Edap TMS SA: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 lowered. The quarter’s numbers.

Key takeaways

Revenue rose 26% year-over-year: Third-quarter revenue was $9.8 million against $7.8 million a year earlier. Sales of goods were $6,489 thousand, up from $4,895 thousand. Source
Revenue below second-quarter level: Revenue was $9.8 million in the third quarter, compared with $13.2 million reported for the second quarter of 2026 in the prior release.
Full-year revenue guidance narrowed: Full-year 2026 revenue is now expected at $50.0 to $52.0 million, 34% to 39% growth over 2025, from the prior $50.0 to $54.0 million range. Source
Seven Focal One systems sold: Seven Focal One systems were sold in the quarter, against six in the same period of 2025, a 17% increase. Source
U.S. procedure volume grew 32%: U.S. Focal One procedures grew 32% year-over-year in the third quarter. The CEO compared this with 15% in 2025. Source
Gross margin rose to 51.4%: Gross margin was 51.4% for the quarter, against 46.6% in the prior year period. Source
Cash reached $56.3 million: Cash and cash equivalents were $56.3 million at September 30, 2026, against $21.5 million at June 30, 2026. Source

“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”
Ryan Rhodes, CEO of FocalTherics

Guidance

Area	Period	Figure	Against last quarter
Revenue Source	full year 2026	$50.0 to $52.0 million (34% to 39% growth over 2025)	Lowered from $50.0 to $54.0 million (34% to 45% growth over 2025)

What changed from last quarter

Guidance lowered: Full-year 2026 revenue range narrowed; the top end moved from $54.0 million to $52.0 million and the low end stayed at $50.0 million. Source
New: Major commercial payers published positive coverage policies for HIFU in radiorecurrent prostate cancer. The prior release did not report this. Source

Results and growth drivers

Revenue rose 26% year-over-year: Third-quarter revenue was $9.8 million against $7.8 million a year earlier. Sales of goods were $6,489 thousand, up from $4,895 thousand. Source
Revenue below second-quarter level: Revenue was $9.8 million in the third quarter, compared with $13.2 million reported for the second quarter of 2026 in the prior release.
Year-to-date growth headline figures: The release headline gives year-to-date revenue growth of 45% and year-to-date U.S. procedure volume growth of 44%. Source
Operating loss widened to $7.8 million: Loss from operations was $7.8 million, against $6.7 million a year earlier. Total operating expenses rose to $12.8 million from $10.3 million. Source
Net loss narrowed on non-cash gains: Net loss was $4.5 million, or $0.10 per share, against $5.9 million, or $0.16 per share. The company attributed the decline mainly to a non-cash warrant gain and a foreign exchange gain. Source
Full-year revenue guidance narrowed: Full-year 2026 revenue is now expected at $50.0 to $52.0 million, 34% to 39% growth over 2025, from the prior $50.0 to $54.0 million range. Source

Segments and regions

HIFU is the sole continuing segment: Continuing operations are the HIFU business. Standalone HIFU historical financials are included at the end of the release, with ESWL and Distribution treated as discontinued. Source
Discontinued operations added income: Income from discontinued operations, net of tax, was $825 thousand, against $721 thousand in the prior year period. Source
HIFU division operating loss: The HIFU division operating loss was $6,142 thousand. Reconciling items of $1,634 thousand bring the consolidated operating loss to $7,777 thousand. Source

“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.”
Ryan Rhodes, CEO of FocalTherics

Products, customers and coverage

Seven Focal One systems sold: Seven Focal One systems were sold in the quarter, against six in the same period of 2025, a 17% increase. Source
Installed base reached 192: The installed base rose to 192 systems, 98 in the U.S. and 94 internationally, from 184 at the prior quarter (96 U.S., 88 international). Source
Endometriosis programs expanded in Europe: Commercial endometriosis programs in Europe grew to three centers, from the first program launched in the second quarter. Source
Payers published HIFU coverage policies: Major commercial payers published positive coverage policies for HIFU in radiorecurrent prostate cancer. Source

Procedure volumes and demand

U.S. procedure volume grew 32%: U.S. Focal One procedures grew 32% year-over-year in the third quarter. The CEO compared this with 15% in 2025. Source
Second-quarter U.S. growth was 47%: The prior release reported 47% U.S. procedure volume growth for the second quarter, above the third-quarter rate of 32%.

Gross margin and operating expenses

Gross margin rose to 51.4%: Gross margin was 51.4% for the quarter, against 46.6% in the prior year period. Source
Standard cost and selling prices lifted margin: The company attributed the margin increase to improved Focal One standard cost and higher average selling prices for systems and Focalpaks. Source
Operating expenses rose to $12.8 million: Operating expenses were $12.8 million against $10.3 million a year earlier. The increase reflects headcount-related compensation, including higher stock-based compensation, and Urology meeting and event costs. Source

Cash, debt and share count

Cash reached $56.3 million: Cash and cash equivalents were $56.3 million at September 30, 2026, against $21.5 million at June 30, 2026. Source
Financing covered operating cash outflow: For the nine months, financing activities provided $50,707 thousand, while operating activities used $10,687 thousand, against $13,955 thousand used a year earlier. Source
Long-term debt rose to $35,233 thousand: Non-current long-term debt was $35,233 thousand at September 30, 2026, against $15,903 thousand at December 31, 2025. Source
Equity rose to $35,938 thousand: Total shareholders' equity was $35,938 thousand at September 30, 2026, against $19,413 thousand at December 31, 2025. Source
Weighted share count rose: Weighted average basic and diluted shares were 42,625,694 in the quarter, against 37,438,630 a year earlier. Source

Figures management reported

Figure	Reported
Focal One systems sold in the quarter Source	7 (6 in the prior-year quarter)
Focal One installed base Source	192 (98 U.S., 94 international)
U.S. Focal One procedure volume growth Source	32% year-over-year
Commercial Focal One endometriosis programs, Europe Source	3 centers

Risks management discussed

Financial: Interest expense on the Tranche A and Tranche B drawdowns was $0.4 million in the quarter. Net interest expense was $559 thousand. Source

Earlier plans management reported on

Not stated: Management narrowed the full-year 2026 revenue range. The release does not state whether this meets an earlier plan. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

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.

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

Forward-looking statements notice

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.

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

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

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS