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]

Core Insights - Profound Medical Corp. has introduced its third TULSA-AI® software module, UA Alignment Assistant, aimed at enhancing the TULSA procedure for prostate treatment [1][5] - The TULSA procedure is positioned as a potential mainstream treatment for various prostate conditions, including prostate cancer and benign prostatic hyperplasia (BPH) [2][9] - The upcoming presentations at RSNA 2024 and SUO 2024 will showcase the efficacy and advancements of the TULSA procedure [5][7] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for diseased tissue ablation [8] - The company is commercializing the TULSA-PRO® system, which integrates real-time MRI guidance and ultrasound technology for precise treatment [9][10] TULSA Procedure Details - The TULSA procedure utilizes real-time MR guidance to precisely target prostate tissue, heating it to 55-57°C without incisions or radiation [2][9] - It is designed to preserve urinary continence and sexual function, with a single-session treatment that typically requires no hospital stay [2][9] UA Alignment Assistant Software - The UA Alignment Assistant streamlines the alignment of the ultrasound applicator during the TULSA procedure, improving workflow consistency and reducing manual steps [4][5] - This software enhancement is expected to simplify the procedure for users, thereby increasing efficiency and confidence in clinical outcomes [3][5] Upcoming Presentations - The RSNA 2024 will feature multiple presentations on the TULSA procedure, including studies on its efficacy and patient outcomes [5][7] - Notable presentations will come from institutions such as the Busch Center, UT Southwestern Medical Center, and the Mayo Clinic [5][7]

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]

TORONTO, Oct. 17, 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, will announce its third quarter 2024 financial results after market close on Thursday, November 7, 2024. 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. ...

Core Insights - Profound Medical Corp. is set to announce its second quarter 2024 financial results on August 8, 2024, after market close [4] - The company is actively commercializing innovative medical technologies, including Sonalleve® and TULSA-PRO®, aimed at non-invasive treatment of various medical conditions [3][6] 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 [4][7] - The company has received CE marking, Health Canada approval, and FDA clearance for its technologies, indicating compliance with regulatory standards [6] Product Developments - Sonalleve® is a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases, with potential applications in non-invasive ablation of abdominal cancers [3] - TULSA-PRO® combines real-time MRI and ultrasound technology for customizable prostate ablation, with applications in various stages of prostate cancer and benign prostatic hyperplasia [6]

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. Date: Thursday, August 8, 2024 Live Call Registration: https://register.vevent.com/register/BIbfa8c9bee6c6463c8ca3a1937fbfd804 About Profound Medical Corp. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide custo ...