Procept Biorobotics Corp (PRCT) 2024 Q4 法說會逐字稿

Good afternoon, and welcome to PROCEPT BioRobotics fourth quarter and year-end 2024 earnings conference call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Matt Bacso, Vice President, Investor Relations, for a few introductory comments.

下午好，歡迎參加 PROCEPT BioRobotics 第四季和 2024 年年終財報電話會議。（操作員指示）提醒一下，此通話將被錄音以供重播。現在，我想將電話轉給投資者關係副總裁 Matt Bacso，請他作一些介紹性評論。

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 Shiblaq, 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. While 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 could cause results to differ materially from the expectations expressed on this conference call. These risks and uncertainties are disclosed in more detail in PROCEPT BioRobotics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov.

下午好，感謝您參加 PROCEPT BioRobotics 2024 年第四季和年終收益電話會議。參加今天電話會議的有執行長 Reza Zadno；凱文·沃特斯（Kevin Waters），財務長；以及首席商務官 Sham Shiblaq。在我們開始之前，我想提醒聽眾，本次電話會議上與未來計畫、事件或表現相關的陳述均為 1995 年《私人證券訴訟改革法》定義的前瞻性陳述。雖然這些前瞻性陳述是基於管理階層目前的期望和信念，但這些陳述受若干風險、不確定性、假設和其他因素的影響，這些因素可能導致結果與本次電話會議上表達的預期有重大差異。這些風險和不確定性在 PROCEPT BioRobotics 提交給美國證券交易委員會的文件中進行了更詳細的披露，所有這些文件都可以在 www.sec.gov 上在線查閱。

Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date, February 25, 2025. Except as required by law, PROCEPT BioRobotics 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.

請聽眾不要過度依賴這些前瞻性陳述，這些陳述僅截至今天（2025 年 2 月 25 日）有效。除法律要求外，PROCEPT BioRobotics 不承擔更新或修改任何前瞻性聲明以反映可能出現的新資訊、情況或意外事件的義務。在電話會議中，我們也會參考某些未依照 GAAP 編製的財務指標。有關我們如何使用這些非 GAAP 財務指標以及這些指標與最接近的 GAAP 等值的調整的其他資訊都包含在我們的收益報告中。說完這些，我將把電話轉給 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 Robotic 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.

下午好，感謝您加入我們。在今天的電話會議上，我將發表開場評論並提供一般業務更新，然後由 Sham 概述 HYDROS 機器人系統的商業發布和第四季度程序趨勢。最後，Kevin 將提供有關我們的財務業績和 2025 年初步財務指導的更多詳細資訊。從我們的季度收入結果開始。2024 年第四季總營收為 6,820 萬美元，與 2023 年第四季相比成長 57%。

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 US 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%.

本季的成長主要得益於機器人銷售增加和工序增加，同時平均銷售價格上漲且國際收入創下歷史新高。截至 2024 年第四季度，我們在美國已安裝 505 個系統，比去年同期成長了 60%。2024年我們總共銷售了190套機器人系統。全年總收入為 2.245 億美元，成長 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% US BPH resective 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 510(k) clearance for our next-generation HYDROS Robotic System, a major milestone for PROCEPT.

在 PROCEPT，我們的重點是先改變 BPH 的全球治療方法並成為治療標準。儘管我們在過去幾年中實現了強勁成長，但我們僅佔有美國 BPH 切除術市場的約 10% 份額。考慮到 BPH 市場的規模，我們還有很長的路要走。為了實現我們的長期願景，2024 年對於 PROCEPT 來說在兩個關鍵領域是富有成果的一年。首先，8 月份，我們的下一代 HYDROS 機器人系統獲得了 FDA 510(k) 批准，這是 PROCEPT 的一個重要里程碑。

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 FirstAssist 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 waterjet.

HYDROS 比 AquaBeam 系統有了重大改進，融合了多年的研究、開發和客戶回饋，專為大眾市場採用而設計，具有先進的功能，可提高外科醫生的準確性並增強護理團隊的可用性體驗。我們相信 HYDROS 將成為我們未來可以創新的平台。隨著 HYDROS 機器人系統的推出，我們推出了 FirstAssist AI。該功能將超音波成像與先進的規劃軟體相結合，幫助泌尿科醫生識別關鍵的解剖標誌，從而能夠使用水射流精確瞄準切除區域。

By tailoring the tissue removal plan to individual anatomy, FirstAssist AI aims to enhance procedural accuracy and outcomes. Structurally, the HYDROS Robotic System fully integrates an advanced ultrasound system and a single-use digital cystoscope providing the ability to improve visualization and streamline the operating room setup process. The HYDROS Handpiece.coms preassembled with a single-use digital scope eliminates the need for cystoscope reprocessing between procedures.

FirstAssist AI 旨在透過根據個體解剖結構定制組織切除計劃來提高手術的準確性和結果。從結構上看，HYDROS 機器人系統完全整合了先進的超音波系統和一次性數位膀胱鏡，能夠改善可視化並簡化手術室設置過程。HYDROS Handpiece.coms 預先組裝有一次性數位內視鏡，無需在手術之間對膀胱鏡進行再處理。

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 HYDROS selling price. The second major milestone we achieved in 2024 was related to our prostate cancer initiative.

這些先進的功能進一步提高了手術的效率，旨在為患有 PTH 的男性提供安全、有效和持久的效果，無論前列腺的大小和形狀或外科醫生的經驗如何。HYDROS 的市場接受度超乎預期，體現為強勁的資本管道和更高的 HYDROS 售價。我們在 2024 年實現的第二個重要里程碑與我們的前列腺癌計畫有關。

First, we successfully demonstrated Aquablation 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 Aquablation procedures in treating BPH patients that also have an active diagnosis of prostate cancer in the United States. Second, we finished enrollment of PRCT-002, an FDA-IDE feasibility study in men with Grade Group 1 or 2 prostate cancer.

首先，我們成功證明了水消融療法在切除過程中不會將癌細胞擴散到全身。這項在同行評審期刊上發表的研究與其他支持數據使我們能夠說服 FDA 取消在美國對被診斷為前列腺癌的 BPH 患者進行 Aquablation 手術治療的禁忌症。其次，我們完成了 PRCT-002 的招募，這是一項針對 1 級或 2 級前列腺癌男性的 FDA-IDE 可行性研究。

We are excited to share our cancer data at AUA in late April. Building on the PRCT-002 feasibility data, in September 2024, we received FDA-IDE approval to initiate a pivotal randomized clinical study for prostate cancer while also receiving breakthrough device designation. The trial known as WATER IV PCa is a global multicenter prospective randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy 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.

我們很高興在四月底與 AUA 分享我們的癌症數據。基於 PRCT-002 可行性數據，2024 年 9 月，我們獲得 FDA-IDE 批准，啟動針對前列腺癌的關鍵隨機臨床研究，同時獲得突破性設備稱號。這項名為 WATER IV PCa 的試驗是一項全球多中心前瞻性隨機臨床研究，評估了水消融療法與根治性前列腺切除術對於 1 至 3 級局限性前列腺癌男性的安全性和有效性。該研究將在多達 50 個中心招募多達 280 名患者，並進行 10 年的追蹤。我們堅信，對於數百萬需要接受前列腺癌治療的男性來說，改善其生活安全和生活品質是一個仍未充分服務的領域。

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 a specific treatment of prostate cancer indication, which no other market-leading treatment have today. Given this positive momentum, we believe Aquablation therapy is laying the foundation to become the BPH 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.

我們相信水消融療法可以成為局部前列腺癌的第一線手術治療方法。啟動 FDA 針對根治性攝護腺切除術的隨機試驗是尋求針對攝護腺癌適應症的特定治療的第一步，目前市面上其他領先的治療方法都沒有做到這一點。鑑於這一積極勢頭，我們相信 Aquablation 療法正在為成為 BPH 手術治療標準奠定基礎，而 PROCEPT 正在成為全球領先的泌尿科公司。說完這些，我將把電話轉給 Sham，讓他提供有關我們的 HYDROS 啟動和第四季度程序的更多細節。

Thanks, Reza. First, I want to reiterate Reza's comments on the team's exceptional performance and execution in 2024 that required an all-in attitude from every part of the organization. Turning to the HYDROS launch. In the fourth quarter, we sold 60 systems, of which 95% were comprised of HYDROS for an average selling price of approximately $460,000. After receiving FDA clearance for HYDROS midway through our fiscal third quarter of 2024, we transitioned into the fourth quarter with awareness and excitement around the launch spreading quickly, which certainly played into our favor as we were able to finish the year very strong.

謝謝，Reza。首先，我想重申 Reza 對球隊在 2024 年出色表現和執行力的評價，這需要組織每個部分的全力以赴。轉向 HYDROS 發射。第四季度，我們銷售了 60 個系統，其中 95% 由 HYDROS 組成，平均售價約為 46 萬美元。在 2024 財年第三季度中期獲得 FDA 對 HYDROS 的批准後，我們進入了第四季度，圍繞該產品發布的認知和興奮迅速蔓延，這無疑對我們有利，因為我們能夠以非常強勁的業績結束這一年。

Initial feedback from customers has been very encouraging. Aside from HYDROS fully-integrated and sleep design, surgeons continue to be impressed with the new FirstAssist AI feature, which we believe has the potential to enable all urologists, new and experienced urologists to improve outcomes for their patients. Other feedback we received, particularly from hospital support staff is how improved the surgeon and staff experience is at every stage of the Aquablation therapy procedure.

客戶的初步回饋非常令人鼓舞。除了 HYDROS 的完全整合和睡眠設計之外，外科醫生對新的 FirstAssist AI 功能印象深刻，我們相信該功能有潛力使所有泌尿科醫生（無論是新手還是經驗豐富的泌尿科醫生）改善患者的治療效果。我們收到的其他回饋，特別是來自醫院支援人員的回饋，即在水消融治療過程的每個階段，外科醫生和工作人員的體驗都有所改善。

Specifically, with a single footprint and improved user-interface, the integrated tower facilitates efficient operating room setup, procedural workflow and operating room turnover. Hospital CFOs are also happy to see that the new HYDROS Handpiece utilizes a single-use digital scope that eliminates the need for scope reprocessing and further streamlined setup, which saves time and money. As we enter 2025, we feel very good about the underlying trends, particularly around system average selling prices, customer demand and HYDROS user sentiment.

具體而言，整合塔佔地面積小，使用者介面改進，有利於高效的手術室設置、程序工作流程和手術室週轉。醫院的財務長們也很高興地看到，新的 HYDROS 手柄採用一次性數位內視鏡，無需再處理內視鏡並進一步簡化設置，從而節省了時間和金錢。當我們進入 2025 年時，我們對潛在趨勢感到非常樂觀，尤其是系統平均銷售價格、客戶需求和 HYDROS 用戶情緒。

Next, I want to provide details on recent macro events that impacted Aquablation procedures in the fourth quarter. We had tremendous momentum heading into our seasonally strongest quarter following a very strong September. Given that BPH is an elective procedure, we typically see very strong seasonality in our fiscal fourth quarter. This is due to typical winter elective surgery volume increases after the summer season and is bolstered by the large percentage of patients who utilize the fourth quarter to schedule procedures once they have met annual insurance deductibles. We estimate approximately 50% of all BPH resective surgeries are Medicare with the other half being private pay. However, in late September, Hurricane Helene flooded Baxter's saline facility in North Carolina.

接下來，我想詳細介紹影響第四季水消融程序的近期宏觀事件。繼 9 月的強勁表現之後，我們以強勁勢頭進入當季最強勁的季度。鑑於 BPH 是一種選擇性手術，我們通常會在財政第四季度看到非常強烈的季節性。這是因為夏季過後，冬季選擇性手術量通常會增加，而且大量患者在達到年度保險免賠額後會利用第四季度安排手術，這也加劇了這一現象。我們估計大約 50% 的 BPH 切除手術屬於醫療保險範圍，另一半為私人支付。然而，9 月底，颶風海倫淹沒了北卡羅來納州巴克斯特的鹽水設施。

Due to the severity of the storm and resulting damage, Baxter's saline production capabilities were disrupted. Why is this important? First, based on industry reports, Baxter accounts for over 50% of US market share for saline production. Second, all resective BPH procedures require the use of saline to irrigate the prostate and bladder during and post-surgery. As it pertains to intra-quarter trends, we saw a more drastic and unexpected decline in the month of November.

由於風暴的嚴重性和造成的損失，巴克斯特的鹽水生產能力受到干擾。為什麼這很重要？首先，根據產業報告，百特佔據美國鹽水生產市場50%以上的份額。其次，所有切除 BPH 手術都需要在手術期間和手術後使用鹽水沖洗前列腺和膀胱。就季度內趨勢而言，我們看到 11 月出現了更劇烈和意外的下降。

Based on our assessment of our installed base, approximately 50% of our accounts use Baxter as their primary supplier of saline. We saw these accounts either stop performing BPH procedures or significantly reduced volumes given that BPH is an elective procedure and can be deferred in favor of more critical procedures. From the hospital's perspective, we were informed that even if they were receiving saline orders, it was typically not at 100% of requested amounts, and thus, we're deprioritizing elective procedures.

根據我們對已安裝客戶群的評估，約有 50% 的客戶使用 Baxter 作為其鹽水的主要供應商。我們發現這些帳戶要么停止執行 BPH 手術，要么大幅減少手術量，因為 BPH 是一種選擇性手術，可以推遲至更關鍵的手術。從醫院的角度來看，我們被告知，即使他們收到鹽水訂單，通常也不會達到要求數量的 100％，因此，我們降低了選擇性手術的優先順序。

To help quantify the impact in the fourth quarter, since roughly 50% of our accounts were not impacted due to supplier arrangements or having adequate supply, those unaffected accounts demonstrated normal seasonal strength in the fourth quarter. Conversely, the other 50% of accounts that experienced sailing shortages realized material slowdowns in November with a modest recovery starting in December as sailing deliveries increased.

為了幫助量化第四季度的影響，由於大約 50% 的帳戶由於供應商安排或供應充足而沒有受到影響，因此這些未受影響的帳戶在第四季度表現出正常的季節性強勁。相反，另外50%遭遇航行短缺的客戶在11月份出現實質放緩，隨著航行交付量的增加，從12月開始出現小幅復甦。

Given this acute macro challenge, we estimate a lack of sailing resulted in a delay or cancellation of between 10% to 20% or up to 2,000 of our expected procedures in the fourth quarter, which ultimately impacts handpiece order patterns. In mid-November, recognizing that accounts affected by the saline shortage would not be rescheduling procedures in December, we realigned our commercial team's efforts to proactively schedule cases for the first quarter.

鑑於這一嚴峻的宏觀挑戰，我們估計，航行不足將導致第四季度預計 10% 至 20% 或多達 2,000 例手術被推遲或取消，最終影響手機訂單模式。11月中旬，我們意識到受到鹽水短缺影響的客戶不會在12月重新安排程序，因此我們重新調整了商業團隊的工作力度，並積極安排第一季的案件。

With an understanding of the anticipated time line for saline shipments to hospitals, our goal was to ensure procedure volumes in the first quarter returned to meeting our expectations. As a result of this proactive strategy, we witnessed a strong recovery in procedure volumes in February and feel positive about the momentum heading into March. As it pertains to recent high-dose account launches, given the saline shortage dynamic, many of our new account launches either restricted the number of procedures they were able to perform or push the launch into the first quarter of 2025. In a moment, Kevin will elaborate more on what this all means for the first quarter of 2025. Lastly, I'm once again incredibly proud of the commercial team and their focus and determination to execute through these short-term challenges.

透過了解鹽水運送到醫院的預計時間表，我們的目標是確保第一季的手術量恢復到我們的預期。由於採取了這項積極主動的策略，我們在 2 月見證了業務量的強勁復甦，並對 3 月的發展勢頭感到樂觀。至於最近的高劑量帳戶啟動，考慮到鹽水短缺的動態，我們的許多新帳戶啟動要么限制了他們能夠執行的程序數量，要么將啟動推遲到 2025 年第一季。稍後，凱文將進一步闡述這對 2025 年第一季意味著什麼。最後，我再次為商業團隊以及他們克服這些短期挑戰的專注和決心感到無比自豪。

I am particularly proud of the resolve and being able to pivot and ensure delay procedures are rescheduled. Specifically, in January and February, we have enhanced our value proposition to hospitals and that we have demonstrated how impactful it is to stack multiple Aquablation procedures in a single operating room day to drive efficiency. This not only helps hospitals, but it also is a significant help to PROCEPT because it optimizes the team's resources when covering procedures. Moving forward, we believe this will be a driver of increased procedure growth in 2025. With that, I'll turn the call over to Kevin.

我對我們的決心以及能夠改變態度並確保重新安排延誤程序感到特別自豪。具體來說，在一月和二月，我們向醫院強調了我們的價值主張，並證明了在單一手術室一天內堆疊多個水消融手術對提高效率的巨大影響。這不僅對醫院有幫助，而且對 PROCEPT 也有很大的幫助，因為它在覆蓋程序時優化了團隊的資源。展望未來，我們相信這將成為 2025 年流程成長的驅動力。說完這些，我會把電話轉給凱文。

Thanks, Sham. Total revenue for the fourth quarter of 2024 was $68.2 million, representing growth of 57% compared to the fourth quarter of 2023. US revenue for the fourth quarter was $60.4 million, representing growth of 50% compared to the prior year period. We generated total US system revenue of $27.6 million, representing system revenue growth of 67% compared to the fourth quarter of 2023.

謝謝，Sham。2024 年第四季總營收為 6,820 萬美元，與 2023 年第四季相比成長 57%。第四季美國營收為 6,040 萬美元，比去年同期成長 50%。我們在美國創造了 2,760 萬美元的總系統收入，與 2023 年第四季相比，系統收入成長了 67%。

In the fourth quarter, we sold 60 new robotic systems at a blended average selling price of approximately $460,000. As anticipated, over 95% of our US system sales were comprised of HYDROS Systems. Additionally, we sold three trade-in units during the quarter, generating total revenue of $245,000. US handpiece and consumable revenue for the fourth quarter of 2024 was $29.3 million, representing growth of 36% compared to the fourth quarter of 2023.

第四季度，我們銷售了 60 套新機器人系統，綜合平均售價約為 46 萬美元。正如預期的那樣，我們在美國系統銷售額的 95% 以上來自 HYDROS 系統。此外，我們在本季銷售了三台以舊換新車，總收入為 245,000 美元。2024 年第四季美國手機和消耗品收入為 2,930 萬美元，與 2023 年第四季相比成長 36%。

We shipped approximately 8,750 handpieces at average selling prices of approximately $3,200 in the US in the fourth quarter, representing unit growth of 37% compared to the fourth quarter of 2023. As previously mentioned by Sham, we estimate the saline supply shortage in the fourth quarter resulted in up to 2,000 procedures not being performed. This estimate was derived from an internal quantitative analysis of account historical trends as well as direct feedback obtained through customer interactions and surveys. We also recorded approximately $1.6 million of other consumable revenue in the fourth quarter of 2024.

我們在第四季在美國出貨了約 8,750 支手機，平均售價約為 3,200 美元，與 2023 年第四季相比，單位成長了 37%。正如 Sham 之前所提到的，我們估計第四季度的鹽水供應短缺導致多達 2,000 例手術無法進行。此估計數來自對帳戶歷史趨勢的內部定量分析以及透過客戶互動和調查獲得的直接回饋。我們也在 2024 年第四季記錄了約 160 萬美元的其他消耗品收入。

International revenue in the fourth quarter of 2024 was $7.8 million, representing growth of 137% compared to the prior year period. Growth in the fourth quarter was once again driven primarily by strong sales momentum in the United Kingdom. Gross margin for the fourth quarter of 2024 was 64%, representing an all-time high. Gross margin expansion in the fourth quarter was primarily due to improved operational efficiencies and higher HYDROS System average selling prices. Moving down the income statement. Total operating expenses for the fourth quarter of 2024 amounted to $63.4 million compared to $50.8 million during the same period in the prior year, and $59.3 million in the third quarter of 2024.

2024 年第四季的國際營收為 780 萬美元，比去年同期成長 137%。第四季的成長再次主要受到英國強勁銷售勢頭的推動。2024年第四季的毛利率為64%，創歷史新高。第四季毛利率擴大主要得益於營運效率的提高和HYDROS系統平均銷售價格的上漲。降低損益表。2024 年第四季總營運費用為 6,340 萬美元，而去年同期為 5,080 萬美元，2024 年第三季為 5,930 萬美元。

Fourth quarter operating expenses exceeded our previously issued guidance by approximately 3.5%. This variance is primarily attributable to higher variable compensation expenses driven by HYDROS system overachievement. The year-over-year increase was driven primarily by increased sales and marketing expenses, mostly to expand the commercial organization and increased general and administrative expenses, offset by lower sequential research and development expenses following the significant effort around HYDROS development in the second and third quarter of 2024. We are very pleased with the operating expense leverage we have demonstrated in 2024. When comparing revenue growth to operating expense growth, revenues increased 65% in fiscal year '24 on 30% operating expense growth. We believe our path to profitability is becoming increasingly clear as reflected in our 2024 results.

第四季的營運費用比我們先前發布的預期高出約 3.5%。這種差異主要歸因於 HYDROS 系統超額完成任務所導致的較高的可變薪酬費用。同比增長主要由於銷售和營銷費用的增加（主要用於擴大商業組織）以及一般和行政費用的增加，但隨著 2024 年第二季度和第三季度圍繞 HYDROS 開發做出大量努力，研發費用連續下降，抵消了這一增長。我們對 2024 年展現的營運費用槓桿感到非常滿意。當收入成長與營業費用成長進行比較時，24 財年收入成長了 65%，而營業費用成長了 30%。我們相信，正如我們 2024 年的業績所反映的那樣，我們的獲利之路正變得越來越清晰。

This clarity is driven by our recent gross margin expansion into the mid-60% range, which is a direct result of our ability to leverage existing overhead at higher revenue levels, along with increased average selling prices across the board. Furthermore, our consistent track record of growing revenue at a significantly faster pace than operating expenses continues to reinforce our trajectory towards profitability, which I will elaborate on further when providing our 2025 guidance. Net loss was $18.9 million for the fourth quarter of 2024 compared to $27.5 million in the same period of the prior year. Adjusted EBITDA was a loss of $10.3 million compared to a loss of $23.3 million in the fourth quarter of 2023.Following our most recent capital raise in late October, our cash, cash equivalents and restricted cash balances as of December 31 were $337 million. Moving to our 2025 financial guidance.

這種清晰的認知源自於我們近期毛利率擴大至 60% 左右，這直接得益於我們能夠利用現有的間接費用來提高收入水平，同時全面提高平均銷售價格。此外，我們一直以來的收入成長速度遠快於營運費用，這繼續鞏固了我們實現盈利的軌跡，我將在提供 2025 年指引時進一步闡述這一點。2024 年第四季淨虧損為 1,890 萬美元，去年同期為 2,750 萬美元。調整後的 EBITDA 虧損 1,030 萬美元，而 2023 年第四季虧損 2,330 萬美元。繼 10 月下旬最近一次融資之後，截至 12 月 31 日，我們的現金、現金等價物和受限現金餘額為 3.37 億美元。轉向我們的2025年財務指導。

We expect full year 2025 total revenue to be approximately $320 million, representing growth of approximately 43% compared to 2024. Beginning with US systems, we expect to sell approximately 210 new robotic systems in 2025. In line with previous years, our robotic sales are estimated to be distributed such that approximately 45% of the total will occur in the first half of 2025. While pleased with the direction of new HYDROS system pricing, we want to stress that capital pricing can be variable quarter-to-quarter. Thus, our updated guidance assumes new system pricing to be in the range of $430,000 to $440,000.

我們預計 2025 年全年總營收約為 3.2 億美元，與 2024 年相比成長約 43%。從美國系統開始，我們預計到 2025 年將銷售約 210 個新的機器人系統。與往年一致，我們預期機器人銷售的分佈是，總銷售額的約 45% 將出現在 2025 年上半年。雖然我們對新 HYDROS 系統定價的方向感到滿意，但我們想強調的是，資本定價可能會因季度而異。因此，我們更新後的指南假設新系統定價在 430,000 美元至 440,000 美元之間。

Our primary focus in 2025 remains on the substantial opportunity to sell HYDROS in greenfield accounts. However, we are also seeing interest from existing customers who are looking to either replace their current AquaBeam system or acquire a second system, which would be HYDROS. In response to this demand, we are incorporating approximately $3 million in system replacement revenue into our 2025 guidance, though this will predominantly be realized in the second half of the year. We continue to believe that the replacement opportunity will serve as a significant long-term driver for the business, although we are still in the early stages of the adoption curve, considering the 2,700 hospitals in the United States currently offering BPH resective options to their patients. Turning to US handpieces.

2025 年，我們的重點依然是在綠地帳戶中銷售 HYDROS 的巨大機會。然而，我們也看到現有客戶的興趣，他們希望更換現有的 AquaBeam 系統或購買第二個系統，即 HYDROS。為了滿足這一需求，我們將約 300 萬美元的系統更換收入納入我們的 2025 年指導方針，但這主要將在今年下半年實現。考慮到美國目前有 2,700 家醫院為患者提供 BPH 切除治療選擇，我們仍處於採用曲線的早期階段，但我們仍然相信替代機會將成為業務的重要長期驅動力。轉向美國手機。

On a full year basis, we expect to sell approximately 52,500 handpieces, representing 63%-unit growth compared to 2024. We also expect handpiece average selling prices to be approximately $3,200. We expect other consumables revenue to be approximately $8 million for the full year. Additionally, we expect US service revenue to be approximately $15.5 million for the full year. Lastly, on international revenue, given strong positive momentum in the United Kingdom and pending launches in Japan, we expect full year international revenue to be approximately $32.5 million, representing annual growth of 36%.

從全年來看，我們預計銷售約 52,500 台手機，與 2024 年相比成長 63%。我們也預計手機平均售價約為 3,200 美元。我們預計全年其他消耗品收入約為 800 萬美元。此外，我們預計全年美國服務收入約為 1550 萬美元。最後，關於國際收入，鑑於英國強勁的積極勢頭和日本即將推出的產品，我們預計全年國際收入約為 3,250 萬美元，年增長率為 36%。

Regarding gross margins, we expect full year 2025 gross margins to be approximately 64.5%, which would be an approximate 400 basis point improvement over 2024. First quarter 2025 gross margins should be relatively consistent to the fourth quarter of 2024. Turning to operating expenses. We expect full year 2025 operating expenses to be approximately $300 million, representing growth of 28% over 2024. In the first quarter of 2025, our operating expense guidance assumes spend of approximately $71 million. While we are forecasting our 2025 revenue to operating expense ratio will be down compared to 2024 levels, I want to provide additional context.

關於毛利率，我們預計 2025 年全年毛利率約為 64.5%，比 2024 年提高約 400 個基點。2025 年第一季的毛利率應與 2024 年第四季相對一致。談到營運費用。我們預計 2025 年全年營運費用約為 3 億美元，比 2024 年成長 28%。在 2025 年第一季度，我們的營運費用指引假設支出約為 7,100 萬美元。雖然我們預測 2025 年的收入與營業費用比率將低於 2024 年的水平，但我想提供更多背景資訊。

First, we believe our strong balance sheet offers us with the flexibility to invest strategically in key areas to drive long-term growth. Specifically, we are making targeted investments to accelerate enrollment in the WATER IV trial. The quicker we enroll patients, the sooner we can potentially begin generating revenue from prostate cancer treatment. Additionally, it is important to note that clinical trial expenses are heavily front-end loaded as most expenses occur during enrollment. We expect these costs will gradually decrease over time, particularly into 2026. Second, the total incremental operating expenses in our 2025 guidance amount to $66 million.

首先，我們相信強勁的資產負債表為我們提供了靈活性，可以在關鍵領域進行策略性投資，以推動長期成長。具體來說，我們正在進行有針對性的投資，以加速 WATER IV 試驗的招募。我們越快招募患者，就越快開始從前列腺癌治療中產生收入。此外，值得注意的是，臨床試驗費用主要是前期支出，因為大多數費用發生在入組期間。我們預計這些成本將隨著時間的推移逐漸下降，特別是到 2026 年。其次，我們 2025 年指引中的增量營運費用總額為 6,600 萬美元。

Of this, approximately $19.5 million is attributed to noncash stock-based compensation, which supports our expanding workforce and reflects our commitment to rewarding employees with equity, thereby aligning their interest with those of our shareholders. On an apples-to-apples basis, if you exclude incremental stock-based compensation, core operating expense growth would be 20% compared to 2024 levels. Finally, consistent with our 2024 guidance philosophy, we aim to provide an initial operating expense target that is expected to remain stable throughout the year with the potential to support higher revenue levels.

其中，約 1,950 萬美元歸因於非現金股票薪酬，這支持了我們不斷擴大的員工隊伍，並反映了我們致力於以股權獎勵員工的承諾，從而使他們的利益與股東的利益保持一致。相較之下，如果不包括增量股票薪酬，核心營運費用成長率將達到 2024 年水準的 20%。最後，與我們的 2024 年指導理念一致，我們旨在提供一個初始營運費用目標，預計該目標將全年保持穩定，並有可能支持更高的收入水平。

This approach ensures any revenue outperformance could contribute directly to the bottom line. Given current interest rates, we expect to generate net interest income of $13.5 million in 2025. When accounting for all these variables, we expect full year 2025 adjusted EBITDA loss to be approximately $35 million. Regarding first quarter revenue, we are forecasting total first quarter revenue of $65.5 million.

這種方法可以確保任何收入的超出預期都能直接為獲利做出貢獻。根據目前的利率，我們預計 2025 年將產生 1,350 萬美元的淨利息收入。考慮到所有這些變量，我們預計 2025 年全年調整後 EBITDA 損失約為 3500 萬美元。關於第一季的收入，我們預測第一季總收入為 6,550 萬美元。

US system revenue is expected to be approximately $18.7 million, and we anticipate selling approximately 10,750 handpieces in the United States. In terms of handpiece sales, we did experience some residual impacts from the saline shortage in January. However, February has returned to expected levels, and we are optimistic about the positive trajectory we are seeing in daily procedures. Additionally, the saline shortage affected our ability to launch new accounts in both the fourth quarter and early January.

美國系統收入預計約 1,870 萬美元，我們預計在美國銷售約 10,750 支手機。就手機銷售而言，我們確實受到了一月份鹽水短缺的一些殘留影響。然而，二月已恢復到預期水平，我們對日常流程中看到的積極軌跡感到樂觀。此外，鹽水短缺影響了我們在第四季和 1 月初開設新帳戶的能力。

However, as we exit February, we have clear visibility and are on track in our first quarter to launch the largest number of accounts ever in a given quarter. As we have communicated, we have observed that it takes new accounts approximately two to three quarters to reach a sustained and normal level of monthly procedural volume. To summarize, the challenges experienced in the fourth quarter appear to be largely behind us, and we have strong visibility into March procedure volumes.

然而，隨著二月的結束，我們有了清晰的願景，並預計在第一季推出有史以來最多的帳戶。正如我們已經溝通過的那樣，我們觀察到新帳戶大約需要兩到三個季度才能達到持續正常的每月程序量水準。總而言之，第四季度遇到的挑戰似乎已基本成為過去，我們對三月份的程序量有很強的可預見性。

At this point, I'd like to turn the call back to Reza for closing comments.

現在，我想將電話轉回給 Reza，請他發表最後評論。

Thanks, Kevin. In closing, I want to provide a brief preview of AUA 2025. AUA 2025 will be an exciting event for PROCEPT as this will be the first year we present cancer results for ad population from both of our trials, PRCT-001 and PRCT-002. The data we plan to present will include procedural anatomical capabilities and safety functional outcomes with respect to incontinence and erectile function and oncologic control measured with biopsy. Given the reproducible nature of our procedure and its safety profile seen during the treatment of BPH, we believe AUA 2025 will provide a glimpse into the future as to how early-stage prostate cancer will be treated. Furthermore, we are the first company ever to receive IDE approval from the FDA to enroll a randomized trial against radical prostatectomy for prostate cancer.

謝謝，凱文。最後，我想對 AUA 2025 做一個簡要的展望。AUA 2025 對 PROCEPT 來說將是一次令人興奮的盛會，因為這是我們第一次展示兩項試驗 PRCT-001 和 PRCT-002 針對廣告族群的癌症結果。我們計劃呈現的數據將包括與失禁和勃起功能以及透過活檢測量的腫瘤控制有關的程序解剖能力和安全功能結果。鑑於我們手術的可重複性及其在 BPH 治療過程中觀察到的安全性，我們相信 AUA 2025 將讓我們一窺未來早期前列腺癌的治療方法。此外，我們是第一家獲得 FDA IDE 批准，開展針對前列腺癌根治性切除術的隨機試驗的公司。

We view this as the first big step in pursuing a specific treatment for prostate cancer indication, which no other treatment has today. Given the amount of quality Level 1 clinical evidence we will be gathering over the next few years, we believe we will be in an advantageous position to drive rapid change in a massively underserved market.

我們認為這是尋求針對前列腺癌的特定治療的第一步，目前還沒有其他治療方法可以做到這一點。鑑於我們將在未來幾年收集大量優質 1 級臨床證據，我們相信我們將處於有利地位，推動這個嚴重服務不足的市場的快速變革。

And finally, to conclude my prepared remarks, we are seeing multiple factors continue to trend positively, allowing us to execute our long-term strategic plan. In summary, the US HYDROS launch is off to a great start and customers are thrilled with the improved features. Our pipeline and sales funnel continued to grow nicely at average selling price for HYDROS that are trending higher than our previous AquaBeam system.

最後，總結我的準備好的發言，我們看到多種因素繼續呈現正面趨勢，使我們能夠執行我們的長期策略計劃。總而言之，美國 HYDROS 的發布取得了良好的開端，客戶對改進的功能感到非常興奮。我們的管道和銷售管道持續良好成長，HYDROS 的平均售價趨勢高於我們先前的 AquaBeam 系統。

Our international business continues to build momentum in the UK and Japan. Our commercial organization is the largest and most tenured in the company's history, which we believe will lead to increased productivity. We are the first company ever to receive IDE approval from the FDA to enroll a randomized trial against radical prostatectomy for prostate cancer. We view this as the first big step in pursuing a specific treatment of prostate cancer indication.

我們的國際業務在英國和日本持續保持強勁發展勢頭。我們的商業組織是公司歷史上規模最大、歷史最悠久的組織，我們相信這將會提高生產力。我們是第一家獲得 FDA IDE 批准，開展針對前列腺癌根治性切除術的隨機試驗的公司。我們認為這是尋求前列腺癌特定治療的第一步。

And lastly, following an acute saline supply disruption in the fourth quarter, we are off to a positive start in the first quarter and feel very confident in delivering another year of strong procedure growth. We believe these underlying fundamentals reflect the technology that is laying the foundation to become the BPH surgical standard of care and a business that will be a leading global urology company. In closing, I want to thank our employees, customers and shareholders for all their support to help us along our journey to becoming the standard of care for BPH. We will continue to leverage our commercial and clinical investments to execute on our long-term strategy. Have a great day and I look forward to seeing many of you at upcoming investor conferences.

最後，繼第四季度出現嚴重的鹽水供應中斷之後，我們在第一季取得了積極的開局，並且非常有信心在接下來的一年中實現強勁的成長。我們相信，這些基本面反映了為成為 BPH 手術治療標準和成為全球領先的泌尿科公司奠定基礎的技術。最後，我要感謝我們的員工、客戶和股東，感謝他們的大力支持，幫助我們成為 BPH 治療的標準。我們將繼續利用我們的商業和臨床投資來執行我們的長期策略。祝大家有愉快的一天，並期待在即將召開的投資者會議上見到大家。

At this point, we will take questions. Operator?

現在，我們將回答問題。操作員？

(Operator Instructions) Craig Bijou, BofA Global Research.

(操作員指示) Craig Bijou，美國銀行全球研究部。

I will lump a couple in here, but they are around the impact from the saline shortage. So first, Kevin or Sham, I would love to understand how maybe the 10% to 20% in delay or cancellation procedures and kind of reconcile that with your estimate and how you got to the estimate of the 2,000 procedures. And beyond that, is there -- I guess, thinking about either the month where you weren't impacted or the hospitals that weren't impacted, is there a way that you can kind of frame what utilization was in that period? And then I will have a quick follow-up on '25 impact.

我將在這裡列舉幾個，但它們都與鹽水短缺的影響有關。首先，Kevin 或 Sham，我很想了解延誤或取消程序中可能佔 10% 到 20% 的比例，並將其與您的估計相協調，以及您是如何得出 2,000 個程序的估計值的。除此之外，還有什麼——我想，想想您沒有受到影響的月份或沒有受到影響的醫院，有沒有辦法可以大致了解該時期的利用率？然後我將快速跟進'25 的影響。

Great. Thanks, Craig. I will take that. This is Kevin. Before I get into your question, I do want to reiterate, we are really pleased with our overall performance in '24.

偉大的。謝謝，克雷格。我會接受的。這是凱文。在回答您的問題之前，我想重申一下，我們對 24 年的整體表現感到非常滿意。

Particularly, we had the launch of our next-generation HYDROS system. We saw significant procedure market share gains. And lastly, we did see significant gross margin expansion, which we hope is a valid proof point on a pathway to profitability here. But to get to your question specifically, as noted in our prepared remarks, we did estimate the impact in Q4 of up to 2,000 procedures from the saline shortage. And this really is multifactorial.

特別是，我們推出了下一代 HYDROS 系統。我們看到程序市場份額顯著增長。最後，我們確實看到了毛利率的顯著擴大，我們希望這是實現盈利的有效證明。但具體到您的問題，正如我們在準備好的評論中所指出的那樣，我們確實估計了第四季度因鹽水短缺而受到影響的手術數量將達到 2,000 例。這確實是多因素的。

We analyzed many different variables. I am going to go through a few of those here today. So first, we did attribute an amount lost to procedures. Frankly, we just know we directly lost as they were scheduled or they were to be scheduled and were not performed. That analysis was done two different ways.

我們分析了許多不同的變數。今天我將在這裡討論其中的幾個。因此，首先，我們確實將一定數量的損失歸因於程序。坦白說，我們只知道我們直接失敗了，因為它們按計劃進行或應該按計劃進行但卻沒有進行。該分析是透過兩種不同的方式進行的。

We had direct customer inquiries in January, where we went out and actually performed a customer survey to assess the impact. And then also, we had direct knowledge of our reps who, as you know, are currently in every case. We have a high degree of visibility into that factor. Second, I would say, is more of a quantitative analysis. Internally, we understand our Q4 ordering patterns.

我們在一月份直接收到了客戶詢問，並實際進行了客戶調查以評估其影響。而且，我們也直接了解我們的代表，正如你所知，他們目前在每一個案例中。我們對這因素有很高的了解。第二，我想說，更多的是定量分析。從內部來看，我們了解我們的第四季訂購模式。

We performed an internal analysis there regarding normal expectations for growth, particularly coming off a very strong September. And this supported the qualitative analysis we did through surveys and rep feedback. So that's factor number two. And then lastly, and this is important, we did quantify lost procedures from new accounts that did not start their Aquablation programs due to the saline shortage. And what I mean by that is, as a reminder, under normal circumstances, once a new system is sold, it typically does not perform procedures in that quarter it's sold.

我們對正常的成長預期進行了內部分析，尤其是在經歷了強勁的9月份之後。這支持了我們透過調查和代表回饋所做的定性分析。這是第二個因素。最後，這是很重要的一點，我們確實量化了由於鹽水短缺而未啟動水消融計劃的新帳戶的損失程序。我這樣說的意思是，提醒一下，在正常情況下，一旦新系統被出售，它通常不會在出售的季度執行程序。

And given this dynamic, we've always talked about that natural lag to utilization. However, because the saline impact was so widespread in the fourth quarter, the reality is the majority of accounts we sold to in the third quarter were pushed into the first quarter, or they were somewhat materially limited from a procedure standpoint. And this is -- it's not exact, which is why we provided a range, but I think we feel very good that it was up to 2,000 procedures. So that's the first part of your question. The second part of your question, we definitely saw intra-quarter trends.

鑑於這種動態，我們一直在談論利用率的自然滯後。然而，由於第四季度的鹽分影響非常廣泛，事實上我們在第三季度銷售的大多數帳戶都被推遲到了第一季度，或者從程序的角度來看受到了一定程度的實質限制。這是 — — 它並不精確，這就是為什麼我們提供了一個範圍，但我認為我們對它達到 2,000 個程式感到非常滿意。這是你問題的第一部分。關於你問題的第二部分，我們確實看到了季度內趨勢。

October was a normal October for us. Sure, we started to hear from accounts. We saw some impacts. But when we were on our Q3 call, we did not anticipate how widespread this issue was going to become and we really saw a precipitous drop in November. And then when you get into December, you start to see some recovery in the back half.

十月對我們來說是一個正常的十月。當然，我們開始聽取帳號的意見。我們看到了一些影響。但是，當我們進行第三季電話會議時，我們沒有預料到這個問題會變得如此普遍，我們確實看到 11 月出現了急劇下降。然後，當進入 12 月時，你會開始看到下半年出現一些復甦。

But more importantly, what we are seeing in Q1 is a lingering impact in January, a very strong February and a high degree of procedures coming back and accounts being launched in March. So apologies for the length there, but I hope I answered both of your questions.

但更重要的是，我們在第一季看到的是，1 月份的影響仍然存在，2 月份的表現非常強勁，3 月份程序的恢復和帳戶的推出程度很高。所以，對於冗長的文字我深表歉意，但我希望我已經回答了您的兩個問題。

Yes. I will take the second part of it, Craig, on the hospitals that weren't impacted. And I'm glad you noticed that because we did have about 50% of our hospitals that didn't have an impact with saline shortage in the fourth quarter. And when we look at the trends of the hospitals that had a normalized utilization in the fourth quarter, we were very encouraged because they performed exactly as we expected in the fourth quarter, which is seasonally a very strong quarter for all procedures, especially elective procedures. I mean, they delivered strong sequential growth in that period of time.

是的。克雷格，我將討論第二部分，關於未受影響的醫院。我很高興你注意到了這一點，因為我們大約有 50% 的醫院在第四季度沒有受到鹽水短缺的影響。當我們觀察第四季度利用率正常化的醫院趨勢時，我們感到非常鼓舞，因為它們的表現完全符合我們的預期，從季節角度來看，第四季度是所有手術，尤其是選擇性手術表現非常強勁的一個季度。我的意思是，他們在那段時間內實現了強勁的連續成長。

And we are in every single case. We track these metrics very closely. And so, we continue to be very excited and bullish about the trends that are going on with our procedures. And if you just look at that segment of customers, it performed as expected.

而我們卻身處每一個案例之中。我們非常密切地追蹤這些指標。因此，我們繼續對我們的程序的趨勢感到非常興奮和樂觀。如果你只看那部分客戶，它的表現就符合預期。

Thanks for the color. If I could just squeeze in a follow-up. Just on Q1, it seems like there's probably some puts and takes there, still some residual effect, but then you did talk about seeing procedures come back that maybe they were delayed or cancelled and done in Q1. So just comment on that, if you wouldn't mind and maybe how we should think about utilization growth overall going forward?

謝謝你的顏色。如果我可以擠出時間進行後續行動的話。僅就第一季而言，似乎可能存在一些變數，仍然存在一些殘留影響，但隨後您確實談到看到程序恢復，也許它們被推遲或取消並在第一季完成。因此，如果您不介意的話，請對此進行評論，也許我們應該如何看待未來的整體利用率成長？

Thanks, Craig. I will take all of your questions. First, I would suggest our Q1 guidance doesn't fully assume that all 2,000 procedures we lost in Q4 come back. I think we get the majority of those back, but there's a practical reality here where they will not all come back in the first quarter. And when you look at our guide in Q1 of 10,750 handpieces, this does apply just overall utilization relatively flat to Q1 of '24.

謝謝，克雷格。我將回答你們的所有問題。首先，我認為我們的第一季指引並不完全假設我們在第四季度損失的所有 2,000 個程序都會恢復。我認為我們已經收回了大部分資金，但實際情況是，他們不會在第一季全部回來。當您查看我們第一季的 10,750 個手機指南時，這確實適用於整體利用率與 24 年第一季相對持平的情況。

But as I previously said, we did see lingering impacts from this into January. So I'd suggest on an apples-to-apples basis, when we're looking at February and March, where the saline impact is behind us, we are seeing expanding utilization in those accounts. And then just lastly, and this is more of a philosophical comment.

但正如我之前所說，我們確實看到了這一事件持續至一月份的影響。因此，我建議，從同類比較的角度看，當我們觀察二月和三月時，鹽水的影響已經過去，我們會看到這些帳戶的利用率不斷擴大。最後，這更像是一個哲學評論。

We are coming off a fourth quarter which is the first quarter where we have experienced some significant headwinds on the procedure side of the business. And while we feel very good about the procedure trends we are seeing in the first quarter, we want to maintain a sense of just cautious optimism here in our guidance to ensure we continue to outperform expectations that we communicate.

我們剛結束第四季度，這是我們第一次在業務流程上遇到重大阻力的季度。雖然我們對第一季看到的程序趨勢感覺非常良好，但我們希望在我們的指導下保持謹慎樂觀的態度，以確保我們繼續超越我們所傳達的預期。

Matthew O'Brien, Piper Sandler.

馬修·奧布萊恩、派珀·桑德勒。

I have two questions as well. One of them to start with is just on the ASP side in terms of what you are assuming here for the handpiece number in the US. I think, Kevin, it's down about 6.5% year-over-year is what we are assuming here. That's the biggest drop, I think we've seen from the company. What's precipitating that kind of drop on the handpiece side?

我也有兩個問題。就您在這裡假設的美國手機數量而言，其中之一就是 ASP 方面。凱文，我認為我們假設它的同比下降幅度約為 6.5%。我認為這是我們公司出現的最大降幅。什麼原因導致手機側出現這種下降？

Yes. Let's talk specifically about handpiece ASP. So our guidance for the full year implies $3,200 ASP for our handpieces, which is actually up slightly from 2024, relatively consistent. I think what you're picking up on, Matt, in your model is other consumables, which is another part of our business that goes into handpiece revenue, but it's not directly correlated to handpiece ASPs. Other consumables include drapes, accessories that we sell.

是的。讓我們具體談談手機 ASP。因此，我們對全年的指導意味著我們的手機的平均銷售價格為 3,200 美元，實際上比 2024 年略有上漲，相對穩定。馬特，我想你在你的模型中註意到的是其他消耗品，這是我們業務的另一部分，它構成了手機收入，但它與手機 ASP 沒有直接關係。其他消耗品包括我們銷售的窗簾、配件。

And we are guiding to a number there of about $8 million, and that's coming off a $7 million number in 2024. But I think that's why you're getting a lower ASP. The fact is our handpiece ASP is steady at $3,200. Does that help?

我們預計該數字約為 800 萬美元，而到 2024 年將達到 700 萬美元。但我認為這就是您獲得較低 ASP 的原因。事實上我們的手機平均售價穩定在 3,200 美元。這樣有幫助嗎？

It does. I keep forgetting about that, but go ahead on HYDROS.

是的。我總是忘記這件事，但繼續使用 HYDROS。

Yes. And let me just talk about HYDROS ASP. So first off, I'd always say we've always guided relatively conservatively on price. We do expect to get a higher handpiece ASP for HYDROS than AquaBeam. But it's important to remember the majority of '25 procedures are still on the AquaBeam system.

是的。讓我只談談 HYDROS ASP。首先，我總是說我們在價格方面一直採取相對保守的指導態度。我們確實預期 HYDROS 的手機平均售價會比 AquaBeam 更高。但重要的是要記住，25 個程式中的大多數仍然採用 AquaBeam 系統。

AquaBeam is 80% of our installed base as we head into '25. So by analogy, you should assume it's the majority of procedures, which are at the lower ASP. But year-over-year, we're relatively consistent.

自進入 25 年以來，AquaBeam 已占我們安裝基數的 80%。因此，透過類比，您應該假設大多數程式都處於較低的 ASP 水準。但與去年同期相比，我們的表現相對穩定。

I appreciate that. Just on the OpEx spend here for the full year, I mean, the total number, I think, is a little bit higher than what we have been expecting and maybe some of the Street. And I think it makes sense with these extra investments that you're making. Can you talk about the upfront loading that's being -- that's going on right now, especially with WATER IV and then the extra spend there, how much faster can you make that enrollment? Or do we have to wait the AUA to really hear more about it?

我很感激。僅就全年的營運支出而言，我認為總數略高於我們的預期，甚至可能高於華爾街的部分預期。我認為你所做的這些額外投資是合理的。能談談目前正在進行的預付費用嗎？尤其是 WATER IV，以及那裡的額外支出，您可以以多快的速度完成註冊？或者我們必須等待 AUA 才能真正聽到有關它的更多信息？

Yes. So OpEx in totality is up about $66 million. I do appreciate that's slightly higher than expectations heading into this call. With that said, I did call out in my prepared remarks, about $20 million of that $66 million is incremental noncash-based stock compensation that as we head into year five of a public company in 2026, that year-over-year comparable should start to come down. So if you exclude stock-based comp, our OpEx growth is actually 20% and not 28%.

是的。因此，營運支出總額增加了約 6,600 萬美元。我確實很欣賞這比本次電話會議的預期略高一些。話雖如此，我在準備好的發言中確實提到過，這 6600 萬美元中約有 2000 萬美元是增量非現金股票薪酬，隨著我們進入 2026 年上市公司的第五年，這一同比水平應該會開始下降。因此，如果不考慮股票薪酬，我們的營運支出成長實際上是 20%，而不是 28%。

And so that's the year-over-year. In terms of R&D investments, we do feel that by making targeted investments, we can accelerate WATER IV on the front end. Think of that spend, just to characterize it, is about $10 million in 2025 in absolute dollars. That is somewhat front-loaded, as I called out. It does mean that R&D as a total of revenue will be about 25% in '25.

這就是同比的情況。在研發投入方面，我們確實認為透過有針對性的投資，我們可以在前端加速 WATER IV 的發展。想想看，到 2025 年，這筆支出的絕對金額約為 1,000 萬美元。正如我所說，這有點前置。這確實意味著到25年，研發費用將佔總收入的25%左右。

That's an improvement from 28% in '24, but this will start to come down over time. I think we've talked about this business getting to kind of a mid-teens run rate on R&D as a percent of revenue in the near future here.

這比 24 年的 28% 有所改善，但隨著時間的推移，這一比例將開始下降。我想我們已經討論過這項業務在不久的將來研發的運行率佔收入的百分比將達到十五六個百分點。

Patrick Wood, Morgan Stanley.

摩根士丹利的派崔克‧伍德 (Patrick Wood)。

I'd love to unpack a little bit more on the HYDROS feedback, the kind of accounts that you're seeing, how it compares to high-volume versus the low-volume, or I should say, lower volume accounts. Like just feedback from how your conversations with customers going on that side? And then I have one quick follow-up.

我很樂意進一步了解 HYDROS 的回饋，您所看到的帳戶類型，以及它與高容量帳戶和低容量帳戶（或者我應該說，較低容量帳戶）之間的比較情況。就像您與客戶對話的進展情況的回饋一樣？然後我還有一個快速的後續問題。

Yes. Thanks. As we mentioned in our prepared remarks, the HYDROS launch exceeds our expectation. Customers are very excited about the features we have put in this robot, the FirstAssist AI, 95% of the procedures are using the AI. And in fact, they are making little or no adjustment to what the ultrasound and the computer is offering.

是的。謝謝。正如我們在準備好的評論中提到的那樣，HYDROS 的發布超出了我們的預期。客戶對我們在這個機器人中添加的功能 FirstAssist AI 感到非常興奮，95％ 的程式都在使用 AI。事實上，他們很少或根本沒有對超音波和電腦提供的結果做出調整。

And of course, other features that help the staff to be more efficient, make the practice more -- streamline the workflow. And of course, the hospital CFOs are very excited about the fact that they don't need to re-sterilize the scope. I'm going to let Sham to talk about that.

當然，還有其他功能可以幫助員工提高效率，讓實務更加簡化—工作流程。當然，醫院的財務長們對於不需要重新消毒內視鏡這一事實感到非常興奮。我要讓 Sham 來談談這個問題。

Yes. Patrick, this is Sham. I'll take the question on the mix. So just to kind of frame up the conversation on mix of hospitals. Keep in mind, there's about 2,700 hospitals in the US perform BPH. In the early years of commercialization, we hyper focused on the high-volume BPH hospitals, and we've talked about that number being 860, and that was the initial strategy. But what we've seen over the recent years with the momentum is a surging demand by medium and low-volume BPH hospitals. Keep in mind, these medium and low-volume BPH hospitals, many of them are very large hospitals. They historically have not done a lot of BPH.

是的。派崔克，這是沙姆。我將回答有關混合的問題。只是為了建構關於混合醫院的討論框架。請記住，美國大約有 2,700 家醫院可治療 BPH。在商業化的早期，我們高度關注患者數量眾多的 BPH 醫院，我們曾討論過這個數字是 860，這是最初的策略。但近年來我們看到的趨勢是中小型 BPH 醫院的需求激增。請記住，這些中小型 BPH 醫院，其中許多都是大型醫院。他們過去並未進行過許多 BPH 治療。

However, with the surge of demand, like I said, with Aquablation, we're seeing many of those hospitals begin to acquire Aquablation systems. So really, in sum here, the mix has been moving over the years significantly more to medium and low-volume BPH hospitals as surgeons begin to do more Aquablation in those centers.

然而，正如我所說的，隨著需求的激增，隨著水消融技術的出現，我們看到許多醫院開始購買水消融系統。因此，總而言之，隨著外科醫生開始在中小型 BPH 醫院進行更多的水消融術，這些年來，手術方式已顯著轉移到這些醫院。

Super helpful. And then maybe as a very quick follow-up. I don't want to get hung up on the 2,000. But any thought on the risk that some of those patients ended up going for procedures that had a slightly lower saline? Obviously, it depends on prostate size, but a lower saline requirement, whether they went for a PAE or something else. Any sense of what the risk of that backlog being pulled away is?

超有幫助。然後可能是一個非常快速的後續行動。我不想被這 2,000 困住。但是，您是否考慮過，有些患者最終選擇接受鹽水稍低的治療，這會帶來風險呢？顯然，這取決於前列腺的大小，但對鹽水的要求較低，無論他們選擇的是 PAE 還是其他。您知道這些積壓貨物被撤走的風險有多大嗎？

No. This is Kevin. We don't feel like we lost any procedures to other resective modalities. I mean, the reality is where we saw accounts not performing Aquablation, they weren't performing any resective procedures. And when you look at the saline used for an Aquablation, it is less than other comparative resective technologies.

不。這是凱文。我們並不覺得我們因為其他切除方式而失去了任何手術程序。我的意思是，現實情況是，我們看到的帳戶沒有進行水消融術，他們沒有進行任何切除手術。當您看到水消融術所使用的鹽水時，您會發現它比其他同類切除技術要少。

So no. No is the short answer. We don't feel we lost any procedures to other modalities.

所以不行。簡短的回答是「不」。我們並不認為我們因其他方式而失去了任何程序。

Brandon Vazquez, William Blair.

布蘭登·巴斯克斯、威廉·布萊爾。

I'll just ask two upfront here. First, on the procedure side, and I hate to kind of myopically focus on near-term trends. But in Q1, we're talking about utilization that's flattish year-over-year, but we're also seem very excited about what we're seeing in terms of rescheduling accounts, opening record new accounts. I frankly would have expected that maybe to be a little bit higher. So maybe talk to us a little bit about do we see that come through a little bit later, the follow-through on this optimism, why maybe we don't see that a little bit higher in Q1?

我只想在這裡提前問兩個問題。首先，從程序方面來說，我不喜歡短視地關注短期趨勢。但在第一季度，我們所談論的利用率與去年同期相比持平，但我們對重新安排帳戶、開設創紀錄新帳戶方面所看到的情況似乎也感到非常興奮。坦白說，我原本預計這個數字可能會更高一些。因此，您能否與我們稍微討論一下，我們是否看到這種樂觀情緒在稍後實現，為什麼我們在第一季可能不會看到這種情緒略有上升？

The follow-up question maybe for Sham is just as you look at -- we don't have perfect numbers anymore since this mix of systems and where they're being placed is changing. But regardless, you're probably looking at greater than 50% penetration in high-volume accounts have an Aquablation system as we go through '25. What does that mean for system placements as we go forward? What does that mean for the durability of system placements from here?

對於 Sham 來說，後續問題可能如您所見——我們不再擁有完美的數字，因為這種系統組合及其放置位置正在改變。但無論如何，隨著我們進入'25年，您可能會看到大容量帳戶中超過 50% 的滲透率擁有 Aquablation 系統。這對於我們未來的系統佈局意味著什麼？這對於系統佈局的持久性意味著什麼？

Thanks, Brandon. I'll take the first part of your question. And the Q1 utilization as an absolute metric is heavily impacted by the lingering impacts in January. So without reading into it too much, it really is flat year-over-year because of the impacts we're seeing in January, but we're seeing tremendous momentum in both February and March. And then I would just remember my comments about us coming off of Q4 and us just being somewhat cautious in our guidance just to continue to ensure we hit our expectations that we put out there as a company.

謝謝，布蘭登。我來回答你問題的第一部分。作為絕對指標的 Q1 利用率受到 1 月持續影響的嚴重影響。因此，無需過多解讀，由於我們在一月份看到的影響，它實際上是與去年同期持平的，但我們在二月和三月都看到了巨大的發展勢頭。然後我只記得我關於我們第四季度的評論，我們只是在指導方面保持謹慎，只是為了繼續確保我們達到我們作為一家公司所設定的預期。

You should start to see in the second and third quarter improved year-over-year utilization. And we're not issuing quarterly guidance at this time for 2Q and 3. But what I can say, what our guidance would imply is that we're going to be exiting the year, Q4 with utilization growth year-over-year of 20%. Now I appreciate that's off a comparable that's not apples-to-apples, but this business is hyper-focused on utilization expansion, not only driving utilization with new accounts, but ensuring that the accounts we're in, we're driving those current surgeons to do more procedures. And with that, maybe I'll turn it over to Sham to talk about the second part of your question.

您應該會在第二季和第三季看到年比利用率的提高。目前我們不會發布第二季和第三季的季度指引。但我可以說，我們的預期是，今年第四季我們的利用率將年增 20%。現在我明白這是一個不太可比的可比性，但這項業務高度專注於利用率的擴大，不僅透過新帳戶推動利用率，而且確保我們所在帳戶，我們正在推動那些現有的外科醫生進行更多的手術。說到這裡，我可能要把話題交給 Sham 來談論你問題的第二部分。

Yes. Brandon, it's Sham. Without giving you specific numbers on the mix, I would just tell you that our data suggests at the current run rate, we have over four years left of pipeline available for high-volume BPH hospitals, let alone a significant opportunity with low- and medium-volume BPH hospitals. This doesn't account for second systems. It doesn't account for potential trade opportunities. It doesn't account for other factors in our business in the future, which could drive sales. So this is just strictly greenfield sales.

是的。布蘭登，我是沙姆。我不會向您提供具體的數字，我只想告訴您，我們的數據表明，按照目前的運行速度，我們還有超過四年的時間可以為高容量 BPH 醫院提供渠道，更不用說為低容量和中等容量 BPH 醫院提供的重要機會。這沒有考慮第二個系統。它沒有考慮到潛在的貿易機會。它沒有考慮到我們未來業務中可能推動銷售的其他因素。所以這只是嚴格意義上的綠地銷售。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

Just the first one, I think you had mentioned that as you were launching HYDROS initially, you had distraction to the kind of consumables or handpiece sales force. I'm just -- it didn't really -- or maybe I missed it, but I didn't hear you guys talk about that at all. It sounds like maybe that's in the rearview. Could you discuss what, if any, impact kind of was there in the fourth quarter, lingering into the first quarter? And can we assume that's behind us moving through 2Q to 4Q? And then I have a follow-up.

僅就第一個問題而言，我認為您曾提到，當您最初推出 HYDROS 時，您的注意力集中在消耗品或手機銷售人員身上。我只是 — — 確實沒有 — — 或者也許我錯過了，但我根本沒有聽到你們談論這個。聽起來也許這只是後視鏡而已。您能否討論一下第四季度產生了哪些影響（如果有的話），並且會持續到第一季？我們是否可以假設這已經從第二季過渡到第四季了？然後我有一個後續問題。

Richard, I'll take that. This is Sham. I'll take the first one on the rep impact. We did talk about that in Q3 and Q4 as we have a large field team need to be training on HYDROS. There's a silver lining in the sailing impact as we accelerated training in the fourth quarter.

理查德，我接受。這就是 Sham。我將首先討論聲譽影響。我們確實在第三季和第四季討論過這個問題，因為我們有一個大型現場團隊需要對 HYDROS 進行培訓。隨著我們在第四季度加快訓練，帆船運動取得了積極的進展。

And as we turn the year -- turn to the New Year here, we have that completely behind us. And so in January, every rep is fully trained on the HYDROS system, and that's no longer something we see as an impact to utilization.

當我們迎來新的一年時，我們已經完全忘記了這一切。因此，在一月份，每位代表都接受了 HYDROS 系統的全面培訓，我們不再認為這會對利用率產生影響。

Okay. Great. And then just on the replacement revenue, I think you said that's $3 million anticipated for 2025. Should we be thinking that that's -- or can you talk a little bit about customers that have maybe purchased the system within the last one to two years and then maybe some of the older portions of your installed base. I would imagine there's a true-up kind of ASP for new -- more recent purchasers than there is for those who have an older system and are upgrading.

好的。偉大的。然後就替代收入而言，我想您說過預計 2025 年將達到 300 萬美元。我們是否應該認為這是——或者您能否談談可能在過去一到兩年內購買了該系統的客戶，以及可能是您安裝的一些較舊的客戶群。我認為，對於新的（較新的）購買者而言，存在一種真實的 ASP，而對於那些擁有舊系統並正在升級的購買者而言，則不存在這種 ASP。

Should we assume that the ASP was obviously something less than $460,000? But I mean, should we assume that's in the $50,000 to $100,000 range on average? Any help there would be helpful.

我們是否應該假設 ASP 顯然低於 460,000 美元？但我的意思是，我們是否應該假設平均金額在 50,000 至 100,000 美元之間？任何幫助都會有幫助。

Yes. Let me address your comments on ASPs and replacements and then I'll turn it over to Sham about kind of our focus and opportunity in both greenfield and replacement. So I would suggest that the replacements that we've talked about in 2024 are not reflective of what an ongoing replacement cycle should look like for average selling prices. And what I mean by that is the replacements that we executed on in Q3 and Q4 were really for AquaBeam customers that had purchased in the previous six months. And therefore, you're correct that those ASPs are fairly low.

是的。讓我來回答一下您對 ASP 和替代品的評論，然後我將把它交給 Sham 來談談我們在綠地和替代品方面的重點和機會。因此，我認為我們在 2024 年討論的替代品並不能反映平均銷售價格的持續替代週期應該是什麼樣的。我的意思是，我們在第三季和第四季執行的替換實際上針對的是過去六個月內購買的 AquaBeam 客戶。因此，您說這些 ASP 相當低是正確的。

They're in the $50,000 to $100,000 range, and those are almost more as exchanges as opposed to replacements given HYDROS was not available when they bought AquaBeam. As we move forward, I think we get into a much more normal replacement opportunity where if you have a HYDROS -- excuse me, if you have an AquaBeam that you bought five years ago, the reality is you're going to buy HYDROS at the same ASP that a greenfield would buy.

它們的價格在 50,000 到 100,000 美元之間，而且由於 HYDROS 在收購 AquaBeam 時還沒有上市，所以它們幾乎更多的是作為交換而不是替代品。隨著我們不斷前進，我認為我們將進入一個更正常的替代機會，如果你有一台 HYDROS——對不起，如果你有一台五年前購買的 AquaBeam，那麼現實情況是你將以與綠地相同的 ASP 購買 HYDROS。

But if you bought AquaBeam in the last two to three years, you will get some discount, but that discount is more in the $100,000 to $150,000 range, not $300,000, which you've been seeing in the last six months. So that's on ASPs, and I hope you appreciate the difference there between kind of the replacements in an initial launch, which address near-term customer concerns and then just a normal ongoing replacement cycle. And I'll turn it over to Sham to kind of talk about the strategy and the why here.

但是，如果您在過去兩到三年內購買了 AquaBeam，您會獲得一些折扣，但折扣更多地是在 100,000 美元到 150,000 美元的範圍內，而不是您在過去六個月中看到的 300,000 美元。這就是關於 ASP 的問題，我希望你能理解首次發布的替代品與後續正常的替換週期之間的差異。接下來我將請 Sham 來談論策略以及原因。

Thank you, Richard. I think it's an interesting dynamic that we have going on. The HYDROS value is compelling for our customers. The customers are excited, and we are getting inbound interest into looking at second system or trade opportunities. And what we're trying to do with our sales team is ensure that we don't lose focus.

謝謝你，理查。我認為我們正在經歷一個有趣的動態。HYDROS 的價值對我們的客戶來說非常有吸引力。客戶們很興奮，我們也對尋找第二個系統或貿易機會產生了興趣。我們與銷售團隊一起努力確保我們不會失去重點。

We stay very disciplined on our effort to become the standard of care in BPH. In order to do that, we need to continue to focus on greenfield hospitals and then focus on opportunities where we believe we can do trades in an expeditious fashion. So selling a trade, even though on the outside may seem like it's faster, it takes a lot of time and energy to work through a hospital purchasing process on a trade. And so that takes away from greenfield selling time. So the focus for our capital sales team in 2025 continues to be greenfield sales.

我們始終嚴謹地努力，以成為 BPH 治療的標準。為了做到這一點，我們需要繼續關注新建醫院，然後關注我們認為可以迅速進行交易的機會。因此，儘管從表面上看銷售交易似乎更快，但完成醫院的採購流程需要花費大量的時間和精力。這就會減少綠地的銷售時間。因此，我們資本銷售團隊在 2025 年的重點仍然是綠地銷售。

When those opportunities come for trades and they will be a larger sales than we've seen in 2024, we will take advantage of those as long as it makes sense and doesn't distract from greenfield sales.

當這些交易機會到來時，它們的銷售額將比我們在 2024 年看到的更大，只要它有意義並且不會分散對綠地銷售的注意力，我們就會利用這些機會。

If I could, just one follow-up on that. Is there a downward pressure on the overall company ASP from that $3 million relative to the $435,000? Or that $435,000 is separate from replacement revenue?

如果可以的話，我只想跟進一下這個問題。相對於 43.5 萬美元，300 萬美元是否會對公司整體 ASP 造成下行壓力？或者說 435,000 美元與更換收入是分開的？

That is separate. So just to be specific here, we guided to 210 systems at an ASP of $430 to $440. Those are completely separate than the $3 million in incremental revenue that you can ascribe that, Rich, to about think of 10 replacements, somewhere in that range in 2025 to get to that $3 million number.

那是分開的。因此，具體來說，我們指導的 210 個系統的平均銷售價格為 430 至 440 美元。這些與 300 萬美元的增量收入完全不同，Rich，您可以將其歸因於大約 10 個替代品，在 2025 年的某個時候達到 300 萬美元的數字。

Chris Pasquale, Nephron Research.

克里斯·帕斯誇萊（Chris Pasquale），腎元研究公司。

International really seems to have inflected in the back half of '24. I know it gets overshadowed by the US business, but we saw a big step up there. Guidance for '25 seems to imply continued momentum and the utilization number, in particular, in the fourth quarter seems to have been quite strong. Maybe just spend a minute on where you're seeing the strength there and what the next dominoes are for you guys in terms of OUS expansion?

國際情勢似乎在24年下半年確實發生了變化。我知道它被美國業務所掩蓋，但我們在那裡看到了巨大的進步。對'25的指導似乎意味著持續的勢頭，特別是第四季度的利用率似乎相當強勁。也許您花一點時間談談您認為那裡的優勢在哪裡，以及就 OUS 擴張而言，下一個骨牌是什麼？

Yes. Maybe I'll start with just providing some help on what was comprised of international. And consistent with previous quarters, the upside in the fourth quarter is primarily demand driven from the UK, both on new systems, but as you pointed out, some really nice procedure growth and utilization. And I think our 2025 guidance really reflects the fact that we're just getting started in the UK and have a lot of runway left here. I'll turn it over to Sham to perhaps talk about some of the other regions that we're making some initial inroads, but at the same time, we do not have a significant amount of revenue in '25.

是的。也許我首先會提供一些有關國際內容的幫助。與前幾季度一致，第四季度的成長主要是由英國的需求推動的，不僅包括新系統，而且正如您所指出的，還有一些非常好的程序增長和利用率。我認為我們的 2025 年指導方針確實反映了我們在英國才剛起步並且還有很大的發展空間。我將把話題交給 Sham，讓她談談我們正在取得初步進展的其他一些地區，但與此同時，我們在 25 年並沒有獲得可觀的收入。

Yes. I think I'll touch on the UK just a little bit more color and then talk about outside the UK. So the first thing I would say is I've been spending some time over in the UK just due to the momentum that's happening in the business there. Very akin to our experience in the US. We're now seeing the government hospitals adopt the technology, but also the private sector that started to adopt in a very nice fashion in the UK.

是的。我想我將稍微詳細地談一談英國，然後再談英國以外的情況。因此，我想說的第一件事是，我在英國待了一段時間，因為那裡的商業發展勢頭良好。與我們在美國的經歷非常相似。我們現在看到英國的政府醫院正在採用這項技術，私營部門也開始以非常好的方式採用它。

Recently, I was over there and met with a large -- with the executive team of the largest IDN and they are looking for a strategy to expand Aquablation throughout the country. So just really, really exciting opportunity there in the UK to become standard of care for BPH procedure as well. Outside of the UK, our primary focus is the direct business is in Japan. We now have established reimbursement. The KOL network is building.

最近，我在那裡會見了最大的 IDN 的執行團隊，他們正在尋找一項將 Aquablation 擴展到全國的策略。因此，在英國，這確實是一個非常令人興奮的機會，可以成為 BPH 治療的標準治療。在英國以外，我們的主要重點是日本的直接業務。現在我們已經確定報銷事宜了。KOL網路正在建置。

2025 will be very much a focus on expanding the installed base to a heavy focus on greenfield sales. And like the US, we'll start -- in the UK, we'll start to build the procedure business over years as we build that direct team in Japan. And beyond those two countries, we've obviously have a large opportunity, and we're focused on countries where we believe we can move the market in the years to come. So building market development activities and building KOLs in those markets.

2025 年的重點將集中在擴大安裝基礎，並將重點放在綠地銷售上。和美國一樣，我們將在英國開始，隨著我們在日本建立直接團隊，我們將用幾年的時間開始建立程序業務。除了這兩個國家之外，我們顯然還擁有巨大的機遇，而且我們專注於那些我們認為可以在未來幾年推動市場發展的國家。因此，要進行市場開發活動，並在這些市場中培養 KOL。

And then this is just one detailed one. Did the size of the WATER IV trial change from what you had contemplated back in the fall? I thought it was 180 before and now it's 280, but maybe I misheard.

這只是一個詳細的。WATER IV 試驗的規模與秋季時您設想的相比有變化嗎？我之前以為是180，現在是280，不過也許我聽錯了。

No, no. We had said WATER IV would be at 280 patients randomized study in the United States.

不，不。我們曾說過 WATER IV 將在美國對 280 名患者進行隨機研究。

Nathan Treybeck, Wells Fargo.

富國銀行的 Nathan Treybeck。

Just circling back to the replacement opportunity. Is there any way you could kind of help us understand the gross margin impact from replacements and then just generally for 2025, how should we think about gross margin cadence through the year? And where do you think you can exit in Q4?

回到替換機會。您能否以某種方式幫助我們了解替換對毛利率的影響，然後總體而言，對於 2025 年，我們應該如何考慮全年的毛利率節奏？您認為您可以在第四季從哪裡退出？

Yes. So Richard just asked this question. The replacement opportunity is factored into our gross margin guide. We're assuming about 10 replacements at a $300,000 ASP in the US. We're assuming 210 Greenfields in the US at $430,000 to $440,000. So our margin expansion takes into account any dilutive impacts that we would have from replacement opportunities. The second part of your question on gross margins, can you just repeat exactly just so I can make sure I answer your question.

是的。所以理查德就問了這個問題。替代機會已計入我們的毛利率指南中。我們預計在美國約有 10 名替換者，平均售價為 30 萬美元。我們預計美國有 210 個 Greenfields，價格為 430,000 至 440,000 美元。因此，我們的利潤率擴張考慮到了替代機會帶來的任何稀釋影響。關於毛利率的問題的第二部分，您能否準確重複一遍，以便我確保回答您的問題。

Yes. Basically, how do you expect gross margin to trend through the year and the exit rate in Q4?

是的。基本上，您預計全年毛利率將如何變化，第四季的退出率將如何變化？

Yes. So we exited -- just to remind everybody, this year, 2024 with Q4 margins of 64% and full year margins of 61%. Now that was a meaningful improvement from 52% in 2023. And then we have guided on a full year basis here to kind of right mid-64.5%. That would suggest an exit velocity of somewhere in the 65% to 66% range in the fourth quarter.

是的。所以我們退出了——只是提醒大家，今年，也就是 2024 年，第四季利潤率為 64%，全年利潤率為 61%。這比 2023 年的 52% 有了顯著改善。然後，我們預計全年成長率將達到 64.5% 左右。這意味著第四季的退出速度在 65% 到 66% 之間。

And we're pleased with that growth, but I don't want anybody to think we're disappointed given how robust '24 was. The reality is '24 was always transformational for us from a gross margin. This was the year we saw a meaningful impact of leveraging our overhead. It's the year we moved in fully to our new facility and took advantage of that. And on top of that, we had a nice surprise in '24 with significantly average selling prices, particularly on the capital side of the business. So given where we're at today in the mid-60s, we don't expect the same magnitude of move in '25.

我們對這種成長感到滿意，但考慮到24年的強勁成長，我不希望任何人認為我們感到失望。事實是，從毛利率來看，24 年對我們來說總是具有改變意義。這是我們親眼見證了管理費用槓桿作用產生重大影響的一年。今年我們全面遷入新工廠並充分利用了這項優勢。除此之外，2024年我們還獲得了一個驚喜，銷售價格明顯達到了平均水平，特別是在業務的資本方面。因此，考慮到我們目前所處的 60 年代中期水平，我們預計 25 年不會出現同樣幅度的變動。

But again, we're going to be exiting the year close to 66%, which we believe, importantly, will be another proof point on a very clear pathway to profitability.

但是，我們今年的獲利能力將接近 66%，我們認為，重要的是，這將是另一個盈利能力非常明確的證明點。

And so, at this point, my understanding is there's a rep at every procedure. And I believe you talked about this in the past, but eventually, you want to move beyond that where you don't need a rep at every procedure. I guess, what are you thinking about timing in terms of transitioning how the procedure is done, how many reps you need in the field?

所以，在這一點上，我的理解是每個程式都有一個代表。我相信您過去也談過這個問題，但最終，您希望超越這一點，不再需要在每個程式中都派代表去做。我想，您在考慮轉變程序執行方式的時間安排方面是怎樣的，您在現場需要多少個代表？

Hey, Nate, it's Sham. So I think there's a couple of factors here that we're considering before we make that decision to be something that's more widespread. Number one is in high-volume hospitals, there are 12 BPH surgeons. And so, our opportunity to sell to the other surgeons that aren't using our technology becomes more and more challenging when we're not in the operating room. It's an unbelievable sales opportunity for our field team to be in those cases and cross-selling to those other surgeons.

嘿，Nate，我是 Sham。因此，我認為，在做出更廣泛的決定之前，我們正在考慮幾個因素。第一名是在病患量大的醫院，有 12 位 BPH 外科醫生。因此，當我們不在手術室時，向未使用我們技術的其他外科醫生銷售產品的機會變得越來越具有挑戰性。對於我們的現場團隊來說，這是一個令人難以置信的銷售機會，可以參與這些案例並向其他外科醫生進行交叉銷售。

The other piece of this is simply the efficiencies of the procedure. When we're in there and we're helping staff and there's a lot of different staff that covers procedures, we're able to get through a lot more cases in a day when our reps are in the room. With HYDROS, that equation could change for us. That's one of the reasons why we're excited about HYDROS is our ability to allow more and more different staff members to have a procedure that can be more efficient for our surgeons.

另一部分只是程式的效率。當我們在那裡幫助工作人員並且有很多不同的工作人員負責處理程序時，當我們的代表在房間裡時，我們一天能夠處理更多的案件。有了 HYDROS，我們的這個等式就可以改變。這就是我們對 HYDROS 感到興奮的原因之一，因為我們能夠讓越來越多不同的工作人員接受對我們的外科醫生更有效率的手術。

So the short answer to your question is we plan to pilot some of these HYDROS accounts in 2025, and we'll see how that goes. And over time, we definitely will see more and more independent surgeons, but for now, we see it as an opportunity when we're in those hospitals to bring more and more surgeons on technology.

所以對你的問題的簡短回答是，我們計劃在 2025 年試行其中一些 HYDROS 帳戶，然後看看進展如何。隨著時間的推移，我們肯定會看到越來越多的獨立外科醫生，但就目前而言，我們認為這是一個機會，當我們在這些醫院時，可以讓越來越多的外科醫生掌握技術。

Mike Kratky, Leerink Partners.

Leerink Partners 的 Mike Kratky。

Kevin, maybe just to go back to one you talked about. I think you've historically talked about 65% gross margins being in the range at which you could start to get a pretty clear path to profitability. So is it fair to think if you're exiting this year at 66, I mean, not to get ahead of ourselves, but does that give you pretty good confidence that 2026 then is the year that, that could happen? And then I have one follow-up.

凱文，也許只是回到你剛才談到的一個話題。我認為您曾經討論過 65% 的毛利率是一個可以開始獲得相當清晰的盈利途徑的範圍。所以，如果今年 66 歲就退休了，這樣想公平嗎？我的意思是，不要超前，但這是否讓您很有信心 2026 年就是實現這一目標的一年？然後我還有一個後續問題。

Yes. I'm going to keep my commentary focused on '25, but I think they'll help with your question anyhow. And I'm going to talk about EBITDA in particular. So we did provide quarterly EBITDA guidance, and I'm going to talk about the fourth quarter. However, we do expect to see sequential improvements in EBITDA throughout the year.

是的。我將繼續關注‘25’的評論，但我認為無論如何它們都會對您的問題有所幫助。我將特別談論 EBITDA。因此，我們確實提供了季度 EBITDA 指導，我將談論第四季度。然而，我們確實預計全年 EBITDA 將持續改善。

And we do believe, exiting '25, we're going to show a very clear pathway to sustained profitability. However, we're not going to comment today on what specific quarter that's going to be or actually comment on 2026 either. But to get to our implied guidance, you get to a place exiting '25, again, where it should be very clear that this is a business with significant top-line growth, expanding margins, leveraged OpEx, and no question about our ability to generate profits moving forward.

我們確實相信，在退出25年後，我們將展示一條通往持續盈利的非常清晰的道路。不過，我們今天不會評論具體是哪個季度，也不會對 2026 年做出實際評論。但要獲得我們的隱含指導，您需要再次進入 25 年，此時應該非常清楚，這是一項收入顯著增長、利潤率不斷擴大、運營支出槓桿化的業務，而且毫無疑問我們有能力在未來創造利潤。

And then maybe just one follow-up. Earlier, you mentioned your guidance implies your handpiece ASP, I think is up slightly, but most of that is still coming from AquaBeam. So can you help quantify how much higher your HYDROS Handpiece revenue is or your -- sorry, ASP is versus AquaBeam on an apples-to-apples basis?

然後可能只需要一次後續行動。之前，您提到您的指導意味著您的手機 ASP 我覺得略有上漲，但大部分仍然來自 AquaBeam。那麼您能否協助量化一下 HYDROS 手把的收入或 — — 抱歉，與 AquaBeam 相比，ASP 高出多少？

Yes. It's too early to comment on specificity. The reality is we're still working through a lot of the HYDROS negotiations. Our installed base of HYDROS is still less than 100 systems that we've sold. So we feel good that we're getting increased ASP, but it's probably too early to comment on what that delta looks like as we're working through multiple customer negotiations. Is that fair?

是的。現在評論具體細節還為時過早。實際情況是，我們仍在進行大量 HYDROS 談判。我們安裝的 HYDROS 系統數量仍不到 100 套。因此，我們很高興看到平均售價有所上漲，但由於我們正在與多位客戶進行談判，因此現在就評論這一變化幅度可能還為時過早。這樣公平嗎？

Yeah. Understood.

是的。明白了。

Josh Jennings, TD Cowen.

喬許詹寧斯（Josh Jennings），TD Cowen。

I guess maybe a hard one to answer, but I was hoping you could just share what competitors are doing as PROCEPT is driving the Aquablation treatment towards standard of care. Are you seeing significant counter marketing in the field? Are there any technology enhancements that you got that are on your radar? I'd love to just hear how you're thinking about the competitive landscape and if it's getting tougher or if you guys are even more confident after the past multiyear run you've been on?

我想這可能很難回答，但我希望你能分享一下競爭對手正在做的事情，因為 PROCEPT 正在推動 Aquablation 治療走向護理標準。您是否看到該領域出現了明顯的反行銷現象？您是否關注過哪些技術改進？我很想聽聽你們對競爭格局的看法，以及競爭是否變得更加激烈，或者經過過去多年的努力之後你們是否更有自信？

Josh, this is Reza. Definitely on the competitive front in the last couple of years, technologies we see are generally in the non-resective area. On the resective, especially, we do not see companies running even an FDA trial. And also -- so this is for BPH treatment. And as far as the prostate cancer, yes, we see some technologies for focal therapy.

喬希，這是雷札。毫無疑問，在過去幾年的競爭中，我們看到的技術一般都處於非切割領域。尤其是在部分方面，我們甚至沒有看到公司進行 FDA 試驗。而且 —— 這是用於 BPH 治療的。就前列腺癌而言，是的，我們看到了一些局部治療技術。

And we are still the only company running an FDA randomized study ID in the United States. So we are very confident with our technology. I'm going to let Sham -- he can add more color to this.

而且我們仍然是唯一一家在美國運行FDA隨機研究ID的公司。所以我們對我們的技術非常有信心。我要讓 Sham —— 他可以為此增添更多色彩。

Josh, it's Sham. I think on the resective front, we've made significant progress in our journey to become standard of care. We'll exit 2025 at roughly 20% of the resective market. And when you look at the competition in the resective market, the gold standard for 100 years has been TURP. And who sells TURP?

喬希，我是沙姆。我認為在切除方面，我們在成為護理標準的過程中取得了重大進展。到 2025 年，我們將佔據切除市場的約 20%。當你觀察切除術市場的競爭時，會發現 100 年來，TURP 一直是黃金標準。還有誰銷售 TURP？

There's a lot of different products to sell TURP. So we don't really have a direct competitor when it comes to TURP, which is a massive advantage for Aquablation and for PROCEPT. The other companies rather touched on the non-resective technologies, which tend to be office-based. But in the hospital market, we feel like we've got an unbelievable opportunity to really continue our journey of becoming standard of care

有很多不同的產品可以銷售 TURP。因此，在 TURP 方面，我們實際上沒有直接競爭對手，這對 Aquablation 和 PROCEPT 來說是一個巨大的優勢。其他公司則更傾向於採用非切除技術，這些技術往往以辦公室為基礎。但在醫院市場，我們覺得我們有一個難以置信的機會，可以真正繼續我們成為醫療標準的旅程

And just wanted to check in on your system guidance and assumptions baked in. I know we're going to see some early prostate cancer data at AUA as my understanding. Sorry, I may have missed part of the prepared remarks session earlier. But I mean, are you baking in any prostate cancer indication-driven system sales in 2025 system guidance? Or is that not baked in?

只是想檢查一下您的系統指導和假設。據我了解，我們將在 AUA 上看到一些早期前列腺癌數據。抱歉，我可能錯過了之前的部分準備好的發言環節。但我的意思是，您是否在 2025 年系統指導中考慮了任何前列腺癌適應症驅動的系統銷售？或者說它還沒被烤熟？

No, that's -- our guidance does not assume any revenue or systems or procedures attributable to prostate cancer.

不，那是——我們的指導不假設任何與前列腺癌相關的收入、系統或程序。

As far as the second part of your question, definitely, we are very excited. We'll give an update on WATER IV enrollment. There will be data presented on PRCT-001, PRCT-002. And so, these are some of the information that will be presented at AUA.

至於你問題的第二部分，我們確實非常興奮。我們將發布有關 WATER IV 註冊的最新情況。將會展示有關 PRCT-001、PRCT-002 的數據。這些就是將在 AUA 上展示的一些資訊。

We have no further questions at this time. I'd like to turn it back to Reza Zadno, CEO, for closing remarks.

目前我們沒有其他問題。我想請執行長 Reza Zadno 作最後發言。

I want to thank everyone for attending our earnings call. We hope to see you at the upcoming conferences and have a nice day.

我要感謝大家參加我們的財報電話會議。我們希望在即將召開的會議上見到您，祝您有個愉快的一天。

This concludes today's conference call. Thank you for participating, and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。