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Edap Tms S.A. (EDAP)
NASDAQ:EDAP
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EDAP TMS (EDAP) AI Stock Analysis

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EDAP

EDAP TMS

(NASDAQ:EDAP)

Rating:45Neutral
Price Target:
$1.50
▲(11.11% Upside)
EDAP TMS's overall stock score is primarily impacted by its financial performance and valuation challenges. Despite strategic achievements in HIFU and regulatory milestones, the company's profitability issues and negative cash flow generation weigh heavily on its score. Technical indicators suggest a bearish trend, further contributing to a cautious outlook.
Positive Factors
Market Expansion
CE Mark certification expected to tap into large market.
Technology and Innovation
The company launched Focal Once I Robotic HIFU system, a next-generation platform that has compatibility with different imaging systems, such as ExactVu, PSMA PET Scans as well capability to integrate different datasets like DynaCAD.
Negative Factors
Competitive and Regulatory Risks
There is a potential need for capital, risk from intensifying prostate cancer tissue ablation competition, and risk from EU tariffs.
Rating Downgrade
Analyst lowers the rating from Buy to Hold, seeing downside to consensus estimates.

EDAP TMS (EDAP) vs. SPDR S&P 500 ETF (SPY)

EDAP TMS Business Overview & Revenue Model

Company DescriptionEDAP TMS S.A., together with its subsidiaries, develops, produces, markets, distributes, and maintains a portfolio of minimally invasive medical devices for the treatment of urological diseases in Asia, France, the United States, and internationally. It operates in three segments: High Intensity Focused Ultrasound (HIFU), Extracorporeal ShockWave Lithotripsy (ESWL), and Distribution Services (DIST). The HIFU segment develops, manufactures, and markets medical devices based on HIFU technology for the minimally invasive treatment of urological and other clinical indications. This segment also offers Ablatherm, an ultrasound guided robotic HIFU device for the treatment of organ-confined prostate cancer; Ablatherm Fusion that incorporates the company's proprietary fusion software, which merges MRI and ultrasound images; and the Focal One, a HIFU robotic device dedicated to the focal therapy of prostate cancer, as well as disposables, and leasing and treatment related services; and maintenance services. The ESWL division manufactures, markets, and services lithotripter for the treatment of urinary tract stones by means of ESWL technology; and offers Sonolith i-move, an extracorporeal shockwave lithotripter to small and mid-size hospitals, as well as sells disposable parts for lithotripters and electrodes. The Distribution division markets, distributes, and services lasers, micro-ultrasound systems, and other medical products from third parties, as well as leases devices; sells disposables and spare parts; and offers maintenance services. The company markets and sells its products through its direct marketing, sales organization, and service platform, as well as through third-party distributors and agents. Its customers include hospitals, urology clinics, and research institutions. The company was incorporated in 1979 and is headquartered in Lyon, France.
How the Company Makes MoneyEDAP TMS generates revenue through multiple channels, primarily by selling its proprietary HIFU devices and related consumables to hospitals and clinics. The company also earns income from providing services associated with the operation of these devices, including training and support for medical professionals. Additionally, EDAP has established partnerships with various healthcare institutions to facilitate the adoption of its technology, which can lead to long-term revenue through contracts and service agreements. The company may also benefit from reimbursement policies in healthcare systems that cover the use of its technologies, further contributing to its financial performance.

EDAP TMS Earnings Call Summary

Earnings Call Date:May 15, 2025
(Q1-2025)
|
% Change Since: -37.50%|
Next Earnings Date:Aug 28, 2025
Earnings Call Sentiment Neutral
The earnings call presented a mix of positive developments and challenges. While there were record placements of Focal One systems and significant clinical and regulatory achievements, the overall revenue decline and increased net loss present challenges. The strategic focus on HIFU and positive trial results are promising, but financial metrics show areas needing improvement.
Q1-2025 Updates
Positive Updates
Record Number of Focal One System Placements
Placed nine Focal One systems in Q1 2025, a record for any prior first quarter period, including six cash sales and three operating leases.
CE Mark Approval for Endometriosis Treatment
Focal One received CE Mark approval for the treatment of posterior deep infiltrating endometriosis, representing a significant regulatory milestone.
First Remote Transatlantic Focal One Robotic HIFU Procedure
Conducted the world's first remote transatlantic Focal One Robotic HIFU procedure between Cleveland Clinic Ohio and Cleveland Clinic Abu Dhabi.
Positive Clinical Trial Results
Results from the FARP Randomized Controlled Trial showed that focal ablation is non-inferior to radical prostatectomy at a three-year follow-up.
HIFU Revenue Growth
Reported HIFU revenues of €6.2 million, an increase of 6.8% compared to Q1 2024.
Negative Updates
Overall Revenue Decline
Total worldwide revenue decreased by 9.1% compared to Q1 2024, mainly due to declines in non-core ESWL and distribution divisions.
Increased Operating Loss
Operating loss for Q1 2025 was €6 million compared to €4.8 million in Q1 2024.
Challenges with Medicare Advantage
Longer and more challenging review and procedure approvals for patients enrolled in Medicare Advantage plans.
Net Loss Increase
Net loss for Q1 2025 was €7.1 million or €0.19 per diluted share, compared to a net loss of €4.5 million or €0.12 per diluted share in the year-ago period.
Cash and Cash Equivalents Decrease
Cash and cash equivalents decreased to €22.8 million at the end of Q1 2025 from €29.8 million at the end of Q4 2024.
Company Guidance
During the first quarter of 2025, EDAP TMS made significant strides in its strategic goal to lead in HIFU focal therapy, highlighted by the placement of a record nine Focal One systems, comprising six cash sales and three operating leases. In the U.S., two sales were made to prominent healthcare systems in Dallas, Texas, and three operating leases were signed with major institutions like Vanderbilt University and the University of Colorado. Internationally, four cash sales were completed across Europe, the Middle East, and Asia. Despite a 6.8% increase in HIFU revenues to €6.2 million, total worldwide revenue declined by 9.1% to €13.6 million due to a strategic focus shift. The company also announced several key achievements, including the CE Mark approval for treating deep infiltrating endometriosis and a groundbreaking remote transatlantic Focal One procedure. Moving forward, EDAP maintains its 2025 guidance, expecting HIFU revenue growth between 16% and 25%, while non-core segments are projected to decline by 20% to 25%.

EDAP TMS Financial Statement Overview

Summary
EDAP TMS shows potential in revenue growth but struggles with profitability and cash flow generation. The balance sheet is relatively stable, but increasing leverage and negative cash flow are concerns.
Income Statement
45
Neutral
EDAP TMS has shown consistent revenue growth over the years, with a 6% increase from 2023 to 2024. However, the company has struggled with profitability, evidenced by consistently negative net income and EBIT margins. The gross profit margin has been relatively stable, but the company needs to control its operating expenses to move toward profitability.
Balance Sheet
50
Neutral
The balance sheet shows a moderate level of financial health with an equity ratio of 47.5% in 2024, indicative of a balanced capital structure. However, the debt-to-equity ratio has slightly increased over the years, suggesting a rising leverage risk, which could be problematic if profitability doesn't improve.
Cash Flow
40
Negative
The cash flow statement highlights challenges in generating positive free cash flow, with negative figures in recent years. Operating cash flow to net income ratio is negative, reflecting operational inefficiencies. The company needs to improve cash flow generation to support its operations and future growth.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue64.11M60.42M55.11M44.07M41.66M
Gross Profit26.56M24.41M24.19M18.42M18.38M
EBITDA-15.93M-18.39M-323.00K309.00K2.37M
Net Income-19.02M-21.18M-2.93M700.00K-1.70M
Balance Sheet
Total Assets86.06M91.55M101.12M77.23M55.19M
Cash, Cash Equivalents and Short-Term Investments29.84M43.47M63.14M47.18M24.70M
Total Debt13.92M8.42M6.66M8.16M5.43M
Total Liabilities45.17M34.63M29.49M27.17M28.95M
Stockholders Equity40.90M56.92M71.63M50.05M26.25M
Cash Flow
Free Cash Flow-17.68M-18.63M-5.21M2.89M107.00K
Operating Cash Flow-13.58M-14.68M-3.02M4.45M1.98M
Investing Cash Flow-4.12M-4.34M-2.38M-1.64M-2.01M
Financing Cash Flow4.63M-911.00K21.74M20.27M3.20M

EDAP TMS Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.35
Price Trends
50DMA
1.51
Negative
100DMA
1.67
Negative
200DMA
2.03
Negative
Market Momentum
MACD
-0.03
Negative
RSI
44.45
Neutral
STOCH
50.42
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For EDAP, the sentiment is Negative. The current price of 1.35 is below the 20-day moving average (MA) of 1.36, below the 50-day MA of 1.51, and below the 200-day MA of 2.03, indicating a bearish trend. The MACD of -0.03 indicates Negative momentum. The RSI at 44.45 is Neutral, neither overbought nor oversold. The STOCH value of 50.42 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for EDAP.

EDAP TMS Risk Analysis

EDAP TMS disclosed 37 risk factors in its most recent earnings report. EDAP TMS 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.
Our by-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. Q4, 2023
2.
The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. Q4, 2023
3.
If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our ADS price and trading volume could decline. Q4, 2023

EDAP TMS Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
-4.15%3.49%
58
Neutral
$80.80M-9.80%15.16%-39.18%
57
Neutral
$98.86M-77.26%-9.59%8.78%
54
Neutral
€4.17B12.59-36.14%2.46%15.95%-24.06%
51
Neutral
$37.69M-210.58%30.16%22.51%
46
Neutral
$124.60M60.56%36.81%-74.26%
45
Neutral
$55.34M-51.63%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
EDAP
EDAP TMS
1.35
-2.70
-66.67%
ICAD
iCAD
3.87
2.17
127.65%
XTNT
Xtant Medical Holdings
0.64
-0.02
-3.03%
ECOR
Electrocore
5.08
-0.88
-14.77%
OWLT
Owlet
7.53
2.97
65.13%
HYPR
Hyperfine
1.23
0.19
18.27%
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: Aug 21, 2025