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PROCEPT BioRobotics Received U.S. FDA Approval to Initiate Pivotal Randomized Clinical Study for Prostate Cancer
GlobeNewswire News Room· 2024-10-07 20:04
A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of Aquablation Therapy in Men with Grade Group 1 to 3 Localized Prostate Cancer Represents Potential Paradigm Shift in How Urologists Might Treat Localized Prostate Cancer SAN JOSE, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the "Company"), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced the U.S. Food a ...
PROCEPT BioRobotics to Present at Upcoming 2024 Wells Fargo Healthcare Conference on September 4, 2024
GlobeNewswire News Room· 2024-08-28 20:03
Company Overview - PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care through transformative solutions in urology [3] - The HYDROSTM Robotic System is the only AI-Powered robotic technology that delivers Aquablation therapy, designed for effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) [3] - BPH is the most common prostate disease, affecting approximately 40 million men in the United States [3] Clinical Evidence - The company has developed a significant and growing body of clinical evidence, with over 150 peer-reviewed publications supporting the benefits and clinical advantages of Aquablation therapy [3] Upcoming Events - Management will present at the 2024 Wells Fargo Healthcare Conference in Boston, Massachusetts, on September 4 at 1:30 p.m. Eastern Time [1] - A live webcast of the event will be available on the company's website, with archived recordings accessible for at least 90 days after the event [2]
Procept BioRobotics: Risk Capital Unlock With FDA Hydros Approval
Seeking Alpha· 2024-08-27 12:30
1 IF D H HT T 100 - 100 1 i T 1 Pgiam/iStock via Getty Images Investment update Following my last publication on PROCEPT BioRobotics Corporation (NASDAQ:PRCT) around 12 months ago, the stock is +146% and now trades above $78/share. The most recent catalyst was the FDA's 510(k) approval of the company's HYDROS Robotic System ("Hydros"), extending PRCT's offerings in benign prostatic hypertrophy ("BPH") even further. Investors have bought PRCT on the news + the stock gapped above a key ~$70/share technical le ...
PROCEPT BioRobotics' (PRCT) HYDROS System Gets FDA Clearance
ZACKS· 2024-08-22 18:06
Company Update - PROCEPT BioRobotics announced FDA 510(k) clearance for its next-generation HYDROS Robotic System, marking a significant milestone in the adoption of Aquablation therapy [1] - The HYDROS Robotic System incorporates major technological innovations developed over years of research and is expected to drive the company's next growth phase [2] - The system is designed to enhance productivity, improve surgeon experience, and deliver precise, consistent treatment plans, with a full market release anticipated within the current quarter [4] Product Features - The HYDROS Robotic System features FirstAssist AI treatment planning, advanced image guidance, and robotic resection, aiming to provide superior clinical outcomes [5] - It integrates digital cystoscopy, next-generation ultrasound imaging, and dual high-definition touchscreens for improved anatomy visualization [6] - The system uses a heat-free waterjet to remove obstructive tissue while protecting vital structures, ensuring efficient and predictable execution across various prostate sizes [7] Industry Outlook - The global BPH treatment devices market was valued at $1.42 billion in 2022 and is projected to grow at a CAGR of 8.9% from 2023 to 2030 [8] - Growth is driven by technological advancements, increasing prevalence of urological illnesses, and rising patient awareness of minimally invasive treatment options [8][9] - Demand for innovative, minimally invasive technologies like Aquablation therapy is expected to rise due to fewer side effects and faster recovery times compared to traditional surgical methods [9] Stock Performance - PRCT's shares have gained 99% year-to-date, significantly outperforming the industry's 9.4% rise and the S&P 500's 17.8% increase [10]
PROCEPT (PRCT) Grows in Urology With FDA Clearance for HYDROS
ZACKS· 2024-08-22 14:16
Company Overview - PROCEPT BioRobotics has received FDA 510(k) clearance for its HYDROS Robotic System, which aims to enhance urological care through advanced features [1] - The HYDROS system is expected to facilitate PROCEPT's expansion in the Aquablation therapy market, which is experiencing significant growth in the U.S. [2] Technology and Innovation - The HYDROS Robotic System utilizes AI-driven technology, specifically FirstAssist AI, to optimize treatment planning by analyzing over 50,000 Aquablation procedures [3] - Advanced imaging capabilities, including next-generation ultrasound and digital cystoscopy, allow for precise tissue removal while protecting critical anatomy [4] - The system's streamlined workflow and intuitive interface are designed to improve surgeon ergonomics and operating room efficiency, promoting quicker adoption among new surgeons [5] Market Prospects - The global urology devices market is projected to grow from $34.1 billion in 2023 to $48.6 billion by 2028, representing a CAGR of 7.3% [5] - Growth drivers include the rising prevalence of urological diseases, increasing demand for minimally invasive surgeries, and technological advancements [5] Share Price Performance - Year-to-date, PROCEPT's stock has surged by 99%, significantly outperforming the industry average growth of 9.1% [6]
PROCEPT BioRobotics Announces FDA Clearance of the HYDROS™ Robotic System, the Next-Generation, AI-Powered Platform for Aquablation® Therapy
GlobeNewswire News Room· 2024-08-21 11:00
SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the "Company"), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. HYDROS is d ...
Is PROCEPT BioRobotics the Next Big Thing in Surgical Robotics?
MarketBeat· 2024-08-14 11:15
Core Viewpoint - PROCEPT BioRobotics is positioned as a significant player in the surgical robotics market, particularly with its AquaBeam Robotic System for treating benign prostatic hyperplasia (BPH), and has shown strong revenue growth and stock performance since its public listing [1][6][7]. Company Overview - PROCEPT BioRobotics specializes in surgical robotics, focusing on the AquaBeam Robotic System designed for BPH treatment [1][4]. - The company went public during the SPAC boom in 2021 and has maintained a stock price near its historical highs, unlike many other SPACs [1]. Market Context - BPH is a prevalent condition among aging men, affecting nearly 50% of men aged 50 to 61, and up to 90% of men over 80 years old, with an estimated 14 million men in the U.S. and 30 million globally suffering from it [2]. - The U.S. market for BPH treatment exceeds $20 billion, indicating a substantial opportunity for growth [2]. Product Details - The AquaBeam Robotic System utilizes Aquablation therapy, a minimally invasive procedure that employs a high-velocity, heat-free water jet to remove excess prostate tissue, providing real-time imaging for precise treatment [3][4]. - The system is sold for approximately $350,000 per unit, with recurring revenue generated from consumables and maintenance services [4]. Financial Performance - In Q3 2024, PROCEPT reported a revenue increase of 61.2% year-over-year to $53.35 million, surpassing consensus estimates [6]. - U.S. handpiece and consumables revenue rose by 101% year-over-year to $27.3 million, with 47 robotic systems sold during the quarter [6]. - The company raised its full-year 2024 revenue guidance to $217 million, reflecting strong operational performance and market penetration [7]. Analyst Ratings and Stock Performance - PROCEPT BioRobotics has a consensus "Buy" rating among analysts, with a 12-month price target of $66.00, indicating a potential upside of 2.17% [6][7]. - The stock has been trading within a rectangle channel pattern, with resistance at $68.94 and support at $53.95 [5].
PROCEPT BioRobotics (PRCT) - 2024 Q2 - Quarterly Report
2024-08-02 20:29
Revenue and Profit - Revenue for the three months ended June 30, 2024, was $53,353 thousand, a 61% increase from $33,104 thousand for the same period in 2023[10] - Gross profit for the six months ended June 30, 2024, was $56,516 thousand, compared to $30,920 thousand for the same period in 2023, reflecting an increase of 83%[10] - Total revenue for the six months ended June 30, 2024, was $97.892 million, a 70.4% increase from $57.508 million for the same period in 2023[45] - U.S. revenue for the three months ended June 30, 2024, was $47.668 million, up 59.3% from $29.928 million in the same period last year[45] Expenses - Research and development expenses for the three months ended June 30, 2024, were $17,501 thousand, up 50% from $11,613 thousand in the same period of 2023[10] - Selling, general and administrative expenses increased to $40,809 thousand for the three months ended June 30, 2024, compared to $32,441 thousand for the same period in 2023, representing a 26% increase[10] - Stock-based compensation for the six months ended June 30, 2024, totaled $14.242 million, an increase from $8.827 million in the same period in 2023[34] - The company recognized rent expenses of $1.8 million and $1.9 million for the three months ended June 30, 2024 and 2023, respectively, and $3.4 million and $4.0 million for the six months ended June 30, 2024 and 2023[49] Net Loss - The net loss for the three months ended June 30, 2024, was $(25,626) thousand, slightly higher than the net loss of $(25,285) thousand for the same period in 2023[10] - Net loss for the six months ended June 30, 2024, was $51,583,000, compared to a net loss of $53,771,000 for the same period in 2023, representing a decrease of 4.1%[16] - The company reported a net loss per share of $(1.01) for the six months ended June 30, 2024, compared to $(1.19) for the same period in 2023[42] Assets and Liabilities - Total current assets decreased to $321,892 thousand as of June 30, 2024, from $350,500 thousand as of December 31, 2023[8] - Total liabilities decreased to $122,571 thousand as of June 30, 2024, from $123,900 thousand as of December 31, 2023[8] - Stockholders' equity decreased to $251,779 thousand as of June 30, 2024, from $280,700 thousand as of December 31, 2023[8] - The company’s total property and equipment, net, was $27,675,000 as of June 30, 2024, compared to $28,740,000 at December 31, 2023, a decrease of 3.7%[29] Cash Flow - Cash used in operating activities decreased to $48,022,000 for the six months ended June 30, 2024, from $64,267,000 in the prior year, a reduction of 25.4%[16] - The company’s cash flow from investing activities was $2,989,000 for the six months ended June 30, 2024, down from $10,711,000 in the prior year, a decrease of 72.0%[16] - The company reported cash and cash equivalents of $214,093,000 as of June 30, 2024, down from $257,222,000 at December 31, 2023, a decrease of 16.7%[25] - Cash and cash equivalents amounted to $214.1 million as of June 30, 2024, with minimal risk associated with fluctuating interest rates due to the nature of the securities held[92] Stock and Equity - The company issued 507 common shares under stock plans, resulting in an increase of $5,296 thousand in additional paid-in capital[12] - The weighted-average common shares used to compute net loss per share increased to 51,622 thousand for the three months ended June 30, 2024, from 45,160 thousand for the same period in 2023[10] - Proceeds from the issuance of common stock from the exercise of stock options amounted to $5,759,000 for the six months ended June 30, 2024, compared to $1,093,000 in the same period of 2023, an increase of 426.5%[16] - As of June 30, 2024, the company had 6.8 million shares available for grant under the 2021 Equity Incentive Award Plan[35] Debt and Obligations - The company’s long-term debt includes a senior secured term loan facility of $52.0 million, fully borrowed in October 2022[30] - The company is obligated to maintain a minimum of $90.0 million in deposit accounts held at the lender[32] - Future minimum annual operating lease payments total $42.866 million, with debt repayments amounting to $52 million, leading to total future payments of $94.866 million[49] Risks and Market Conditions - The company is exposed to interest rate risks with loan facility amounts bearing interest at an annual rate based on the secured overnight financing rate (SOFR) plus a margin of 2.25%[93] - A portion of net sales and expenses are denominated in foreign currencies, exposing the company to foreign currency risks, particularly with fluctuations in the Euro[95] - Inflation has generally increased costs related to labor and research and development, but it is not believed to have had a material effect on financial statements[96] - No customer accounted for greater than 10% of accounts receivable as of June 30, 2024, indicating a diversified customer base and mitigated credit risk[94] Regulatory and Product Developments - The AquaBeam Robotic System received 510(k) clearance from the FDA on August 30, 2023, allowing it to treat BPH in patients with an active diagnosis of prostate cancer[17] - The company awarded approximately 61,000 performance stock units (PSUs) during the six months ended June 30, 2024, with performance conditions to be defined later[38] - Approximately $1.8 million of unrecognized cost related to the Employee Stock Purchase Plan (ESPP) is expected to be recognized over a weighted average period of 0.8 years[41]
PROCEPT BioRobotics Corporation (PRCT) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-01 22:51
PROCEPT BioRobotics Corporation (PRCT) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.52. This compares to loss of $0.56 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 3.85%. A quarter ago, it was expected that this company would post a loss of $0.55 per share when it actually produced a loss of $0.51, delivering a surprise of 7.27%. Over the last four quarters, the comp ...
PROCEPT BioRobotics® Reports Second Quarter 2024 Financial Results and Increases 2024 Revenue and EBITDA Guidance
GlobeNewswire News Room· 2024-08-01 20:03
SAN JOSE, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics Corporation (Nasdaq: PRCT) (the "Company"), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported unaudited financial results for the quarter ended June 30, 2024. Recent Highlights Total revenue of $53.4 million for the second quarter of 2024, an increase of 61% compared to the prior period in 2023 U.S. handpiece and consumables revenue of $27.3 million for the se ...