Core Viewpoint - PROCEPT BioRobotics Corporation reported a strong financial performance for Q2 2025, with a 48% year-over-year revenue growth, driven by increased demand for its Aquablation therapy and expansion in both U.S. and international markets [3][4]. Financial Performance - Total revenue for Q2 2025 was $79.2 million, a 48% increase compared to Q2 2024 [4][9]. - U.S. revenue reached $69.6 million, reflecting a 46% growth year-over-year, primarily from system sales and increased handpiece revenue [4][9]. - International revenue was $9.6 million, marking a 69% increase compared to the prior year [4][9]. - U.S. handpiece and consumable revenue was $43.1 million, up 58% year-over-year [4][9]. - Gross margin improved to 65% in Q2 2025 from 59% in the prior year, attributed to operational efficiencies and higher selling prices [5]. Operating Expenses and Losses - Operating expenses for Q2 2025 were $73.9 million, up from $58.3 million in Q2 2024, driven by expansion of the commercial organization and increased R&D expenses [6]. - The net loss for Q2 2025 was $19.6 million, an improvement from a loss of $25.6 million in the same period last year [7][9]. - Adjusted EBITDA loss was $8.0 million for Q2 2025, compared to a loss of $17.9 million in Q2 2024 [7][9]. Future Guidance - The company projects full-year 2025 revenue to be approximately $325.5 million, representing a 45% growth over the previous year [8][9]. - Full-year 2025 gross margin is expected to be around 64.5% [15]. - The company anticipates total operating expenses for 2025 to be approximately $302.0 million [15]. Leadership Changes - Larry Wood has been appointed as the new CEO, effective September 2, 2025, bringing 40 years of experience in the medical technology industry [9]. Product and Market Focus - The company is focused on expanding the utilization of Aquablation therapy in the U.S. and enhancing its presence in international markets [3]. - PROCEPT BioRobotics aims to revolutionize BPH treatment globally through its robotic solutions, which are designed to deliver effective outcomes for patients [11].

Forward-Looking Statements This press release may contain forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those anticipated or implied in such statements. PROCEPT BioRobotics undertakes no obligation to publicly update or revise any forward-looking statements. WATER IV PCa is a U.S. FDA investigational device exemption (IDE) approved clinical study co ...

Core Viewpoint - PROCEPT BioRobotics Corporation is set to report its financial results for Q2 2025 on August 6, 2025, with a conference call scheduled for the same day [1]. Company Overview - PROCEPT BioRobotics focuses on advancing patient care in urology through innovative surgical robotics solutions [1]. - The company manufactures the AQUABEAM and HYDROS™ Robotic Systems, with the HYDROS system being the only AI-powered technology delivering Aquablation therapy [3]. - Aquablation therapy is designed to provide effective and durable outcomes for men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), regardless of prostate size 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]. - The company has established a robust clinical foundation with over 150 peer-reviewed publications supporting the benefits of Aquablation therapy [3].

Core Insights - PROCEPT BioRobotics Corporation announced that Aquablation therapy has been assigned a Category I CPT code effective January 1, 2026, marking a significant milestone for the company and the urology community [1][3] - The new Category I CPT code 52XX1 will replace the previous Category III CPT code 0421T and is associated with a proposed national average payment of approximately $540 under the 2026 Medicare Physician Fee Schedule [2][3] - The transition to a Category I code is expected to enhance surgeon adoption and increase patient access to Aquablation therapy, which offers durable symptom relief with a low risk of sexual side effects [3] Payment Structure - The 2026 proposed payment for Aquablation therapy is set at 16.14 total RVUs, compared to 15.82 total RVUs for TURP, which translates to an average payment of approximately $529 [3] - The Proposed Physician Fee Schedule was released on July 14, 2025, and will undergo a public comment period until September 2025, with a final rule expected in November 2025 [4] Aquablation Therapy Overview - Aquablation therapy is the first and only ultrasound-guided, robotic-assisted, heat-free waterjet treatment for benign prostatic hyperplasia (BPH), providing personalized treatment planning based on real-time imaging [5][6] - The technology allows for precise removal of prostate tissue while preserving critical anatomy related to erectile and ejaculatory function, making it suitable for a wide range of patients [5][6] - BPH affects approximately 40 million men in the United States, highlighting the significant market potential for Aquablation therapy [6]

BPH Market & Aquablation Therapy - Benign Prostatic Hyperplasia (BPH) affects approximately 40 million men in the U S [21] - The U S BPH surgical market represents a ~$20 billion opportunity [27] - Approximately 70% of prostates treated with Aquablation in the U S are less than 100ml in size [41] - Aquablation therapy provides effective, safe, and durable outcomes independent of prostate size, shape, and surgeon experience [36] Financial Performance & Guidance - Total revenue increased by 72% year-over-year to $24 4 million in Q1 2023 [51] - U S Aquabeam install base increased by 106% year-over-year to 192 systems in Q1 2023 [51] - U S handpieces sold increased by 139% year-over-year in Q1 2023 [51] - The company projects total revenue of $128 0 million for 2023, representing approximately 71% year-over-year growth [53, 54] - The company anticipates a gross margin of 54% for 2023 [54] Commercial Strategy & Expansion - The company is targeting 860 high-volume hospitals in the U S with an annual resective volume of ≥100 procedures [62] - 17 Strategic IDNs account for ~29% of BPH hospitals and ~26% of high-volume centers [70] - 65% of high volume hospitals are within a 100-mile radius of Robotic Sales Representatives [73]

Financial Performance & Guidance - PROCEPT BioRobotics reported Q1 2024 global revenue of $445 million, an 83% year-over-year increase [22] - International revenue in Q1 2024 reached $43 million, a 65% year-over-year increase [22] - The U S installed base grew to 354 systems, an 84% year-over-year increase [22] - U S handpiece sales reached 6800, a 100% year-over-year increase [22] - The company projects total revenue for 2024 to be approximately $2135 million, representing a 57% year-over-year growth [26] - The company anticipates a gross margin of approximately 58% to 59% for 2024 [26] - Adjusted EBITDA loss is projected to be approximately $70 million for 2024 [26] - As of March 31, 2024, the company had a total cash and cash equivalents balance of $226 million and a debt balance of $52 million [27] Commercial Strategy & Market Expansion - The company aims to convert all resective BPH hospital-based procedures to Aquablation Therapy [39] - The company reports that over 95% of U S covered lives are now under signed majority IDN contracts [43] - Aquablation Therapy cases at Georgia Urology have increased 95x since 2019 [67] Prostate Cancer Research & Development - Approximately 1/3 of men with BPH also have prostate cancer, representing 300000 diagnoses per year [89] - Initial Aquablation impressions for prostate cancer show promise, with real-time imaging and surgeon confidence [113, 114] - Early results from a study (n=5) show 0% incontinence and 0% erectile dysfunction, as well as 0% actionable disease and 0% residual tumor on MRI [138, 148]

Company Milestones and Financial Performance - PROCEPT BioRobotics achieved significant milestones, including Medicare reimbursement in 2021 and FDA clearance of the HYDROS System in 2023[12, 15] - The company's global revenue reached $224.5 million in 2024 and projects revenue guidance of $323 million[15, 18] - The company completed a $150 million equity follow-on and a $175 million equity follow-on[14, 15] HYDROS System and Market Penetration - The HYDROS Robotic System is resonating with all BPH hospital segments, driving market awareness[31, 34] - U.S. install base has shifted towards higher volume hospitals, with high-volume hospitals representing 61% of the install base in 1Q25, compared to 20% in 1Q23[30] - The company is on pace to become the 2 hospital-based resective BPH procedure in the U.S[18] Aquablation Therapy and Clinical Practice - Kansas City Urology & Oncology (KCUC) has increased annual BPH procedure volumes by 42% since 2021[56] - Dr Park's annual Aquablation procedures at KCUC doubled, demonstrating a 124% growth[58] - Aquablation therapy has increased surgical conversion rates from 10% to 25% due to more objective evaluation[62] Prostate Cancer and Aquablation Therapy - Approximately 26% of localized prostate cancer diagnoses are high risk, 50% are intermediate risk, and 24% are low risk[79] - Early data from PRCT001 + PRCT002 trials includes 88 prostate cancer patients treated, with 47 patients having 6-month follow-up data[125] - 70% of prostate cancer patients in PRCT001 + PRCT002 trials have intermediate-risk disease[127] - Single center data suggests Aquablation may delay cancer progression, with a 30% progression avoidance at 5 years compared to active surveillance[168]

Group 1 - The company, PROCEPT BioRobotics, is focused on advancing patient care in urology through transformative robotic solutions [3] - The company will present at four investor conferences in May and June 2025, including the Bank of America Health Care Conference and the Jefferies Global Healthcare Conference [1][2] - PROCEPT BioRobotics manufactures the AQUABEAM and HYDROS™ Robotic Systems, with the HYDROS system being the only AI-powered technology delivering Aquablation therapy [3] Group 2 - Aquablation therapy is designed to provide effective, safe, and durable outcomes for men suffering from lower urinary tract symptoms due to benign prostatic hyperplasia (BPH), impacting approximately 40 million men in the U.S. [3] - The company has developed a significant body of clinical evidence, with over 150 peer-reviewed publications supporting the benefits of Aquablation therapy [3] - The company aims to revolutionize BPH treatment globally in partnership with urologists by delivering best-in-class robotic solutions [3]

Key Milestones & Financials - PROCEPT BioRobotics achieved global revenue of $224.5 million in 2024[15] - The company's revenue guidance for 2025 is $323 million[18] - In 2021, PROCEPT BioRobotics had an IPO at $1.2 billion market capitalization[12] HYDROS System & Commercial Update - HYDROS resonates with all BPH hospitals, with a 20% BPH hospital penetration rate[31] - The U.S. install base shows a shift from 1Q23 to 1Q25, with low-volume hospitals decreasing from 73% to 61%, medium-volume increasing from 6% to 8%, and high-volume increasing from 20% to 31%[30] Prostate Cancer & Aquablation Therapy - Approximately 60% of Active Surveillance patients will undergo radical treatment in 10-15 years[100] - In the U.S., 26% of localized prostate cancer diagnoses are high risk, 50% are intermediate risk, and 24% are low risk[79] - Early data from PRCT001 + PRCT002 trials includes 88 prostate cancer patients treated, with 65 having 3-month follow-up and 47 having 6-month follow-up[125] - 70% of prostate cancer patients in PRCT001 + PRCT002 have intermediate-risk disease[127] - 76% of patients in PRCT001 + PRCT002 have cancer in the Peripheral Zone[130]

Core Insights - PROCEPT BioRobotics Corporation is showcasing its leadership in BPH treatment through extensive scientific presentations and workshops at the 2025 AUA Annual Meeting [1][2] - Aquablation therapy is highlighted as a transformative solution for BPH, offering durable symptom relief with minimal side effects [2][15] Company Overview - PROCEPT BioRobotics focuses on advancing urologic care through innovative surgical robotics, specifically the AQUABEAM and HYDROS Robotic Systems [15] - The company aims to revolutionize BPH treatment globally, impacting approximately 40 million men in the United States [15] Clinical Data and Presentations - Clinical presentations at AUA will emphasize long-term outcomes, safety, and durability of Aquablation therapy [2] - A series of thought leader presentations will take place, featuring insights from various experts on the role of Aquablation in modern urology [3][4][5][6][7] Event Activities - PROCEPT's booth will host hands-on demonstrations of the HYDROS Robotic System, allowing urologists to explore the technology and discuss clinical experiences [8] - The AUA Scientific Program will feature multiple podium and poster presentations focused on Aquablation therapy [9][10] Technology and Innovation - Aquablation therapy is described as the first ultrasound-guided, robotic-assisted, heat-free waterjet treatment for BPH, allowing for personalized treatment planning [13] - The technology enables precise and controlled removal of prostate tissue while preserving critical anatomical functions [13]