FOCL 10-K & 10-Q changes, risk factors and insider trading
Edap Tms Sa · Nasdaq · Electromedical & Electrotherapeutic Apparatus · CIK 1041934 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Comparison not available: Not available: fewer than two 10-K filings on EDGAR to compare (only one so far)..
What changed in the latest 10-Q
Risk Factors
As of the date of this Quarterly Report, there have been no material changes to the risk factors previously disclosed in Part I, Item 1A of our 2025 Annual Report other than the additional risk factor included below. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.
Our plan to discontinue our ESWL and Distribution operating segments may materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.
While our plan to discontinue our ESWL and Distribution operating segments and report and classify them as discontinued operations in our financial statements aligns with our long-term strategic goals, it carries inherent risks, including:
The execution of this discontinuance may involve significant risks, even beyond those outlined above, that could materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.
New heading “Our plan to discontinue our ESWL and Distribution operating segments may materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.”
Largest changes
“Our plan to discontinue our ESWL and Distribution operating segments may materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.”see in full comparison
“While our plan to discontinue our ESWL and Distribution operating segments and report and classify them as discontinued operations in our financial statements aligns with our long-term strategic goals, it carries inherent risks, including:”see in full comparison
“The execution of this discontinuance may involve significant risks, even beyond those outlined above, that could materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.”see in full comparison
Full comparison: every changed paragraph (4)
As of the date of this Quarterly Report, there have been no material changes to the risk factors previously disclosed in Part I, Item 1A of our 2025 Annual Report.Report other than the additional risk factor included below. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.
Our plan to discontinue our ESWL and Distribution operating segments may materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.
While our plan to discontinue our ESWL and Distribution operating segments and report and classify them as discontinued operations in our financial statements aligns with our long-term strategic goals, it carries inherent risks, including:
The execution of this discontinuance may involve significant risks, even beyond those outlined above, that could materially and adversely affect our business, financial condition, operating results and prospects or cause revenue disruption.
Management's Discussion & Analysis (MD&A)
New heading “Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025”
New heading “Profit (loss) from discontinued operations, net of tax”
New heading “Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025”
New heading “Cost of Sales and Gross Margin”
New heading “Operating Expenses”
New heading “Financial (Expense) Income, Net”
New heading “Foreign Currency Exchange Gain (Loss), Net”
New heading “Profit (loss) from discontinued operations, net of tax”
Removed heading “Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025”
Removed heading “Distribution Division”
Largest changes
“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. …”see in full comparison
“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. …”see in full comparison
“Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025”see in full comparison
“Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025”see in full comparison
“Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025”see in full comparison
Full comparison: every changed paragraph (73)
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.
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.
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.
Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025
The following table sets forth our net sales and profit (loss), including by division, for the three months ended MarchJune 31,30, 2026 and 2025, and for the six months ended June 30, 2026 and 2025:
Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025
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.
HIFU Division
The HIFU division’s total revenues increased by 78.3%38.8% from $6.5$9.5 million in the three months ended MarchJune 31,30, 2025 to $11.6$13.2 million in the three months ended MarchJune 31,30, 2026, reflecting growth of equipment sales and treatment-driven revenue.
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 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.
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.
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.
ESWL Division
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.
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.
Distribution Division
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.
The Distribution division’s sales of medical devices decreasedincreased 44.9%,57.5% fromwith $3.2$7.5 million in the three months ended MarchJune 31,30, 20252026, with 13 Focal One units sold (including 8 in the United States), as compared to $1.8$4.8 million in the three months ended MarchJune 31,30, 2026.2025, with 9 Focal One units sold (including 5 in the United States).
SalesTreatment-driven revenue, which includes sales of Distribution-relatedrevenue-per-procedure consumables,(“RPP”) spare& parts,leases, supplies,sales leasing,of disposables, and servicestreatment-related services, increased 6.6%,by from37.5% $2.7to $5.0 million in the three months ended MarchJune 31,30, 20252026, as compared to $2.9$3.7 million in the threesame monthsperiod endedin March 31, 2026.2025.
Cost of sales increased 16.8%,26.2%, from $8.3$4.6 million in the three months ended MarchJune 31,30, 2025 to $9.7$5.9 million in the three months ended MarchJune 31,30, 2026, and represented 54%44.4% of net sales in the three months ended MarchJune 31,30, 2026, down from 58%48.9% of net sales in the three months ended MarchJune 31,30, 2025. Gross margin increased to 45.7%55.6% during the three months ended MarchJune 31,30, 2026, compared to 42.0%51.1% for the three months ended MarchJune 31,30, 2025. The increase in gross margin was primarily attributable to improvement on standard cost of the growthFocal in HIFU unit sales which have higher relative gross marginsOne and favorable absorption of our fixed costs due to higher production volumes, partially offset by impact of tariffs.volumes.
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.
Marketing and salesOperating expenses wereincreased $7.133.8%, or $3.9 million, from $11.5 million in the three months ended MarchJune 31,30, 2026, compared2025 to $6.1$15.4 million in the three months ended MarchJune 31,30, 2025.2026.
ResearchMarketing and development (“R&D”)sales expenses remainedwere flat at $2.6$7.5 million in the three months ended MarchJune 31,30, 20262026, compared to $2.6$5.3 million in the three months ended MarchJune 31,30, 2025.
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.
General and administrative expenses increased $3.7$1.6 million, or 58.5%,41.5%, infrom the three months ended March 31, 2025 to $5.8$3.9 million in the three months ended MarchJune 31,30, 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.
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.
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.
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$5.5 million and the interest expense of the EIB loan of $0.4$0.7 million in the three months ended MarchJune 31,30, 2026.
In the three months ended March 31,June, 2026, we recorded a net foreign currency exchange gainloss of $142$76 thousand, mainly due to the variation of the U.S.Japanese dollarYen against the Euro, compared to a lossnet gain of $1.0$362 millionthousand in the three months ended MarchJune 31,30, 2025.
Income tax expenses in the consolidated statement of operations remained relatively flat at $145$8 thousand in the three months ended MarchJune 31,30, 2026, compared to $144$14 thousand in the three months ended MarchJune 31,30, 2025.
Profit (loss) from discontinued operations, net of tax
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.
As a result of the above, we recorded a consolidated net loss of $9.1$14.5 million in the three months ended MarchJune 31,30, 2026, compared with a consolidated net loss of $7.4$6.4 million in the three months ended MarchJune 31,30, 2025.
Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
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.
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).
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.
Cost of Sales and Gross Margin
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.
Operating Expenses
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.
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.
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.
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.
Financial (Expense) Income, Net
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.
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.
Foreign Currency Exchange Gain (Loss), Net
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.
Income Taxes
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.
Profit (loss) from discontinued operations, net of tax
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.
Net Loss
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.
Our primary sources of capital have historically been from ongoing operations, proceeds from our public and private securities offerings,offerings and the issuances of debt.
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.
We have a history of operating losses and expect such losses to continue in the foreseeable future. As of MarchJune 31,30, 2026, we had $15.0$21.5 million in cash and cash equivalents, aan decreaseincrease of $5.4$1.1 million from December 31, 2025.2025 Weincluding drew$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”), 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.
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.
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.
FOCL insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 9 Form 4 filings (8 insiders, 2 trade dates, 126,000 shares, about $593.2K) and open-market sales in 0 filings. Net open-market shares: 126,000 (purchases minus sales); net value about $593.2K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-14 | Horn David R. |
Open-market purchase | 10,000 | $4.75 | $47.5K |
| 2026-08-14 | Schulz Fran |
Open-market purchase | 10,000 | $4.75 | $47.5K |
| 2026-08-14 | Levine Joshua |
Open-market purchase | 10,000 | $4.75 | $47.5K |
| 2026-08-14 | Mobeck Kenneth S. |
Open-market purchase | 5,000 | $4.75 | $23.8K |
| 2026-08-14 | Willsey Lance |
Open-market purchase | 50,000 | $4.75 | $237.5K |
| 2026-08-14 | Rhodes Ryan |
Open-market purchase | 21,000 | $4.75 | $99.8K |
| 2026-08-14 | Shah Sanket |
Open-market purchase | 5,000 | $4.75 | $23.8K |
| 2026-08-14 | Annen Steven |
Open-market purchase | 5,000 | $4.75 | $23.8K |
| 2026-05-12 | Annen Steven |
Grant/award | 90,000 | — | — |
| 2026-05-12 | Shah Sanket |
Grant/award | 67,500 | — | — |
| 2026-05-12 | Rhodes Ryan |
Grant/award | 304,500 | — | — |
| 2026-05-12 | Mobeck Kenneth S. |
Grant/award | 120,000 | — | — |
| 2026-05-11 | Levine Joshua |
Open-market purchase | 10,000 | $4.22 | $42.2K |
Well-known investors holding FOCL (13F)
None of the 59 investors we track reported a position in their latest 13F.