EarningsQ2 2026 Earnings Report
DE:EDA Q2 2026 EPS Results
Actual EPS-€0.35
Consensus EPS-€0.19
Beat/MissMissed by -€0.16
One Year Ago EPS-€0.16
DE:EDA Q2 2026 Revenue Results
Actual Revenue€11.74M
Expected Revenue€13.43M
Beat/MissMissed by -€1.69M
YoY Revenue Growth-27.49%
Earnings Announcement Details
QuarterQ2 2026
Date08/13/2026
TimeAfter Close
Conference CallThursday, August 13, 2026
DE:EDA Upcoming Earnings
FocalTherics's next earnings date is estimated for November 5, 2026, based on past reporting schedules.
Q2 2026 Earnings Call Audio
DE:EDA Q2 2026 Earnings Call
0:00 / 0:00
Q2 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q2 2026 Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed clear commercial momentum: double-digit revenue growth (39% YoY), record capital system sales, strong procedure volume growth (47% YoY), margin improvement to 55.6%, meaningful regulatory/reimbursement progress, and a near-term $40M equity raise to fund commercial expansion and R&D. Offsetting these positives are rising operating expenses, a sizable noncash warrant charge ($6.3M) that pushed shareholder equity negative ($-3.2M), reliance on the pending equity raise to strengthen the balance sheet, and a 34% decline in discontinued operations revenue. On balance, the business shows accelerating revenue, improving margins and strategic progress that outweigh the financial and accounting headwinds, with the upcoming equity close expected to materially improve capitalization.Company Guidance
Strong HIFU Revenue Growth
HIFU revenue of $13.2 million in Q2 2026, up 39% year-over-year from $9.5 million in Q2 2025.
Record Capital System Sales
13 Focal One capital system sales in Q2 2026, a 44% increase vs. prior-year period (9 sales), marking the best second quarter ever for HIFU capital system sales globally.
Growing Installed Base
Worldwide installed base reached 184 systems (96 U.S., 88 international), including 8 U.S. sales in the quarter and 15 U.S. hospital networks with 2+ systems.
Procedure Utilization Expansion
U.S. Focal One procedure volumes increased 47% year-over-year, indicating stronger utilization and recurring revenue from disposables and service.
Gross Margin Improvement
HIFU gross margin increased to 55.6% from 51.1% a year earlier, a ~450 basis point improvement driven by lower system costs, pricing strategy and higher consumable volumes.
Reimbursement Momentum
CMS proposed an ~11.6%–12% increase in HIFU facility payment for 2027 (if finalized), which would be the fifth consecutive annual CMS increase and supports hospital reimbursement economics for Focal One.
Regulatory & Product Progress
510(k) submission for FocalConnect submitted in July 2026; CE-marked endometriosis program active in Europe with first commercial site (Toulouse) treating patients.
Indication Expansion and Clinical Progress
BPH study progressing (14 patients treated in Latin America); U.S. BPH treatments planned later this year at Mount Sinai; HIFUSA study nearing readout (expected late 2026/early 2027).
International Validation and Market Access
Notable international wins: Imperial College London converted to Focal One; new capital sale in France following universal coverage announcement; expansion in India (2 systems) and Latin America.
Strengthened Balance Sheet Near-Term
Cash and cash equivalents increased to $21.5 million at quarter-end (Q2 2026); company expects to close an underwritten public offering with gross proceeds of $40 million on August 14, 2026 to bolster capital for growth initiatives.
Large Addressable Market
Company estimates combined TAM across prostate cancer, BPH and endometriosis of >4.3 million procedures and over $10 billion in potential revenue.
Innovation Pipeline (Histotripsy)
Active R&D and patent filings for histotripsy; management cites an accelerated development timeline (management guidance ~1–2 years for milestones) supported by the recent equity raise.
DE:EDA Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed