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Ambulatory Surgery Center Completes WATER IV Trial Procedures for Prostate Cancer with Aquablation® Therapy
Globenewswire· 2025-07-23 12:00
Core Viewpoint - PROCEPT BioRobotics Corporation has successfully completed three prostate cancer procedures using Aquablation therapy in an Ambulatory Surgery Center, marking a significant milestone in the treatment of localized prostate cancer [1][3]. Group 1: Aquablation Therapy and Clinical Trial - Aquablation therapy is an image-guided, minimally invasive surgical procedure that utilizes a robotically-controlled waterjet to remove diagnosed cancer and most of the prostate [2]. - The WATER IV PCa Trial is a U.S. FDA investigational device exemption (IDE) approved clinical study comparing Aquablation therapy with radical prostatectomy for men with localized prostate cancer [2]. - The trial aims to evaluate the safety and efficacy of Aquablation therapy for men with Grade Group 1 to 3 localized prostate cancer [2]. Group 2: Treatment Setting and Outcomes - Dr. Rahul Mehan has chosen to conduct the randomized Aquablation therapy trial at an Ambulatory Surgery Center, demonstrating that early-stage prostate cancer can be safely treated in this setting [3]. - All procedures were completed successfully, with patients discharged the same day without complications, indicating a safe prostate resection [3]. - The approach of using Aquablation therapy could lead to a more scalable and cost-effective care model in the evolving healthcare market [3]. Group 3: Industry Impact and Future Prospects - The unique design of the WATER IV PCa trial focuses on harm reduction and could potentially change the treatment paradigm for localized prostate cancer among millions of men [3]. - The FDA's approval of the IDE for this trial reflects a thorough review process and opens up possibilities for this novel treatment approach [3]. - PROCEPT BioRobotics is committed to advancing patient care through transformative urology solutions, with a significant body of clinical evidence supporting the benefits of Aquablation therapy [5].
PROCEPT BioRobotics® to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-21 20:03
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].
Aquablation® Therapy’s Assigned Category I Code in 2026 Medicare Proposed Physician Fee Schedule
GlobeNewswire· 2025-07-15 01:15
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]
PROCEPT BioRobotics (PRCT) 2023 Earnings Call Presentation
2025-06-24 14:47
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]
PROCEPT BioRobotics (PRCT) 2024 Earnings Call Presentation
2025-06-24 14:46
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]
PROCEPT BioRobotics (PRCT) 2025 Earnings Call Presentation
2025-06-24 14:44
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]
PROCEPT BioRobotics (PRCT) 2025 Conference Transcript
2025-06-17 19:22
Summary of PROCEPT BioRobotics (PRCT) 2025 Conference Call Company Overview - **Company**: PROCEPT BioRobotics (PRCT) - **Industry**: Medical Technology, specifically focusing on surgical solutions for Benign Prostatic Hyperplasia (BPH) Key Points and Arguments Business Trends and Performance - **Q1 Performance**: The company experienced a strong procedure beat in Q1, with positive momentum continuing into April and May, indicating a rebound from previous challenges such as saline shortages [2][3][4] - **Surgeon Metrics**: Surgeon retention rates remain above 90%, and the company is seeing growth in new account launches and multiple surgeon engagements [4][3] - **Utilization Growth**: The company anticipates low to mid-single-digit year-over-year growth in utilization, which is viewed positively given the number of systems being added annually [8][11] Capital Component and Product Launch - **Hydro System Launch**: The Hydro system is early in its launch phase but has shown great receptivity, with a significant sales funnel and positive selling prices [4][5] - **Market Penetration**: The AquaBlation program currently holds about 50% market share within existing accounts, with expectations for further market expansion [11][19] - **Future Installations**: The company plans to install over 200 robots in 2025, which will contribute to incremental procedures despite a ramp-up period of three to four quarters for new accounts [12][11] IDN Relationships and Sales Strategy - **IDN Engagement**: The company has increased its engagement with Integrated Delivery Networks (IDNs), which account for 25% to 30% of all BPH surgeries in the U.S. This is seen as crucial for becoming the standard of care in the surgical BPH space [33][34] - **Predictability in Sales**: Relationships with IDNs are expected to improve the predictability of capital sales, allowing for better resource allocation [37][39] Pricing and Market Environment - **Average Selling Price (ASP)**: The average selling price of the robots has increased from approximately $300,000 at the time of going public to around $430,000 to $440,000, indicating strong demand and value perception [41][42] - **Capital Environment**: The company does not sense a material shift in overall sentiment regarding the capital environment, maintaining that their products are viewed as beneficial for hospitals, which helps in retaining patients and surgeons [45][47] Reimbursement and Regulatory Considerations - **CPT Code Change**: The transition from Category III to Category I CPT codes is expected to have a minimal impact on physician fees, with a slight decrease anticipated but not affecting adoption rates [49][50] - **Facility Payment**: The company expects to maintain its APC level six status, which is crucial for facility reimbursement, and has seen an increase in procedure pricing over the past 12 to 24 months [51][52] Future Outlook and Prostate Cancer Treatment - **Prostate Cancer Treatment**: The company is addressing concerns about the potential spread of cancer during procedures and has received FDA support for treating patients with known prostate cancer. They aim to enroll the majority of patients within 18 months, with commercialization expected by early 2028 [66][69][72] Additional Important Insights - **Operational Efficiency**: The Hydro system is designed to improve operational efficiency in hospitals, reducing reliance on specific staff and potentially increasing profitability for hospitals [22][23] - **Market Expansion**: The company is focused on penetrating high-volume hospitals while also seeing interest from medium-volume hospitals, which are expected to follow similar utilization trajectories as high-volume hospitals [28][30] This summary encapsulates the key insights and strategic directions discussed during the PROCEPT BioRobotics conference call, highlighting the company's growth potential, market strategies, and future plans in the medical technology sector.
PROCEPT BioRobotics (PRCT) FY Conference Transcript
2025-06-04 16:00
Summary of Procept BioRobotics (PRCT) FY Conference Call - June 04, 2025 Company Overview - Procept BioRobotics is a surgical robotic company aiming to become a global leader in urology [3][4] - The company focuses on treating Benign Prostatic Hyperplasia (BPH), a condition affecting a significant portion of the male population [5] Industry Insights - BPH affects one in two men aged 50-60, with 40 million men in the U.S. suffering from this condition [5] - There is a large unmet clinical need, with only 12 million of the 40 million men under medical management [6] - The majority of men avoid surgical options due to side effects associated with current treatments [6][7] Product and Technology - Aquablation therapy is designed to address the unmet clinical need for BPH treatment, effective for all prostate sizes and shapes [6][9] - The technology utilizes an automated water jet, avoiding unnecessary damage to surrounding tissue [9] - Clinical studies show that aquablation has superior safety outcomes compared to traditional resective procedures like TURP [11][12] Market Access and Reimbursement - Full Medicare coverage is available for aquablation, with 95% of eligible patients having access to the treatment [15] - The facility payment for aquablation is just over $9,200, with expectations for reimbursement to align with other resective procedures [36][37] Financial Performance - The company reported a revenue of $69.2 million for the first quarter, a 55% year-over-year growth [22] - The installed base in the U.S. reached 547 systems, with significant international revenue growth, particularly in the U.K. and Japan [23][24] - Revenue guidance for 2025 is set at $323 million, with an expected growth rate of 63% to 64.5% [24] Future Opportunities - Procept is exploring the use of aquablation for prostate cancer treatment, addressing a significant unmet clinical need [16][18] - There are over 3 million men in the U.S. with prostate cancer, with 300,000 new cases annually [16] - The company is conducting clinical studies to demonstrate the safety and efficacy of aquablation in prostate cancer patients [19][22] Challenges and Execution - The company is focused on surgeon retention and increasing procedure volumes, with over 30,000 cases performed in the U.S. last year [32][33] - The transition from Category III to Category I reimbursement codes is a key milestone, expected to simplify pre-authorization processes [36][39] Conclusion - Procept BioRobotics is positioned to capitalize on the growing demand for effective BPH and prostate cancer treatments through innovative technology and strong clinical data [44]
PROCEPT BioRobotics (PRCT) 2025 Conference Transcript
2025-05-14 23:00
Summary of PROCEPT BioRobotics (PRCT) Q1 2025 Conference Call Company Overview - **Company**: PROCEPT BioRobotics (PRCT) - **Industry**: Medical Technology Key Points Q1 Performance and Guidance - Q1 procedures exceeded expectations with 11,200 cases completed, surpassing the guidance of 10,700, representing a year-over-year increase of approximately 4.5% [4][5] - The company maintained its full-year guidance despite the strong Q1 performance, reflecting a conservative approach due to market conditions [5][12] - Monthly procedure growth showed improvement: February was better than January, and March was better than February [3] Capital Expenditure (CapEx) and Systems Sales - Q1 systems sales met expectations, with the average selling price at the high end of guidance [11] - The company noted that Q1 is typically challenging for capital equipment sales due to unvetted hospital budgets, but they are optimistic about the sales funnel for the remainder of the year [10] Utilization and Procedures - Utilization in Q1 was reported at 7.1%, with a 5% growth [15] - The company did not provide specific quarterly guidance for procedures but expressed confidence in meeting market expectations for Q2 and Q3 [18] - The company tracks metrics such as active surgeons and utilization rates, indicating positive trends in surgeon engagement and case volume [20][22] Tariffs and Gross Margin Impact - The company faced a tariff impact of approximately $5 million on gross margins due to a 145% import tariff on key components from China, which has since been reduced to 30% [30][31] - The anticipated impact on gross margins is now estimated to be between $1 million to $2 million, significantly less than previously communicated [31] Reimbursement and CPT Code Change - The transition from a Category 3 to a Category 1 CPT code is expected to occur in summer 2025, with no significant changes anticipated in reimbursement rates compared to other resective procedures [33][40] - The company expects to remain competitive in reimbursement rates, aligning with existing procedures in the market [39] Prostate Cancer Opportunity - The company is exploring opportunities in prostate cancer treatment, with a focus on minimizing side effects such as incontinence and erectile dysfunction [42] - Initial studies have shown promising results, and the company is optimistic about the potential market size, estimating significant revenue growth from prostate cancer procedures by 2028 [49][51] Financial Outlook - The company is on track to potentially achieve EBITDA breakeven by Q4 2025, although this is not the primary focus as they prioritize growth investments [55][57] - Gross margin expansion is expected to continue, driven by leveraging fixed costs as the business scales [58][59] Additional Insights - The management emphasizes a long-term growth strategy, focusing on maintaining a balance between investment in growth and achieving profitability [57] - The company has a robust cash position of $300 million, providing a strong foundation for future growth initiatives [57] This summary encapsulates the key insights and data points from the PROCEPT BioRobotics Q1 2025 conference call, highlighting the company's performance, strategic outlook, and market opportunities.
PROCEPT BioRobotics (PRCT) - 2025 Q1 - Quarterly Report
2025-05-02 20:51
Financial Performance - Revenue for the three months ended March 31, 2025, was $69,162,000, representing a 55.5% increase from $44,539,000 in the same period of 2024[15] - Gross profit for the same period was $44,161,000, up from $25,034,000, indicating a gross margin improvement[15] - Net loss for Q1 2025 was $24,737,000, a slight improvement compared to a net loss of $25,957,000 in Q1 2024[15] - Total stock-based compensation recognized for the three months ended March 31, 2025, was $10.1 million, compared to $6.3 million for the same period in 2024, indicating a year-over-year increase of approximately 61.5%[45] - U.S. revenue accounted for 87% of total revenue in Q1 2025, compared to 90% in Q1 2024[60] Operating Expenses - Total operating expenses increased to $71,599,000 in Q1 2025 from $52,683,000 in Q1 2024, primarily due to higher research and development costs[15] Cash and Liquidity - Cash and cash equivalents at the end of Q1 2025 were $316,207,000, down from $336,763,000 at the beginning of the period[20] - The company reported a net cash used in operating activities of $16,980,000 for Q1 2025, compared to $32,286,000 in Q1 2024[20] - Total cash and cash equivalents decreased from $333.7 million as of December 31, 2024, to $316.2 million as of March 31, 2025, representing a decline of approximately 5.0%[29] Assets and Liabilities - Total current assets decreased to $465,791,000 as of March 31, 2025, from $481,800,000 as of December 31, 2024[13] - Total liabilities as of March 31, 2025, were $130,218,000, a slight decrease from $131,700,000 as of December 31, 2024[13] Stock and Equity - The company issued 560,000 shares of common stock under stock plans during the first quarter of 2025, increasing total shares outstanding to 55,278,000[17] - The weighted-average common stock outstanding increased to 54.917 million shares in Q1 2025 from 51.011 million shares in Q1 2024[53] Inventory and Property - Total inventory rose from $56.2 million as of December 31, 2024, to $62.3 million as of March 31, 2025, marking an increase of approximately 10.0%[31] - Total property and equipment, net, increased from $26.7 million as of December 31, 2024, to $28.1 million as of March 31, 2025, a growth of about 5.3%[32] Debt and Interest - The Company achieved a twelve-month revenue target of $200 million as of December 31, 2024, which allowed for an extension of the interest-only period on the Term Loan Facility[35] - The weighted-average interest rate for the Term Loan Facility decreased from 7.8% for the period ending March 31, 2024, to 6.6% for the period ending March 31, 2025[36] - Future minimum annual debt repayments total $52 million, with $8.67 million due in 2026 and $43.33 million due in 2027[38] Stock-Based Compensation - The Company recorded a total of $10.7 million of unrecognized stock-based compensation expense related to stock options as of March 31, 2025[47] - The fair value of options granted to employees was estimated at a weighted-average fair value of $35.00 for the three months ended March 31, 2025[47] - As of March 31, 2025, the total unrecognized stock-based compensation expense related to RSUs was $99.6 million[48] - The Company awarded 683,000 RSUs during the three months ended March 31, 2025, with a weighted-average fair value of $61.15[48] Employee Contributions - Employer contributions to the defined contribution retirement savings plan were $0.9 million for the three months ended March 31, 2025[64] Segment Information - The Company operates as a single operating segment, with no customers accounting for more than 10% of revenue during the three months ended March 31, 2025[58]