Profound(PROF) - 2025 Q2 - Quarterly Results

Profound Medical Announces Second Quarter 2025 Financial Results This report details Profound Medical's financial and operational performance for the second quarter of 2025, highlighting key business developments and financial results Business Highlights Profound Medical reported continued growth in TULSA-PRO system utilization and a robust sales pipeline in Q2 2025. Key developments included positive clinical trial data for TULSA, the launch of the TULSA-AI Volume Reduction Module, and strategic partnerships, despite some short-term delays in capital sales TULSA-PRO System Utilization and Sales Pipeline TULSA-PRO procedure volumes increased sequentially, and the sales pipeline expanded with numerous new systems in advanced stages - TULSA-PRO 'same store' procedure volumes increased by 10% sequentially from Q1-2025[2] - The TULSA-PRO qualified sales pipeline now includes 80 new systems in the 'Verify, Negotiate and Contracting' stages[2] Patient Demographics and Treatment Intent Analysis of TULSA-PRO patient data reveals primary use for prostate cancer, with a significant portion for hybrid treatments and varying cancer grades TULSA-PRO Patient Treatment Breakdown (Q2 2025) | Category | Percentage | | :-------------------------------- | :--------- | | Prostate cancer only | 79% | | Hybrid (cancer & BPH) | 17% | | Salvage | 3% | | BPH only | 1% | TULSA-PRO Patient Cancer Grade Breakdown (Q2 2025) | Cancer Grade | Percentage | | :------------- | :--------- | | GG1 | 4% | | GG2 | 53% | | GG3 | 28% | | GG4 & GG5 | 15% | TULSA-PRO Patient Intention-to-Treat Breakdown (Q2 2025) | Intention-to-Treat | Percentage | | :------------------- | :--------- | | Whole gland | 48% | | Sub-total (> half gland) | 26% | | Hemi-ablations or focal therapy | 26% | Clinical Data and Research Initial CAPTAIN trial data indicates TULSA's significant perioperative benefits over robotic radical prostatectomy - Initial perioperative data from the CAPTAIN randomized trial showed MRI-guided TULSA provided statistically significant improvement in post-operative experience compared to robotic radical prostatectomy (RP), with no blood loss, no overnight stay, reduced pain, and faster recovery[2] Product Development and Strategic Partnerships Profound launched the TULSA-AI Volume Reduction Module and is on track with Siemens Healthineers for a combined prostate solution - The first commercial BPH treatment using the new TULSA-AI Volume Reduction Module was successfully conducted in June 2025, with a full launch expected in Q4-2025[2][3] - Profound and Siemens Healthineers remain on track to initiate sales of their combined total prostate solution (TULSA-PRO and Magnetom Free.Max MR scanner) before the end of 2025[3] Corporate Governance and Brand Advocacy Shareholders approved all matters at the AGM, and a former NFL player was appointed Global Ambassador for TULSA-PRO - All matters presented at the Annual General and Special Meeting of Shareholders in May 2025 were approved, and six nominees were elected to the board of directors[2] - Leonard Wheeler, a former NFL player and TULSA procedure recipient, was named Global Ambassador for TULSA-PRO in June 2025 to drive global awareness and advocacy[2] CEO Commentary and 2025 Outlook CEO noted short-term capital sales delays in Q2 2025 but reaffirmed the target of 70% to 75% year-over-year revenue growth for 2025 - CEO Arun Menawat noted short-term delays in completing a few TULSA-PRO capital sales in Q2 2025, which would have pushed total revenues over $3 million[3] - The Company continues to target total year-over-year revenue growth in the approximate range of 70% to 75% for 2025, driven by a growing sales pipeline and strong procedure volume growth[3] Summary Second Quarter 2025 Financial Results Profound Medical's Q2 2025 revenue remained flat year-over-year at $2.2 million, with recurring revenue showing a slight increase. Gross margin improved significantly to 73%, but operating expenses rose substantially due to increased headcount, trial enrollment, and sales force expansion, leading to a higher net loss Revenue Performance Q2 2025 total revenue remained stable year-over-year at $2.2 million, with recurring non-capital revenue slightly increasing Q2 2025 Revenue Breakdown (USD in thousands) | Category | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :------ | :------ | :----------- | | Recurring - non-capital | $1,561 | $1,460 | +$101 | | Capital equipment | $650 | $773 | -$123 | | Total Revenue | $2,211 | $2,233 | -$22 | - Total revenue for Q2 2025 was approximately $2.2 million, essentially unchanged from the prior year period[4] Gross Margin Analysis Gross margin significantly improved to 73% in Q2 2025, driven by enhanced manufacturing efficiency Q2 2025 Gross Margin | Period | Gross Margin | | :----- | :----------- | | Q2 2025 | 73% | | Q2 2024 | 64% | - Gross margin expanded to 73% in Q2 2025 from 64% in the prior year period, primarily due to higher manufacturing efficiency rates[5] Operating Expenses Operating expenses increased substantially to $15.4 million in Q2 2025 due to higher headcount, trial enrollment, and sales force expansion Q2 2025 Total Operating Expenses (USD in thousands) | Period | Total Operating Expenses | | :----- | :----------------------- | | Q2 2025 | $15,424 | | Q2 2024 | $9,263 | - Total operating expenses increased to approximately $15.4 million in Q2 2025 from $9.3 million in Q2 2024, driven by increased headcount, CAPTAIN trial enrollment, sales force expansion, commissions, and infrastructure costs[6] Net Loss and Per Share Data Net loss for Q2 2025 significantly widened to $15.7 million, resulting in a higher loss per common share Q2 2025 Net Loss and EPS | Period | Net Loss (USD in thousands) | EPS | | :----- | :-------------------------- | :---- | | Q2 2025 | $15,695 | $0.52 | | Q2 2024 | $6,919 | $0.28 | - Net loss for Q2 2025 was approximately $15.7 million, or $0.52 per common share, compared to $6.9 million, or $0.28 per common share, in Q2 2024[7] Liquidity and Outstanding Share Capital As of June 30, 2025, Profound Medical held $35.2 million in cash. The number of common shares outstanding increased slightly since the end of 2024 Liquidity and Share Capital | Metric | As of June 30, 2025 | As of August 14, 2025 | | :------------------------ | :------------------ | :-------------------- | | Cash | ~$35.2 million | N/A | | Common Shares Outstanding | 30,053,142 | 30,053,142 | - As of June 30, 2025, Profound had cash of approximately $35.2 million[8] About Profound Medical Corp. Profound Medical is a commercial-stage medical device company specializing in incision-free therapies for diseased tissue ablation. Its primary technologies are TULSA-PRO for prostate diseases and Sonalleve for uterine fibroids and palliative pain Company Profile Profound Medical is a commercial-stage medical device company focused on developing and marketing customizable, AI-powered, incision-free tissue ablation therapies - Profound Medical Corp. is a commercial-stage medical device company developing and marketing customizable, AI-powered, incision-free therapies for diseased tissue ablation[1][11] TULSA-PRO Technology Overview TULSA-PRO is an MRI-guided, robotically-driven transurethral ultrasound system for prostate disease, offering incision- and radiation-free treatment - TULSA-PRO combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for treating the entire prostate disease spectrum[12] - The TULSA procedure is incision- and radiation-free, performed in a single session, and aims to preserve urinary continence and sexual function while ablating targeted prostate tissue[12] - TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA[12] Sonalleve Technology Overview Sonalleve is a therapeutic platform CE marked for uterine fibroids and palliative pain, with FDA approval for osteoid osteoma and ongoing exploration for other cancers - Sonalleve is a therapeutic platform CE marked for uterine fibroids and palliative pain treatment of bone metastases, and approved in China for uterine fibroids[13] - Sonalleve also has FDA approval under a Humanitarian Device Exemption for osteoid osteoma and is being explored for non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy[13] Forward-Looking Statements This section outlines the forward-looking nature of certain statements in the release, including expectations for technology efficacy, TULSA-PRO sales, 2025 revenue growth, and commercialization strategy. It cautions that actual results may differ due to various known and unknown risks inherent in the medical device industry and market conditions - Forward-looking statements include expectations regarding the efficacy of Profound's technology, timing of TULSA-PRO system sales, full-year 2025 revenue growth (70-75%), and U.S. commercialization strategy[14] - Such statements are subject to known and unknown risk factors and uncertainties, including those related to the medical device industry, regulatory approvals, reimbursement, economic factors, and competition[14] Conference Call Details Profound Medical invited interested parties to a conference call on August 14, 2025, at 4:30 pm ET to discuss the Q2 2025 results, with pre-registration required for telephone participation and a live webcast available on the company's website - A conference call was scheduled for August 14, 2025, at 4:30 pm ET to discuss the Q2 2025 results[10] - Participants could pre-register for dial-in or access a live broadcast and archive on Profound's website[10] Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated financial statements for Profound Medical Corp., including the Balance Sheets, Statements of Operations and Comprehensive Loss, and Statements of Cash Flows, providing detailed financial performance and position for Q2 2025 and the six months ended June 30, 2025, compared to prior periods Condensed Consolidated Balance Sheets The balance sheets show a decrease in cash and total shareholders' equity from December 31, 2024, to June 30, 2025 Condensed Consolidated Balance Sheets (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Assets | | | | Cash | $35,195 | $54,912 | | Total current assets | $48,811 | $69,065 | | Total assets | $49,668 | $70,234 | | Liabilities | | | | Total current liabilities | $5,724 | $6,565 | | Total liabilities | $10,409 | $9,812 | | Shareholders' Equity | | | | Total shareholders' equity | $39,259 | $60,422 | - Cash decreased from $54.9 million at December 31, 2024, to $35.2 million at June 30, 2025[17] - Total shareholders' equity decreased from $60.4 million at December 31, 2024, to $39.3 million at June 30, 2025[17] Condensed Consolidated Statements of Operations and Comprehensive Loss Statements show increased total revenue for the six months ended June 30, 2025, but also a significant rise in net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenue | $2,211 | $2,233 | $4,832 | $3,672 | | Gross profit | $1,618 | $1,421 | $3,471 | $2,287 | | Total operating expenses | $15,424 | $9,263 | $28,443 | $18,006 | | Operating loss | $13,806 | $7,842 | $24,972 | $15,719 | | Net loss attributed to shareholders | $15,695 | $6,919 | $26,419 | $13,504 | | Basic and diluted net loss per common share | $0.52 | $0.28 | $0.88 | $0.55 | - For the six months ended June 30, 2025, total revenue increased to $4.8 million from $3.7 million in the prior year period, while net loss increased to $26.4 million from $13.5 million[18] Condensed Consolidated Statements of Cash Flows Cash flow statements indicate a substantial increase in net cash used in operating activities for the six months ended June 30, 2025 Condensed Consolidated Statements of Cash Flows (USD in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(22,027) | $(10,748) | | Net cash provided by (used in) financing activities | $(290) | $19,853 | | Net increase (decrease) in cash and cash equivalents | $(22,317) | $9,105 | | Cash, end of period | $35,195 | $34,079 | - Net cash used in operating activities significantly increased to $22.0 million for the six months ended June 30, 2025, compared to $10.7 million in the prior year period[19] - Cash at the end of the period was $35.2 million, a decrease from $54.9 million at the beginning of the period (December 31, 2024, from balance sheet) but comparable to $34.1 million at June 30, 2024[19][17]