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Axsome Therapeutics Inc. (AXSM)
:AXSM

Axsome Therapeutics (AXSM) AI Stock Analysis

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Axsome Therapeutics

(NASDAQ:AXSM)

Rating:54Neutral
Price Target:
$108.00
▲(4.49%Upside)
Axsome Therapeutics' overall stock score reflects strong revenue growth and positive pipeline developments, balanced by significant financial challenges, including high leverage and negative profitability. The company's strategic corporate actions and technical indicators provide moderate support, though valuation concerns persist.
Positive Factors
Earnings Potential
Visible Alpha consensus sales for 2025 are currently around $480 million, growing to approximately $1 billion by 2027.
Market Performance
Total Auvelity prescriptions for the first quarter reached about 167,000, representing a 5% quarter-over-quarter growth, in contrast to a sequential decline in the overall antidepressant market of about 2%.
Product Launch
Symbravo has become commercially available in the US and is expected to be a solid and steady contributor with significant projected peak year sales.
Negative Factors
Prescription Trends
Auvelity prescriptions saw a meaningful dip, with weekly TRx/NRx decline of -9%/-9%.
Regulatory Challenges
The FDA refusal to file letter regarding the new drug application for AXS-14 indicates a delay in potential approval times, impacting enthusiasm for the product.
Sales Projections
Management expects Symbravo sales in 2Q25 to be de minimis.

Axsome Therapeutics (AXSM) vs. SPDR S&P 500 ETF (SPY)

Axsome Therapeutics Business Overview & Revenue Model

Company DescriptionAxsome Therapeutics, Inc. is a biopharmaceutical company focused on developing and delivering novel therapies for the management of central nervous system (CNS) disorders. Based in New York, the company aims to address unmet medical needs through its innovative drug candidates. Axsome's core products include therapies targeting conditions such as major depressive disorder, migraine, and narcolepsy, leveraging its expertise in CNS pharmacology and drug delivery technologies.
How the Company Makes MoneyAxsome Therapeutics makes money primarily through the development, commercialization, and potential sales of its proprietary drug candidates targeting CNS disorders. The company's revenue model includes multiple streams: upfront and milestone payments from licensing agreements, potential royalties from partnered products, and eventual sales of FDA-approved drugs. Revenue can also be generated from strategic collaborations and partnerships with other pharmaceutical companies, which may provide Axsome with funding to support its research and development activities. The success of Axsome's revenue model is highly dependent on the clinical progress and regulatory approval of its drug candidates.

Axsome Therapeutics Earnings Call Summary

Earnings Call Date:May 05, 2025
(Q1-2025)
|
% Change Since: -7.89%|
Next Earnings Date:Aug 11, 2025
Earnings Call Sentiment Positive
The earnings call reflected a positive outlook with strong revenue growth, successful product launches, and significant pipeline advancements. However, the company faces challenges in achieving profitability and navigating regulatory and market landscapes.
Q1-2025 Updates
Positive Updates
Significant Revenue Growth
Axsome Therapeutics reported a year-over-year total revenue growth of 62% for the first quarter of 2025, with total product revenues reaching $121.5 million.
Successful Product Launch and FDA Approval
The FDA approved Symbravo, Axsome's second internally developed product, marking a significant achievement in expanding their product portfolio.
Strong Performance of Key Products
Auvelity achieved an 80% year-over-year growth in net product sales, reaching $96.2 million in the first quarter of 2025.
Pipeline Advancements
Axsome submitted an NDA for AXS-14 for fibromyalgia and plans to submit an sNDA for AXS-05 for Alzheimer's disease agitation in the third quarter of 2025.
Expansion in Clinical Programs
Announced positive top-line results from Phase III trials for Solriamfetol in ADHD and Symbravo in migraine, paving the way for further trials and potential market expansion.
Negative Updates
Net Loss Reported
Reported a net loss of $59.4 million for the first quarter of 2025, though this was an improvement from the $68.4 million loss in the same period of 2024.
Regulatory and Market Challenges
Potential challenges due to proposed pharmaceutical tariffs and the need to navigate complex payer coverage and negotiation processes for new and existing products.
Company Guidance
In the Axsome Therapeutics First Quarter 2025 Conference Call, the company reported a strong performance with a 62% year-over-year increase in total revenue, attributed mainly to the demand for Auvelity and Sunosi. The recent FDA approval of Symbravo was highlighted as a significant milestone. Key pipeline priorities were discussed, including advancing three novel NDA-stage product candidates: AXS-14 for fibromyalgia, AXS-05 for Alzheimer's disease agitation, and AXS-12 for cataplexy and narcolepsy. The company successfully submitted the NDA for AXS-14 and plans to submit the sNDA for AXS-05 in the third quarter, with a potential launch in 2026. Several Phase III trials are underway, including Solriamfetol for ADHD, MDD, binge eating disorder, and excessive sleepiness related to shift work disorder. Financially, Axsome reported $121.5 million in total product revenues for the quarter, with net product sales of $120.4 million. The company ended Q1 2025 with $300.9 million in cash and cash equivalents and expressed confidence in reaching cash flow positivity with its current resources.

Axsome Therapeutics Financial Statement Overview

Summary
Axsome Therapeutics exhibits strong revenue growth, particularly with a significant increase from $50M in 2022 to $432M in TTM 2025. However, persistent net losses, high leverage, negative equity, and cash flow challenges undermine overall financial health, reflecting common issues in research-intensive biotech firms.
Income Statement
30
Negative
Axsome Therapeutics has shown significant revenue growth over the past few years, highlighted by a substantial increase from $50M in 2022 to $432M TTM (Trailing-Twelve-Months) 2025. However, the company continues to operate at a loss, with negative EBIT and net income margins due to high operating expenses and R&D costs typical in biotech. The gross profit margin remains healthy, reflecting strong product margins. Despite revenue growth, the consistent net losses detract from the overall income statement strength.
Balance Sheet
25
Negative
The company's balance sheet reflects a high level of liabilities compared to equity, with a debt-to-equity ratio indicating significant leverage. Stockholders' equity has been declining, which is concerning. Although cash reserves are substantial, the low equity ratio and negative equity in previous years suggest financial instability. The biotech industry's typical high leverage risk and reliance on external funding are evident here.
Cash Flow
20
Very Negative
Axsome Therapeutics faces challenges with cash flows, as evidenced by negative operating and free cash flows, compounded by substantial R&D investments. The operating cash flow to net income ratio remains negative, indicating persistent cash flow issues. While financing activities have supplemented cash reserves, the company remains heavily reliant on external financing to sustain operations, highlighting cash flow risk.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue432.16M385.69M270.60M50.04M0.000.00
Gross Profit395.36M352.39M244.53M44.84M-1.16M-77.72K
EBITDA-266.13M-272.60M-224.99M-174.23M-123.55M-99.06M
Net Income-278.27M-287.22M-239.24M-197.77M-134.94M-105.39M
Balance Sheet
Total Assets596.67M568.50M588.24M331.48M-338.36M186.13M
Cash, Cash Equivalents and Short-Term Investments300.91M315.35M386.19M200.84M86.47M183.88M
Total Debt209.42M192.96M186.37M94.68M49.71M50.12M
Total Liabilities543.47M511.48M397.26M221.92M70.84M72.34M
Stockholders Equity53.20M57.02M190.98M109.56M-409.20M-278.80M
Cash Flow
Free Cash Flow-118.25M-128.68M-145.66M-117.21M-108.53M-78.50M
Operating Cash Flow-118.32M-128.41M-145.08M-116.51M-108.23M-78.46M
Investing Cash Flow-510.00K-270.00K-582.00K-53.70M-307.55K-45.89K
Financing Cash Flow88.30M57.84M331.01M284.58M11.13M42.41M

Axsome Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price103.36
Price Trends
50DMA
106.67
Negative
100DMA
112.99
Negative
200DMA
102.79
Positive
Market Momentum
MACD
-1.35
Positive
RSI
45.22
Neutral
STOCH
49.74
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AXSM, the sentiment is Neutral. The current price of 103.36 is below the 20-day moving average (MA) of 105.71, below the 50-day MA of 106.67, and above the 200-day MA of 102.79, indicating a neutral trend. The MACD of -1.35 indicates Positive momentum. The RSI at 45.22 is Neutral, neither overbought nor oversold. The STOCH value of 49.74 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for AXSM.

Axsome Therapeutics Risk Analysis

Axsome Therapeutics disclosed 72 risk factors in its most recent earnings report. Axsome Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Axsome Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
71
Outperform
$4.01B33.4513.90%247.53%118.34%
68
Neutral
$7.99B-72.73%-157.53%
54
Neutral
$5.09B-282.16%72.16%9.65%
53
Neutral
$1.68B19.61-23.61%59.15%-1881.09%
51
Neutral
$7.41B0.36-61.88%2.33%16.99%1.69%
50
Neutral
$8.28B-47.71%99.19%48.43%
44
Neutral
$3.96B435.49%412.21%1.75%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AXSM
Axsome Therapeutics
103.36
22.33
27.56%
CYTK
Cytokinetics
33.16
-21.54
-39.38%
SRPT
Sarepta Therapeutics
17.11
-139.64
-89.08%
BPMC
Blueprint Medicines
128.11
18.93
17.34%
VRNA
Verona Pharma
93.82
78.31
504.90%
KRYS
Krystal Biotech
138.88
-43.39
-23.81%

Axsome Therapeutics Corporate Events

Product-Related Announcements
Axsome Therapeutics Launches SYMBRAVO for Migraine Relief
Positive
Jun 10, 2025

On June 10, 2025, Axsome Therapeutics announced the commercial availability of SYMBRAVO®, a novel treatment for acute migraine with or without aura in adults. SYMBRAVO offers a multi-mechanistic approach, providing rapid and sustained pain relief, and is supported by comprehensive patient services. This launch addresses a significant unmet need in migraine treatment, potentially benefiting millions of individuals dissatisfied with existing options.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Shareholder MeetingsBusiness Operations and Strategy
Axsome Therapeutics Shareholders Approve Key Proposals at Meeting
Positive
Jun 9, 2025

At the 2025 Annual Meeting of Stockholders held on June 6, Axsome Therapeutics presented four proposals, all of which were approved by the shareholders. These included the election of a Class I director, approval of the 2025 Long-Term Incentive Plan, ratification of Deloitte & Touche LLP as the independent auditor for 2025, and a non-binding advisory vote on executive compensation. The approval of these proposals reflects strong shareholder support and positions the company for continued strategic growth and governance stability.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Product-Related AnnouncementsRegulatory Filings and Compliance
FDA Refuses Axsome’s NDA for Fibromyalgia Drug
Negative
Jun 9, 2025

On June 9, 2025, Axsome Therapeutics announced that the FDA issued a Refusal to File letter for its NDA for AXS-14, a drug intended for fibromyalgia management. The FDA found one of the trials inadequate due to its design, prompting Axsome to plan an additional trial in late 2025 to meet FDA requirements, reflecting the company’s commitment to addressing unmet needs in fibromyalgia treatment.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Product-Related AnnouncementsLegal Proceedings
Axsome Therapeutics Settles Patent Litigation on SUNOSI
Neutral
May 27, 2025

On May 27, 2025, Axsome Therapeutics announced a settlement agreement with Hetero Labs Ltd. to resolve patent litigation regarding Axsome’s product SUNOSI (solriamfetol). The agreement allows Hetero to sell a generic version of SUNOSI in the U.S. starting in 2040, contingent on FDA approval and other conditions. This settlement is subject to review by U.S. regulatory authorities, and similar litigation with other parties remains pending.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Private Placements and FinancingBusiness Operations and Strategy
Axsome Therapeutics Secures $570M Loan with Blackstone
Positive
May 13, 2025

On May 8, 2025, Axsome Therapeutics entered into a $570 million loan agreement with Blackstone, replacing its previous loan with Hercules Capital. This agreement, which includes a term loan and revolving credit facility, is expected to reduce interest expenses and support Axsome’s growth and profitability goals. The company also completed a private placement of common stock with Blackstone, raising approximately $15 million. These financial moves aim to enhance Axsome’s operational and financial agility, supporting its mission to improve patient outcomes in CNS disorders.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jun 13, 2025