AXSM
Axsome Therapeutics, INC
NASDAQ
10-Q: Axsome Therapeutics Reports Q3 2024 Results: Revenue Growth Driven by Auvelity and Sunosi Sales
Sentiment:
Quarterly Report
12 November 2024 9:43 AM
Axsome Therapeutics' Q3 2024 results show significant revenue growth driven by increased sales of Auvelity and Sunosi, alongside ongoing clinical development programs.
Worse than expected
The company's net loss increased compared to the same period last year, indicating worse than expected results.
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 $64.6 million for the third quarter of 2024, compared to a net loss of $62.2 million for the same period in 2023.
- The company's total revenue for Q3 2024 was $104.8 million, a significant increase from $57.8 million in Q3 2023, primarily driven by product sales.
- Product sales, net, reached $103.7 million in Q3 2024, with Auvelity contributing $80.4 million and Sunosi contributing $23.4 million.
- License revenue was $0 for Q3 2024, compared to $65.7 million in Q3 2023, which was related to the Pharmanovia agreement.
- Royalty revenue from Sunosi sales by Pharmanovia was $1.0 million in Q3 2024, compared to $0.7 million in Q3 2023.
- Research and development expenses increased to $45.4 million in Q3 2024 from $28.8 million in Q3 2023, due to ongoing clinical trials.
- Selling, general, and administrative expenses also increased to $95.6 million in Q3 2024 from $83.2 million in Q3 2023, due to commercial activities.
- The company's cash and cash equivalents were $327.3 million as of September 30, 2024, down from $386.2 million at the end of 2023.
- 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: 6
Explanation: The document presents a mixed sentiment. While there is strong revenue growth and ongoing clinical development, the increasing net loss and reliance on future capital raises temper the overall outlook. The company is making progress but faces financial challenges.
Positives
- Significant revenue growth driven by increased sales of Auvelity and Sunosi.
- 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 Fifth Amendment to the Loan Agreement provides additional financial flexibility.
- The company is actively advancing its clinical development programs.
Negatives
- The company reported a net loss of $64.6 million for Q3 2024.
- Operating expenses, including research and development and selling, general, and administrative costs, have increased.
- Cash and cash equivalents decreased from $386.2 million at the end of 2023 to $327.3 million as of September 30, 2024.
Risks
- The company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable.
- The company's ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties.
- The company may need to raise additional capital to fund its operations.
- The company is subject to a number of factors that can affect its operating results and financial condition, including the results of clinical testing and trial activities of the Companys product candidates; the Companys ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Companys products; the Companys ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Companys ability to raise additional capital.
- The company has a limited number of contract manufacturers for its products and may have only one manufacturer or supplier for its products at times.
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 and Sunosi while continuing to further develop the company's pipeline assets.
Industry Context
The announcement reflects the ongoing challenges and opportunities in the biopharmaceutical industry, where companies are focused on developing and commercializing innovative therapies for central nervous system disorders. The increase in revenue from Auvelity and Sunosi indicates a growing market acceptance of these products, while the rise in R&D expenses highlights the continued investment in future growth.
Comparison to Industry Standards
- Axsome's revenue growth in Q3 2024 is notable compared to many other commercial-stage biopharmaceutical companies, particularly those focused on CNS disorders.
- The increase in R&D spending is consistent with industry trends, where companies are investing heavily in clinical trials to expand their product pipelines.
- The company's cash position is relatively strong, providing a buffer for ongoing operations and future development activities.
- However, the net loss reported by Axsome is not uncommon for companies in this stage of development, as they often prioritize growth and clinical development over immediate profitability.
- Compared to companies like Jazz Pharmaceuticals, which previously held the rights to Sunosi, Axsome is demonstrating a strong ability to commercialize and grow sales of the product.
- The company's focus on novel mechanisms of action and differentiated products aligns with the industry's push for innovative therapies.
Stakeholder Impact
- Shareholders may be concerned about the increasing net loss and the need for potential future capital raises.
- Employees may be affected by the company's financial performance and any potential restructuring or cost-cutting measures.
- Customers (patients and healthcare providers) may benefit from the availability of new therapies, but may also be affected by pricing and reimbursement decisions.
- Suppliers and creditors may be impacted by the company's financial stability and ability to meet its obligations.
Next Steps
- Continue commercialization efforts for Auvelity and Sunosi.
- Advance ongoing Phase 3 clinical trials for solriamfetol, AXS-05, and AXS-12.
- Resubmit the NDA for AXS-07 for the acute treatment of migraine.
- Evaluate other product candidates for CNS disorders.
Legal Proceedings
- The company is involved in ongoing securities class action and shareholder derivative litigation.
- The company has commenced patent infringement actions against Teva Pharmaceuticals, Inc. relating to Teva's Abbreviated New Drug Application for Auvelity.
- The company has commenced patent infringement actions against Hikma and other drug companies relating to each defendant's ANDA for Sunosi.
- The company entered into a settlement agreement with Unichem resolving patent litigation related to Sunosi.
- The company reached an agreement with Sandoz Inc. to dismiss the patent litigation related to Sunosi.
Related Party Transactions
- The company recorded royalty expense of $6.0 million for the nine months ended September 30, 2024, for royalty due to Antecip, an entity owned by Axsomes Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., equal to 3.0 % of Auvelity net sales.
Key Dates
- 2012-01-12: Axsome Therapeutics, Inc. was incorporated.
- 2019: Sunosi was approved for the treatment of EDS in the United States.
- 2020-01-01: Sunosi was approved in Europe by the European Commission.
- 2020-01-09: Axsome entered into an exclusive license agreement with Pfizer for reboxetine.
- 2020-09-25: Axsome entered into a Loan and Security Agreement with Hercules Capital, Inc.
- 2021-10-14: Axsome entered into a First Amendment to the Loan and Security Agreement with Hercules.
- 2022-03-27: Axsome entered into a Second Amendment to the Loan and Security Agreement with Hercules.
- 2022-05-09: Axsome completed the U.S. acquisition of Sunosi from Jazz Pharmaceuticals.
- 2022-08-01: FDA approved Auvelity.
- 2022-10-01: U.S. commercial availability of Auvelity for the treatment of major depressive disorder in adults.
- 2022-11-14: Axsome acquired the ex-U.S. assets of Sunosi from Jazz.
- 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 a 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.
- 2024-01-31: PDUFA action goal date for AXS-07.
- 2024-05-31: The first offering period pursuant to the ESPP ended.
- 2024-09-30: Axsome entered into a Fifth Amendment to the Loan Agreement with Hercules.
- 2024-11-05: There were 48,462,376 shares of the registrants common stock outstanding.
Keywords
Axsome Therapeutics, Auvelity, Sunosi, CNS disorders, clinical trials, revenue growth, pharmaceutical, biopharmaceutical, regulatory approval, product sales
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.
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.
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.
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.
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.
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.