Focalthericstm Reports Third Quarter 2026 Financial Results

(MENAFN- GlobeNewsWire - Nasdaq) 45% Revenue Increase and 44% Growth in U.S. Procedure Volume Year-to-date

FocalThericsTM Reports Third Quarter 2026 Financial Results

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

AUSTIN, Texas, Nov. 05, 2026 (GLOBE NEWSWIRE) -- FocalThericsTM (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:

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
...

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
(Amounts in thousands of U.S. Dollars)

		September 30,		December 31,
		2026		2025
		$US		$US
Cash, cash equivalents and short-term investments		56,269		20,452
Accounts receivable, net		10,177		14,948
Inventory		8,329		7,770
Other current assets		2,681		2,439
Total current assets of discontinued operations		17,328		11,555
TOTAL CURRENT ASSETS		94,784		57,164
Property, plant and equipment, net		9,052		8,789
Goodwill		732		757
Other non-current assets		6,149		6,181
Total non-current assets of discontinued operations		-		6,106
TOTAL ASSETS		110,717		78,997
Accounts payable & other accrued liabilities		17,857		17,436
Deferred revenues, current portion		7,326		6,452
Short term borrowing		426		4,386
Other current liabilities		1,318		3,005
Total current liabilities of discontinued operations		9,143		5,862
TOTAL CURRENT LIABILITIES		36,070		37,141
Obligations under operating and finance leases non-current		615		1,183
Long-term debt, non-current		35,233		15,903
Deferred revenues, non-current		898		768
Other long-term liabilities		1,963		1,632
Total non-current liabilities of discontinued operations		-		2,957
TOTAL LIABILITIES		74,779		59,584
TOTAL SHAREHOLDERS'EQUITY		35,938		19,413
TOTAL LIABILITIES & SHAREHOLDERS' EQUITY		110,717		78,997

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of U.S. Dollars)

		Nine Months Ended		Nine Months Ended
		September 30,		September 30,
		2026		2025
		($US)		($US)
NET INCOME (LOSS)		(28,032)		(19,790)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)		12,450		5,136
OPERATING CASH FLOW		(15,582)		(14,654)
Increase/Decrease in operating assets and liabilities		4,895		699
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES		(10,687)		(13,955)
Additions to capitalized assets produced by the company and other capital expenditures		(3,361)		(4,002)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES		(3,361)		(4,002)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES		50,707		(2,847)
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS		(842)		2,217
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS		35,817		(18,587)

⁽¹⁾including share-based compensation expenses for $2,359 thousand for the nine months ended September 30, 2026 and $1,746 thousand for the nine months ended September 30, 2025, as well as warrant fair value adjustment of $3,036 thousand related to Tranche A and $839 thousand related to Tranche B for the nine months ended September 30, 2026

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
nine months ended September 30, 2026
(Amounts in thousands of U.S. Dollars)

Nine months ended		HIFU				Reconciling		Total After
September 30, 2026		Division				Items		Consolidation
Sales of goods		24,272				-		24,272
Sales of RPP and leases		7,617				-		7,617
Sales of spare parts and services		2,736				-		2,736
TOTAL REVENUES		34,624				-		34,624
GROSS PROFIT (% of Net Sales)		18,353		53.0	%	-		18,353		53.0	%
Research & development expenses		(7,242)				-		(7,242)
Selling, general & administrative expenses		(29,046)				(5,899)		(34,945)
OPERATING PROFIT (LOSS)		(17,935)				(5,899)		(23,834)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended September 30, 2026
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
September 30, 2026		Division				Items		Consolidation
Sales of goods		6,489				-		6,489
Sales of RPP and leases		2,367				-		2,367
Sales of spare parts and services		972				-		972
TOTAL REVENUES		9,828				(0)		9,828
GROSS PROFIT (% of Net Sales)		5,053		51.4	%	(0)		5,053		51.4	%
Research & development expenses		(2,458)				-		(2,458)
Selling, general & administrative expenses		(8,737)				(1,634)		(10,371)
OPERATING PROFIT (LOSS)		(6,142)				(1,634)		(7,777)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended June 30, 2026
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
June 30, 2026		Division				Items		Consolidation
Sales of goods		9,527				-		9,527
Sales of RPP and leases		2,758				-		2,758
Sales of spare parts and services		918				-		918
TOTAL REVENUES		13,202				-		13,202
GROSS PROFIT (% of Net Sales)		7,338		55.6	%	-		7,338		55.6	%
Research & development expenses		(2,317)				-		(2,317)
Selling, general & administrative expenses		(10,869)				(2,185)		(13,054)
OPERATING PROFIT (LOSS)		(5,848)				(2,185)		(8,033)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended March 31, 2026
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
March 31, 2026		Division				Items		Consolidation
Sales of goods		8,256				-		8,256
Sales of RPP and leases		2,492				-		2,492
Sales of spare parts and services		845				-		845
TOTAL REVENUES		11,593				-		11,593
GROSS PROFIT (% of Net Sales)		5,962		51.4	%	-		5,962		51.4	%
Research & development expenses		(2,467)				-		(2,467)
Selling, general & administrative expenses		(9,439)				(2,080)		(11,520)
OPERATING PROFIT (LOSS)		(5,944)				(2,080)		(8,024)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
twelve months ended December 31, 2025
(Amounts in thousands of U.S. Dollars)

Twelve months ended		HIFU				Reconciling		Total After
December 31, 2025		Division				Items		Consolidation
Sales of goods		24,857				-		24,857
Sales of RPP and leases		8,791				-		8,791
Sales of spare parts and services		3,703				-		3,703
TOTAL REVENUES		37,351				-		37,351
GROSS PROFIT (% of Net Sales)		17,978		48.1	%	-		17,978		48.1	%
Research & development expenses		(8,909)				-		(8,909)
Selling, general & administrative expenses		(29,748)				(5,843)		(35,591)
OPERATING PROFIT (LOSS)		(20,679)				(5,843)		(26,522)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended December 31, 2025
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
December 31, 2025		Division				Items		Consolidation
Sales of goods		9,776				-		9,776
Sales of RPP and leases		2,476				-		2,476
Sales of spare parts and services		1,262				-		1,262
TOTAL REVENUES		13,513				(0)		13,513
GROSS PROFIT (% of Net Sales)		6,311		46.7	%	(0)		6,311		46.7	%
Research & development expenses		(1,958)				-		(1,958)
Selling, general & administrative expenses		(8,514)				(2,324)		(10,838)
OPERATING PROFIT (LOSS)		(4,161)				(2,324)		(6,485)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended September 30, 2025
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
September 30, 2025		Division				Items		Consolidation
Sales of goods		4,895				-		4,895
Sales of RPP and leases		2,216				-		2,216
Sales of spare parts and services		717				-		717
TOTAL REVENUES		7,828				-		7,828
GROSS PROFIT (% of Net Sales)		3,647		46.6	%	-		3,647		46.6	%
Research & development expenses		(2,303)				-		(2,303)
Selling, general & administrative expenses		(6,756)				(1,258)		(8,014)
OPERATING PROFIT (LOSS)		(5,412)				(1,258)		(6,669)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended June 30, 2025
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
June 30, 2025		Division				Items		Consolidation
Sales of goods		6,385				-		6,385
Sales of RPP and leases		2,155				-		2,155
Sales of spare parts and services		969				-		969
TOTAL REVENUES		9,509				-		9,509
GROSS PROFIT (% of Net Sales)		4,863		51.1	%	-		4,863		51.1	%
Research & development expenses		(2,291)				-		(2,291)
Selling, general & administrative expenses		(8,036)				(1,158)		(9,194)
OPERATING PROFIT (LOSS)		(5,465)				(1,158)		(6,623)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended March 31, 2025
(Amounts in thousands of U.S. Dollars)

Three months ended		HIFU				Reconciling		Total After
March 31, 2025		Division				Items		Consolidation
Sales of goods		3,800				-		3,800
Sales of RPP and leases		1,945				-		1,945
Sales of spare parts and services		755				-		755
TOTAL REVENUES		6,500				-		6,500
GROSS PROFIT (% of Net Sales)		3,158		48.6	%	-		3,158		48.6	%
Research & development expenses		(2,358)				-		(2,358)
Selling, general & administrative expenses		(6,441)				(1,104)		(7,545)
OPERATING PROFIT (LOSS)		(5,641)				(1,104)		(6,745)

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
twelve months ended December 31, 2024
(Amounts in thousands of U.S. Dollars)

Twelve months ended		HIFU				Reconciling		Total After
December 31, 2024		Division				Items		Consolidation
Sales of goods		16,046				-		16,046
Sales of RPP and leases		6,789				-		6,789
Sales of spare parts and services		2,967				-		2,967
TOTAL REVENUES		25,803				-		25,803
GROSS PROFIT (% of Net Sales)		13,283		51.5	%	-		13,283		51.5	%
Research & development expenses		(7,245)				-		(7,245)
Selling, general & administrative expenses		(24,936)				(4,585)		(29,520)
OPERATING PROFIT (LOSS)		(18,897)				(4,585)		(23,482)

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