EDAP TMS SA

Previous 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:

Current wording

The following table sets forth our net sales and profit (loss), for the three months ended September 30, 2026 and 2025, and for the nine months ended September 30, 2026 and 2025:

Previous 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.

Current wording

The total revenues increased by 25.5% from $7.8 million in the three months ended September 30, 2025 to $9.8 million in the three months ended September 30, 2026, reflecting growth of equipment sales and treatment-driven revenue.

Previous 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).

Current wording

The sales of medical devices increased 29.8% with $4.3 million in the three months ended September 30, 2026, with 7 Focal One units sold (including 2 in the United States), as compared to $3.3 million in the three months ended September 30, 2025, with 6 Focal One units sold (including 3 in the United States).

Previous 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.

Current wording

Treatment-driven revenue, which includes sales of revenue-per-procedure (“RPP”) & leases, sales of disposables, and treatment-related services, increased by 24.3% to $4.8 million in the three months ended September 30, 2026, as compared to $3.9 million in the same period in 2025.

Previous wording

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 wording

Cost of sales increased 14.2%, from $4.2 million in the three months ended September 30, 2025 to $4.8 million in the three months ended September 30, 2026, and represented 48.6% of net sales in the three months ended September 30, 2026, down from 53.4% of net sales in the three months ended September 30, 2025. Gross margin increased to 51.4% during the three months ended September 30, 2026, compared to 46.6% for the three months ended September 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.

Previous 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.

Current wording

Marketing and sales expenses were $5.9 million in the three months ended September 30, 2026, compared to $4.2 million in the three months ended September 30, 2025.

Previous 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.

Current wording

Research and development (“R&D”) expenses increased 6.9%, or $0.2 million, from $2.3 million in the three months ended September 30, 2025 to $2.5 million in the three months ended September 30, 2026.

Previous 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.

Current wording

General and administrative expenses increased $0.6 million, or 16.3%, from $3.8 million in the three months ended September 30, 2025 to $4.5 million in the three months ended September 30, 2026, primarily driven by an increase in fees related to our transition to domestic filer status.

Previous 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.

Current wording

Net financial income was $2,038 thousand in the three months ended September 30, 2026, compared to net financial expense of $60 thousand in the three months ended September 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 $5.5 million and the interest expense of the EIB loan of $0.7 million in the three months ended June 30, 2026.

Current wording

Net financial income was primarily driven by the gain on the variation of the fair value of the warrants we issued to European Investment Bank (“EIB”) of $2.6 million, partially offset by the interest expense of the EIB loan of $0.7 million in the three months ended September 30, 2026.

Previous 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.

Current wording

In the three months ended September 30, 2026, we recorded a net foreign currency exchange gain of $467 thousand, mainly due to the variation of the Japanese Yen and the U.S dollar against the Euro, compared to a net gain of $85 thousand in the three months ended September 30, 2025.

Previous 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.

Current wording

Income tax expenses in the consolidated statement of operations remained relatively flat at $15 thousand in the three months ended September 30, 2026, compared to $16 thousand in the three months ended September 30, 2025.

Previous wording

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 wording

Net profit from discontinued operations was $825 thousand in the three months ended September 30, 2026, compared to $721 thousand in the three months ended September 30, 2025.

Previous 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.

Current wording

As a result of the above, we recorded a consolidated net loss of $4.5 million in the three months ended September 30, 2026, compared with a consolidated net loss of $5.9 million in the three months ended September 30, 2025.

Previous wording

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 wording

The total revenues increased by 45.2% from $23.8 million in the nine months ended September 30, 2025 to $34.6 million in the nine months ended September 30, 2026, reflecting growth of equipment sales and treatment-driven revenue.

Previous wording

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 wording

The sales of medical devices increased 70.6% with $18.2 million in the nine months ended September 30, 2026, with 31 Focal One units sold (including 15 in the United States), as compared to $10.7 million in the nine months ended September 30, 2025, with 21 Focal One units sold (including 10 in the United States).

Previous 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.

Current wording

Treatment-driven revenue increased by 30.7% to $14.3 million in the nine months ended September 30, 2026, as compared to $11.0 million in the same period in 2025.

Previous 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.

Current wording

Cost of sales increased 33.7%, from $12.2 million in the nine months ended September 30, 2025 to $16.3 million in the nine months ended September 30, 2026, and represented 47.0% of net sales in the nine months ended September 30, 2026, down from 51.1% of net sales in the nine months ended September 30, 2025. Gross margin increased to 53.0% during the nine months ended September 30, 2026, compared to 48.9% for the nine months ended September 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

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 wording

Marketing and sales expenses were $19.7 million in the nine months ended September 30, 2026, compared to $13.9 million in the nine months ended September 30, 2025.

Previous wording

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 wording

R&D expenses increased 4.2% to $7.2 million in the nine months ended September 30, 2026 compared to $7.0 million the nine months ended September 30, 2025.

Previous wording

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 wording

General and administrative expenses increased $4.3 million, or 39.7%, from $10.9 million in the nine months ended September 30, 2025 to $15.2 million in the nine months ended September 30, 2026, primarily driven by an increase in fees related to our transition to domestic filer status.

Previous wording

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 wording

Net financial expense was $6.0 million in the nine months ended September 30, 2026, compared to net financial expense of $142 thousand in the nine months ended September 30, 2025.

Previous wording

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 wording

The financial expense was primarily driven by the variation of the fair value of the warrants we issued to EIB of $4.3 million and the interest expense of the EIB loan of $1.8 million in the nine months ended September 30, 2026.

Previous wording

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 wording

In the nine months ended September 30, 2026, we recorded a net foreign currency exchange gain of $544 thousand, mainly due to the variation of the U.S dollar and the Japanese Yen against the Euro, compared to a net loss of $579 thousand in the nine months ended September 30, 2025.

Previous wording

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 wording

Income tax expenses in the consolidated statement of operations remained relatively flat at $40 thousand in the nine months ended September 30, 2026, compared to $39 thousand in the nine months ended September 30, 2025.

Previous wording

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 wording

As a result of the above, we recorded a consolidated net loss of $28.0 million in the nine months ended September 30, 2026, compared with a consolidated net loss of $19.8 million in the nine months ended September 30, 2025.

Previous 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”).

Current wording

We have a history of operating losses and expect such losses to continue in the foreseeable future. As of September 30, 2026, we had $56.3 million cash and equivalent, an increase of $35.8 million from December 31, 2025, primarily reflecting net proceeds of approximately $43.1 million from our August 2026 underwritten offering and $14.0 million of net proceeds from drawing of 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

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 wording

In August 2026, the Company completed an underwritten offering of American Depositary Shares (“ADSs”) where it sold an aggregate of 9,688,750 ADSs for net proceeds of approximately $42.4 million, following deduction of underwriting discounts and commissions and estimated offering expenses.

Previous wording

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 believe we 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.

Previous wording

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 wording

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 our revenues, and our ability to manage operating

Previous 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.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026, was $10.7 million, consisting of net loss of $28.0 million offset by non-cash expenses of $12.6 million and positive changes in working capital of $4.9 million. These non-cash expenses primarily consisted of $2.9 million of depreciation and amortization, $2.4 million of stock-based compensation expense, and $6.0 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 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.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026, was $3.4 million, consisting primarily of investments of $2.4 million in capitalized assets and investment of $0.8 million in property and equipment.

Previous 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.

Current wording

Net cash generated by financing activities for the nine months ended September 30, 2026, was $50.7 million, consisting primarily of the net proceeds of $43.1 million from the underwritten offering, the net proceeds of $14.0 million from borrowings under the EIB credit facility, the repayment of long-term borrowings and financing leases of $2.0 million and reduction of short-term borrowings of $4.4 million.