Establishment Labs Holdings Inc (ESTA) 2022 Q4 法說會逐字稿

Greetings, and welcome to the Establishment Labs Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please note, this conference is being recorded.

您好，歡迎參加 Establishment Labs 2022 年第四季度財務業績電話會議。 （操作員說明）請注意，正在錄製此會議。

I will now turn the conference over to our host, Raj Denhoy, Chief Financial Officer. Thank you. You may begin.

我現在將會議轉交給我們的主持人，首席財務官 Raj Denhoy。謝謝。你可以開始了。

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 from 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. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For 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.

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來自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。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以及其他 SEC 文件，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. 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.

我還想提醒您，我們的評論將包括與我們的業績相關的某些非 GAAP 財務指標；包括但不限於可以按固定貨幣基礎列示的銷售業績。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。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。

We continually seek to expand the geographies in which our products are regulatory approved. Please check with the local authorities for specific product availability. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, February 27, 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.

我們不斷尋求擴大我們的產品獲得監管批准的地區。請與地方當局核實具體產品的可用性。本次電話會議的內容包含僅截至本次直播之日 2023 年 2 月 27 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. Record revenue in the quarter of 2022 totaled $43.8 million, a 24% increase over the fourth quarter of 2021. Excluding the negative impact of foreign currency changes, our growth in the fourth quarter would have been approximately 28%. For the full year of 2022, revenue totaled $161.7 million, a 28% increase over 2021, excluding changes in currency growth in 2022 would have been 32%. These results are at the midpoint of the preannounced ranges we provided in early January. We are growing well in excess of our underlying markets and the key to these market share gains is our singular focus on building a new breast aesthetics and reconstruction industry on the fundamental pillars of women's health. This focus has allowed us to develop a 12-year track record of excellent clinical and aesthetic outcomes since we first commercialized Motiva implants.

謝謝你，Raj，大家下午好。 2022 年季度創紀錄的收入總計 4380 萬美元，比 2021 年第四季度增長 24%。排除外匯變動的負面影響，我們第四季度的增長率約為 28%。 2022 年全年收入總計 1.617 億美元，比 2021 年增長 28%，不包括 2022 年貨幣增長的變化為 32%。這些結果處於我們在 1 月初提供的預先宣布範圍的中點。我們的增長遠遠超過我們的基礎市場，這些市場份額增長的關鍵是我們專注於在女性健康的基本支柱上建立一個新的乳房美學和重建行業。自從我們首次將 Motiva 植入物商業化以來，這種專注使我們能夠在 12 年的時間裡取得出色的臨床和美學效果。

Over that period of time, we have elevated standards for breast aesthetics and reconstruction by bringing to market a number of meaningful innovations based on science and patient-centric design and this will continue into 2023 and beyond.

在那段時間裡，我們通過將一些基於科學和以患者為中心的設計的有意義的創新推向市場，提高了乳房美學和重建的標準，這將持續到 2023 年及以後。

For 2023, we are providing revenue guidance in the range of $200 million to $210 million. This outlook represents estimated growth of 24% to 30% over 2022. Raj will provide additional detail on our fourth quarter performance and our 2023 guidance in a moment. Last week was another big moment at Establishment Labs, and I am pleased to report that we filed Module 4 of our modular PMA with the FDA. This is a significant step toward Motiva being approved for sale in the United States. The submission of the final module also represents a transition in the approval process where the FDA will now begin their formal review of our full PMA.

對於 2023 年，我們提供 2 億至 2.1 億美元的收入指導。這一前景預估比 2022 年增長 24% 至 30%。Raj 稍後將提供有關我們第四季度業績和 2023 年指導的更多詳細信息。上周是 Establishment Labs 的另一個重要時刻，我很高興地報告我們向 FDA 提交了模塊化 PMA 的模塊 4。這是 Motiva 獲准在美國銷售的重要一步。最終模塊的提交也代表了批准過程中的一個轉變，FDA 現在將開始對我們的完整 PMA 進行正式審查。

Our interactions with the FDA through the modular review period have been very collaborative and the level of interaction has been high. We look forward to the relationship continuing on a positive path as we work to bring Motiva to the United States. On Mia Femtech, the new category we are creating in breast aesthetics, we provided an update in early January that we have signed up our first clinic partner. Seishin Plastic and Aesthetic Surgery Clinic operates a network of 10 high-end aesthetic practices in Japan. They will first offer Mia at their 2 locations in Tokyo, their flagship clinic in Roppongi and their newest clinic in Ginza.

我們在模塊化審查期間與 FDA 的互動非常協作，互動水平很高。在我們努力將 Motiva 帶到美國的過程中，我們期待這種關係繼續朝著積極的方向發展。在我們正在創建的乳房美學新類別 Mia Femtech 上，我們在 1 月初提供了更新，我們已經簽署了我們的第一個診所合作夥伴。 Seishin 整形美容外科診所在日本經營著一個由 10 家高端美容診所組成的網絡。他們將首先在東京的 2 個地點、六本木的旗艦診所和銀座的最新診所提供 Mia。

Seishin is one of the most prestigious aesthetic practices in the world, and we are so happy to have them as our first partner in the global rollout of Mia. Our practice development and medical education team are actively engaged with them in preparation for our launch. With Mia, we are creating a new category in aesthetics for women that don't want a traditional augmentation, but are conscious about the shape and proportions of their breast. Mia offered these women a minimally invasive procedure that can be performed without general anesthesia in less than 15 minutes with an easy return to their daily activities. By providing a solution that is more appealing to consumers, we are opening up a whole new group of women to breast aesthetics.

Seishin 是世界上最負盛名的美學實踐之一，我們很高興他們成為我們在全球推出 Mia 的第一個合作夥伴。我們的實踐開發和醫學教育團隊正積極與他們合作，為我們的發布做準備。借助 Mia，我們正在為不想進行傳統隆胸手術但關注乳房形狀和比例的女性創造一個新的美學類別。 Mia 為這些女性提供了一種微創手術，無需全身麻醉即可在不到 15 分鐘的時間內完成，並且可以輕鬆恢復日常活動。通過提供對消費者更具吸引力的解決方案，我們正在向全新的女性群體開放乳房美學。

As we launch Mia, 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.

當我們推出 Mia 時，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。

We look forward to providing updates over the coming months. In our aesthetic breast recon franchise, the rollout of our Motiva Flora tissue expander continues. The market feedback is very positive with more and more surgeons making it their expander of choice in post-mastectomy breast reconstruction. In November, we announced regulatory approval for Flora and Motiva implants in Japan. As we commented at the time, launching Flora with Motiva implants in the Japanese market is a significant step in changing the global standard in breast reconstruction, which continues to resonate with clinicians globally is that Flora is a much improved offering with many new advances in what has unfortunately been a neglected category in breast reconstruction.

我們期待在未來幾個月提供更新。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。 11 月，我們宣佈在日本監管部門批准 Flora 和 Motiva 植入物。正如我們當時所評論的那樣，在日本市場推出帶有 Motiva 植入物的 Flora 是改變乳房再造全球標準的重要一步，這繼續引起全球臨床醫生的共鳴，因為 Flora 是一種大大改進的產品，在什麼方面有許多新進展不幸的是，在乳房重建中一直是一個被忽視的類別。

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 reconstruction surgeries that achieve the aesthetic ideals to which they aspire. As a global medical device company focused on women's health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction. We are not only bringing to market new technologies like Flora that can improve outcomes, but we are also engaging in advocacy efforts to promote education, awareness and access.

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。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。我們不僅將像 Flora 這樣可以改善結果的新技術推向市場，而且我們還參與宣傳工作以促進教育、意識和獲取。

The need and the opportunity are significant. 1 in 8 women globally will experience breast cancer in her lifetime. But very few of them will undergo a reconstruction as part of the recovery from the disease. As we make progress in our aesthetic breast recon initiatives, the global impact will be meaningful.

需求和機會都很重要。全球每 8 名女性中就有 1 名在其一生中會患上乳腺癌。但是，作為從疾病中恢復的一部分，他們中很少有人會進行重建。隨著我們在審美乳房重建計劃中取得進展，全球影響將是有意義的。

On China, we continue to make progress in the regulatory approval process, and we expect approval for Motiva in this market in the first half of 2023. The recent lifting of COVID restrictions and the return to more normal activity in China are encouraging, not only for our approval, but also for adoption once we launch into what is the second largest market in the world.

在中國，我們在監管審批過程中繼續取得進展，我們預計 Motiva 將在 2023 年上半年獲得該市場的批准。最近取消 COVID 限制和恢復更多正常活動令人鼓舞，不僅供我們批准，也供我們進入世界第二大市場後採用。

In January, at the JPMorgan Healthcare Conference, we provided an outlook for Establishment Labs to achieve $500 million in revenue in 2026. This works out to an average annual growth rate of 33%, and it contemplates contributions from our existing markets, Mia China, U.S. and from breast reconstruction globally. With the many layers of growth behind this target, we don't expect growth will be linear over the next 4 years. However, the many layers also suggest that this target is well supported, even conservative and that growth will continue for many years beyond 2026.

1 月，在摩根大通醫療保健會議上，我們為 Establishment Labs 提供了 2026 年實現 5 億美元收入的展望。這意味著平均年增長率為 33%，並考慮了我們現有市場 Mia China 的貢獻，美國和全球的乳房重建。由於該目標背後有多個層次的增長，我們預計未來 4 年的增長不會是線性的。然而，許多層面也表明這一目標得到了很好的支持，甚至是保守的，並且增長將在 2026 年之後的許多年內持續。

We are ready for the next chapter in their growth story and providing a long-range view, not only suggests the potential we see before us, but it provides us with a target around which to plan and organize. It is well within our reach to become the leading global company in breast aesthetics and reconstruction. We will continue to transform our markets. And in doing so, we will create new opportunities for growth and more importantly, create new options for women around the world.

我們已經為他們成長故事的下一章做好了準備，並提供了一個長遠的觀點，不僅暗示了我們在我們面前看到的潛力，而且還為我們提供了一個計劃和組織的目標。成為乳房美容和重建領域的全球領先公司是我們力所能及的。我們將繼續改造我們的市場。這樣做，我們將創造新的增長機會，更重要的是，為世界各地的女性創造新的選擇。

I will now turn the call over to Raj.

我現在將把電話轉給 Raj。

Thank you, Juan Jose. Total revenue for the fourth quarter was $43.8 million. Reported revenue growth in the fourth quarter was 24.1%. Foreign currency changes reduced our fourth quarter revenue growth by approximately $1.3 million. Excluding the impact of currency, revenue growth in the quarter would have been 27.7%. Direct sales were approximately 37% of sales this quarter, while distributor sales made up the balance. From a regional perspective, sales in Europe were approximately 28% of global sales, Asia Pacific and Middle East, 40% and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 14.6% of total quarterly sales. Our revenue distribution this quarter reflected a rebound in sales in Europe from the seasonally slower third quarter, as well as strong sales to our distribution partners across multiple geographies. Our gross profit for the fourth quarter was $28.2 million or 64.3% of revenue. This compared to $24.2 million or 68.6% of revenue for the same period in 2021.

謝謝你，胡安何塞。第四季度的總收入為 4380 萬美元。第四季度報告的收入增長率為 24.1%。外幣變動使我們第四季度的收入增長減少了約 130 萬美元。排除貨幣的影響，本季度的收入增長將達到 27.7%。直銷約佔本季度銷售額的 37%，而分銷商銷售額佔其餘部分。從地區來看，歐洲的銷售額約佔全球銷售額的 28%，亞太和中東地區佔 40%，其餘為拉丁美洲。巴西是我們全球最大的單一市場，約佔季度總銷售額的 14.6%。我們本季度的收入分佈反映了歐洲銷售額從季節性放緩的第三季度反彈，以及我們在多個地區的分銷合作夥伴的強勁銷售。我們第四季度的毛利潤為 2820 萬美元，佔收入的 64.3%。相比之下，2021 年同期收入為 2420 萬美元，佔收入的 68.6%。

Our gross profit in the fourth quarter was negatively impacted by approximately 300 basis points from foreign currency rate fluctuations. Average selling prices in the fourth quarter were also down from the third quarter of 2022. We see regular fluctuations in gross margin and mix and other factors; however, the overall trend in our gross margin continues to be positive over time. SG&A expenses for the fourth quarter increased approximately $7.3 million to $34.8 million. This compared to $27.6 million in the fourth quarter of 2021. The increase in SG&A in the fourth quarter resulted from continued normalization of business practices and our investments in new growth initiatives like Mia and preparations for our launch in the U.S.

我們第四季度的毛利受到外匯匯率波動約 300 個基點的負面影響。第四季度的平均售價也低於 2022 年第三季度。我們看到毛利率和產品組合等因素有規律的波動；然而，隨著時間的推移，我們毛利率的總體趨勢繼續保持積極。第四季度的 SG&A 費用增加了約 730 萬美元，達到 3480 萬美元。相比之下，2021 年第四季度為 2760 萬美元。第四季度 SG&A 的增加是由於業務實踐的持續正常化以及我們對 Mia 等新增長計劃的投資以及我們在美國推出的準備工作。

R&D expenses for the fourth quarter increased approximately $400,000 from the same quarter a year ago to $6.5 million. Total operating expenses for the fourth quarter were $41.3 million, an increase of approximately $7.7 million from the year ago period. The increase this period was again due primarily to the normalization of activity and spending relative to a year ago, as well as the investments in growth initiatives. While we are investing our operating expenses as a percentage of revenue were down slightly from the year ago period, as we continue to focus on managing our costs.

第四季度的研發費用比去年同期增加了約 40 萬美元，達到 650 萬美元。第四季度總運營費用為 4130 萬美元，比去年同期增加約 770 萬美元。這一時期的增長再次主要是由於活動和支出相對於一年前的正常化，以及對增長計劃的投資。雖然我們正在投資，但由於我們繼續專注於管理成本，我們的運營費用佔收入的百分比比去年同期略有下降。

Net loss from operations for the fourth quarter was $13.2 million compared to a net loss of $9.4 million in the same period in 2021. Our cash position as of December 31, 2022 was $66.4 million, compared to $53.4 million at the end of the previous year. The increase in cash was a net result of the new term loan we secured in April. With achievement of the acquired revenue milestone, we drew the second tranche of the facility in December. The term loan has 2 additional tranches totaling $50 million of nondilutive capital we can access on the achievement of revenue and regulatory milestones. Cash used in the fourth quarter included approximately $9.6 million of investment in our new manufacturing facility. In total, we invested approximately $32 million in the new facility in 2022. We are providing revenue guidance for 2023 of $200 million to $210 million, representing annual reported growth of 24% to 30%. At current rates, we estimate foreign currency will have a minimal impact on 2023 sales.

第四季度運營淨虧損為 1320 萬美元，而 2021 年同期為淨虧損 940 萬美元。截至 2022 年 12 月 31 日，我們的現金頭寸為 6640 萬美元，而去年年底為 5340 萬美元.現金增加是我們在 4 月份獲得的新定期貸款的淨結果。隨著獲得的收入里程碑的實現，我們在 12 月提取了該設施的第二部分。定期貸款有 2 筆額外的款項，總計 5000 萬美元的非稀釋性資本，我們可以在實現收入和監管里程碑時獲得。第四季度使用的現金包括對我們新製造設施的大約 960 萬美元投資。 2022 年，我們對新設施的總投資約為 3200 萬美元。我們為 2023 年提供了 2 億至 2.1 億美元的收入指導，年報告增長率為 24% 至 30%。按照目前的匯率，我們估計外幣對 2023 年銷售額的影響微乎其微。

As we saw in our 2022 results, there is considerable momentum in our business, and we expect this will continue into 2023. We're also expecting early contributions from new initiatives like Mia in China. It's important to note that contributions from some of these new areas will be modest in 2023, and they will build as the year unfolds and these launches take place. As we look down the rest of the P&L, we expect gross margin in 2023 to be similar to 2022.

正如我們在 2022 年的業績中看到的那樣，我們的業務發展勢頭強勁，我們預計這種勢頭將持續到 2023 年。我們還期待中國 Mia 等新舉措的早期貢獻。重要的是要注意，其中一些新領域的貢獻在 2023 年將是適度的，並且隨著時間的推移和這些啟動的進行，它們將不斷增加。當我們向下看其餘損益表時，我們預計 2023 年的毛利率將與 2022 年相似。

Gross margin in 2023 will see the impact of new product and geographic launches, as well as the start of production from our new facility. As noted previously, we view the overall trend of our gross margin to be positive over time. Operating expenses as a percent of revenue in 2023 are also expected to be similar to 2022. While operating spending over the near term is reflecting our investment in a significant number of development and commercialization programs we have underway, we expect expenses as a percentage of revenue will trend down as we get further into these growth initiatives.

2023 年的毛利率將受到新產品和地域發布以及我們新工廠投產的影響。如前所述，我們認為隨著時間的推移，我們的毛利率總體趨勢是積極的。預計 2023 年運營支出佔收入的百分比也將與 2022 年相似。雖然近期的運營支出反映了我們對正在進行的大量開發和商業化計劃的投資，但我們預計支出佔收入的百分比隨著我們進一步實施這些增長計劃，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. 2022 was a year of tremendous progress for our company, and we are preparing for a busy 2023. Among the events we have coming are the commercial launch of Mia, our Motiva launch into China and the approval process for Motiva in the United States. In 2023, we will also finish the initial phases of construction of our new Sulàyöm campus, and begin producing commercially sellable units out of the facility. As a reminder, the new manufacturing capacity at Solium more than doubles the number of implants we can produce per year, and it allows us to provide over half the current world demand.

謝謝你，拉吉。 2022 年是我們公司取得巨大進步的一年，我們正在為忙碌的 2023 年做準備。我們即將舉行的活動包括 Mia 的商業發布、我們在中國推出 Motiva 以及 Motiva 在美國的審批程序。 2023 年，我們還將完成新 Sulàyöm 校區建設的初始階段，並開始在該設施外生產可商用的單元。提醒一下，Solium 的新製造能力是我們每年可以生產的植入物數量的兩倍多，它使我們能夠提供當前世界需求的一半以上。

We are also planning for the presentation of the 3-year data from our U.S. PMA study. With the PMA now submitted to the FDA, we will look for an appropriate forum to share this data with the scientific community. As impactful as each of these initiatives will be, they are all part of a broader strategy we have to continue to heal the relationship that women have with the legacy breast implant industry by offering innovative and safer options backed by science, and supported by clinical data, which could expand the existing market. Normalized breast aesthetics with valuable new categories so that new groups of women will be open to our technologies.

我們還計劃展示來自美國 PMA 研究的 3 年數據。隨著 PMA 現已提交給 FDA，我們將尋找合適的論壇與科學界分享這些數據。儘管這些舉措中的每一項都將產生影響，但它們都是更廣泛戰略的一部分，我們必須通過提供有科學支持和臨床數據支持的創新和更安全的選擇，繼續修復女性與傳統乳房植入物行業的關係，這可以擴大現有市場。使用有價值的新類別標準化乳房美學，以便新的女性群體對我們的技術持開放態度。

And finally, and perhaps most importantly, democratize access to breast reconstruction so that the restorative benefits of reconstruction after breast cancer can be available to women globally to at least the level of access that is available in the United States. If we are successful in these initiatives, we will be able to achieve and even exceed the recent long-term revenue goal we provided of $500 million in revenue in 2026 and much more beyond. We are better positioned than we have ever been to transform our markets and to make a meaningful change in the lives of women around the world.

最後，也許是最重要的是，使乳房重建的普及化，這樣全球女性就可以享受到乳腺癌後重建的恢復性好處，至少達到美國可獲得的水平。如果我們在這些舉措中取得成功，我們將能夠實現甚至超過我們最近提出的長期收入目標，即 2026 年收入 5 億美元甚至更多。我們比以往任何時候都更有能力改變我們的市場，並為世界各地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 comes from Matt Taylor with Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Matt Taylor。

Zack on for Matt. I was just curious if you could talk about the infrastructure you're putting in place to support the U.S. launch and then also the Mia launch in Europe.

扎克替補馬特。我只是想知道您是否可以談談您為支持美國發布以及 Mia 在歐洲的發布而建立的基礎設施。

Yes. Thank you, Matt. And we couldn't be more excited today with this news of the submission of module 4, which basically means that we are now in the full PMA approval phase. For competitive reasons and because we are getting closer to the timing of approval, we are not going to give details on exactly what we are going to do, but make no mistake, we will be prepared. And this year, we are continuing, just like we did last year to put in place systems. We continue to work through what our logistics strategy is going to be like in the United States, and as we get obviously closer, then we will be willing to share more. When it comes to Mia, in Europe, and I would also mention in Japan, it's very important to understand that Mia is done through a business model without sales reps. It is done in a completely different way. It's a partnership that we create with selected clinics that can be good partners that they have already good marketing assets that can be mixed with our amazing technologies that are embedded in Mia.

是的。謝謝你，馬特。今天我們對模塊 4 提交的消息感到無比興奮，這基本上意味著我們現在處於完整的 PMA 批准階段。出於競爭原因，並且因為我們越來越接近批准的時間，我們不會詳細說明我們將要做什麼，但請不要誤會，我們會做好準備。今年，我們將像去年一樣繼續建立系統。我們將繼續研究我們在美國的物流戰略，隨著我們明顯接近，我們將願意分享更多。談到 Mia，在歐洲，我還要提到在日本，了解 Mia 是通過沒有銷售代表的商業模式完成的，這一點非常重要。它以完全不同的方式完成。這是我們與選定診所建立的合作夥伴關係，這些診所可以成為良好的合作夥伴，因為他們已經擁有良好的營銷資產，可以與我們嵌入 Mia 的驚人技術相結合。

So when we think about like what we can do with Mia in the first half of this year, with launches in Japan and Europe, it's super exciting because it is really a different type of business model. So we are looking to this year as one of the most exciting ones in the history of our company.

因此，當我們考慮今年上半年我們可以用 Mia 做些什麼，在日本和歐洲推出時，這非常令人興奮，因為它確實是一種不同類型的商業模式。因此，我們期待今年成為我們公司歷史上最激動人心的一年。

Our next question comes from Josh Jennings with Cowen.

我們的下一個問題來自 Josh Jennings 和 Cowen。

Congratulations on a strong finish to the year and on the submission of the fourth PMA module. I wanted to ask about 2023 guidance. And I think, Raj, you mentioned that there were some modest contributions baked in from Mia in China. Just wanted to make sure I was clear that we are all clear that this guidance range is not assume any revenues from the United States, but that does not preclude any type of approval in 2023.

祝賀今年取得了優異的成績並提交了第四個 PMA 模塊。我想問一下2023年的指導。我想，Raj，你提到過中國的 Mia 做出了一些微不足道的貢獻。只是想確保我很清楚，我們都清楚這個指導範圍不假設來自美國的任何收入，但這並不排除在 2023 年獲得任何類型的批准。

Yes, I think that's a fair way to put it, Josh. I mean we haven't endorsed the time line for U.S. approval, so we haven't included it in our 2023 guidance. But as you mentioned, Mia in China, we do expect contribution from those to build as the year unfolds.

是的，我認為這是一個公平的說法，喬什。我的意思是我們還沒有批准美國批准的時間表，所以我們沒有把它包括在我們的 2023 年指南中。但正如你提到的，米婭在中國，我們確實希望隨著時間的推移，這些人的貢獻會增加。

Juan Jose, maybe just wanted to -- just with the fourth model being submitted and full review going on, you mentioned that 3-year data may be presented in the appropriate form at some point. I know you're not giving that time line or I'm assuming that you're not. But maybe it would be helpful just as a refresher to remind us of the pathophysiology of capture, contracture, rupture and maybe just reoperation rates as a whole. And in terms of precedent data sets in the breast implant sector, just the increase of capsular contracture and rupture, the operation rates from year 2 to year 3 would just be helpful to review and understand.

Juan Jose，也許只是想——在提交第四個模型並進行全面審查時，你提到 3 年數據可能會在某個時候以適當的形式呈現。我知道你沒有給出那個時間線，或者我假設你沒有。但是，提醒我們俘獲、攣縮、破裂的病理生理學，也許只是作為一個整體的再手術率，作為複習可能會有所幫助。而就隆胸行業的先例數據集而言，僅包膜攣縮和破裂的增加，從第2年到第3年的手術率就有助於回顧和理解。

Yes. Thank you, Josh. As you well noted, we are always looking forward to showing our numbers, let the data speak for itself and for the safety of the Motiva implants. When we published in Nature Biomedical Engineering about the mechanism by which our surface design creates higher biocompatibility, what we wanted to highlight is that when you see the numbers, whether in our 10-year post-market surveillance data with more than 2.5 million implants. When you look at the different data sets, when you look at our 2-year data, what you're looking at is the downstream effect of that design. And of course, we do track numbers year 2 years. We've been in the market now for 12 years internationally. And what we see is that, of course, complications get aggregated over time. but capsular contracture is a phenomenon that takes place mostly in year 1 and 2.

是的。謝謝你，喬希。正如您所注意到的，我們一直期待著展示我們的數字，讓數據說明一切並為 Motiva 植入物的安全性說話。當我們在 Nature Biomedical Engineering 上發表關於我們的表面設計創造更高生物相容性的機制時，我們想要強調的是，當您看到這些數字時，無論是在我們 10 年的上市後監測數據中有超過 250 萬個植入物。當您查看不同的數據集時，當您查看我們的 2 年數據時，您正在查看的是該設計的下游效應。當然，我們會跟踪 2 年的數字。我們已經進入國際市場 12 年了。我們看到的是，當然，並發症會隨著時間的推移而累積。但包膜攣縮是一種主要發生在第 1 年和第 2 年的現象。

Of course, you can continue capturing some of those numbers as patients come back for their checkup. But overall, these additions tend to be modest. Same thing with rupture over time. For the first few years, you will see things that may have happened inadvertently during the procedure or things that may happen towards the tail end of the life of those implants, but that would be many, many years later. So overall, I think based on all the data sets that we have, we are extremely confident on our ability to gain approval for Motiva implants in the U.S.

當然，您可以在患者回來接受檢查時繼續獲取其中一些數字。但總的來說，這些增加往往是適度的。隨著時間的推移破裂也是如此。在最初的幾年裡，您會看到在手術過程中可能無意中發生的事情，或者在這些植入物的生命即將結束時可能發生的事情，但那將是很多很多年後的事情。所以總的來說，我認為基於我們擁有的所有數據集，我們對我們在美國獲得 Motiva 植入物批准的能力非常有信心。

And our next question comes from George Sellers with Stephens.

我們的下一個問題來自 George Sellers 和 Stephens。

Congrats on a great quarter. Maybe sticking with Mia in Japan. Could you just give us some additional color on how that launch is progressing and maybe some early feedback from surgeons and patients and also maybe timing for expanding that launch to the additional clinics that this group sells through.

祝賀一個偉大的季度。也許在日本堅持使用 Mia。你能不能給我們一些額外的顏色，說明發射的進展情況，也許是外科醫生和患者的一些早期反饋，也可能是將發射擴展到該集團銷售的其他診所的時間。

Yes. Thanks, George. And to be clear, we have signed up our first group of clinics, which is the Seishin Plastic and Aesthetic Surgery Clinics, which manage 10 high-end clinics overall in Japan. We are planning to launch soon. Our medical education and practice development teams are working hard with them to put everything in place. So as soon as we start doing commercial cases with Seishin, we will let you know. And of course, we are very happy to do this in Japan. Japan is at the genesis of Mia. That's where we had the original idea of the need for this type of procedure. And eventually, we realized that there were these type of customers all over the world.

是的。謝謝，喬治。需要明確的是，我們已經簽約了第一批診所，即 Seishin 整形美容外科診所，該診所在日本總共管理著 10 家高端診所。我們計劃很快推出。我們的醫學教育和實踐開發團隊正在與他們一起努力，以確保一切就緒。因此，一旦我們開始與 Seishin 進行商業案例，我們就會通知您。當然，我們很高興在日本這樣做。日本是 Mia 的發源地。這就是我們對需要此類程序的最初想法。最終，我們意識到全世界都有這些類型的客戶。

So what we plan to do with Mia this year is to prove that we have new consumers that we're not seeking for a traditional breast augmentation. We want to be able to show how these clinics basically scale up because as we bring Mia to different geographies, this is the type of information that I think is going to get everyone excited about the market expansion that it can create.

所以我們今年計劃與 Mia 一起做的是證明我們有新的消費者，我們不是在尋求傳統的隆胸手術。我們希望能夠展示這些診所基本上是如何擴大規模的，因為當我們將 Mia 帶到不同的地區時，我認為這種信息會讓每個人都對它可以創造的市場擴張感到興奮。

Okay. Got it. That's really helpful. Maybe switching gears a little bit to margins. There's obviously a lot of moving pieces this year with the launch of Mia in Japan and in Europe as well, hopefully, Motiva in China and then potentially the U.S. at the end of the year. So could you just maybe help us with how we should think about the quarterly cadence for gross margins. It sounded like there were some maybe some ASP headwinds here in the fourth quarter. But how should we think about that as the year progresses and these additional markets start to contribute more significantly.

好的。知道了。這真的很有幫助。也許稍微切換一下利潤率。隨著 Mia 在日本和歐洲的推出，今年顯然有很多動人的作品，希望 Motiva 在中國推出，然後可能在年底在美國推出。那麼，您能否幫助我們了解我們應該如何考慮毛利率的季度節奏。聽起來第四季度這裡可能存在一些 ASP 逆風。但隨著時間的推移，我們應該如何考慮這一點，這些額外的市場開始做出更大的貢獻。

Yes. Good question, George. So you noticed in the quarter that the gross margin was down in the quarter, as we said in the prepared remarks, it was currency with the revaluation of the euro in the fourth quarter, and the fact that a lot of our inventory is denominated in euros, we had to revalue it and so that translational effect flow through our COGS. But overall, as we said, the trend in our gross margin is positive over time. And everything we're doing in terms of launching into these new geographies, to the Mia system, these are all positive to gross margin over time. And so the trend there is definitely to the upside. As you think about 2023, there are some puts and takes. The early launch of Mia, as well as standing up the new facility and the lower yields out of the new facility initially will be slightly negative to gross margin, but the things like China, continued new products going through will be positive to gross margin. And so the guidance is we really expect it to remain sort of flattish year in 2023. But over time, we should definitely see that margin going higher.

是的。問得好，喬治。所以你注意到本季度毛利率下降了，正如我們在準備好的評論中所說的那樣，這是第四季度歐元重估的貨幣，事實上我們的很多存貨都是以美元計價的歐元，我們必須對其進行重估，以便轉化效應通過我們的 COGS 流動。但總的來說，正如我們所說，隨著時間的推移，我們的毛利率趨勢是積極的。我們在進入這些新地區、進入 Mia 系統方面所做的一切，隨著時間的推移，這些都對毛利率產生積極影響。因此，趨勢肯定是向上的。當你想到 2023 年時，有一些投入和投入。 Mia 的早期推出，以及支持新設施和新設施的較低收益率最初將對毛利率產生輕微負面影響，但像中國這樣的持續新產品將對毛利率產生積極影響。因此，指導方針是我們真的預計它在 2023 年將保持平穩。但隨著時間的推移，我們肯定會看到利潤率上升。

Our next question comes from Anthony Petrone with Mizuho Group.

我們的下一個問題來自瑞穗集團的 Anthony Petrone。

Congratulations on the submission of the clinical module. Maybe just a little bit on guidance, $200 million to $210 million, how should we be thinking about contribution from Japan from the Mia launch in January, does that flow through in the $200 million to $210 million. And then when we think about Mia in China in the second half potentially being launched upon receipt of regulatory clearances, how should we be thinking about that contribution in the top line guidance? And I'll have a couple of follow-ups.

恭喜您提交了臨床模塊。也許只是一點點指導，2 億美元到 2.1 億美元，我們應該如何考慮日本在 1 月份推出 Mia 的貢獻，這筆錢是否會流入 2 億美元到 2.1 億美元。然後，當我們考慮下半年在中國的 Mia 可能會在收到監管許可後推出時，我們應該如何考慮頂線指導中的貢獻？我將進行一些跟進。

Sure, Anthony. When we think about guidance, right? There are a lot of moving parts, as you suggested here in 2023. When we think about providing numbers, though, we're looking at different scenarios around when we could see the timing of these, the contribution of them, when we started looking at kind of risk adjusting the various pieces of that, that's how we kind of come up with that $200 million to $210 million number. Certainly, the different analysts yourself included, will have different expectations for that. And it's difficult for us to provide exact numbers. But I think you will see the contribution from those new things build as the year unfolds with the underlying business still posting really strong growth as we saw in 2022.

當然，安東尼。當我們考慮指導時，對嗎？正如您在 2023 年在這裡建議的那樣，有很多變化的部分。不過，當我們考慮提供數字時，我們正在考慮不同的場景，當我們開始尋找時，我們可以看到這些的時間、它們的貢獻冒著調整其中各個部分的風險，這就是我們得出 2 億至 2.1 億美元數字的方式。當然，包括你自己在內的不同分析師對此會有不同的期望。我們很難提供確切的數字。但我認為，隨著這一年的展開，你會看到這些新事物的貢獻越來越大，基礎業務仍然會像我們在 2022 年看到的那樣實現強勁增長。

And then maybe a couple of follow-ups here. One would be on the near -- the sort of medium-term sort of outlook on manufacturing, if you will. If I'm not mistaken, the new manufacturing site brings you from about 700,000 implants to, I think, nearly 2 million per year in terms of production capacity. And fully understand in the early days, maybe it's margin dilutive, but as you get out into your 2, 3 and 4, how does the new facility play into gross margins specifically of the Mia implants? And then I'll have one last follow-up.

然後可能會在這裡進行一些跟進。如果你願意的話，一個是關於近期的——那種對製造業的中期展望。如果我沒記錯的話，新的生產基地每年可以生產大約 700,000 個植入物，而我認為，就生產能力而言，將近 200 萬個。並且在早期完全理解，也許它會稀釋利潤，但當你進入你的 2、3 和 4 時，新設施如何影響 Mia 植入物的毛利率？然後我將進行最後一次跟進。

Overall, the new facilities, you mentioned the volumes at that facility is capable of producing and the efficiencies that we can get out of that facility is definitely a positive to our margin over time. You couple that with things like the United States, China, which are ASP accretive, Mia, which is ASP accretive. The margin profile of our company on the gross margin line is going higher over time. As we mentioned, 2023, there's some moving parts here. But overall, that margin is well supported by a lot of different factors over time. .

總的來說，新設施，你提到該設施能夠生產的數量以及我們可以從該設施中獲得的效率隨著時間的推移肯定對我們的利潤率產生積極影響。你把它與像美國、中國這樣的東西結合起來，它們是 ASP 增長的，Mia 是 ASP 增長的。隨著時間的推移，我們公司在毛利率線上的利潤率狀況越來越高。正如我們提到的，2023 年，這裡有一些活動部件。但總的來說，隨著時間的推移，許多不同的因素都很好地支持了這一利潤率。 .

And last and I'll hop back in, is just the $500 million in 2026 when we think about how we should be sort of modeling that from a geographic standpoint? Any kind of directional point as you can give us would be helpful.

最後，我會跳回來，當我們考慮我們應該如何從地理角度建模時，2026 年的 5 億美元？您可以給我們的任何方向點都會有所幫助。

Yes. It's an interesting -- or a good question, right? Because there's a lot of layers to how you get to $500 million for us over time. And the number of permutations I can get you there is infinite, right? When we look at a number like that, though, and all the different supports we have underneath it, Juan, and as I mentioned, it's not only well supported, it could even be proven conservative over time. But in terms of breaking out individual contributions to that number, I think it's a little bit early for us to do that as we get further into it, we'll certainly provide more visibility into what contributes to it, and then ultimately also kind of how we look at the margin profile over time as we move through that. So we'll be providing more of our time on that number.

是的。這是一個有趣的——或者說是一個好問題，對吧？因為隨著時間的推移，你如何為我們獲得 5 億美元的資金有很多層次。我可以為您提供的排列數量是無限的，對嗎？但是，當我們看到這樣的數字，以及我們在它下面擁有的所有不同支持時，胡安，正如我提到的，它不僅得到了很好的支持，而且隨著時間的推移甚至可以證明是保守的。但就打破個人對這個數字的貢獻而言，我認為隨著我們進一步深入，我們現在這樣做還為時過早，我們肯定會提供更多的可見性，以了解對它有貢獻的因素，然後最終也會有點隨著時間的推移，我們如何看待利潤率概況。因此，我們將在該號碼上投入更多時間。

And our next question comes from Neil Chatterji with B. Riley Securities.

我們的下一個問題來自 B. Riley Securities 的 Neil Chatterji。

Maybe since we haven't touched on it yet in Q&A. Just curious if you could provide maybe some additional color just on the kind of traction you're seeing with Flora for the breast recon market and maybe the pipeline that you're planning for that market.

可能是因為我們還沒有在問答中談到它。只是好奇你是否可以提供一些額外的顏色，只是你在 Flora 中看到的那種牽引力，用於乳房偵察市場，也許你正在為該市場計劃的管道。

Yes, of course, I'm glad you asked about breast reconstruction because it is, to us, one of the most important things. This is such an underpenetrated market globally, and Flora is the first of a series of technologies that we will bring to market to make sure that we democratize access to breast recon, and what we mean by that is that the current market may be considered of appropriate size in the United States. But when you look at outside of the United States, if you were to take those same access numbers and moved it to the rest of the world that market would be substantially higher.

是的，當然，我很高興你問起乳房再造的問題，因為對我們來說，這是最重要的事情之一。這是一個全球滲透率低的市場，而 Flora 是我們將推向市場的一系列技術中的第一個，以確保我們使乳房檢查的訪問民主化，我們的意思是當前市場可能被認為是在美國合適的尺寸。但是當你看看美國以外的地區時，如果你使用相同的訪問號碼並將其轉移到世界其他地區，那麼該市場將會大幅上漲。

Now when we look at Flora, we continue to make gains quarter-to-quarter. However, this is a market that is based on tenders. It takes time. There are regions around the world that do this on an annual and even biannual basis. So we have to wait for them as they happen. However, we do plan to make sure over the next few years that we become the market leaders in breast reconstruction as we see it today. But more than that, that we are able to create the kind of market that we see in the United States for breast reconstruction.

現在，當我們查看 Flora 時，我們繼續按季度取得收益。然而，這是一個基於招標的市場。這需要時間。世界上有些地區每年甚至每兩年這樣做一次。所以我們必須等待它們發生。但是，我們確實計劃在未來幾年內確保我們成為今天所見的乳房再造市場領導者。但更重要的是，我們能夠創造我們在美國看到的那種乳房再造市場。

Great. And maybe just one quick follow-up. You've already kind of talked about the launch partner for Mia, but just kind of curious how might that launch partner in Japan kind of serve as a model for future clinics that you're either prospecting or targeting?

偉大的。也許只是一個快速跟進。您已經談到了 Mia 的啟動合作夥伴，但有點好奇日本的啟動合作夥伴如何成為您正在尋找或瞄準的未來診所的典範？

I think Seishin is a great model for what you will see in the future because you're talking about the chain of 10 clinics with marketing assets with a professional staff on the business side that can scale this to the right level. So we will be looking for partners like Seishin around the world. And again, it's not a buy-sell relationship. This is a true partnership .

我認為 Seishin 是您將來會看到的一個很好的模型，因為您談論的是 10 家具有營銷資產的連鎖診所，在業務方面擁有專業人員，可以將其擴展到合適的水平。因此，我們將在全球範圍內尋找像 Seishin 這樣的合作夥伴。再說一遍，這不是買賣關係。這是真正的伙伴關係。

(Operator Instructions) Our next question comes from Marie Thibault with BTIG.

（操作員說明）我們的下一個問題來自 BTIG 的 Marie Thibault。

This is Sam Eiber, on for Marie. Maybe I can start on OpEx cadence for this year, and I appreciate the commentary on the outlook for this year. But maybe in terms of cadence, would we expect maybe some leverage more towards the back half of the year? It sounds like maybe you're front-loading some investments here. And then as you get the contribution on the top line, that's when we might start to see leverage towards the back half and then more so in '24?

這是 Sam Eiber，代表 Marie。也許我可以從今年的 OpEx 節奏開始，我很欣賞對今年前景的評論。但也許就節奏而言，我們是否希望在今年下半年有更多的槓桿作用？聽起來您可能正在這裡預先加載一些投資。然後當你在頂線做出貢獻時，我們可能會開始看到對後半部分的影響，然後在 24 年更是如此？

Yes, I think that's the right way to think about it. I mean, as we've described here, right in 2023, there's just so many opportunities for us to support between the launch of Mia, preparation to the United States, the standing up of the new facility, moving into an operational capacity there, the early days in China, which again, we're using a distributor there, but there's some efforts we'll be supporting. And as we move into those initiatives, you'll start to see the leverage flow out of them. But this year is a year where we're investing. And as you get into '24 and beyond, you should start to see that leverage materialize in our model.

是的，我認為這是正確的思考方式。我的意思是，正如我們在這裡所描述的那樣，就在 2023 年，在 Mia 的發布、美國的準備、新設施的建立、進入那裡的運營能力之間，我們有很多機會提供支持，在中國的早期，我們再次在那裡使用經銷商，但我們會支持一些努力。當我們進入這些計劃時，您將開始看到它們的影響力。但今年是我們投資的一年。當你進入 24 世紀及以後，你應該開始看到我們模型中的槓桿作用。

Okay. Really helpful. And then maybe I can ask a follow-up here on the regulatory environment in the U.S. I guess, any updates on if you're expecting an adcom? How soon might you be able to figure that out? And is there even potential for a faster approval process considering you've had this modular submission process for a number of months now?

好的。真的很有幫助。然後也許我可以在這裡詢問有關美國監管環境的後續行動。我想，如果你期待一個 adcom，是否有任何更新？你多久能弄明白？考慮到您已經使用這種模塊化提交流程幾個月了，是否還有可能加快審批流程？

Yes, I think it's a little bit early for that. The most important thing is that we focus on the final stage of the regulatory process. I think as this unfolds, there may be opportunities, but I think we just have to keep ourselves to the proprietary of the trial and making sure that we answer every single question that comes our way from the FDA.

是的，我認為現在還為時過早。最重要的是我們專注於監管過程的最後階段。我認為隨著事情的發展，可能會有機會，但我認為我們只需要保持試驗的專有性，並確保我們回答來自 FDA 的每一個問題。

Thank you. There are no further questions at this time. I will hand the floor back over to Juan Jose Chacon Quiros for closing remarks. Thank you.

謝謝。目前沒有其他問題。我將把發言權交還給 Juan Jose Chacon Quiros 作閉幕詞。謝謝。

Thank you for joining us on today's call. We look forward to providing our next quarterly update in mid-May, 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 5 月中旬提供下一個季度更新，並祝大家身體健康、幸福快樂。

Thank you. This concludes today's conference. All parties may disconnect. Have a great day.

謝謝。今天的會議到此結束。各方可能會斷開連接。祝你有美好的一天。