Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $69.2 million, representing a growth of 55% compared to Q1 2024 [7][29] - Gross margin for Q1 2025 was 63.9%, consistent with Q4 2024 and up 750 basis points year-over-year [35] - Net loss for Q1 2025 was $24.7 million, compared to a net loss of $26 million in the same period of the prior year [37] Business Line Data and Key Metrics Changes - US revenue for Q1 2025 was $60.3 million, representing a growth of 50% compared to the prior year [29] - The company sold 43 robotic systems in Q1 2025, with an average selling price of approximately $435,000 [31] - US handpiece revenue for Q1 2025 was $38 million, representing a growth of 61% year-over-year, with 11,235 handpieces sold [33] Market Data and Key Metrics Changes - International revenue in Q1 2025 was $8.9 million, representing growth of 104% compared to the prior year, primarily driven by strong sales in the UK [26][34] - The US installed base of robotic systems reached 547, reflecting a growth of 55% compared to the prior year [8] Company Strategy and Development Direction - The company is focused on expanding the installed base of Hydro systems in greenfield accounts while also seeing interest from existing customers for replacements [39] - The management believes that the current tariff environment will not compromise the path to achieving long-term profitability objectives [44] - The company aims to standardize aquablation therapy across hospital networks, driven by consistent outcomes and operational efficiency [22][112] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to continue growing the installed base and procedural volumes despite macroeconomic challenges [25] - The company anticipates a modest impact on 2025 gross margin due to strong inventory positions and limited exposure to foreign suppliers [11][53] - Management highlighted the positive changes in Medicare coverage that will expand access to aquablation therapy [15][126] Other Important Information - The company is preparing for the AUA conference, where it will present significant clinical data related to aquablation therapy [47][49] - The management is actively evaluating operational strategies to mitigate future tariff exposure [44][102] Q&A Session Summary Question: Can you discuss the CapEx environment and buyer interest in the system? - Management has not seen an impact on capital interest in acquiring Hydro systems, with a strong pipeline and high hospital interest [59][60] Question: How many handpieces sold in Q1 were pushed from Q4? - The impact from deferrals in Q4 was largely offset by the saline issue, resulting in Q1 procedures driven by business strength [66] Question: Can you provide more color on procedure volume growth in March? - March showed a return to normalcy, with guidance for Q2 and Q3 assuming similar utilization rates to Q1 [71][72] Question: What is the current utilization in IDN accounts? - Utilization is driven by surgeons, with IDNs showing interest in educating staff to increase patient volume for aquablation [108][110] Question: How is the company balancing growth in OUS markets? - The company is focusing on the UK as a key market while ensuring disciplined growth strategies [86][87] Question: What are the implications of the recent LCD changes? - The removal of certain limitations will streamline patient pre-workup and expand access to aquablation therapy [126][128]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $69.2 million, representing a growth of 55% compared to Q1 2024 [7][29] - Gross margin for Q1 2025 was 63.9%, consistent with Q4 2024 and up 750 basis points year-over-year [35] - Net loss for Q1 2025 was $24.7 million, compared to a net loss of $26 million in the same period of the prior year [37] Business Line Data and Key Metrics Changes - US revenue for Q1 2025 was $60.3 million, representing a growth of 50% compared to the prior year [29] - The company sold 43 robotic systems in Q1 2025, with an average selling price of approximately $435,000 [31] - US handpiece revenue for Q1 2025 was $38 million, representing a growth of 61% year-over-year, with 11,235 handpieces sold [33] Market Data and Key Metrics Changes - International revenue in Q1 2025 was $8.9 million, representing growth of 104% compared to the prior year, driven primarily by strong sales in the UK [26][34] - The US installed base of robotic systems reached 547, reflecting a growth of 55% compared to the prior year [8] Company Strategy and Development Direction - The company is focused on expanding the installed base of Hydro systems in greenfield accounts while also seeing interest from existing customers for replacements [39] - The management believes that the current tariff environment will not compromise the path to achieving long-term profitability objectives [44] - The company aims to standardize aquablation therapy across hospital networks, driven by consistent outcomes and operational efficiency [22][112] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to continue growing the installed base and procedural volumes despite macroeconomic challenges [25][39] - The company anticipates a modest impact on 2025 gross margin due to strong inventory positions and limited exposure to foreign suppliers [11][53] - Management highlighted the positive changes in Medicare coverage that will streamline access to aquablation therapy for a broader patient population [15][126] Other Important Information - The company is preparing for the AUA conference, where it will present data from trials that could influence future treatment guidelines for prostate cancer [49][50] - The company has received IDE approval from the FDA to enroll a randomized trial comparing surgical therapy against radical prostatectomy for prostate cancer [50] Q&A Session Summary Question: Can you discuss the CapEx environment and buyer interest in the system? - Management noted that there has been no impact on capital interest in acquiring Hydro systems, with a strong pipeline and daily conversations indicating continued excitement [59][60] Question: What was the procedure volume growth in March? - Management reported a return to normalcy in March, with guidance for Q2 and Q3 assuming similar utilization rates to Q1 [71][72] Question: How do you view the utilization in IDNs? - Management indicated that IDNs are increasingly interested in standardizing procedures and improving utilization through education and support [106][112] Question: What are the implications of the LCD changes? - Management stated that the removal of certain limitations will streamline patient pre-workup and expand access to aquablation therapy [126][128] Question: How is the company balancing growth in international markets? - Management emphasized a disciplined approach to entering new markets, focusing on the UK and Japan while ensuring strong support in existing markets [86][87]

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. PROCEPT BioRobotics Corporation (PRCT) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.49. This compares to loss of $0.51 per share a year ago. These figures are adju ...

Revenue Growth - Total revenue for Q1 2025 was $69.2 million, a 55% increase compared to Q1 2024[4] - U.S. revenue reached $60.3 million, reflecting a growth of 50% year-over-year[4] - U.S. handpiece and consumable revenue was $38.0 million, up 61% from the prior year[4] - International revenue was $8.9 million, representing a 104% increase compared to the previous year[4] - Total revenue for PROCEPT BioRobotics Corporation in Q1 2025 reached $69,162,000, a significant increase from $44,539,000 in Q1 2024, representing a growth of 55.4%[26] - U.S. revenue totaled $60,294,000 in Q1 2025, up from $40,201,000 in Q1 2024, marking a year-over-year increase of 50.1%[26] - Revenue from handpieces and other consumables in the U.S. rose to $38,011,000, compared to $23,618,000 in the previous year, reflecting a growth of 60.7%[26] - Total revenue outside of the U.S. was $8,868,000 in Q1 2025, more than doubling from $4,338,000 in Q1 2024, indicating a growth of 104.1%[26] - Handpieces and other consumables revenue outside the U.S. increased to $4,477,000, compared to $2,343,000 in the prior year, showing a growth of 90.1%[26] - Service revenue in the U.S. grew to $3,596,000, up from $2,347,000, representing a year-over-year increase of 53.2%[26] - Service revenue outside the U.S. also saw growth, reaching $538,000 compared to $255,000, which is a 111.4% increase[26] Financial Performance - Gross margin for Q1 2025 improved to 64%, compared to 56% in Q1 2024[5] - Operating expenses for Q1 2025 totaled $71.6 million, an increase from $52.7 million in the prior year[6] - Net loss for Q1 2025 was $24.7 million, an improvement from a loss of $26.0 million in Q1 2024[7] - The company increased its full-year 2025 revenue guidance to $323 million, a 44% growth compared to the previous year[10] - The projected full-year 2025 Adjusted EBITDA loss is expected to be $35.0 million, unchanged from prior guidance[12] Market Presence and Innovation - As of March 31, 2025, the company had an installed base of 547 robotic systems in the U.S.[4] - The company continues to focus on expanding its market presence and enhancing its product offerings to drive future growth[26] - PROCEPT BioRobotics Corporation is committed to ongoing research and development to innovate new products and technologies in the medical robotics field[26]

Core Insights - PROCEPT BioRobotics Corporation reported a strong performance in Q1 2025, achieving total revenue growth of 55% year-over-year, driven by robust procedural momentum and strategic placements of its Hydros™ system [3][4]. Financial Performance - Total revenue for Q1 2025 was $69.2 million, a 55% increase compared to $44.5 million in Q1 2024 [4][9]. - U.S. revenue reached $60.3 million, reflecting a 50% growth from the previous year, primarily due to system sales and increased handpiece revenue [4][9]. - U.S. handpiece and consumable revenue was $38.0 million, up 61% year-over-year, while system revenue was $18.7 million, a 31% increase [4][9]. - International revenue was $8.9 million, marking a significant 104% increase compared to the prior year [4][9]. Profitability Metrics - Gross margin for Q1 2025 improved to 64%, up from 56% in the prior year, attributed to operational efficiencies and higher average selling prices [5]. - Operating expenses increased to $71.6 million from $52.7 million in the previous year, driven by expansion of the commercial organization and increased R&D expenses [6]. - The net loss for Q1 2025 was $24.7 million, slightly improved from a loss of $26.0 million in Q1 2024 [7][19]. - Adjusted EBITDA loss was $15.8 million, compared to a loss of $20.4 million in the prior year [7][19]. Future Guidance - The company raised its full-year 2025 revenue guidance to $323 million, representing a 44% increase over the previous year [10][11]. - Projected gross margin for the full year is approximately 64.5%, with potential headwinds from global tariff rates estimated to impact margins by about 150 basis points [10][11]. - Total operating expenses for 2025 are projected to be around $300 million, with an expected Adjusted EBITDA loss of $35 million [11]. Market Position and Strategy - The U.S. launch of the Hydros™ system is gaining traction, particularly among large Integrated Delivery Networks, with 45% of U.S. system placements coming from corporate multi-unit orders [3][4]. - The company aims to revolutionize BPH treatment through its robotic solutions, with a focus on delivering effective outcomes for patients [12].

Company Overview - PROCEPT BioRobotics Corporation aims to revolutionize BPH treatment globally by providing advanced robotic solutions that enhance patient outcomes and deliver value [3] - The company manufactures the AQUABEAM® and HYDROS™ Robotic Systems, with the HYDROS system being the only AI-powered technology for Aquablation therapy [3] - Aquablation therapy is designed to provide effective, safe, and durable outcomes for men suffering from lower urinary tract symptoms (LUTS) due to BPH, regardless of prostate size, shape, or surgeon experience [3] - BPH affects approximately 40 million men in the United States, highlighting the significant market potential for the company's solutions [3] - PROCEPT BioRobotics has established a robust clinical foundation with over 150 peer-reviewed publications supporting the efficacy and advantages of Aquablation therapy [3] Upcoming Investor Event - The company will host an in-person investor event on April 25, 2025, at the Aria Resort in Las Vegas during the American Urological Association Annual Meeting [1] - The event will feature presentations from the management team and clinical perspectives from various physicians [2] - A live webcast of the event will be available, along with an archived recording accessible for at least 90 days post-event [2]

Core Insights - Aquablation therapy shows comparable symptom relief to laser enucleation while significantly preserving ejaculatory function and continence in patients with large prostates [1][2][4] Group 1: Study Overview - The WATER III trial is an international, prospective, multicenter study comparing Aquablation therapy to laser enucleation for prostate sizes between 80-180 mL, involving 186 men treated from December 2020 to September 2024 [2] - The study reported three-month primary safety and efficacy endpoints, with plans to follow patients for five years [2] Group 2: Clinical Outcomes - Aquablation therapy resulted in a 14.8% rate of ejaculatory dysfunction compared to 77.1% for laser enucleation, and a 0% rate of stress incontinence compared to 9.1% for laser enucleation [2] - The procedural transfusion rate for Aquablation therapy was 0%, indicating a strong safety profile in managing bleeding risk [3] Group 3: Expert Commentary - The CEO of PROCEPT BioRobotics emphasized that the results of the WATER III trial reinforce the company's commitment to establishing Aquablation therapy as the standard of care for BPH, highlighting its effectiveness in preserving quality of life factors [4] - Dr. Naeem Bhojani noted that the consistent efficacy and lower rates of complications represent a significant advancement for patients seeking BPH treatment [4] Group 4: Technology and Innovation - Aquablation therapy is the first and only ultrasound-guided, robotic-assisted, heat-free waterjet treatment for BPH, allowing for personalized treatment planning based on real-time imaging [5] - The technology enables precise and controlled removal of prostate tissue while preserving critical anatomical structures [5] Group 5: Company Background - PROCEPT BioRobotics is focused on advancing patient care through innovative urology solutions, manufacturing the AQUABEAM and HYDROS Robotic Systems [6] - The company has developed a substantial body of clinical evidence, including over 150 peer-reviewed publications, supporting the benefits of Aquablation therapy [7]

Core Insights - PROCEPT BioRobotics Corporation will host an in-person investor event on April 25, 2025, at the Venetian Hotel in Las Vegas during the American Urological Association Annual Meeting [1] - The company will report its financial results for Q1 2025 on April 24, 2025, before market open, followed by a conference call at 8:00 a.m. Eastern Time [2][3] Company Overview - PROCEPT BioRobotics focuses on advancing patient care through surgical robotics, specifically in urology, with products like the AQUABEAM and HYDROS™ Robotic Systems [4] - The HYDROS Robotic System is noted as the only AI-powered robotic technology delivering Aquablation therapy, which is designed for effective treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) [4] - BPH affects approximately 40 million men in the United States, highlighting a significant market opportunity for the company's solutions [4] - The company has established a robust clinical foundation with over 150 peer-reviewed publications supporting the efficacy of Aquablation therapy [4]

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Market Opportunity - The total addressable market opportunity for the company's products in the United States is estimated to exceed $20 billion, driven by approximately 8.2 million patients[23]. - The global incidence of BPH among men over 50 years old presents a significant incremental market opportunity outside of the United States[23]. - The total addressable market opportunity for BPH in the United States is estimated to exceed $20 billion, with approximately 8.2 million patients in the addressable population[35]. - Approximately 290,000 of the 400,000 annual BPH surgeries in the U.S. are resective procedures performed across about 2,700 hospitals[32]. - The aging demographics in the U.S. are expected to drive future growth, with the number of men over 65 projected to double by 2060[35]. Clinical Evidence and Efficacy - The company has developed a significant body of clinical evidence, including nine clinical studies and over 150 peer-reviewed publications, supporting the efficacy and safety of Aquablation therapy[27]. - In the U.S. pivotal trial, Aquablation therapy demonstrated surgical retreatment rates of only 5.2% and 3.0% at five years in the WATER and WATER II studies, respectively[26]. - Aquablation therapy has shown low rates of irreversible complications, maintaining a significantly higher level of sexual function compared to TURP[29]. - Aquablation therapy demonstrated a transfusion rate of only 0.8% in a study of 2,089 men, significantly lower than the 25% rate associated with traditional procedures[51]. - Clinical studies reported incontinence rates between 0%-2% and ejaculatory dysfunction rates between 6.9%-24.6% for Aquablation therapy[51]. - The WATER study, pivotal for FDA approval, showed superiority in safety and non-inferiority in efficacy compared to TURP, with results published in 2018[65]. - The WATER II study focused on patients with prostate sizes between 80 ml and 150 ml, demonstrating significant efficacy and safety outcomes[65]. - The OPEN WATER study included a diverse patient population with prostate sizes from 20 ml to 150 ml, providing robust data for Aquablation therapy[65]. Regulatory Environment - The company is subject to extensive government regulation and oversight, which could impact its ability to maintain necessary marketing authorizations for its robotic systems[19]. - The company is subject to extensive regulation by the FDA and other authorities, impacting the development and commercialization of its medical devices[99]. - The company's currently marketed robotic systems are classified as Class II devices, initially authorized through a de novo classification[106]. - The FDA requires a 510(k) premarket notification for most Class II devices, demonstrating substantial equivalence to a legally marketed predicate device[110]. - The PMA process for Class III devices is more demanding, requiring extensive data from preclinical studies and human clinical trials[112]. - The FDA has 180 days to complete its review of a PMA application, although the actual review often takes significantly longer[112]. - The European Union's Medical Device Regulation (MDR) requires all medical devices to be certified under the MDR, impacting the marketing of devices previously certified under older directives[128]. - Compliance with the General Safety and Performance Requirements (GSPRs) is mandatory for all medical devices marketed in the EU, which includes undergoing a conformity assessment procedure[130]. Financial Performance - Revenue for the year ended December 31, 2024, was $224.5 million, compared to $136.2 million for 2023, representing a year-over-year increase of 64.7%[31]. - The net loss for the year ended December 31, 2024, was $91.4 million, an improvement from a net loss of $105.9 million in 2023[31]. - For the years ended December 31, 2024 and 2023, the company reported net losses of $91.4 million and $105.9 million, respectively, with an accumulated deficit of $546.0 million as of December 31, 2024[164]. - As of December 31, 2024, the company had $333.7 million in cash and cash equivalents, which is expected to be sufficient to meet capital requirements for at least the next 12 months[174]. Business Strategy and Growth - The company aims to expand its market presence by educating urologists about the clinical benefits of Aquablation therapy and enhancing training programs[30]. - The company plans to expand its install base of robotic systems by increasing its direct sales team and establishing relationships with key surgeons and decision-makers[32]. - The company aims to increase awareness of Aquablation therapy among primary care physicians, targeting approximately 3.9 million men under their care[36]. - The company is committed to broadening private payor coverage and improving patient access to Aquablation therapy in key international markets[32]. - The company plans to expand its direct sales organization to enhance adoption and utilization of Aquablation therapy among urologists[64]. - Marketing initiatives will target primary care physicians to increase awareness and referrals for BPH patients to urologists[65]. - The company plans to significantly expand its commercial infrastructure to increase customer base and awareness, which requires substantial time and resources[185]. Competition and Market Challenges - The company faces intense competition from both resective surgical treatments and non-surgical treatments for BPH, with competitors having greater resources and established market presence[83]. - The company faces competition from larger companies and alternative treatments, which may impact its market penetration and operating results[195]. - The company faces significant hurdles in product adoption due to established treatment patterns, requiring education and supportive clinical data[197]. - The company may face pricing pressure from group purchasing organizations and integrated delivery networks seeking discounts on its robotic systems[187]. - The company must continuously innovate and deliver new product enhancements to maintain its competitive edge in the market[196]. Operational Risks - The company currently operates a sole manufacturing facility in San Jose, California, which poses risks to growth if damaged or affected by unforeseen events[199]. - Manufacturing capabilities are limited by the company's experience and reliance on single-source suppliers, which could lead to supply shortages and impact production capacity[202]. - The company has not qualified alternative suppliers for critical components, which could result in manufacturing delays and increased expenses if current suppliers fail to meet demand[203]. - Warranty claims and service requirements could significantly increase operating expenses, adversely affecting financial results and market reputation[206]. - The company must accurately forecast customer demand to manage inventory effectively; failure to do so could lead to excess inventory or inability to meet customer needs[210]. - The company is vulnerable to cyberattacks and security breaches, which could disrupt operations and result in significant liabilities and reputational damage[212]. Employee and Governance - The company aims to foster a diverse workplace and has a growing employee base of 756 as of December 31, 2024, which is crucial for its success[151]. - The company has published its Environmental, Social, and Governance (ESG) Report annually since 2022, detailing its human capital programs and initiatives[153]. - The company emphasizes employee engagement and retention through comprehensive compensation and benefits programs, including annual bonuses and flexible work arrangements[157]. Funding and Capital Requirements - The company may need additional funding to finance planned operations, and changing circumstances could lead to a faster consumption of capital than currently anticipated[174]. - The company anticipates requiring additional capital in the future to expand its sales and marketing organization, invest in clinical trials, and support research and development efforts[175]. - Future funding requirements will depend on various factors, including market acceptance of products, investment scope in the sales force, and costs associated with clinical trials and regulatory approvals[176]. - The company may seek to raise additional capital through equity offerings or debt financings, which could result in dilution to existing stockholders[177].