AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reports Strong First Quarter Growth and Pipeline Progress
Sentiment:
Quarterly Report
6 May 2024 7:05 AM
Axsome Therapeutics announced a 160% year-over-year increase in total net product revenue for the first quarter of 2024, driven by strong sales of Auvelity and Sunosi, and provided updates on its clinical pipeline.
Worse than expected
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.
Summary
- Axsome Therapeutics reported a total net product revenue of $75.0 million for the first quarter of 2024, a 160% increase compared to the same period in 2023.
- Auvelity net product sales reached $53.4 million, showing a 240% year-over-year growth.
- Sunosi net product revenue was $21.6 million, representing a 64% year-over-year increase.
- The company's research and development expenses increased to $36.8 million, up from $17.8 million in the first quarter of 2023, due to ongoing clinical trials and manufacturing costs.
- Selling, general, and administrative expenses rose to $99.0 million, compared to $74.2 million in the prior year, primarily due to commercialization activities.
- Axsome reported a net loss of $68.4 million, or $(1.44) per share, for the first quarter of 2024, compared to a net loss of $11.2 million, or $(0.26) per share, for the same period in 2023.
- The company's cash and cash equivalents totaled $331.4 million as of March 31, 2024.
- Axsome believes its current cash is sufficient to fund operations into cash flow positivity.
- Approximately 95,000 prescriptions were written for Auvelity in the first quarter of 2024, a 12% sequential increase from the previous quarter.
- Payer coverage for Auvelity is stable at approximately 70% of all covered lives.
- Approximately 42,000 prescriptions were written for Sunosi in the U.S. in the first quarter of 2024, a 1.6% decrease compared to the fourth quarter of 2023.
- Axsome is advancing its pipeline with multiple Phase 3 trials, including AXS-05 for Alzheimer's disease agitation, AXS-12 for narcolepsy, and solriamfetol for ADHD, MDD, and BED.
Sentiment
Score: 6
Explanation: The document presents a mixed picture. While there is strong revenue growth and pipeline progress, the significant increase in net loss and operating expenses tempers the positive aspects. The company's cash position is adequate, but the path to profitability is still uncertain.
Positives
- Axsome experienced significant revenue growth in the first quarter of 2024, driven by strong sales of Auvelity and Sunosi.
- Auvelity sales showed a substantial 240% year-over-year increase, indicating strong market adoption.
- Sunosi also demonstrated solid growth with a 64% year-over-year increase in revenue.
- The company secured a second large GPO contract for Auvelity, which should expand its market reach.
- Positive Phase 3 results for AXS-12 in narcolepsy were announced, moving the drug closer to market approval.
- Axsome initiated multiple Phase 3 trials for solriamfetol, expanding its pipeline.
- The company is on track to resubmit the NDA for AXS-07 and submit the NDA for AXS-14 in the second quarter of 2024.
- Axsome's cash position is considered sufficient to fund operations into cash flow positivity.
Negatives
- The company reported a net loss of $68.4 million for the first quarter of 2024, significantly higher than the $11.2 million loss in the same period of 2023.
- Research and development expenses increased substantially to $36.8 million, reflecting the cost of ongoing clinical trials.
- Selling, general, and administrative expenses also increased to $99.0 million, driven by commercialization efforts.
- Sunosi prescription volume decreased slightly by 1.6% compared to the previous quarter.
Risks
- The company's increased operating expenses, particularly in R&D and SG&A, contributed to a significant net loss.
- The success of the company's pipeline depends on positive clinical trial results and regulatory approvals.
- The company's ability to achieve cash flow positivity is dependent on continued revenue growth and cost management.
- There are risks associated with the commercialization of new products and market acceptance.
- The company's forward-looking statements are subject to various risks and uncertainties, including regulatory approvals and market conditions.
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 several key milestones in the coming months, including NDA submissions and topline results from multiple Phase 3 trials.
Management Comments
- The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea, said Herriot Tabuteau, MD, CEO of Axsome Therapeutics.
- We also significantly advanced our innovative neuroscience pipeline in the quarter.
- We announced positive Phase 3 results for AXS-12 in narcolepsy, a major step toward making this new medicine available to patients living with this debilitating condition, and we launched two pivotal trials of solriamfetol in major depressive disorder and binge eating disorder.
- In the coming months we look forward to resubmitting our NDA for AXS-07 in migraine, and to submitting our NDA for AXS-14 in fibromyalgia.
Industry Context
Axsome's focus on central nervous system (CNS) disorders aligns with the growing need for innovative treatments in this area. The company's pipeline includes multiple late-stage product candidates targeting conditions with limited treatment options, positioning it to potentially capture a significant share of the market. The positive results for AXS-12 in narcolepsy and the initiation of Phase 3 trials for solriamfetol in MDD and BED demonstrate the company's commitment to addressing unmet needs in the CNS space.
Comparison to Industry Standards
- Axsome's 240% year-over-year growth in Auvelity sales is significantly higher than the average growth rate for pharmaceutical products in the CNS market, suggesting strong market uptake.
- The company's R&D spending of $36.8 million in Q1 2024 is substantial, reflecting its commitment to advancing its pipeline, which is comparable to other biotech companies focused on late-stage clinical development.
- The net loss of $68.4 million is higher than some peers, but this is typical for companies investing heavily in clinical trials and commercialization efforts.
- The company's cash position of $331.4 million is adequate to fund its operations into cash flow positivity, which is a positive sign compared to companies with limited cash reserves.
- The successful contracting with two of the three largest GPOs for Auvelity is a positive development, as it indicates a strong potential for market access and coverage, which is a key factor for commercial success in the pharmaceutical industry.
Stakeholder Impact
- Shareholders may be concerned about the increased net loss, but encouraged by the strong revenue growth and pipeline progress.
- Employees may benefit from the company's growth and expansion, but may also face increased pressure to meet targets.
- Patients may benefit from the development of new treatment options for CNS disorders.
- Customers (physicians and pharmacies) may see increased availability of Axsome's products.
- Suppliers may see increased demand for their products and services.
- Creditors may be reassured by the company's cash position and revenue growth.
Next Steps
- Axsome will resubmit the NDA for AXS-07 in migraine and submit the NDA for AXS-14 in fibromyalgia in the second quarter of 2024.
- The company will continue enrollment in the ACCORD-2 trial of AXS-05 for Alzheimer's disease agitation, with completion expected mid-year 2024.
- Axsome will initiate a Phase 3 trial of solriamfetol in shift work disorder in the second quarter of 2024.
- The company anticipates topline results from several Phase 3 trials in the second half of 2024, including ADVANCE-2, EMERGE, FOCUS, and the open-label safety extension trial of AXS-12.
- Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 for smoking cessation in 2024.
- The company expects topline results from the PARADIGM and ENGAGE trials of solriamfetol in 2025.
Key Dates
- March 2024: Positive topline results from the SYMPHONY trial of AXS-12 in narcolepsy were announced, and Phase 3 trials for solriamfetol in MDD and BED were initiated.
- March 31, 2024: End of the first quarter, with cash and cash equivalents totaling $331.4 million.
- May 1, 2024: Axsome contracted with a second large group purchasing organization (GPO) for potential formulary coverage of Auvelity.
- May 6, 2024: Date of the press release announcing Q1 2024 financial results.
- Mid-year 2024: Anticipated completion of enrollment in the ACCORD-2 trial of AXS-05 for Alzheimer's disease agitation.
- 2Q 2024: Target for NDA resubmission for AXS-07 in migraine and NDA submission for AXS-14 in fibromyalgia, and initiation of Phase 3 trial of solriamfetol in shift work disorder.
- 2H 2024: Anticipated completion of the ADVANCE-2 trial of AXS-05 for Alzheimer's disease agitation, topline results from the EMERGE study of AXS-07 in migraine, topline results from the FOCUS study of solriamfetol in ADHD, and completion of the open-label safety extension trial of AXS-12 in narcolepsy.
- 2024: Planned initiation of a pivotal Phase 2/3 trial of AXS-05 for smoking cessation.
- 2025: Anticipated topline results from the PARADIGM trial of solriamfetol in major depressive disorder and the ENGAGE trial of solriamfetol in binge eating disorder.
Keywords
Axsome Therapeutics, Auvelity, Sunosi, AXS-05, AXS-12, AXS-07, AXS-14, solriamfetol, narcolepsy, Alzheimer's disease agitation, migraine, fibromyalgia, ADHD, major depressive disorder, binge eating disorder, clinical trials, NDA, GPO, CNS disorders
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.
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.
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.
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.
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.