EDAP TMS SA (FOCL): Results of Operations and Financial Condition
EDAP TMS SA (FOCL) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 FocalTherics™ Reports Second Quarter 2026 Financial Results 39% Revenue Increase and 47% Growth in U.S. Procedures AUSTIN, Texas, August 13, 2026 - FocalTherics™ (Nasdaq: FOCL) (the “Company”), a global leader in robotic focal therapy, today announced financial resul
How this was made
The 30-second read
Why it matters
Q2 continuing-operations performance shows 39% YoY revenue growth to $13.2M and gross margin expansion to 55.6%, while net loss widened to $14.4M largely due to a $5.5M European Investment Bank warrant valuation impact. The company also announced an underwritten public offering for $40M gross proceeds expected to close Aug. 14, 2026, creating a near-term dilution and liquidity catalyst.
Market read
This is a combined fundamentals and event-risk update: continuing-operations growth and margin improvement alongside a scheduled financing close next week.
What to watch
Discontinued operations reclassification (ESWL and Distribution held for sale) changes comparability; traders should focus on continuing-operations metrics and watch for any offering terms not included in this excerpt.
FocalTherics™ Reports Second Quarter 2026 Financial Results 39% Revenue Increase and 47% Growth in U.S. Procedures
Continuing-operations revenue, U.S. procedures, system sales, and gross margin increased year-over-year, but operating loss and net loss widened, including a $5.5 million European Investment Bank warrant valuation impact, while operating expenses increased.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenue, continuing operations (HIFU Segment)GAAP | $13.2 million | – | 39% |
| Sales of goodsGAAP | $US 9,527 (Amounts in thousands of U.S. Dollars) | – | – |
| Sales of RPPs & leasesGAAP | $US 2,758 (Amounts in thousands of U.S. Dollars) | – | – |
| Sales of spare parts and servicesGAAP | $US 918 (Amounts in thousands of U.S. Dollars) | – | – |
| Gross profitGAAP | $US 7,338 (Amounts in thousands of U.S. Dollars) | – | – |
| Gross marginGAAP | 55.6% | – | – |
| Research & development expensesGAAP | $US (2,317) (Amounts in thousands of U.S. Dollars) | – | – |
| Selling, general & administrative expensesGAAP | $US (13,054) (Amounts in thousands of U.S. Dollars) | – | – |
| Total operating expensesGAAP | $15.4 million | – | – |
| Loss from operationsGAAP | $US (8,033) (Amounts in thousands of U.S. Dollars) | – | – |
| Interest (expense) income, netGAAP | $US (748) (Amounts in thousands of U.S. Dollars) | – | – |
| Loss from change in fair value of warrant liabilityGAAP | $US (5,547) (Amounts in thousands of U.S. Dollars) | – | – |
| Currency exchange gains (loss), netGAAP | $US (76) (Amounts in thousands of U.S. Dollars) | – | – |
| Loss before taxes from continuing operationsGAAP | $US (14,404) (Amounts in thousands of U.S. Dollars) | – | – |
| Income tax (expense) credit, net from continuing operationsGAAP | $US (8) (Amounts in thousands of U.S. Dollars) | – | – |
| Loss from continuing operationsGAAP | $US (14,412) (Amounts in thousands of U.S. Dollars) | – | – |
| Income(loss) from discontinued operations, net of taxGAAP | $US (75) (Amounts in thousands of U.S. Dollars) | – | – |
| Net lossGAAP | $US (14,487) (Amounts in thousands of U.S. Dollars) | – | – |
| Loss per share, basic and dilutedGAAP | ($0.39) | – | – |
| Average number of shares used in computation of EPS, basic and dilutiveGAAP | 37,527,950 | – | – |
| Focal One systems soldother | 13 | – | 44% |
| U.S. Focal One procedure growthother | 47% | – | 47% |
| Focal One system installed baseother | 184 | – | – |
| Six-month total revenuesGAAP | $US 24,796 (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month gross profitGAAP | $US 13,300 (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month total operating expensesGAAP | $US (29,357) (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month loss from operationsGAAP | $US (16,057) (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month loss from continuing operationsGAAP | $US (24,007) (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month net lossGAAP | $US (23,570) (Amounts in thousands of U.S. Dollars) | – | – |
| Six-month loss per share, basic and dilutedGAAP | ($0.63) | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| HIFU SegmentThe Company sold thirteen Focal One systems during the quarter, versus nine systems in the same period in 2025, and U.S. Focal One procedures grew 47% year-over-year. | $13.2 million | – | 39% |
2026 outlook
- Revenue$50.0 - $54.0 million, representing 34% - 45% year-over-year growth
What drove it
- Revenue growth reflected thirteen Focal One system sales, including 2 conversions from operating leases, compared to nine systems in the prior-year period.
- U.S. Focal One procedure volume grew 47% year-over-year.
- Gross-margin expansion was primarily attributable to improvement of the standard cost of the Focal One system and favorable absorption due to higher production volumes.
- The Company launched its first commercial Focal One Endometriosis Program in Europe.
- The Company completed its corporate name change to FocalTherics™.
Concerns
- Operating expenses were $15.4 million and included approximately $0.8 million in one-time costs primarily attributable to corporate initiatives regarding rebranding, domestic filer transition and discontinued operations classification.
- Net loss was affected by the European Investment Bank warrant valuation impact of $5.5 million during the quarter.
- The Company reported a loss from continuing operations of $US (14,412) and a net loss of $US (14,487) for the three months ended June 30, 2026, each in amounts in thousands of U.S. Dollars.
- TOTAL SHAREHOLDERS’EQUITY was $US (3,225) as of June 30, 2026 (Amounts in thousands of U.S. Dollars).
- ESWL and Distribution were classified as discontinued operations after meeting held-for-sale criteria, and prior-period results were recast.
What to watch
- Execution against reiterated 2026 total revenue guidance of $50.0 - $54.0 million, representing 34% - 45% year-over-year growth.
- Focal One capital-system sales, including conversions from operating leases, and U.S. procedure-volume growth.
- Sustainability of gross-margin improvement from standard-cost improvements and higher production-volume absorption.
- Commercial progress of the endometriosis launch in Europe and additional Focal One program establishment.
- The expected closing and proceeds of the $40 million gross-proceeds underwritten public offering on August 14, 2026.
Balance sheet and cash flow
- Cash and cash equivalents as of June 30, 2026 totaled $21.5 million.
- Cash, cash equivalents: $US 21,542 as of June 30, 2026; $US 20,452 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- Accounts receivable, net: $US 10,060 as of June 30, 2026; $US 14,948 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- Inventory: $US 8,251 as of June 30, 2026; $US 7,770 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- TOTAL ASSETS: $US 74,548 as of June 30, 2026; $US 78,997 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- Short term borrowing: $US 1,860 as of June 30, 2026; $US 4,386 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- Long-term debt, non-current: $US 37,197 as of June 30, 2026; $US 15,903 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- TOTAL LIABILITIES: $US 77,773 as of June 30, 2026; $US 59,584 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- TOTAL SHAREHOLDERS’EQUITY: $US (3,225) as of June 30, 2026; $US 19,413 as of December 31, 2025 (Amounts in thousands of U.S. Dollars).
- NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES: $US (6,663) for the six months ended June 30, 2026; $US (10,047) for the six months ended June 30, 2025 (Amounts in thousands of U.S. Dollars).
- Additions to capitalized assets produced by the company and other capital expenditures: $US (2,017) for the six months ended June 30, 2026; $US (2,917) for the six months ended June 30, 2025 (Amounts in thousands of U.S. Dollars).
- NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES: $US (2,017) for the six months ended June 30, 2026; $US (2,917) for the six months ended June 30, 2025 (Amounts in thousands of U.S. Dollars).
- NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES: $US 10,402 for the six months ended June 30, 2026; $US (1,198) for the six months ended June 30, 2025 (Amounts in thousands of U.S. Dollars).
- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS: $US 1,090 for the six months ended June 30, 2026; $US (11,931) for the six months ended June 30, 2025 (Amounts in thousands of U.S. Dollars).
- The Company announced an underwritten public offering for $40 million of gross proceeds expected to close August 14, 2026.
Analysis
FocalTherics reported continuing-operations revenue of $13.2 million, up 39% from $9.5 million in the prior-year period. Commercial activity increased, with thirteen Focal One system sales versus nine in the prior-year period and 47% year-over-year growth in U.S. Focal One procedures. The installed base reached 184 systems, comprising 96 in the U.S. and 88 internationally.
Revenue growth was accompanied by gross-margin expansion to 55.6% from 51.1%. Management attributed the improvement to a lower standard cost for the Focal One system and favorable absorption from higher production volumes. Sales of goods were $US 9,527, sales of RPPs & leases were $US 2,758, and sales of spare parts and services were $US 918, with all amounts stated in thousands of U.S. Dollars.
Profitability remained under pressure. Operating expenses increased to $15.4 million from $11.5 million, including approximately $0.8 million of one-time costs. Loss from operations was $US (8,033), while the loss from continuing operations was $US (14,412), both in thousands of U.S. Dollars. The quarter also included a $US (5,547) loss from the change in fair value of warrant liability, and the Company identified a $5.5 million European Investment Bank warrant valuation impact as the primary cause of the increase in net loss.
Liquidity was $21.5 million of cash and cash equivalents as of June 30, 2026. For the six months ended June 30, 2026, net cash used in operating activities was $US (6,663), capital expenditures were $US (2,017), and financing activities generated $US 10,402, with all amounts stated in thousands of U.S. Dollars. The Company also announced an underwritten public offering for $40 million of gross proceeds expected to close August 14, 2026.
Management reiterated 2026 continuing-operations revenue guidance of $50.0 - $54.0 million, representing 34% - 45% year-over-year growth. The filing does not provide prior-quarter operating results for comparison. The release recast prior periods to present HIFU as continuing operations and ESWL and Distribution as discontinued operations, making HIFU sales, procedure activity, gross margin, operating-expense levels, and the warrant-related loss key figures for assessing execution.
Management, verbatim
We continue to demonstrate commercial success with our strongest second quarter ever, reflecting the growing strength of our core business and further supporting the strategic shift to Focal Therapy with our corporate rebranding to FocalTherics.
Ryan Rhodes, CEO of FocalTherics
Not in the filing
stated, not guessed- Previous-quarter outlook was not provided, so no comparison of actual results with prior guidance is available.
- Non-GAAP revenue, gross margin, operating income, net income, and EPS were not reported.
- Quarterly operating cash flow and quarterly capital expenditures were not reported.
- Free cash flow was not reported.
- Share repurchases and dividends were not reported.
- A prior-quarter comparison was not reported for revenue, gross margin, operating expenses, operating loss, net loss, EPS, system sales, procedure volume, or installed base.
- Revenue for the discontinued ESWL and Distribution segments was not separately reported in this release.
- Gross-margin, operating-expense, tax-rate, profitability, or EPS guidance was not reported.
AlphAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
SEC 8-K Item 2.02 with Exhibit 99.1 reporting Q2 2026 financial results and reiterating 2026 guidance, after reclassifying ESWL and Distribution as discontinued operations.
Ticker impact
FocalTherics reported Q2 2026 HIFU results and reiterated 2026 revenue guidance, plus disclosed a $40M underwritten public offering expected to close Aug. 14.
Near-term volatility likely around the offering close and any follow-through on guidance credibility; direction depends on whether investors view the financing as supportive runway versus dilution.
The article provides concrete Q2 operating metrics and guidance ranges, and it explicitly states the offering size and expected closing date, both of which are actionable for positioning and event-risk management.
Market effects
Robotic focal therapy and focused ultrasound device peers may see read-across on commercial adoption metrics (installed base, procedure growth) and financing appetite.
U.S. procedure volume growth (47% YoY) highlights demand momentum that can influence investor sentiment toward U.S.-commercialized medtech platforms.
Europe endometriosis program launch and EIB warrant valuation impact underscore cross-region execution and financing structure sensitivity.
Counterpoint
The headline HIFU growth and gross margin improvement may be partially offset by elevated operating expenses and warrant valuation effects, so the financing could be interpreted as funding needs rather than purely growth capital.
Key entities
- issuerFocalTherics
Robotic focal therapy company reporting Q2 2026 HIFU continuing-operations results and 2026 guidance, and announcing a $40M underwritten public offering.
- executiveRyan Rhodes
CEO quoted on commercial momentum, endometriosis program launch, and growth plans across indications.
- financing counterpartyEuropean Investment Bank
Warrant valuation impact of $5.5M cited as a driver of increased net loss in Q2.
