AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reports Strong 2023 Revenue Growth and Pipeline Progress
Sentiment:
Annual Results
20 February 2024 7:05 AM
Axsome Therapeutics announced significant revenue growth for 2023, driven by its commercial products Auvelity and Sunosi, and provided updates on its clinical pipeline.
Better than expected
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
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.
Summary
- Axsome Therapeutics reported a total net product revenue of $204.9 million for the full year 2023, representing a 309% year-over-year increase.
- Auvelity net product sales reached $130.1 million in its first full year of launch, while Sunosi net product revenue was $74.8 million, a 67% year-over-year growth.
- The company's total revenue for 2023 was $270.6 million, including $65.7 million from out-licensing Sunosi in certain ex-U.S. territories.
- Research and development expenses increased to $97.9 million for the full year, primarily due to the advancement of clinical trials and manufacturing costs.
- Selling, general, and administrative expenses rose to $323.1 million, driven by commercialization activities for Auvelity and Sunosi.
- The net loss for the full year was $239.2 million, or $(5.27) per share, which includes $117.9 million in non-cash charges.
- Axsome's cash and cash equivalents totaled $386.2 million at the end of 2023.
- The company anticipates submitting NDAs for AXS-07 in migraine and AXS-14 in fibromyalgia in the first half of 2024.
- Topline results from the SYMPHONY Phase 3 trial in narcolepsy are expected in the first quarter of 2024.
- Topline results from the ADVANCE-2 Phase 3 trial in Alzheimer's disease agitation and the FOCUS Phase 3 trial in ADHD are expected in the second half of 2024.
- Phase 3 trials for solriamfetol in major depressive disorder, binge eating disorder, and shift work disorder are expected to begin in the first quarter of 2024.
Sentiment
Score: 8
Explanation: The document conveys a positive sentiment due to strong revenue growth, successful product launches, and a robust pipeline. However, the significant net loss and increased expenses temper the overall optimism.
Positives
- Axsome experienced substantial revenue growth in 2023, driven by strong sales of Auvelity and Sunosi.
- Auvelity's launch has been successful, with significant sales in its first full year.
- Sunosi continues to show strong growth, both in sales and prescriptions.
- The company has a robust pipeline with multiple late-stage product candidates.
- Axsome has a strong cash position of $386.2 million, which is expected to fund operations into cash flow positivity.
- Payer coverage for Auvelity is stable at approximately 70% of all covered lives.
- Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered.
Negatives
- The company reported a net loss of $239.2 million for the full year 2023.
- Selling, general, and administrative expenses increased significantly due to commercialization efforts.
- The net loss includes $117.9 million in non-cash charges, including stock-based compensation and contingent consideration expenses.
- The ADVANCE-2 trial completion is now anticipated in the second half of 2024 due to enrollment trends and market dynamics.
Risks
- The company's future success depends on the continued commercial success of Auvelity and Sunosi.
- There are risks associated with the timing and success of ongoing clinical trials.
- The company's ability to obtain regulatory approvals for its product candidates is not guaranteed.
- The company may face challenges in defending its intellectual property.
- Unforeseen circumstances or disruptions to normal business operations could impact results.
- The company's ability to fund additional clinical trials is dependent on its cash position and revenue generation.
Future Outlook
Axsome expects to continue its growth trajectory in 2024, driven by its commercial products and pipeline advancements, with potential NDA submissions and multiple Phase 3 trial readouts anticipated.
Management Comments
- 2023 was a transformational year for Axsome, based on successful commercial execution as well as substantial pipeline advancement and expansion.
- We expect to continue the momentum in 2024 as we drive further growth for our two currently marketed products, and potentially submit two NDAs for migraine and fibromyalgia, read out three Phase 3 trials in narcolepsy, Alzheimers disease agitation, and ADHD, and, in the near term, initiate an equal number of new pivotal trials in depression, binge eating disorder, and shift work disorder.
Industry Context
Axsome's focus on central nervous system disorders aligns with the growing need for innovative treatments in this area, and the company's pipeline addresses several significant unmet medical needs. The company's commercial success with Auvelity and Sunosi positions it as a key player in the CNS therapeutics market.
Comparison to Industry Standards
- Axsome's 309% year-over-year revenue growth significantly exceeds the average growth rate for pharmaceutical companies in the CNS space, which typically ranges from 10-20% for established products.
- The successful launch of Auvelity, with $130.1 million in sales in its first full year, is comparable to other successful novel drug launches in the CNS market, such as Vraylar by AbbVie, which achieved similar sales figures in its initial launch period.
- The company's R&D spending of $97.9 million is in line with other biotech companies at a similar stage of development, such as Sage Therapeutics, which also invests heavily in clinical trials for CNS drugs.
- Axsome's cash position of $386.2 million is relatively strong compared to other companies of similar size, providing a solid foundation for continued operations and clinical development.
- The company's pipeline, with multiple Phase 3 trials underway, is comparable to other companies like Intra-Cellular Therapies, which also has a diverse portfolio of CNS drug candidates.
Stakeholder Impact
- Shareholders will likely react positively to the strong revenue growth and pipeline progress.
- Employees may benefit from the company's growth and expansion.
- Patients may gain access to new treatment options for CNS disorders.
- Suppliers and creditors may see increased business opportunities with the company's growth.
Next Steps
- The company plans to submit NDAs for AXS-07 and AXS-14 in the first half of 2024.
- Topline results from the SYMPHONY trial are expected in the first quarter of 2024.
- Phase 3 trials for solriamfetol in MDD, BED, and SWD are expected to begin in the first quarter of 2024.
- Topline results from the ADVANCE-2 and FOCUS trials are expected in the second half of 2024.
- The company plans to initiate a pivotal Phase 2/3 trial of AXS-05 for smoking cessation in 2024.
Key Dates
- October 19, 2022: Auvelity was launched.
- May 2022: The U.S. portion of the acquisition of Sunosi closed.
- November 2022: The ex-U.S. portion of the acquisition of Sunosi closed.
- February 20, 2024: Date of the press release announcing financial results and business update.
- 1Q 2024: Anticipated topline results of the SYMPHONY Phase 3 trial in narcolepsy, and initiation of Phase 3 trials of solriamfetol in MDD, BED, and SWD.
- 1H 2024: Anticipated NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine.
- 2H 2024: Anticipated topline results of the ADVANCE-2 Phase 3 trial in Alzheimer's disease agitation and the FOCUS Phase 3 trial in ADHD.
Keywords
Axsome Therapeutics, Auvelity, Sunosi, CNS disorders, clinical trials, NDA submission, revenue growth, pharmaceuticals, neuroscience, AXS-05, AXS-07, AXS-12, AXS-14, solriamfetol, Alzheimer's disease, migraine, narcolepsy, fibromyalgia, ADHD, MDD, BED, SWD
AXSM
Axsome Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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