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Axsome Therapeutics Inc (AXSM)
NASDAQ:AXSM

Axsome Therapeutics (AXSM) AI Stock Analysis

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Axsome Therapeutics

(NASDAQ:AXSM)

Rating:49Neutral
Price Target:
$107.00
▼(-1.05%Downside)
Axsome Therapeutics' overall stock score reflects its strong revenue growth and strategic financial maneuvers, like the loan agreement with Blackstone. However, ongoing challenges with profitability, cash flow, and regulatory hurdles limit the score, highlighting the risks typical in the biotech sector.
Positive Factors
Market Access
Payer coverage for AUVELITY across all channels is about 78% of all covered lives as most recently reported by Axsome management.
Product Pipeline
The company has three FDA-approved products and three NDA-stage products and four products currently in Phase III clinical trials, with a potential for seven new drug launches through 2027.
Revenue Potential
Management expressed confidence in Auvelity MDD $1 billion peak sales guidance floor, already annualizing about $400 million, and a confluence of factors could drive revenues to $3 billion peak ceiling.
Negative Factors
Market Competition
Total Auvelity prescriptions for 1Q25 reached ~167K, representing ~5% Q/Q growth, compared to a sequential decline in the overall antidepressant market of ~2%.
Prescription Growth
Auvelity prescription growth was flat, with weekly TRx/NRx growth of 0%/-1%.

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: -3.63%|
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 has shown robust revenue growth, a positive trend for a biotech firm. However, significant challenges persist due to ongoing net losses, high leverage, and negative cash flows. The company's financial health is strained by its reliance on external funding and persistent cash flow issues, common in research-intensive sectors.
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.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
432.16M385.69M270.60M50.04M0.000.00
Gross Profit
395.36M352.39M244.53M44.84M-1.16M-77.72K
EBIT
-270.27M-280.56M-231.82M-176.50M-124.71M-99.14M
EBITDA
-266.13M-272.60M-224.99M-174.23M-123.55M-99.06M
Net Income Common Stockholders
-278.27M-287.22M-239.24M-197.77M-134.94M-105.39M
Balance SheetCash, Cash Equivalents and Short-Term Investments
331.44M315.35M386.19M200.84M86.47M183.88M
Total Assets
545.73M568.50M588.24M331.48M-338.36M186.13M
Total Debt
189.43M192.96M186.37M94.68M49.71M50.12M
Net Debt
-142.01M-122.40M-199.82M-106.16M-36.76M-133.75M
Total Liabilities
401.69M511.48M397.26M221.92M70.84M72.34M
Stockholders Equity
144.04M57.02M190.98M109.56M-409.20M-278.80M
Cash FlowFree 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 Flow
88.30M57.84M331.01M284.58M11.13M42.41M

Axsome Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price108.14
Price Trends
50DMA
107.48
Positive
100DMA
111.88
Negative
200DMA
101.56
Positive
Market Momentum
MACD
-0.46
Negative
RSI
51.75
Neutral
STOCH
76.76
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AXSM, the sentiment is Positive. The current price of 108.14 is above the 20-day moving average (MA) of 106.81, above the 50-day MA of 107.48, and above the 200-day MA of 101.56, indicating a bullish trend. The MACD of -0.46 indicates Negative momentum. The RSI at 51.75 is Neutral, neither overbought nor oversold. The STOCH value of 76.76 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 3 New Risks
1.
We are subject to a variety of U.S. and international laws and regulations. Q4, 2024
2.
Political uncertainty may have an adverse impact on our operating performance and results of operations. Q4, 2024
3.
We are exposed to market risk from fluctuations in currency exchange rates and interest rates. Q4, 2024

Axsome Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
71
Outperform
$3.78B31.8013.90%247.53%118.34%
68
Neutral
$7.22B-72.73%-157.53%
55
Neutral
$3.82B19.61-23.61%59.15%-1881.09%
53
Neutral
$5.25B3.24-45.38%2.81%16.79%-0.06%
50
Neutral
$8.24B-47.71%99.19%48.43%
49
Neutral
$5.30B-282.16%72.16%9.65%
36
Underperform
$3.82B435.49%412.21%1.75%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AXSM
Axsome Therapeutics
108.14
33.38
44.65%
CYTK
Cytokinetics
32.41
-19.87
-38.01%
SRPT
Sarepta Therapeutics
39.54
-77.90
-66.33%
BPMC
Blueprint Medicines
128.10
23.68
22.68%
VRNA
Verona Pharma
83.98
71.97
599.25%
KRYS
Krystal Biotech
132.03
-33.65
-20.31%

Axsome Therapeutics Corporate Events

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
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.