license agreement with Pfizer.
- 2022-05-09: Axsome completed the U.S. acquisition of Sunosi from Jazz Pharmaceuticals.
- 2022-08-01: Axsome announced the FDA approval of Auvelity.
- 2022-10-01: Axsome announced the U.S. commercial availability of Auvelity.
- 2022-11-14: Axsome acquired the ex-U.S. assets of Sunosi from Jazz Pharmaceuticals.
- 2023-01-09: Axsome entered into a Third Amendment to the Loan Agreement with Hercules.
- 2023-02-01: Axsome entered into a licensing transaction with Pharmanovia to market Sunosi in Europe and certain countries in the Middle East / North Africa.
- 2023-05-08: Axsome entered into the Fourth Amendment to the Loan Agreement with Hercules.
- 2023-06-01: Axsome commenced the first offering period pursuant to the ESPP.
- 2023-06-01: Axsome completed an underwritten public offering of its common stock.
- 2024-03-01: Axsome announced the initiation of the PARADIGM study, a Phase 3 trial for solriamfetol in MDD.
- 2024-04-01: Axsome announced the initiation of the ENGAGE study, a Phase 3 trial for solriamfetol in BED.
- 2024-05-01: Axsome announced the initiation of the ACCORD-2 study, a Phase 3 trial for AXS-05 in AD agitation.
- 2024-06-30: End of the quarterly period covered by this report.
- 2024-07-29: Date of share count.
- 2024-08-01: Axsome announced the initiation of the SUSTAIN study, a Phase 3 trial for solriamfetol in SWD.
Keywords
Axsome Therapeutics, AXSM, Auvelity, Sunosi, clinical trials, CNS disorders, pharmaceutical, biotechnology, regulatory approval, product sales, research and development, operating expenses, net loss, financial results, 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.
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.
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.
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.
Disclaimer: This summary was generated by artificial intelligence and its accuracy is not guaranteed. The information provided here is for general informational purposes only and does not constitute financial advice, recommendation, or endorsement of any kind. It may contain errors or omissions. You should not rely on this information to make financial decisions. Always seek the advice of a qualified financial professional before making any investment or financial decisions. Use of this information is at your own risk.