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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:58Neutral
Price Target:
$2.50
▲(2.04% Upside)
EDAP's overall stock score is driven by strong growth prospects in its core HIFU business and positive technical indicators. However, financial performance challenges, particularly in profitability and cash flow, along with valuation concerns, weigh down the score. Strategic investments and positive earnings call sentiment provide a counterbalance, suggesting potential for future improvement.
Positive Factors
Revenue Growth
The significant increase in HIFU revenues indicates strong market adoption and potential for sustained growth, enhancing EDAP's market position in the medical devices sector.
Positive Reimbursement Developments
Improved reimbursement rates enhance the financial attractiveness of EDAP's offerings, likely boosting demand and supporting long-term revenue growth.
Strategic Financing
Securing a significant financing facility provides EDAP with the capital needed for expansion and innovation, supporting long-term growth and competitive positioning.
Negative Factors
Profitability Challenges
Rising operating losses highlight ongoing profitability challenges, which could strain financial resources and hinder future investment in growth initiatives.
Cash Flow Issues
Decreasing cash reserves indicate potential liquidity issues, which may impact EDAP's ability to fund operations and strategic initiatives without external financing.
Rising Debt Levels
Increasing leverage could pose financial risks, limiting flexibility and increasing vulnerability to economic downturns if profitability does not improve.

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:Aug 28, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 12, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant growth in the core HIFU business driven by strong adoption and positive reimbursement developments. However, challenges with Medicare Advantage plans and a decline in non-core businesses present hurdles. Despite these challenges, the company is making strategic investments and financing moves to support future growth.
Q2-2025 Updates
Positive Updates
Strong Growth in HIFU Revenue
Global HIFU revenues reached USD 9.7 million, marking an 89% year-over-year increase, driven by the net placement of 12 Focal One systems, which is a 140% growth compared to Q2 2024.
Focal One System Expansions
Significant growth in the adoption of Focal One systems, including placements at Cleveland Clinic facilities worldwide and an additional system at major hospital networks like Hackensack Meridian Health and Baptist Health.
Positive Reimbursement Developments
The Centers for Medicare and Medicaid Services proposed a 5.6% increase in hospital payment for Focal One HIFU procedures in 2026, with higher physician fees compared to other prostate ablation methods.
Progress in Endometriosis Treatment
Received CE marking for the use of HIFU in treating rectal endometriosis, with commercialization efforts initiated in Europe.
Strategic Financing Facility
Entered into a letter of intent for a strategic financing facility with the European Investment Bank for EUR 36 million (USD 42 million) to support the expansion of Focal One and new clinical indications.
Negative Updates
Challenges with Medicare Advantage Plans
Intermittent challenges with certain healthcare plan providers impacting growth and adoption of HIFU, particularly with Medicare Advantage plans.
Decline in Non-core Businesses
Continued decline in the non-core distribution and ESWL businesses, which fell by 31.2% in Q2 2025 compared to Q2 2024.
Increased Operating Loss
Operating loss for the first half of 2025 was EUR 11.8 million, up from EUR 11 million in the same period in 2024.
Decrease in Cash Reserves
Total cash and cash equivalents decreased to EUR 16.3 million at the end of Q2 2025 from EUR 22.8 million at the end of Q1 2025, primarily due to cash used in operating activities.
Company Guidance
During the EDAP Second Quarter 2025 Earnings Conference Call, CEO Ryan Rhodes reported robust performance driven by the Focal One HIFU system. Global HIFU revenues reached USD 9.7 million, marking an 89% increase year-over-year, with the net placement of 12 Focal One systems reflecting a 140% growth compared to Q2 2024. The company's U.S. procedures grew by 4.8% over the same period, despite facing challenges with Medicare Advantage plans. Rhodes highlighted a proposed increase in 2026 CMS hospital payment for Focal One HIFU procedures to $9,765, a 5.6% rise, alongside 26.43 RVUs for physician reimbursement, further solidifying the system's strategic value. Additionally, EDAP's focus on expanding its market presence includes pursuing strategic financing of EUR 36 million to support further growth and development initiatives. The updated guidance for 2025 projects core HIFU business revenue growth of 26% to 34%, underscoring the company's positive outlook and strategic positioning.

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 stable, but increasing leverage is a concern. The company needs to improve operational efficiencies and manage its debt better.
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
Positive
Last Price2.45
Price Trends
50DMA
1.67
Positive
100DMA
1.77
Positive
200DMA
2.00
Positive
Market Momentum
MACD
0.32
Negative
RSI
63.15
Neutral
STOCH
54.05
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For EDAP, the sentiment is Positive. The current price of 2.45 is above the 20-day moving average (MA) of 2.04, above the 50-day MA of 1.67, and above the 200-day MA of 2.00, indicating a bullish trend. The MACD of 0.32 indicates Negative momentum. The RSI at 63.15 is Neutral, neither overbought nor oversold. The STOCH value of 54.05 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 (51)
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
$97.59M-51.63%
57
Neutral
$106.08M-77.26%-9.59%8.78%
52
Neutral
$80.94M-9.80%15.16%-39.18%
51
Neutral
$8.02B-0.31-43.38%2.24%22.31%-2.14%
51
Neutral
$38.07M-210.58%30.16%22.51%
46
Neutral
$120.33M60.56%36.81%-74.26%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
EDAP
EDAP TMS
2.45
-0.79
-24.38%
ICAD
iCAD
3.87
2.23
135.98%
XTNT
Xtant Medical Holdings
0.63
0.05
8.62%
ECOR
Electrocore
4.74
-1.36
-22.30%
OWLT
Owlet
6.95
2.92
72.46%
HYPR
Hyperfine
1.42
0.38
36.54%

EDAP TMS Corporate Events

EDAP TMS Focuses on Robotic HIFU Leadership in Prostate Cancer
Sep 9, 2025

EDAP TMS S.A. has announced its strategic focus on becoming the global market leader in robotic HIFU focal therapy for prostate cancer, a move supported by compelling clinical evidence and increasing demand. The company’s Focal One technology is highlighted as a superior treatment option, offering better functional outcomes compared to traditional methods like radical prostatectomy, and is positioned to drive a paradigm shift in prostate cancer treatment.

EDAP TMS Secures HIFU Reimbursement for Prostate Cancer in France
Sep 8, 2025

On September 8, 2025, EDAP TMS announced that the French Ministry of Health has approved reimbursement for the High Intensity Focused Ultrasound (HIFU) procedure for prostate cancer treatment in France. This reimbursement milestone allows broader patient access to the Focal One Robotic HIFU procedure, marking a significant commercial achievement for EDAP TMS. The decision is expected to enhance the company’s market position in Europe and potentially accelerate similar approvals in other countries, benefiting stakeholders by expanding treatment options for prostate cancer.

EDAP TMS Reports Record Q2 2025 HIFU Growth and Strategic Expansion Plans
Aug 28, 2025

EDAP TMS reported a strong performance in the second quarter of 2025, highlighted by a 140% year-over-year growth in net placements of its Focal One Robotic HIFU Systems and a 76.8% increase in HIFU revenue. The company also executed a letter of intent for a 36 million Euro credit facility with the European Investment Bank to support further growth and strategic expansion of its HIFU business. EDAP raised its 2025 HIFU revenue growth guidance to a range of 26% to 34%, reflecting the increasing demand for its Focal One platform. Despite a decline in its non-core business revenue, the company continues to focus on expanding its HIFU operations, supported by significant clinical evidence and growing adoption in the urology community.

EDAP TMS Secures EUR 36 Million Credit Facility for Growth
Aug 26, 2025

On August 26, 2025, EDAP TMS announced a letter of intent for a EUR 36 million credit facility with the European Investment Bank. This funding aims to support the expansion of Focal One® Robotic HIFU in prostate cancer treatment and the development of new clinical indications. The credit facility is expected to close by the end of 2025, enhancing EDAP’s financial position and enabling broader access to its innovative technologies.

EDAP TMS Announces Transition to U.S. Domestic Filer Status
Jul 1, 2025

On July 1, 2025, EDAP TMS announced its transition from a foreign private issuer to a U.S. domestic filer, effective January 1, 2026. This change signifies a major milestone for the company, highlighting its commitment to transparency and regulatory best practices, and is expected to enhance its relationship with shareholders and attract new institutional investors.

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: Sep 05, 2025