AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reports Strong 2024 Financial Results and Advances Pipeline
Sentiment:
Annual Results
18 February 2025 7:06 AM
Axsome Therapeutics announces positive financial results for 2024, driven by strong commercial growth and pipeline advancements, including FDA approval of Symbravo and progress in clinical trials.
Better than expected
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
Topline results from the ENGAGE Phase 3 trial of solriamfetol in BED are now anticipated in 2026.
Summary
- Axsome Therapeutics reported its fourth quarter and full year 2024 financial results, highlighting significant revenue growth and pipeline progress.
- Total net product revenues for 4Q 2024 were $118.8 million, and $385.7 million for the full year, representing year-over-year growth of 66% and 88%, respectively.
- Auvelity net product sales were $92.6 million for 4Q 2024 and $291.4 million for the full year, showing year-over-year growth of 89% and 124%, respectively.
- Sunosi net product revenues were $26.2 million for 4Q 2024 and $94.3 million for the full year, representing year-over-year growth of 16% and 26%, respectively.
- The company's net loss for 4Q 2024 was $74.9 million, or $(1.54) per share, and for the full year, it was $287.2 million, or $(5.99) per share.
- Cash and cash equivalents totaled $315.4 million as of December 31, 2024.
- Axsome believes its current cash is sufficient to fund anticipated operations into cash flow positivity.
- The FDA approved Symbravo for acute migraine treatment in January 2025, with commercial availability expected in approximately four months.
- NDA submissions for AXS-05 in Alzheimers disease agitation and AXS-12 in narcolepsy are anticipated in the second half of 2025.
- Topline results from Phase 3 trials of solriamfetol in ADHD and MDD, and Symbravo in migraine are expected in 1Q 2025.
- A pivotal Phase 2/3 trial of AXS-05 in smoking cessation is planned for initiation in 2025.
Sentiment
Score: 8
Explanation: The document presents a positive outlook with strong financial performance, regulatory approvals, and pipeline advancements. While there are some negatives like net losses and trial delays, the overall tone is optimistic and suggests potential for future growth.
Positives
- Significant revenue growth driven by Auvelity and Sunosi.
- FDA approval of Symbravo expands the commercial portfolio.
- Advancement of the pipeline with successful completion of Phase 3 trials for AXS-05 in Alzheimers disease agitation and AXS-12 in narcolepsy.
- Anticipated NDA submissions for AXS-05 and AXS-12 in the second half of 2025.
- Strong payer coverage for Auvelity and Sunosi.
- Settlement of patent litigation related to Auvelity provides clarity on market exclusivity.
- Current cash position is expected to fund operations into cash flow positivity.
Negatives
- The company reported a net loss of $74.9 million for 4Q 2024 and $287.2 million for the full year.
- Increased R&D and SG&A expenses contributed to the net loss.
- The ENGAGE Phase 3 trial of solriamfetol in BED now anticipates topline results in 2026, a delay from previous expectations.
Risks
- The commercial success of Sunosi, Auvelity, and Symbravo is subject to market acceptance and competition.
- The company's ability to obtain regulatory approval for its product candidates is not guaranteed.
- Clinical trial results may not be indicative of final results.
- The company's intellectual property rights may be challenged.
- Unforeseen circumstances or disruptions to normal business operations could impact results.
- The company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales is a risk.
Future Outlook
Axsome anticipates multiple value-driving catalysts ahead, including new product/indication launches through 2027 and Phase 3 topline data readouts through 2026. The company expects its current cash to fund operations into cash flow positivity.
Management Comments
- 2024 was another defining year for Axsome, driven by strong commercial growth and a rapidly advancing late-stage pipeline, which culminated in the successful completion of our Phase 3 clinical program for AXS-05 in Alzheimers disease agitation, and most recently, the U.S. approval of Symbravo last month for the acute treatment of migraine with or without aura in adults, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics.
- With potentially five marketed products across six CNS indications of great unmet need over the next 12-18 months, we are well positioned to continue delivering innovative new medicines to patients, and significant nearand long-term value to shareholders.
Industry Context
Axsome is operating in the central nervous system (CNS) therapeutics market, which addresses a broad range of psychiatric and neurological conditions. The company's focus on novel mechanisms of action and differentiated products positions it to compete effectively in this space. The approval of Symbravo and the advancement of its pipeline programs demonstrate its commitment to addressing unmet needs in CNS disorders.
Comparison to Industry Standards
- Axsome's revenue growth for Auvelity at 124% year-over-year is strong compared to other recent antidepressant launches, suggesting a successful market penetration.
- The company's focus on CNS disorders aligns with the industry's increasing attention to mental health and neurological conditions.
- Competitors in the antidepressant market include companies like Eli Lilly (Prozac, Cymbalta) and Pfizer (Zoloft), while companies like Teva and Amgen compete in the migraine treatment space.
- Axsome's pipeline, including AXS-05 and AXS-12, targets areas with significant unmet needs, potentially offering differentiated treatments compared to existing options.
Stakeholder Impact
- Shareholders can expect potential value appreciation from pipeline advancements and commercial success.
- Patients will benefit from new treatment options for CNS disorders.
- Employees may experience growth opportunities within the company.
- Payers will need to consider coverage for new and existing Axsome products.
Next Steps
- Submit NDA for AXS-14 in fibromyalgia (1Q 2025).
- Report topline results from Phase 3 EMERGE trial of AXS-07 in migraine (1Q 2025).
- Report topline results from Phase 3 FOCUS trial of solriamfetol in ADHD (1Q 2025).
- Report topline results from Phase 3 PARADIGM trial of solriamfetol in MDD (1Q 2025).
- Initiate Phase 2/3 trial of AXS-05 in smoking cessation (2025).
- Submit NDAs for AXS-05 in Alzheimers disease agitation and AXS-12 in narcolepsy (2H 2025).
- Report topline results from Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026).
- Report topline results from Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026).
Key Dates
- January 30, 2025: FDA approved Symbravo for the acute treatment of migraine with or without aura in adults.
- February 18, 2025: Date of the press release announcing financial results and business update.
- 1Q 2025: Anticipated NDA submission for AXS-14 in fibromyalgia.
- 1Q 2025: Topline results expected from Phase 3 EMERGE trial of AXS-07 in migraine.
- 1Q 2025: Topline results expected from Phase 3 FOCUS trial of solriamfetol in ADHD.
- 1Q 2025: Topline results expected from Phase 3 PARADIGM trial of solriamfetol in MDD.
- 2H 2025: Anticipated NDA submission for AXS-05 in Alzheimers disease agitation.
- 2H 2025: Anticipated NDA submission for AXS-12 in narcolepsy.
- 2025: Planned initiation of pivotal Phase 2/3 trial of AXS-05 in smoking cessation.
- 2026: Anticipated topline results from Phase 3 ENGAGE trial of solriamfetol in binge eating disorder.
- 2026: Anticipated topline results from Phase 3 SUSTAIN trial of solriamfetol in shift work disorder.
- March 31, 2039: Teva can sell its generic version of Auvelity beginning on or after this date if pediatric exclusivity is granted.
- September 30, 2038: Teva can sell its generic version of Auvelity beginning on or after this date if no pediatric exclusivity is granted.
Keywords
Axsome Therapeutics, Financial Results, Auvelity, Sunosi, Symbravo, Clinical Trials, NDA Submission, Alzheimers Disease Agitation, Narcolepsy, ADHD, MDD, Binge Eating Disorder, Shift Work Disorder, Migraine
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.
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.
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.
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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