Establishment Labs Holdings Inc (ESTA) 2023 Q1 法說會逐字稿

Good afternoon, and welcome to Establishment Labs' First Quarter 2023 Earnings Call. (Operator Instructions) As a reminder, today's call is being recorded.

下午好，歡迎來到 Establishment Labs 的 2023 年第一季度收益電話會議。 （操作員說明）提醒一下，今天的通話正在錄音中。

I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go ahead, Raj.

我現在將電話轉給首席財務官 Raj Denhoy。請繼續，拉吉。

Thank you, operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacon Quiros, Our Chief Executive Officer. Following our prepared remarks, we'll take your questions.

謝謝接線員，也謝謝大家加入我們。今天和我在一起的是我們的首席執行官 Juan Jose Chacon Quiros。在我們準備好的評論之後，我們將回答您的問題。

Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements withing the meaning of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales.

在我們開始之前，我想提醒您，管理層在本次電話會議中發表的評論將包括符合聯邦證券法含義的前瞻性陳述。其中包括關於 Establishment Labs 財務前景的聲明以及公司產品開發和銷售的計劃和時間安排。

These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q as well as other SEC filings, which are available on our website at establishmentlabs.com.

這些前瞻性陳述基於管理層當前的預期，涉及風險和不確定性。為了討論可能影響我們的業績或導致實際結果與這些陳述存在重大差異的主要風險因素和不確定性，我鼓勵您查看我們最近的 10-K 表格和 10-Q 表格年度和季度報告與其他 SEC 文件一樣，可在我們的網站 establishmentlabs.com 上找到。

I'd also like to remind you that our comments will include certain non-GAAP financial measures with respect to our performance, including but not limited to sales results, which can be stated on a constant currency basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website.

我還想提醒您，我們的評論將包括與我們業績相關的某些非 GAAP 財務指標，包括但不限於銷售業績，這些業績可以按固定匯率計算。可在今天的新聞稿中找到與最直接可比的 GAAP 財務指標的對賬，該新聞稿可在我們的網站上獲取。

Please also note that Establishment Labs received an investigational device exemption from the FDA for Motiva implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authorities for specific product availability.

另請注意，Establishment Labs 獲得了 FDA 對 Motiva 植入物的研究設備豁免，並且正在進行臨床試驗以支持美國的監管批准。我們不斷尋求擴大我們的產品獲得監管批准的地區。請與您當地的主管部門核實具體產品的可用性。

The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, May 8, 2023. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statements to reflect events or circumstances after the date of this call.

本次電話會議的內容包含僅截至本次直播之日 2023 年 5 月 8 日準確的時效信息。除法律要求外，Establishment Labs 不承擔修改或以其他方式更新任何聲明以反映事件或情況的義務在這次通話的日期之後。

With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

因此，我很高興將電話轉給我們的首席執行官胡安何塞。

Thank you, Raj, and good afternoon, everyone. Revenue in the first quarter of 2023 totaled $46.5 million, a 21% increase over the first quarter of 2022 and a new quarterly record for our company. Excluding the negative impact of foreign currency changes, our growth in the first quarter would have been approximately 22.9%. Our revenue guidance for 2023 remains unchanged at $200 million to $210 million, representing growth of 24% to 30% over 2022. Raj will provide additional details on our first quarter performance and our outlook in a moment.

謝謝你，Raj，大家下午好。 2023 年第一季度的收入總計 4650 萬美元，比 2022 年第一季度增長 21%，創下了我們公司的季度新紀錄。排除外匯變動的負面影響，我們第一季度的增長率約為 22.9%。我們對 2023 年的收入指引保持在 2 億美元至 2.1 億美元不變，比 2022 年增長 24% 至 30%。Raj 稍後將提供有關我們第一季度業績和展望的更多詳細信息。

The last few weeks have seen a number of significant events at Establishment Labs. On March 29, we announced that we have 3 million Motiva devices in market. This is an important event, not only because of the scale we have achieved in markets since we began commercialization over 12 years ago, but also because of the exceedingly positive outcomes we have achieved with such a large number of devices. Just like we do every year, we recently released to the scientific community our post-market surveillance report, which includes data from independent national registries, all consistently showing less than 1% device-related complications.

過去幾週，Establishment Labs 發生了許多重大事件。 3 月 29 日，我們宣布市場上有 300 萬台 Motiva 設備。這是一個重要的事件，不僅因為我們在 12 年前開始商業化以來在市場上取得的規模，還因為我們使用如此大量的設備取得了極其積極的成果。正如我們每年所做的那樣，我們最近向科學界發布了我們的上市後監測報告，其中包括來自獨立國家登記處的數據，所有這些數據始終顯示與設備相關的並發症低於 1%。

These excellent results were corroborated and expanded upon when the 3-year data from our Motiva U.S. IDE study was presented at The Aesthetic Meeting on April 20. Dr. Caroline Glicksman, the principal investigator of the study, provided an update following the aesthetic cohort passing the 3-year endpoint in the trial. What is particularly notable about the results is that the rates of the major device related complications of capsular contracture rupture did not change from year 2 to year 3. There continue to be only 2 patients with capsular contracture and only 1 patient with a suspected rupture at 3 years, which was the exact same number at 2 years.

我們的 Motiva U.S.IDE 研究的 3 年數據於 4 月 20 日在美學會議上公佈時，這些出色的結果得到了證實和擴展。該研究的首席研究員 Caroline Glicksman 博士在美學隊列通過後提供了更新試驗中的 3 年終點。結果特別值得注意的是，從第 2 年到第 3 年，包膜攣縮破裂的主要器械相關並發症的發生率沒有變化。 3 年，與 2 年時的數字完全相同。

Beyond the rates themselves being quite low and much lower than it has ever been seen in a major trial like this, the consistency of the results from year 2 to year 3 are very encouraging and starting to create a lot of positive buzz in our industry. U.S. plastic surgeons are now asking the most important question: When will Motiva be available in the United States? And while we can't give them a definitive answer, we can tell them that our final module of our PMA was submitted to the FDA in the first quarter, and the full PMA has now been accepted and is under review by the agency.

除了利率本身非常低，而且遠低於像這樣的大型試驗中的任何一次，第 2 年到第 3 年結果的一致性非常令人鼓舞，並開始在我們的行業中產生很多積極的影響。美國整形外科醫生現在提出了最重要的問題：Motiva 什麼時候可以在美國上市？雖然我們不能給他們一個明確的答案，但我們可以告訴他們，我們的 PMA 最終模塊已在第一季度提交給 FDA，現在完整的 PMA 已經被該機構接受並正在審查中。

Of course, with so many catalysts in the near future, how we are going to fund our growth is always an important question. We answered this, to a large degree, on April 27 when we completed a follow-on share offering that raised gross proceeds of $90.4 million. Our team did a wonderful job in just a 1-day work cross that was many times oversubscribed and that brought significant new investors in our shareholder base. Especially in this market, conducting an offering with such demand from high-quality investor is a remarkable achievement.

當然，在不久的將來有如此多的催化劑，我們如何為我們的增長提供資金始終是一個重要的問題。 4 月 27 日，我們在很大程度上回答了這個問題，當時我們完成了後續股票發行，籌集了 9040 萬美元的總收益。我們的團隊在短短 1 天的工作交叉中做得非常出色，多次超額認購，並為我們的股東基礎帶來了大量新投資者。尤其是在這個市場上，在如此優質投資者的需求下進行發行，更是了不起的成就。

On April 10, we announced the launch of Mia Femtech in Japan. The idea for Mia originated a decade ago when we recognized that breast augmentation was not meeting the needs of women in Japan. With the experience of Mia Femtech, we are providing a solution. With Mia, a plastic surgeon can shape the breast in a 15-minute, minimally invasive procedure without the need for general anesthesia. The result is natural and discrete with a 1 to 2 cup proportionate result. The procedure requires minimal downtime with women returning to most activities the same day. By providing a solution that overcomes many of the obstacles of traditional breast augmentation, we are opening up a whole new group of women to breast aesthetics.

4 月 10 日，我們宣佈在日本推出 Mia Femtech。 Mia 的想法起源於十年前，當時我們認識到隆胸不能滿足日本女性的需求。憑藉 Mia Femtech 的經驗，我們正在提供解決方案。借助 Mia，整形外科醫生可以在 15 分鐘內完成乳房整形，微創手術無需全身麻醉。結果自然而離散，比例為 1 到 2 杯。該過程需要最少的停機時間，女性可以在同一天恢復大部分活動。通過提供克服傳統隆胸術諸多障礙的解決方案，我們正在為乳房美學開闢全新的女性群體。

Our launch activities are centered on creating this new category in Japan with our partner clinics. We have created marketing materials localized for the Japanese market, including a Japanese-language Mia Femtech website, social media and traditional media, all directed at creating demand and then directing interested women to our clinic partners. Mia Femtech is being launched initially at 2 clinic chains in Japan. Seishin Plastic and Aesthetic Surgery Clinic operates 10 premium clinics with Mia Femtech now available at their main Tokyo Clinic in Roppongi and at their newest Clinic in Ginza. Joe Clinic is a high-end medical aesthetics chain in Japan that will offer Mia Femtech initially at its Tokyo and Osaka locations.

我們的發布活動的重點是與我們的合作夥伴診所在日本創建這個新類別。我們為日本市場製作了本地化的營銷材料，包括日語 Mia Femtech 網站、社交媒體和傳統媒體，所有這些都是為了創造需求，然後將感興趣的女性引向我們的診所合作夥伴。 Mia Femtech 最初在日本的 2 家連鎖診所推出。 Seishin Plastic and Aesthetic Surgery Clinic 經營著 10 家採用 Mia Femtech 的高級診所，現在位於六本木的主要東京診所和位於銀座的最新診所均有提供。 Joe Clinic 是日本的一家高端醫學美容連鎖店，最初將在其東京和大阪分店提供 Mia Femtech。

It is still early in the launch of Mia and we are focused on demonstrating that this is a new category, bringing new women into breast aesthetics and that surgeons are seeing improved efficiency and our partner clinics are benefiting from higher economics. These proof points will be important as we look to scale Mia into the multibillion dollar opportunity that it has the potential to become. We look forward to providing updates on our progress in Japan for the coming months.

Mia 的推出還處於早期階段，我們專注於證明這是一個新類別，將新女性帶入乳房美學領域，外科醫生的效率正在提高，我們的合作診所也從更高的經濟效益中受益。這些證明點將很重要，因為我們希望將 Mia 擴展到它有可能成為的數十億美元的機會。我們期待在未來幾個月提供有關我們在日本取得的進展的最新信息。

We recently also announced our first European clinic partners for Mia. We have partner clinics in Spain, Switzerland and Sweden, and I'm pleased to report that we have signed our first Mia partner in France. Clinique des Champs Elysées is a prestigious center for medical and surgical aesthetics based in Paris with a chain of 12 clinics throughout France. We continue to make good progress on finalizing European Union approval for the tools that are part of the minimally invasive system used for Mia Femtech.

我們最近還宣布了 Mia 的第一個歐洲診所合作夥伴。我們在西班牙、瑞士和瑞典都有合作診所，我很高興地報告我們已經在法國簽署了我們的第一個 Mia 合作夥伴。 Clinique des Champs Elysées 是一家著名的醫學和外科美容中心，總部位於巴黎，在法國各地擁有 12 家連鎖診所。我們繼續在最終確定歐盟批准作為用於 Mia Femtech 的微創系統的一部分的工具方面取得良好進展。

In our aesthetic breast recon franchise, the rollout of our Motiva Flora tissue expander continues. The market feedback continues to be very positive with more and more surgeons making it their expander of choice in post-mastectomy breast reconstruction. What continues to resonate with clinicians globally is that Flora is a much improved offering with many new advances in what is, unfortunately, a large and often neglected category in breast reconstruction.

在我們的美學乳房偵察專營權中，我們的 Motiva Flora 組織擴張器繼續推出。市場反饋繼續非常積極，越來越多的外科醫生將其作為乳房切除術後乳房重建的首選擴張器。繼續引起全球臨床醫生共鳴的是，Flora 是一種大大改進的產品，在不幸的是乳房重建中一個龐大且經常被忽視的類別中取得了許多新進展。

In a recently published paper, scientists at the Medical University of Innsbruck in Austria were able to confirm in a comparative study that Flora provides much improved patient comfort and satisfaction in their breast reconstruction journeys. As a global medical device company focused on women's health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction. Flora is only the first step in our aesthetic breast recon initiative, where Establishment Labs will offer tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire.

在最近發表的一篇論文中，奧地利因斯布魯克醫科大學的科學家們能夠在一項比較研究中證實，Flora 在乳房重建過程中大大提高了患者的舒適度和滿意度。作為一家專注於女性健康的全球醫療器械公司，Establishment Labs 有機會也有責任改善乳房再造。 Flora 只是我們審美乳房重建計劃的第一步，Establishment Labs 將提供工具和技術，讓女性能夠接受重建手術，從而實現她們嚮往的審美理想。

On China, we are actively preparing for the launch of Motiva with our distribution partner. Over the last couple of months, we have conducted a significant amount of research in order to understand the opportunity in what is now the second largest market for breast devices globally. The market in China continues to recover, with procedures in 2025 expected to exceed pre-COVID levels. There continues to be a very healthy luxury segment in China, where consumers are paying procedure prices similar to the upper end of market in places like United States and Europe. Given the premium positioning of Motiva in other Asian markets, including South Korea and Japan and the strong awareness of our devices in the Chinese market, we are very encouraged by what we are learning about this market and the opportunity. We continue to make progress in the regulatory process and expect to launch Motiva in this market in the second half of 2023.

在中國，我們正在積極準備與我們的分銷合作夥伴一起推出 Motiva。在過去的幾個月裡，我們進行了大量研究，以了解目前全球第二大乳房設備市場的機會。中國市場繼續復甦，預計 2025 年的程序將超過 COVID 之前的水平。中國仍然有一個非常健康的奢侈品市場，消費者支付的程序價格與美國和歐洲等地的高端市場相似。鑑於 Motiva 在其他亞洲市場（包括韓國和日本）的高端定位以及我們的設備在中國市場的強烈知名度，我們對我們對這個市場和機會的了解感到非常鼓舞。我們繼續在監管過程中取得進展，預計將於 2023 年下半年在該市場推出 Motiva。

I will now turn over the call to Raj.

我現在將把電話轉給 Raj。

Thank you, Juan Jose. Total revenue for the first quarter was $46.5 million. Reported revenue growth in the first quarter was 21%. Foreign currency changes reduced our first quarter revenue growth by approximately $750,000. Excluding the impact of currency, revenue growth in the quarter would have been 22.9%. Direct sales were approximately 36% of global Motiva implant sales, while distributor sales made up the balance.

謝謝你，胡安何塞。第一季度的總收入為 4650 萬美元。第一季度報告的收入增長為 21%。外幣變動使我們第一季度的收入增長減少了約 750,000 美元。排除貨幣的影響，本季度的收入增長將達到 22.9%。直接銷售額約佔全球 Motiva 種植體銷售額的 36%，而經銷商銷售額則佔其餘部分。

From a regional perspective, Motiva sales in Europe, Middle East and Africa were approximately 44% of the global total; Asia Pacific 31%; and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 13% of total quarterly Motiva sales. Our gross profit for the first quarter was $30.1 million or 64.7% of revenue compared to $24.9 million or 64.8% of revenue for the same period in 2022. Our gross profit in the first quarter was negatively impacted by higher overhead and labor costs. Direct labor costs were higher in part from changes in foreign currency exchange rates between the U.S. dollar and the Costa Rican colón. As we report in U.S. dollars, a significant revaluation of the colón resulted in higher costs in the period.

從區域來看，Motiva在歐洲、中東和非洲的銷售額約佔全球總銷售額的44%；亞太地區 31%；拉丁美洲彌補了平衡。巴西是我們全球最大的單一市場，約佔 Motiva 季度總銷售額的 13%。我們第一季度的毛利潤為 3010 萬美元，佔收入的 64.7%，而 2022 年同期為 2490 萬美元，佔收入的 64.8%。我們第一季度的毛利潤受到較高的間接費用和勞動力成本的負面影響。直接人工成本較高，部分原因是美元與哥斯達黎加科朗之間的匯率變化。正如我們以美元報告的那樣，科隆的大幅重估導致該期間的成本增加。

Average selling prices in the first quarter were up from the fourth quarter of 2022. We continue to see regular fluctuations in gross margin on mix and other factors. However, the trend in our gross margin is expected to be positive over time. SG&A expenses for the first quarter increased approximately $4.8 million to $31.7 million compared to $26.9 million in the first quarter of 2022. The increase in SG&A in the first quarter resulted in part from our investments in new growth initiatives like Mia and preparations for our launch in the United States.

第一季度的平均售價高於 2022 年第四季度。我們繼續看到毛利率因組合和其他因素而定期波動。然而，隨著時間的推移，我們的毛利率趨勢預計將為正。第一季度的 SG&A 費用從 2022 年第一季度的 2690 萬美元增加了約 480 萬美元至 3170 萬美元。第一季度 SG&A 的增加部分是由於我們對 Mia 等新增長計劃的投資以及我們在美國。

R&D expenses in the first quarter increased approximately $2.9 million in the same quarter a year ago to $6.5 million. Higher personnel costs and increased activity related to our U.S. clinical trial contributed to higher spending in this period. Total operating expenses for the first quarter were $38.2 million an increase of approximately $7.7 million in the year ago period. Net loss from operations for the first quarter was $11.9 million compared to a net loss of $5.9 million in the same period in 2022.

第一季度的研發費用比去年同期增加了約 290 萬美元，達到 650 萬美元。更高的人員成本和與我們美國臨床試驗相關的活動增加導致這一時期的支出增加。第一季度的總運營費用為 3820 萬美元，比去年同期增加了約 770 萬美元。第一季度的運營淨虧損為 1190 萬美元，而 2022 年同期為淨虧損 590 萬美元。

Our cash position as of March 31 was $42.8 million compared to $66.4 million at the end of 2022. Cash used in the first quarter included approximately $3.8 million of investments in our new manufacturing facility as well as a planned increase in inventory of $8.5 million as we prepare for the growth we expect over the near future.

截至 3 月 31 日，我們的現金狀況為 4,280 萬美元，而 2022 年底為 6,640 萬美元。第一季度使用的現金包括對我們新製造設施的大約 380 萬美元投資，以及計劃增加的 850 萬美元庫存，因為我們為我們在不久的將來預期的增長做好準備。

On April 27, we completed a 1.265 million share follow-on offering with net proceeds to Establishment Labs after fees and expenses of approximately $84 million. With the cash on hand at the end of the first quarter, the proceeds of the offering as well as the 2 remaining tranches of our debt facility, which totaled $50 million and become available on the achievement of sales and regulatory milestones, we have access to approximately $175 million.

4 月 27 日，我們完成了 126.5 萬股的後續發行，在扣除費用和支出約 8400 萬美元後，向 Establishment Labs 的淨收益。憑藉第一季度末的手頭現金、發行收益以及剩餘的兩筆債務融資（總計 5000 萬美元，在實現銷售和監管里程碑時可用），我們可以獲得約 1.75 億美元。

We are reaffirming the revenue guidance we provided for 2023 of $200 million to $210 million, representing annual growth of 24% to 30%. We continue to expect gross margins in 2023 to be similar to 2022. Operating expenses as a percent of revenue in 2023 are also expected to be similar to 2022. Operating spending over the near term is reflecting our investments in development and commercialization programs. However, we expect expenses as a percentage of revenue will trend down as we move into these new initiatives and begin to leverage our spending.

我們重申我們為 2023 年提供的 2 億至 2.1 億美元的收入指導，年增長率為 24% 至 30%。我們繼續預計 2023 年的毛利率將與 2022 年相似。預計 2023 年運營支出佔收入的百分比也將與 2022 年相似。近期的運營支出反映了我們對開發和商業化計劃的投資。然而，我們預計隨著我們採取這些新舉措並開始利用我們的支出，支出佔收入的百分比將呈下降趨勢。

I will now turn the call back to Juan Jose.

我現在將電話轉回 Juan Jose。

Thank you, Raj. With the launch of Mia Femtech in Japan, the presentation of the 3-year data from our U.S. study and the successful follow-on offering, the last few weeks have been very meaningful for our company, but we expect the coming months to be just as eventful. We look forward to providing updates on the commercial launch of Mia in Japan and the expansion into Europe. We are also preparing for the launch of Motiva into China. As we enter the United States and China, it is a major step in our efforts to build a breast aesthetics and reconstruction industry based on technology solutions to improve women's health and wellbeing.

謝謝你，拉吉。隨著 Mia Femtech 在日本的推出、我們美國研究的 3 年數據的展示以及成功的後續產品，過去幾週對我們公司來說意義重大，但我們預計未來幾個月將只是作為多事。我們期待提供有關 Mia 在日本的商業發布和向歐洲擴張的最新信息。我們還準備在中國推出 Motiva。隨著我們進入美國和中國，這是我們努力建立基於技術解決方案的乳房美容和重建行業以改善女性健康和福祉的重要一步。

This has been more than a 12-year journey for us since we first went to market with Motiva. And each year, we publish our post-market surveillance report, which in effect, details how we are doing. This is the only document of its kind in our industry, released every year as an exercise of transparency with our stakeholders. It catalogs the clinical data that has been collected on the performance of our devices from several different countries. The report includes our own product and warranty claims information as well as registry data from different countries and independent clinical publications on Motiva. They are all telling the same story, namely that after over 12 years in the market, Motiva implants continue to have device-related complications in the very low single digits, in many cases, well less than 1%.

自從我們第一次與 Motiva 一起進入市場以來，這對我們來說已經超過了 12 年的旅程。每年，我們都會發布上市後監督報告，實際上詳細說明了我們的表現。這是我們行業中唯一的此類文件，每年發布一次，作為與我們的利益相關者保持透明度的做法。它對從幾個不同國家收集到的關於我們設備性能的臨床數據進行了分類。該報告包括我們自己的產品和保修索賠信息，以及來自不同國家的註冊數據和 Motiva 上的獨立臨床出版物。他們都在講述同一個故事，即在市場上超過 12 年之後，Motiva 植入物繼續出現與設備相關的並發症，其發生率僅為非常低的個位數，在許多情況下，遠低於 1%。

And this is not a surprise for us. It is downstream effect of science and technology as all the papers about Motiva in published peer-reviewed publications attest. We look forward to making our products and solutions available to the largest markets in the world. We continue to publish this report every year. It is available on our website at establishmentlabs.com and we encourage everyone to download it and review it.

這對我們來說並不奇怪。它是科學和技術的下游效應，因為在已發表的同行評審出版物中所有關於 Motiva 的論文都證明了這一點。我們期待著將我們的產品和解決方案推向世界上最大的市場。我們繼續每年發布這份報告。它可以在我們的網站 establishmentlabs.com 上找到，我們鼓勵大家下載並查看它。

We will also hold the opening ceremony for our new Sulàyöm campus on July 19. The new manufacturing capacity at Sulàyöm more than doubles the number of implants we can produce per year. And it allows us to provide over half the current world demand. This facility also brings us significant new capabilities in R&D, media and surgeon training. We are making progress every day towards our goal of building a strong women's health foundation to create vibrant and expanding markets for breast aesthetics and reconstruction, and to make a meaningful change in the lives of women around the world.

我們還將在 7 月 19 日舉行 Sulàyöm 新校區的開幕式。Sulàyöm 的新製造能力使我們每年可以生產的植入物數量增加了一倍多。它使我們能夠提供當前世界需求的一半以上。該設施還為我們帶來了研發、媒體和外科醫生培訓方面的重要新能力。我們每天都在朝著建立強大的女性健康基礎的目標邁進，為乳房美容和重建創造充滿活力和不斷擴大的市場，並為全世界女性的生活帶來有意義的改變。

I will now turn the call over to the operator for your questions.

我現在將把電話轉給接線員來回答您的問題。

(Operator Instructions) Our first question is coming from Anthony Petrone from Mizuho Group.

（操作員說明）我們的第一個問題來自瑞穗集團的 Anthony Petrone。

Congratulations to your strong start to the year and then, of course, on the IDE data from a couple of weeks ago. I think I'm going to start on Japan. Maybe just qualitatively, how the launch of Mia in Japan is going. And then maybe more specifically, when we think about the Seishin network of clinics, there was the initial launch in Tokyo there, but there's also the Joe clinics as well, the medical aesthetic locations. When we think about those collective sites, I think Seishin has 10 sites, not sure many -- how many Joe has in their network. But how many sites are represented in those 2 networks? And how many of those are you in currently? And then I have a couple of follow-ups.

祝賀您今年開局良好，當然還有幾週前的 IDE 數據。我想我要從日本開始。也許只是定性的，Mia 在日本的推出情況如何。然後也許更具體地說，當我們想到 Seishin 診所網絡時，那裡最初是在東京推出的，但也有 Joe 診所，醫療美容地點。當我們考慮這些集體站點時，我認為 Seishin 有 10 個站點，不確定有多少個 Joe 在他們的網絡中有多少個。但是這兩個網絡中代表了多少站點？你目前在其中有多少？然後我有幾個後續行動。

Yes. Thank you, Anthony, and we're very pleased with our launch of Mia in Japan. But I do have to remind absolutely everyone of the importance to see this as the launch of a new category and not another product into traditional breast aesthetics. If it was a traditional launch, our main target would be to get as much market share as quickly as possible, while preserving our average selling prices. The objective here is really to bring in consumers that are currently not interested in traditional breast augmentation. And that's why it is so important to address the potential obstacles that these women would see in traditional breast augmentation.

是的。謝謝你，安東尼，我們對在日本推出 Mia 感到非常高興。但我確實必須提醒所有人，將其視為一個新類別的推出的重要性，而不是傳統乳房美學的另一種產品。如果是傳統發布，我們的主要目標是盡快獲得盡可能多的市場份額，同時保持我們的平均售價。這裡的目標實際上是吸引目前對傳統隆胸不感興趣的消費者。這就是為什麼解決這些女性在傳統隆胸手術中會遇到的潛在障礙如此重要的原因。

If you look at all the marketing efforts that we are doing in partnership with Seishin and Joe Clinic, they are focused on that. So it hasn't been yet 1 month, but we are already pleased with the amount of traffic we are getting in the different digital assets that we are utilizing. We are working right now with Tokyo and expect to see expansion into Osaka and furthermore, later in the next year, to the other locations. These are chains of clinics, so they have a presence all over Japan. And we do expect to see Mia expanding as well geographically throughout Japan.

如果你看看我們與 Seishin 和 Joe Clinic 合作所做的所有營銷工作，他們就會專注於此。所以還不到 1 個月，但我們已經對我們正在使用的不同數字資產中獲得的流量感到滿意。我們目前正在與東京合作，預計會擴展到大阪，並在明年晚些時候擴展到其他地點。這些是連鎖診所，因此它們在日本各地都有業務。我們確實希望看到 Mia 在整個日本的地理範圍內擴張。

That's helpful. And then the follow-up would be just on the U.S. side and following the final clinical module submission. Not necessarily on timing, but maybe as we look at the remainder of 2023, when you think about the buildup of the infrastructure on the U.S. side, how much of that really is ongoing now, potentially accelerates ahead of a potential approval? And then how much sort of bridges after a potential approval, whenever that may come over the next year or so? And congratulations.

這很有幫助。然後後續行動將僅在美國方面進行，並在提交最終臨床模塊之後進行。不一定在時間上，但也許當我們展望 2023 年剩餘時間時，當您考慮美國方面的基礎設施建設時，其中有多少現在真正在進行中，可能會在潛在批准之前加速？然後在潛在批准之後有多少種橋樑，無論何時可能在明年左右？祝賀你。

Yes, we have a very detailed, carefully thought-out plan for launch in the U.S. It's going to be our most important launch ever for this company. We have now launched Motiva in more than 85 countries. So we have a very clear blueprint of how we do things. We've already been building up towards the launch. And as we get closer and closer, we're adding people to that team, we're making sure that we have what is necessary, while we don't bring in people too early that would increase our potential spend unnecessarily. So that's kind of like the balance that we're trying to play with our U.S. launch strategy.

是的，我們有一個非常詳細、經過深思熟慮的在美國推出的計劃。這將是我們公司有史以來最重要的推出。我們現在已經在超過 85 個國家推出了 Motiva。因此，我們對如何做事有一個非常清晰的藍圖。我們已經在為發布做準備。隨著我們越來越接近，我們正在為該團隊增加人員，我們確保我們擁有必要的東西，同時我們不會過早引入人員，這會不必要地增加我們的潛在支出。所以這有點像我們試圖在美國推出戰略中取得的平衡。

Next question is coming from Joshua Jennings from TD Cowen.

下一個問題來自 TD Cowen 的 Joshua Jennings。

And echo Anthony's congratulations on a strong start to the year and on the progress. I was hoping to just first ask just 2 questions on Mia. First, maybe getting a little bit ahead of myself or -- but just thinking about the U.S. approval track for Mia once you have Motiva approved. Is a supplemental PMA pathway a reasonable pathway to think of that could be open for establishment for Mia approval?

並附和安東尼對今年開局良好和取得進展的祝賀。我希望首先只問 2 個關於 Mia 的問題。首先，也許有點超前了，或者——但只要考慮一下美國對 Mia 的批准軌道，一旦你獲得了 Motiva 的批准。補充 PMA 途徑是否是一種合理的途徑，可以考慮為 Mia 批准開放建立？

Thanks, Josh. So right now, all of our efforts are geared towards getting approval for Motiva Round and Ergonomix. Ergonomix2 is the next-generation platform that makes Mia possible. And we do believe, and our regulatory experts have supplemented this, that once we gain approval for Motiva in the U.S., we would be able potentially to use that approval, to build on it with an extension for these new catalogs that are necessary for Mia. So that's something that we need to explore more. And definitely, they will become more and more important as we get over with the current approval process. But that's the important thing right now.

謝謝，喬希。所以現在，我們所有的努力都是為了獲得 Motiva Round 和 Ergonomix 的批准。 Ergonomix2 是使 Mia 成為可能的下一代平台。我們確實相信，我們的監管專家對此進行了補充，一旦我們在美國獲得 Motiva 的批准，我們將有可能利用該批准，在其基礎上擴展 Mia 所需的這些新目錄.所以這是我們需要更多探索的東西。毫無疑問，隨著我們完成當前的審批流程，它們將變得越來越重要。但這是現在最重要的事情。

Understood. And then just second question. Getting ahead of myself again here, but just thinking about Mia, the approach, the technique -- the many ways of technique your team has developed, I mean, should investors be thinking of Mia as a potential platform technology in aesthetics?

明白了。然後是第二個問題。在這裡再次超越自己，但只是想一想 Mia，方法，技術——你的團隊開發的許多技術方法，我的意思是，投資者是否應該將 Mia 視為一種潛在的美學平台技術？

So if you think about other surgical specialties moving into minimally invasive, the creation of Mia as an experience required not only the Ergonimix2 platform, but also a series of tools and techniques that go with it so that you can have a true minimally invasive approach. So absolutely, you can use these technologies to go into other types of treatments in which minimally invasive would be required in order to get a similar experience at what you see with Mia. So it's a little bit early to go into that, but we absolutely do think that it is a platform.

因此，如果您考慮其他外科專業進入微創領域，那麼創建 Mia 作為一種體驗不僅需要 Ergonimix2 平台，還需要一系列與之配套的工具和技術，這樣您才能擁有真正的微創方法。因此，絕對可以使用這些技術進行其他類型的治療，在這些治療中需要微創才能獲得與 Mia 相似的體驗。所以現在討論這個還為時過早，但我們絕對認為它是一個平台。

Next question is coming from George Sellers from Stephens.

下一個問題來自 Stephens 的 George Sellers。

This is Harrison on for George. I just want to reiterate again, congrats on the strong quarter. So I wanted to start on Flora. I was wondering if you can give us an update on where you are as you build out that international market and specifically, what your expectations are in 2023 in terms of Flora contributing to growth? And any additional geographic areas that Florida -- Flora, sorry, could enter into later this year?

這是喬治的哈里森。我只想再次重申，祝賀強勁的季度。所以我想從 Flora 開始。我想知道您是否可以向我們介紹您在建立國際市場時所處的最新情況，具體來說，您對 2023 年 Flora 對增長的貢獻有何期望？佛羅里達州 - Flora，對不起，今年晚些時候可以進入的任何其他地理區域？

Yes. Thank you. And Flora is the first technology that we have exclusively devoted to our aesthetic breast recon program. So it is very important to us. And what we see is quarter-to-quarter, more surgeons and more hospitals taking on Flora. The build-out though of breast reconstruction demand is lower because it requires different tenders that may vary in timing from region and countries. So it is a build-out that cannot happen as accelerated as a normal breast aesthetics launch.

是的。謝謝。 Flora 是我們專門用於我們的美學乳房偵察計劃的第一項技術。所以這對我們來說非常重要。我們看到的是每季度都有更多的外科醫生和更多的醫院接受 Flora。乳房重建需求的增加雖然較低，因為它需要不同的招標，這些招標的時間可能因地區和國家而異。因此，這是一個無法像正常的乳房美學發布那樣加速的擴建。

Now we are, though, very pleased with the response that we get and also for the scientific backing that we are getting. This paper that I referenced in my remarks earlier is particularly important because it compares a direct competitor from the United States and their tissue expander to our Flora tissue expander in the same patient. So this is a true direct comparative evidence and one in which most women were pleased with our expander as being their choice.

不過，現在我們對得到的回應以及得到的科學支持感到非常高興。我之前在發言中提到的這篇論文特別重要，因為它將來自美國的直接競爭對手及其組織擴張器與我們的 Flora 組織擴張器在同一患者身上進行了比較。因此，這是一個真正的直接比較證據，並且大多數女性對我們的擴張器作為她們的選擇感到滿意。

So as we move along, and we will continue to do so, I think this evidence will further prove the importance of this technology. And I would mention also the importance of Japan with Flora because we received approval there at the end of last year, and we continue to add hospitals in Japan. So I think that's going to be further proof that in this type of sophisticated markets, we can do very well with Flora.

因此，隨著我們的前進，我們將繼續這樣做，我認為這些證據將進一步證明這項技術的重要性。我還要提到日本對 Flora 的重要性，因為我們在去年年底在那裡獲得了批准，我們將繼續在日本增加醫院。所以我認為這將進一步證明在這種複雜的市場中，我們可以用 Flora 做得很好。

Yes. Yes. That sounds great. And then I wanted to ask one on Mia as well. As the launch in Japan and across Europe progresses, I wanted to ask about the partnership model and what kind of investment is required from the company as well as the clinics. As well as this partnership model, should we expect this to be used across the company more broadly going forward? Or is this specific to the launch of Mia?

是的。是的。聽起來不錯。然後我也想問一個關於 Mia 的問題。隨著在日本和整個歐洲的推出，我想問一下合作模式以及公司和診所需要什麼樣的投資。除了這種合作模式，我們是否應該期望它在整個公司中得到更廣泛的應用？或者這是特定於 Mia 的發布？

So as a company, Establishment Labs has been moving closer and closer to consumer over the last decade. Mia is the first offering that is truly conceptualized and designed for the type of experience that Mia is. So when we look at this partnership model, it also is a different business proposition, one in which we are partnering with selected clinics. These clinics understand very well that they will have to invest alongside with us to be able to bring in these new consumers that are not looking for traditional breast augmentation.

因此，作為一家公司，Establishment Labs 在過去十年中越來越貼近消費者。 Mia 是第一個真正針對 Mia 的體驗類型進行概念化和設計的產品。因此，當我們審視這種合作模式時，它也是一種不同的商業主張，我們與選定的診所合作。這些診所非常清楚，他們必須與我們一起投資，才能吸引這些不尋求傳統隆胸手術的新消費者。

So it is a very different type of thing. You remember, we don't have any sales reps for Mia. We invest this money in creating demand. So we will continue working with this model in Europe, once we are able to launch there. And we are very happy with the type of interactions that we are doing with these partner clinics. We'll see what happens in the future if this is a model that we want to move across the organization.

所以這是一種非常不同的東西。你記得，我們沒有米婭的銷售代表。我們將這筆錢投資於創造需求。因此，一旦我們能夠在那裡推出，我們將繼續在歐洲使用這種模式。我們對與這些合作診所進行的互動類型感到非常滿意。如果這是我們想要在整個組織中推廣的模型，我們將看看未來會發生什麼。

Next question today is coming from Neil Chatterji from B. Riley Securities.

今天的下一個問題來自 B. Riley Securities 的 Neil Chatterji。

Congrats on the strong quarter. Maybe just sticking with Mia. Just curious more broadly how that partner funnel is shaping up in other markets. And then just secondly, what does that, the French market look like with a new partner there, maybe in comparison to the Swiss market that had about, I believe, 400,000 women eligible for Mia and about 200,000 that were interested?

祝賀強勁的季度。也許只是堅持米婭。只是更廣泛地好奇該合作夥伴漏斗在其他市場是如何形成的。其次，法國市場有一個新的合作夥伴，與瑞士市場相比，我相信有大約 400,000 名符合 Mia 資格的女性和大約 200,000 名感興趣的女性，這與瑞士市場相比有何不同？

Yes. Thank you. And we are as excited as everyone with Mia and the possibilities that it can have over time. We are looking at a multibillion-dollar opportunity at peak. And our job is to basically develop that market and prepare for it with these partner clinics. So if you look at Europe right now, we are looking at the first European partners in Sweden, Switzerland, Spain and now also in France.

是的。謝謝。我們和每個人一樣對 Mia 及其隨著時間的推移可能擁有的可能性感到興奮。我們正在尋找一個價值數十億美元的機會。我們的工作基本上是開發該市場並與這些合作診所一起為它做準備。所以如果你現在看看歐洲，我們正在尋找瑞典、瑞士、西班牙的第一批歐洲合作夥伴，現在也在法國。

So when you look at clinics like Nordiska in Scandinavia, Leman and Utoquai in Switzerland or Planas and Clinique des Champs Elysées in Spain and France, respectively, what we are looking at is like literally the best of the best in terms of the potential partners that you can use to go direct-to-consumer and compliantly be able to get them to understand that this is a different type of offering.

因此，當您分別查看斯堪的納維亞半島的 Nordiska、瑞士的 Leman 和 Utoquai 或西班牙和法國的 Planas 和 Clinique des Champs Elysées 等診所時，就潛在合作夥伴而言，我們所看到的實際上是最好中的最好您可以使用直接面向消費者並順從地讓他們了解這是一種不同類型的產品。

When we look at the next few months, I think, again, it's about the qualitative part. It's about being able to get through that door, a new type of consumer. With Clinique des Champs Elysées is a particularly interesting group if they have 12 clinics throughout France. We are going to begin at their main location in Paris and 9 additional other clinics throughout the country. So very excited about all these possibilities.

當我們回顧接下來的幾個月時，我認為，這又是關於定性的部分。這是關於能夠通過那扇門，一種新型的消費者。 Clinique des Champs Elysées 是一個特別有趣的團體，如果他們在法國擁有 12 家診所。我們將從他們位於巴黎的主要地點和全國其他 9 家診所開始。對所有這些可能性感到非常興奮。

Right. Great. Maybe just switching to China. So I just wanted to check in on how things are tracking with kind of the regulatory process for Motiva there, targeting that second half launch. And then just also, I believe you're planning to leverage the distributor you have for (inaudible). Just curious, if you could just elaborate on what they're seeing on the ground and from any market research in front of that launch?

正確的。偉大的。也許只是轉向中國。所以我只是想檢查事情是如何跟踪 Motiva 那裡的監管流程的，目標是下半年的發布。然後，我相信您正計劃利用您擁有的分銷商（聽不清）。只是好奇，您是否可以詳細說明他們在實地看到的內容以及發布前的任何市場調查？

Yes, actually, we've been doing more and more work in preparation for the launch in the second half and one of the important things is that breast aesthetics is bouncing in China from the COVID levels into something that looks more like what we were seeing before COVID. And it is expected that by 2025, we will be back at 2019 levels.

是的，實際上，我們一直在做越來越多的工作來為下半年的發布做準備，其中一件重要的事情是乳房美學在中國從 COVID 水平反彈到看起來更像我們所看到的東西在 COVID 之前。預計到 2025 年，我們將回到 2019 年的水平。

Now the other very important thing is that you do see patients continuing to request premium brands. So that plays particularly well for us. And we are working with our partner, Human Wellness Corporation. One of the reasons we chose them as our partner for China is that the Chinese consumer does look up to what is going on in South Korea when it comes to aesthetics. Now of course, our partner is putting together an entire team in the ground in China, locals that understand the particularities of each region and can deal with those. So as soon as we receive the approval from the NMPA, we will move on into the launch phase with our partners.

現在另一件非常重要的事情是你確實看到患者繼續要求優質品牌。所以這對我們來說特別好。我們正在與我們的合作夥伴 Human Wellness Corporation 合作。我們選擇他們作為我們在中國的合作夥伴的原因之一是中國消費者在審美方面確實關注韓國正在發生的事情。當然，現在我們的合作夥伴正在中國組建一個完整的團隊，當地人了解每個地區的特殊性並可以處理這些問題。因此，一旦我們獲得 NMPA 的批准，我們將與我們的合作夥伴一起進入啟動階段。

Next question is coming from Marie Thibault from BTIG.

下一個問題來自 BTIG 的 Marie Thibault。

Just wanted to follow up on Neil's question about China. I heard you say that you're expecting to launch in second half. In the past, you've said approval is planned in the first half. Is that still true? Are you able to reiterate that?

只是想跟進尼爾關於中國的問題。我聽說你說你希望在下半年推出。過去，你說過計劃在上半年批准。現在還是這樣嗎？你能重申一下嗎？

We are so close to it that we think that it is time to focus on the launch. It is in the hands of the NMPA, but we have enough visibility to feel strongly that we are in the preparation last phase of the launch.

我們離它如此之近，以至於我們認為是時候專注於發布了。它在 NMPA 的手中，但我們有足夠的知名度，可以強烈地感覺到我們正處於發射的最後階段。

Okay. And then a question here, probably a follow-up from what Anthony asked earlier about U.S. commercialization preparation. Your SG&A was particularly well controlled this quarter. I wanted to ask what drove that and how to think about the trend for the rest the year, given you do have plans for the U.S. launch here. So how to think about the sales rep build and the SG&A build from here for the rest of the year. Definitely heard the commentary on it being OpEx being similar to 2022 for the full year, but just trying to understand the cadence.

好的。然後是這裡的一個問題，可能是 Anthony 早些時候提出的關於美國商業化準備的後續問題。本季度您的 SG&A 控制得特別好。我想問一下是什麼推動了這一點，以及如何考慮今年剩餘時間的趨勢，因為你確實有在美國推出的計劃。那麼如何考慮今年剩餘時間的銷售代表構建和 SG&A 構建。肯定聽到評論說全年的 OpEx 與 2022 年相似，但只是想了解節奏。

Yes. Thanks for the question, Marie. I would say that the first quarter, as we entered the year, just given some of the uncertainty that we and a lot of other companies were seeing, we took a very prudent approach to our spending, and I think you saw that in the numbers. As we've talked about, though, we do expect OpEx, as you noted, to be similar this year to last year as a percentage of revenue. And we continue to expect that. So as we move through the year, some of the investments in things like Mia will continue to pick up, and then certainly the U.S. will start to come on. So I would really look at the first quarter as really as being kind of prudent as we started the year, but the spending is still on tap as the year unfolds.

是的。謝謝你的問題，瑪麗。我想說的是，在我們進入今年的第一季度，鑑於我們和許多其他公司所看到的一些不確定性，我們對支出採取了非常謹慎的方法，我想你在數字中看到了這一點.不過，正如我們所討論的那樣，正如您所指出的，我們確實希望今年的運營支出佔收入的百分比與去年相似。我們繼續期待這一點。因此，隨著這一年的推移，對 Mia 等項目的一些投資將繼續增加，然後美國肯定會開始出現。因此，我真的會像今年年初那樣審慎看待第一季度，但隨著今年的展開，支出仍在隨時待命。

Next question is coming from Matt Taylor from Jefferies.

下一個問題來自 Jefferies 的 Matt Taylor。

So I had a couple of guidance questions for you. First thing I wanted to ask you to be clear about is, can you talk about how much China revenue and if there's any U.S. revenue in guidance this year?

所以我有幾個指導問題要問你。首先我想請你明確的是，你能談談今年中國的收入是多少，美國的收入是否有指導？

So we haven't given specific numbers around that. So China is in the guidance for this year, and we continue to have a lot of confidence in that. As Juan Jose mentioned, we're moving into the preparation for launch into China. I think you asked about the U.S. We have not included the U.S. in our guidance for this year. So that is still something that we're leaving out for now just given the -- we're all waiting along with everybody else for the FDA's progress. And so we've just elected not to put it in at this point.

所以我們沒有給出具體數字。所以中國在今年的指導中，我們繼續對此充滿信心。正如 Juan Jose 提到的，我們正在為進入中國做準備。我想你問的是美國。我們沒有將美國納入我們今年的指導中。所以這仍然是我們現在遺漏的事情，因為我們都在和其他所有人一起等待 FDA 的進展。所以我們剛剛選擇不在此時放入它。

Got you. And then, Raj, one follow-up though. Just on the guidance range for the year, Q1 needed 23% growth on kind of the second easiest comp. So I guess what I'm getting at is maybe you could talk about the big factors that would take you to the higher versus the lower end of the guidance this year. In your mind, are they more macro or more of the micro things that you're discussing here with the product launches?

明白了然後，Raj，還有一個跟進。就今年的指導範圍而言，第一季度需要增長 23%，這是第二個最簡單的競爭。所以我想我的意思是，也許你可以談談今年將帶你進入指導的較高端和較低端的重要因素。在您看來，您在這裡討論的產品發布是更宏觀還是更微觀？

Yes. I'd say it's -- certainly, the macro is always something that we're watching. But I think the real swing factor is really the timing of some of these initiatives, right? So when China comes, the pace of Mia coming on, these are things that we are watching very closely and controlling a little bit in terms of the spending we're devoting to them. But the range really does reflect, I think, that there's still a little bit of uncertainty in how these things are going to unfold this year. I think as we reiterated the guidance this year, we're still very confident in the outlook, and nothing has really changed in how we're seeing things.

是的。我想說的是——當然，宏觀總是我們正在觀察的東西。但我認為真正的搖擺因素確實是其中一些舉措的時機，對吧？因此，當中國到來時，Mia 的步伐也在加快，這些都是我們正在密切關注的事情，並在我們投入的支出方面進行了一些控制。但我認為，這個範圍確實反映了今年這些事情將如何展開仍然存在一些不確定性。我認為，正如我們今年重申的指導方針一樣，我們對前景仍然非常有信心，我們對事情的看法並沒有真正改變。

Thank you. We reached end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

謝謝。我們的問答環節結束了。我想把發言權轉回去征求更多意見或結束意見。

Thank you for joining us on today's call. We look forward to providing our next quarterly update in August, and we wish everyone continued good health and happiness.

感謝您參加今天的電話會議。我們期待在 8 月提供下一個季度更新，並祝大家身體健康，幸福快樂。

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網絡廣播到此結束。您可以在此時斷開您的線路，並度過美好的一天。感謝您今天的參與。