AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reports Strong Q3 2024 Revenue Growth and Pipeline Progress
Sentiment:
Quarterly Report
12 November 2024 7:07 AM
Axsome Therapeutics announced a robust third quarter with significant revenue growth and advancements in its clinical pipeline, including upcoming data readouts and regulatory submissions.
Better than expected
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.
Summary
- Axsome Therapeutics reported a strong third quarter in 2024, with total net product revenue reaching $104.8 million, an 81% increase year-over-year.
- Auvelity net product sales were $80.4 million, showing a 113% year-over-year growth, while Sunosi net product revenue was $24.4 million, a 21% increase year-over-year.
- The company is planning a second expansion of its Auvelity sales force in the first quarter of 2025 due to strong demand.
- The FDA has accepted the NDA resubmission for AXS-07 for migraine treatment, with a PDUFA goal date of January 31, 2025.
- Topline results from several Phase 3 trials, including AXS-05 in Alzheimer's agitation and AXS-12 in narcolepsy, are expected in the fourth quarter of 2024.
- Topline results for solriamfetol trials in ADHD and MDD are anticipated in the first quarter of 2025.
- The company expects to submit an NDA for AXS-14 for fibromyalgia in November 2024.
- Axsome believes its current cash is sufficient to fund operations into cash flow positivity based on the current operating plan.
- The company's cash and cash equivalents totaled $327.3 million as of September 30, 2024.
Sentiment
Score: 8
Explanation: The document conveys a positive sentiment due to strong revenue growth, pipeline advancements, and sufficient cash runway. The company is executing well on its commercial and development plans, with multiple catalysts expected in the near term. However, the net loss and increased expenses temper the overall sentiment slightly.
Positives
- Axsome experienced significant revenue growth in Q3 2024, driven by strong sales of Auvelity and Sunosi.
- Auvelity sales showed exceptional growth, indicating strong market acceptance and demand.
- The company has a robust pipeline with multiple late-stage clinical trials progressing towards key milestones.
- The FDA acceptance of the AXS-07 NDA resubmission and the upcoming PDUFA date are positive regulatory developments.
- Axsome has sufficient cash to fund operations into cash flow positivity, based on the current operating plan.
- Payer coverage for Auvelity and Sunosi is strong, with 78% and 83% of covered lives, respectively.
- The company is expanding its sales force to meet the growing demand for Auvelity.
Negatives
- The company reported a net loss of $64.6 million for the third quarter of 2024, although this included $40.9 million in non-cash charges.
- Research and development expenses increased to $45.4 million in Q3 2024, compared to $28.8 million in the same period in 2023.
- Selling, general, and administrative expenses also increased to $95.6 million in Q3 2024, compared to $83.2 million in the same period in 2023.
- 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's future success depends on the continued commercial success of Auvelity and Sunosi.
- There are risks associated with the success, timing, and cost of ongoing and anticipated clinical trials.
- The company's ability to obtain and maintain regulatory approvals for its product candidates is not guaranteed.
- There are risks related to intellectual property protection and potential litigation.
- The company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales is a risk.
- Unforeseen circumstances or disruptions to normal business operations could impact the company's performance.
Future Outlook
Axsome believes its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. The company anticipates multiple clinical trial readouts and regulatory submissions in the near term, with potential new product launches through 2027.
Management Comments
- In the third quarter, we continued our strong commercial performance and advanced our innovative, industry-leading, late-stage development pipeline towards important near-term milestones, said Herriot Tabuteau, MD, Chief Executive Officer.
- In response to continued strong demand growth, a second expansion of the Auvelity sales force is planned for the first quarter of 2025.
- With the January 31, 2025, PDUFA date for our AXS-07 product candidate for migraine fast approaching, commercial preparations are underway for a timely and successful launch, if approved.
- We expect a busy end to the year with several clinical catalysts anticipated, including a planned simultaneous release of topline results from the ongoing Phase 3 ADVANCE-2 and ACCORD-2 trials of AXS-05 in Alzheimers disease agitation in the fourth quarter.
- Our growth as an organization positions us well to potentially deliver multiple innovative new medicines to the millions of individuals living with central nervous system disorders in the U.S.
- Importantly, we have the resources in hand to execute our operating plans and create substantial value for shareholders.
Industry Context
Axsome's focus on central nervous system disorders aligns with a growing need for innovative treatments in this space. The company's pipeline addresses several unmet needs, including Alzheimer's agitation, migraine, narcolepsy, and fibromyalgia. The strong commercial performance of Auvelity and Sunosi indicates a positive market reception for novel CNS therapies.
Comparison to Industry Standards
- Axsome's 113% year-over-year growth in Auvelity sales significantly outpaces the average growth rate for pharmaceutical products in the CNS space, which typically ranges from 5-20% for established products.
- The company's pipeline includes multiple Phase 3 trials, which is comparable to other mid-sized biopharmaceutical companies focused on CNS disorders, such as Sage Therapeutics and Intra-Cellular Therapies.
- The PDUFA goal date for AXS-07 is a critical milestone, and its success will be compared to other recent migraine drug launches, such as Nurtec ODT and Ubrelvy, in terms of market uptake and patient satisfaction.
- The planned expansion of the Auvelity sales force is a strategic move similar to what other companies do when they see strong demand for a new product, such as what happened with the launch of Trintellix by Lundbeck and Takeda.
- Axsome's focus on novel mechanisms of action, such as the NMDA receptor antagonism of AXS-05, is a differentiator compared to companies that focus on more traditional approaches, such as SSRIs for depression.
Stakeholder Impact
- Shareholders are likely to react positively to the strong revenue growth and pipeline progress.
- Employees may benefit from the company's growth and expansion.
- Patients may benefit from the potential approval and launch of new treatments for CNS disorders.
- Customers (physicians and pharmacies) will see increased availability of Axsome's products.
- Suppliers and creditors will benefit from the company's financial stability and growth.
Next Steps
- The company will submit an NDA for AXS-14 for fibromyalgia in November 2024.
- Topline results from multiple Phase 3 trials are expected in the fourth quarter of 2024 and the first quarter of 2025.
- The company will continue commercial preparations for the potential launch of AXS-07 for migraine.
- The company will expand its Auvelity sales force in the first quarter of 2025.
- The company will initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 2025.
Legal Proceedings
- The patent litigation with Sandoz Inc. related to Sunosi was dismissed following Sandoz's withdrawal of its ANDA for a generic equivalent of Sunosi.
Key Dates
- September 30, 2024: End of the third quarter for which financial results are reported.
- November 12, 2024: Date of the press release and 8-K filing announcing Q3 2024 results.
- November 2024: Anticipated NDA submission for AXS-14 for the management of fibromyalgia.
- December 2024: Anticipated completion of enrollment in the FOCUS trial of solriamfetol in ADHD.
- December 31, 2023: Date of previous financial results for comparison.
- January 31, 2025: PDUFA goal date for the AXS-07 NDA for migraine treatment.
- 1Q 2025: Anticipated topline results for FOCUS and PARADIGM trials of solriamfetol and completion of Auvelity sales force expansion.
- 2025: Anticipated topline results for the ENGAGE trial of solriamfetol in binge eating disorder and initiation of Phase 2/3 trial of AXS-05 in smoking cessation.
- 2026: Anticipated topline results for the SUSTAIN trial of solriamfetol in shift work disorder.
Keywords
Axsome Therapeutics, Auvelity, Sunosi, AXS-05, AXS-07, AXS-12, AXS-14, solriamfetol, Alzheimer's disease, migraine, narcolepsy, fibromyalgia, ADHD, MDD, CNS disorders, clinical trials, FDA, PDUFA, pharmaceuticals
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.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
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 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.
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.
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.
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.