EDAP TMS SA
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
FOCL$3.32-21.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104659-26-057094
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001104659-26-097063
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 66 previous paragraphs and 83 current paragraphs.
29 unchanged; 20 reworded; 23 added; 17 removed; 0 previous and 11 current paragraphs rearranged.
Tables are not compared: 2 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (23)
Current report
On May 28, 2026, our Board of Directors approved a plan to exit our ESWL and Distribution segments, and on May 29, 2026 we announced our rebrand to FocalTherics and our strategic realignment to focus exclusively on our robotic focal therapy business built around the Focal One®HIFU platform. At the end of the second quarter of 2026, the ESWL and Distribution segments met the criteria to be reported as discontinued operations, and their results are excluded from continuing operations for all periods presented in this Quarterly Report. Prior to this classification, the ESWL and Distribution businesses represented a significant portion of our consolidated results, including approximately 47% of our consolidated revenue for the year ended December 31, 2025. We expect to complete the disposals through one or more transactions within one year of the held-for-sale classification, and until completion the timing, structure and terms of any transaction remain subject to negotiation and execution risk. Unless otherwise indicated, the discussion below relates to our continuing operations, which consist of our HIFU business. See Note 18 to our unaudited condensed consolidated financial statements for additional information.
Current report
Operating expenses increased 33.8%, or $3.9 million, from $11.5 million in the three months ended June 30, 2025 to $15.4 million in the three months ended June 30, 2026.
Current report
Profit (loss) from discontinued operations, net of tax
Current report
Net loss from discontinued operations was $75 thousand in the three months ended June 30, 2026, compared to $51 thousand in the three months ended June 30, 2025.
Current report
Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
Current report
The sales of medical devices increased 89.0% with $13.9 million in the six months ended June 30, 2026, with 24 Focal One units sold (including 13 in the United States), as compared to $7.4 million in the six months ended June 30, 2025, with 15 Focal One units sold (including 7 in the United States).
Current report
Operating Expenses
Current report
Operating expenses increased 37.3%, or $8.0 million, from $21.4 million in the six months ended June 30, 2025 to $29.4 million in the six months ended June 30, 2026.
Current report
Marketing and sales expenses were $13.8 million in the six months ended June 30, 2026, compared to $9.7 million in the six months ended June 30, 2025.
Current report
R&D expenses increased 2.9% at $4.8 million in the six months ended June 30, 2026 compared to $4.6 million the six months ended June, 2025.
Current report
Financial (Expense) Income, Net
Current report
Net financial expense was $8.0 million in the six months ended June 30, 2026, compared to net financial expense of $81 thousand in the six months ended June 30, 2025.
Current report
Income Taxes
Current report
Profit (loss) from discontinued operations, net of tax
Current report
Net profit from discontinued operations was $437 thousand in the six months ended June 30, 2026, compared to $285 thousand in the six months ended June 30, 2025.
Current report
Net Loss
Current report
On August 14, 2026, the Company completed an underwritten offering of American Depositary Shares (“ADSs”) where it sold 8,425,000 ADSs for net proceeds of approximately $37.1 million, following deduction of underwriting discounts and commissions and estimated offering expenses.
Current report
Although the additional capital provides us with increased liquidity and is expected to support our operations beyond the next twelve months, we continue to expect operating losses for the foreseeable future. Our ability to achieve profitability and generate positive cash flow from operations will depend on, among other things, the continued growth of our HIFU business, the successful commercialization and adoption of our products, the timing and level of revenues, and our ability to manage operating expenses and other cash requirements. If we are unable to achieve profitability and positive cash flow from operations within the period supported by our existing liquidity, or if our capital requirements are greater than currently anticipated, we may require additional financing in the future. The timing, terms and availability of any future financing will depend on a number of factors, including our operating performance, market conditions and our financial position at the time.
Current report
Net Cash Generated by Financing Activities
Current report
Our contractual obligations and commitments are discussed in Note 6 – Long Term Debt.
Current report
Identified accounting estimates are as follows:
Current report
The classification and measurement of the ESWL and Distribution disposal groups as discontinued operations and assets held for sale requires significant judgment. Management evaluates whether the planned disposal represents a component or group of components, whether the held-for-sale criteria are met, and whether the disposal represents a strategic shift that has, or will have, a major effect on the Company’s operations and financial results. Upon classification as held for sale, the disposal groups are measured at the lower of carrying amount and fair value less costs to sell. The determination of fair value less costs to sell requires management to use estimates and assumptions, including expected transaction perimeter, expected buyer interest, market-based pricing indications, projected cash flows, discount rates, and expected costs to sell. Changes in these assumptions could result in a material impairment charge or adjustment to the carrying amount of the disposal groups.
Current report
The Company measures certain warrants at fair value, with changes in fair value recognized in earnings. The fair value measurement requires judgment in selecting an appropriate valuation model and assumptions, including expected volatility, expected term, risk-free interest rate, share price, exercise price and expected dividends. Although certain inputs may be observable, changes in the Company’s share price, volatility assumptions or expected term could materially affect the fair value of the warrant liability and the resulting non-cash gain or loss recognized in the statement of operations.
Removed paragraphs (17)
Previous report
Our activities are organized into three divisions: High Intensity Focused Ultrasound (“HIFU”), Lithotripsy (“ESWL”) and Distribution services (“Distribution”). We have shifted to a growth strategy focused on developing our core proprietary HIFU activities and placing less emphasis on our non-HIFU Distribution and ESWL business activities. This strategy has impacted, and we expect it will continue to impact, our operating results.
Previous report
In our HIFU division, revenue is generated through sales of Focal One® robotic HIFU systems and disposables, revenue-per-procedure (“RPP”) arrangements and leases, and maintenance services. In the U.S. and certain other jurisdictions, we provide Focal One systems under operating leases with the intent to convert to capital sales at the end of the defined period. In Europe, we provide Focal One systems under an RPP model, which generates a smaller but more predictable revenue stream. In our ESWL division, final Sonolith i-move system sales were concluded in the second half of 2025, and revenue going forward will consist of consumable electrodes, spare parts, and repair services for the installed base. In our Distribution division, revenue has declined as a result of the termination of certain distribution agreements, consistent with our strategic de-emphasis of non-HIFU activities.
Previous report
Our total revenues increased 24.8%, from $14.3 million in the three months ended March 31, 2025 to $17.8 million in the three months ended March 31, 2026.
Previous report
HIFU Division
Previous report
As a result of this growth, the HIFU division represented an increasing share of our total revenues in the three months ended March 31, 2026 compared to the prior year period, consistent with our strategic focus on expanding our higher-margin HIFU business while revenues from legacy Distribution and ESWL activities continue to represent a smaller portion of total revenues over time.
Previous report
ESWL Division
Previous report
The ESWL division’s total revenues decreased 15.8%, from $1.8 million in the three months ended March 31, 2025 to $1.5 million in the three months ended March 31, 2026, primarily due to the decrease in sales of equipment, consistent with our strategic shift to de-emphasize our ESWL division.
Previous report
Sales of ESWL-related consumables, spare parts, supplies, RPP, leasing, and services decreased 11.4% from $1.6 million in the three months ended March 31, 2025 to $1.4 million in the three months ended March 31, 2026.
Previous report
Distribution Division
Previous report
The Distribution division’s total revenues decreased 21.2%, from $5.9 million in the three months ended March 31, 2025 to $4.7 million in the three months ended March 31, 2026, consistent with our strategic shift to de-emphasize our Distribution division.
Previous report
The Distribution division’s sales of medical devices decreased 44.9%, from $3.2 million in the three months ended March 31, 2025 to $1.8 million in the three months ended March 31, 2026.
Previous report
Sales of Distribution-related consumables, spare parts, supplies, leasing, and services increased 6.6%, from $2.7 million in the three months ended March 31, 2025 to $2.9 million in the three months ended March 31, 2026.
Previous report
Operating expenses increased 26%, or $3.2 million, from $12.3 million in the three months ended March 31, 2025 to $15.5 million in the three months ended March 31, 2026.
Previous report
We have based our short-term capital needs and planned operating requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. We may require additional financing to fund our operations and planned growth. We may also seek additional financing opportunities. We may seek to raise any additional capital through public or private equity offerings or debt financings, credit or loan facilities, or a combination of one or more of these funding sources. Additional funds may not be available to us on acceptable terms or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce, or terminate our product development programs, commercialization efforts, or other operations. If we raise additional funds by issuing equity securities, our shareholders will suffer dilution and the terms of any financing may adversely affect the rights of our shareholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing shareholders. If we raise additional capital through collaboration agreements, licensing arrangements, or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or products, or grant licenses that may not be favorable to us. Debt financing, if available, may involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.
Previous report
However, we may need to raise substantial additional financing in order to meet its cash flow needs in the subsequent period and until we achieve profitability. We may not be able to raise additional financing on acceptable terms or at all and this condition may in the future raise uncertainty regarding our ability to continue as a going concern. Management is actively exploring various alternatives, including seeking additional funding through the debt and equity capital markets, cost-cutting measures, and restructuring opportunities, but there is no assurance that these efforts will be successful or sufficient to address these liquidity concerns. If we are unable to raise capital when needed on acceptable terms, or at all, we may be forced to restructure our business or delay, reduce, or terminate our research and product development programs, future commercialization efforts or other operations.
Previous report
Net Cash Used in Financing Activities
Reworded paragraphs (20)
Previous wording
The following table sets forth our net sales and profit (loss), including by division, for the three months ended March 31, 2026 and 2025:
Current wording
The following table sets forth our net sales and profit (loss), including by division, for the three months ended June 30, 2026 and 2025, and for the six months ended June 30, 2026 and 2025:
Previous wording
The HIFU division’s total revenues increased by 78.3% from $6.5 million in the three months ended March 31, 2025 to $11.6 million in the three months ended March 31, 2026, reflecting growth of equipment sales and treatment-driven revenue.
Current wording
The total revenues increased by 38.8% from $9.5 million in the three months ended June 30, 2025 to $13.2 million in the three months ended June 30, 2026, reflecting growth of equipment sales and treatment-driven revenue.
Previous wording
The HIFU division's sales of medical devices increased 146.7% with $6.4 million in the three months ended March 31, 2026, with 11 Focal One units sold (including 5 in the United States), as compared to $2.6 million in the three months ended
Current wording
The sales of medical devices increased 57.5% with $7.5 million in the three months ended June 30, 2026, with 13 Focal One units sold (including 8 in the United States), as compared to $4.8 million in the three months ended June 30, 2025, with 9 Focal One units sold (including 5 in the United States).
Previous wording
March 31, 2025, with 6 Focal One units sold (including 2 in the United States). Treatment-driven revenue, which includes sales of revenue-per-procedure (“RPP”) & leases, sales of disposables, and treatment-related services, increased by 30.5% to $4.5 million in the three months ended March 31, 2026, as compared to $3.4 million in the same period in 2025.
Current wording
Treatment-driven revenue, which includes sales of revenue-per-procedure (“RPP”) & leases, sales of disposables, and treatment-related services, increased by 37.5% to $5.0 million in the three months ended June 30, 2026, as compared to $3.7 million in the same period in 2025.
Previous wording
Marketing and sales expenses were $7.1 million in the three months ended March 31, 2026, compared to $6.1 million in the three months ended March 31, 2025.
Current wording
Marketing and sales expenses were $7.5 million in the three months ended June 30, 2026, compared to $5.3 million in the three months ended June 30, 2025.
Previous wording
Research and development (“R&D”) expenses remained flat at $2.6 million in the three months ended March 31, 2026 compared to $2.6 million the three months ended March 31, 2025.
Current wording
Research and development (“R&D”) expenses remained flat at $2.3 million in the three months ended June 30, 2026, compared to $2.3 million in the three months ended June 30, 2025.
Previous wording
General and administrative expenses increased $3.7 million, or 58.5%, in the three months ended March 31, 2025 to $5.8 million in the three months ended March 31, 2026, primarily driven by an increase in fees related to our transition to domestic filer status.
Current wording
General and administrative expenses increased $1.6 million, or 41.5%, from $3.9 million in the three months ended June 30, 2025 to $5.5 million in the three months ended June 30, 2026, primarily driven by an increase in fees related to our transition to domestic filer status.
Previous wording
Net financial expense was $1,714 thousand in the three months ended March 31, 2026, compared to net financial income of $15 thousand in the three months ended March 31, 2025.
Current wording
Net financial expense was $6,295 thousand in the three months ended June 30, 2026, compared to net financial expense of $79 thousand in the three months ended June 30, 2025.
Previous wording
The financial expense was primarily driven by the variation of the fair value of the warrants we issued to European Investment Bank (“EIB”) of $1.3 million and the interest expense of the EIB loan of $0.4 million in the three months ended March 31, 2026.
Current wording
The financial expense was primarily driven by the variation of the fair value of the warrants we issued to European Investment Bank (“EIB”) of $5.5 million and the interest expense of the EIB loan of $0.7 million in the three months ended June 30, 2026.
Previous wording
In the three months ended March 31, 2026, we recorded a net foreign currency exchange gain of $142 thousand, mainly due to the variation of the U.S. dollar against the Euro, compared to a loss of $1.0 million in the three months ended March 31, 2025.
Current wording
In the three months ended June, 2026, we recorded a net foreign currency exchange loss of $76 thousand, mainly due to the variation of the Japanese Yen against the Euro, compared to a net gain of $362 thousand in the three months ended June 30, 2025.
Previous wording
Income tax expenses in the consolidated statement of operations remained relatively flat at $145 thousand in the three months ended March 31, 2026, compared to $144 thousand in the three months ended March 31, 2025.
Current wording
Income tax expenses in the consolidated statement of operations remained relatively flat at $8 thousand in the three months ended June 30, 2026, compared to $14 thousand in the three months ended June 30, 2025.
Previous wording
As a result of the above, we recorded a consolidated net loss of $9.1 million in the three months ended March 31, 2026, compared with a consolidated net loss of $7.4 million in the three months ended March 31, 2025.
Current wording
As a result of the above, we recorded a consolidated net loss of $14.5 million in the three months ended June 30, 2026, compared with a consolidated net loss of $6.4 million in the three months ended June 30, 2025.
Previous wording
Sales of HIFU maintenance services increased by 50.1% to $0.7 million in the three months ended March 31, 2026 reflecting our growing installed base, as compared to $0.5 million the same period in 2025.
Current wording
Treatment-driven revenue increased by 34.1% to $9.5 million in the six months ended June 30, 2026, as compared to $7.1 million in the same period in 2025.
Previous wording
Cost of sales increased 16.8%, from $8.3 million in the three months ended March 31, 2025 to $9.7 million in the three months ended March 31, 2026, and represented 54% of net sales in the three months ended March 31, 2026, down from 58% of net sales in the three months ended March 31, 2025. Gross margin increased to 45.7% during the three months ended March 31, 2026, compared to 42.0% for the three months ended March 31, 2025. The increase in gross margin was primarily attributable to the growth in HIFU unit sales which have higher relative gross margins and favorable absorption of our fixed costs due to higher production volumes, partially offset by impact of tariffs.
Current wording
Cost of sales increased 43.9%, from $8.0 million in the six months ended June 30, 2025 to $11.5 million in the six months ended June 30, 2026, and represented 46.4% of net sales in the six months ended June 30, 2026, down from 49.9% of net sales in the six months ended June 30, 2025. Gross margin increased to 53.6% during the six months ended June 30, 2026, compared to 50.1% for the six months ended June 30, 2025. The increase in gross margin was primarily attributable to focused effort on components cost reduction on standard cost of the Focal One and favorable absorption of our fixed costs due to higher production volumes for system and consumables.
Previous wording
Our primary sources of capital have been from ongoing operations, proceeds from our public and private securities offerings, and the issuances of debt.
Current wording
Our primary sources of capital have historically been proceeds from our public and private securities offerings and issuances of debt.
Previous wording
We have a history of operating losses and expect such losses to continue in the foreseeable future. As of March 31, 2026, we had $15.0 million in cash and cash equivalents, a decrease of $5.4 million from December 31, 2025. We drew Tranche B of our credit facility (the “Credit Facility”) established pursuant to that certain finance contract (the “Finance Contract”), dated October 17, 2025, with European Investment Bank (“EIB”), in April 2026 (refer to note 19). With these additional proceeds, we believe we will have sufficient funds to support our operations for at least a period of twelve months from the date of issue of these interim condensed consolidated financial statements.
Current wording
We have a history of operating losses and expect such losses to continue in the foreseeable future. As of June 30, 2026, we had $21.5 million in cash and cash equivalents, an increase of $1.1 million from December 31, 2025 including $14.0 million of net proceeds from the drawing of the Tranche B of our credit facility (the “Credit Facility”) established pursuant to that certain finance contract (the “Finance Contract”), dated October 17, 2025, with European Investment Bank (“EIB”).
Previous wording
Net cash used in operating activities for the three months ended March 31, 2026, was $3.0 million, consisting of net loss of $9.1 million offset by non-cash expenses of $3.4 million and positive changes in working capital of $2.7 million. These non-cash expenses primarily consisted of $0.9 million of depreciation and amortization, $0.3 million of stock-based compensation expense, and $1.7 million related to the change in the fair value of the EIB warrants and loan amortizations.
Current wording
Net cash used in operating activities for the six months ended June 30, 2026, was $6.7 million, consisting of net loss of $23.6 million offset by non-cash expenses of $11.8 million and positive changes in working capital of $5.2 million. These non-cash expenses primarily consisted of $1.9 million of depreciation and amortization, $1.2 million of stock-based compensation expense, and $7.9 million related to the change in the fair value of the EIB warrants and loan amortizations.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2026, was $0.8 million, consisting primarily of investments of $0.4 million in capitalized assets and investment of $0.5 million in property and equipment.
Current wording
Net cash used in investing activities for the six months ended June 30, 2026, was $2.0 million, consisting primarily of investments of $1.4 million in capitalized assets and investment of $0.6 million in property and equipment.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2026, was $1.4 million, consisting primarily of the repayment of long-term borrowings and financing leases of $0.7 million and reduction of short-term borrowings of $0.7 million.
Current wording
Net cash generated by financing activities for the six months ended June 30, 2026, was $10.4 million, consisting primarily of the net proceeds of $14.0 million from borrowings under the EIB credit facility, the repayment of long-term borrowings and financing leases of $1.3 million and reduction of short-term borrowings of $2.2 million.
Previous wording
Management has not identified any estimates made in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the registrant.
Current wording
Management has identified estimates made in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the registrant.
Rearranged current paragraphs (11)
Current report — wording carried from elsewhere
Cost of sales increased 26.2%, from $4.6 million in the three months ended June 30, 2025 to $5.9 million in the three months ended June 30, 2026, and represented 44.4% of net sales in the three months ended June 30, 2026, down from 48.9% of net sales in the three months ended June 30, 2025. Gross margin increased to 55.6% during the three months ended June 30, 2026,
Current report — wording carried from elsewhere
compared to 51.1% for the three months ended June 30, 2025. The increase in gross margin was primarily attributable to improvement on standard cost of the Focal One and favorable absorption of our fixed costs due to higher production volumes.
Current report — wording carried from elsewhere
The total revenues increased by 54.9% from $16.0 million in the six months ended June 30, 2025 to $24.8 million in the six months ended June 30, 2026, reflecting growth of equipment sales and treatment-driven revenue.
Current report — wording carried from elsewhere
Cost of Sales and Gross Margin
Current report — wording carried from elsewhere
General and administrative expenses increased $3.7 million, or 52.4%, from $7.0 million in the six months ended June 30, 2025 to $10.7 million in the six months ended June 30, 2026, primarily driven by an increase in fees related to our transition to domestic filer status.
Current report — wording carried from elsewhere
The financial expense was primarily driven by the variation of the fair value of the warrants we issued to EIB of $6.8 million and the interest expense of the EIB loan of $1.1 million in the six months ended June 30, 2026.
Current report — wording carried from elsewhere
Foreign Currency Exchange Gain (Loss), Net
Current report — wording carried from elsewhere
In the six months ended June, 2026, we recorded a net foreign currency exchange gain of $77 thousand, mainly due to the variation of the US dollars against the Euro, compared to a net loss of $664 thousand in the six months ended June 30, 2025.
Current report — wording carried from elsewhere
Income tax expenses in the consolidated statement of operations remained relatively flat at $25 thousand in the six months ended June 30, 2026, compared to $23 thousand in the six months ended June 30, 2025.
Current report — wording carried from elsewhere
As a result of the above, we recorded a consolidated net loss of $23.6 million in the six months ended June 30, 2026, compared with a consolidated net loss of $13.9 million in the six months ended June 30, 2025.
Current report — wording carried from elsewhere
With these additional proceeds, we believe we will have sufficient funds to support our operations for at least a period of twelve months from the date of issue of these interim condensed consolidated financial statements.