Profound Medical Reports Fourth Quarter and Full Year 2025 Financial Results

Executive Summary

• Profound Medical reported record Q4 2025 revenue of $6.0 M (up 43% YoY) and full‑year 2025 revenue of $16.1 M, but posted a larger net loss of $42.6 M for the year.
• The company closed a $36.0 M registered direct offering in the U.S. and an upsized $6.45 M private placement in Canada, strengthening its cash position to ~$59.7 M.
• Significant commercial milestones were announced (e.g., first TULSA‑PRO cases at Johns Hopkins and Mount Sinai, 500th Sonalleve procedure in Poland) and a board appointment of Frank Baylis following Kris Shah’s resignation.

Key Details

• Q4 2025 Financial Highlights
• Revenue: $6.0 M (43% YoY increase; 13% sequential).
• Gross margin: 67% (down from 71% YoY, due to product mix and introductory pricing).
• Operating expenses: $11.4 M (up marginally YoY).

• Net loss: $8.2 M or $0.27 per share (vs. $4.9 M loss YoY).

• FY 2025 Financial Highlights

• Revenue: $16.1 M (≈50% YoY growth).
• Gross margin: 71% (up from 66% YoY).
• Operating expenses: $52.6 M (↑ 31%).

• Net loss: $42.6 M or $1.41 per share (vs. $27.8 M loss YoY).

• Liquidity

• Cash balance as of Dec 31 2025: $59.7 M (up from $54.9 M).

• Shares outstanding: 36,293,640 common shares.

• Financing Activities

• Completed a $36.0 M registered direct offering (U.S.) – equity only, no warrants.
• Upsized a private placement in Canada to $6.45 M – equity only, led by healthcare investors and existing shareholders.

• Net cash provided by financing activities for FY 2025: $41.1 M.

• Commercial & Clinical Milestones

• TULSA‑PRO installed base: 78 systems (Dec 31 2025); target ~120 installations by end‑2026.
• Qualified sales pipeline: 110 new systems in “Verify, Negotiate and Contracting” stages.
• First commercial cases at Johns Hopkins Hospital and Mount Sinai Hospital (Jan 2026).
• 500th Sonalleve procedure performed at PRO FAMILIA Specialist Hospital, Poland (Feb 2026).

• Launch of TULSA‑AI Volume Reduction module for BPH at RSNA meeting (Nov/Dec 2025).

• Strategic Partnerships & Distribution

• Regained exclusive distribution rights for TULSA‑PRO in Canada.
• Exclusive distribution and supply agreement for Saudi Arabia with Al Faisaliah Medical Systems Co.

• Strategic distribution agreement with Getz Healthcare for Australia & New Zealand.

• Board Change

• Kris Shah resigned from the Board of Directors.

• Frank Baylis appointed as his successor, effective immediately; background includes leadership at Baylis Medical and experience in medical‑device M&A (acquired by Boston Scientific).

• Upcoming Catalysts

• Presentation of Level 1 post‑market CAPTAIN trial results at the EAU Congress (London, March 13 2026).

Notable Quotes

“We continued to execute well, delivering record revenues… Moving forward, with the strengthening of our balance sheet … and several upcoming potential catalysts, including the clinical outcomes from the Level 1 post‑market CAPTAIN study, we believe that we are on the right path toward driving high double digit to low triple digit revenue growth and, ultimately, positive cash flows and net profitability.” – Arun Menawat, CEO & Chairman

All forward‑looking statements are subject to risks and uncertainties detailed in Profound Medical’s filings.