Report Information [Filing Details](index=1&type=section&id=Filing%20Details) Profound Medical Corp. filed its Form 10-Q quarterly report for the period ended June 30, 2025, identifying as a non-accelerated filer and smaller reporting company with 30,053,142 common shares outstanding - Profound Medical Corp. submitted its Form 10-Q quarterly report for the period ended June 30, 2025[2](index=2&type=chunk) Filing Details Status | Metric | Status | | :--- | :--- | | Filing Type | Quarterly Report (Form 10-Q) | | Quarter End Date | June 30, 2025 | | Commission File Number | 001-39032 | | Jurisdiction of Incorporation | Ontario, Canada | | Trading Symbol | PROF | | Registered Exchange | Nasdaq Stock Market LLC | | Accelerated Filer Status | Non-accelerated filer | | Company Size | Smaller reporting company | | Common Shares Outstanding (as of August 14, 2025) | 30,053,142 shares | [Explanatory Note](index=2&type=section&id=Explanatory%20Note) The company, as a "foreign private issuer," is exempt from Form 10-Q filing but voluntarily submitted this report - Profound Medical Corp. qualifies as a "foreign private issuer" and is exempt from filing Form 10-Q quarterly reports under Rules 13a-13 and 15d-13 of the Securities Exchange Act[7](index=7&type=chunk) - The company voluntarily chose to file this quarterly report for the period ended June 30, 2025[7](index=7&type=chunk) PART I. Financial Information [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Profound Medical Corp.'s unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, shareholders' equity, and cash flows, along with related notes detailing business operations, accounting policies, and changes in assets, liabilities, and equity [Condensed Consolidated Balance Sheets (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) As of June 30, 2025, total assets decreased to **$49,668 thousand** from **$70,234 thousand** at December 31, 2024, primarily due to reduced cash and receivables, while total liabilities slightly increased and shareholders' equity significantly declined Condensed Consolidated Balance Sheets Key Data (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Cash | 35,195 | 54,912 | (19,717) | -35.9% | | Trade and Other Receivables, Net | 4,898 | 7,045 | (2,147) | -30.5% | | Inventory | 8,353 | 5,801 | 2,552 | 44.0% | | Total Current Assets | 48,811 | 69,065 | (20,254) | -29.3% | | Total Assets | 49,668 | 70,234 | (20,566) | -29.3% | | Total Current Liabilities | 5,724 | 6,565 | (841) | -12.8% | | Total Liabilities | 10,409 | 9,812 | 597 | 6.1% | | Shareholders' Equity | 39,259 | 60,422 | (21,163) | -35.0% | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) For the three and six months ended June 30, 2025, the company experienced a significant increase in net loss, driven by higher R&D and SG&A expenses despite some revenue growth and improved gross profit margins Condensed Consolidated Statements of Operations and Comprehensive Loss Key Data (USD in thousands) | Metric | June 30, 2025 (3 months) | June 30, 2024 (3 months) | Change (%) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 2,211 | 2,233 | -1% | 4,832 | 3,672 | 32% | | Cost of Sales | 593 | 812 | -27% | 1,361 | 1,385 | -2% | | Gross Profit | 1,618 | 1,421 | 14% | 3,471 | 2,287 | 52% | | Research and Development Expenses | 6,098 | 4,205 | 45% | 10,906 | 8,150 | 34% | | Selling, General and Administrative Expenses | 9,326 | 5,058 | 84% | 17,537 | 9,856 | 78% | | Operating Loss | 13,806 | 7,842 | 76% | 24,972 | 15,719 | 59% | | Net Loss | 15,695 | 6,919 | 127% | 26,419 | 13,504 | 96% | | Basic and Diluted Loss Per Share | 0.52 | 0.28 | 86% | 0.88 | 0.55 | 60% | [Condensed Consolidated Statements of Shareholders' Equity (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(Unaudited)) As of June 30, 2025, total shareholders' equity significantly decreased to **$39,259 thousand** from **$60,422 thousand** at December 31, 2024, primarily due to accumulated net losses, despite increases from share-based compensation and accumulated other comprehensive income Shareholders' Equity Changes (USD in thousands) | Metric | December 31, 2024 Balance | March 31, 2025 Balance | June 30, 2025 Balance | | :--- | :--- | :--- | :--- | | Number of Common Shares | 30,039,809 | 30,053,142 | 30,053,142 | | Common Shares Amount | 281,552 | 281,641 | 281,641 | | Additional Paid-in Capital | 21,298 | 22,198 | 23,649 | | Accumulated Other Comprehensive Income (Loss) | 2,742 | 2,845 | 5,558 | | Accumulated Deficit | (245,170) | (255,894) | (271,589) | | Total Shareholders' Equity | 60,422 | 50,790 | 39,259 | **Key Changes (December 31, 2024 to June 30, 2025):** * Net Loss: (10,724) + (15,695) = (26,419) * Share-based Compensation: 989 + 1,451 = 2,440 * Accumulated Translation Adjustment: 103 + 2,713 = 2,816 [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) For the six months ended June 30, 2025, the company reported a net cash outflow of **$22,027 thousand** from operating activities and **$290 thousand** from financing activities, resulting in an ending cash balance of **$35,195 thousand**, a decrease compared to the prior year's period which saw net cash inflow from financing activities Condensed Consolidated Statements of Cash Flows Key Data (USD in thousands) | Metric | June 30, 2025 (6 months) | June 30, 2024 (6 months) | Change Amount | | :--- | :--- | :--- | :--- | | Net Cash from Operating Activities | (22,027) | (10,748) | (11,279) | | Net Cash from Financing Activities | (290) | 19,853 | (20,143) | | Effect of Exchange Rate Changes | 2,600 | (1,239) | 3,839 | | Net Increase (Decrease) in Cash | (22,317) | 9,105 | (31,422) | | Cash, End of Period | 35,195 | 34,079 | 1,116 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes to the condensed consolidated financial statements, covering the company's business description, liquidity risk, significant accounting policies, composition and changes in various assets, liabilities, and equity, as well as detailed information on revenue, loss per share, and segment reporting [1 Description of business and liquidity risk](index=9&type=section&id=1%20Description%20of%20business%20and%20liquidity%20risk) Profound Medical Corp. is a commercial-stage medical device company focused on developing and selling incision-free treatment systems for ablating diseased tissue, with **$35,195 thousand** in cash as of June 30, 2025, and an anticipated need for additional financing by Q3 2026 - Profound Medical Corp. is a commercial-stage medical device company focused on developing and selling incision-free treatment systems that utilize platform technology for ablating diseased tissue[19](index=19&type=chunk) Cash Balance (USD in thousands) | Date | Cash Balance | | :--- | :--- | | June 30, 2025 | 35,195 | | December 31, 2024 | 54,912 | - The company anticipates that existing cash and product sales will meet operating and capital expenditure needs for the next 12 months, but achieving all future strategic plans by Q3 2026 remains dependent on securing additional financing or executing other strategic alternatives[22](index=22&type=chunk) [2 Summary of significant accounting policies](index=9&type=section&id=2%20Summary%20of%20significant%20accounting%20policies) The company prepares its condensed consolidated financial statements in accordance with US GAAP, utilizing estimates and assumptions, and is currently evaluating the disclosure impact of recent accounting standard updates (ASU 2024-03 and ASU 2025-01) - The company prepares its condensed consolidated financial statements in accordance with US Generally Accepted Accounting Principles (US GAAP) and includes all necessary adjustments[23](index=23&type=chunk)[25](index=25&type=chunk) - The financial statements involve management's estimates and assumptions regarding assets, liabilities, revenue, and expenses, and actual results may differ from these estimates[26](index=26&type=chunk) - The FASB issued ASU 2024-03 and ASU 2025-01, requiring improved expense disclosures in the income statement, and the company is evaluating their impact on disclosures, with the standards effective for fiscal years beginning after December 15, 2026[27](index=27&type=chunk) [3 Trade and other receivables, net](index=11&type=section&id=3%20Trade%20and%20other%20receivables%2C%20net) As of June 30, 2025, trade and other receivables, net, decreased to **$4,898 thousand** from **$7,045 thousand** at December 31, 2024, primarily due to reductions in gross trade receivables and contract assets, while the allowance for expected credit losses increased Trade and Other Receivables, Net (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Gross Trade Receivables | 4,114 | 5,245 | (1,131) | -21.6% | | Gross Contract Assets | 596 | 1,340 | (744) | -55.5% | | Trade Receivables and Contract Assets | 4,710 | 6,585 | (1,875) | -28.5% | | Allowance for Expected Credit Losses | (531) | (158) | (373) | 236.1% | | Trade Receivables, Net | 4,179 | 6,427 | (2,248) | -35.0% | | Tax Receivables | 557 | 308 | 249 | 80.8% | | Other Receivables | 162 | 310 | (148) | -47.7% | | **Total Trade and Other Receivables, Net** | **4,898** | **7,045** | **(2,147)** | **-30.5%** | Allowance for Expected Credit Losses Changes (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Beginning Balance | 158 | 76 | | Provision for Expected Credit Losses | 373 | 82 | | Ending Balance | 531 | 158 | [4 Inventory](index=12&type=section&id=4%20Inventory) As of June 30, 2025, total inventory increased to **$8,353 thousand** from **$5,801 thousand** at December 31, 2024, primarily driven by growth in finished goods and raw materials, while inventory charged to cost of sales decreased during the reporting period Inventory Composition (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Finished Goods | 5,621 | 3,837 | 1,784 | 46.5% | | Raw Materials | 2,732 | 1,964 | 768 | 39.1% | | **Total Inventory** | **8,353** | **5,801** | **2,552** | **44.0%** | Inventory Charged to Cost of Sales (USD in thousands) | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | Inventory Charged to Cost of Sales | 496 | 751 | 1,156 | 1,188 | [5 Property and equipment, net](index=12&type=section&id=5%20Property%20and%20equipment%2C%20net) As of June 30, 2025, property and equipment, net, decreased to **$278 thousand** from **$425 thousand** at December 31, 2024, mainly due to equipment depreciation and sales to customers, with depreciation expense also decreasing during the period Property and Equipment, Net Composition (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Leasehold Improvements | 542 | 542 | 0 | 0.0% | | Operating Lease Equipment | 1,640 | 2,273 | (633) | -27.9% | | Total | 2,182 | 2,815 | (633) | -22.5% | | Accumulated Depreciation | (1,904) | (2,390) | 486 | -20.3% | | **Property and Equipment, Net** | **278** | **425** | **(147)** | **-34.6%** | Depreciation Expense and Equipment Sales (USD in thousands) | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | Depreciation Expense | 102 | 184 | 218 | 383 | | Sales of Operating Lease Equipment | 135 | — | 213 | — | [6 Intangible assets](index=12&type=section&id=6%20Intangible%20assets) As of June 30, 2025, net intangible assets decreased to **$175 thousand** from **$261 thousand** at December 31, 2024, primarily comprising an exclusive license agreement and software, with the company holding an exclusive license for MRI-guided transurethral ultrasound therapy technology Intangible Assets Composition (USD in thousands) | Metric | June 30, 2025 (Net) | December 31, 2024 (Net) | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Exclusive License Agreement | 83 | 89 | (6) | -6.7% | | Software | 92 | 172 | (80) | -46.5% | | **Total Intangible Assets, Net** | **175** | **261** | **(86)** | **-32.9%** | - The company has an exclusive license agreement with Sunnybrook Health Sciences Centre for MRI-guided transurethral ultrasound therapy technology[31](index=31&type=chunk) [7 Accrued expenses and other current liabilities](index=13&type=section&id=7%20Accrued%20expenses%20and%20other%20current%20liabilities) As of June 30, 2025, total accrued expenses and other current liabilities increased to **$3,802 thousand** from **$2,835 thousand** at December 31, 2024, mainly driven by significant growth in accrued employee compensation and clinical trial expenses Accrued Expenses and Other Current Liabilities Composition (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | Accrued Employee Compensation | 2,000 | 706 | 1,294 | 183.3% | | Clinical Trials | 1,293 | 325 | 968 | 297.8% | | Other General Accruals | 509 | 1,804 | (1,295) | -71.8% | | **Total Accrued Expenses and Other Current Liabilities** | **3,802** | **2,835** | **967** | **34.1%** | [8 Long-term debt](index=13&type=section&id=8%20Long-term%20debt) The company entered into an amended and restated credit agreement with CIBC on March 3, 2025, converting existing long-term debt into a new revolving credit facility with financial covenants, and anticipates a potential covenant breach by December 31, 2025, regarding unrestricted cash levels - The company entered into an amended and restated credit agreement with CIBC on March 3, 2025, converting existing long-term debt into a new revolving credit facility maturing on March 3, 2027[33](index=33&type=chunk) - The credit agreement includes financial covenants requiring unrestricted cash to always exceed EBITDA for the most recent nine-month period and 12-month revenue to grow by 15% over the prior year's comparable period[33](index=33&type=chunk) - The company anticipates a breach of one covenant by December 31, 2025, where unrestricted cash will no longer exceed the required liquidity amount, but management believes sufficient unrestricted cash exists to repay all outstanding debt if it becomes due, even without a waiver[34](index=34&type=chunk) Long-term Debt Changes (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Beginning Balance | 4,661 | 7,104 | | Interest Expense | 190 | 600 | | Interest Paid | (139) | (582) | | Foreign Exchange Impact | 40 | (483) | | Repayments | (290) | (1,978) | | **Ending Balance** | **4,462** | **4,661** | | Less: Current Portion | — | 1,737 | | **Long-term Portion** | **4,462** | **2,924** | [9 Share capital](index=14&type=section&id=9%20Share%20capital) The company is authorized to issue an unlimited number of common shares, with **30,053,142 shares** outstanding as of June 30, 2025, totaling **$281,641 thousand**, granting holders full voting rights and entitlements to dividends and assets upon liquidation - The company is authorized to issue an unlimited number of common shares[36](index=36&type=chunk) Common Shares Issued and Outstanding (USD in thousands) | Date | Number of Shares | Amount | | :--- | :--- | :--- | | June 30, 2025 | 30,053,142 | 281,641 | | December 31, 2024 | 30,039,809 | 281,552 | - Common shareholders possess all voting rights, with one vote per share, and are entitled to dividends declared by the Board of Directors and an equal per-share amount of company assets upon liquidation[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) [10 Share-based payments](index=14&type=section&id=10%20Share-based%20payments) The company's share-based payment activities, including stock options, RSUs, and DSUs, resulted in a significant increase in share-based compensation expense during the reporting period ended June 30, 2025 Stock Option Activity Summary | Metric | December 31, 2024 Balance | Granted | Forfeited/Expired | June 30, 2025 Balance | | :--- | :--- | :--- | :--- | :--- | | Number of Options | 2,291,152 | 54,100 | (197,684) | 2,147,568 | | Weighted Average Exercise Price (C$) | 14.13 | 6.87 | 17.77 | 13.61 | RSUs Activity Summary | Metric | December 31, 2024 Balance | Granted | Vested | Forfeited | June 30, 2025 Balance | | :--- | :--- | :--- | :--- | :--- | :--- | | Number of RSUs | 324,621 | 801,000 | (13,333) | (36,834) | 1,075,454 | | Weighted Average Grant Date Fair Value (C$) | 11.18 | 9.26 | 11.27 | 9.83 | 9.80 | Share-based Compensation Expense (USD in thousands) | Period | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | Stock Options | 125 | 129 | 758 | 298 | | RSUs | 627 | 528 | 869 | 1,017 | | DSUs | 699 | 111 | 813 | 220 | | **Total Share-based Compensation** | **1,451** | **768** | **2,440** | **1,535** | [11 Revenue](index=16&type=section&id=11%20Revenue) For the three months ended June 30, 2025, total revenue slightly decreased due to lower capital sales, offset by recurring revenue growth, while for the six months, total revenue significantly increased, driven by higher US recurring revenue and international capital sales Revenue by Product and Service Type (USD in thousands) | Period | Recurring Non-Capital Revenue (2025 3 months) | Capital Equipment Revenue (2025 3 months) | Total Revenue (2025 3 months) | Recurring Non-Capital Revenue (2024 3 months) | Capital Equipment Revenue (2024 3 months) | Total Revenue (2024 3 months) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 1,561 | 650 | 2,211 | 1,460 | 773 | 2,233 | | Period | Recurring Non-Capital Revenue (2025 6 months) | Capital Equipment Revenue (2025 6 months) | Total Revenue (2025 6 months) | Recurring Non-Capital Revenue (2024 6 months) | Capital Equipment Revenue (2024 6 months) | Total Revenue (2024 6 months) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 3,362 | 1,470 | 4,832 | 2,899 | 773 | 3,672 | [12 Loss per share](index=17&type=section&id=12%20Loss%20per%20share) For the three and six months ended June 30, 2025, basic and diluted loss per share both increased to **$0.52** and **$0.88**, respectively, with diluted loss per share equaling basic loss per share due to the anti-dilutive effect of share-based awards Basic and Diluted Loss Per Share (USD) | Metric | June 30, 2025 (3 months) | June 30, 2024 (3 months) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | 15,695 | 6,919 | 26,419 | 13,504 | | Weighted Average Common Shares Outstanding | 30,053,142 | 24,440,444 | 30,055,047 | 24,373,869 | | Basic and Diluted Loss Per Share | 0.52 | 0.28 | 0.88 | 0.55 | - Diluted loss per share is equal to basic loss per share due to the anti-dilutive effect of stock options, RSUs, and DSUs[52](index=52&type=chunk) [13 Segment reporting](index=17&type=section&id=13%20Segment%20reporting) The company operates as a single medical technology segment, with the United States being the primary source of revenue, followed by Canada and Germany, and total assets predominantly located in Canada - The company's operations are classified as a single medical technology segment, focusing on MRI-guided ablation therapy[53](index=53&type=chunk) Revenue by Geographic Area (USD in thousands) | Period | Canada (2025 3 months) | United States (2025 3 months) | Germany (2025 3 months) | Total (2025 3 months) | Canada (2024 3 months) | United States (2024 3 months) | Germany (2024 3 months) | Total (2024 3 months) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Recurring Non-Capital Revenue | 94 | 1,327 | 140 | 1,561 | 99 | 1,101 | 260 | 1,460 | | Capital Equipment Revenue | — | 650 | — | 650 | 773 | — | — | 773 | | **Total Revenue** | **94** | **1,977** | **140** | **2,211** | **872** | **1,101** | **260** | **2,233** | | Period | Canada (2025 6 months) | United States (2025 6 months) | Germany (2025 6 months) | Total (2025 6 months) | Canada (2024 6 months) | United States (2024 6 months) | Germany (2024 6 months) | Total (2024 6 months) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Recurring Non-Capital Revenue | 376 | 2,620 | 366 | 3,362 | 203 | 2,259 | 437 | 2,899 | | Capital Equipment Revenue | 570 | 900 | — | 1,470 | 773 | — | — | 773 | | **Total Revenue** | **946** | **3,520** | **366** | **4,832** | **976** | **2,259** | **437** | **3,672** | Total Assets by Geographic Area (USD in thousands) | Geographic Area | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Canada | 38,180 | 58,743 | | United States | 6,802 | 6,351 | | Germany | 1,502 | 1,661 | | China | 60 | 92 | | Finland | 3,124 | 3,387 | | **Total Assets** | **49,668** | **70,234** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Profound Medical Corp.'s financial condition and operating results for the period ended June 30, 2025, highlighting its business overview, operational performance, key financial components, liquidity and capital resources, and critical accounting policies [Overview](index=19&type=section&id=Overview) Profound Medical Corp. is a commercial-stage medical device company developing and selling incision-free treatment systems for image-guided tissue ablation, utilizing its TULSA-PRO system for prostate tissue ablation and Sonalleve platform for uterine fibroids and bone metastases, with a hybrid revenue model in the US and capital sales internationally - The company is a commercial-stage medical device company focused on developing and selling incision-free treatment systems for image-guided ablation of diseased tissue[56](index=56&type=chunk) - Its primary product, the TULSA-PRO system, combines real-time MRI, robotically driven transurethral thermal ultrasound, and closed-loop temperature feedback control for prostate tissue ablation, holding CE Mark, Health Canada approval, and FDA 510(k) clearance[56](index=56&type=chunk)[57](index=57&type=chunk) - The Sonalleve platform has CE Mark for uterine fibroids and palliative pain treatment of bone metastases, FDA Humanitarian Device Exemption approval for osteoid osteoma, and approval in China for non-invasive treatment of uterine fibroids[58](index=58&type=chunk) - The company employs a hybrid recurring revenue business model in the United States (one-time equipment, system usage, Genius service, or capital sale plus per-patient fee) and primarily a capital sales model outside North America[59](index=59&type=chunk)[60](index=60&type=chunk)[64](index=64&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2025, revenue slightly decreased by 1%, but gross profit increased by 14% with a 73% gross margin; however, significant increases in R&D and SG&A expenses led to a 127% rise in net loss, while for the six months, revenue grew by 32% and gross profit by 52% with a 72% gross margin, but increased operating expenses and foreign exchange losses resulted in a 96% surge in net loss Results of Operations Summary (USD in thousands) | Metric | June 30, 2025 (3 months) | June 30, 2024 (3 months) | Change (%) | June 30, 2025 (6 months) | June 30, 2024 (6 months) | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 2,211 | 2,233 | -1% | 4,832 | 3,672 | 32% | | Cost of Sales | 593 | 812 | -27% | 1,361 | 1,385 | -2% | | Gross Profit | 1,618 | 1,421 | 14% | 3,471 | 2,287 | 52% | | Gross Margin | 73% | 64% | +9pp | 72% | 62% | +10pp | | Research and Development Expenses | 6,098 | 4,205 | 45% | 10,906 | 8,150 | 34% | | Selling, General and Administrative Expenses | 9,326 | 5,058 | 84% | 17,537 | 9,856 | 78% | | Operating Loss | 13,806 | 7,842 | 76% | 24,972 | 15,719 | 59% | | Net Loss | 15,695 | 6,919 | 127% | 26,419 | 13,504 | 96% | | Basic and Diluted Loss Per Share | 0.52 | 0.28 | 86% | 0.88 | 0.55 | 60% | [Key Components of Our Results of Operations](index=23&type=section&id=Key%20Components%20of%20Our%20Results%20of%20Operations) This section analyzes changes in the company's revenue, cost of sales, operating expenses (R&D, SG&A), and finance income/expense, highlighting revenue composition from recurring non-capital and capital equipment sales, improved gross margins due to efficiency, increased operating expenses from commercialization and R&D investments, and decreased net finance income due to lower cash interest [Revenue_MDA](index=23&type=section&id=Revenue_MDA) For the three months ended June 30, 2025, total revenue was **$2,211 thousand**, a 1% year-over-year decrease primarily due to reduced capital sales, partially offset by growth in US recurring revenue, while for the six months, total revenue was **$4,832 thousand**, a 32% year-over-year increase driven by higher US recurring revenue and international capital sales Revenue Composition and Changes (USD in thousands) | Period | Recurring Non-Capital Revenue (2025) | Capital Equipment Revenue (2025) | Total Revenue (2025) | Recurring Non-Capital Revenue (2024) | Capital Equipment Revenue (2024) | Total Revenue (2024) | Total Revenue Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 3 months | 1,561 | 650 | 2,211 | 1,460 | 773 | 2,233 | -1% | | 6 months | 3,362 | 1,470 | 4,832 | 2,899 | 773 | 3,672 | 32% | - The three-month revenue decrease was primarily driven by reduced capital sales, partially offset by growth in US recurring revenue[65](index=65&type=chunk) - The six-month revenue increase was primarily due to higher US recurring revenue and international capital sales[66](index=66&type=chunk) [Cost of Sales_MDA](index=24&type=section&id=Cost%20of%20Sales_MDA) For the three months ended June 30, 2025, cost of sales decreased by 27% to **$593 thousand**, improving gross margin to 73%, while for the six months, cost of sales decreased by 2% to **$1,361 thousand**, improving gross margin to 72%, with gross profit growth attributed to manufacturing efficiencies and a favorable sales mix of high-margin capital equipment Cost of Sales, Gross Profit, and Gross Margin (USD in thousands) | Period | Cost of Sales (2025) | Gross Profit (2025) | Gross Margin (2025) | Cost of Sales (2024) | Gross Profit (2024) | Gross Margin (2024) | Cost of Sales Change (%) | Gross Profit Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 3 months | 593 | 1,618 | 73% | 812 | 1,421 | 64% | -27% | 14% | | 6 months | 1,361 | 3,471 | 72% | 1,385 | 2,287 | 62% | -2% | 52% | - The decrease in cost of sales and increase in gross profit are primarily attributable to existing customers purchasing capital equipment (which has higher margins) and improved manufacturing efficiencies[68](index=68&type=chunk)[69](index=69&type=chunk) [Operating Expenses_MDA](index=24&type=section&id=Operating%20Expenses_MDA) Operating expenses, comprising R&D and SG&A, significantly increased during the reporting period due to higher personnel costs, increased clinical trial investments, expanded commercialization activities, and elevated marketing expenses [R&D Expenses](index=24&type=section&id=R%26D%20Expenses) For the three months ended June 30, 2025, R&D expenses increased by 45% to **$6,098 thousand**, primarily due to increased personnel, higher recruitment and treatment activities for the CAPTAIN trial, and rising travel expenses, with the six-month increase of 34% to **$10,906 thousand** also including higher material expenditures for MRI compatibility and cost reduction efforts Research and Development Expenses and Changes (USD in thousands) | Period | 2025 | 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | 3 months | 6,098 | 4,205 | 1,893 | 45% | | 6 months | 10,906 | 8,150 | 2,756 | 34% | - The increase in R&D expenses is primarily attributable to: * Increased personnel * Higher recruitment and treatment activities for the CAPTAIN trial * Rising travel expenses * Increased material expenditures to improve MRI scanner compatibility, reduce design costs, and enhance efficiency (for the six-month period)[72](index=72&type=chunk)[73](index=73&type=chunk) [SG&A expenses](index=26&type=section&id=SG%26A%20expenses) For the three months ended June 30, 2025, SG&A expenses increased by 84% to **$9,326 thousand**, mainly due to sales team expansion, higher commission payments, and increased travel and infrastructure costs, with the six-month increase of 78% to **$17,537 thousand** also including costs for educational events like Pro-Talk Live Selling, General and Administrative Expenses and Changes (USD in thousands) | Period | 2025 | 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | 3 months | 9,326 | 5,058 | 4,268 | 84% | | 6 months | 17,537 | 9,856 | 7,681 | 78% | - The increase in selling, general and administrative expenses is primarily attributable to: * Expansion of the sales team * Higher commission payments * Increased travel and infrastructure costs * Costs associated with hosting educational events like Pro-Talk Live (for the six-month period)[77](index=77&type=chunk)[78](index=78&type=chunk) [Net finance (income) expense](index=26&type=section&id=Net%20finance%20(income)%20expense) For the three and six months ended June 30, 2025, net finance (income) expense decreased, primarily due to a reduction in cash interest income Net Finance (Income) Expense and Changes (USD in thousands) | Period | 2025 | 2024 | Change Amount | Change Percentage | | :--- | :--- | :--- | :--- | :--- | | 3 months | (343) | (422) | 79 | -19% | | 6 months | (788) | (884) | 96 | -11% | - The decrease in net finance (income) expense is primarily due to lower cash interest income[80](index=80&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company's cash balance was **$35,195 thousand**, a decrease from December 31, 2024, with existing cash and product sales expected to support operations for the next 12 months, but additional financing will be required by Q3 2026 to achieve all future strategic plans Cash Balance (USD in thousands) | Date | Cash Balance | | :--- | :--- | | June 30, 2025 | 35,195 | | December 31, 2024 | 54,912 | - The company anticipates that existing cash and product sales will meet operating and capital expenditure needs for the next 12 months, but achieving all future strategic plans by Q3 2026 remains dependent on securing additional financing or executing other strategic alternatives[82](index=82&type=chunk) [Use of Proceeds](index=27&type=section&id=Use%20of%20Proceeds) The company detailed the use of proceeds from its 2024 public offering, primarily for commercialization and development of TULSA-PRO and Sonalleve systems, as well as working capital and general corporate purposes, and outlined the terms, financial covenants, and potential default risks of its amended CIBC credit agreement 2024 Public Offering Proceeds Usage (as of June 30, 2025, USD in thousands) | Purpose | Amount Expended | | :--- | :--- | | TULSA-PRO Commercialization | 18,277 | | Sonalleve Development and Commercialization | 6,092 | | Working Capital and General Corporate Purposes | 4,826 | | **Total** | **29,195** | - The company entered into an amended and restated credit agreement with CIBC on March 3, 2025, converting existing long-term debt into a new revolving credit facility up to **$15,000 thousand**, which includes financial covenants[87](index=87&type=chunk) [Cash Flows_MDA](index=27&type=section&id=Cash%20Flows_MDA) For the six months ended June 30, 2025, the company experienced a net cash outflow of **$22,027 thousand** from operating activities, primarily due to net loss and increased expenses from commercialization, and a net cash outflow of **$290 thousand** from financing activities, mainly for long-term debt repayments, while foreign exchange rate changes positively impacted cash by **$2,600 thousand** Cash Flows Summary (USD in thousands) | Metric | June 30, 2025 (6 months) | June 30, 2024 (6 months) | Change Amount | | :--- | :--- | :--- | :--- | | Net Cash from Operating Activities | (22,027) | (10,748) | (11,279) | | Net Cash from Financing Activities | (290) | 19,853 | (20,143) | | Effect of Exchange Rate Changes | 2,600 | (1,239) | 3,839 | | Net Increase (Decrease) in Cash | (19,717) | 7,866 | (27,583) | [Operating Activities](index=29&type=section&id=Operating%20Activities) For the six months ended June 30, 2025, net cash outflow from operating activities was **$22,027 thousand**, primarily driven by a net loss of **$26,419 thousand** and increased expenses related to commercialization and product expansion, including personnel, travel, clinical trial, and marketing costs - Net cash outflow from operating activities for the first half of 2025 was **$22,027 thousand**, primarily due to a net loss of **$26,419 thousand** and increased expenses from commercialization and product expansion[89](index=89&type=chunk) - Increased expenses include personnel, travel, clinical trial costs, and marketing expenses[89](index=89&type=chunk) [Financing Activities](index=29&type=section&id=Financing%20Activities) For the six months ended June 30, 2025, net cash outflow from financing activities was **$290 thousand**, primarily for long-term debt principal repayments, contrasting with a net cash inflow of **$19,853 thousand** in the prior year's comparable period, mainly from common share issuance proceeds - Net cash outflow from financing activities for the first half of 2025 was **$290 thousand**, primarily used for long-term debt principal repayments[91](index=91&type=chunk) - Net cash inflow from financing activities for the first half of 2024 was **$19,853 thousand**, mainly from **$21,079 thousand** in common share issuance proceeds, partially offset by **$1,227 thousand** in long-term debt repayments[91](index=91&type=chunk) [Foreign Exchange on Cash](index=29&type=section&id=Foreign%20Exchange%20on%20Cash) Exchange rate fluctuations impacted the company's foreign currency-denominated cash, resulting in a **$2,600 thousand** increase in cash holdings - Exchange rate fluctuations impacted the company's foreign currency-denominated cash, resulting in a **$2,600 thousand** increase in cash holdings[17](index=17&type=chunk)[88](index=88&type=chunk)[92](index=92&type=chunk) [Funding Requirements](index=29&type=section&id=Funding%20Requirements) The company anticipates existing cash and product sales will cover operations and capital expenditures for the next 12 months, but additional capital may be needed for R&D and operational expansion, with potential funding sources including equity/debt financing, development agreements, or strategic collaborations, and failure to secure such funding could lead to operational adjustments or delays - The company anticipates that existing cash and product sales will meet operating and capital expenditure needs for the next 12 months, but expects increased expenses primarily due to the ongoing commercialization of TULSA-PRO and Sonalleve[93](index=93&type=chunk) - The company may require additional capital to fund research and development activities and any significant operational expansion[95](index=95&type=chunk) - Potential funding sources include equity and/or debt financing, development or marketing agreements, revenue from future commercialization activities, and/or new strategic collaboration agreements[95](index=95&type=chunk) - Failure to obtain additional funding could lead to operational adjustments, delays in clinical trials, hindered product development programs, or an inability to pursue market approvals in a timely manner[95](index=95&type=chunk) [Critical Accounting Policies and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no significant changes to the company's critical accounting policies since December 31, 2024, with detailed information available in the 2024 annual report - There have been no significant changes to the company's critical accounting policies since December 31, 2024[96](index=96&type=chunk) - For a detailed description of critical accounting policies, refer to Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," in the company's 2024 Annual Report filed on March 7, 2025[96](index=96&type=chunk) [Recent Accounting Pronouncements_MDA](index=31&type=section&id=Recent%20Accounting%20Pronouncements_MDA) For detailed information on recent accounting pronouncements, please refer to Note 2 of the condensed consolidated financial statements in Part I, Item 1 of this quarterly report - For detailed information on recent accounting pronouncements, please refer to Note 2 of the condensed consolidated financial statements in Part I, Item 1 of this quarterly report[97](index=97&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable - This section is not applicable[98](index=98&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) This section assesses the effectiveness of the company's disclosure controls and procedures and discloses a material weakness in internal control over financial reporting, along with ongoing remediation efforts [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) As of June 30, 2025, the company's management, including the Chief Executive Officer and Chief Financial Officer, assessed and determined that its disclosure controls and procedures were effective in ensuring timely recording, processing, summarizing, and reporting of required information - As of June 30, 2025, the company's management, including the Chief Executive Officer and Chief Financial Officer, assessed and determined that its disclosure controls and procedures were effective[100](index=100&type=chunk) - Disclosure controls and procedures are designed to ensure that required information is recorded, processed, summarized, and reported within SEC-prescribed timeframes and communicated to management for disclosure decisions[99](index=99&type=chunk) [Changes in Internal Control Over Financial Reporting](index=31&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) For the three months ended June 30, 2025, there were no significant changes in internal control over financial reporting, apart from ongoing remediation activities for a previously identified material weakness in revenue recognition controls as of December 31, 2024, which is expected to be completed in 2025 through financial team expansion and third-party consultant engagement - For the three months ended June 30, 2025, there were no significant changes in internal control over financial reporting, apart from ongoing remediation activities for a previously identified material weakness[101](index=101&type=chunk) - As of December 31, 2024, the company's internal control over financial reporting had a material weakness, specifically that controls over the review of contract terms and customer arrangements for revenue recognition (ASC 606) were not operating effectively, leading to audit adjustments[102](index=102&type=chunk)[104](index=104&type=chunk) - The company is implementing a remediation plan, including expanding its finance team with CPAs possessing US GAAP expertise and engaging third-party consultants to assist in evaluating complex revenue contracts, with completion expected in 2025[105](index=105&type=chunk) PART II. Other Information [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in or aware of any legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations - The company is not currently involved in or aware of any legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations[107](index=107&type=chunk) - Regardless of the outcome, litigation could adversely affect the company due to defense and settlement costs, diversion of management resources, and other factors[107](index=107&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors since the disclosure in its 2024 annual report - There have been no material changes to the company's risk factors since the disclosure in its 2024 annual report[108](index=108&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds during this reporting period - There were no unregistered sales of equity securities or use of proceeds during this reporting period[109](index=109&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during this reporting period - There were no defaults upon senior securities during this reporting period[110](index=110&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) There were no mine safety disclosures during this reporting period - There were no mine safety disclosures during this reporting period[111](index=111&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) This section discloses that no Rule 10b5-1(c) trading plans were adopted, modified, or terminated by the company's directors or officers during the reporting period [Rule 10b5-1 Trading Plans](index=33&type=section&id=Rule%2010b5-1%20Trading%20Plans) For the three months ended June 30, 2025, no contracts, instructions, or written plans intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) for buying or selling securities were adopted, modified, or terminated by the company's directors or officers - For the three months ended June 30, 2025, no contracts, instructions, or written plans intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) for buying or selling securities were adopted, modified, or terminated by the company's directors or officers[112](index=112&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with this quarterly report, including articles of incorporation, bylaws, and certifications from the Chief Executive Officer and Chief Financial Officer Exhibit List | Exhibit Number | Exhibit Description | Filed with this Report | | :--- | :--- | :--- | | 3.1 | Articles of Incorporation | No | | 3.2 | Amendments | No | | 3.3 | Amalgamated Articles | No | | 3.4 | By-laws | No | | 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | Yes | | 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | Yes | | 32† | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | Yes | | 101.INC | Inline XBRL Instance Document | Yes | | 101.SCH | Inline XBRL Taxonomy Extension Schema Document | Yes | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | Yes | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | Yes | | 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | Yes | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | Yes | | 104 | Cover Page Interactive Data File | Yes | - The certification document for Exhibit 32 is not deemed filed with the Securities and Exchange Commission and shall not be incorporated by reference into any filing by the company under the Securities Act of 1933 or the Securities Exchange Act of 1934[114](index=114&type=chunk) Signatures [Signature Details](index=34&type=section&id=Signatures_Details) This report was duly signed by Arun Menawat, Chief Executive Officer, and Rashed Dewan, Chief Financial Officer, of Profound Medical Corp. on August 14, 2025 - This report was signed by Arun Menawat, Chief Executive Officer, and Rashed Dewan, Chief Financial Officer, of Profound Medical Corp. on August 14, 2025[118](index=118&type=chunk)

Core Viewpoint - Profound Medical Corp. is set to announce its second quarter 2025 financial results on August 14, 2025, and will host a conference call to discuss these results and business developments [1][2]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, incision-free therapies for the ablation of diseased tissue [3]. Product Offerings - The company is commercializing TULSA-PRO, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven transurethral ultrasound for the treatment of prostate diseases. The TULSA procedure is designed to preserve urinary continence and sexual function while effectively targeting prostate tissue [4]. - TULSA is a single-session, incision-free procedure that operates at temperatures of 55-57°C, with no associated bleeding or hospital stay required, allowing for quick recovery [4]. - Profound is also marketing Sonalleve, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases. It has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments [5].

TULSA-PRO Overview - FDA cleared TULSA-PRO in August 2019, with the first commercial site in January 2020, and AI assistant cleared in May 2024[1] - Over 50 sites have installed TULSA-PRO, treating over 3,000 patients using a patient cash pay business model[1] - New reimbursement codes established by AMA, placed by CMS in urology Level 7, effective January 2025[1] - TULSA-AI Volume Reduction announced at AUA 2025, expanding the applicability of TULSA-PRO[1] Clinical Evidence and Utilization - 99% of patients treated with TULSA-PRO have prostate cancer (PCa), with 28% of those also having low-grade BPH[33] - 53% of ablations performed are whole gland ablations, offering flexibility in treatment[33] - TACT pivotal trial showed a median perfused prostate volume decrease of 91%, from 37 cc to 3 cc, on MRI at 1 year[60] Market and Reimbursement - The total addressable market (TAM) for TULSA is approximately $5 billion, with about 70% in recurring revenue[36] - Medicare reimbursement for TULSA treatment became effective January 1, 2025, classified at Urology Level 7[107] TULSA-AI Volume Reduction - TULSA-AI Volume Reduction uses Volume Customizer and Treatment Arc for BPH symptom relief[54] - TULSA for BPH resulted in a 73% improvement in IPSS symptoms in a Phase I-II study[69]

Core Viewpoint - Profound Medical Corp. has successfully conducted the first commercial treatment for benign prostatic hyperplasia (BPH) using the new TULSA-AI Volume Reduction Module, enhancing the TULSA-PRO system's capabilities for incision-free therapies [1][4]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, AI-powered, incision-free therapies for the ablation of diseased tissue [1][7]. - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology to treat various prostate diseases, including BPH and prostate cancer [8]. Treatment Details - The TULSA procedure is a "one-and-done" treatment that is incision- and radiation-free, performed in a single session lasting a few hours, with no bleeding or hospital stay required [3][8]. - The new TULSA-AI Volume Reduction module streamlines the procedure, allowing for personalized treatment plans and reducing total skin-to-skin time to an expected 60-90 minutes [5][6]. Clinical Efficacy - A recent Phase II study showed significant improvements in urinary function and quality of life for BPH patients treated with TULSA, with the International Prostate Symptom Score (IPSS) decreasing from 17 to 4 and maximum urine flow rate increasing from 11.1 to 18.3 mL/s [4]. - 96% of patients who were on BPH medications prior to the TULSA procedure discontinued their use after treatment [4]. Market Potential - The introduction of the TULSA-AI Volume Reduction module is expected to expand the total addressable market for prostate disease patients from 200,000 to 600,000 annually [7].

Core Insights - Profound Medical Corp has entered a consulting agreement with Leonard Wheeler, a former NFL player, to enhance awareness and advocacy for its TULSA-PRO system, a treatment for prostate cancer [1][2][10] - The TULSA procedure is a non-invasive, AI-powered therapy that utilizes real-time MRI guidance and sound absorption technology to treat prostate tissue while preserving urinary continence and sexual function [7][12] Company Overview - Profound Medical Corp is a commercial-stage medical device company focused on developing customizable, incision-free therapies for the ablation of diseased tissue [11] - The company is commercializing the TULSA-PRO system, which is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA [12] Product Details - The TULSA procedure is designed for a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [7][12] - The procedure is performed in a single session, takes a few hours, and does not require hospitalization, with most patients reporting a quick recovery [7][12] Partnership and Advocacy - Leonard Wheeler, who underwent the TULSA procedure, will create platforms to educate and empower men regarding prostate health and the TULSA-PRO system [2][8] - The partnership aims to launch a comprehensive awareness campaign utilizing digital media, social media, and podcasting to reach a broader audience [10]

Core Points - Profound Medical Corp. held its Annual General and Special Meeting of Shareholders, with 20,587,011 common shares represented, accounting for 68.5% of the outstanding shares [1][2] - All matters presented to shareholders were approved by the requisite majority [2] Election of Directors - All six nominees for the board of directors were elected with the following voting results: - Arun Menawat: 11,147,209 votes (94.536% for) [3] - Brian Ellacott: 11,048,084 votes (93.695% for) [3] - Cynthia Lavoie: 11,438,299 votes (97.005% for) [3] - Murielle Lortie: 11,291,509 votes (95.76% for) [3] - Arthur Rosenthal: 10,899,784 votes (92.438% for) [3] - Kris Shah: 11,040,268 votes (93.629% for) [3] Other Matters - Shareholders approved the appointment of PricewaterhouseCoopers LLP as the auditor until the next annual meeting [4] - An ordinary resolution was passed approving all unallocated options under the Company's share option plan [4] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for the ablation of diseased tissue [5] - The company is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, and robotically driven ultrasound for prostate disease treatment [6] - TULSA-PRO® is designed to preserve urinary continence and sexual function while effectively treating prostate tissue [6] - Profound is also commercializing Sonalleve®, a platform for treating uterine fibroids and palliative pain from bone metastases, with various regulatory approvals [7]

Group 1 - Profound Medical Corporation held its Q1 2025 earnings conference call on May 8, 2025, at 4:30 PM ET [1] - The call featured key company participants including the Head of Investor Relations, CFO, COO, Chief Commercial Officer, and CEO [1] - The conference call was recorded and included a question and answer session following the presentations [1] Group 2 - The Head of Investor Relations, Stephen Kilmer, initiated the call and mentioned that it would include forward-looking statements as per applicable securities laws in the US and Canada [2][3] - Forward-looking statements are based on the company's current beliefs and expectations regarding future financial performance and the efficacy of its technologies in treating various medical conditions [3] - The company cautioned listeners about the inherent risks and uncertainties associated with forward-looking statements, emphasizing that actual results may differ materially from those implied [3]

分组1 - Profound Medical reported a quarterly loss of $0.36 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.29, and a decline from a loss of $0.26 per share a year ago, indicating an earnings surprise of -24.14% [1] - The company generated revenues of $2.62 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 24.03%, and showing an increase from $1.91 million in the same quarter last year [2] - Profound Medical shares have decreased by approximately 36% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] 分组2 - The earnings outlook for Profound Medical is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.27 on revenues of $4.2 million, and for the current fiscal year at -$1.06 on revenues of $19.04 million [7] - The Medical - Drugs industry, to which Profound Medical belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7][8] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [8] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [8] - The net loss for Q1 2025 was $10.7 million, or $0.36 per share, compared to a net loss of $6.6 million, or $0.27 per share, in Q1 2024 [9] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million of total revenue, while $820,000 came from one-time capital equipment sales [7] - The TULSA PRO technology was highlighted for its strong presence at medical meetings, particularly the American Urological Association meeting [10] Market Data and Key Metrics Changes - The CAPTAIN clinical trial data was presented, showing TULSA's effectiveness compared to robotic radical prostatectomy, which is expected to drive adoption [10][11] - The introduction of the TULSA AI volume reduction module is anticipated to enhance procedure efficiency and expand the total addressable market [19] Company Strategy and Development Direction - The company aims to leverage the CAPTAIN trial results to drive mainstream adoption of TULSA technology [29] - The TULSA Plus program is designed to facilitate adoption by providing a comprehensive solution for urologists [21][24] - The company is focusing on expanding its commercial organization to support growth and enhance market presence [20][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline and the impact of Medicare reimbursement on future revenue growth [58][59] - The company is optimistic about the increasing patient demand and the positive feedback from the medical community regarding TULSA technology [36][41] Other Important Information - The TULSA AI volume reduction module is set for limited release in June 2025, with a full release planned for Q4 2025 [19] - The company is actively engaging with commercial insurers to secure reimbursement policies for TULSA procedures [38][39] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals eager to adopt the data for mainstream use [36][37] Question: Plans for presenting to commercial insurers - Conversations with insurers have begun, and there is optimism about securing reimbursement policies [38][39] Question: Activity at the AUA booth - The level of interest from physicians was high, and the feedback on the volume reduction module was tremendous [41][42] Question: Guidance for the year - The company remains on track for 70% to 75% growth compared to 2024, with a back-end loaded revenue model [46][50] Question: Sales resources and team readiness - The sales team is fully ramped up, with specialized teams in place for health economics and market access [51][53] Question: Engagement of Medicare and Medicaid patients - Initial impacts of reimbursement were limited, but there is growing engagement and billing activity from hospitals [58][59] Question: Marketing plans and materials - The company is ramping up digital marketing efforts and plans to utilize satisfied patients as advocates [60][62] Question: Capital revenue details - Most capital revenue came from new sites, with some conversions from existing sites [73][74] Question: Timing for TULSA Plus availability - The TULSA Plus model is expected to be compatible by the end of Q3 2025, with specific deals to be announced [78][79]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7][8] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [8] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [8] - The net loss for Q1 2025 was $10.7 million, or $0.36 per share, compared to a net loss of $6.6 million, or $0.27 per share, in Q1 2024 [9] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million of total revenue, while $820,000 came from one-time capital equipment sales [7] - The TULSA PRO technology was highlighted for its strong presence at medical meetings, particularly the American Urological Association meeting [10] Market Data and Key Metrics Changes - The CAPTAIN clinical trial data was presented, showing TULSA's effectiveness compared to robotic radical prostatectomy, which is expected to drive adoption [10][11] - The introduction of the TULSA AI volume reduction module is anticipated to expand the total addressable market for BPH treatments [19] Company Strategy and Development Direction - The company aims to leverage the CAPTAIN trial data to drive mainstream adoption of TULSA technology and establish guidelines for its use [29] - The TULSA Plus program is designed to facilitate adoption by providing a comprehensive solution for urologists [21][24] - The company is focusing on expanding its commercial organization to support growth and enhance market access [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline and the impact of Medicare reimbursement on future revenue growth [58][59] - The company is optimistic about the increasing patient demand and the positive feedback from the medical community regarding TULSA technology [36][41] Other Important Information - The TULSA AI volume reduction module is expected to be released in Q4 2025, enhancing the efficiency of BPH procedures [19][31] - The company is actively engaging with commercial insurers to secure reimbursement policies for TULSA treatments [38][39] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals eager to adopt the data for mainstream use [36][37] Question: Plans for presenting CAPTAIN data to commercial insurers - Conversations with insurers have begun, and there is optimism about securing reimbursement policies [38][39] Question: Activity at the AUA booth - The level of interest from physicians was high, and the introduction of the volume reduction module received tremendous feedback [41][42] Question: Guidance for the year and revenue growth expectations - Management remains confident in achieving 70% to 75% revenue growth compared to 2024, with a back-end loaded pipeline [46][49] Question: Status of sales resources and team ramp-up - The sales team is fully ramped, with specialized teams in place for health economics and market access [52][54] Question: Engagement of Medicare and Medicaid patients - Initial impacts of reimbursement were limited, but there is growing confidence in the pipeline and patient engagement [58][59] Question: Marketing plans and patient engagement - The company is ramping up digital marketing efforts and plans to utilize satisfied patients as advocates for TULSA [60][62] Question: Capital revenue details for the quarter - Most capital revenue came from new sites, with some conversions from existing sites [73][74] Question: Timing and benefits of the TULSA Plus program - The TULSA Plus program is expected to be compatible by the end of Q3 2025, with ongoing discussions about economic models [78][81]