Revenue Performance - For Q4 2024, Profound recorded revenue of approximately $4.2 million, a 108% increase from $2.0 million in Q4 2023[4] - Full year 2024 revenue was approximately $10.7 million, compared to $7.2 million in 2023, with recurring revenue of $8.2 million[8] - Revenue for Q4 2024 reached $4.177 million, a 108.8% increase from $2.009 million in Q4 2023[26] - Recurring non-capital revenue increased to $2.679 million, up 33.3% from $2.009 million year-over-year[26] - Capital equipment revenue surged to $1.498 million, compared to $0 in Q4 2023, marking a significant growth[26] Operating Expenses - Total operating expenses for Q4 2024 were $11.3 million, up from $9.8 million in the prior year, primarily due to increased headcount and R&D investments[5] - Total operating expenses rose to $40.099 million in 2024, up 21.7% from $32.963 million in 2023[27] - Research and development expenses for Q4 2024 were $4.649 million, up 17.0% from $3.978 million in Q4 2023[27] Net Loss - The net loss for Q4 2024 was approximately $4.9 million, or $0.20 per share, a 45% improvement from a net loss of $8.9 million, or $0.42 per share, in Q4 2023[6] - For the full year 2024, Profound's net loss was approximately $27.8 million, or $1.12 per share, compared to a net loss of $28.3 million, or $1.34 per share, in 2023[10] - Net loss for the year was $27.816 million, slightly down from $28.323 million in 2023[28] - Basic and diluted net loss per share improved to $0.20 in Q4 2024 from $0.42 in Q4 2023[27] Cash Position - As of December 31, 2024, Profound had cash of approximately $54.9 million, an increase from $26.2 million in 2023[11] - Cash and cash equivalents at the end of 2024 increased to $54.912 million, compared to $26.213 million at the end of 2023[29] - Issuance of common shares generated $62.106 million in financing activities, significantly higher than $0 in 2023[29] Collaborations and Innovations - The company announced a non-exclusive collaboration with Siemens Healthineers to expand access to the TULSA procedure[7] - Profound launched the TULSA-AI module 'UA Alignment Assistant' in November 2024, simplifying the TULSA procedure[7] - The CAPTAIN clinical trial has completed patient enrollment, with data expected to be released at the AUA 2025 annual meeting[7] Credit Agreement - The amended credit agreement with CIBC allows for a revolving line of credit of up to $15 million, contingent on achieving certain revenue thresholds[17]

Financial Data and Key Metrics Changes - For Q4 2024, the company recorded revenue of $4.2 million, a 108% increase from $2 million in Q4 2023 [9] - Gross margin in Q4 2024 was 71%, compared to 52% in Q4 2023 [9] - Total operating expenses in Q4 2024 were $11.3 million, up from $9.8 million in Q4 2023 [10] - The net loss for Q4 2024 was $4.9 million, or $0.20 per share, a 45% improvement from a net loss of $8.9 million, or $0.42 per share, in Q4 2023 [10][11] - As of December 31, 2024, the company had cash of $54.9 million [11] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2024 was $2.7 million, while one-time capital equipment sales contributed $1.5 million [9] - The company transitioned from a placement model to a capital model, which is expected to enhance revenue streams [25][56] Market Data and Key Metrics Changes - The company is focusing on the top 50 cancer centers and regional hospitals for TULSA-PRO adoption [28] - The introduction of the BPH TULSA AI module is expected to triple the total addressable market from 200,000 cancer patients to 600,000 prostate disease patients annually [40] Company Strategy and Development Direction - The company aims to enhance awareness and adoption of TULSA-PRO through increased patient education and a robust sales team [37][42] - Plans to introduce TULSA Plus, a combined solution with Siemens interventional MRI, are set for the second half of 2025 [41] - The company anticipates high double-digit growth in 2025, with potential for triple-digit growth in 2026 and beyond [42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value and economic model of TULSA, noting a positive response from hospitals regarding profitability [46][51] - The CAPTAIN trial is expected to provide significant data to support reimbursement and acceptance of TULSA as a treatment modality [38][71] Other Important Information - The company had 17 presentations featuring TULSA-PRO at major society meetings in Q4 2024 [12] - The CAPTAIN trial has randomized 201 patients as of January 2025, with 174 treated or scheduled for treatment [20] Q&A Session Summary Question: What gives confidence for robust growth acceleration in the post-Medicare reimbursement environment? - Management highlighted the clinical value of the product and the economic models showing profitability for hospitals, contributing to confidence in growth rates [46][51] Question: Update on the target of reaching 75 sites and the capital vs. recurring revenue model? - Management indicated that while the target of 75 sites may not be reached, the transition to a capital plus recurring model is yielding positive results [52][53] Question: Timing and regulatory clearances for the BPH product launch? - The BPH module is on track for a mid-year launch, with demo plans at AUA [63] Question: Uptake among Medicare payers and actual payments? - Management noted that actual payments from Medicare take time, but early data suggests positive trends in recurring revenue and satisfaction among users [66][68] Question: Strategy for pursuing specific insurance companies for reimbursement? - A specialized team is being developed to prioritize insurance companies based on payment history and regional install bases [71][72]

Company Performance - Profound Medical reported a quarterly loss of $0.20 per share, better than the Zacks Consensus Estimate of a loss of $0.30, and an improvement from a loss of $0.42 per share a year ago, representing an earnings surprise of 33.33% [1] - The company posted revenues of $4.18 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.55%, but showing growth from year-ago revenues of $2.01 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times, but has not been able to beat consensus revenue estimates [2] Stock Outlook - Profound Medical shares have declined approximately 2.4% since the beginning of the year, compared to a decline of 0.7% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.27 on revenues of $3.8 million, and for the current fiscal year, it is -$1.07 on revenues of $24.09 million [7] - The estimate revisions trend for Profound Medical is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Drugs industry, to which Profound Medical belongs, is currently ranked in the bottom 46% of over 250 Zacks industries, suggesting that the outlook for the industry can significantly impact stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Core Viewpoint - Profound Medical (PROF) is anticipated to report a year-over-year increase in earnings driven by higher revenues, with the actual results being a significant factor influencing its near-term stock price [1][2]. Earnings Expectations - The earnings report is scheduled for March 6, 2025, and is expected to show a quarterly loss of $0.30 per share, reflecting a year-over-year change of +28.6% [3]. - Revenues are projected to reach $4.2 million, representing a 109% increase from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 7.02% higher in the last 30 days, indicating a collective reassessment by analysts [4]. - A positive Earnings ESP of +13.33% suggests that analysts have recently become more optimistic about the company's earnings prospects [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive reading is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [8]. - However, the current Zacks Rank for Profound Medical is 4, which complicates the prediction of an earnings beat despite the positive Earnings ESP [11]. Historical Performance - In the last reported quarter, Profound Medical was expected to post a loss of $0.33 per share but actually reported a loss of $0.38, resulting in a surprise of -15.15% [12]. - Over the past four quarters, the company has only beaten consensus EPS estimates once [13]. Conclusion - While the potential for an earnings beat exists, the combination of a positive Earnings ESP and a Zacks Rank of 4 suggests that Profound Medical may not be a compelling candidate for an earnings surprise [16].

Core Insights - K18 Biomimetic Hairscience is launching its products at Cosmo Prof, enhancing its commitment to the stylist community with innovative products and educational support [1][2] - The brand's products will be available on the Cosmo Prof App and website starting March 21, 2025, with nationwide availability in the US and Canada from April 1, 2025 [2] - K18 focuses on empowering stylists and consumers through advanced biotechnology, aiming to transform haircare and enhance self-expression without damage [3][4] Product Offerings - K18's flagship product, the Leave-In Molecular Repair Hair Mask, utilizes the K18PEPTIDE™ to repair hair damage in minutes, alongside the K18REPAIR™ Service, a two-step treatment for restoring hair vitality [4][9] - The brand's innovative AirWash™ Dry Shampoo features odorBIND™, a technology that eliminates odors and provides fragrance for up to three days [9] - K18 has received over 20 billion TikTok views and more than 25 awards, including WWD Product of the Year and Fast Company's Most Innovative [5][11] Strategic Partnerships - The partnership with Cosmo Prof allows K18 to reach a broader audience of professional stylists, providing them with innovative tools and educational resources to enhance their artistry and business [4][6] - K18 is committed to educating stylists on the science behind its products and the business aspects of the K18REPAIR™ service, supporting their income growth [6] Company Background - K18 is a biotechnology-driven haircare brand co-founded by Suveen Sahib, known for its patented K18PEPTIDE™, which mimics human hair's molecular structure to repair damage [8][12] - The brand has expanded its reach to over 100 countries and was acquired by Unilever in 2024, furthering its mission to deliver sustainable and science-backed haircare solutions [11]

Group 1 - Shares of Profound Medical (PROF) have increased by 2.8% over the past four weeks, closing at $7.83, with a mean price target of $15.67 indicating a potential upside of 100.1% [1] - The average price targets range from a low of $12 to a high of $18, with a standard deviation of $3.21, suggesting a potential increase of 53.3% to 129.9% from the current price [2] - Analysts show strong agreement in revising EPS estimates higher, which correlates with potential stock price movements [9][10] Group 2 - The Zacks Consensus Estimate for the current year has increased by 9.5%, indicating positive sentiment among analysts [10] - PROF holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11] - While consensus price targets may not be reliable for predicting exact gains, they can provide guidance on price movement direction [12]

Group 1 - Profound Medical Corp. intends to offer and sell common shares in an underwritten public offering, with a 30-day option for underwriters to purchase an additional 15% of the shares sold [1][3] - The net proceeds from the offering are expected to fund the commercialization and development of the TULSA-PRO® and Sonalleve® systems, as well as for working capital and general corporate purposes [2] - The offering is expected to close on or about December 10, 2024, subject to customary closing conditions and necessary approvals [4] Group 2 - A preliminary prospectus supplement has been filed, and a subsequent prospectus supplement will be filed in accordance with securities regulations in Canada and the United States [5][6] - The common shares are being offered under the prospectus supplement, which will be accessible on SEDAR+ and EDGAR [6] - Profound Medical Corp. is a commercial-stage medical device company that develops incision-free therapies for the ablation of diseased tissue, including the TULSA-PRO® and Sonalleve® systems [9]

TORONTO, Nov. 26, 2024 (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, is pleased to announce the unveiling of its third TULSA-AI® software module, UA Alignment Assistant, in addition to six presentations featuring the Transurethral Ultrasound Ablation (“TULSA”) procedure, at the upcoming 110th Scientific Assembly and ...

Financial Data and Key Metrics Changes - For Q3 2024, the company recorded revenue of $2.83 million, a 64% increase from $1.73 million in Q3 2023, with $2.65 million from recurring revenue and $179,000 from one-time capital equipment sales [7] - Gross margin in Q3 2024 was 64%, up from 61% in Q3 2023, with expectations to maintain or improve this margin throughout 2024 [8] - Total operating expenses for Q3 2024 were $10.8 million, a 42% increase from $7.6 million in Q3 2023, with R&D expenses up 22%, G&A expenses up 84%, and sales and distribution expenses up 34% [9] - The net loss for Q3 2024 was $9.4 million, or $0.38 per share, compared to a net loss of $5.6 million, or $0.26 per share, in Q3 2023 [10] Business Line Data and Key Metrics Changes - The TULSA procedure is gaining traction, with 64% of treatments for primary prostate cancer, 28% for hybrid patients with both cancer and BPH, and 6% for salvage treatments [18] - The commercial use of the TULSA procedure continues to grow, with 82% of treated patients classified as intermediate risk and 11% as high risk [18] Market Data and Key Metrics Changes - The company anticipates revenue for the full year 2024 to be in the range of $11 million to $12 million, based on current business planning [8] - The Medicare national average facility payment for the TULSA procedure will be $12,992, which is 25% higher than that for robotic radical prostatectomy [20] Company Strategy and Development Direction - The company is transitioning from a recurring revenue model to a more traditional medical device business model, which includes upfront capital sales and service agreements [31] - The introduction of TULSA AI modules is expected to enhance treatment efficiency and confidence among urologists, with plans to launch a BPH TULSA AI module in the second half of 2025 [28] - The CAPTAIN study is ongoing, with expectations for data to support further reimbursement acceptance by private insurance companies [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong pipeline and the positive reception of the TULSA procedure following the PRO-TALK Live event [26][38] - The upgraded reimbursement codes are expected to drive adoption and utilization of the TULSA procedure, with management optimistic about achieving growth in 2025 [41][42] Other Important Information - The company held a successful PRO-TALK Live event, which attracted 70 physicians and highlighted the capabilities of the TULSA procedure [11] - The company is actively recruiting to expand its sales team, aiming to grow from 13-15 salespeople to about 40 [53] Q&A Session Summary Question: Update on the goal of reaching 75 installs by year-end - Management reaffirmed strong pipeline and revenue guidance, but achieving 75 installs by year-end may be optimistic due to the transition period [35][36] Question: Response from attendees of the PRO-TALK Live event - Attendees had a strong positive reaction, with many ready to discuss financial justification and moving forward with installations [38] Question: Implications of higher reimbursement on physician uptake and revenue growth - Management believes the upgraded reimbursement will positively impact physician uptake and revenue growth, aligning well with clinical data and existing user satisfaction [40][41] Question: Dynamics behind sales and install pipeline - There was a notable wait-and-see approach from prospects regarding the final reimbursement rule, but now there is increased urgency to close deals [46][49] Question: Sales team hiring plans - The company plans to add at least five more salespeople this year, aiming for a total of about 40 to support growth [53] Question: Interest in traditional model versus pay-per-use model - The shift to a traditional model is driven by increased predictability in patient treatment volumes, making it easier for practices to justify capital expenditures [56][59] Question: Plans for commercial insurance reimbursement - The company is prioritizing getting added to commercial insurance plans, leveraging clinical data from the CAPTAIN trial to support these efforts [63][66]

Profound Medical (PROF) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.33. 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 -15.15%. A quarter ago, it was expected that this company would post a loss of $0.28 per share when it actually produced a loss of $0.28, delivering no surprise. Over the last four quarters, the company has surpassed con ...