AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reports Strong Q1 2025 Results, Advances Pipeline
Sentiment:
Quarterly Report
5 May 2025 7:33 AM
Axsome Therapeutics announces a successful first quarter in 2025, marked by significant revenue growth, regulatory progress, and pipeline advancements.
Better than expected
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.
Summary
- Axsome Therapeutics reported its first quarter 2025 financial results and provided a business update.
- Total net product revenue for 1Q 2025 was $121.5 million, a 62% increase year-over-year.
- AUVELITY net product sales were $96.2 million, representing an 80% year-over-year growth.
- SUNOSI net product revenue was $25.2 million, a 17% increase year-over-year.
- SYMBRAVO was approved for acute migraine treatment, with a commercial launch expected in June 2025.
- An NDA for AXS-14 for fibromyalgia management has been submitted to the FDA.
- A supplemental NDA submission for AXS-05 in Alzheimer's disease agitation is on track for 3Q 2025.
- An NDA submission for AXS-12 for cataplexy in narcolepsy patients is anticipated in 2H 2025.
- Positive topline results were announced for the FOCUS Phase 3 trial of solriamfetol in ADHD.
- A Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness is anticipated in 2025.
- Positive topline results were announced for the EMERGE Phase 3 trial of SYMBRAVO in migraine patients with prior inadequate response to oral CGRP inhibitors.
- The company's cash and cash equivalents totaled $300.9 million as of March 31, 2025.
- Axsome believes its current cash is sufficient to fund anticipated operations into cash flow positivity.
Sentiment
Score: 8
Explanation: The document presents a positive outlook with strong financial results, regulatory approvals, and pipeline advancements. The company's expectation of reaching cash flow positivity further contributes to the positive sentiment.
Positives
- Total net product revenue increased by 62% year-over-year, reaching $121.5 million.
- AUVELITY net product sales grew by 80% year-over-year, totaling $96.2 million.
- SUNOSI net product revenue increased by 17% year-over-year, reaching $25.2 million.
- SYMBRAVO received FDA approval for acute migraine treatment.
- The company submitted an NDA for AXS-14 for fibromyalgia management.
- Axsome is on track to submit a supplemental NDA for AXS-05 in Alzheimer's disease agitation in 3Q 2025.
- The company anticipates submitting an NDA for AXS-12 for cataplexy in narcolepsy patients in 2H 2025.
- Positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD were announced.
- Positive topline results from the EMERGE Phase 3 trial of SYMBRAVO in migraine patients with prior inadequate response to oral CGRP inhibitors were announced.
- Axsome believes its current cash is sufficient to fund anticipated operations into cash flow positivity.
Negatives
- The net loss for the first quarter of 2025 was $59.4 million, although this is an improvement compared to a net loss of $68.4 million for the same period in 2024.
- Selling, general, and administrative (SG&A) expenses increased to $120.8 million for the first quarter of 2025, compared to $99.0 million for the comparable period in 2024.
Risks
- The company's ability to obtain regulatory approval for its product candidates is subject to uncertainty.
- Commercial success of SUNOSI, AUVELITY, and SYMBRAVO is not guaranteed.
- The company's ability to maintain and expand payer coverage is subject to uncertainty.
- Clinical trials may face delays or unfavorable results.
- The company's intellectual property may be challenged.
- Unforeseen circumstances or disruptions to normal business operations could occur.
Future Outlook
Axsome anticipates continued momentum throughout 2025, with potential new product/indication launches through 2027 and expects current cash to fund operations into cash flow positivity.
Management Comments
- The first quarter was strong and eventful, with the approval of SYMBRAVO for the acute treatment of migraine, continued growth of AUVELITY and SUNOSI, and significant advancements across our broad late-stage neuroscience pipeline, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics.
- Commercial availability of SYMBRAVO is on track for this June, and preparations are underway to enable a successful launch.
- We have submitted our NDA for AXS-14 for the management of fibromyalgia, and are on track for our planned NDA submissions this year for AXS-05 in Alzheimers disease agitation and for AXS-12 in cataplexy in patients with narcolepsy.
- Our development programs with solriamfetol continue to advance, with the recently announced Phase 3 topline results in ADHD and MDD, and progress across the Phase 3 trials in binge eating disorder and excessive sleepiness associated with shift work disorder.
- Overall, our neuroscience portfolio positions us to deliver potentially five marketed products across ten indications that collectively impact over 150 million patients in the U.S. alone.
Industry Context
Axsome is operating in the competitive CNS therapeutics market, focusing on areas with unmet needs. The company's pipeline and recent approvals position it to compete with established players and address a broad range of neurological and psychiatric conditions.
Comparison to Industry Standards
- Axsome's 62% year-over-year revenue growth in Q1 2025 is significant compared to the average growth rate of established pharmaceutical companies, which typically ranges from 5-15%.
- The 80% growth in AUVELITY sales indicates strong market adoption, potentially exceeding the initial launch trajectories of similar CNS drugs from companies like Eli Lilly (e.g., Cymbalta) and Pfizer (e.g., Zoloft) during their early years.
- The company's focus on novel mechanisms of action, such as NMDA receptor antagonism and sigma-1 agonism, differentiates it from competitors primarily focused on traditional SSRI/SNRI approaches.
- The development of SYMBRAVO, a multi-mechanistic migraine treatment, positions Axsome to compete with companies like Amgen, Novartis, and Teva in the migraine market, particularly among patients who have not responded adequately to CGRP inhibitors.
- Axsome's pipeline, targeting conditions like Alzheimer's disease agitation and fibromyalgia, addresses areas with limited treatment options, potentially giving it a first-mover advantage over companies like Biogen and Eisai, which are primarily focused on amyloid-targeting Alzheimer's therapies.
Stakeholder Impact
- Shareholders can expect potential value appreciation due to positive financial performance and pipeline progress.
- Patients will have access to new treatment options for CNS disorders.
- Employees may benefit from company growth and expansion.
- The company's success could lead to increased collaboration with suppliers and partners.
- Creditors can be reassured by the company's strong financial position and prospects.
Next Steps
- Commercial launch of SYMBRAVO in June 2025.
- FDA filing acceptance decision for NDA for AXS-14 in fibromyalgia in 2Q 2025.
- sNDA submission for AXS-05 in Alzheimers disease agitation in 3Q 2025.
- NDA submission for AXS-12 in narcolepsy in 2H 2025.
- Initiation of Phase 2/3 trial of AXS-05 in smoking cessation in 2025.
- Initiation of Phase 3 trial of solriamfetol in ADHD in pediatric patients in 2025.
- Initiation of Phase 3 trial of solriamfetol in MDD with EDS in 2025.
- Topline results from ENGAGE Phase 3 trial of solriamfetol in BED in 2026.
- Topline results from SUSTAIN Phase 3 trial of solriamfetol in SWD in 2026.
Key Dates
- June 2020: AXS-05 was granted Breakthrough Therapy designation for the treatment of AD agitation.
- January 2025: The U.S. Food and Drug Administration (FDA) approved SYMBRAVO for the acute treatment of migraine with or without aura in adults.
- February 2025: Axsome announced positive topline results from the EMERGE Phase 3 open-label trial of SYMBRAVO in patients experiencing inadequate response to oral CGRP inhibitors.
- March 2025: Axsome received formal pre-NDA meeting minutes from the FDA for AXS-05 in AD agitation, supporting a supplemental NDA (sNDA) submission.
- March 2025: Axsome announced positive topline results from the FOCUS Phase 3 trial evaluating the efficacy and safety of solriamfetol in ADHD in adults.
- March 2025: Axsome announced that it resolved patent litigation with Hikma Pharmaceuticals USA, Inc. (Hikma) related to Hikmas Abbreviated New Drug Application (ANDA) for a generic version of SUNOSI.
- March 31, 2025: Cash and cash equivalents totaled $300.9 million.
- April 2025: Axsome announced topline results from the PARADIGM Phase 3 proof-of-concept trial evaluating the efficacy and safety of solriamfetol in MDD with and without excessive daytime sleepiness (EDS).
- April 2025: Axsome presented the positive topline results from the ACCORD-2 Phase 3 trial of AXS-05 in Alzheimers disease agitation and the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy at the 2025 American Academy of Neurology (AAN) Annual Meeting.
- May 5, 2025: Date of report.
- June 2025: SYMBRAVO commercial launch.
- 3Q 2025: AXS-05 for Alzheimers disease agitation, sNDA submission.
- 2H 2025: AXS-12 for narcolepsy, NDA submission.
- 2026: Phase 3 ENGAGE trial of solriamfetol in binge eating disorder topline results.
- 2026: Phase 3 SUSTAIN trial of solriamfetol in shift work disorder topline results.
- September 1, 2040: Hikma can begin selling its generic version of SUNOSI if pediatric exclusivity is granted.
- March 1, 2040: Hikma can begin selling its generic version of SUNOSI if no pediatric exclusivity is granted.
Keywords
Axsome Therapeutics, Financial Results, AUVELITY, SUNOSI, SYMBRAVO, AXS-05, AXS-12, AXS-14, Solriamfetol, Migraine, Alzheimers Disease Agitation, Fibromyalgia, Narcolepsy, ADHD, MDD, Binge Eating Disorder, Shift Work Disorder, CNS Disorders, 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.
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.
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.
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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