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Operator
Operator
Ladies and gentlemen, thank you for standing by. Welcome to the Intuitive Surgical Q4 2017 Earnings Release Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded.
女士們、先生們,感謝你們的耐心等待。歡迎參加直覺外科公司2017年第四季財報電話會議。(操作說明)提醒各位,今天的會議正在錄音。
I would now like to turn the conference over to your first speaker, Calvin Darling, the Senior Director of Finance and Investor Relations. Please go ahead, sir.
現在,我謹將會議交給你們的第一位發言人,財務和投資者關係高級總監卡爾文·達林。請繼續,先生。
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
Thank you. Good afternoon, and welcome to Intuitive Surgical's Fourth Quarter Earnings Conference Call. With me today, we have Gary Guthart, our President and CEO; and Marshall Mohr, our Chief Financial Officer. Note that Patrick Clingan, who has participated on these calls in the past, will not be joining us today. Patrick's scope of responsibilities in the company has grown over the past couple of years, and going forward, he will be dedicating less time to Investor Relations.
謝謝。下午好,歡迎參加直覺外科公司第四季財報電話會議。今天和我在一起的還有我們的總裁兼執行長 Gary Guthart;以及我們的財務長 Marshall Mohr。請注意,過去曾參與這些電話會議的帕特里克·克林根今天將不會參加。過去幾年,帕特里克在公司承擔的職責範圍不斷擴大,未來他將減少投入投資者關係的時間。
Before we begin, I'd like to inform you that comments mentioned on today's call may be deemed to contain forward-looking statements. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in the company's Securities and Exchange Commission filings, including our most recent Form 10-K filed on February 6, 2017, and 10-Q filed on October 20, 2017. These filings can be found through our website or at the SEC EDGAR database. Prospective investors are cautioned not to place undue reliance on such forward-looking statements.
在開始之前,我想告知各位,今天電話會議中提到的評論可能被視為包含前瞻性陳述。由於存在某些風險和不確定性,實際結果可能與明示或暗示的結果有重大差異。這些風險和不確定性在公司向美國證券交易委員會提交的文件中均有詳細描述,包括我們最近於 2017 年 2 月 6 日提交的 10-K 表格和於 2017 年 10 月 20 日提交的 10-Q 表格。這些文件可透過我們的網站或美國證券交易委員會 (SEC) EDGAR 資料庫找到。潛在投資者應注意,不要過度依賴此類前瞻性陳述。
Please note that this conference call will be available for audio replay on our website at intuitivesurgical.com on the Audio Archive section under our Investor Relations page. In addition, today's press release and supplementary financial data tables have been posted to our website.
請注意,本次電話會議的音訊回放可在我們網站intuitivesurgical.com的「投資者關係」頁面下的「音訊存檔」部分找到。此外,今天的新聞稿和補充財務數據表已發佈在我們的網站上。
Today's format will consist of providing you with highlights of our fourth quarter results, as described in our press release announced earlier today, followed by a question-and-answer session. Gary will present the quarter's business and operational highlights. Marshall will provide a review of our fourth quarter financial results, then I will discuss procedures and clinical highlights and provide our financial outlook for 2018. And finally, we will host a question-and-answer session.
今天的會議形式將包括向您介紹我們今天早些時候發布的新聞稿中所述的第四季度業績亮點,然後進行問答環節。Gary 將介紹本季的業務和營運亮點。馬歇爾將回顧我們第四季的財務業績,然後我將討論流程和臨床亮點,並提供我們對 2018 年的財務展望。最後,我們將舉行問答環節。
With that, I'll turn it over to Gary.
接下來,我將把麥克風交給蓋瑞。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Good afternoon, and thank you for joining us on the call today. As you know, Intuitive is dedicated to the mission of expanding the availability of minimally invasive surgery, increasing its efficacy and decreasing its invasiveness. The fourth quarter concluded a solid year in pursuit of this mission. During the year, we made progress in several areas, including accelerated use of our systems and the related growth in our installed base, along with the achievement of significant milestones and regional market access and product development. While we're pleased with our progress in the year, the opportunity for improvement in surgery is substantial, and much work remains to be done.
下午好,感謝各位今天參加我們的電話會議。如您所知,Intuitive 致力於擴大微創手術的普及範圍,提高其療效並降低其創傷性。第四季為這一年紮實的使命探索畫上了圓滿的句點。今年,我們在多個領域取得了進展,包括加速系統使用和相關安裝基礎成長,以及實現重大里程碑、區域市場准入和產品開發。雖然我們對今年的進展感到滿意,但手術方面仍有很大的改進空間,還有很多工作要做。
Global procedure growth was strong at approximately 17% in the fourth quarter and 16% for the full year. Growth patterns in procedures were largely consistent through the year with increased use of da Vinci in general surgery in the United States, continued growth in urology in Europe and Japan and multispecialty growth in Korea and China. General surgery growth was led by hernia repair and colon resection, while mature procedures in the United States, particularly prostatectomy, outperformed our expectations, predominantly due to macro trends in the prostate cancer market. Procedure growth in several countries, including Germany, Korea and China, was healthy through the year, and adoption in Japan was solid for those procedures that have been reimbursed. This month, the Ministry of Health in Japan listed for reimbursement 12 procedures in which da Vinci could be used in addition to prostatectomy and nephrectomy, which are already reimbursed. While this is clearly a positive step regarding interest in da Vinci procedures in Japan, the final level of reimbursement has not been communicated. Calvin will review procedure trends and Marshall, our progress in Japan in greater detail later in the call.
全球手術量成長強勁,第四季成長約 17%,全年成長約 16%。全年手術量的成長模式基本上保持一致,美國普通外科手術中達文西手術的使用量增加,歐洲和日本泌尿外科手術持續成長,韓國和中國多專科手術持續成長。一般外科手術的成長主要由疝氣修補術和結腸切除術引領,而美國成熟的手術,特別是前列腺切除術,表現超出了我們的預期,這主要是由於前列腺癌市場的宏觀趨勢。包括德國、韓國和中國在內的幾個國家的手術量全年增長良好,而日本對已報銷的手術的接受度也很穩定。本月,日本厚生勞動省將達文西機器人可用於報銷的 12 項手術列入報銷範圍,此前前列腺切除術和腎切除術已獲得報銷。雖然這顯然是日本對達文西手術興趣的一個積極進展,但最終的報銷水平尚未公佈。稍後在通話中,Calvin 將回顧流程趨勢,Marshall 將更詳細地介紹我們在日本的進展。
Turning to capital placements. We expanded our da Vinci system offering this year with the launch of our da Vinci X Surgical System, a response to customer need. da Vinci X delivers our fourth generation robotics, imaging and fully articulated instrumentation, an attractive -- at an attractive entry price and procedure capability with logical upgrade pathways. Reception to the -- to X has been positive, catalyzing interest in robotics programs in price-sensitive markets. Taken together, our generation 4 products, da Vinci X, da Vinci Xi and our future da Vinci SP, which is not yet cleared, represent a balanced and upgradable portfolio of choices for customers building or expanding their robotics surgery programs.
轉向資金配置。今年,為了回應客戶需求,我們推出了達文西X手術系統,進一步擴展了我們的達文西系統產品線。達文西 X 提供了我們第四代機器人、影像和全關節式器械,具有極具吸引力的入門價格和手術能力,並具有合理的升級途徑。對 -- 到 X 的反應是正面的,激發了價格敏感市場對機器人專案的興趣。綜合來看,我們的第四代產品,達文西 X、達文西 Xi 以及我們未來的達文西 SP(尚未獲得批准),為正在建造或擴展其機器人手術專案的客戶提供了均衡且可升級的選擇組合。
Overall, our capital placement performance in 2017 accelerated relative to 2016, with growth in total placements rising 27% from 537 in 2016 to 684 in 2017. Net of trade-ins and retirements, our da Vinci installed base grew 13% over 2016 from 3,919 to 4,409.
整體而言,我們 2017 年的資本配置績效相對於 2016 年有所加快,總配置量成長了 27%,從 2016 年的 537 筆成長到 2017 年的 684 筆。扣除以舊換新和退役設備後,我們的達文西手術系統安裝基礎比 2016 年增長了 13%,從 3,919 台增至 4,409 台。
U.S. capital placements stood out in the year and the fourth quarter, largely driven by growth in general surgery. European placement performance in the fourth quarter was strong. Placements in the fourth quarter in Japan were also healthy, perhaps a onetime uptick in anticipation of broader reimbursement. Capital placements overall have been lumpy, and we anticipate volatility in placements in 2018.
美國資本配置在今年和第四季表現突出,這主要得益於一般外科手術的成長。歐洲市場第四季的業績表現強勁。日本第四季的安置情況也相當不錯,這或許是由於預期更廣泛的報銷政策而出現的一次性增長。整體而言,資本配置一直不穩定,我們預期 2018 年配置狀況將會出現波動。
Operating performance in the fourth quarter and for the full year exceeded our expectations, with strong performance in manufacturing efficiency, product quality and cost-reduction projects and with average selling prices as expected. Investments to deepen our regional capabilities and to develop new technologies and services were important in the past year. As our business strengthened, we increased some investment through 2017 to strengthen our corporate infrastructure and position us to benefit from increased scale.
第四季和全年的經營業績超出預期,在生產效率、產品品質和成本削減項目方面表現強勁,平均售價也符合預期。過去一年,加大對區域能力建設和新技術、新服務開發的投資至關重要。隨著業務的增強,我們在 2017 年增加了一些投資,以加強公司基礎設施,並使我們能夠從規模擴大中受益。
Turning to highlights of our fourth quarter operating results. Procedures grew approximately 17% over the fourth quarter of last year. We shipped 216 da Vinci Surgical systems, up from 163 in the fourth quarter of 2016. Revenue for the quarter was $892 million, up 18%. Pro forma gross profit margin was 72.3% compared to 71.1% in the fourth quarter last year. Instrument and accessory revenue increased to $457 million, up 18%. Total recurring revenue in the quarter was $618 million, representing 69% of total revenue. We generated a pro forma operating profit of $384 million in the quarter, up 20% from the fourth quarter of last year. Pro forma net income was $298 million, up 23%. And we concluded our accelerated share buyback program initiated in Q1 of 2017 at a weighted average price of $310 per share.
接下來,讓我們來看看第四季經營業績的亮點。與去年第四季相比,手術量增加了約 17%。我們交付了 216 套達文西手術系統,高於 2016 年第四季的 163 套。本季營收為 8.92 億美元,成長 18%。以備考基準計算,毛利率為 72.3%,而去年第四季為 71.1%。儀器及配件收入增至 4.57 億美元,成長 18%。本季經常性收入總額為 6.18 億美元,佔總營收的 69%。本季我們實現了 3.84 億美元的備考營業利潤,比去年第四季成長了 20%。以備考計算,淨收入為 2.98 億美元,成長 23%。我們於 2017 年第一季啟動的加速股票回購計畫已圓滿結束,加權平均價格為每股 310 美元。
Highlights of the full year 2017 are as follows: Procedures grew approximately 16% over 2016. We installed 684 systems in 2017, up from 537 in 2016. Revenue for the year was $3.1 billion, up 16%. Pro forma gross margin was 71.9% for the full year compared with 71.6% for 2016. Total recurring revenue for the year was $2.2 billion, representing 72% of total revenue. Pro forma operating profit for the year was $1.3 billion, up 13% from 2016. And pro forma net income was $1 billion, up 19%. Marshall will take you through our finances in greater detail shortly.
2017 年全年亮點如下:手術量比 2016 年增加了約 16%。2017 年我們安裝了 684 套系統,高於 2016 年的 537 套。本年度營收為 31 億美元,成長 16%。全年以備考毛利率計算為 71.9%,而 2016 年為 71.6%。本年度經常性收入總額為 22 億美元,佔總收入的 72%。本年度的備考營業利潤為 13 億美元,較 2016 年成長 13%。經調整後的淨收入為 10 億美元,成長 19%。馬歇爾稍後會更詳細地向您介紹我們的財務狀況。
While Intuitive completed its 22nd year in 2017, I firmly believe that computer-assisted medical interventions are in their infancy. A careful read of the clinical literature makes clear the need for more effective, less invasive and lower total cost to treat solutions to many disease states. The rise of robotic technology, powerful computing, improved sensing, microfabrication and molecular imaging enable new approaches to old problems. We have been investing in improvements, both incremental and revolutionary, towards the same and anticipate continuing this investment trajectory in 2018. The opportunity to improve surgery using advanced technologies is now recognized broadly, and we anticipate the entry of additional competitive systems into some regions of the world over the next several quarters. Customers appreciate choice, and it is possible that sales cycles lengthen in some countries as customers evaluate more options. Our company has anticipated increased competition, and we are focused on understanding the market's needs and excelling in delivering products and services today and in the future that meet them.
雖然 Intuitive 公司在 2017 年完成了成立 22 週年,但我堅信電腦輔助醫療介入仍處於起步階段。仔細閱讀臨床文獻可以清楚看出,許多疾病都需要更有效、侵入性更小、總成本更低的治療方案。機器人技術、強大的運算能力、改進的感測技術、微加工技術和分子成像技術的興起,為解決舊問題提供了新的方法。我們一直在投資漸進式和革命性的改進,以朝著這個目標邁進,並預計在 2018 年繼續保持這種投資勢頭。利用先進技術改善外科手術的機會現在已被廣泛認可,我們預計在未來幾個季度內,世界上一些地區將會出現更多具有競爭力的系統。顧客喜歡選擇,因此在某些國家,由於顧客需要評估更多選項,銷售週期可能會延長。我們公司預見競爭將日益激烈,因此我們專注於了解市場需求,並致力於提供能夠滿足當前和未來需求的優質產品和服務。
Turning to our da Vinci SP system. We submitted our 510(k) for urology last month. We call SP as a platform technology that allows high dexterity access with great 3D vision to confined surgical spaces. As we've discussed on prior calls, we plan first markets to include urologic surgery, head and neck surgery and colorectal surgery. In 2017, SP was used in human trials in the United States and Hong Kong, completing cases spanning initial target procedures. We anticipate a phased launch of SP in 2018, pending clearance.
接下來我們來看看達文西SP系統。我們上個月提交了泌尿科的 510(k) 申請。我們將 SP 稱為平台技術,它能夠以極高的靈敏度和出色的 3D 視覺進入狹小的手術空間。正如我們在之前的電話會議中討論過的,我們計劃首先進入泌尿外科、頭頸外科和結直腸外科等市場。2017 年,SP 在美國和香港進行了人體試驗,完成了涵蓋初始目標程序的病例。我們預計 SP 將於 2018 年分階段推出,具體時間取決於核准情況。
We are also making good progress on our flexible robotics platform, first targeted to address the acute need in diagnosis of lung cancer, one of the most commonly diagnosed forms of cancer in the world and for which early detection is important. Our program hit its milestones in 2017, completing its first clinical experience in Australia. Preliminary results were reported at the CHEST conference in Q4 of 2017. Feedback from physicians evaluating our technology relative to existing and emerging alternatives has been strongly supportive of our efforts. Our design and operations teams are working hard to incorporate feedback, complete its production design and supply chain optimization and complete validations for regulatory submissions. We do not expect revenue from our flexible robotics program in 2018.
我們的柔性機器人平台也取得了良好進展,該平台最初的目標是解決肺癌診斷方面的迫切需求,肺癌是世界上最常見的癌症之一,早期發現至關重要。2017 年,我們的計畫取得了里程碑式的進展,在澳洲完成了首次臨床實務。初步結果已於 2017 年第四季在 CHEST 會議上公佈。醫生們對我們的技術與現有和新興的替代方案進行評估後,給予了我們強有力的支持。我們的設計和營運團隊正在努力整合回饋意見,完成生產設計和供應鏈優化,並完成監管申報的驗證工作。我們預計 2018 年我們的柔性機器人專案不會產生收入。
Our fourth generation product platform has enabled greater access to our latest advanced instruments. Use and satisfaction with our stapling and energy products has been rising as gen 4 products have increased in the installed base. Both stapling and energy instruments are important to surgeons, and we've been investing in broadening our product line and incorporating customer feedback in both areas. In the fourth quarter of 2017, we submitted our 510(k) application for our 60-millimeter stapler for da Vinci X and Xi.
我們的第四代產品平台讓更多人能夠使用我們最新的先進儀器。隨著第四代產品在安裝基數上的增加,使用者對我們訂書機和能源產品的使用率和滿意度也不斷提高。對於外科醫生來說,縫合器械和能量器械都非常重要,我們一直在投資擴大產品線,並將客戶回饋融入這兩個領域。2017 年第四季度,我們為達文西 X 和 Xi 手術系統提交了 60 毫米訂書機的 510(k) 申請。
Lastly, our imaging teams continue to explore new ways to identify tissue, including good progress in our molecular imaging program as well as improvements to our endoscopes and image processing algorithms. We have been introducing improvements in our imaging hardware routinely and expect to continue to do so in 2018. Molecular imaging agents are long-term investments. We expect our lead agent to enter Phase II trials in 2018.
最後,我們的成像團隊繼續探索識別組織的新方法,包括分子成像計劃的良好進展以及內視鏡和影像處理演算法的改進。我們一直在不斷改進成像硬件,並預計在 2018 年繼續這樣做。分子造影劑是長期投資。我們預計我們的主導藥物將於 2018 年進入 II 期臨床試驗。
In closing, as we start 2018, our focus remains in completing the task we've set for ourselves: First, continued adoption of da Vinci in general surgery; second, continued development of European markets and access to customers in Asia; third, advancing our new platforms, imaging, advanced instruments, da Vinci SP and our diagnostic platform; and finally, support for additional clinical and economic validation by global region.
最後,在2018年開始,我們的重點仍然是完成我們為自己設定的任務:首先,繼續在普通外科手術中採用達文西手術系統;其次,繼續開發歐洲市場並拓展亞洲客戶;第三,推進我們的新平台、成像、先進儀器、達文西SP和我們的診斷平台;最後,支持全球各區域進行額外的臨床和經濟驗證。
I'll now turn the call over to Marshall, who will review financial highlights.
現在我將把電話交給馬歇爾,他將回顧財務要點。
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Good afternoon. Overall, our fourth quarter financial performance was strong. I will start by describing highlights of this performance on a GAAP and non-GAAP or pro forma basis. I will also take you through our analysis of the impact of the U.S. 2017 Tax Cuts and Jobs Act on our financial results. As a reminder, our results are also posted on our website.
午安.整體而言,我們第四季的財務業績表現強勁。我將首先按 GAAP 和非 GAAP 或備考基準描述此次業績的亮點。我也會帶您了解我們對美國 2017 年減稅和就業法案對我們財務表現的影響的分析。再次提醒大家,我們的測試結果也會發佈在我們的網站上。
Consistent with our preliminary press release on January 10, fourth quarter 2017 revenue was $892 million, an increase of 18% compared with $757 million for the fourth quarter of 2016, an increase of 11% compared with the third quarter revenue of $806 million. In the fourth quarter, we completed the da Vinci X trade-up program offered to certain first quarter customers. The impact of this program was to increase fourth quarter revenue by approximately $2 million and third quarter revenue by approximately $21 million.
與 1 月 10 日的初步新聞稿一致,2017 年第四季營收為 8.92 億美元,比 2016 年第四季的 7.57 億美元成長了 18%,比第三季的 8.06 億美元成長了 11%。第四季度,我們完成了向部分第一季客戶提供的達文西 X 升級換購計畫。該計劃的影響是使第四季營收增加約 200 萬美元,第三季營收增加約 2,100 萬美元。
As mentioned earlier in the call, fourth quarter 2017 procedures increased approximately 17% compared with the fourth quarter 2016 and increased 12% compared with last quarter. Procedure growth continues to be driven by general surgery in the U.S. and urology worldwide. Calvin will review details of procedure growth later in this call.
如同先前在電話會議中所提到的,2017 年第四季的手術量比 2016 年第四季成長了約 17%,比上一季成長了 12%。手術量的成長主要由美國的普通外科手術和全球的泌尿外科手術所推動。Calvin將在本次通話中稍後詳細介紹手術進展。
Instrument and accessory revenue of $457 million increased 18% compared with last year, which is slightly higher than procedure growth. Instrument and accessory revenue realized per procedure was approximately $1,910, which is relatively unchanged compared to last year, reflecting increased advanced instrument usage, mostly offset by customer buying patterns.
儀器及配件收入為 4.57 億美元,比去年增長 18%,略高於手術量增長。每台手術的器械和配件收入約為 1910 美元,與去年相比基本保持不變,這反映出先進器械的使用量增加,但大部分都被顧客的購買模式所抵消。
Systems revenue of $283 million increased 20% compared with the fourth quarter of 2016, primarily reflecting higher system placements. We placed 216 systems in the fourth quarter of 2017 compared with 163 systems in the fourth quarter of 2016 and 169 systems last quarter. 40 systems were placed under operating lease transactions in the current quarter compared with 13 systems in the fourth quarter of 2016. Systems placed under operating leases represented 19% of system placements compared with 8% last year. Our installed base of da Vinci systems ended the year at 4,409 systems, up 13% year-over-year. Consistent with recent trends, average system utilization continues to grow in the middle -- mid-single-digit range.
系統營收為 2.83 億美元,比 2016 年第四季成長了 20%,主要反映了系統安裝量的增加。2017 年第四季度,我們安裝了 216 套系統,而 2016 年第四季為 163 套系統,上一季為 169 套系統。本季共有 40 套系統採用經營租賃方式進行交易,而 2016 年第四季只有 13 套系統採用經營租賃方式進行交易。透過經營租賃方式安置的系統佔系統安置總數的 19%,而去年這一比例為 8%。截至年底,我們已安裝的達文西手術系統數量為 4,409 套,年增 13%。與近期趨勢一致,平均係統利用率持續在中等個位數範圍內成長。
Globally, our average selling price, which excludes the impact of operating leases and lease buyouts and revenue deferrals, was approximately $1.47 million, which is similar to the fourth quarter of 2016 and the same as last quarter. 51, or 24% of systems placed in the quarter, were da Vinci X systems compared with 16 or 9% systems last quarter. We are seeing demand for da Vinci X from cost-sensitive customers as well as customers wishing to upgrade to, or standardize on, our fourth-generation technology. We believe that flexible financing programs like operating leases have allowed us to be more agile in meeting customer needs for systems. While the number of leases is difficult to predict in the short term, we expect the proportion of these types of arrangements will increase over time.
在全球範圍內,我們的平均售價(不包括營業租賃、租賃買斷和收入遞延的影響)約為 147 萬美元,與 2016 年第四季相似,與上一季相同。在本季安裝的系統中,有 51 台是達文西 X 系統,佔總數的 24%,而上一季只有 16 台,佔總數的 9%。我們看到,對成本敏感的客戶以及希望升級到或採用我們第四代技術的客戶對達文西 X 手術系統都有需求。我們相信,像經營租賃這樣的彈性融資方案使我們能夠更靈活地滿足客戶對系統的需求。雖然短期內租賃數量難以預測,但我們預計隨著時間的推移,這類安排的比例將會增加。
Outside of the U.S., results were as follows: Fourth quarter revenue outside of the U.S. of $248 million increased 17% compared with both the fourth quarter of 2016 and the third quarter of 2017. OUS procedures grew approximately 21% compared with the fourth quarter of 2016. Outside the U.S., we placed 86 systems in the fourth quarter compared with 63 in the fourth quarter of 2016 and 62 systems last quarter. Current quarter system placements included 47 into Europe and 22 into Japan. 25 of the 47 systems placed into Europe were X systems. Placements outside of U.S. will continue to be lumpy as some of the OUS markets are in early stages of adoption, some markets are highly seasonal, reflecting budget cycles or vacation patterns, and sales into some markets are constrained by government regulations.
在美國以外,業績如下:第四季美國以外地區的營收為 2.48 億美元,比 2016 年第四季和 2017 年第三季均成長了 17%。與 2016 年第四季相比,OUS 手術量增加了約 21%。在美國以外,我們在第四季安裝了 86 套系統,而 2016 年第四季為 63 套,上一季為 62 套。在當前季度製分配方案中,47人分配到歐洲,22人分配到日本。部署到歐洲的 47 個系統中,有 25 個是 X 系統。由於一些美國以外的市場仍處於早期採用階段,一些市場具有很強的季節性,反映了預算週期或度假模式,而且一些市場的銷售受到政府法規的限制,因此美國以外地區的市場佈局仍將不穩定。
As Gary indicated, a committee of the MHLW in Japan has recommended 12 procedures for reimbursement. It is anticipated that by the end of this quarter, MHLW will determine the reimbursement levels for each procedure. The applicable opportunity for da Vinci surgery within this set of procedures is difficult to estimate at this time due to the uncertainty in reimbursement levels as well as the perceived value of da Vinci relative to alternative surgical approaches. With nearly 300 systems installed in Japan, the level of system expansion over the year or so -- over the next year or so is difficult to predict. We expect system expansion in Japan to be modest in 2018.
正如 Gary 所指出的,日本厚生勞動省的一個委員會建議報銷 12 項醫療程序。預計到本季末,厚生勞動省將確定每項手術的報銷標準。由於報銷程度的不確定性以及達文西手術相對於其他手術方法的感知價值,目前很難估計達文西手術在這一系列手術中的適用機會。日本已安裝了近 300 套系統,未來一年左右的系統擴張規模難以預測。我們預計2018年日本的系統擴張將較為溫和。
Moving on to the remainder of the P&L. The pro forma gross margin for the fourth quarter of 2017 was 72.3% compared with 71.1% for the fourth quarter of 2016 and 71.8% for the third quarter of 2017. The increase compared with the third quarter primarily reflects lower manufacturing costs, partially offset by seasonally higher proportion of systems revenue. Future margins will also fluctuate based on the mix of our newer products, the mix of systems and instrument and accessory revenue, system ASPs and our ability to further reduce product costs and improve manufacturing efficiency.
接下來來看損益表的其餘部分。2017 年第四季的備考毛利率為 72.3%,而 2016 年第四季為 71.1%,2017 年第三季為 71.8%。與第三季相比,成長主要反映了製造成本的降低,但部分被季節性較高的系統收入比例所抵銷。未來的利潤率也會根據我們新產品的組合、系統和儀器及配件收入的組合、系統平均售價以及我們進一步降低產品成本和提高生產效率的能力而波動。
Pro forma operating expenses increased 19% compared with the fourth quarter 2016 and increased 13% compared with last quarter. The increase compared with the third quarter reflects increased variable compensation. Our spending was consistent with our plan, reflecting investments in da Vinci SP, catheter-based robotics, imaging and advanced instrumentation and expansion of our OUS markets. These investments involve multiyear commitment. Our pro forma effective tax rate for the fourth quarter was 24.9% compared with our expectations of 26.5% to 28.5%.
預計營運費用較 2016 年第四季成長 19%,較上一季成長 13%。與第三季相比,成長反映了可變薪酬的增加。我們的支出與計劃一致,反映了對達文西SP、導管機器人、成像和先進儀器的投資以及我們OUS市場的擴張。這些投資涉及多年承諾。我們第四季的預期實際稅率為 24.9%,而我們先前的預期為 26.5% 至 28.5%。
I will take you through the items included in our GAAP tax rate, including the impacts of the U.S. Tax Act in a minute. Our tax rates will fluctuate with changes in the mix of U.S. and OUS income, changes in tax rates made by local authorities and with the impact of onetime items.
稍後我將帶您了解我們 GAAP 稅率中包含的項目,包括美國稅法的影響。我們的稅率會隨著美國境內和境外收入組成的變化、地方當局稅率的變化以及一次性項目的影響而波動。
Our fourth quarter 2017 pro forma net income was $298 million, or $2.57 per share, compared with $242 million, or $2.03 per share, for the fourth quarter of 2016, and $324 million, or $2.77 per share, for the third quarter of 2017. All per-share amounts reflect the 3-for-1 stock split effected in October.
2017 年第四季,我們的備考淨收入為 2.98 億美元,即每股 2.57 美元;而 2016 年第四季為 2.42 億美元,即每股 2.03 美元;2017 年第三季為 3.24 億美元,即每股 2.77 美元。所有每股金額均已反映 10 月實施的 1 比 3 的股票分割。
Third quarter 2017 GAAP and pro forma net income per diluted share benefited by $0.09 per share from the recognition of $21 million of deferred revenue, net of costs and income tax, and by $0.59 per share related to the tax reserve reversal of $68 million.
2017 年第三季 GAAP 和備考每股攤薄淨收益受惠於確認 2,100 萬美元遞延收入(扣除成本和所得稅後)每股增加 0.09 美元,以及與 6,800 萬美元稅收準備金衝回相關的每股增加 0.59 美元。
I will now summarize our GAAP results. Inclusive of the impacts of the U.S. Tax Act, we incurred a GAAP net loss of $39 million or $0.35 per share for the fourth quarter of 2017 compared with GAAP net income of $204 million or $1.71 per share in the fourth quarter of 2016 and GAAP net income of $298 million or $2.55 per share for the third quarter of 2017. The following items are excluded from our fourth quarter pro forma net income but included in our GAAP net loss: $270 million or $2.41 per share, reflecting a 14% onetime tax for historical OUS earnings and profits under the U.S. Tax Act; $48 million or $0.42 per share for the write-down of net deferred assets to reflect the reduction in corporate tax rates under the U.S. Tax Act; $20 million or $0.18 per share of excess tax benefits associated with employee stock awards; and $57 million of net charges or $0.51 per share associated with employee equity charges, IP charges and legal settlements.
現在我將總結一下我們的GAAP業績。計入美國稅法的影響,2017 年第四季我們按美國通用會計準則 (GAAP) 計算淨虧損 3900 萬美元,即每股虧損 0.35 美元;而 2016 年第四季度我們按美國通用會計準則 (GAAP) 計算淨利潤為 2.04 億美元,即每股收益 1.71 年每股收益標準 (AP) 20171713333533333333333年333333個年。 2.98 億美元,即每股收益 2.55 美元。以下項目不計入我們第四季備考淨利潤,但計入我們按美國通用會計準則計算的淨虧損:2.7億美元,即每股2.41美元,反映根據美國稅法對歷史海外收益和利潤徵收的14%一次性稅款;4800萬美元,即每股0.42美元,用於減記淨遞延資產,以反映根據美國稅法降低的企業所得稅稅率;2000萬美元,即每股0.18美元,與員工股票獎勵相關的超額稅收優惠;以及5700萬美元,即每股0.51美元,與員工股權費用、知識產權費用和法律和解相關的淨費用。
Note that the IRS has not issued final tax rate regulation associated with the recent U.S. tax legislation. Therefore, impacts of the U.S. Tax Act reflected in our fourth quarter results and our projection of future tax rates represent our best estimates of the impact of the U.S. Tax Act and could change as tax regulations are finalized and interpreted.
請注意,美國國稅局尚未發布與近期美國稅法相關的最終稅率規定。因此,美國稅法對我們第四季度業績的影響以及我們對未來稅率的預測,代表了我們對美國稅法影響的最佳估計,並且隨著稅收法規的最終確定和解釋,這些估計可能會發生變化。
We ended the quarter with cash and investments of $3.8 billion, approximately the same as at September 30, 2017. During the quarter, cash generated from operations were mostly offset by a final payment of $274 million associated with the accelerated share repurchase agreement we entered in the first quarter. Under that agreement, we repurchased 7.3 million shares at approximately $310 per share. We have approximately $718 million remaining under the board buyback authorization. As a result of the 2017 Tax Act, we have the option to repatriate OUS cash with minimal tax impact. We have significant opportunity for growth outside of the U.S. We will evaluate the need to repatriate cash relative to our business and overall environment over time.
本季末,我們的現金和投資總額為 38 億美元,與 2017 年 9 月 30 日的金額大致相同。本季度,經營活動產生的現金流量大部分被與我們在第一季簽訂的加速股票回購協議相關的 2.74 億美元最終付款所抵銷。根據該協議,我們以每股約 310 美元的價格回購了 730 萬股股票。根據董事會授權的回購資金,我們目前還剩下約 7.18 億美元。由於 2017 年稅法的實施,我們可以選擇將海外現金匯回國內,並將稅務影響降至最低。我們在美國以外地區擁有巨大的成長機會。我們將根據業務和整體環境的變化,評估是否需要將現金匯回國內。
And with that, I'd like to turn it over to Calvin, who will go over procedure performance and our outlook for 2018.
接下來,我將把發言權交給卡爾文,他將介紹手術流程的執行情況以及我們對 2018 年的展望。
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
Thank you, Marshall. Our overall fourth quarter procedure growth was 17% compared to 15% during the fourth quarter of 2016 and 15% last quarter. Our Q4 procedure growth was driven by strong results globally and 16% growth in U.S. procedures, reflecting broad-based strength across our procedure categories. Q4 likely benefited modestly from cases deferred out of Q3 due to hurricanes. In total, approximately 877,000 da Vinci procedures were performed in 2017, up about 16% for the year.
謝謝你,馬歇爾。我們第四季的整體手術量成長了 17%,而 2016 年第四季和上一季均為 15%。我們第四季度手術量的成長得益於全球市場的強勁表現以及美國手術量 16% 的成長,這反映了我們各個手術類別的全面強勁勢頭。第四季可能略微受益於因颶風而從第三季推遲的病例。2017 年,達文西手術總共進行了約 877,000 例,比前一年增長了約 16%。
In the U.S., general surgery, on a run rate basis, has surpassed gynecology as our largest specialty. Approximately 246,000 U.S. general surgery procedures were performed in 2017, up 32% compared to 2016. 2017 growth was again driven by hernia repair, ventral and inguinal combined, which continue to drive the most incremental cases and continued da Vinci adoption in colorectal procedures. Early-stage adoption in bariatric procedures and growth across the general surgery category also contributed to growth. In U.S. gynecology, fourth quarter and full year 2017 procedures grew modestly year-over-year, with growth led by hysterectomy. We continue to see an increasing proportion of U.S. gynecology procedures being performed by physicians that specialize in complex, benign and cancer surgery who tend to be users of da Vinci systems. U.S. urology procedures exceeded our expectations for the fourth quarter and the year, driven by prostatectomy volumes. As a mature procedure category, we believe that our U.S. prostatectomy volumes have been tracking to the broader prostate surgery market, which has benefited from recent macro trends.
在美國,以手術量計算,一般外科已經超過婦科,成為我們最大的專科。2017 年美國進行了約 246,000 例普通外科手術,比 2016 年增加了 32%。2017 年的成長再次由疝氣修補術(包括腹股溝疝氣和腹股溝疝氣)推動,這些手術仍然是新增病例最多的手術,並且達文西手術系統在結直腸手術中的應用也持續增長。減重手術的早期普及以及普通外科手術領域的成長也促進了成長。在美國婦科領域,2017 年第四季和全年手術量年增幅度不大,其中以子宮切除術的成長最為顯著。我們持續看到,越來越多的美國婦科手術是由專門從事複雜良性腫瘤和癌症手術的醫生進行的,而這些醫生往往是達文西手術系統的使用者。受前列腺切除術數量的推動,美國泌尿外科手術量在第四季度和全年均超出了我們的預期。作為一個成熟的手術類別,我們認為,我們在美國進行的前列腺切除手術量與更廣泛的前列腺手術市場的發展趨勢相符,而前列腺手術市場也受益於近期的宏觀趨勢。
In other U.S. procedures, adoption of lobectomies and other thoracic procedures was again strong during the fourth quarter and full year. This set of procedures is particularly well-served by our da Vinci Xi System and surgical staplers. Outside of the United States, approximately 233,000 procedures were performed in 2017, up approximately 21% in the fourth quarter and approximately 23% for the full year. Growth was driven by the continued adoption of da Vinci Prostatectomy, with solid contributions from kidney procedures and earlier-stage growth in general surgery and gynecology. Fourth quarter OUS procedure growth was slightly lower, largely reflecting leveling system utilization and moderating growth in China as we anticipate future system sales quota.
在美國其他手術領域,肺葉切除術和其他胸腔外科手術在第四季度和全年再次強勁普及。我們的達文西 Xi 系統和手術縫合器非常適合進行這一系列手術。在美國以外,2017 年大約進行了 233,000 例手術,第四季度增長約 21%,全年增長約 23%。成長主要得益於達文西前列腺切除術的持續普及,腎臟手術也做出了穩健的貢獻,此外,一般外科和婦科的早期成長也功不可沒。第四季 OUS 手術量成長略有下降,這主要反映了系統利用率趨於穩定以及中國市場成長放緩,因為我們預計未來系統銷售配額將有所減少。
The value proposition regarding any da Vinci procedure is based upon the differentiated clinical value that can be offered to patients compared to other treatment alternatives, including economic factors. Since the introduction of the da Vinci system, over 15,000 clinical papers have been published involving da Vinci surgery, including approximately 2,300 in 2017 alone. As I mentioned in my procedure discussion, lung procedures in the U.S. have contributed to recent procedure growth. In November 2017, a team of investigators from the University of Southern California, the University of Michigan Ann Arbor, Penn State Health and Intuitive published a large-scale study titled Robotic-Assisted, Video-Assisted Thoracic and Open Lobectomy: Propensity-Matched Analysis of Recent Premier Data in The Annals of Thoracic Surgery. In this study, the Premier Healthcare Database was analyzed for open, video-assisted thoracic or VATS and robotic-assisted lobectomies performed between January 1, 2011, and September 30, 2015. The results from this study show a continual increase in the number of robotic-assisted lobectomies during the study period. The combined total of robotic-assisted and VATS approaches accounted for more of half -- more than half of the lobectomies in the U.S. database, indicating a strong trend towards adoption of minimally invasive approaches. While a proportion of VATS remained virtually unchanged during the study period, the robotic rate grew as open declined. After propensity score matching, which controls for heterogeneity of patients in hospitals, the robotic-assisted cases were compared to VATS procedures in a sample size of 2,775 in each group, and robotic-assisted cases were compared to open with 2,951 patients in each group. Compared to open surgery, robotic-assisted lobectomy demonstrated statistically significant lower postoperative complication rate, shorter hospital stay, higher percentage of patients discharged to home and lower hospital mortality rate. Compared to VATS, robotic-assisted surgery demonstrated statistically significant lower rate of conversion to thoracotomy, lower post-operative complication rate, shorter hospital stay and a higher percentage of patients discharged to home.
任何達文西手術的價值主張都基於其與其它治療方案相比所能為患者提供的差異化臨床價值,包括經濟因素。自達文西系統問世以來,已有超過 15,000 篇臨床論文發表,涉及達文西手術,光是 2017 年就有約 2,300 篇。正如我在手術流程討論中提到的,美國的肺部手術促進了近期手術量的成長。2017 年 11 月,南加州大學、密西根大學安娜堡分校、賓州州立大學健康中心和 Intuitive 公司的研究人員組成的一個研究團隊在《胸腔外科年鑑》上發表了一項題為「機器人輔助、視訊輔助胸腔和開放式肺葉切除術:近期 Premier 資料的傾向性配對分析」的大規模研究。本研究分析了 Premier Healthcare 資料庫中 2011 年 1 月 1 日至 2015 年 9 月 30 日期間進行的開放式、視訊輔助胸腔鏡手術 (VATS) 和機器人輔助肺葉切除術。研究結果顯示,在研究期間,機器人輔助肺葉切除術的數量持續增加。機器人輔助手術和胸腔鏡輔助手術的總和占美國資料庫中肺葉切除術總數的一半以上,顯示微創手術的普及趨勢十分明顯。在研究期間,VATS 的比例幾乎沒有變化,而隨著開放性手術比例的下降,機器人手術的比例卻在增加。在傾向評分配對(控制醫院病患的異質性)之後,將機器人輔助手術病例與胸腔鏡手術病例進行比較,每組樣本量為 2,775;並將機器人輔助手術病例與開放性手術病例進行比較,每組樣本量為 2,951。與開放手術相比,機器人輔助肺葉切除術在統計學上顯示出更低的術後併發症發生率、更短的住院時間、更高的出院回家患者比例和更低的院內死亡率。與胸腔鏡輔助手術相比,機器人輔助手術在統計上顯示出更低的開胸手術轉換率、更低的術後併發症發生率、更短的住院時間和更高的出院回家患者比例。
As we've said in the past, we continue to invest in clinical research in our key geographic markets to assess da Vinci surgery outcomes and help educate the market. We support large-scale data registries, including those managed by the American Hernia Society Quality Collaborative and the Society of Gynecological Oncology Clinical Outcomes Registry. As large da Vinci data sets accumulate in these registries and are compared to baseline results, the value of da Vinci surgery can be evaluated. We also support clinical research grants at SAGES, ASCRS and the European Coloproctology Society as well as da Vinci fellowship programs, which several -- with surgical societies, which often yield clinical studies.
正如我們過去所說,我們將繼續投資於我們主要地理市場的臨床研究,以評估達文西手術的結果並幫助教育市場。我們支持大規模資料註冊,包括由美國疝氣學會品質協作組織和婦科腫瘤學會臨床結果註冊組織管理的資料註冊。隨著大量達文西手術數據在這些註冊庫中積累,並與基線結果進行比較,就可以評估達文西手術的價值。我們也支持 SAGES、ASCRS 和歐洲結直腸病學會的臨床研究資助,以及達文西獎學金項目,其中一些項目與外科協會合作,經常進行臨床研究。
I will now turn to our financial outlook for 2018.
接下來,我將談談我們對2018年的財務展望。
Starting with procedures. As described in our announcement earlier this month, 2017 total da Vinci procedures grew approximately 16% to roughly 877,000 procedures performed worldwide. During 2018, we anticipate full year procedure growth within a range of 11% to 15%. We expect 2018 procedure growth to continue to be driven by U.S. general surgery and procedures outside of the United States, where we are still in earlier stages of adoption. We expect similar seasonal timing of procedures in 2018, as we've experienced in previous years, with Q1 being the seasonally weakest quarter as patient deductibles are reset.
首先從流程入手。正如我們本月稍早發布的公告中所述,2017 年達文西手術總量增加了約 16%,達到全球約 877,000 例手術。2018 年,我們預計全年手術量成長幅度在 11% 到 15% 之間。我們預計 2018 年手術量的成長將繼續由美國普通外科手術以及美國以外地區的手術量推動,在這些地區,我們仍處於早期採用階段。我們預計 2018 年的手術量季節性變化與往年類似,第一季通常是季節性最弱的季度,因為患者的自付額會重新計算。
In Q1, we expect a modest procedure headwind compared to Q1 2017 as a result of our estimates of working days, mostly due to the timing of the Good Friday holiday. With respect to revenue, as we've mentioned previously, capital sales are ultimately driven by procedure growth, catalyzing hospitals to establish or expand robotic system capacity. Capital sales can vary substantially from period-to-period based upon many factors, including U.S. health care policy, hospital capital spending cycles, reimbursement in government quotas, product cycles and competitive factors. Within this framework, we'd expect 2018 capital placement seasonality to generally follow historical patterns by quarter. During the fourth quarter of 2017, 40 of the 216 systems shipped or 19% were under operating leases. In 2018, we'd expect the proportion of systems placed under operating leases to trend modestly up from there with variation by quarter.
由於我們對工作日的估計,我們預計第一季程序方面將比 2017 年第一季略有不利影響,這主要是由於耶穌受難日假期的時間安排所致。就收入而言,正如我們之前提到的,資本銷售最終是由手術量的成長所驅動的,這促使醫院建立或擴大機器人系統容量。資本銷售額會因多種因素而隨時間發生顯著變化,包括美國醫療保健政策、醫院資本支出週期、政府配額報銷、產品週期和競爭因素。在此框架下,我們預計 2018 年的資本配置季節性將大致遵循按季度劃分的歷史模式。2017 年第四季度,出貨的 216 套系統中有 40 套(佔 19%)是透過經營租賃方式交付的。2018 年,我們預計採用經營租賃方式部署的系統比例將在此基礎上略有上升,但每季會有波動。
Turning to gross profit. Our full year 2017 gross -- pro forma gross profit margin was 71.9%. In 2018, we expect our pro forma gross profit margin to be within a range of between 70% and 71.5% net revenue. We're projecting a modestly lower gross profit margin in 2018, reflecting higher costs associated with new products. Our actual gross product -- gross profit margin will vary quarter-to-quarter, depending largely on product and regional mix.
接下來計算毛利。我們 2017 年全年毛利-以備考毛利率計算為 71.9%。2018 年,我們預計我們的備考毛利率將達到淨收入的 70% 至 71.5%。我們預計 2018 年毛利率將略有下降,反映出新產品相關的成本較高。我們的實際毛產品毛利率會因季度而異,主要取決於產品和地區組合。
Turning to operating expenses. As Gary and Marshall described, in 2018, we will continue to make substantive investments in several strategic areas that are poised to benefit the company over the long run. As a result, we expect to grow 2018 pro forma operating expenses between 16% and 18% above 2017 levels. We expect our noncash stock compensation expense to range between $225 million and $235 million in 2018 compared to $209 million in 2017. We expect other income, which is comprised mostly of interest income, to total between $45 million and $55 million in 2018.
接下來談談營運費用。正如 Gary 和 Marshall 所描述的那樣,2018 年,我們將繼續在幾個策略領域進行實質投資,這些投資預計將在長期內使公司受益。因此,我們預計 2018 年的備考營運費用將比 2017 年的水準成長 16% 至 18%。我們預計 2018 年的非現金股票補償支出將在 2.25 億美元至 2.35 億美元之間,而 2017 年為 2.09 億美元。我們預計 2018 年其他收入(主要包括利息收入)總額將在 4,500 萬美元至 5,500 萬美元之間。
With regard to income tax, incorporating projected impacts of the new U.S. tax law, we expect our 2018 pro forma income tax rate to be between 20% and 22% of pretax income. Note that in the future, as the IRS issues additional guidance and interpretation of the new tax law, our estimated rate may be impacted. Our share count for calculated diluted EPS pro forma EPS in Q4 was 117.4 million shares. In Q1, we expect our diluted share count to range between 117.6 million and 118.4 million shares. The actual diluted share count will depend on several factors, including the share price.
關於所得稅,考慮到美國新稅法的預期影響,我們預計 2018 年的預計所得稅稅率將在稅前收入的 20% 至 22% 之間。請注意,未來隨著美國國稅局發布更多關於新稅法的指導和解釋,我們的預估稅率可能會受到影響。我們計算第四季稀釋後每股盈餘(以備考每股收益計算)的股份數量為 1.174 億股。第一季度,我們預計稀釋後的股份數量將在 1.176 億股至 1.184 億股之間。實際稀釋後的股份數量將取決於幾個因素,包括股價。
That concludes our prepared comments. We will now open the call to your questions.
我們的發言到此結束。現在開始回答各位的問題。
Operator
Operator
(Operator Instructions)
(操作說明)
And our first question today comes from the line of Bob Hopkins with Bank of America.
今天我們的第一個問題來自美國銀行的鮑伯霍普金斯。
Robert Adam Hopkins - MD of Equity Research
Robert Adam Hopkins - MD of Equity Research
Appreciate the opportunity to ask a few questions here. So maybe just to start out on the product side, I just want to make sure I have a good sense for what you're saying. So Gary, I guess, on the flexible endoscope platform, I realize you said no revenues in 2018. But is there a scenario where you have any regulatory approvals for flexible endoscope? Any major country maybe towards the end of 2018?
非常感謝有機會在這裡提問。所以,或許先從產品方面著手,我只是想確保我完全理解你的意思。所以 Gary,我想,關於柔性內視鏡平台,我知道你說過 2018 年沒有收入。但是,是否存在軟式內視鏡獲得監管部門批准的情況?2018年底之前,某個主要國家可能會採取行動嗎?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
We're not -- hi, Bob. We're not calling the clearance date yet of the flex platform. I'm pleased with where we are. We're working the plan. Our tradition with you has been to let you know when we do a submission, and that gives us a little bit better estimate of time lines, and I'd rather not guess in this setting. So we're feeling good about it, but I don't have a date for you yet.
我們不是--嗨,鮑伯。我們目前還不能確定 Flex 平台的最終銷售日期。我對我們目前的狀況很滿意。我們正在執行計劃。我們一直以來的慣例是,提交稿件時都會通知您,這樣我們就能更好地預估時間進度,在這種情況下,我寧願不去猜測。所以我們感覺不錯,但我還沒確定你的約會日期。
Robert Adam Hopkins - MD of Equity Research
Robert Adam Hopkins - MD of Equity Research
Okay. Feeling good about it. Does that mean the potential for submissions in '18?
好的。感覺很好。這是否意味著 2018 年有可能提交作品?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
No. I'm feeling good about the progress of the team and their ability to deliver on what we think this is capable of doing.
不。我對團隊的進展以及他們實現我們認為它能夠達到的目標的能力感到滿意。
Robert Adam Hopkins - MD of Equity Research
Robert Adam Hopkins - MD of Equity Research
Okay. And then on your comments on Japan, I'm just curious, what do you assume for Japan in the current 11% to 15%? And maybe said another way, if reimbursement comes in the way you would hope, does that suggest the potential for the higher end of that 11% to 15%?
好的。關於您對日本的評論,我很好奇,您認為日本目前的11%到15%的成長率意味著什麼?換句話說,如果報銷如你所願,這是否意味著有可能達到 11% 到 15% 的較高水準?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
The -- we haven't baked a lot of growth in there. Again, we don't really know at this point what the reimbursement levels are going to be. And therefore, that could vastly impact the number of -- the procedure adoption curve. So there's not a lot in there. But even then, the magnitude of Japan relative to the total world is not substantial. And the highest growth drivers for the -- for us for next year really are general surgery procedures in the U.S. and urological procedures outside of the U.S.
——我們並沒有在那裡預留太多成長空間。再次強調,目前我們還不清楚具體的報銷金額是多少。因此,這可能會對程序採納曲線的數量產生巨大影響。所以裡面東西不多。但即便如此,日本在全球經濟總量中所佔的比重也不大。而對我們而言,明年成長最快的驅動因素實際上是美國的普通外科手術和美國以外的泌尿外科手術。
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
And with these clearances, Bob, or reimbursements, I should say, it's really -- it's going to be building a foundation time for us. There's going to be large investments made or we have been making, and we're going to follow through on things like training surgeons and building the teams up to speed. So it's really more about building a foundation here for the future in 2018 than a substantive contribution to the growth.
鮑勃,有了這些許可,或者應該說是報銷款項,這真的——這將是我們打好基礎的時期。我們將進行或已經進行大量投資,並且我們將繼續推進諸如培訓外科醫生和提升團隊能力等工作。所以,與其說是對成長做出實質貢獻,不如說是為 2018 年的未來奠定基礎。
Robert Adam Hopkins - MD of Equity Research
Robert Adam Hopkins - MD of Equity Research
And then Gary, just real quickly, given the success you've had as a company in 2017 on the procedure side, I wanted to ask one quick question on how you view the market opportunity because in 2016 to 2017, your slide decks talked about 4 million accessible procedures worldwide for approved technologies. And I'm just curious if you could update us on your latest thoughts on kind of the addressable procedures, where you stand today relative to that 4 million, given that you've got SP coming along with, obviously, other technologies.
然後,Gary,鑑於貴公司在 2017 年在手術方面取得的成功,我想快速問一個關於您如何看待市場機會的問題,因為在 2016 年至 2017 年,您的幻燈片提到全球範圍內有 400 萬例經批准的技術可用於手術。我很好奇您能否向我們介紹一下您對可尋址程序的最新想法,以及您目前相對於那 400 萬個目標的立場,因為您顯然還有 SP 以及其他技術。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Yes. Yes, fair question. As you described, I think the -- for current products in the market and current countries in which we operate, I think our estimates are that we're under -- we're not yet 1/4 penetrated. So even with what our commercial teams have to do, we have plenty of upside. I think as you move time -- whenever you talk about total available market, I'll tell you how we think about it. We look out and start with, where do we see differentiated clinical value by procedure given what we can bring and try to get an estimate of what segment or population of our customer base that can make a positive impact. And we, you know us, start conservatively. And what tends to happen over time as we get into those, history has been that, as we get clinical data and our customers use our products, we get a better, clearer view of TAM. Often, the TAM has increased. Not always. Some TAMs have decreased. But mostly, they have increased. And so that's how we look at it. SP is clearly an opportunity for us to explore some procedures in patient populations that we have not done a lot in, and that, I think, is why we're excited about it. And flex, I think, opens a new set of opportunities for us that's why we have done the investments. I think flexible technologies we are pursuing in the pulmonology space and the thoracic cavity, and we'll be focused on that for the next few years. But as you know, we're really excited about platform ideas, things that have generic capability that can be broadened over time. And we think flex robotics, diagnostics and other interventions can do that as well. We don't have a crystal ball as to those TAMs, and we're not ready yet to describe how big we think they can be in part because our estimates are large ranges. It could be quite a lot of variability. But we invest in them because we think they bring the real opportunities for outcome improvements in the hands of our customers, decreases in variability across the customer base, and as a result, an opportunity to grow the footprint of Intuitive going forward.
是的。是的,問得好。正如您所描述的那樣,我認為——就目前市場上的產品和我們目前運營的國家而言,我認為我們的估計是——我們還沒有達到 1/4 的市場滲透率。所以即使考慮到我們商業團隊需要做的事情,我們仍然有很多上升空間。我認為隨著時間的推移——每當你談到總可用市場時,我都會告訴你我們是如何看待這個問題的。我們放眼外部,首先思考,鑑於我們所能提供的優勢,哪些手術具有差異化的臨床價值,並嘗試估算出哪些客戶群或人群能夠產生積極影響。而我們,你們也知道,我們總是從保守開始。隨著時間的推移,當我們深入了解這些領域時,歷史經驗表明,隨著我們獲得臨床數據,我們的客戶使用我們的產品,我們對 TAM 有了更好、更清晰的認識。通常情況下,TAM(目標市場規模)會增加。不總是如此。部分TAM有所下降。但總體而言,它們的數量有所增加。所以,我們就是這樣看待這個問題的。SP 顯然為我們提供了一個機會,讓我們能夠探索一些我們以前很少涉足的患者群體中的手術流程,我認為,這就是我們對此感到興奮的原因。我認為,Flex 為我們開啟了一系列新的機遇,這也是我們進行投資的原因。我認為我們正在肺病學領域和胸腔內探索的靈活技術,也是我們未來幾年將重點關注的方向。但如您所知,我們對平台理念非常感興趣,這些理念具有通用功能,可以隨著時間的推移而擴展。我們認為柔性機器人、診斷和其他幹預措施也能做到這一點。我們沒有水晶球可以預知這些TAM(潛在市場規模),而且我們還不准備描述我們認為它們能有多大,部分原因是我們的估計範圍很大。可能存在相當大的變數。但我們投資於它們,是因為我們認為它們能為我們的客戶帶來真正的改善結果的機會,減少客戶群的差異,從而為 Intuitive 未來的發展帶來機會。
Operator
Operator
And we do have a question from the line of David Lewis with Morgan Stanley.
我們也收到來自摩根士丹利的戴維·劉易斯的提問。
David Ryan Lewis - MD
David Ryan Lewis - MD
A few quick questions for me. First, Gary, just coming back to the pipeline. Just on SP, is there a chance we get additional label approvals or submissions for head, neck and colorectal this year on SP? And is second half of the year a decent time for them to think about the 40-millimeter stapler approval?
我有幾個問題想問一下。首先,加里,我剛回到管道部分。僅就SP而言,今年我們是否有機會在SP上獲得頭頸外科和結直腸外科方面的額外標籤批准或提交?下半年是否是他們考慮批准 40 毫米訂書機的合適時機?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Yes. So let's go to the -- I think you meant 60-millimeter stapler. On the SP front, not ready to call timing on labeling -- additional indications. We'll pursue them with FDA over time. And it depends a lot on what kind of data requirements we have and how that conversation goes. We're focused right now on the first one. And in terms of clinical capability and customer feedback, we're feeling quite positive. And so I think the conversation with FDA should be pretty direct and grounded. Predicting the time line, we're not ready to do yet at this time. On the 60-millimeter, that's a set of products that we have gone back and forth over the years with approvals. I don't think it's wildly different in terms of what we can expect. And I think historical time lines for approvals for us are probably good predictors of what happens on the 60-millimeter. So I'm hopeful that we'll see it this year.
是的。所以讓我們來看看吧——我想你指的是60毫米訂書機。在SP方面,目前還無法確定標籤的發佈時間——還有其他跡象。我們會逐步向FDA提出申訴。這很大程度上取決於我們有什麼樣的數據需求以及相關的討論進度如何。我們現在專注於第一個問題。就臨床能力和客戶回饋而言,我們感覺相當樂觀。所以我認為與FDA的對話應該相當直接且務實。目前我們還無法預測具體時間表。關於 60 毫米規格的產品,我們多年來一直在反覆討論並尋求批准。我認為就我們可以預期的情況而言,不會有太大的不同。我認為,我們過去獲得批准的時間軸可能很好地預測了 60 毫米鏡頭的發展趨勢。所以我希望今年就能看到它。
David Ryan Lewis - MD
David Ryan Lewis - MD
Okay. And just a couple more for me, Gary. Just one on spending. I think you're wisely investing away some of the tax benefit, but year-on-year, it's probably $150 million of incremental OpEx and probably $50 million more than we expected for 2018. If you could just sort of give us a sense of where some of the key investment dollars are going here in '18. And then you mentioned this last quarter but not this quarter, in terms of hiring the management team for the China JV, where are you on CEO, CFO? And what are their near-term priorities?
好的。加里,我再來幾杯。只談消費。我認為你明智地將部分稅收優惠用於投資,但與前一年相比,營運支出可能會增加 1.5 億美元,比我們 2018 年的預期高出 5,000 萬美元。如果您能大致介紹一下 2018 年一些重要的投資資金流向哪裡,那就太好了。然後,您在上個季度提到了這件事,但這個季度沒有提到,關於為中國合資企業招募管理團隊,CEO、CFO方面有什麼進展嗎?那麼,他們近期的優先事項是什麼?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Yes. Fair question. On the investment side, as the business has strengthened over the last couple of years, we've increased our investments I think rationally. They have been focused on a couple of things. One has been building depth in OUS markets. Our market presence and penetration in places like Japan and China and Germany, France, U.K. and so on are less than they are in the U.S. We think there is real opportunity for value creation in those markets. We want to make sure that we're not underinvesting there relative to the opportunity. So that's one segment. The next segment is, I really believe computer-assisted surgery, I think, has moved from an interesting part of minimally invasive surgery department to kind of an essential part of the portfolio. And as that happens, I think more and more opportunities, competitors and interest is being generated. And we want to make sure that Intuitive is investing for the long term. And I think you all will hold us to the quality of those investments. Mostly, the challenge here has not been identifying opportunity. It's been making sure that if we invest in something, that we have the skill and capabilities to deliver it with excellence. And so we've been investing behind things that we think are good opportunities. And I think, over time, the wisdom of those decisions will play out. So that's kind of mark, too. I think the last thing for us has been, as the business has accelerated, we see opportunities for taking advantage of scale and efficiency, and we think that will serve the company well and our customer base well in the future. So as volumes go up, we can convert some capital investments into operating efficiency. You've seen us doing that, and I think that, that allows us to share with the customer some of those efficiencies that drives better quality performance in our products. We think that's important as well. And so we've -- as we've seen strengthening, we've loosened some of those dollars, and I have to thank our operations team who've done a beautiful job investing for them wisely. Marshall, why don't you take the JV and China question, and I'll fill in behind.
是的。問得好。在投資方面,隨著公司業務在過去幾年中不斷增強,我們增加了投資,我認為這是合理的。他們一直專注於兩件事。其中一家一直在美國境外市場累積實力。我們在日本、中國、德國、法國、英國等地的市佔率和滲透率都低於美國。我們認為這些市場存在著創造價值的真正機會。我們希望確保我們在那裡的投資不會低於其發展機會。這是其中一部分。下一個部分,我真的相信電腦輔助手術,已經從微創手術部門一個有趣的部分發展成為該部門不可或缺的一部分。隨著這種情況的發生,我認為會產生越來越多的機會、競爭對手和興趣。我們希望確保 Intuitive 進行的是長期投資。我認為你們都會對我們這些投資的品質提出質疑。主要挑戰不在於發現機會。我們一直致力於確保,如果我們投資某件事,我們就擁有足夠的技能和能力,能夠出色地完成任務。因此,我們一直在投資我們認為有發展機會的項目。我認為,隨著時間的推移,這些決定的明智性終將得到體現。所以這也是一個標誌。我認為對我們來說,最後一點是,隨著業務的加速發展,我們看到了利用規模和效率優勢的機會,我們認為這將在未來對公司和我們的客戶群大有裨益。因此,隨著銷售量的成長,我們可以將一些資本投資轉化為營運效率的提升。您已經看到我們這樣做了,我認為,這使我們能夠與客戶分享一些提高產品品質效能的效率。我們也認為這一點很重要。因此,隨著市場走強,我們放寬了一些投資,我必須感謝我們的營運團隊,他們為客戶進行了明智的投資,做得非常出色。馬歇爾,你先回答合資企業和中國的問題,我來補充。
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Sure. In China, we have hired a CEO. We actually have also hired a CFO and a few other key members of the management team. Right now, they are focused on building out that management team and getting prepared for eventual launch of the business itself. Of course, the gating factor there is we're still working on the development of the catheter-based product here in the United States. And as that's completed, then elements of it in the business will start to be handed over to the JV.
當然。我們在中國聘請了一位執行長。我們實際上也聘請了財務長和一些其他重要的管理團隊成員。目前,他們正專注於組建管理團隊,並為最終啟動業務做好準備。當然,目前的阻礙因素是我們仍在美國開發基於導管的產品。隨著這一過程的完成,公司業務的各個部分將開始移交給合資企業。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Yes. The early performance of that team, as they've entered our organization, is encouraging. The human capital that they're bringing to board looks pretty strong. So that has been a positive step for us in '17.
是的。團隊加入我們組織後的早期表現令人鼓舞。他們引入的人才儲備看起來相當強大。所以這對我們來說是2017年的一個積極進展。
Operator
Operator
And we do have a question from the line of Tycho Peterson with JPMorgan.
我們也收到來自摩根大通的泰科彼得森提出的問題。
Tycho W. Peterson - Senior Analyst
Tycho W. Peterson - Senior Analyst
I guess first question on Japan. I know you don't want to comment on reimbursement levels at this point. It's bit of a waiting game here. But if we think about the 12 procedures that you got approval for, are there ones you want to call out that may be more exciting than others? And maybe could you talk about what percentage of those are done open versus lapped across the 12 that have been approved?
我想第一個問題是關於日本的。我知道你現在不想對報銷金額發表評論。現在有點像是在等待。但是,如果我們想想你獲得批准的 12 項手術,有沒有哪些手術是你特別想提及的,比其他手術更令人興奮的?或許您可以談談在已獲批准的 12 個項目中,開放式施工和半封閉式施工的比例分別是多少?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Well, it's hard to characterize which ones we're most excited about when you don't know what reimbursements are going to be. So I -- we can -- you've seen the list, and I think you can size yourself what you think the market opportunity might be. But again, caution you that until reimbursements are announced, we're really not going to know. And as Calvin said, there's also an element of adoption in terms of -- that will take place in terms of building out the sales force, building training capabilities and so forth. There's also the -- as I said in my script, there's the alternate surgical approaches that may be used that you also have to deal with in adoption. So I think once we understand reimbursements and we start to dig into a little bit more after April 1 is when we'll know that, maybe we can start to talk a little bit more about the specific procedures.
嗯,在不知道報銷金額的情況下,很難說我們最期待哪些項目。所以,我已經看過這份清單了,我想你可以自己評估市場機會可能有多大。但再次提醒大家,在報銷方案公佈之前,我們真的無法知道結果。正如卡爾文所說,這其中也包含著採納的因素──這將體現在銷售團隊的擴充、訓練能力的提升等等。正如我在劇本中所說,還有一些替代的手術方法,這也是收養過程中你必須面對的問題。所以我覺得,一旦我們了解了報銷情況,並且在 4 月 1 日之後開始更深入地研究一下,我們就可以開始更多地討論具體的流程了。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
For me, just looking at the clinical side, I think there are a few things that are pretty exciting in the underlying dynamic in conversations that surgical societies have been having. First, Marshall had mentioned that a laparoscopy is fairly penetrated in some of the markets in Japan. Laparoscopic surgeons are quite capable and skilled in that market. And yet, we continue to have quite strong interest in use of our technologies there. And I think that's a positive development for us. It indicates that they are looking for clinical improvements and tool improvements over time. And so things like hysterectomy, I think, are interesting for us. Hard for us to predict exactly what will happen. It's a highly penetrated laparoscopic procedure with very skilled surgeons in Japan. And yet, the interest is quite high. And that was one of the things that was studied pretty deeply. So I personally am excited to see how that unfolds over time. It will change, as to Bob Hopkins' earlier question, how do you think about TAM? Japan is a great example of thinking through how do you do these TAM calculations because we'll see what the mix is with regard to laparoscopy versus robotics. But I'm excited to see how that unfolds. There are thoracic opportunities in the reimbursement as well that include -- and other things, GYN oncology. So I think there are several things in there that, in the mid- to long term, I think will be really exciting for us in Japan. I think the Japanese surgical societies and Japanese surgeons are thoughtful and deep, and that will be a great market to serve. The one caution you've heard us say several times is that, it's more than reimbursement. We have to have the technology training pathways and resources in place. The proctoring networks will be built over time. Our sales team has to get deep with our customer. And so the near term, there is some hard work and sleeve-rolling to go do. I would -- that would not diminish my enthusiasm for the long term.
就我個人而言,僅從臨床角度來看,我認為外科協會之間的對話中,有一些非常令人興奮的潛在動態。首先,馬歇爾曾提到,腹腔鏡手術在日本的一些市場已經相當普及。腹腔鏡外科醫師在這個領域能力很強,技術也很嫻熟。然而,我們仍然對在那裡使用我們的技術抱有濃厚的興趣。我認為這對我們來說是一個積極的進展。這表明他們正在尋求臨床改進和工具改進。所以像子宮切除術這樣的手術,我認為對我們來說很有趣。我們很難準確預測將會發生什麼。這是日本技術非常嫻熟的外科醫生進行的高難度腹腔鏡手術。然而,人們對此卻非常感興趣。而這正是我們深入研究過的問題之一。所以我個人很期待看看事情會如何發展。它會改變的,至於鮑伯霍普金斯之前提出的問題,你如何看待TAM?日本就是一個很好的例子,它教我們如何進行這些 TAM 計算,因為我們將看到腹腔鏡手術與機器人手術的比例是多少。但我很期待看到事情如何發展。報銷範圍還包括胸腔外科手術機會,以及其他一些項目,例如婦科腫瘤。所以我認為,從中長期來看,這裡面有幾件事對我們日本人來說將會非常令人興奮。我認為日本外科協會和日本外科醫生都很有思想、很有深度,這將是一個巨大的市場。我們已經多次提醒大家,這不只是報銷的問題。我們必須建立起相應的技術訓練途徑和資源。監考網絡將隨著時間的推移而逐步建立。我們的銷售團隊必須深入了解客戶。因此,在短期內,還有一些艱苦的工作和擼起袖子加油乾。我會的——但這並不會削弱我對長期發展的熱情。
Tycho W. Peterson - Senior Analyst
Tycho W. Peterson - Senior Analyst
Okay. That's helpful. And then a question on older systems, kind of 2 parts here: One, you had a big OUS trade-in number. Was that just a function of the end of the X trading program? And then you're still sort of selling a number of Si systems. I think it was 20 this quarter. Why are customers opting for that versus the X?
好的。那很有幫助。然後還有一個關於舊系統的問題,這個問題分為兩部分:第一,你們有一個很大的 OUS 以舊換新數量。那隻是X交易計畫結束的結果嗎?然後你仍然在銷售一些矽系統。我記得這季是20。為什麼顧客會選擇這款而不是X?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
For -- so last one first. For Si product, there are countries where we do not yet have regulatory approval for X, and therefore, we're still selling Sis. There's also -- some customers have Sis already, and they don't want yet to move away from -- move in with a world where they have 2 sets of inventory and 2 sets of training protocol and so forth, and so they would rather step into an Si. And then there are some countries where reimbursements are not so high, and they're looking for the cheapest product they can get, and an Si refurb fits that bill. But you probably will see the number of Sis we sell decline over time going forward as we get regulatory approvals and we're able to move Xs.
所以——所以最後一個先說。對於 Si 產品,在某些國家我們還沒有獲得 X 的監管批准,因此,我們仍在銷售 Sis。還有一些客戶已經擁有 Sis 系統,他們還不想放棄 Sis 系統,不想進入一個擁有兩套庫存和兩套培訓協議等的世界,所以他們寧願進入 Si 系統。還有一些國家的報銷額度不高,他們會尋找最便宜的產品,而翻新的 Si 正好符合他們的要求。但隨著我們獲得監管部門的批准,並且能夠銷售 X,您可能會看到我們未來銷售的 Sis 數量逐漸減少。
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
Yes. On the system retirement side, I think there were 21 total, 18 retired in the field plus 3 that were in lease returns. It's been higher than we've been running, but it's really an expected part of our business cycle. And as you know, when a customer elects to stop using a particular system, they're usually going to trade it in, purchase a new system or just retire it out there in the field. And most of them end up being traded in, but some will end up being retired in the field and we saw that. In Q4, we're able to confirm that there were 18 of these over 4,400 systems in the field, mostly older models, that are no longer being used. So we just removed them from our installed base count.
是的。在系統退役方面,我認為總共有 21 台,其中 18 台在現場退役,3 台是租賃歸還的。雖然比我們之前的營運水準要高,但這確實是我們業務週期中一個預期的一部分。如您所知,當客戶選擇停止使用某個系統時,他們通常會將其置換、購買新系統或直接將其從現場淘汰。他們中的大多數最終都會被交易出去,但有些最終會在球場上退役,我們也看到了這一點。第四季度,我們確認現場有超過 4400 套系統中有 18 套是舊型號,這些系統已不再使用。所以我們直接把它們從安裝用戶數量中移除了。
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Yes. I think you were also asking about Europe and the trade-ins in Europe. Is that correct?
是的。我想你當時也問到了歐洲以及歐洲的以舊換新狀況。是這樣嗎?
Tycho W. Peterson - Senior Analyst
Tycho W. Peterson - Senior Analyst
Yes.
是的。
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
The trade-ins in Europe, even -- despite what I said about some customers want to -- don't want to enter into a world where they have 2 sets of inventory, there are those customers that want to standardize in the fourth generation product. And there's also a larger installed base of Ss and Sis in Europe in terms of mix relative to, let's say, the United States. And so we did see a number of customers in Europe trade out their Sis for X product so to get into the fourth generation product and have access into the latest instrumentation.
即使在歐洲,以舊換新也——儘管我說過有些客戶想要——他們不想進入擁有兩套庫存的世界,但也有一些客戶希望在第四代產品中實現標準化。而且,就產品組合而言,歐洲的 S 和 Si 的安裝基數也比美國更大。因此,我們看到歐洲的一些客戶將他們的 Sis for X 產品置換為第四代產品,以便使用最新的儀器。
Tycho W. Peterson - Senior Analyst
Tycho W. Peterson - Senior Analyst
Okay. And then last one, thinking about the mature procedures, in particular the dVP in the U.S. Anything in '18 that will change the trajectory relative to what you saw in '17? I think you kind of mentioned you're back to kind of the market growth rate there. But just curious, I mean, I think there's been this expectation that it will decelerate a little bit for a while. I'm curious as to your thoughts.
好的。最後一個問題,關於成熟的流程,特別是美國的dVP流程。 2018年有哪些因素會改變其發展軌跡,使其與2017年相比有所不同?我想你剛才也提到過,市場成長率已經恢復正常水準了。但我很好奇,我的意思是,我覺得大家一直都預期這種趨勢會在一段時間內放緩。我很想知道你的想法。
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
Yes. I mean, the results in 2017 exceeded our expectation. Urology was up 8% for the year, and DVP is a big piece of that. So as kind of the standard for the surgical treatment of prostate cancer, we think that we'd be moving with the overall incidence rate, which is more like low single digits. So our expectation within our guidance range at the low end of the high end is some moderation in the U.S. on prostatectomy in 2018.
是的。我的意思是,2017 年的成績超出了我們的預期。泌尿科業務今年成長了 8%,其中 DVP 業務佔了很大一部分。因此,作為前列腺癌手術治療的標準,我們認為我們應該與整體發病率保持一致,而整體發病率更像是個位數低位。因此,我們預計,在指導範圍的低端到高端之間,2018 年美國的前列腺切除術數量將有所減少。
Operator
Operator
And we do have a question from the line of Larry Biegelsen with Wells Fargo.
我們也收到來自富國銀行的 Larry Biegelsen 的一個問題。
Lawrence H. Biegelsen - Senior Analyst
Lawrence H. Biegelsen - Senior Analyst
One on China, one in the flex catheter and just on the tax rate as well. So on the Chinese quota, where are you guys in the process there? Do you have any visibility? And is it still -- is it too late at this point to impact 2018? On the flex catheter, Gary, on the last call, you sounded maybe optimistic that the CHEST data would be enough for FDA clearance in the U.S. Do you have confirmation of that at this point or any clarification? And just lastly, Marshall, on the tax rate. I thought it would be a little bit lower than 20% to 22%. Is there some conservatism there given the uncertainty? Or is there something else that we maybe didn't factor into some of the estimates we had?
一篇關於中國,一篇關於柔性導管,還有一篇關於稅率。那麼,關於中國配額,你們那邊進展到什麼程度了?你能看到什麼嗎?現在是否還為時已晚,無法對 2018 年產生影響?Gary,關於柔性導管,在上次通話中,你似乎比較樂觀地認為 CHEST 研究的數據足以獲得美國 FDA 的批准。目前你是否已經確認這一點,或有任何補充說明?最後,馬歇爾先生,請談談稅率問題。我以為會比 20% 到 22% 略低。鑑於目前的不確定性,是否存在某種保守主義傾向?或者,是否還有其他我們未納入某些估算的因素?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Thanks, Larry. Why don't you take that first one, Marshall?
謝謝你,拉里。馬歇爾,你為什麼不選第一個呢?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Quota? There's no new news on the quota. I mean, we sit here waiting, as do you, for news as to what the quota will be.
配額?關於配額問題,目前還沒有新的消息。我的意思是,我們和你們一樣,都坐在這裡等待配額公佈的消息。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
On China, we don't have any indication that is either, a, intuitive-specific or something that we should be foundationally worried about. So we're not looking at it and thinking something's wrong here or there's an Intuitive-specific indication. Nothing looks like that. If you ask the question, is it too late to impact 2018, I don't think so yet. Marshall, looking at you, I don't know how you feel about it.
關於中國,我們沒有任何跡象顯示這是直覺特有的,或者說是我們應該從根本上擔憂的事情。所以,我們不會看著它就覺得這裡出了什麼問題,或是有什麼直覺特有的跡象。看起來不像。如果你問現在是否為時已晚,無法影響 2018 年,我認為還不算太晚。馬歇爾,看著你,我不知道你對此有何感想。
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Yes. I -- it's hard to know how long the tender process will take at the hospitals. Last time we got a quota approved, quota was approved in 2013, and we didn't see many of the systems sold until the end of 2015. I don't know whether that same time line will apply here.
是的。我——很難說醫院的招標過程需要多長時間。上次我們獲得配額批准是在 2013 年,但直到 2015 年底我們才看到很多系統售出。我不知道同樣的時間表是否適用於這裡。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Moving to the flex question. No change in my opinion about data requirements. Either way, I wouldn't read anything in my comments last time or this time that would indicate a change. And go to tax...
接下來討論彈性工作制的問題。我對數據需求的看法沒有改變。無論如何,我從上次或這次的評論中都看不出任何變化的跡象。然後去繳稅…
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Tax, the tax rate, the range that Calvin gave is our best estimate. You said that you thought it would have been lower. Clearly, a greater portion of our revenue is still generated in the United States, so more at the higher end. There are -- there's the rate itself, the 21%, but then there are other elements of the Tax Act that add additional taxation on top of that. And so we've given you the range that we think will -- is the best estimate of what it is. I don't -- I wouldn't call it conservative.
稅、稅率,卡爾文給的範圍是我們能做出的最佳估計。你說你以為它會更低。顯然,我們大部分的收入仍然來自美國,因此高端產品也更多。確實存在一些問題——首先是稅率本身,即 21%,但稅法中還有其他條款在此基礎上增加了額外的稅收。因此,我們給出的範圍是我們認為最合理的估計。我不這麼認為──我不會稱之為保守主義。
Operator
Operator
And we do have the question from the line of Amit Hazan with Citi.
我們也收到了來自花旗銀行的 Amit Hazan 的提問。
Amit Hazan - Director
Amit Hazan - Director
Let me start with gross margin guidance. I think the last 2 years, you've kind of been nearing that 72% range. FX is now kind of in your favor. You had pretty big capital year last year at lower margin. You're kind of implying that might not repeat again in '18, which is understandable. It seems like very little revenue is from new products, like the SP this year, as you're talking about how we should think about that brand. So why shouldn't that gross margin number, at the very least, stay consistent with '17, if not go up a bit?
首先,我來談談毛利率預期。我認為過去兩年,你的比例已經接近 72% 的水平了。FX現在對你有點有利。去年你們的資本規模相當大,但利潤率較低。你的言下之意是,這種情況在 2018 年可能不會再發生,這也可以理解。看起來,像今年的 SP 這樣的新產品帶來的收入非常少,正如你所說,我們應該如何看待這個品牌。那麼,毛利率至少應該與 2017 年保持一致,甚至略有上升,這是為什麼呢?
Calvin Darling - Senior Director of IR
Calvin Darling - Senior Director of IR
Yes. I think, like we said in the prepared comments, Amit, the primary driver there is going to be impact of new products. And yes, we are going to do a phased launch of SPs as soon as we get clearance there in 60-millimeter like we talked about. And you have the direct margin on the product, but there's investments we make in the line and the teams and kind of the structure to make these things that kind of run through on the cost line. It's -- a lot of that runs ahead of the higher revenue amounts.
是的。我認為,正如我們在準備好的評論中所說,Amit,主要驅動因素將是新產品的影響。是的,正如我們之前討論的那樣,一旦我們獲得 60 毫米口徑的許可,我們將分階段推出 SP 產品。產品本身有直接利潤,但我們在生產線、團隊和組織架構上也有投資,這些都會反映在成本上。很多時候,這些支出都發生在更高的收入水平之前。
Amit Hazan - Director
Amit Hazan - Director
Yes. And then just a follow-up on the U.S. trade-in. I'm kind of looking at the year. Maybe a little bit surprised how, I think, trade-ins ended the year and the U.S. market actually down 50 units year-over-year, below even 2016 levels. And I realize that's actually a positive for the installed base and for procedures. But in terms of just thinking about the replacement opportunity, given an aging installed base in the U.S., how do we best think about the next couple of years for trade-ins?
是的。然後,再跟進一下美國的以舊換新情況。我正在回顧這一年。或許有點出乎我的意料,我認為,以舊換新交易最終導緻美國市場同比下降了 50 輛,甚至低於 2016 年的水平。我意識到這實際上對已安裝的用戶群和流程來說是一件好事。但就更換機會而言,考慮到美國老舊的設備基數,我們應該如何最好地考慮未來幾年的以舊換新?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
Yes. That's -- it's hard to estimate when the customers will get to where they want to, either standardized on fourth generation product or avail themselves to latest generation. I mean, the Si drives a substantial amount of our procedures. It's a very capable system. And in fact, even in situations where customers have suggested that they want to do a trade-in, at the end of the day, they're keeping the Si for either an outpatient care meeting other than the surgery center or they've decided that they've just got volume such that they want to keep it. So I don't know how to predict what the trade-in cycle would do over the next couple of years.
是的。也就是說,很難估計客戶何時會達到他們想要的目標,要么標準化使用第四代產品,要么使用最新一代產品。我的意思是,Si 驅動著我們大量的流程。這是一個非常強大的系統。事實上,即使在客戶表示想要以舊換新的情況下,最終他們還是會保留 Si,要么是為了在手術中心以外的門診就診,要么是因為他們已經積累了足夠的銷量,所以決定保留它。所以我不知道如何預測未來幾年的以舊換新周期會如何發展。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Directionally, in terms of our intent, we think gen 4 is quite strong. We think X is a good product, and we can deliver X to the installed base in attractive economic packages. And so that's an opportunity for us. It's just really a question -- I think directionally, we know where it's headed. I think the question is just how long it takes. And we want to -- we'll support our customers in their needs, but I think we have a good offer for them.
從方向和意圖來看,我們認為第四代產品相當強勁。我們認為 X 是一款好產品,我們可以以經濟實惠的優惠方案將 X 交付給現有客戶群。所以這對我們來說是一個機會。這其實只是一個問題──我認為從方向來看,我們知道它要往哪個方向發展。我認為問題在於需要多長時間。我們希望-我們會支持客戶滿足他們的需求,但我認為我們能為他們提供很好的方案。
Amit Hazan - Director
Amit Hazan - Director
And just last one. Maybe I heard you wrong, just on imaging hardware for this year how much more you can tell us on what to expect in terms timing of new products, if it's possible that they'd be introduced in '18 like augmented reality, et cetera, and what we might expect there in terms of potentiality?
最後一個。也許我聽錯了,就今年的成像硬體而言,您能否透露更多關於新產品發佈時間的資訊?例如,是否有可能在 2018 年推出擴增實境等技術?以及這些技術在潛力方面有哪些發展前景?
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
Yes. Fair question. So when we think about imaging, there's 3 buckets that we think about in investments we make. There's the hardware endoscope side, the sensors, the chips, the optics, the package. And we have been investing in that and routinely improving those things, sometimes in big steps, sometimes in small steps. Just as you would imagine each release of a cellphone has better camera systems, we follow a similar idea. And that's been powerful. Those compound effects of improvements are pretty impressive. Second thing is image processing software. The algorithms themselves to shape the image have also been improving over time, and also we can release in patches and updates. And then there's the contrast agents and molecules. And we work all of them. And we often talk about molecules. They're kind of the big thing to see. They are long-term investments. And I was reminding everybody here, there are other things going on, too, that the hardware and the underlying software is good. Augmented reality and -- or mix reality, the idea that you can take pre-opted images, manage them and get them in, we are making nice progress there. I don't expect material revenue in the year, but I do think that we'll start getting increased customer feedback over the year. And at least as we get close to the customer, we'll inform you more of where we are.
是的。問得好。所以當我們考慮影像技術時,我們在投資時會考慮以下三個面向。內視鏡硬體部分包括感測器、晶片、光學元件和封裝。我們一直在投資並不斷改進這些方面,有時是大刀闊斧,有時是小步前進。就像你認為每一代新手機的相機系統都會更好一樣,我們也遵循類似的概念。這產生了強大的影響。這些改進帶來的複合效應非常顯著。第二點是影像處理軟體。用於塑造圖像的演算法本身也在不斷改進,我們也可以以補丁和更新的形式發布。此外,還有顯影劑和分子。我們都參與其中。我們經常談論分子。它們是絕對不容錯過的亮點。它們是長期投資。我當時也在提醒大家,除了硬體和底層軟體之外,還有其他因素在運作。擴增實境和/或混合現實,即你可以獲得預先選擇的圖像,管理它們並將它們導入,我們在這方面取得了不錯的進展。我預計今年不會有實質的收入成長,但我認為我們會在這一年中收到越來越多的客戶回饋。至少當我們接近客戶時,我們會告知您我們的具體位置。
Operator
Operator
And we do have a question from the line of Isaac Ro with Goldman Sachs.
我們還有一個來自高盛的 Isaac Ro 的問題。
Isaac Ro - VP
Isaac Ro - VP
Two questions on Asia, one on China. Just curious what you guys are doing to try and drive penetration while we wait for the quota. Are you better off waiting for the government to give official order? Are there other avenues that you're pursuing to try and drive access? And then secondly on Japan. Just appreciate all the comments you made earlier, but I'm wondering how we should think about market development in that region as you get new applications. Are there a couple of obvious ways in which position training and so forth need to be different? And how we should think about your process there?
兩個問題關於亞洲,一個問題關於中國。我只是好奇,在我們等待配額期間,你們都在採取哪些措施來提高市場滲透率。等待政府發布正式命令是否更適合?您還在嘗試透過其他途徑來推動取得存取權限嗎?其次是關於日本。非常感謝您之前提出的所有意見,但我想知道隨著新應用的推出,我們應該如何看待該地區的市場發展。職位培訓等方面是否存在一些顯而易見的差異?我們該如何看待你們那裡的流程?
Marshall L. Mohr - Senior VP & CFO
Marshall L. Mohr - Senior VP & CFO
So for China, we have a number of systems -- 38 systems I think it is installed in the public hospitals that were subject to the quota. But our distributor is driving clinical adoption there, training surgeons and moving it up. That's why you see -- why you've heard us talk about increased utilization of those systems and increased number of procedures. The systems that are not subject to the quota really are those in military hospitals in Hong Kong. We actually sold 3 systems this quarter. That's not nearly the market of the public hospitals, but nonetheless, we're making progress in those markets and continue to try to drive expansion.
所以對中國來說,我們有一些系統——我認為有 38 個系統安裝在受配額限制的公立醫院。但是我們的分銷商正在推動該技術的臨床應用,培訓外科醫生並提升其應用水準。這就是為什麼你們會看到——為什麼你們會聽到我們談論這些系統的使用率提高和手術數量的增加。不受配額限制的系統其實是指香港軍醫院的系統。本季我們實際售出了3套系統。雖然這遠不及公立醫院的市場規模,但儘管如此,我們仍在這些市場取得進展,並將繼續努力推動擴張。
Gary S. Guthart - CEO, President & Director
Gary S. Guthart - CEO, President & Director
And we think demand from Chinese surgeons and Chinese hospitals is very high, and so education and engagement is something that we can continue to do. I'll answer the Japan question, and operator, this will be our last question after that answer. With regard to Japan, I'd like to quote, "History doesn't repeat, but it does rhyme." I think about what we need to do in Japan in terms of market development. We -- our team in Japan is quite capable. They are engaged deeply with -- in communication with surgical societies around what training pathways look like, what educational and courseware kind of look like, things like fellowship programs and so on. And so I don't think the work is a mystery. But it does take time in education, education of our own team and education of the market. I think we have a senior leader in our General Manager in Japan. I think this is a team that's capable. So we will give them time to make progress here. But I think they have a playbook they can work down. And while it's not identical to the playbook that we use in the U.S. or the ones that we use in Germany, the main elements of engagement are present.
我們認為中國外科醫生和中國醫院的需求非常高,因此教育和交流是我們能夠繼續做的事情。我會回答關於日本的問題,操作員,這將是我們回答完這個問題後的最後一個問題。關於日本,我想引用一句名言:「歷史不會重演,但總是會押韻。」我一直在思考,就市場開發而言,我們在日本需要做些什麼。我們——我們在日本的團隊能力很強。他們與外科協會進行了深入的溝通,探討培訓途徑、教育和課程內容、研究員專案等議題。所以,我不認為這份工作是個謎。但這確實需要時間進行教育,包括對我們自己團隊的教育和對市場的教育。我認為我們日本的總經理是一位資深領導者。我認為這是一支有能力的隊伍。所以我們會給他們時間,讓他們在這裡取得進展。但我認為他們有一套可以按部就班執行的方案。雖然它與我們在美國或德國使用的策略手冊並不完全相同,但參與的主要要素都存在。
As we conclude this call -- that was our last question. As we've said previously, while we focus on financial metrics such as revenues and profits and cash flow during these conference calls, our organizational focus remains on increasing value by enabling surgeons to improve surgical outcomes and reduce surgical trauma. We have built our company to take surgery beyond the limits of the human hand, and I assure you that we remain committed to driving the vital few things that truly make a difference. This concludes today's call. I thank you for your participation and support on this extraordinary journey to improve surgery, and we look forward to talking to you again in 3 months.
通話即將結束——這是我們最後一個問題。正如我們之前所說,雖然我們在這些電話會議中關注的是收入、利潤和現金流等財務指標,但我們組織的重點仍然是透過幫助外科醫生改善手術結果和減少手術創傷來增加價值。我們創立這家公司的目的是為了突破人手所能達到的外科手術極限,我向你們保證,我們將繼續致力於推動那些真正能帶來改變的關鍵因素。今天的電話會議到此結束。感謝您參與並支持這項旨在改進外科手術的非凡旅程,我們期待在 3 個月後再次與您交流。
Operator
Operator
And ladies and gentlemen, that does conclude your conference for today. Thank you for your participation and for using the AT&T Executive TeleConference service. You may now disconnect.
女士們、先生們,今天的會議到此結束。感謝您的參與以及使用 AT&T 高階主管電話會議服務。您現在可以斷開連線了。