EDAP TMS narrows 2026 revenue outlook to $50M–$52M

Q: What was FOCL's revenue in the third quarter of 2026?

FOCL reported third-quarter 2026 revenue of $9.8 million, up 26% from $7.8 million in the third quarter of 2025. It sold seven Focal One systems, compared with six a year earlier.

Q: What is FOCL's 2026 revenue guidance?

FOCL narrowed full-year 2026 revenue guidance to $50.0 million–$52.0 million, from the prior $50.0 million–$54.0 million range. The revised range represents 34%–39% growth over 2025.

The revised full-year range is $50.0 million to $52.0 million, down from the prior $50.0 million to $54.0 million.

Available on EDGAR 11/05/2026 - 04:10 PM EST Accepted by SEC EDGAR 11/05/2026 - 04:10 PM EST

Filing Impact

(High)

Filing Sentiment

(Neutral)How Sentiment works

Sentiment and the balance of points

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How Sentiment works How the balance works

Form Type

8-K

Rhea-AI Filing Summary

EDAP TMS S.A. (FOCL), identified as FocalTherics in its results release, reported third-quarter 2026 revenue of $9.8 million, up 26% from $7.8 million a year earlier. It sold seven Focal One systems versus six, while U.S. Focal One procedures grew 32% year over year. Gross margin was 51.4%, compared with 46.6%.

Operating expenses increased to $12.8 million from $10.3 million, and operating loss widened to $7.8 million from $6.7 million. Net loss narrowed to $4.5 million from $5.9 million, reflecting a favorable non-cash $2.6 million change in fair value of European Investment Bank warrants and a $0.5 million foreign-exchange gain, partly offset by higher operating loss and $0.4 million interest expense on Tranche A and Tranche B drawdowns.

For the nine months ended September 30, 2026, revenue rose 45% to $34.624 million from $23.838 million, while net loss was $28.032 million versus $19.790 million. Cash and cash equivalents were $56.3 million as of September 30, 2026. Full-year revenue guidance was narrowed to $50.0 million–$52.0 million, representing 34%–39% growth over 2025, from the prior $50.0 million–$54.0 million range.

2 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance works How Sentiment works

0 major · 2 points

How the balance works

Positive

Moderate pointQuarterly revenue rose 26% year over year to $9.8 million.
Minor pointNine-month revenue rose 45% to $34.624 million.

Negative

Moderate pointThird-quarter operating loss widened to $7.8 million from $6.7 million.
Moderate pointNine-month net loss widened to $28.032 million from $19.790 million.

Filing Explained

At September 30, cash equaled 1,286.5 days of operating cash use at the latest-quarter rate, while non-current long-term debt was $35,233 thousand.

The September 30 balance sheet reports non-current long-term debt of $35,233 thousand, compared with $15,903 thousand at December 31, 2025.

Cash and equivalents equaled 1,286.5 days of operating cash use at the latest reported quarterly rate, a backward-looking sizing rather than a forecast.

Sources and calculations

EDAP TMS S.A. Form 8-K and Exhibit 99.1 (2026-11-05)
FocalTherics third-quarter 2026 fundamentals (2026Q3)

Available liquidity against the last reported quarterly operating outflow, in days at that rate $56,269,000 / ($4,024,000 / 92) = 1286.5 days

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Third-quarter revenue: $9.8 million Nine-month revenue: $34.624 million Gross margin: 51.4% +4 more

7 metrics

Third-quarter revenue $9.8 million Third quarter 2026; up 26% from $7.8 million in the prior-year period

Nine-month revenue $34.624 million Nine months ended September 30, 2026; up 45% from $23.838 million

Gross margin 51.4% Third quarter 2026, compared with 46.6% in the prior-year period

Operating loss $7.8 million Third quarter 2026, compared with $6.7 million in the prior-year period

Net loss $4.5 million Third quarter 2026, compared with $5.9 million in the prior-year period

Nine-month net loss $28.032 million Nine months ended September 30, 2026, compared with $19.790 million

Full-year 2026 revenue guidance $50.0 million–$52.0 million Represents 34%–39% growth over 2025; revised from $50.0 million–$54.0 million

Key Terms

fair value of warrants liability, discontinued operations, HIFU, Tranche A, +1 more

5 terms

fair value of warrants liability financial

"change in fair value of warrants liability"

discontinued operations financial

"Income(loss) from discontinued operations, net of tax"

Discontinued operations are parts of a company that it has decided to sell or shut down, and no longer plans to run in the future. This matters to investors because it helps them understand which parts of the business are ongoing and which are being phased out, providing a clearer picture of the company’s current performance and future prospects. Think of it like a store closing a department—it no longer contributes to sales or profits.

HIFU medical

"Focal One Robotic HIFU"

High-Intensity Focused Ultrasound (HIFU) is a non-invasive medical treatment that uses tightly focused ultrasound waves to heat and destroy targeted tissue inside the body without cutting skin, like using a magnifying glass to burn a tiny spot with sunlight. For investors, HIFU matters because it represents a device and therapy market where clinical results, regulatory approvals, equipment sales, and insurance coverage determine revenue potential and adoption rates.

Tranche A financial

"interest expense on the Tranche A and Tranche B drawdown"

stock-based compensation financial

"including higher stock-based compensation"

Stock-based compensation is when a company pays employees, directors or consultants with shares or the right to buy shares instead of or in addition to cash. It matters to investors because issuing stock or options spreads ownership thinner (like cutting a pie into more slices), which can reduce each existing share’s claim on profits and can also change reported earnings; investors watch it to assess true cost of running the business and how management is incentivized.

Earnings Snapshot

Revenue: $9.8 million · Guidance included

Third quarter ended September 30, 2026

Revenue $9.8 million Up 26% year over year from $7.8 million

Gross margin 51.4% Compared with 46.6% in the prior-year period

Operating loss $7.8 million Compared with $6.7 million in the prior-year period

Net loss $4.5 million Compared with $5.9 million in the prior-year period

Guidance

Full-year 2026 revenue guidance narrowed to $50.0 million–$52.0 million, representing 34%–39% growth over 2025, from the prior $50.0 million–$54.0 million range.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What was FOCL's revenue in the third quarter of 2026?

FOCL reported third-quarter 2026 revenue of $9.8 million, up 26% from $7.8 million in the third quarter of 2025. It sold seven Focal One systems, compared with six a year earlier.

What is FOCL's 2026 revenue guidance?

FOCL narrowed full-year 2026 revenue guidance to $50.0 million–$52.0 million, from the prior $50.0 million–$54.0 million range. The revised range represents 34%–39% growth over 2025.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________________________________________________

FORM 8-K

________________________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2026

_________________________________________________________

EDAP TMS SA

(Exact name of registrant as specified in its charter)

__________________________________________________________

France	000-29374	98-1644844
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

Parc d’Activites la Poudrette-Lamartine

4/6, rue du Dauphiné

Vaulx-en-Velin, France 69120

(Address of Principal Executive Offices) (Zip Code)

(+33) 47-215-3150

(Registrant's telephone number, including area code)

(Former name or former address, if changed since last report)

_________________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing one Ordinary Share (Ordinary Shares, nominal value €0.13 per share)	FOCL	NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On November 5, 2026, EDAP TMS S.A. issued a press release and will hold a conference call regarding its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report. The press release also includes certain historical financial information of the HIFU division.

The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1	Press Release dated November 5, 2026
104	Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 5, 2026	EDAP TMS S.A.

	/s/ Blandine Confort
	Blandine Confort
	Assistant Corporate Secretary

Exhibit 99.1

FocalTherics™ Reports Third Quarter 2026 Financial Results

45% Revenue Increase and 44% Growth in U.S. Procedure Volume Year-to-date

AUSTIN, Texas, November 5, 2026 - FocalTherics™ (Nasdaq: FOCL) (the “Company”^[1]), a global leader in robotic focal therapy, today announced financial results for the third quarter of 2026.

Third Quarter 2026 Results and Recent Highlights

Increased Revenue to $9.8 million, a 26% Increase Compared to the Prior Year Period

32% Increase in U.S. Procedure Volume over the Prior Year Period

Recorded Seven Focal One® Capital System Sales compared to Six in the Prior Year Period,

Expanded Focal One System Installed Base to 192, including 98 in the U.S. and 94 Internationally

Increased Gross Margin to 51.4%, Compared to 46.6% in the Prior Year Period

Expanded Commercial Focal One Endometriosis Programs to Three Centers in Europe

Positive Coverage Policies Published by Major Commercial Payers for HIFU in Radiorecurrent Prostate Cancer

“We demonstrated steady commercial momentum in the third quarter, highlighted by expanding adoption across multiple new regions and additional system sales in the United States, Turkey, Mexico, and France,” said Ryan Rhodes, CEO of FocalTherics. “U.S. procedure volumes accelerated year-over-year to 32% for the third quarter of 2026, compared to 15% in 2025. Driven by our sustained commercial traction, accelerating technology adoption, and our focus on our HIFU opportunity, we remain highly confident in our growth strategy and on the opportunity ahead as we close out the year.”

Third Quarter 2026 Financial Results

Total revenue for the third quarter of 2026 was $9.8 million, compared to $7.8 million for the same period in 2025, representing an increase of 26% year-over-year. The Company sold seven Focal One systems during the quarter, versus six systems in the same period in 2025, representing a year-over-year growth of 17%. The Company’s U.S. Focal One procedures grew 32% year-over-year.

Gross margin for the third quarter of 2026 was 51.4%, compared to 46.6% in the prior year period. The increase in gross margin was primarily attributable to improvement on standard cost of the Focal One and higher average selling price of our Focal One systems and Focalpaks.

Operating expenses were $12.8 million for the third quarter of 2026, compared to $10.3 million in the prior year period. The increase was due to incremental headcount-related compensation costs including higher stock-based compensation, and additional sales and marketing expenses related to various Urology meetings and events.

Operating loss was $7.8 million for the third quarter of 2026, compared to $6.7 million in the prior year period. Net loss was $4.5 million for the third quarter of 2026, or ($0.10) per share, compared to a net loss of $5.9 million, or ($0.16) per share in the prior year period. The decrease in net loss was primarily attributable to favorable non-cash impact of $2.6 million related to change in fair value of the European Investment Bank warrants and $0.5 million foreign currency exchange gain, partially offset by the higher operating loss of $1.1 million and $0.4 million of interest expense on the Tranche A and Tranche B drawdown.

Cash and cash equivalents as of September 30, 2026 totaled $56.3 million.

Narrowing 2026 Guidance

We are narrowing our full-year 2026 revenue guidance to be in the range of $50.0 to $52.0 million, representing 34% to 39% growth over 2025, from the prior range of $50.0 to $54.0 million.

We have included standalone historical financials for the HIFU business at the end of the document

Conference Call Information

A conference call and webcast to discuss the second quarter 2026 financial results will be hosted by Ryan Rhodes, Chief Executive Officer and Ken Mobeck, Chief Financial Officer. Please refer to the information below for conference call dial-in information and webcast registration.

Date:	Thursday, November 5, 2026, at 4:30 p.m. Eastern Time
Domestic:	1-833-419-0865
International:	1-785-838-9333
Passcode:	FOCAL
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1776674&tp_key=37ee4700b1

About FocalTherics
A recognized global leader in robotic focal therapy, FocalTherics develops, manufactures, and markets minimally invasive medical devices worldwide to treat various conditions using proprietary focused ultrasound technology. The Company’s flagship platform, Focal One Robotic HIFU, combines advanced imaging, real-time treatment planning, robotic precision, and HIFU technology to deliver personalized focal therapy designed to optimize clinical outcomes while preserving quality of life.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved, and include statements such as quote from our Chief Executive Officer and our narrowed financial performance guidance. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and our ability to successfully discontinue and wind down our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Investor Contact

Louisa Smith

Gilmartin Group

investor.relations@focalone.com

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of U.S. Dollars, except per share data)


	Three Months Ended:
	September 30,			September 30,
	2026			2025
	$US			$US
Sales of goods		6,489			4,895
Sales of RPP and leases		2,367			2,216
Sales of spare parts and services		972			717
TOTAL NET SALES		9,828			7,828
Other revenues		—			(0	)
TOTAL REVENUES		9,828			7,828
Cost of sales		(4,776	)		(4,181	)
GROSS PROFIT		5,053			3,647
Research & development expenses		(2,458	)		(2,303	)
Selling, general & administrative expenses		(10,371	)		(8,014	)
Total operating expenses		(12,829	)		(10,316	)
LOSS FROM OPERATIONS		(7,777	)		(6,669	)
Interest (expense) income, net		(559	)		(60	)
Gain (loss) from change in fair value of warrants liability		2,596			—
Currency exchange gains (loss), net		467			85
LOSS BEFORE TAXES FROM CONTINUING OPERATIONS		(5,272	)		(6,645	)
Income tax (expense) credit, net from continuing operations		(15	)		(16	)
LOSS FROM CONTINUING OPERATIONS		(5,287	)		(6,661	)
Income(loss) from discontinued operations, net of tax		825			721
NET LOSS		(4,462	)		(5,940	)
Loss per share – Basic and diluted		(0.10	)		(0.16	)
Average number of shares used in computation of EPS - basic and dilutive		42,625,694			37,438,630

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of U.S. Dollars, except per share data)


	Nine Months Ended:
	September 30,			September 30,
	2026			2025
	$US			$US
Sales of goods		24,272			15,081
Sales of RPP and leases		7,617			6,315
Sales of spare parts and services		2,736			2,441
TOTAL REVENUES		34,624			23,838
Cost of sales		(16,271	)		(12,170	)
GROSS PROFIT		18,353			11,667
Research & development expenses		(7,242	)		(6,951	)
Selling, general & administrative expenses		(34,945	)		(24,753	)
Total operating expenses		(42,186	)		(31,704	)
LOSS FROM OPERATIONS		(23,834	)		(20,037	)
Interest (expense) income, net		(1,710	)		(142	)
Gain (loss) from change in fair value of warrants liability		(4,254	)		—
Currency exchange gains (loss), net		544			(579	)
LOSS BEFORE TAXES FROM CONTINUING OPERATIONS		(29,254	)		(20,757	)
Income tax (expense) credit, net from continuing operations		(40	)		(39	)
LOSS FROM CONTINUING OPERATIONS		(29,294	)		(20,796	)
Income(loss) from discontinued operations, net of tax		1,263			1,006
NET LOSS		(28,032	)		(19,790	)
Loss per share – Basic and diluted		(0.71	)		(0.53	)
Average number of shares used in computation of EPS - basic and dilutive		39,227,611			37,417,439

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS