TORONTO, July 24, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, will announce its second quarter 2025 financial results after market close on Thursday, August 14, 2025. Profound management will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period. ...

Incision-Free Ablative Intervention With Vision TULSA – A real-time imaging guided therapy platform for ablation of prostate tissue malignant or benign Corporate Presentation | May 2025 © 2025 Profound Medical Corp. NASDAQ: PROF, TSX: PRN 1 • FDA cleared in August 2019; first commercial site in January 2020, AI assistant cleared in May 2024 • Using patient cash pay business model installed >50 sites, >3,000 patients treated • New reimbursement codes established by AMA, placed by CMS in urology Level 7, effe ...

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]

Profound Medical (PROF) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.26 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -24.14%. A quarter ago, it was expected that this company would post a loss of $0.30 per share when it actually produced a loss of $0.20, delivering a surprise of 33.33%.Over the last four quarters, the company has surpas ...

Profound Medical (PROF) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Stephen Kilmer - Investor RelationsRashed Dewan - CFOMathieu Burtnyk - PresidentTom Tamberrino - Chief Commercial OfficerArun Menawat - Chairman & CEOBen Haynor - Managing DirectorJohn McAulay - AVPScott McAuley - Head of Research Conference Call Participants Michael Freeman - Equity Research Analyst - Healthcare Operator Good day, and thank you for standing by. Welcome to the Profound Medical First Quarter twenty tw ...

Profound Medical (PROF) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Stephen Kilmer - Investor RelationsRashed Dewan - CFOMathieu Burtnyk - PresidentTom Tamberrino - Chief Commercial OfficerArun Menawat - Chairman & CEOBen Haynor - Managing DirectorJohn McAulay - AVPScott McAuley - Head of Research Conference Call Participants Michael Freeman - Equity Research Analyst - Healthcare Operator Good day, and thank you for standing by. Welcome to the Profound Medical First Quarter twenty tw ...

Financial Data and Key Metrics Changes - For Q1 2025, the company recorded revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [7] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [7] - 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 [8] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million, while one-time sales of capital equipment contributed $820,000 to total revenue in Q1 2025 [7] Market Data and Key Metrics Changes - The TULSA PRO had a strong presence at medical meetings, including the American Urological Association meeting, where initial data from the CAPTAIN trial was presented [9][10] - The CAPTAIN trial is the first successful randomized controlled trial comparing TULSA technology to robotic radical prostatectomy, highlighting TULSA's advantages [10][11] Company Strategy and Development Direction - The company is focusing on expanding the TULSA technology's adoption through clinical data and patient satisfaction, which is expected to drive demand [15][27] - The introduction of the TULSA AI volume reduction module aims to enhance efficiency and expand the total addressable market for BPH treatments [17][18] - The TULSA Plus program is designed to provide a comprehensive solution for urologists, facilitating the adoption of TULSA technology [20][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growing pipeline and the impact of Medicare reimbursement on patient engagement and revenue [58] - The transition to a capital model in 2025 is expected to lead to back-end loaded revenue growth, with a focus on building relationships with top cancer centers [49][66] Other Important Information - The company is leveraging AI technology to improve treatment efficiency and patient outcomes, which is expected to enhance market competitiveness [17][27] - The TULSA PRO is positioned as a key player in the interventional MRI space, with a focus on urology and prostate disease treatment [20][25] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals and physicians, indicating that the data will help drive adoption and guideline development [33][35] Question: Plans for presenting CAPTAIN data to commercial insurers - Conversations with insurers have begun, and there is optimism about obtaining policies for TULSA treatments as awareness of Medicare reimbursement grows [36][37] Question: Activity at the AUA booth - The booth activity was highly successful, with significant interest from physicians and positive feedback on the volume reduction module [39][40] Question: Guidance for the year and revenue growth expectations - Management remains confident in achieving 70% to 75% revenue growth compared to 2024, despite a back-end loaded revenue model [45][49] Question: Sales force readiness and resources - The company has established a comprehensive sales team and is making progress in training and market development [52][53] Question: Engagement with Medicare and Medicaid patients - Initial revenue impacts from Medicare reimbursement were limited, but there is growing confidence in the pipeline and patient engagement as billing and payments begin to materialize [58] Question: Marketing plans and materials - The company is ramping up digital marketing efforts and plans to utilize satisfied patients, including ex-NFL players, to promote TULSA [60][62] Question: Timing for TULSA Plus availability and economic model - The TULSA Plus model is expected to be compatible by the end of Q3 2025, with ongoing discussions about economic benefits from partnerships with MRI manufacturers [79][81]

[Business Highlights](index=1&type=section&id=Business%20Highlights) Profound Medical achieved 82% Q1 2025 revenue growth, driven by TULSA procedure flexibility and new Urology APC Level 7 codes, with plans for TULSA-AI and TULSA+ launches in H2 2025 - Q1 2025 revenue grew **82%** compared to Q1 2024[4](index=4&type=chunk) - The company's new Urology APC **Level 7** codes provide a competitive advantage with higher payment levels and applicability in more settings (hospitals, ASCs, imaging centers, offices) compared to peers at **Level 6**[3](index=3&type=chunk) - Profound plans to launch two new offerings in the second half of 2025: the **TULSA-AI** module for BPH and the **TULSA+** total interventional-MRI solution[3](index=3&type=chunk) TULSA-PRO Patient Treatment Mix (Q1 2025) | Category | Breakdown | | :--- | :--- | | **Indication** | 82% Prostate Cancer, 10% Hybrid (Cancer & BPH), 8% Salvage | | **Cancer Grade** | 11% GG1, 64% GG2, 17% GG3, 8% GG4 & GG5 | | **Ablation Type** | 33% Whole Gland, 31% Sub-total, 18% Hemi-ablation, 18% Focal | | **Prostate Size** | 6% <20cc, 38% 20-40cc, 39% 40-60cc, 13% 60-100cc, 4% >100cc | - Initial data from the **CAPTAIN trial** presented at AUA 2025 showed that MRI-guided TULSA offered statistically significant improvements in post-operative experience versus robotic radical prostatectomy, including no blood loss, no overnight stay, and reduced pain[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Profound Medical's Q1 2025 revenue reached **$2.6 million** with **71%** gross margin, but increased operating expenses led to a **$10.7 million** net loss, ending with **$46.4 million** cash [Q1 2025 Financial Summary](index=2&type=section&id=Summary%20First%20Quarter%202025%20Results) Profound's Q1 2025 revenue grew **82%** to **$2.6 million**, with gross margin at **71%**, but operating expenses rose **49%** to **$13.0 million**, resulting in a **$10.7 million** net loss Q1 2025 vs Q1 2024 Financial Highlights | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $2.6M | $1.4M | +82% | | - Recurring Revenue | $1.8M | $1.4M | +28% | | - Capital Equipment | $0.8M | $0 | N/A | | **Gross Margin** | 71% | 60% | +11 p.p. | | **Operating Expenses** | $13.0M | $8.7M | +49% | | **Net Loss** | $10.7M | $6.6M | +62% | | **Net Loss per Share** | $0.36 | $0.27 | +33% | - The increase in operating expenses was driven by investments to expand the commercial organization, increased variable compensation, accelerated R&D, and higher travel and conference costs[7](index=7&type=chunk) [Liquidity and Share Capital](index=2&type=section&id=Liquidity%20and%20Outstanding%20Share%20Capital) Profound Medical maintained **$46.4 million** in cash as of March 31, 2025, with **30,053,142** common shares outstanding as of May 8, 2025 Liquidity and Share Capital Overview | Item | Amount | As of Date | | :--- | :--- | :--- | | Cash | $46.4 million | March 31, 2025 | | Common Shares Outstanding | 30,053,142 | May 8, 2025 | [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Profound's total assets decreased to **$60.9 million** by March 31, 2025, primarily due to reduced cash, leading to a decline in shareholders' equity to **$50.8 million** Balance Sheet Summary (in thousands USD) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $46,433 | $54,912 | | Total Current Assets | $59,912 | $69,065 | | **Total Assets** | **$60,864** | **$70,234** | | Total Current Liabilities | $5,295 | $6,565 | | **Total Liabilities** | **$10,074** | **$9,812** | | **Total Shareholders' Equity** | **$50,790** | **$60,422** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHESIVE%20LOSS) Q1 2025 revenue rose to **$2.6 million** and gross profit to **$1.9 million**, but increased operating expenses, especially SG&A, resulted in an **$11.2 million** operating loss and **$10.7 million** net loss Statement of Operations (in thousands USD) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $2,621 | $1,439 | | Gross Profit | $1,853 | $866 | | Research and development | $4,808 | $3,945 | | Selling, general and administrative | $8,211 | $4,798 | | **Total operating expenses** | **$13,019** | **$8,743** | | **Operating loss** | **($11,166)** | **($7,877)** | | **Net loss** | **($10,724)** | **($6,585)** | | **Loss per share** | **$0.36** | **$0.27** | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Q1 2025 saw **$8.3 million** net cash used in operations, leading to an **$8.5 million** decrease in cash, ending the quarter with **$46.4 million** Cash Flow Summary (in thousands USD) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,283) | ($4,529) | | Net cash provided by (used in) financing activities | ($290) | $20,456 | | **Net increase (decrease) in cash** | **($8,573)** | **$15,927** | | **Cash, end of period** | **$46,433** | **$41,180** | [Corporate Information and Products](index=2&type=section&id=About%20Profound%20Medical%20Corp.) Profound Medical is a medical device company focused on incision-free therapies, primarily TULSA-PRO for prostate diseases and Sonalleve for uterine fibroids and bone metastases - **TULSA-PRO** is the company's primary commercialized technology, combining real-time MRI, AI-enhanced planning, and robotically-driven ultrasound to treat the entire prostate disease spectrum from cancer to BPH[13](index=13&type=chunk) - **Sonalleve** is a therapeutic platform commercialized for uterine fibroids and palliative pain treatment of bone metastases, with potential for expansion into other areas like abdominal cancers[15](index=15&type=chunk) - The company will host a conference call at **4:30 pm ET** to discuss the financial results, with a live webcast available on its investor relations website[11](index=11&type=chunk)

[PART I. Financial Information](index=4&type=section&id=PART%20I.%20Financial%20Information) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Q1 2025 unaudited financials show total assets at $60.9 million, revenue at $2.6 million, and a net loss of $10.7 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $60.9 million as of March 31, 2025, primarily due to a reduction in cash, while shareholders' equity declined to $50.8 million Condensed Consolidated Balance Sheet Highlights (USD in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $46,433 | $54,912 | | Total current assets | $59,912 | $69,065 | | **Total assets** | **$60,864** | **$70,234** | | **Liabilities & Equity** | | | | Total current liabilities | $5,295 | $6,565 | | **Total liabilities** | **$10,074** | **$9,812** | | **Total shareholders' equity** | **$50,790** | **$60,422** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 revenue grew 82% to $2.6 million, but operating expenses increased 49% to $13.0 million, leading to a net loss of $10.7 million Q1 2025 vs. Q1 2024 Performance (USD in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $2,621 | $1,439 | | Gross Profit | $1,853 | $866 | | Total Operating Expenses | $13,019 | $8,743 | | Operating Loss | ($11,166) | ($7,877) | | Net Loss | ($10,724) | ($6,585) | | Basic and Diluted Net Loss per Share | ($0.36) | ($0.27) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $8.3 million in Q1 2025, resulting in an $8.5 million decrease in cash, ending at $46.4 million Cash Flow Summary (USD in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,283) | ($4,529) | | Net cash provided by (used in) financing activities | ($290) | $20,456 | | **Net increase (decrease) in cash** | **($8,573)** | **$15,927** | | **Cash, end of period** | **$46,433** | **$41,180** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 revenue growth driven by product mix, increased operating expenses, and ongoing remediation of a material weakness in revenue recognition controls [Overview](index=18&type=section&id=Overview) Profound Medical is a medical device company specializing in MRI-guided therapeutic systems like TULSA-PRO for prostate ablation and Sonalleve for uterine fibroids - The company's lead product, **TULSA-PRO**, is approved by CE, Health Canada, and FDA for incision-free prostate tissue ablation[51](index=51&type=chunk)[52](index=52&type=chunk) - The **Sonalleve** platform is commercialized for uterine fibroids and bone metastases, with approvals in Europe, China, and an FDA Humanitarian Device Exemption[53](index=53&type=chunk) - A hybrid recurring revenue model is employed in the U.S., while a capital sales model is used internationally in Europe and Asia[54](index=54&type=chunk)[55](index=55&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q1 2025 revenue increased 82% to $2.6 million with improved gross margin, while R&D and SG&A expenses rose significantly due to headcount and commercialization efforts Q1 2025 vs Q1 2024 Operational Changes (USD in thousands) | Item | Q1 2025 | Q1 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Revenue | $2,621 | $1,439 | $1,182 | 82% | | Gross Profit | $1,853 | $866 | $987 | 114% | | Gross Margin | 71% | 60% | - | - | | R&D Expenses | $4,808 | $3,945 | $863 | 22% | | SG&A Expenses | $8,211 | $4,798 | $3,413 | 71% | - The increase in R&D expenses was primarily due to increased headcount, higher enrollment for the **CAPTAIN trial**, and greater material expenditures[64](index=64&type=chunk) - SG&A increase was driven by higher sales force commissions, increased travel for conferences, and costs for the 'Pro-Talk Live' educational event[66](index=66&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash and equivalents totaled $46.4 million, deemed sufficient for 12 months, following a credit agreement amendment and partial use of public offering proceeds - Cash and cash equivalents totaled **$46,433 thousand** as of March 31, 2025, expected to fund operations for at least the next 12 months[69](index=69&type=chunk)[70](index=70&type=chunk) - On March 3, 2025, the company amended its credit agreement with CIBC, converting the existing loan into a new revolving line of credit maturing in March 2027[31](index=31&type=chunk)[74](index=74&type=chunk) Use of Proceeds from 2024 Public Offering (as of March 31, 2025, in thousands) | Use of Proceeds | Spending to Date | | :--- | :--- | | TULSA-PRO commercialization | $7,060 | | Sonalleve development and commercialization | $2,541 | | Working capital and general corporate purposes | $2,560 | | **Total** | **$12,161** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section on market risk disclosures is not applicable for the registrant - The company indicates that Quantitative and Qualitative Disclosures About Market Risk are not applicable[86](index=86&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective as of March 31, 2025, but remediation continues for a material weakness in internal control over financial reporting related to revenue recognition - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[88](index=88&type=chunk) - A material weakness in internal control over financial reporting was identified as of December 31, 2024, concerning ineffective controls over revenue recognition contract terms[90](index=90&type=chunk)[92](index=92&type=chunk) - Remediation efforts, including hiring CPAs and engaging consultants, began in Q1 2025 and are expected to conclude in 2025[93](index=93&type=chunk) [PART II. Other Information](index=30&type=section&id=PART%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect - The company is not currently involved in any legal proceedings anticipated to have a material adverse impact[97](index=97&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the 2024 Annual Report on Form 10-K - No material changes have occurred to the risk factors described in the 2024 Annual Report on Form 10-K[98](index=98&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[99](index=99&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans in Q1 2025 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1 trading plans in Q1 2025[102](index=102&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including certifications and Inline XBRL documents - The report includes a list of filed exhibits, such as certifications pursuant to the Sarbanes-Oxley Act and XBRL data files[103](index=103&type=chunk)