FOCL FocalTherics

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FocalTherics Beat Consensus Estimates, Narrows Guidance

Thursday, November 5, 2026 · 4:05 PM ET

FocalTherics (FOCL) reported a loss of $0.10 per share on revenue of $9.83 million for the third quarter ended September 2026. The consensus estimate was a loss of $0.18 per share on revenue of $10.95 million. The company beat consensus estimates by 44.44%.

The company said it now expects 2026 revenue of $50.0 million to $52.0 million. The company's previous guidance was revenue of $50.0 million to $54.0 million. The current consensus revenue estimate is $52.2 million for the year ending December 31, 2026.

EDAP TMS S.A. develops, produces, markets and distributes minimally invasive medical devices, primarily for the treatment of urological diseases. They currently produce and market devices for treatment of benign prostate hyperplasia and urinary tract stones. They are also developing a third range of products for minimally invasive destruction of certain types of tumors.

Earnings Whisper Grade
Power Rating
Reported Earnings
($0.10)
Earnings Whisper®
—
Consensus Estimate
($0.18)
Earnings Surprise
Earnings Growth—
Reported Revenue
$9.83M
Revenue Estimate
$10.95M
Revenue Surprise
Revenue Growth—

*Reported earnings and revenue figures shown above, and any guidance given, are preliminary and may be updated upon further review.*

FocalTherics™ Reports Third Quarter 2026 Financial Results

Thursday, November 5, 2026 · 4:05 PM ET GlobeNewswire

FocalTherics™ 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) -- 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
(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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Source: FocalTherics (TM)