The HIFU growth story is intact and accelerating, but the company is burning cash rapidly ($5.4M in Q1 alone, leaving only $15M). With a $135M market cap and no path to near-term profitability, the stock will likely remain range-bound until either (a) the company demonstrates operating leverage or (b) announces a capital raise. Watch for the June 1 Investor Day for any strategic updates.
Price Chart
Executive Summary
EDAP reported Q1 2026 total revenue of $17.8M (up 25% YoY from $14.3M), driven by record HIFU revenue of $11.6M (+78% YoY). However, the net loss widened to $9.1M (-$0.24/share) from $7.4M (-$0.20/share) a year ago, and the company reiterated (not raised) its 2026 guidance. The HIFU business is accelerating, but the company remains deeply unprofitable with negative operating cash flow and a rapidly shrinking cash balance.
Key Financial Metrics
Key Facts
- Q1 2026 total revenue $17.8M vs $14.3M YoY (+25%)
- HIFU revenue $11.6M, up 78% YoY — record quarter
- 11 Focal One systems sold vs 6 YoY (+83%)
- U.S. Focal One procedures up 53% YoY
- Gross margin improved to 45.7% from 42.0% YoY
- Net loss widened to $9.1M (-$0.24/share) from $7.4M (-$0.20/share)
- Operating loss $7.4M vs $6.3M YoY
- Cash burn continues: cash dropped to $15.0M from $20.5M in 3 months
- 2026 guidance reiterated (not raised): HIFU $50-54M, total $72-80M
- HIFI-2 study published in European Urology Oncology — positive salvage HIFU data
Financial Impact
HIFU revenue growth of 78% YoY to $11.6M is the key positive; net loss of $9.1M and cash burn of $5.4M in the quarter are the key negatives
Risk Factors
- Cash burn: $15M cash at March 31 vs $20.5M at Dec 31 — less than 3 quarters of runway at current burn rate
- No EPS or revenue consensus beat — EPS miss vs Street estimates
- Guidance reiterated, not raised, despite strong Q1 — suggests management sees H2 headwinds
- Non-core ESWL/Distribution revenue declining ($6.2M vs $7.8M YoY) as company pivots to HIFU
- Historical performance shows EDAP reports have consistently been followed by negative stock movement (avg T+20 -10.7%)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001171843-26-003113 |
| Document: f8k_050726.htm | 0001171843-26-003113 |
| Document: 0001171843-26-003113-index-headers.html | 0001171843-26-003113 |
| Document: 0001171843-26-003113-index.html | 0001171843-26-003113 |
| Document: 0001171843-26-003113.txt | 0001171843-26-003113 |
| 8-K Data (Synthetic) | 0001171843-26-003113 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 17, 2026 6w ago | Insider Cluster | — | awaiting T+20 | — | — |
May 29, 2026 18w ago | 8-K | $4.32 $5.10 | ▲ +18.06% | ▲ +19.85% | — |
May 14, 2026 20w ago | DEFA14A | $4.13 $4.77 | ▼ −15.50% | ▼ −16.35% | — |
May 14, 2026 20w ago | DEFA14A | $4.13 $4.77 | ▲ +15.50% | ▲ +16.35% | — |
May 14, 2026 20w ago | Press Release | $4.13 $4.77 | ▲ +15.50% | ▲ +16.35% | — |
May 7, 2026 21w ago | 8-K | $4.16 $4.69 | ▲ +12.74% | ▲ +9.60% | — |
Apr 16, 2026 24w ago | Press Release | $3.59 $4.16 | ▲ +15.88% | ▲ +10.06% | — |
Apr 1, 2026 26w ago | EFFECT | $3.53 $3.31 | ▼ −6.23% | ▼ −15.95% | — |
Mar 27, 2026 27w ago | S-3/A | $3.73 $3.22 | ▼ −13.67% | ▼ −26.41% | — |
Mar 25, 2026 27w ago | S-3 | $3.77 $3.22 | ▼ −14.59% | ▼ −25.25% | — |
US Market Status
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