Profound Medical — Second Quarter 2026 Earnings Summary

Financial Performance

• Total revenue for Q2 2026 was approximately $2.5 million, a 12% increase year-over-year.
• Revenue composition included $1.6 million from recurring non-capital sources (single-use devices and services) and $871,000 from capital equipment sales.
• Excluding $3.1 million in revenue shifted to Q3 due to shipment timing, Q2 revenue would have been approximately $5.6 million, representing 153% year-over-year growth.
• Gross margin expanded to 78% in Q2 2026 from 73% in the prior-year period, driven by a favorable product mix including capital system sales previously under operating leases.
• Operating expenses declined 16% year-over-year to approximately $13.0 million, primarily due to lower personnel, commercial, travel, insurance, and CAPTAIN clinical trial costs following enrollment completion.
• Net loss for Q2 2026 was approximately $9.5 million ($0.26 per share), a 39% improvement from a net loss of $15.7 million ($0.52 per share) in Q2 2025.
• Cash balance stood at approximately $38.3 million as of June 30, 2026, down from $59.7 million at December 31, 2025.
• Long-term debt increased to $4.5 million as of June 30, 2026, compared to $4.5 million in long-term debt and $0 in current long-term debt at December 31, 2025.
• Deferred revenue totaled $960,000 ($342,000 current, $618,000 non-current) as of June 30, 2026.
• Net cash used in operating activities for the six months ended June 30, 2026, was $19.9 million.

Guidance and Future Outlook

• The Company reiterated its full-year 2026 revenue guidance of approximately $25.0 million, representing 56% growth compared to the prior year.
• Full-year 2026 gross margin is expected to be 70% or higher.
• Management cites continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline as drivers for the outlook.
• The Company notes that $3.1 million of revenue was shifted to early Q3 due to temporary logistics issues, which have since been resolved.

Business Segments and Product Lines

• The TULSA-PRO installed base increased to 84 units at the end of Q2 2026.
• The qualified sales pipeline for TULSA-PRO and Sonalleve is estimated at approximately $70.0 million.
• New purchase orders exceeded $7.0 million in Q2 2026, a quarterly record, with $2.5 million recognized in the quarter and $3.1 million shipped in July.
• The Company launched an initiative to explore integrating PSMA PET molecular imaging technologies with the TULSA Procedure.
• Sonalleve continues to be commercialized for pain palliation of bone metastases, desmoid tumors, osteoid osteoma, uterine fibroids, and adenomyosis.

Market and Competitive Landscape

• Payer coverage expanded by approximately 18.3 million covered lives during Q2 2026, primarily through state Medicaid and managed Medicaid (Ambetter) programs.
• The Johns Hopkins Employee Health Plan and Prime Healthcare Employee Health Plan became the first employer-owned health plans to list the TULSA Procedure as a covered service, covering over 50,000 and 55,000 individuals respectively.
• The TULSA INDEX20 (a cohort of 20 active sites) showed a 22% year-over-year growth in average procedures per quarter for Q2 2026, though sequential growth was -12%.
• H1 2026 average procedures per quarter for the INDEX20 grew 39% compared to H1 2025.
• Physician engagement generated over 160 qualified commercial opportunities at the SRS2026 meeting.

Risks and Challenges

• The press release notes that there can be no assurance regarding the extent or timing of the qualified sales pipeline resulting in recognized revenue.
• Forward-looking statements highlight risks including medical device industry factors, regulatory approvals, reimbursement changes, economic factors, equity market volatility, and competition.
• A temporary logistics issue impacted shipment timing in Q2, though it did not reflect a change in customer demand.

Management Commentary and Tone

• CEO Arun Menawat stated that commercial momentum continued to accelerate, describing the current position as the "strongest commercial position in the Company's history."
• Management highlighted meaningful operating leverage, noting gross margins above the 70% long-term target and a 39% improvement in net loss.
• The tone emphasized strong clinical data, reimbursement expansion, and a robust sales pipeline as key drivers for future growth.

Other Key Points

• The post-market CAPTAIN Level 1 randomized clinical data demonstrated statistically significant advantages of the TULSA Procedure over robotic radical prostatectomy, with new penile length preservation data presented in July 2026.
• The Company has 36,532,594 common shares issued and outstanding as of August 6, 2026.
• A conference call was held on August 6, 2026, to discuss the results.
• The TULSA Procedure is cleared by the FDA in the U.S. and approved in Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE.
• Sonalleve is approved by the FDA as an HDE in the U.S. and cleared in Europe, Canada, China, and Saudi Arabia.