Inmode Ltd (INMD) 2021 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Hello, and welcome to the InMode Ltd. Third Quarter 2021 Earnings Conference Call. (Operator Instructions) Please note, today's event is being recorded.

    您好,歡迎參加 InMode Ltd. 2021 年第三季度收益電話會議。 (操作員說明)請注意,今天的活動正在錄製中。

  • I would now like to turn the conference over to Miri Segal, President of MS-IR. Please go ahead.

    我現在想把會議交給 MS-IR 總裁 Miri Segal。請繼續。

  • Miri Segal-Scharia - CEO

    Miri Segal-Scharia - CEO

  • Thank you, operator, and thank you all for joining us today. Welcome to InMode's third quarter 2021 earnings call. Before we begin, I would like to remind our listeners that certain information provided on this call may contain forward-looking statements, and the safe harbor statement outlined in today's earnings release also pertains to this call. If you have not received a copy of the release, please download one from the Investor Relations section of the company's website.

    謝謝你,接線員,謝謝大家今天加入我們。歡迎參加 InMode 2021 年第三季度財報電話會議。在我們開始之前,我想提醒我們的聽眾,本次電話會議中提供的某些信息可能包含前瞻性陳述,今天收益發布中概述的安全港聲明也與本次電話會議有關。如果您沒有收到新聞稿的副本,請從公司網站的投資者關係部分下載一份。

  • Changes in business, competitive, technological, regulatory and other factors could cause actual results to differ materially from these expressed by the forward-looking statements made today. Our historical results are not necessarily indicative of future performance. Therefore, we can give no assurance as to the accuracy of our forward-looking statements and assume no obligation to update them, except as required by law.

    業務、競爭、技術、監管和其他因素的變化可能導致實際結果與今天做出的前瞻性陳述所表達的結果大不相同。我們的歷史結果不一定代表未來的表現。因此,我們不能保證我們的前瞻性陳述的準確性,並且不承擔更新它們的義務,除非法律要求。

  • Today, with us are Moshe Mizrahy, InMode's Chairman of the Board and CEO, who will start us off with a business update. Then he will turn the call over to Shakil Lakhani, InMode's President of North America to discuss North American operations. Finally, Yair Malca, the CFO, will discuss the financials of the third quarter in some more detail.

    今天,InMode 的董事會主席兼首席執行官 Moshe Mizrahy 與我們同在,他將從業務更新開始。然後,他將把電話轉給 InMode 北美總裁 Shakil Lakhani,討論北美業務。最後,首席財務官 Yair Malca 將更詳細地討論第三季度的財務狀況。

  • With that, I'd like to pass the call over to Moshe Mizrahy. Moshe, congratulations on another record quarter. Please go ahead.

    有了這個,我想把電話轉給 Moshe Mizrahy。 Moshe,恭喜你又創紀錄的季度。請繼續。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Thank you, Miri, and thank you all, everyone, for joining us on our third quarter 2021 earnings call. With me today are Dr. Michael Kreindel, our Co-Founder and Chief Technology Officer; Mr. Yair Malca, our CFO; Mr. Shakil Lakhani, our President of North America; Dr. Spero Theodorou, our Chief Medical Officer; and Rafael Lickerman, our VP, Finance. Following our prepared remarks, we will all be available for Q&A session.

    謝謝你,美里,也謝謝大家加入我們的 2021 年第三季度財報電話會議。今天和我在一起的是我們的聯合創始人兼首席技術官 Michael Kreindel 博士;我們的首席財務官 Yair Malca 先生;我們的北美總裁 Shakil Lakhani 先生;我們的首席醫療官 Spero Theodorou 博士;以及我們的財務副總裁 Rafael Lickerman。在我們準備好的評論之後,我們都可以參加問答環節。

  • We are happy to report again a record quarter of profitable growth. Thanks to our innovative unique technology, growing market demand, our excellent employees, and collaborative work to our network around the world, we posted record revenue of $94.2 million for the third quarter of 2021, an increase of 58% over the same quarter last year. We continue to closely control our expenses, and our net income for the quarter on a GAAP basis reached a record of $44.7 million, reflecting a 87% growth year-over-year.

    我們很高興再次報告創紀錄的季度盈利增長。得益於我們創新的獨特技術、不斷增長的市場需求、我們優秀的員工以及與全球網絡的協作,我們在 2021 年第三季度實現創紀錄的 9420 萬美元收入,比去年同期增長 58% .我們繼續嚴格控制開支,按公認會計原則計算的本季度淨收入達到創紀錄的 4470 萬美元,同比增長 87%。

  • During that -- during the third quarter of 2021, sales of capital equipment accounted for 90% of our total revenue. Despite summer slowdown, sales from consumable and services remained strong, representing 10% of our total revenue at $9.1 million, a 68% increase over the same quarter last year. A strong demand for our consumable, show widespread market acceptance, indicating that physicians buy more platforms and perform more treatment every months.

    在此期間——在 2021 年第三季度,固定設備的銷售占我們總收入的 90%。儘管夏季放緩,但消耗品和服務的銷售額仍然強勁,占我們總收入的 10%,為 910 萬美元,比去年同期增長 68%。對我們的耗材的強勁需求顯示出廣泛的市場接受度,這表明醫生每月購買更多平台並進行更多治療。

  • Our minimally invasive surgical technology represents 73% of our revenue for the quarter, compared to 59% in the third quarter last year. Hands-Free devices were 18% of total revenue, while our traditional laser and noninvasive RF platforms contributed 9%. The U.S. was once again a major contributor to our top line with total sales reaching $62.6 million compared to $40.9 million in the third quarter of 2020, reflecting a 53% increase.

    我們的微創手術技術占我們本季度收入的 73%,而去年第三季度為 59%。免提設備佔總收入的 18%,而我們的傳統激光和無創射頻平台貢獻了 9%。美國再次成為我們收入的主要貢獻者,總銷售額達到 6260 萬美元,而 2020 年第三季度為 4090 萬美元,增長了 53%。

  • It's worth noting that EmpowerRF was recently launched and is currently limited to the U.S., as we focus on early adopters in the gynecology space. This strategy will lay the necessary groundwork for successful introduction to a global market.

    值得注意的是,EmpowerRF 是最近推出的,目前僅限於美國,因為我們專注於婦科領域的早期採用者。這一戰略將為成功引入全球市場奠定必要的基礎。

  • Our ROW sales have continued to grow. Total sales outside the U.S. were 31.6%, a 68% increase compared to the same period last year, and a great results for what is usually slower summer quarter. This represents 34% of our total revenue compared to 30% for the same quarter last year.

    我們的 ROW 銷售額持續增長。美國以外的總銷售額為 31.6%,與去年同期相比增長了 68%,這對於通常較為緩慢的夏季季度來說是一個很好的結果。這占我們總收入的 34%,而去年同期為 30%。

  • We currently operate in 72 countries, and expect that the numbers to rise as we seek to expand into new markets. We are currently exploring establishing a new subsidiary in another major European market, which we hope will able to begin operation in Q1 2022.

    我們目前在 72 個國家/地區開展業務,並預計隨著我們尋求擴展到新市場,這一數字將會上升。我們目前正在探索在另一個主要的歐洲市場建立新的子公司,我們希望能夠在 2022 年第一季度開始運營。

  • Our ESG effort continue every day to ensure get up the standard for ESG protocols within our industry. Accordingly, we work with our suppliers and subcontractors to ensure that they comply with the same ESG standard set by InMode. We prepared an ESG activity plan for the fourth quarter and for 2022, which will be published on our website.

    我們的 ESG 工作每天都在繼續,以確保達到我們行業內 ESG 協議的標準。因此,我們與供應商和分包商合作,以確保他們遵守 InMode 制定的相同 ESG 標準。我們準備了第四季度和 2022 年的 ESG 活動計劃,並將在我們的網站上發布。

  • Now I would like to turn your attention to Shakil, our President of North America. Shakil?

    現在我想把你的注意力轉向我們的北美總裁沙基爾。沙基爾?

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Thanks, Moshe, and to everyone joining us. It's a pleasure to announce that we delivered a record-breaking performance again this quarter, just as it is to share the news of the launch of 2 new platforms, EvolveX and EmpowerRF.

    感謝 Moshe,感謝加入我們的每一個人。很高興地宣布,我們在本季度再次創造了創紀錄的業績,就像分享 EvolveX 和 EmpowerRF 兩個新平台推出的消息一樣。

  • In the third quarter, our sales of capital equipment continued to be a driving force behind revenue, which reached $85 million. As mentioned, consumables and service revenue continued to contribute to the strong performance from the previous quarter. The third quarter of 2021 raised the bar for record attendance of our workshops, enhancing our educational support network, vitalizes both our existing and new customer base.

    第三季度,我們的固定設備銷售繼續成為收入的推動力,收入達到 8500 萬美元。如前所述,消耗品和服務收入繼續為上一季度的強勁表現做出貢獻。 2021 年第三季度提高了我們研討會出席人數的標準,增強了我們的教育支持網絡,激活了我們現有和新的客戶群。

  • Despite the variations in COVID protocols across North America, physician offices are becoming increasingly busy. This reflects normalizing of elevated demand that positively impacts our financial results.

    儘管北美各地的 COVID 協議有所不同,但醫生辦公室正變得越來越繁忙。這反映了需求上升的正常化,這對我們的財務業績產生了積極影響。

  • Consequently, we see a lot of interest expressed in our existing and newer platforms, accelerating market acceptance. Our history of successful launches, combined with market demand, fortifies us to grow different revenue segments even during seasonal and other fluctuations.

    因此,我們看到對我們現有和更新的平台表達了很多興趣,加速了市場接受度。我們成功發布的歷史,加上市場需求,使我們即使在季節性和其他波動期間也能增加不同的收入部分。

  • The soft launch of EmpowerRF has been instrumental in giving us necessary insight to create an effective strategy. As doctors and patients learn how to better navigate life under the COVID-19 pandemic, part of our marketing strategy is to increase the number of in-person events that we host in the coming months. Such events allow us to familiarize ourselves with the medical and wellness community with InMode's comprehensive product portfolio.

    EmpowerRF 的軟啟動有助於為我們提供必要的洞察力以製定有效的戰略。隨著醫生和患者學習如何在 COVID-19 大流行下更好地生活,我們的營銷策略的一部分是增加我們在未來幾個月舉辦的面對面活動的數量。此類活動使我們能夠通過 InMode 的全面產品組合熟悉醫療和健康社區。

  • Finally, I'd like to thank the North American team for the ongoing efforts and the impressive performance that led to these record results. Their loyalty, dedication and hard work is very much appreciated and have proven vital and indispensable in supporting InMode's operations.

    最後,我要感謝北美團隊的持續努力和令人印象深刻的表現,從而取得了這些創紀錄的成績。他們的忠誠、奉獻和辛勤工作受到高度讚賞,並已證明對支持 InMode 的運營至關重要和不可或缺。

  • With that, I'd like to hand over the call to Yair for a review of our financial results. Yair?

    有了這個,我想把電話交給 Yair 來審查我們的財務業績。耶爾?

  • Yair Malca - CFO

    Yair Malca - CFO

  • Thanks, Shakil, and good day, everyone. I'd like to review our strong financial results in more detail. Total revenue in the third quarter of 2021 increased 58% year-over-year to $94.2 million with a gross margin of 85% on a GAAP basis. The increase in revenues stemmed primarily from the new level of demand for aesthetic procedures that we are experiencing as well as a recovery from the lower revenue levels reported during Q3 of 2020, which was still significantly impacted by the COVID-19 pandemic.

    謝謝,Shakil,大家好。我想更詳細地回顧一下我們強勁的財務業績。 2021 年第三季度的總收入同比增長 58% 至 9420 萬美元,按公認會計原則計算的毛利率為 85%。收入的增長主要源於我們正在經歷的對美容程序的新需求水平,以及從 2020 年第三季度報告的較低收入水平中恢復,該水平仍受到 COVID-19 大流行的顯著影響。

  • Our minimally invasive and traditional laser and noninvasive segment grew significantly in comparison to the same period last year. Minimally invasive and subdermal ablative technologies grew 95%, while laser and noninvasive grew 85%.

    與去年同期相比,我們的微創和傳統激光和無創領域增長顯著。微創和皮下消融技術增長了 95%,而激光和無創技術增長了 85%。

  • International sales were on track with the projected growth rate and increased year-over-year as we are successfully duplicating our U.S. growth strategy across these markets. Furthermore, capital equipment accounted for 90% of our revenue with consumables and service revenues representing the remaining 10%.

    隨著我們成功地在這些市場上複製我們的美國增長戰略,國際銷售額與預期的增長率和同比增長保持一致。此外,固定設備占我們收入的 90%,消耗品和服務收入佔剩餘的 10%。

  • GAAP operating expenses in the third quarter of 2021 was $35.2 million, a 30% increase year-over-year. GAAP sales and marketing expenses for the quarter increased 30% compared to the third quarter of 2020. Share-based compensation increased to $3.1 million this quarter compared to $2.4 million in the third quarter of 2020.

    2021 年第三季度的 GAAP 運營費用為 3520 萬美元,同比增長 30%。與 2020 年第三季度相比,本季度的 GAAP 銷售和營銷費用增加了 30%。本季度基於股票的薪酬從 2020 年第三季度的 240 萬美元增加到 310 萬美元。

  • On a non-GAAP basis, operating expenses totaled approximately $32.3 million in the third quarter of 2021 compared to operating expenses of $24.8 million in the same quarter of 2020, an increase of 30%. GAAP operating margin was 47.8% in the third quarter of 2021 compared to 39% in the third quarter of 2020.

    按非公認會計原則計算,2021 年第三季度的營業費用總額約為 3230 萬美元,而 2020 年同期的營業費用為 2480 萬美元,增長了 30%。 2021 年第三季度 GAAP 營業利潤率為 47.8%,而 2020 年第三季度為 39%。

  • Non-GAAP operating margin in the third quarter of 2021 was 51% compared to 43% in the third quarter of 2020. Despite the usual cyclical nature of our industry leading to a slow Q3, our record results can be credited to growing customer demand, global trends, exceptional results achieved by our treatment as well as lower volume of travel relative to pre-COVID era.

    2021 年第三季度非美國通用會計準則營業利潤率為 51%,而 2020 年第三季度為 43%。儘管我們行業通常具有周期性導致第三季度放緩,但我們創紀錄的業績可歸功於客戶需求的增長,全球趨勢、我們的治療取得的非凡成果以及相對於 COVID 之前時代的更少旅行量。

  • In addition, we are successfully managing component shortages in our supply chain through the various distributor and supply network we have established during the pandemic.

    此外,我們通過在大流行期間建立的各種分銷商和供應網絡,成功地管理了供應鏈中的零部件短缺。

  • GAAP diluted earnings per share for the quarter ended September 30, 2021, was $0.52 compared to $0.28 per diluted share in the third quarter of 2020. Non-GAAP diluted earnings per share in the third quarter of 2021 was $0.55 compared to $0.31 per diluted share for the same quarter of 2020.

    截至 2021 年 9 月 30 日的季度,GAAP 攤薄後每股收益為 0.52 美元,而 2020 年第三季度為 0.28 美元2020 年同一季度。

  • I'd like to remind our listeners that we completed a 2-for-1 stock split earlier in the quarter, making our shares more affordable to the investment community, and our employees. We completed the third quarter with a strong balance sheet. As of September 30 of this year, the company had cash and cash equivalents, marketable securities and deposits of $387.4 million. On the cash flow front, the company generated $50.5 million from operating activities for the third quarter of 2021.

    我想提醒我們的聽眾,我們在本季度早些時候完成了 2 比 1 的股票分割,使投資界和我們的員工更能負擔得起我們的股票。我們以強勁的資產負債表完成了第三季度。截至今年 9 月 30 日,該公司擁有現金及現金等價物、有價證券和存款 3.874 億美元。在現金流方面,該公司從 2021 年第三季度的經營活動中產生了 5050 萬美元。

  • I will now hand the call back over to Moshe.

    我現在將電話轉回給 Moshe。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Thanks, Yair. Thanks, Shakil. Operator, we are ready for Q&A.

    謝謝,亞爾。謝謝,沙基爾。接線員,我們準備好進行問答了。

  • Operator

    Operator

  • (Operator Instructions) And the first question comes from Travis Steed with Barclays.

    (操作員說明)第一個問題來自巴克萊銀行的 Travis Steed。

  • Travis Lee Steed - Analyst

    Travis Lee Steed - Analyst

  • When I'm looking at the quarter, it looks like things really shaped up nicely. August-September, you didn't really see as much seasonality as you expected. So curious, if you can kind of comment a little bit on how the quarter shaped up and what you're seeing here and in early October or late October. And curious if you could comment on the growth in your various channels like dermatologists versus med spas, if you're seeing anything different with your different customer base?

    當我看這個季度時,看起來事情真的很好。 8 月至 9 月,您並沒有真正看到預期的季節性。太好奇了,如果你能稍微評論一下這個季度是如何形成的,以及你在這里以及 10 月初或 10 月下旬看到的情況。並且好奇您是否可以評論您的各種渠道(例如皮膚科醫生與醫療水療中心)的增長,如果您看到不同客戶群有什麼不同?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes, let's start -- Travis, this is Moshe. Let's start with the U.S., Shakil will start, and I will complement him.

    是的,讓我們開始吧——特拉維斯,我是摩西。讓我們從美國開始,Shakil 將開始,我將補充他。

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Sure. Yes, Travis hello. So we did -- going to one part of your question, for October we've seen a good start so far. Going to last quarter, we've definitely -- normally, we're used to kind of seasonality. It does affect certain product lines, so -- differently than others, right. So minimally invasive kind of been quite well, and then in our Hands-Free side of things we did see a little bit of pullback, but we expected that in Q3, of course.

    當然。是的,特拉維斯你好。所以我們這樣做了——回答你問題的一部分,到目前為止,我們已經看到了一個良好的開始。到上個季度,我們肯定——通常情況下,我們已經習慣了某種季節性。它確實會影響某些產品線,所以 - 與其他產品線不同,對。因此,微創技術非常好,然後在我們的免提方面,我們確實看到了一些回調,但我們當然預計在第三季度會出現這種情況。

  • So we, obviously, are pretty optimistic about Q4 and where we're going with that. However, in terms of specialties, it's kind of been status quo for a little bit now. What we will be doing as we continue to grow the soft launch of EmpowerRF, obviously, we're going to start focusing -- penetrating on the core markets first like we did with some of our minimally invasive technology, and really build a solid network and support structure around that in order to really create what we like to call staying power for the devices. So that's a little bit of the North American side of things. Moshe, did you want to talk about international?

    因此,顯然,我們對第四季度以及我們的發展方向非常樂觀。然而,就專業而言,它現在有點現狀。隨著我們繼續擴大 EmpowerRF 的軟啟動,我們將做什麼,顯然,我們將開始關注——首先滲透核心市場,就像我們使用一些微創技術所做的那樣,並真正建立一個穩固的網絡並支持圍繞它的結構,以便真正為設備創造我們所謂的持久力。這就是北美方面的一點點。莫舍,你想談國際嗎?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes, yes, yes. Sure, sure. Travis, you know that there are some countries in Europe, for example, that in the third quarter closed operation for at least 6 to 8 weeks, like France, Spain, Italy. And therefore, in these countries most of the business came in September, a little bit in the beginning of July and then from the last week of August, where everybody is coming back to work after vacationing.

    對對對。一定一定。特拉維斯,你知道歐洲有一些國家,例如,在第三季度關閉運營至少 6 到 8 週,如法國、西班牙、意大利。因此,在這些國家/地區,大部分業務都是在 9 月進行的,7 月初有一點點,然後是 8 月的最後一周,每個人都在休假後返回工作崗位。

  • In Asia, I would say that we didn't see any slowdown in the summertime. We had a good quarter with Korea, a good quarter with India, which is now a little bit better from the COVID pandemic there. Australia was mainly on lockdown most of the quarter. So we didn't see much there. China, I would say, one months -- in August-September did very well.

    在亞洲,我想說我們在夏季沒有看到任何放緩。我們在韓國度過了一個不錯的季度,在印度度過了一個不錯的季度,現在從那裡的 COVID 大流行中好一點。澳大利亞本季度大部分時間都處於封鎖狀態。所以我們在那裡沒有看到太多。中國,我會說,一個月——8-9月的表現非常好。

  • In South America, Brazil was in a slowdown, I would say, in July-August, and they started again in September. But if I look on the -- on all the countries outside U.S., which you know, it's something like 71 countries that we sell to, this summertime, this quarter was better than any summertime quarter that I remember. And I'm in this industry, I would say for all the way from ESC and Lumenis for 25 years.

    在南美洲,巴西在 7 月至 8 月處於放緩狀態,而他們在 9 月又開始了。但是,如果我看看美國以外的所有國家,你知道,我們在這個夏天向 71 個國家銷售產品,這個季度比我記得的任何一個夏季季度都要好。我從事這個行業,我會說從 ESC 和 Lumenis 一路走來 25 年。

  • So I don't want to say we were surprised. We believe that this is because we have a different product. Usually, summertime is not the best time to get laser treatment, because you are tanned, you just came from vacation. You don't go to get optical energy on your skin if you don't want to get the burns. But all of our minimally invasive technology, which are color or color-free or, I would say color blind, we saw a little bit more procedures compared to the -- I would say, to the traditional laser treatment. We hope that that will continue.

    所以我不想說我們很驚訝。我們相信這是因為我們有不同的產品。通常,夏季不是接受激光治療的最佳時間,因為你曬黑了,你剛從假期回來。如果您不想燒傷,就不會在皮膚上獲得光能。但是我們所有的微創技術,無論是有色還是無色,或者我會說色盲,與傳統的激光治療相比,我們看到了更多的程序。我們希望這種情況會繼續下去。

  • October started very strong in most of the countries. We see momentum, which we believe will continue in November-December. The last quarter, the fourth quarter is usually the strongest one. Did we answer your question?

    大多數國家的 10 月開局都非常強勁。我們看到了勢頭,我們相信這種勢頭將在 11 月至 12 月持續。最後一個季度,第四季度通常是最強的一個。我們有沒有回答你的問題?

  • Travis Lee Steed - Analyst

    Travis Lee Steed - Analyst

  • That's super helpful detail. My next question is really thinking about next year. It seems like you've got a ton of momentum in the base business. So I would say really no change in that $50 million to $70 million growth that you typically see in the base business. But then thinking through the GYN launch, I'm curious if you could add some color on some of the initial feedback on that. And should we expect something like $20 million for next year incremental from the GYN launch?

    這是超級有用的細節。我的下一個問題是真的在考慮明年。看起來你在基礎業務方面有很大的發展勢頭。所以我想說的是,你通常在基礎業務中看到的 5000 萬到 7000 萬美元的增長確實沒有變化。但是考慮到 GYN 的發布,我很好奇你是否可以在一些最初的反饋上添加一些顏色。我們是否應該期望明年 GYN 的推出會增加 2000 萬美元?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Spero, do you want to talk a little bit about our strategy launching to the gynecology market?

    Spero,您想談談我們在婦科市場推出的戰略嗎?

  • Spero Theodorou - Chief Medical Officer

    Spero Theodorou - Chief Medical Officer

  • Sure, Travis. It's a great question. I think we've seen in the past what's happened with different GYN products, and the competitors in the past, and we certainly don't want to do the same mistake. So we took the path that we took with plastic surgery and dermatology, especially plastic surgery. We took the hardest way and the hardest sort of adopters to convince that our technology is different. And in this case, we're starting off with the urogynecologist, which would be equivalent of the plastic surgeons.

    當然,特拉維斯。這是一個很好的問題。我想我們過去已經看到不同 GYN 產品和過去的競爭對手發生了什麼,我們當然不想犯同樣的錯誤。所以我們走上了整形外科和皮膚科,尤其是整形外科的道路。我們採取了最艱難的方式和最困難的採用者來說服我們的技術是不同的。在這種情況下,我們從泌尿婦科醫生開始,這相當於整形外科醫生。

  • A lot of the offerings that we have, we had to convince them that this is the case. And -- so what we're seeing right now, it's been quite enthusiastic. And so it's going to be a slow ramp in this respect, because we do need to give it credibility. And these are -- this group is probably the group that will -- is actually doing it for us. A lot of our KOLs are in that area.

    我們提供的很多產品,我們必須讓他們相信情況就是如此。而且 - 所以我們現在看到的,它非常熱情。所以在這方面這將是一個緩慢的斜坡,因為我們確實需要賦予它可信度。這些是——這個小組可能是那個小組——實際上是在為我們做這件事。我們的很多 KOL 都在那個領域。

  • As urogynecologist and some of the gynecologists as well start adopting it, it'll move into general GYN and everyone else. So that's how this is different, and this is why we're performing a lot of studies and putting a lot of effort to go with this group, which will take some time, of course, but it's definitely worth in the long run, especially when you want to have staying power. We don't want to market device that goes up 1 year or 2 years, then it goes back down, which has been the norm for -- usually in this industry. And as you've seen, it's not been the case with us. Does that answer your question, Travis?

    隨著泌尿婦科醫生和一些婦科醫生也開始採用它,它將進入一般婦科和其他所有人。所以這就是不同的地方,這就是為什麼我們要進行大量研究並投入大量精力來與這個小組合作,這當然需要一些時間,但從長遠來看絕對值得,尤其是當你想擁有持久力時。我們不希望銷售 1 年或 2 年然後又回落的設備,這通常是這個行業的常態。正如你所看到的,我們的情況並非如此。這能回答你的問題嗎,特拉維斯?

  • Travis Lee Steed - Analyst

    Travis Lee Steed - Analyst

  • It did, yes.

    確實如此,是的。

  • Spero Theodorou - Chief Medical Officer

    Spero Theodorou - Chief Medical Officer

  • This is the first part. And Moshe you can comment on the rest, yes.

    這是第一部分。 Moshe 你可以評論其餘的,是的。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes. I would say that right now, we launched the Empower only in the U.S. We're still working -- getting the regulation approvals in certain other countries, which is in the process. We are submitting our documentation, studies according to any regulatory body. And we have to deal with close to 30 of them worldwide, and it's not approved yet. We believe that starting January, we will launch the product in Europe, probably during IMCAS in Paris, that's the end of January.

    是的。我想說的是,目前,我們僅在美國推出了 Empower。我們仍在努力——在某些其他國家獲得監管批准,該過程正在進行中。我們正在根據任何監管機構提交我們的文件和研究。我們必須在全球範圍內處理其中近 30 個,但尚未獲得批准。我們相信從一月份開始,我們將在歐洲推出該產品,可能是在巴黎的英卡思期間,也就是一月底。

  • So to give you a number, what will be the total revenue for next year, just because this gynecology market is new to us, and just because we want to be very careful with what we claim and indication to the doctors -- and this is according to what Spero said, we're spending a lot of money on studies, and all kind of checking for every indication that we claim. By the way, this is the only system on the market that has a very broad indication approval from the FDA, and we believe we will get it from other regulatory bodies.

    所以給你一個數字,明年的總收入是多少,因為這個婦科市場對我們來說是新的,只是因為我們想要非常小心我們對醫生的要求和指示——這是根據斯佩羅的說法,我們在研究上花了很多錢,並且對我們聲稱的每一個跡象進行了各種檢查。順便說一句,這是市場上唯一獲得 FDA 廣泛適應症批准的系統,我們相信我們會從其他監管機構獲得它。

  • So $20 million sounds reasonable to me. But as we go in November-December, and we will check ourselves as we are educating the market, and learning from the market and arriving on the learning curve with this new product, and other products that we will bring to this category, I will be more, I would say, definite be able to give you some numbers and some focus.

    所以 2000 萬美元對我來說聽起來很合理。但隨著我們在 11 月至 12 月進行,我們會檢查自己,因為我們正在教育市場,向市場學習,並通過這個新產品以及我們將帶來的其他產品進入這個類別的學習曲線,我會更多,我會說,肯定能給你一些數字和一些重點。

  • We're in a very early stage. We have to remember, this product was launched in the last week of August, so basically, we have only 1 month's experience -- only 1 month's experience with this product.

    我們處於非常早期的階段。我們必須記住,這個產品是在八月的最後一周推出的,所以基本上,我們只有 1 個月的經驗——只有 1 個月的這個產品的經驗。

  • Operator

    Operator

  • And the next question comes from Matt Taylor with UBS.

    下一個問題來自瑞銀的馬特泰勒。

  • Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices

    Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices

  • So the first question I wanted to ask you, Moshe was, in the past, you have talked about the scale of the organization and being able to grow. You used to be $50 million in terms of absolute dollars on the top line, and you've talked about some increased numbers in recent months. And obviously, this year you have an easy comp, but you're growing potentially $140 million over last year in 2021. So I just wanted you to frame some thoughts on the scale of the organization, and how much you think you may be able to grow in dollars now with your current size and your products and expansion to international?

    所以我想問你的第一個問題,Moshe,過去,你談到了組織的規模和成長的能力。以絕對收入計算,你曾經是 5000 萬美元,而且你談到最近幾個月的數字有所增加。很明顯,今年你有一個簡單的組合,但到 2021 年,你可能會比去年增長 1.4 億美元。所以我只是想讓你對組織的規模提出一些想法,以及你認為自己能做到多少以您當前的規模和產品以及向國際擴張的方式現在以美元增長?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes. Thank you, Matt, very good question. I would say that in 2020, we grew from $156 million to $206 million, that's about $50 million in 2020. But we all need to remember that, that was a COVID year. I believe that if we want to normalize 2020, I would say that at least $30 million or $35 million from 2021 belong to 2020. So we need to make some kind of an average between 2020 and 2021 to understand what was the real growth.

    是的。謝謝你,馬特,非常好的問題。我想說,到 2020 年,我們從 1.56 億美元增長到 2.06 億美元,到 2020 年大約是 5000 萬美元。但我們都需要記住,那是 COVID 年。我相信,如果我們要讓 2020 年正常化,我會說從 2021 年起至少有 3000 萬美元或 3500 萬美元屬於 2020 年。所以我們需要在 2020 年到 2021 年之間做出某種平均值,以了解真正的增長是多少。

  • But I agree with you. I mean the total growth this year exceeded our expectation. If you remember the first guidance that we gave for 2021 was $250 million to $260 million. And every quarter, we continue to update the guidance according to the performance of the last quarter and what we believe will be the performance of the next quarter.

    但我同意你的看法。我的意思是今年的總增長超出了我們的預期。如果您還記得我們為 2021 年提供的第一個指導是 2.5 億至 2.6 億美元。每個季度,我們都會根據上一季度的表現以及我們認為下一季度的表現繼續更新指引。

  • I mean, 2021 is a great year for us. I would say that maybe because 2020 was a COVID year, and everybody now go to make aesthetic procedures, people call it a Zoom effect, or all kind of other effect that people give a name to this. If you look in the future, 2022 and 2023, I cannot promise that we will continue to grow with $140 million every year. But we see a great momentum in the aesthetic, and we see some good sign in the gynecology, and hopefully in 2022, we will come up with another platform for the medical, more ophthalmology or some others, and continue to develop products for the aesthetic, which we have right now on our R&D pipeline close to 15 products or 15 projects, I would say, to enhance our portfolio.

    我的意思是,2021 年對我們來說是偉大的一年。我想說這可能是因為 2020 年是 COVID 年,現在每個人都去做美容程序,人們稱之為縮放效果,或者人們給它命名的各種其他效果。如果你展望未來,2022 年和 2023 年,我不能保證我們將繼續以每年 1.4 億美元的速度增長。但是我們在美容方面看到了很大的勢頭,我們在婦科方面也看到了一些好的跡象,希望在2022年,我們會拿出另一個醫療平台,更多的眼科或其他,繼續開髮美容產品。 ,我想說,我們目前在研發管道上擁有近 15 個產品或 15 個項目,以增強我們的產品組合。

  • So the total system that we sold up to now was around 10,000 systems out of which 5,000 and a change in the United States and the others in OUS. This is, I would say, very embryonic stage of our business. Since we believe that if we go into all the medical -- business, medical communities that we want to enter in the future, the total available market could reach $200 million, -- 200,000, sorry -- 200,000 clinics. And we will continue to grow, probably much more than $50 million a year. How much? We will give a guidance at the end of this year.

    因此,到目前為止,我們銷售的整個系統大約是 10,000 個系統,其中 5,000 個,在美國發生變化,其他在 OUS。我想說,這是我們業務的萌芽階段。因為我們相信,如果我們進入我們未來想要進入的所有醫療——商業、醫療社區,總可用市場可能達到 2 億美元,——200,000,抱歉——200,000 家診所。我們將繼續增長,每年可能超過 5000 萬美元。多少?我們將在今年年底給予指導。

  • Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices

    Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices

  • I do want to ask a follow-up on the pipeline. Could you talk about ophthalmology and the timing of that, and what the ramp could look like there? You mentioned these 15 projects. Are there any other ones that you could give us some color on in terms of the timing or the composition?

    我確實想詢問有關管道的後續行動。你能談談眼科及其時間安排,以及那裡的坡道會是什麼樣子嗎?你提到了這 15 個項目。在時間或組成方面,您還有其他可以給我們一些顏色的嗎?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • I can tell you what projects we are working on. We're working on 3 projects right now for the aesthetic. We just came with the Transform on the Evolve. We do something similar on the Evoke for the face to enhance our Hands-Free device.

    我可以告訴你我們正在進行哪些項目。我們現在正在為美學設計 3 個項目。我們剛剛推出了 Evolve 上的 Transform。我們在 Evoke 上做了類似的事情來增強我們的免提設備。

  • We're developing product on the ophthalmology for dry eye, which will come probably early next year. We're doing a study now. We are working on ENT platform for snoring, for septal treatment, for turbinate and others. That will be a separate platforms.

    我們正在開髮乾眼症眼科產品,可能會在明年初推出。我們現在正在做一項研究。我們正在開髮用於打鼾、鼻中隔治療、鼻甲等的耳鼻喉平台。那將是一個單獨的平台。

  • We're working on the platforms for erection dysfunction for urology, mainly for men. Plenty of projects. Some of them are new platforms, some of them are handpieces, some of them are new indications. It's a variety.

    我們正在開髮用於泌尿科勃起功能障礙的平台,主要針對男性。很多項目。其中有些是新平台,有些是手機,有些是新適應症。這是一個品種。

  • Operator

    Operator

  • And the next question comes from Kyle Rose of Canaccord Genuity.

    下一個問題來自 Canaccord Genuity 的 Kyle Rose。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • I wanted to just see if we could talk a little bit more about Empower. I mean I realized that it had a small contribution in the quarter, and you've got a controlled launch taking place. But when I just think about what the business looked like several years ago when the gynecology market was still growing, and you guys were launching the Votiva product. Just trying to understand how should we think about the contribution of Empower maybe in the first 12 to 18 months of launch? Can it be what Votiva was on a percentage of sales basis? I'm just trying to understand how we should kind of frame that opportunity given it seems like you might be one of the only companies in the space really investing and launching new technologies here?

    我想看看我們是否可以多談談 Empower。我的意思是我意識到它在本季度的貢獻很小,並且您已經進行了可控的發布。但是當我想到幾年前婦科市場仍在增長時的業務情況時,你們正在推出 Votiva 產品。只是想了解我們應該如何看待 Empower 在發布的前 12 到 18 個月內的貢獻?可以是 Votiva 的銷售額百分比嗎?我只是想了解我們應該如何構建這個機會,因為看起來你可能是該領域唯一真正在這裡投資和推出新技術的公司之一?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Shakil, you want to start?

    沙基爾,你想開始嗎?

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Sure. Hey, Kyle. So I think the way to look at it is, again, I appreciate you noting our controlled kind of release of this product. The one thing we definitely want to do is, as I mentioned before, get it into the right core specialties, the right hands, and make sure that it's doing what it's doing. I think we'll have a better idea probably in the next one to 2 quarters as to what the potential looks like for the longer outlook here.

    當然。嘿,凱爾。所以我認為看待它的方式是,再次感謝您注意到我們對該產品的受控發布。正如我之前提到的,我們絕對想做的一件事是,把它放到正確的核心專業、正確的手中,並確保它正在做它正在做的事情。我認為我們可能會在接下來的一到兩個季度內對這里長期前景的潛力有一個更好的了解。

  • However, we all know what the total addressable market is for this particular segment. And it's a big -- it's a large segment. However, the one thing to note is that typically the women's health and wellness physicians and specialties, they're used to dealing with the insurance. The biggest hiccup that we have in dealing with them is getting them to understand how cash-based procedures work.

    但是,我們都知道這個特定細分市場的總目標市場是多少。這是一個很大的 - 這是一個很大的部分。然而,需要注意的一件事是,通常女性的健康和保健醫生和專業,他們習慣於處理保險。我們在與他們打交道時遇到的最大問題是讓他們了解基於現金的程序是如何運作的。

  • And luckily, we have a ton of experience and a lot of people that have sold in that market over the last 4, 5 years, so I think it gives us a leg up. But before doing anything, we wanted to have enough statistical data that goes behind it, so that we could actually back it up, because when you look at urologists, you are going to call just OB/GYN, they're very, very, very heavy on data. So we're investing the fund and they're doing that, which explains kind of the controlled release. We want to do it right. We want to make sure that if we're offering something for SUI, that's going to work and it's going to change women's lives.

    幸運的是,在過去的 4 到 5 年裡,我們有大量的經驗和很多人在那個市場上賣過東西,所以我認為這給了我們一個幫助。但在做任何事情之前,我們希望有足夠的統計數據支持它,這樣我們才能真正支持它,因為當你看泌尿科醫生時,你只會打電話給 OB/GYN,他們非常非常,非常重視數據。因此,我們正在投資該基金,他們正在這樣做,這解釋了一種受控釋放。我們想把它做好。我們想確保,如果我們為 SUI 提供一些東西,那將會奏效,並且會改變女性的生活。

  • So far, preliminarily, we've seen that. I think we're going to have, as I said, a better idea in the next 1 to 2 quarters as to what the maximum potential is. But we are definitely very, very optimistic as to what the total potential market for this is. Does that make sense?

    到目前為止,我們已經初步看到了這一點。正如我所說,我認為我們將在接下來的 1 到 2 個季度內對最大潛力有一個更好的想法。但我們絕對非常非常樂觀地看待這方面的潛在市場。那有意義嗎?

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • It does. And then I'll just ask my last 2 questions, just kind of at the same time. One, can we get an update just on China and where you stand from a regulatory aspect as far as the number of systems that are approved there? And then secondarily, you've obviously had very strong system sales over the last 24 months? I guess, you've had strong system sales, the entirety of your business. Just trying to understand how we should think about the mix of consumables and service maybe moving forward? I think the service contracts don't kick in until after 12 months, so just trying to understand how that mix might change when we think about 2022 and beyond?

    確實如此。然後我會同時問我最後兩個問題。第一,我們能否獲得有關中國的最新信息,以及您從監管方面的立場,就在那裡批准的系統數量而言?其次,在過去的 24 個月裡,您顯然擁有非常強勁的系統銷售?我猜,您的整個業務都擁有強勁的系統銷售。只是想了解我們應該如何考慮消耗品和服務的組合可能會向前發展?我認為服務合同要到 12 個月後才會生效,所以只是想了解當我們考慮 2022 年及以後時這種組合可能會如何變化?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Okay, let's start with China. Right now, we have 3 products -- the invasive products approved in China. And we expect to get in the first quarter approval for laser IPL, and some noninvasive products, which we submitted to the CFDA something like 8 months ago. The problem with China, they don't give you time line. The CFDA has no commitment. They can come back to you after 3 months and ask questions. They come back to you after 8 months and ask questions. And they don't tell you when they start and when they finish, that's the philosophy of the CFDA. And we have to comply and we have to deal with it.

    好吧,讓我們從中國開始。目前,我們有3種產品——在中國獲批的侵入性產品。我們預計將在第一季度獲得激光 IPL 和一些非侵入性產品的批准,我們大約在 8 個月前向 CFDA 提交了這些產品。中國的問題,他們沒有給你時間線。 CFDA 沒有任何承諾。他們可以在 3 個月後回复您並提出問題。他們會在 8 個月後回复您並提出問題。他們不會告訴你什麼時候開始什麼時候結束,這就是 CFDA 的理念。我們必須遵守,我們必須處理它。

  • We have a team in China today, and we also hired a consultant in order to expedite approvals within the CFDA. The CFDA usually makes it more difficult to foreign companies. But we believe we know how to deal with it, and we will continue to deal. To give you an exact date when we get -- when we will get more approval, I don't know, and I cannot.

    我們今天在中國有一個團隊,我們還聘請了一名顧問來加快 CFDA 的審批。 CFDA 通常會讓外國公司更加困難。但我們相信我們知道如何處理它,我們將繼續處理它。給你一個確切的日期——什麼時候我們會得到更多的批准,我不知道,我也不知道。

  • But even with those 3 categories that right now are cleared in China, the market is growing and we're doing well. I believe that we're -- now we're doing about $2 million, $2.5 million a quarter. Hopefully, next year, we will go to $4 million a quarter on average between the fourth quarter, that's my estimate.

    但即使這三個類別目前在中國被清除,市場也在增長,我們做得很好。我相信我們 - 現在我們每季度的收入約為 200 萬美元,250 萬美元。希望明年,我們將在第四季度之間平均每季度達到 400 萬美元,這是我的估計。

  • Now, regarding the numbers of systems that we sold, in the last quarter, we sold 1,200 systems worldwide, 100 more than the second quarter. Disposable we sold 91,000 compared to 92,000 on the second quarter. And I already mentioned that the summertime usually is slower as far as treatment by at least 10% to 15%. So the fact that we did exactly the same number -- almost exactly the same number as Q2 is a good sign for us. And this is about, I would say around 70% growth in disposable compared to last year -- to the same period last year. So the disposable are growing faster than the system that we sell on an average -- not quarter -- on an average per quarter. So this is also a good sign for us.

    現在,關於我們銷售的系統數量,上一季度我們在全球銷售了 1,200 台系統,比第二季度增加了 100 台。一次性我們售出 91,000 個,而第二季度為 92,000 個。而且我已經提到,就治療而言,夏季通常要慢至少 10% 到 15%。因此,我們做了完全相同的數字 - 幾乎與第二季度完全相同的數字這一事實對我們來說是一個好兆頭。我想說的是,與去年同期相比,一次性用品的增長率約為 70%。因此,一次性用品的增長速度超過了我們平均每季度銷售的系統——而不是季度——的平均增長速度。所以這對我們來說也是一個好兆頭。

  • Another thing I wanted to say, the Empower -- the Empower platform has 3 different disposable or even 4 different disposable, the VTone, the Morpheus8V, the FormaV and the AVIVA. All of them are one-time use. So it depends what treatment the doctor is doing on a patient, but at least in every treatment, he will use 1 or 2 disposable, and this is good, because that will enlarge the numbers of disposable that we will sell.

    我想說的另一件事是 Empower——Empower 平台有 3 種不同的一次性甚至 4 種不同的一次性,VTone、Morpheus8V、FormaV 和 AVIVA。所有這些都是一次性使用。因此,這取決於醫生對患者進行的治療,但至少在每次治療中,他將使用 1 或 2 個一次性用品,這很好,因為這會增加我們將出售的一次性用品的數量。

  • Almost every system that we are now developing will have at least one disposable. So the disposable number right now is, between, 10% to 11%, depending on the quarter. I assume that once the installed base of platforms will reach 20,000 platforms worldwide, the numbers of disposable will probably go to, I would say between, 15% to 18% of the total revenue. Does that answer your question?

    幾乎我們現在正在開發的每一個系統都至少有一個一次性的。因此,現在的一次性數量在 10% 到 11% 之間,具體取決於季度。我假設一旦平台的安裝基礎將達到全球 20,000 個平台,一次性的數量可能會達到總收入的 15% 到 18% 之間。這是否回答你的問題?

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • It does.

    確實如此。

  • Operator

    Operator

  • And the next question comes from Mike Matson with Needham & Company.

    下一個問題來自 Needham & Company 的 Mike Matson。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • I guess, I'll start with the international business. You mentioned you were looking at opening a subsidiary in a major European country. Just wondering if you could provide more detail on that? And can you talk about kind of the financial implications of doing that?

    我想,我將從國際業務開始。您提到您正在考慮在歐洲主要國家開設子公司。只是想知道您是否可以提供更多詳細信息?你能談談這樣做的財務影響嗎?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes, yes, of course, of course. Well, I don't want to mention the name of the country, but it's one of the biggest. Right now, we have Spain, U.K. and France. And we have distributors in Italy and distributor in Germany. Probably, we will go and establish a subsidiary in one of those 2, and that we'll start operation in the beginning.

    是的,是的,當然,當然。好吧,我不想提這個國家的名字,但它是最大的國家之一。現在,我們有西班牙、英國和法國。我們在意大利有經銷商,在德國有經銷商。可能,我們會去在其中一個建立子公司,然後我們將開始運營。

  • We already hired the team. We are now training the team. The team was trained in Europe, and probably will come to Israel to train in more detail on every system. The team consists of a manager, 2 sales manager, one clinical manager, and one admin. We are looking for a space to operate from. This all will be done in the next 2 months. So we would like to start January 1, afresh in the country and we will work.

    我們已經聘請了團隊。我們現在正在訓練球隊。該團隊在歐洲接受過培訓,並且可能會來以色列對每個系統進行更詳細的培訓。該團隊由一名經理、兩名銷售經理、一名臨床經理和一名管理人員組成。我們正在尋找一個可以操作的空間。這一切都將在未來 2 個月內完成。所以我們想從 1 月 1 日開始,在這個國家重新開始,我們會努力的。

  • When we sell direct, we get close to the doctor or to the customers. We know what the customer wants, and we don't need to depend on the loyalty of the distributors. Around 81% of our sales today worldwide are direct. And this is done in -- we have 2 subsidiaries in North America. Currently, 3 subsidiaries in Europe, and 2 subsidiaries in Asia, Australia and India. So currently, we are finishing the -- to establish a subsidiary in China, and also an additional country in Europe. So next year, we'll have 9 subsidiaries. And that will probably increase the percentage of what we sell direct compared to indirect.

    當我們直接銷售時,我們會接近醫生或客戶。我們知道客戶想要什麼,我們不需要依賴分銷商的忠誠度。今天,我們全球約 81% 的銷售是直接銷售。這是在 - 我們在北美有 2 家子公司。目前在歐洲有3家子公司,在亞洲、澳大利亞和印度有2家子公司。所以目前,我們正在完成——在中國建立一個子公司,並在歐洲建立一個額外的國家。所以明年,我們將擁有 9 家子公司。與間接相比,這可能會增加我們直接銷售的百分比。

  • When we sell direct, we recognize the full value. We know what the doctor want. We service him better. And I have to say another thing, doctors in every country would like to buy from the company and not from distributors, we realized that, because the distributors one day he work for you, and one day he go to another company, and they want to have redundancy. So this is the plan. Do you want more detail, Matt?

    當我們直接銷售時,我們會認識到全部價值。我們知道醫生想要什麼。我們更好地為他服務。我不得不說另一件事,每個國家的醫生都想從公司而不是經銷商那裡購買,我們意識到,因為經銷商有一天他為你工作,有一天他去另一家公司,他們想要有冗餘。所以這是計劃。你想要更多細節嗎,馬特?

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • No, no, that was great. That's great. And then just wanted to ask on EmpowerRF. So just -- I understand it's early days of the launch here, but what are you seeing in terms of the different handpieces and options there? Is it -- what's the most popular handpiece? And is it really being driven primarily by the SUI option?

    不,不,那太好了。那太棒了。然後只是想問一下 EmpowerRF。所以只是 - 我知道這是在這裡發布的早期階段,但你對那裡的不同手機和選項有什麼看法?是不是——最受歡迎的手機是什麼?它真的主要由 SUI 選項驅動嗎?

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Yes. I'll hand it over to Spero, one second Moshe.

    是的。我會把它交給 Spero,一秒鐘的 Moshe。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Okay. Go ahead. Sorry.

    好的。前進。對不起。

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Yes. No, problem. From the commercial aspect, we only really have a month to judge it on, and it's a really small sample size. Of course, it's a little tough to really figure out things like I said earlier, it's probably going to take us at least 3 to 6 months to get an idea of what the patterns are.

    是的。沒問題。從商業方面來看,我們真的只有一個月的時間來判斷它,而且樣本量非常小。當然,要像我之前所說的那樣真正弄清楚事情有點困難,我們可能需要至少 3 到 6 個月的時間才能了解這些模式是什麼。

  • From an interest level though, SUI is something that's very, very popular and common and something that's -- there's not a major solution for. So we do have a lot of excitement. But as I mentioned before, we want to make sure that we have significant clinical data behind it so that we can live up to what we're promising.

    不過,從興趣層面來看,SUI 是非常、非常流行和常見的東西,而且是 - 沒有主要的解決方案。所以我們確實有很多興奮。但正如我之前提到的,我們希望確保我們擁有重要的臨床數據,這樣我們才能實現我們的承諾。

  • So, I do think that the VTone handpiece and the MorpheusV, are going to be significant drivers in terms of what's on the workstation itself. From more of the clinical side, and the physician's perspective, I'll hand it over to Spero.

    所以,我確實認為 VTone 手機和 MorpheusV 將成為工作站本身的重要驅動因素。從更多的臨床方面和醫生的角度來看,我會把它交給斯佩羅。

  • Spero Theodorou - Chief Medical Officer

    Spero Theodorou - Chief Medical Officer

  • Thank you, Shak. That's a great question. Within the gynecology, and urogynecology world, right, everyone has a certain category and focus on what they're interested in. So when we talk to the urogynecologists, the whole fact about the intravaginal microneedling is a novel treatment. It's something that we've patented, and that's causing a lot of the excitement initially so far what we've seen.

    謝謝你,沙克。這是一個很好的問題。在婦科和泌尿婦科領域,對,每個人都有特定的類別並專注於他們感興趣的東西。所以當我們與泌尿婦科醫生交談時,關於陰道內微針的整個事實是一種新穎的治療方法。這是我們已經獲得專利的東西,到目前為止,這引起了我們所看到的很多興奮。

  • When we go over to gynecologists who are working still and delivering -- or even OBs who are delivery babies, and they're very excited about the ability to treat women right after delivery, which includes all aspects of this, right. It includes VTone for public floor rehabilitation. In addition to our EMS device for diastasis closure and they're looking at selling it as a packet to the patients after postpartum. So this is very, very unique. This has never been done before to actually be able to offer comprehensive postpartum solution. So for the doctors that are doing a lot of OB and looking at this very differently.

    當我們轉向仍在工作和分娩的婦科醫生——甚至是正在分娩的產科醫師時,他們對分娩後立即治療女性的能力感到非常興奮,這包括所有方面,對吧。它包括用於公共地板修復的 VTone。除了我們用於舒張閉合的 EMS 設備外,他們還考慮在產後將其作為包裝出售給患者。所以這是非常非常獨特的。這是以前從未做過的,實際上能夠提供全面的產後解決方案。因此,對於進行大量 OB 並以非常不同的方式看待這一點的醫生。

  • So within -- however, globally, when you look at all these groups, everyone has a solution for something. So whether you're urogynecologists or general gynecologists, whether you do a combination of both treatments, this platform has such versatility that it offers a different things that you can do.

    因此,在全球範圍內,當您查看所有這些組時,每個人都有解決方案。因此,無論您是泌尿婦科醫生還是普通婦科醫生,無論您是同時進行這兩種治療,該平台都具有多功能性,它提供了您可以做的不同事情。

  • In addition, let's not forget, right, we're an aesthetics company, and we're introducing aesthetics into this category through that. So holding their hand initially. Here is a medical indication, here is where existing population of patients that you have. And by the way, here is they can also enter the cash-based business, which is aesthetics. So typical, this is our philosophy, how we move into these different categories.

    此外,我們不要忘記,對,我們是一家美學公司,我們正在通過它將美學引入這個類別。所以最初握著他們的手。這是一個醫學指徵,這裡是您現有的患者群體。順便說一句,他們也可以進入以現金為基礎的業務,這就是美學。如此典型,這是我們的理念,我們如何進入這些不同的類別。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • And then my final question is really just on the supply chain. So obviously, demand appears to be really strong in your business. But one thing that I worry a little bit about is that we're just going to see an announcement one day that you had some kind of shortage in terms of semiconductors or some other component -- your products, and so I just wanted to kind of gauge your confidence level, and your ability to meet this tremendous growth that you're seeing -- volume growth that you're seeing in your business, given everything that's happening out there in the supply chain.

    然後我的最後一個問題實際上只是關於供應鏈。很明顯,您的業務需求似乎非常強勁。但我有點擔心的一件事是,有一天我們會看到一個公告,說你們在半導體或其他一些組件方面存在某種短缺——你們的產品,所以我只是想說明一下衡量您的信心水平,以及您滿足您所看到的這種巨大增長的能力 - 考慮到供應鏈中發生的一切,您在業務中看到的數量增長。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Yes, as far as supply chain and logistic, you're absolutely right, Matt. We are seeing a lot of, I would say, companies that we used to get component in 4 weeks, today, we get delivery time of 14 weeks. So basically, I don't know if you noticed our inventory grew a little bit, because we don't want to take any chance of shortage, and we buy from everyone that can supply us.

    是的,就供應鍊和物流而言,你是絕對正確的,馬特。我們看到很多,我想說,我們過去在 4 週內獲得組件的公司,今天,我們的交貨時間是 14 週。所以基本上,我不知道你是否注意到我們的庫存增加了一點,因為我們不想冒任何短缺的機會,我們從每個可以供應我們的人那裡購買。

  • On every component, and subassembly that we use in our manufacturing line, we have at least -- at least 2 suppliers and in most of them, 3 suppliers. We buy components from China, U.S., Europe. We buy from different territories. As far as manufacturing capacity, currently, we have manufacturing capacity to 2,500 systems, 100 platforms per quarter, which is -- and today, we're using only 50% of it, but we've prepared ourselves for the future.

    在我們在生產線上使用的每個組件和子組件上,我們至少有 - 至少 2 個供應商,其中大多數是 3 個供應商。我們從中國、美國、歐洲購買零部件。我們從不同的地區購買。就製造能力而言,目前,我們每季度擁有 2,500 個系統和 100 個平台的製造能力——而今天,我們只使用了其中的 50%,但我們已經為未來做好了準備。

  • I mean, unlike some of our competitors, we've delivered everything -- everything in the third quarter according to the plan and according to the orders. No one waited more than, I would say, 10 days before we got the order either at distributors or at doctor, and we will continue to watch it. We have a special engineering department that established and built here. That the only thing they do is to check on alternative component whenever we have a problem with one component or one supplier.

    我的意思是,與我們的一些競爭對手不同,我們已經按照計劃和訂單在第三季度交付了所有東西。我想說,在我們從分銷商或醫生那裡得到訂單之前,沒有人等了超過 10 天,我們將繼續觀察它。我們有一個專門的工程部門在這裡建立和建造。他們唯一要做的就是在我們遇到一個組件或一個供應商問題時檢查替代組件。

  • So we do it all the time, and this is the major, I would say, effort in our part. In Israel, everything is manufacturing in Israel and shipping from here. One issue we have with the shipping and the logistic, the prices of sending either by sea or by air in the last year went up 4x and this is why right now we're shipping mainly in containers, and not by air in order to save money. All this is done in order to maintain the 85% gross margin, which, for us, as I said before, it's a must. It's not nice to have.

    所以我們一直都在這樣做,我想說,這是我們的主要努力。在以色列,一切都在以色列製造並從這裡發貨。我們在運輸和物流方面遇到的一個問題是,去年海運或空運的價格上漲了 4 倍,這就是為什麼我們現在主要用集裝箱運輸,而不是空運,以節省成本錢。所有這些都是為了保持 85% 的毛利率,正如我之前所說,這對我們來說是必須的。擁有它並不好。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • And just the container comment, I'm hearing a lot about ports being backed up and things like that. So you're not worried about these things getting stuck in a container somewhere on a boat, floating around, waiting to get in a port or in a back of an 18-wheeler or somewhere?

    就容器評論而言,我聽到了很多關於備份端口之類的事情。所以你不擔心這些東西會卡在船上某個地方的容器裡,四處漂浮,等待進入港口或 18 輪車的後部或其他地方嗎?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • No, we are not worried. But you know, you never know what will happen. Hopefully, people learn to live with the pandemic and everything will go back to normal in the next year. It will not take months. It will take at least a full year until everything from a manufacturing, from the supply chain will go back to normal. But we have prepared ourselves very well to this time, and I believe we are coping with that in the right way.

    不,我們不擔心。但你知道,你永遠不知道會發生什麼。希望人們學會與大流行一起生活,明年一切都會恢復正常。這不會需要幾個月的時間。至少需要一整年的時間,從製造到供應鏈的一切都恢復正常。但是我們已經為這次做好了充分的準備,我相信我們正在以正確的方式應對。

  • Operator

    Operator

  • And the next question comes from Jeff Johnson with Baird.

    下一個問題來自 Jeff Johnson 和 Baird。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • Moshe, it's not too dissimilar from a question I've asked in the past. But I'd be interested in the quarter, in the U.S., what percentage of your revenues or even qualitatively if you can talk about what -- how many of the systems of the handpieces of the platforms that were sold in the U.S. during the quarter went into current customers. So they were buying a second, or third, or fourth handpiece or a system or -- versus how many went into brand new accounts? Just trying to understand penetration and where we are on kind of penetration in the U.S. of the derm and the plastic side of the market?

    Moshe,這與我過去提出的問題並沒有太大的不同。但我對這個季度感興趣進入現有客戶。所以他們購買了第二個、第三個或第四個手機或系統,或者 - 有多少進入了全新的賬戶?只是想了解滲透率以及我們在美國市場的真皮和塑料方面的滲透率如何?

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Shakil, could you please answer that?

    沙基爾,你能回答一下嗎?

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Yes, sure. Jeff, so yes, we -- unfortunately, in some ways, we're not the type of company that has -- that -- it's not going to be like a Stryker or something where you have these relationships type of sales per se, meaning that you just go in and sell something every month, every quarter or anything like that, right. These are 6 figure devices. We definitely do go after our existing customers, but we do it once we know that they're successful, right. So it's a lot easier for them to reinvest in what we have. And because of our robust pipeline, we always have something new that's coming out, and you keep them kind of excited.

    是的,當然。傑夫,所以是的,我們 - 不幸的是,在某些方面,我們不是那種擁有 - 那 - 它不會像 Stryker 或你擁有這些關係類型的銷售本身的公司,這意味著您每個月,每個季度或類似的東西都進去賣東西,對。這些是 6 位數的設備。我們肯定會追求現有客戶,但一旦我們知道他們成功了,我們就會這樣做,對吧。因此,他們更容易對我們擁有的東西進行再投資。而且由於我們強大的管道,我們總是有新的東西出來,你讓他們有點興奮。

  • But our first task is to definitely get them so that they are successful, right, so it kind of starts with that. In terms of what we're doing percentage-wise, I don't want to give you anything that I'm not 100% certain of, but majority of our business is new business. So although, we have a lot of existing customers who have purchased different devices, I know earlier on, I talked about some of our workshops and we've seen some record attendance, and things like that, we have a good mix of existing customers and new customers.

    但我們的首要任務是肯定地讓他們成功,對,所以從那開始。就我們所做的百分比而言,我不想給你任何我不是 100% 確定的東西,但我們的大部分業務都是新業務。因此,儘管我們有很多現有客戶購買了不同的設備,但我之前知道,我談到了我們的一些研討會,我們已經看到了一些創紀錄的出席人數,諸如此類,我們擁有很好的現有客戶組合和新客戶。

  • However, what I do feel, as Spero even mentioned talking about Empower, as we get a lot of these specialties into doing things they're not used to doing, so we're going after the women's health and wellness. They already have some -- a large degree of -- or a large audience, I should say, have been captive patient base that they can now start talking about that too. While, a lot of those patients are getting cosmetic and aesthetic procedures done elsewhere.

    然而,我的感覺是,正如 Spero 甚至提到談論 Empower 一樣,因為我們讓很多這些專業從事他們不習慣做的事情,所以我們正在追求女性的健康和保健。我應該說,他們已經有一些 - 很大程度 - 或大量觀眾是俘虜的患者群,他們現在也可以開始談論這個問題了。同時,其中許多患者正在其他地方進行美容和美容手術。

  • So the idea is getting used to starting to charge cash pay for these procedures and then slowly be able to help them kind of do that on the cosmetics side. So I know it's not an exact answer that you're looking for, but I do see a lot of our business in North America being to newer customers. Although, we do still have a very good existing customer base. But the main thing for us is we want to make sure that they succeed first, and then it's so much easier for our sales force to go in and talk to them about new technology. Does that make sense?

    所以這個想法是習慣於開始對這些程序收取現金支付,然後慢慢地能夠幫助他們在化妝品方面做到這一點。所以我知道這不是您正在尋找的確切答案,但我確實看到我們在北美的很多業務都是針對新客戶的。儘管如此,我們仍然擁有非常好的現有客戶群。但對我們來說,最重要的是我們要確保他們首先取得成功,然後我們的銷售人員就更容易進入並與他們討論新技術。那有意義嗎?

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • Yes, it does. And maybe to follow-up…

    是的,它確實。也許要跟進……

  • Yair Malca - CFO

    Yair Malca - CFO

  • Jeff, this is Yair, just to complement what Shakil said. I can tell you that at least in the U.S., over 70% of our sales this year were to new customers. So as Shakil mentioned, most of our revenue is still coming from new customers.

    Jeff,這是 Yair,只是為了補充 Shakil 所說的話。我可以告訴你,至少在美國,我們今年超過 70% 的銷售額來自新客戶。所以正如 Shakil 提到的,我們的大部分收入仍然來自新客戶。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • That's helpful. Thank you, Yair. And then, I guess, a follow-up to that, and it's kind of is an international question as well. Should we think then that Evolve and Evoke didn't necessarily go into customers who own an AccuTite, BodyTite platform that those procedure or those products were going more into med spas things like that?

    這很有幫助。謝謝你,亞爾。然後,我想,這是一個後續行動,這也是一個國際問題。那麼我們是否應該認為 Evolve 和 Evoke 不一定會進入擁有 AccuTite、BodyTite 平台的客戶,而這些程序或那些產品更多地進入了類似的醫療水療中心?

  • And Moshe, you mentioned in China getting IPL and Hands-Free potentially next year. Does that move you in China into med spas, whereas right now with the other MIRF platforms, you've been more focused on the physician, hospitals category more so? I'm just trying to understand, one, does Evolve, Evoke -- are you doing well on the med spa side with some of those Hands-Free technologies? And in China, is the opportunity to go into Hands-Free and IPL opening a new door that you're not necessarily in right now with the MIRF platform.

    還有 Moshe,你提到中國可能會在明年獲得 IPL 和免提。這是否會讓您在中國進入醫療水療中心,而現在使用其他 MIRF 平台,您更專注於醫生、醫院類別?我只是想了解,一個,Evolve,Evoke - 你在醫療水療方面做得很好嗎?在中國,這是進入免提和 IPL 的機會,打開了一扇新的大門,您現在不一定要使用 MIRF 平台。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Well, let me answer you regarding China. Shakil will answer you about the med spa in North America. By the way, the Evoke and Evolve were introduced in the OUS only this year. And we're now just getting the first, I would say, approvals in certain countries. It's already been approved in Europe, but not in Asia yet and not in China.

    好吧,讓我來回答你關於中國的問題。 Shakil 將為您解答有關北美 med spa 的問題。順便說一句,Evoke 和 Evolve 僅在今年才在 OUS 中推出。我想說,我們現在剛剛在某些國家獲得了第一個批准。它已經在歐洲獲得批准,但尚未在亞洲和中國獲得批准。

  • The market in China, you're absolutely right, is if you want to categorize it, you have the hospital, the private clinics, and what they call the spa market, which is the biggest. The spa market is all the way from small shops to well-organized spa market -- spa chains.

    中國的市場,你說的很對,如果你要分類的話,有醫院,有私人診所,還有他們所說的水療市場,這是最大的。水療市場從小商店一直到井井有條的水療市場——水療連鎖店。

  • Yes, definitely. Once we get the approval for the Hands-Free devices in China, we will go to the spa market. We can also go to the doctors -- to the doctor clinics and sell them -- plastic surgeons and dermatologists, which are now become something very popular in China. It used to be only in the hospital. But right now, they are private clinics as well. Definitely, we will go to the spa market and also to those customers. Shakil, you want to say something about North America?

    當然是。一旦我們在中國獲得免提設備的批准,我們將進入水療市場。我們也可以去找醫生——去醫生診所,賣給他們——整形外科醫生和皮膚科醫生,這些現在在中國很受歡迎。以前只在醫院。但現在,它們也是私人診所。當然,我們會去水療市場和那些客戶。 Shakil,你想談談北美嗎?

  • Shakil Lakhani - President of North America

    Shakil Lakhani - President of North America

  • Yes sure, absolutely. So I think we've always kind of penetrated the market going after physicians, specifically. The Hands-Free technology does allow us into the med spa side of things, and we do some med spa of that add, obviously medical directors and certain physicians that can finance it. So that's the other thing. We're always going to be medical. So if it's medical spa -- the actual spa market itself, it's really tough to get people financed, and things of that nature when you're looking at just the spa market, right. And it's tough for a lot of those smaller places to afford it.

    是的,絕對的。所以我認為我們一直在進入市場,特別是在追逐醫生。免提技術確實讓我們進入了醫療水療方面,我們做了一些醫療水療,顯然醫療主任和某些可以資助它的醫生。所以這是另一回事。我們總是要醫療。因此,如果它是醫療水療——實際的水療市場本身,很難讓人們獲得資金,而當你只關注水療市場時,這種性質的事情,對吧。對於很多小地方來說,很難負擔得起。

  • So a lot of our focus is on the medical professionals. But in terms of the med spas yes, I mean, the Hands-Free technologies are applicable to them. But also as you asked, with someone who has AccuTite or BodyTite or FaceTite, or whatever it is, just remember that the Hands-Free technology is kind of set it and forget it, right? So you're able to delegate that, so you could have that one patient room generating a bunch of revenue for the office, while the physician is still out there doing their AccuTite or BodyTite or whatever it is, right.

    因此,我們的很多重點都放在了醫療專業人員上。但就醫療水療中心而言,是的,我的意思是,免提技術適用於他們。但正如您所問的,對於擁有 AccuTite、BodyTite 或 FaceTite 或其他任何東西的人,請記住免提技術是一種設置並忘記它的人,對吧?所以你可以委派它,這樣你就可以讓那個病房為辦公室帶來一大筆收入,而醫生還在外面做他們的 AccuTite 或 BodyTite 或其他任何東西,對吧。

  • So we do have the passive income side of things from the hands-free while they can still keep doing what they're doing, if they are using different technologies. So I think as far as the Hands-Free goes, I don't think we've really scratched the surface yet. Hands-Free is not new as we know with some of our former competitors and things like that. I do think that our offering is a lot more unique than anything else that's come into the marketplace between the Evoke and EvolveX and the things that we have -- that we're working on those platforms.

    因此,我們確實從免提設備中獲得了被動收入的一面,而如果他們使用不同的技術,他們仍然可以繼續做他們正在做的事情。所以我認為就免提設備而言,我認為我們還沒有真正觸及表面。正如我們之前的一些競爭對手所知道的那樣,免提並不是什麼新鮮事。我確實認為,我們的產品比 Evoke 和 EvolveX 以及我們擁有的東西(我們正在這些平台上工作)之間進入市場的任何其他產品都要獨特得多。

  • Operator

    Operator

  • And this concludes the question-and-answer session. I would like to turn the call to Moshe Mizrahy, Chairman and CEO, for closing comments.

    問答環節到此結束。我想將電話轉給董事長兼首席執行官 Moshe Mizrahy,以發表結束評論。

  • Moshe Mizrahy - Chairman & CEO

    Moshe Mizrahy - Chairman & CEO

  • Okay. Thank you, operator. Again, thanks everybody, for joining us today. I want also to express thanks to all of our employees worldwide. I'm sure that some of them are on the line. We had a very successful quarter, but a very tough one. We work very hard on the logistics, on the manufacturing, sales, marketing, support, training, and I believe as a team, we did a very good job. And we will continue the momentum for the benefit of the employees, all the stakeholders and the shareholders. Thank you, everybody. Bye, bye.

    好的。謝謝你,接線員。再次感謝大家今天加入我們。我還要感謝我們在全球範圍內的所有員工。我敢肯定他們中的一些人已經上線了。我們有一個非常成功的季度,但也非常艱難。我們在物流、製造、銷售、營銷、支持、培訓方面非常努力,我相信作為一個團隊,我們做得非常好。為了員工、所有利益相關者和股東的利益,我們將繼續保持這種勢頭。謝謝大家。再見。

  • Operator

    Operator

  • Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

    謝謝你。會議現已結束。感謝您參加今天的演講。您現在可以斷開線路。