SofWave Medical (SOFW) investor relations material

Q3 performance and business model

• Q3 2026 revenue was $28.5M, up 35% YoY; capital equipment sales grew 19%.

• Utilization fees reached $13.3M, 47% of revenue, up 60% YoY; the software-based pulse charge generates close to 100% gross margin.

• Q3 gross margin was 76.7%, versus 73.7% YoY; non-IFRS operating margin was 17.2%, and non-IFRS net income was $4.6M.

• Six consecutive quarters were profitable; 1.1M treatments had been performed, and 3,400 systems sold since launch.

Platform and market opportunity

• The ultrasound platform has 12 FDA clearances for face and body treatments, including skin laxity, lifting, wrinkles and acne scars; treatment is non-invasive with no downtime described.

• More than 14 clinical studies covered 600+ subjects and 1,000+ treatments; proprietary cooling protects the epidermis while ultrasound targets the mid-dermis.

• A complementary muscle-toning device extends the offering for patients experiencing muscle loss during weight reduction; management cited GLP-1, menopause and longevity trends as demand drivers.

• Medical-aesthetic consumer spending was cited at $63B, projected to reach $97B by 2029 at 9% CAGR; consumer awareness and demand for natural outcomes were identified as growth drivers.

• Digital metrics included 58% share of voice, 94% positive brand sentiment, 600,000+ monthly website users growing nearly 200% YoY, and 1.6M+ social followers.

Commercial expansion and outlook

• NMPA approval in China was received in September 2026; an opening order was 70 systems, with 10 delivered in Q3 and 60 scheduled for Q4 2026.

• HTDK is preparing China commercialization, supported by a local clinical study of nearly 200 patients across five hospitals and investment in launch infrastructure.

• Q3 revenue was 51% outside the U.S.; Asia contributed 37%, led by Korea, Japan and Australia, with China added as a new market.

• Plans for the rest of 2026 include expanding U.S. sales capacity, preparing the China launch, scaling internationally, and continuing investment in the next-generation platform.

• A larger ultrasound applicator launched in 2025 is intended to expand skin-tightening treatments from face and neck to the body, with faster and more efficient procedures.