PROCEPT BioRobotics Corporation

Good afternoon and welcome to PROSAP, Biorobotics' fourth quarter and year-end 2024 earnings conference call. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Matt Baxo, Vice President, Investor Relations, for a few introductory comments.

Good afternoon, and thank you for joining Procept Biorobotics' fourth quarter and year-end 2024 earnings conference call. Presenting on today's call are Reza Zadno, Chief Executive Officer, Kevin Waters, Chief Financial Officer, and Sham Shablak, Chief Commercial Officer. Before we begin, I'd like to remind listeners that statements made on this conference call that relate to future plans, events, or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All these forward-looking statements are based on management's current expectations and beliefs. These statements are subject to several risks, uncertainties, assumptions, and other factors that can cause results to differ materially from the expectations expressed on this conference call. These risks and uncertainties are disclosed in more detail in Procept by Robots filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Listeners are cautioned not to place under reliance on these forward-looking statements, which speak only as of today's date, February 25, 2025. Except as required by law, Procept by Robotics undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, or unanticipated events that may arise. During the call, we will also reference certain financial measures that are not prepared in accordance with GAAP. Other information about how we use these non-GAAP financial measures, as well as reconciliations of these measures to their nearest GAAP equivalent, are included in our earnings release. With that, I will turn the call over to Reza.

Good afternoon, and thank you for joining us. For today's call, I will provide opening comments and a general business update, followed by Sham, who will provide an overview of the Hydros Robotics Systems commercial launch and fourth quarter procedure trends. Lastly, Kevin will provide additional details regarding our financial performance and initial 2025 financial guidance. Starting with our quarterly revenue results, total revenue for the fourth quarter of 2024 was $68.2 million, representing growth of 57% compared to the fourth quarter of 2023. Growth in the quarter was driven by increased robot sales and increased procedures, both at higher average selling prices and record international revenues. We exited the fourth quarter of 2024 with a U.S. installed base of 505 systems. representing growth of 60% compared to the prior year period. We sold a total of 190 robotic systems in 2024. On a full year basis, total revenue was $224.5 million, representing growth of 65%. At Procept, our focus is to first transform the global treatment of BPH and become the standard of care. While we have delivered robust growth over the last few years, we only have approximately 10% U.S. BPH-receptive market share. Given the size of the BPH market, we still have a long runway in front of us. In pursuit of our long-term vision, 2024 was a productive year for Procept in two key areas. First, in August, we received FDA 510K clearance for our next-generation hydrostrobotic system. a major milestone for process. Hydros brings significant advancement over the AquaBeam system, incorporating years of research, development, and customer feedback. Designed for mass market adoption with advanced features to enhance surgeon accuracy and enhance the care team's usability experience, we believe Hydros will be the platform we can innovate on in the future. With the introduction of the Hydros robotic system, we unveiled First Assist AI. This feature combines ultrasound imaging with the advanced planning software to assist urologists in identifying key anatomical landmarks, enabling precise targeting of the resection area using the water jet. By tailoring the tissue removal plan to individual anatomy, First Assist AI aims to enhance procedural accuracy and outcomes. Structurally, the HYDROS robotic system fully integrates an advanced ultrasound system and a single-use digital sister scope, providing the ability to improve visualization and streamline the operating room setup process. The HYDROS handpiece that comes pre-assembled with a single-use digital scope eliminates the need for sister scope reprocessing between procedures. These advanced features further enhance the efficiency of the procedure and are designed to deliver safe, effective, and durable results for men suffering from PTH, regardless of prostate size and shape or surgeon experience. The market receptivity of hydros has exceeded expectations, which has manifested itself into a robust capital pipeline and a higher hydro selling price. The second major milestone we achieved in 2024 was related to our prostate cancer initiative. First, we successfully demonstrated aqua ablation therapy does not spread cancer cells throughout the body during resection. This study published in a peer-reviewed journal, along with other supporting data, enabled us to persuade FDA to lift the contraindication for aqua ablation procedures in treating BPH patients that also have an active diagnosis of prostate cancer in the United States. Second, we finished enrollment of PRCT002, an FDA IDE feasibility study in men with grade group one or two prostate cancer. We are excited to share our cancer data at AUA in late April. Building on the PRCT002 feasibility data in September, a pivotal randomized clinical study for prostate cancer while also receiving breakthrough device designation. The trial, known as WATER-4-PCA, is a global multicenter prospective randomized clinical study assessing the safety and efficacy of aquabulation therapy compared to radical prostateectomy in men with grade group 1 to 3 localized prostate cancer. The study will enroll up to 280 patients at up to 50 centers with 10-year follow-up. We strongly believe that the need to improve safety and quality of life outcomes for millions of men needing treatment for prostate cancer is an area that remains significantly underserved. We believe aquablation therapy could become a first-line surgical treatment for localized prostate cancer. Initiating an FDA randomized trial against radical prostatectomy is the first big step in pursuing specific treatment of prostate cancer indication, which no other market-leading treatment has today. Given this positive momentum, we believe aqua ablation therapy is laying the foundation to become the DPH surgical standard of care, and Procept is emerging as a leading global urology company. With that, I will turn the call over to Sham to provide more detail on our Hydros launch and fourth quarter procedures.