Establishment Labs Holdings Inc. (ESTA) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good morning. Welcome to Establishment Labs First Quarter 2026 Earnings Call. (Operator Instructions) As a reminder, today's call is being recorded.

    早安。歡迎參加 Establishment Labs 2026 年第一季財報電話會議。(接線員指示)提醒各位,今天的電話會議將被錄音。

  • I will now turn the call over to Malavika William. Global Head of Corporate Communications and Marketing. Please go ahead.

    現在我將把電話交給 Malavika William,全球企業傳播與行銷主管。請開始。

  • Malavika William - Global Head of Corporate Communications and Marketing

    Malavika William - Global Head of Corporate Communications and Marketing

  • Thank you, operator, and thank you, everyone, for joining us. With me today is Peter Caldini, our Chief Executive Officer; and Sandra Harris, our Chief Financial Officer. Following our prepared remarks, we'll take your questions.

    謝謝接線員,也謝謝各位今天加入。我今天與會的有我們的執行長 Peter Caldini,以及我們的財務長 Sandra Harris。在我們的準備發言之後,我們將回答各位的提問。

  • Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities law. These include statements of 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.

    在開始之前,我想提醒各位,管理層在本次電話會議中的評論將包含符合聯邦證券法定義的前瞻性陳述。這些陳述包括 Establishment Labs 的財務展望,以及公司在產品開發與銷售方面的計畫與時程。這些前瞻性陳述係基於管理層目前的預期,並涉及風險與不確定性。

  • 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.

    關於可能影響我們表現或導致實際結果與上述陳述存在重大差異的主要風險因素與不確定性之討論,我建議各位查閱我們最新的 Form 10-K 年報與 Form 10-Q 季報,以及其他 SEC 申報文件;這些文件可於我們的網站 establishmentlabs.com 取得。

  • I'd also like to remind you that our comments may 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 or EBITDA, which we disclose on an adjusted EBITDA basis. Reconciliations to comparable GAAP financial measures for non-GAAP measures, if available, may be found in today's press release, which is available on our website.

    我也想提醒各位,我們的評論可能包含若干與公司表現相關的非 GAAP 財務衡量指標,包括但不限於銷售結果(可能以固定匯率基礎表達)或 EBITDA(我們以調整後 EBITDA 基礎揭露)。如可取得,非 GAAP 指標與可比 GAAP 財務衡量指標之調節表可見於今日新聞稿,並已發布於我們的網站。

  • The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, May 6, 2026. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call.

    本次電話會議內容包含具時效性的資訊,僅在本次直播日期(2026 年 5 月 6 日)當日為準確。除法律要求外,Establishment Labs 不承擔修訂或以其他方式更新任何陳述以反映本次電話會議日期之後事件或情況的義務。

  • With that, it is my pleasure to turn the call over to Peter.

    接下來,我很榮幸把電話交給 Peter。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Good morning, and thank you for joining us. Q1 2026 was a strong start to the year with $59.9 million in revenue and adjusted EBITDA of $1.2 million, representing revenue growth of 45% over Q1 2025. The US business continued to outperform with $19.6 million of revenue, a growth of 216% over Q1 2025 and quarter-over-quarter growth of 13.3%. It's worth noting that Q1 is a seasonally light quarter for breast augmentation and reconstruction, so to grow quarter-over-quarter is a testament to the strength and acceleration of our US launch.

    早安,感謝各位加入我們。2026 年第一季為今年帶來強勁開局,營收達 5,990 萬美元,調整後 EBITDA 為 120 萬美元,較 2025 年第一季營收成長 45%。美國業務持續表現超越預期,營收 1,960 萬美元,較 2025 年第一季成長 216%,且較上一季成長 13.3%。值得注意的是,第一季在隆乳與重建方面屬於季節性較淡的季度,因此仍能季對季成長,證明我們美國上市推進的力道與加速成效。

  • Outside the US, we delivered 15% growth, driven by strong execution on both our direct and distributor markets. Our minimally invasive platform is showing immense promise as well, generating $9.1 million in revenue in Q1. At the same time, we had our third quarter of positive adjusted EBITDA. Our gross margin improved by 350 basis points in Q1 2026 to 70.7%, up from 67.2% in Q1 2025.

    在美國以外市場,我們實現 15% 的成長,主要來自我們在直營與經銷市場的強勁執行。我們的微創平台同樣展現巨大潛力,第一季創造 910 萬美元營收。同時,我們也連續第三個季度達成調整後 EBITDA 為正。2026 年第一季毛利率提升 350 個基點至 70.7%,高於 2025 年第一季的 67.2%。

  • We refinanced our credit facility and expect to reach cash flow positive in the second half of the year. Our increasing profitability is demonstrating the operational leverage in our business as well as our ability to generate meaningful earnings per share in the coming years. We continue to be conservative as we forecast our business due to the geopolitical landscape as well as our hyper focus on achieving and scaling a cash flowing positive business.

    我們已為信貸融資安排完成再融資,並預期在今年下半年達到現金流轉正。我們獲利能力的提升,展現了業務的營運槓桿,以及我們在未來幾年創造具意義每股盈餘的能力。鑑於地緣政治局勢,以及我們高度聚焦於達成並擴大現金流轉正的業務,我們在業務預測上仍維持保守。

  • As such, we are raising our guidance to $266.5 million to $268.5 million, up from a previous range of $264 million to $266 million. Our confidence comes from the strong start we are having in Q2, we are setting new weekly highs in our US order counts. We expect our growth to continue throughout 2027 as well.

    因此,我們將全年財測上調至 2.665 億至 2.685 億美元,高於先前的 2.64 億至 2.66 億美元區間。我們的信心來自第二季的強勁開局;我們在美國的每週訂單數正創下新高。我們也預期成長將延續至 2027 年。

  • As we've mentioned on prior calls, there is a good likelihood we may be included in several indices, beginning with the Russell 2000. As we're seeing increased interest from firms that benchmark to these indices, we thought it would be helpful to provide an overview for those being introduced to our company for the first time. The robust growth we reported this quarter is a reflection of our work since 2011.

    如同我們在先前電話會議中提到的,我們很可能被納入多個指數,首先可能是 Russell 2000。隨著我們看到以這些指數為基準的機構興趣增加,我們認為有必要為首次認識本公司的投資人提供概覽。我們本季所報告的強勁成長,反映了自 2011 年以來的努力成果。

  • Establishment Labs is a women's health company focused on transforming breast aesthetics and reconstruction through innovation. Since the moratorium on breast implants in the US was imposed in 1992, this category has seen very little meaningful innovation. And as a result, patient behavior, surgeon adoption and overall market growth has remained relatively static.

    Establishment Labs 是一家女性健康公司,專注於透過創新改變乳房美學與重建。自 1992 年美國對乳房植入物實施暫停令以來,該類別幾乎沒有出現具實質意義的創新。因此,患者行為、醫師採用率以及整體市場成長都相對停滯。

  • Establishment Labs was founded on the belief that a deep investment in science could fundamentally improve existing technology and provide better options for women. From the beginning, we reexamined every aspect of the breast implant from surface technology to manufacturing, leveraging advances in material science, biomedical engineering and device design. This work is reflected in a robust intellectual property portfolio with more than 200 patents issued and pending worldwide.

    Establishment Labs 的創立基於一項信念:對科學的深度投入能從根本上改善既有技術,並為女性提供更好的選擇。從一開始,我們便重新檢視乳房植入物的每個面向,從表面技術到製造流程,並運用材料科學、生物醫學工程與器械設計的進步。這些成果體現在我們強大的智慧財產權組合中,全球已核准與申請中的專利超過 200 件。

  • In 2015, we brought on Dr. Robert Langer to lead our Scientific Advisory Board. Bob Langer is one of the most accomplished scientists of the 21 century, and his contributions are behind the founding of several prominent companies. His work at MIT continues to impact science at the highest levels. Our partnership resulted in a seminal paper for plastic surgery.

    2015 年,我們邀請 Robert Langer 博士領導我們的科學諮詢委員會。Bob Langer 是 21 世紀最傑出的科學家之一,他的貢獻促成多家知名公司的創立。他在麻省理工學院(MIT)的研究持續在最高層級影響科學界。我們的合作也促成了一篇對整形外科具有里程碑意義的論文。

  • Published in Nature Biomedical Engineering in 2021, this paper focused on breast implant surface technologies and highlighted that the 4-micron surface, which was intentionally designed to enhance biocompatibility, consistently demonstrated low inflammation. These results explain how Motiva implants outperformed the category.

    該論文於 2021 年發表於《Nature Biomedical Engineering》,聚焦於乳房植入物表面技術,並指出為提升生物相容性而刻意設計的 4 微米表面,持續展現低發炎反應。這些結果解釋了 Motiva 植入物如何優於同類產品。

  • The US FDA clinical trial matched both our research findings and clinical data from around the world and is quite frankly, game-changing. All these data points show device-related complication rates at new industry lows, including capsular contracture rates of less than 1%. To put this in perspective, the FDA trials for competitive products have device-related complications rates that are upward to 20%. And in some cases, the complication rates far exceed 20%.

    美國 FDA 的臨床試驗同時印證了我們的研究發現與全球臨床數據,坦白說,這是改變遊戲規則的成果。所有這些數據顯示,器械相關併發症率降至產業新低,包括莢膜攣縮率低於 1%。作為對照,競品的 FDA 試驗中,器械相關併發症率最高可達 20%;在某些情況下,併發症率甚至遠高於 20%。

  • Perhaps most interesting is our extended global warranty data with over 49,000 warranties sold and only 377 claims submitted, the resulting complication rate is less than 1%. We publish this data annually on our post-market surveillance report and are the only company in the industry that publicly shares this information, which you can find readily available on our company website.

    或許更值得關注的是,我們延伸的全球保固數據:已售出超過 49,000 份保固,僅提交 377 件理賠,因此對應的併發症率低於 1%。我們每年在上市後監測報告中公布此數據,且我們是業界唯一公開分享此資訊的公司;各位可在公司網站上輕易查閱。

  • Fear of complications are one of the top barriers for patients when considering a breast augmentation. Having a product that has an outstanding safety profile helps to diminish that concern and provides extra peace of mind for both patients and surgeons. Less complications leads to happy patients and more referrals, which is the lifeblood for any plastic surgery practice.

    對併發症的恐懼是患者考慮隆乳時的主要障礙之一。擁有安全性表現卓越的產品,有助於降低這項疑慮,並為患者與醫師提供額外的安心感。併發症越少,患者越滿意、轉介越多,而轉介正是任何整形外科診所的命脈。

  • The significant technology moat that has been established is enhanced by our R&D pipeline of continuous innovation. Not only do we believe that we can take a substantial majority of breast implant market in time, we also believe we can significantly expand the market from where it is today. That is best evidenced by the launch of our Motiva minimally invasive platform.

    我們已建立的顯著技術護城河,並由持續創新的研發管線進一步強化。我們不僅相信隨時間推進可取得乳房植入物市場的相當大部分份額,也相信能顯著擴大目前的市場規模。這點最能由我們 Motiva 微創平台的推出得到印證。

  • We have 2 minimally invasive procedures in market right now, Mia and Preserve. A third is currently in development called GEM and is a revolutionary advancement for gluteal augmentation that should offer a safer, more predictable alternative to the Brazilian Butt Lift. Both Mia and Preserve are available outside the United States with a presence in more than 45 markets globally.

    目前我們已有兩項微創療程在市場上:Mia 與 Preserve。第三項名為 GEM 的療程正在開發中,這將是臀部增大領域的革命性進展,可望提供比巴西提臀(Brazilian Butt Lift)更安全、更可預測的替代方案。Mia 與 Preserve 目前皆在美國以外地區提供,並已進入全球超過 45 個市場。

  • While Mia is not yet available in the United States, we recently introduced Preserve to the US market. Both are built on tissue-preserving practices, which Establishment Labs has pioneered, and they allow for the use of minimal anesthesia while preserving the patient's native breast tissue, nipple sensation and chest muscles.

    雖然 Mia 尚未在美國上市,我們近期已將 Preserve 引進美國市場。兩者皆建立在保留組織的實務之上,這是 Establishment Labs 所開創的作法;並可在保留患者原生乳房組織、乳頭感覺與胸肌的同時,使用最少量的麻醉。

  • Mia features the Motiva Ergonomix2 Diamond shaped implant, which has a unique shape that allows for greater projection than a conventional round implant as the shape creates more projection with less volume. It also includes a proprietary shell, which allows insertion through the smallest incision possible within the Motiva portfolio. These characteristics make for a true scarless breast augmentation done by a small incision in the underarm. This procedure is meant for patients looking for a subtle enhancement with 1 to 2 cup size increase.

    Mia 採用 Motiva Ergonomix2 菱形植入物,其獨特形狀使其相較於傳統圓形植入物能提供更大的前凸度,因為該形狀能以較小體積創造更高投射效果。它亦包含專有外殼,可在 Motiva 產品組合中透過可能最小的切口完成置入。這些特性使其能透過腋下的小切口完成真正近乎無疤痕的隆乳。此療程適用於希望細緻提升、罩杯增加 1 至 2 個尺寸的患者。

  • Preserve can feature either the Motiva Ergonomix1 or 2 implants and accommodates both primary breast augmentation and primary breast augmentation mastopexy, offering patients smaller scars tucked under the breast crease and allows for larger sizes to be used. The launch of minimally invasive techniques into any specialty almost always dramatically increases the market.

    Preserve 可搭配 Motiva Ergonomix1 或 2 植體,並可同時適用於初次隆乳與初次隆乳合併乳房提乳(mastopexy),為患者提供更小、隱藏於乳房下皺襞的疤痕,且允許使用更大尺寸。將微創技術導入任何專科,幾乎總是會大幅擴大市場。

  • For example, there were approximately 95,000 total knee arthroplasty procedures in 1991. Between 2000 and 2005, minimally invasive knee procedures became the standard. And by 2010, there were approximately 250,000 procedures annually. In 2025 alone, this number rose to approximately 1.3 million, an increase of close to 14 times. This kind of growth exists in other major procedure types as well, such as LASIK eye surgery and fat reduction.

    例如,1991 年全膝關節置換術(total knee arthroplasty)約有 95,000 例。2000 至 2005 年間,微創膝關節手術成為標準。到 2010 年,每年約有 250,000 例。僅 2025 年,該數字上升至約 130 萬例,增加接近 14 倍。此類成長也存在於其他主要手術類型,例如 LASIK 近視雷射與減脂。

  • In the United States, our minimally invasive technologies command a premium over 2 times higher than traditional breast augmentation. And if our overseas growth is any indication, we can expect that minimally invasive will create significant market expansion and be a meaningful driver of growth. The value proposition for patients is well defined, smaller scars, minimal anesthesia, preservation of tissue and sensation and a faster recovery, combined with the safety and performance benefits of Motiva.

    在美國,我們的微創技術相較於傳統隆乳的定價溢價超過 2 倍。若以我們海外成長作為指標,我們預期微創將帶來顯著的市場擴張,並成為重要的成長驅動力。對患者而言,其價值主張非常明確:更小疤痕、最少麻醉、保留組織與感覺以及更快復原,再加上 Motiva 的安全性與性能優勢。

  • Our initial 3-year study on Mia was published in the Aesthetic Surgery Journal in October 2025 and showed no device-related complications. Like our FDA trial data, this is game-changing. It's clear that this procedure is fundamentally different from what has come before. Many women no longer view this as the traditional breast augmentation they once knew, but rather as a more accessible almost lunchtime procedure where they can return to normal social activities within hours. Women that have never considered breast augmentation before are now getting the procedure, and we are expanding the market.

    我們針對 Mia 的初步 3 年研究已於 2025 年 10 月發表在《Aesthetic Surgery Journal》,結果顯示沒有任何與器械相關的併發症。與我們的 FDA 試驗數據一樣,這具有顛覆性意義。很明顯,這項手術在本質上不同於以往。許多女性不再將其視為她們過去所熟知的傳統隆乳,而是更容易接觸、幾乎像午休就能完成的手術,並可在數小時內恢復正常社交活動。過去從未考慮隆乳的女性如今也開始接受手術,我們正在擴大市場。

  • RealSelf, a popular online platform for aesthetic patients, published last week that breast augmentation page views were up 45% from Q4 and that breast implant revision page views were up 89%, indicating that patients' interest in the category is surging.

    受歡迎的醫美患者線上平台 RealSelf 上週發布資料指出,隆乳頁面瀏覽量較第四季(Q4)增加 45%,而乳房植體修復(revision)頁面瀏覽量增加 89%,顯示患者對該類別的興趣正在快速升溫。

  • Not only do our patients benefit, our minimal invasive platform also has the potential to increase surgeon productivity, allowing surgeons to run two operating rooms, one where the patient is being prepped or the room is being cleaned and the other where the surgeon is operating. We had one plastic surgeon that started surgery at 6:00 AM and by 10:30 AM, he had completed 10 minimal invasive surgeries. Scheduling a minimally invasive procedure day like this can generate more than 2 times additional revenue for a practice.

    不僅患者受益,我們的微創平台也有潛力提升外科醫師生產力,使醫師可同時運作兩間手術室:一間用於患者準備或清潔,另一間由醫師進行手術。我們曾有一位整形外科醫師早上 6:00 開始手術,到 10:30 已完成 10 台微創手術。像這樣安排一整天的微創手術,可為診所帶來超過 2 倍的額外營收。

  • The introduction of our minimal invasive platform enhances the Motiva portfolio, creating a clear, good, better, best framework. This allows the plastic surgeon to address a broader range of patient needs across the aesthetics outcomes, lifestyle consideration and price points. This portfolio approach is not just about product breadth, it enables us to expand the category, increase procedure volumes and drive higher value per procedure while giving surgeons the flexibility to tailor their solutions to each patient. Patients are now engaging with surgeons very differently than before. In a category where it was historically very unusual for patients to ask about implant brands, 78% of surgeons now report being asked for a brand by name. And in those cases, 93% of the time, that brand is Motiva.

    我們微創平台的導入強化了 Motiva 產品組合,建立清晰的 good、better、best 架構。這使整形外科醫師能在美學效果、生活型態考量與價格帶上,滿足更廣泛的患者需求。此產品組合策略不僅是擴充品項,更讓我們得以擴大類別、提升手術量,並在每次手術中創造更高價值,同時賦予醫師彈性,為每位患者量身打造解決方案。患者如今與醫師互動的方式也與以往大不相同。在過去患者很少會詢問植體品牌的類別中,現在有 78% 的醫師表示患者會指名詢問品牌;而在這些情況下,有 93% 指名的品牌是 Motiva。

  • And now just 18 months into our US launch, we are seeing the next step. Patients are not only asking for Motiva, they are actively seeking out surgeons who are trained in minimally invasive procedures. We expect to see a similar dynamic as we enter breast reconstruction in the United States, an opportunity that is equal in size to the breast augmentation market. We submitted Motiva implants to the US FDA for approval in primary and revision breast reconstruction in December 2025 and are currently progressing through the review process. I hope that reintroduction to our business was helpful and that the context explains our success to date.

    而在美國上市僅 18 個月後,我們已看到下一步:患者不僅指名 Motiva,還會主動尋找受過微創手術訓練的醫師。我們預期當我們在美國進入乳房重建領域時,也會出現類似動態;該機會的市場規模與隆乳市場相當。我們已於 2025 年 12 月向美國 FDA 提交 Motiva 植體,用於初次與修復乳房重建的核准申請,目前正處於審查流程中。我希望這次對我們業務的重新介紹有所幫助,並且上述背景能說明我們迄今的成功。

  • The US remains the most important driver for our growth. Motiva continues to be one of the fastest launches in the history of breast aesthetics, and we continue to expand our footprint, recently surpassing 1,700 accounts. We are seeing increased adoption from higher-volume surgeons who have moved beyond initial evaluation and are now fully committed to Motiva. This is reflected in our order growth, where we have experienced 30% increase in average orders since the end of Q4. We officially launched our minimally invasive platform in the United States in March, and the response has been exceptional.

    美國仍是我們成長最重要的驅動力。Motiva 持續成為乳房醫美史上最快速的上市之一,我們也持續擴大覆蓋範圍,近期已超過 1,700 個客戶帳戶。我們看到更多高量能醫師的採用,他們已超越初期評估階段,並全面投入 Motiva。這反映在訂單成長上:自 Q4 結束以來,我們的平均訂單量增加了 30%。我們於 3 月在美國正式推出微創平台,市場反應極為出色。

  • While we initially trained surgeons on Preserve in our campus in Costa Rica, early demand was so strong, we began training in the United States as well. This has allowed us to train surgeons at a much faster rate, and we have now certified more than 260 surgeons in the US. For context, our goal was to train 200 surgeons by the end of 2026, and we soared past that number by the end of the first quarter. Those trained have shown a strong intent to purchase, and we have seen relatively quick adoption with the first procedures being performed shortly after training.

    雖然我們最初在哥斯大黎加的園區為外科醫師進行 Preserve 訓練,但早期需求非常強勁,因此我們也開始在美國進行訓練。這使我們能以更快速度培訓外科醫師,目前已在美國認證超過 260 位外科醫師。作為對照,我們原本目標是在 2026 年底前訓練 200 位外科醫師,但在第一季末就大幅超越該數字。受訓者展現出強烈的採購意願,我們也看到相對快速的導入,許多醫師在受訓後不久即開始進行首批手術。

  • A surgeon in the Northeast recently shared that he began offering Preserve after being trained and promoted the procedure on social media. He now has 50 Preserve cases scheduled in Q2 at a 30% premium to his traditional breast augmentation price. Another surgeon in Southern California was thrilled that Preserve has completely changed her practice and that she is consistently seeing patients that had previously deferred surgery due to the concerns around anesthesia and recovery.

    美國東北部一位外科醫師近期分享,他在受訓後開始提供 Preserve,並在社群媒體上推廣該手術。他目前在第二季(Q2)已排定 50 例 Preserve 手術,收費較其傳統隆乳價格溢價 30%。南加州另一位外科醫師則表示 Preserve 徹底改變了她的診所經營,她持續看到過去因擔心麻醉與復原而延後手術的患者前來就診。

  • When you remove historic barriers, you bring new patients into the market. A recent Preserve patient who is a Pilates instructor got her procedure done on a Saturday, went to dinner with friends that night and was back teaching Pilates on Monday. This kind of recovery is traditionally unheard of. And for the first time, patients are truly returning to normal activity with a minimal downtime.

    當你移除歷史性的障礙,就能把新患者帶入市場。近期一位 Preserve 患者是皮拉提斯教練,她在週六完成手術,當晚就與朋友外出用餐,週一便回去授課。這種復原速度在傳統上幾乎聞所未聞。而且首次出現患者真正以極短停工期回到正常活動。

  • In a recent survey conducted with 94 Preserve patients, 3 months post-surgery, 98% stated that they experienced minimal disruption to their daily lives with 95% satisfied or extremely satisfied with the results. In addition, 15% of patients said they were new to the category and had not considered breast augmentation until they learned about Preserve. 84% of the Preserve patient survey said they were willing to pay a premium for the benefits of the procedure with 99% saying that they would choose this procedure again.

    在一項針對 94 位 Preserve 患者的近期調查中,術後 3 個月,98% 表示日常生活受到的影響極小,且 95% 對結果感到滿意或非常滿意。此外,15% 的患者表示自己是此類別的新客群,在了解 Preserve 之前從未考慮過隆乳。84% 的 Preserve 患者調查回覆表示願意為手術效益支付溢價,且 99% 表示若再選一次仍會選擇此手術。

  • Outside the United States, our business continues to perform well. We delivered approximately 15% growth with strong performance across our direct markets, which continues to be a major focus area for us. Our minimally invasive platform continues to be a key driver for growth globally. It is interesting that surgeons generally view the 2 procedures as complements to each other and all Mia accounts are offering Preserve, showcasing the value of a minimally invasive portfolio approach that provides patients options to meet their aesthetic goals.

    在美國以外,我們的業務表現持續良好。我們實現約 15% 的成長,直營市場表現強勁,而直營市場仍是我們的重點投入領域。我們的微創平台持續成為全球成長的關鍵驅動力。有趣的是,外科醫師普遍將這兩種手術視為互補;所有 Mia 帳戶也都提供 Preserve,展現微創產品組合策略的價值,讓患者能有多元選項以達成其美學目標。

  • Preserve continues to attract surgeons to the overall Motiva portfolio. In our OUS markets, we are seeing strong growth across European direct markets, including the UK, Germany, Nordics and our newly acquired Benelux affiliate. Continued stabilization in Latin America with solid performance in Argentina due to the adoption of the Motiva minimally invasive platform as well as steady demand across all our distributor markets. Our exposure to the Middle East remains less than 5% of total revenue, limiting risk from regional volatility.

    Preserve 持續吸引外科醫師採用整體 Motiva 產品組合。在我們的 OUS 市場中,我們看到歐洲直營市場(包括英國、德國、北歐,以及我們新收購的比荷盧(Benelux)子公司)均呈現強勁成長。拉丁美洲持續趨於穩定,阿根廷因採用 Motiva 微創平台而表現穩健;同時我們所有經銷市場的需求也保持穩定。我們對中東地區的曝險仍低於總營收的 5%,因此可降低區域波動帶來的風險。

  • In our US and OUS markets, we expect growth to continue to accelerate into 2027. We also expect to continue the innovation pipeline by expansion in breast reconstruction in the United States, which effectively doubles our addressable market, gaining CE Mark for Zen temperature, marking our entrance into biosensing capabilities, introducing smaller sizes to our US product matrix and thus expanding our reach within existing accounts, continue to develop our pipeline, including GEM, our glue augmentation solution.

    在美國與 OUS 市場,我們預期成長將持續加速至 2027 年。我們也預期將持續推進創新管線,包括在美國擴展至乳房重建,實質上使我們的可服務市場規模加倍;為 Zen temperature 取得 CE Mark,標誌我們進入生物感測能力;在美國產品矩陣中導入更小尺寸,從而擴大我們在既有帳戶中的覆蓋;並持續開發我們的管線,包括 GEM(我們的黏合式隆乳解決方案)。

  • We also plan to submit for Health Canada medical device license for expansion in the Canadian market. As part of our overall strategy, we are taking steps to secure our future growth. This includes our signed agreement with Oaktree that refinances our debt and enhances our financial flexibility.

    我們也計畫向加拿大衛生部(Health Canada)提交醫療器材許可申請,以擴展加拿大市場。作為整體策略的一部分,我們正採取措施以確保未來成長,包括與 Oaktree 簽署的協議,該協議為我們的債務進行再融資並提升財務彈性。

  • And finally, we are in active conversations with NuSil, our silicone supplier as we both look to establish a long-term agreement. We've had strong working relationship with NuSil for the last 15 years, and our ongoing conversations are very focused on what we can accomplish together as partners.

    最後,我們正與矽膠供應商 NuSil 進行積極洽談,雙方皆希望建立長期協議。我們與 NuSil 在過去 15 年維持良好的合作關係,而目前的持續對話也非常聚焦於作為合作夥伴,我們能共同達成哪些成果。

  • I will now turn the call over to Sandra.

    我現在把電話交給 Sandra。

  • Cassandra Harris - Senior Vice President, Chief Financial Officer

    Cassandra Harris - Senior Vice President, Chief Financial Officer

  • Thank you, Peter. We delivered an exceptional start to 2026 with nearly 45% revenue growth, gross margin expansion over 70% and our third consecutive quarter of positive adjusted EBITDA, demonstrating the strength, scalability and operating leverage of our business.

    謝謝你,Peter。我們在 2026 年取得了非凡的開局,營收成長接近 45%,毛利率擴張至超過 70%,並且連續第三季實現正向的調整後 EBITDA,展現了我們業務的實力、可擴展性與營運槓桿。

  • Total revenue for the first quarter was $59.9 million, an increase of 44.7% from Q1 2025. Starting with our geographic performance. Our business outside the United States remains the largest contributor to revenue and continues to perform well. In the first quarter, OUS revenue grew approximately 15% over Q1 2025, driven by strength across our distributor and direct markets with direct markets delivering double-digit growth. Our exposure to the Middle East remains limited at less than 5% of total annual revenue.

    第一季總營收為 5,990 萬美元,較 2025 年第一季成長 44.7%。先從地區表現談起。我們在美國以外的業務仍是營收的最大貢獻來源,且持續表現良好。第一季 OUS(美國以外)營收較 2025 年第一季約成長 15%,主要受惠於經銷與直營市場的全面走強,其中直營市場實現雙位數成長。我們對中東地區的曝險仍然有限,全年總營收占比低於 5%。

  • In the United States, we see strong momentum early in our expansion. US revenue reached $19.6 million in the quarter and now represents 32.7% of total revenue, up from 26.8% in Q4 2025 and higher than the 15% from Q1 of 2025. This growth reflects both continued adoption of Motiva and the March launch of our minimally invasive platform, which is contributing to higher realized price points.

    在美國市場,我們在擴張初期就看到強勁動能。該季度美國營收達 1,960 萬美元,目前占總營收的 32.7%,高於 2025 年第四季的 26.8%,也高於 2025 年第一季的 15%。這項成長反映了 Motiva 持續被採用,以及我們於 3 月推出的微創平台;該平台正推動更高的實現價格水準。

  • Our gross profit for the first quarter was $42.3 million or 70.7% of revenue, a 350 basis point increase compared to 67.2% of revenue in Q1 of 2025. This expansion was primarily driven by the increasing contribution of our higher-margin US business, along with the growing impact of our minimally invasive platform, which carries higher average selling prices and margins.

    第一季毛利為 4,230 萬美元,或占營收的 70.7%,較 2025 年第一季占營收 67.2% 提升 350 個基點。此一擴張主要來自毛利率較高的美國業務貢獻占比提升,以及微創平台影響力日增;該平台具備更高的平均售價與毛利率。

  • SG&A expenses increased $3.9 million to $43.6 million compared to $39.7 million in the first quarter of 2025. The increase was primarily driven by variable costs associated with higher sales, including freight as well as the impact of foreign exchange with continued investment in the US business. Excluding a one-time item, adjusted SG&A was $41 million or 68.4% of revenue, representing approximately 50 basis points of leverage versus the prior year as we began to scale the business.

    SG&A(銷售、一般及行政)費用較 2025 年第一季的 3,970 萬美元增加 390 萬美元至 4,360 萬美元。增加主要由與銷售成長相關的變動成本所帶動(包括運費),以及外匯影響,同時我們持續投資美國業務。排除一次性項目後,調整後 SG&A 為 4,100 萬美元,或占營收的 68.4%;隨著我們開始擴大規模,較去年約展現 50 個基點的槓桿效益。

  • R&D expenses for the first quarter were $5.2 million, consistent with prior quarters. Adjusted EBITDA was positive $1.2 million in the first quarter compared to a loss of $12.1 million in the first quarter of last year. This is our third consecutive quarter of positive adjusted EBITDA.

    第一季研發費用為 520 萬美元,與前幾季一致。第一季調整後 EBITDA 為正 120 萬美元,相較去年第一季虧損 1,210 萬美元大幅改善。這是我們連續第三季實現正向調整後 EBITDA。

  • During the quarter, cash decreased $7.5 million to $68.1 million from December 31, 2025. The decrease was primarily driven by investments in the US market. We recently completed a refinancing of our debt, which enhances our financial flexibility, improves our liquidity profile and introduces PIK interest that supports our path to cash flow generation. We have enough cash on hand to reach cash flow positive and have no needs or plans to do any type of equity financing.

    本季度現金較 2025 年 12 月 31 日減少 750 萬美元至 6,810 萬美元。下降主要由於對美國市場的投資。我們近期完成了債務再融資,提升了財務彈性、改善了流動性結構,並引入 PIK(實物支付)利息,以支持我們邁向現金流產生。我們手上現金足以達到現金流轉正,且沒有任何需求或計畫進行任何形式的股權融資。

  • Following our strong performance in the first quarter, we are increasing our full year revenue guidance to $266.5 million to $268.5 million, up from our prior range of $264 million to $266 million. This represents growth of approximately 26% to 27% over 2025. We expect our OUS business to grow in the single digits, while the US is expected to exceed 30% of total revenue for the year, up from approximately 22% last year.

    在第一季強勁表現之後,我們上調全年營收指引至 2.665 億至 2.685 億美元,高於先前的 2.64 億至 2.66 億美元區間。這代表較 2025 年約成長 26% 至 27%。我們預期 OUS 業務將呈現個位數成長,而美國業務預計全年營收占比將超過 30%,高於去年的約 22%。

  • At $9.1 million in the quarter, our minimally invasive business is above expectations, and we now expect to exceed $35 million in 2026, up from the $30 million we guided to in February. We expect gross margins in the range of 71.2% to 72.2% for the full year. Operating expenses are expected to remain between $195 million and $200 million, with some variability in quarterly spending based on timing. We also expect to be adjusted EBITDA positive in each quarter of 2026.

    本季度我們的微創業務營收為 910 萬美元,優於預期;我們目前預期 2026 年將超過 3,500 萬美元,高於我們 2 月所指引的 3,000 萬美元。我們預期全年毛利率介於 71.2% 至 72.2%。營運費用預計維持在 1.95 億至 2.00 億美元之間,季度支出可能因時點而有所波動。我們也預期 2026 年每一季都將維持調整後 EBITDA 為正。

  • As it relates to cash flow, we are on track to achieve cash flow positive in the second half of the year, driven by improved profitability and greater working capital efficiency. In the near term, we expect higher cash usage in the second quarter compared to the first quarter, primarily due to the final $4.7 million payment related to the Benelux acquisition, the normal timing of the short-term incentive payouts and continued investment to support the US commercial expansion, partially offset by $6 million of proceeds from our recent debt refinancing.

    就現金流而言,我們正按計畫在下半年達成現金流轉正,主要由獲利能力提升與營運資金效率改善所驅動。短期內,我們預期第二季的現金使用量將高於第一季,主要因為與 Benelux 收購相關的最後一筆 470 萬美元付款、短期激勵獎金發放的正常時點,以及持續投資以支持美國商業擴張;部分將由近期債務再融資取得的 600 萬美元款項所抵銷。

  • We expect cash performance to improve meaningfully in the third and fourth quarters, supported by increased profitability and the benefit of PIK interest of more than $5 million per quarter. Historically, Q2 and Q4 are the strongest quarters in the industry with Q4 being the largest, while Q3 is typically softer due to summer seasonality. Operating expenses will be elevated in Q2 as we continue to invest in the US business. Despite this, we expect Q2 EBITDA to be approximately double that of Q1, reflecting the underlying operating leverage in the business.

    我們預期第三季與第四季的現金表現將顯著改善,受惠於獲利提升以及每季超過 500 萬美元的 PIK 利息效益。歷史上,產業中第二季與第四季通常是最強的季度,其中第四季最大;而第三季通常因夏季季節性而較疲弱。第二季營運費用將偏高,因我們持續投資美國業務。儘管如此,我們預期第二季 EBITDA 約為第一季的兩倍,反映出業務內在的營運槓桿。

  • With respect to index inclusion, April 30 marked the Russell reconstitution rank date. And based on our current market capitalization, we believe we are well positioned to qualify for inclusion in the Russell indices with final membership to be confirmed in the coming months.

    關於指數納入方面,4 月 30 日為 Russell 指數重組的排名日期。根據我們目前的市值,我們認為我們具備良好條件可望符合納入 Russell 指數的資格,最終成分股資格將於未來幾個月確認。

  • With that, I'll turn the call back to Peter.

    接下來我把電話交回給 Peter。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Thank you, Sandra. As you think about our business, we hope we get a chance to interact with you at one of our many events we attend throughout the year. If you're interested in learning more, we selectively invite investors to visit us in Costa Rica at our innovation campus alongside our US plastic surgeon delegations. Investors have found this trip very useful in validating our business and the overall opportunity.

    謝謝你,Sandra。談到我們的業務,我們希望今年在我們參與的眾多活動中,有機會與各位互動。如果你有興趣進一步了解,我們會選擇性邀請投資人前往哥斯大黎加參訪我們的創新園區,並與我們的美國整形外科醫師代表團同行。投資人認為這趟行程對於驗證我們的業務與整體機會非常有幫助。

  • We are also hosting a small dinner in Boston around The Aesthetic MEET Plastic Surgery Conference from May 14 to May 17. If you're interested in either of these, please reach out as space is limited. I appreciate you taking the time to listen, and I hope to see you on the next call soon.

    我們也將於 5 月 14 日至 5 月 17 日、在波士頓 The Aesthetic MEET Plastic Surgery Conference 期間舉辦一場小型晚宴。如果你對其中任何一項有興趣,請與我們聯繫,因名額有限。感謝你撥冗收聽,也希望很快在下一次電話會議上見到你。

  • Operator, we're ready to take questions.

    接線員,我們準備開始提問。

  • Operator

    Operator

  • Thank you, sir. Ladies and gentlemen, we will now be conducting the question-and-answer session. (Operator Instructions)

    謝謝您,先生。各位女士、先生,我們現在開始問答環節。(接線員指示)

  • Anthony Petrone, Mizuho Group.

    Mizuho Group 的 Anthony Petrone。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thanks. Congratulations, Pete, Sandra and to the team on a strong start to the year here. Maybe the US momentum here, it looks like an inflection and you have really almost 2 simultaneous launches, if you will, ongoing. It's the US Motiva platform in and of itself. There's still a push into new accounts. And then, of course, we have the Preserve launch. So maybe how much was just new accounts bringing in Motiva as a platform versus the Preserve go-live counts? I mean, by our estimate, you're probably approaching somewhere between 75 and 100 go-live Preserve accounts. I'll start there, and I'll have a quick follow-up.

    謝謝。恭喜 Pete、Sandra 以及團隊今年有個強勁的開局。也許先談談美國的動能,看起來像是一個拐點,而且你們幾乎同時有兩個持續進行的上市推進:一個是美國的 Motiva 平台本身,仍在推進新客戶;另一個當然是 Preserve 的上市。所以想請教,這其中有多少是新客戶導入 Motiva 平台所帶來的,對比 Preserve 上線(go-live)帳戶數的貢獻?按我們估計,你們可能已接近約 75 到 100 個 Preserve 上線帳戶。我先問這個,之後我還有個簡短追問。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Thanks, Anthony. As you highlighted, I mean, the progress in the US has been tremendous. I mean it's exceeded all our expectations. And you see that with all the different metrics that we look at. I mean we've increased the number of accounts. We continue to grow the base Motiva business. And a lot of that is driven and it shouldn't be a surprise. I mean we've come to the market with what we believe to be the best implants from a performance as well as a safety standpoint, and we couple that with a best-in-class organization. So that's really helping to drive that growth. And a lot of that currently is still based off of expanding the Motiva-based Motiva business and getting into more accounts, but we're also driving utilization in the accounts that we're in.

    謝謝你,Anthony。正如你所提到的,美國的進展非常驚人,甚至超出我們所有預期。你也可以從我們觀察的各項不同指標看到這點。我們增加了帳戶數量,持續擴大 Motiva 的基礎業務。而這背後的驅動因素其實不令人意外:我們以我們認為在性能與安全性方面最好的植入物進入市場,同時搭配一流的組織能力。這確實有助於推動成長。目前相當一部分仍來自擴大以 Motiva 為基礎的 Motiva 業務、進入更多帳戶,但我們也在推動既有帳戶的使用量提升。

  • And clearly, Preserve is a significant -- will be a significant driver for us in the future. I mean, it's not a surprise as well. I mean, there's very clear patient benefits with minimal anesthesia, with smaller scars, quicker recovery. And I think it's creating a lot of interest and excitement from a patient as well as a surgeon standpoint. So we're seeing good growth opportunities just on our base as well as on the Preserve launch.

    而且很明顯,Preserve 將會是我們未來的重要驅動力。這同樣不令人意外:在更少麻醉、更小疤痕、更快復原方面,對病患有非常明確的好處。我認為這也從病患與醫師的角度帶來了很大的興趣與期待。因此,無論是在我們既有基礎上,或是在 Preserve 上市推進上,我們都看到良好的成長機會。

  • Operator

    Operator

  • Josh Jennings, TD Cowen.

    Josh Jennings,TD Cowen。

  • Joshua Jennings - Analyst

    Joshua Jennings - Analyst

  • Hi, good morning. Great to see the strong start to the year. I wanted to ask about the minimally invasive platform, follow-up to Anthony's question and clearly gaining more and more traction. I'd love to just hear you build out more, Peter, on just how Preserve is not cannibalizing the Motiva business or Motiva cases, but it's actually incremental to kind of the traditional augmentation patient. And then maybe do the same for Preserve and Mia, and just help us understand how they may be complementary and how the Preserve launch internationally may be even boosting Mia traction as well.

    嗨,早安。很高興看到今年開局強勁。我想追問一下微創平台,延續 Anthony 的問題,而且顯然正獲得越來越多的動能。我很想請你再多談談,Peter,Preserve 如何不是在蠶食 Motiva 的業務或 Motiva 的手術案例,而是對傳統隆乳患者而言屬於增量需求。然後也請你同樣談談 Preserve 與 Mia,幫助我們理解它們如何可能互補,以及 Preserve 在國際市場的上市是否也進一步帶動 Mia 的動能。

  • And if you could tie it all into just -- it sounds like you're optimistic that the breast implant market globally, especially in the United States can actually see stronger growth here in the coming quarters, years and then how this all ties in. Sorry for the multilayer question, but I appreciate you taking it.

    另外,如果你能把這些串起來談一下——聽起來你對全球乳房植入物市場、尤其是美國,在接下來幾季、幾年其實可能出現更強勁成長感到樂觀,以及這一切如何相互關聯。抱歉問題有點多層次,但感謝你回答。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yeah. Thanks, Josh. As you highlighted, the minimally invasive platform, we're seeing a lot of very strong growth. When you look at our OUS markets where we have both Mia and Preserve, what we've seen, and we've been very pleased to see this is they operate very complementary. So in all the accounts that we currently have Mia, which is close to 150 accounts, we have Preserve. There's clear distinction between the 2 where Mia is much more of in the premium segment, smaller scars to no scar, it's under the armpit. But it's somewhat restrictive in terms of the number of -- or the type of patients and the type of surgeons that would use that.

    是的。謝謝你,Josh。正如你提到的,微創平台我們看到非常強勁的成長。當你看我們的海外(OUS)市場——我們同時有 Mia 和 Preserve——我們看到的情況,而且我們非常樂見的是,它們的運作非常互補。因此,在我們目前擁有 Mia 的所有客戶(接近 150 個客戶)中,我們也有 Preserve。兩者之間有明確區隔:Mia 更偏向高端市場,疤痕更小甚至無疤,從腋下進入。但在可適用的患者數量——或患者類型,以及會使用它的外科醫師類型方面,相對更具限制。

  • While Preserve is much more day-to-day and it's a premium versus our base, but it's less lower priced than Mia. So they work very complementary. What we've been able to see in a lot of markets in OUS is just with the minimally invasive rollout with Preserve as well as Mia. We've been able to expand our account base in a number of markets that's really helped to drive that.

    而 Preserve 更偏向日常使用;它相對於我們的基礎產品屬於高端,但價格又低於 Mia。因此它們的搭配非常互補。我們在許多海外市場看到的是,隨著 Preserve 與 Mia 的微創推廣,我們得以在多個市場擴大客戶基礎,這確實有助於帶動成長。

  • And then to answer your last question, and we're seeing this with some of the market research that in the US with Preserve, 15% of women that have used the procedure were not currently considering breast augmentation. So we believe that the minimally invasive, both Mia and Preserve has a real opportunity to drive category growth. And I think there is just increasing a lot more interest in the area of transparency with -- not only with the Preserve and Mia, but as well as just more openness and interest in breast augmentation, and we feel that we're a big part of that.

    再回答你最後一個問題:我們也從一些市場研究看到,在美國使用 Preserve 手術的女性中,有 15% 原本並未考慮進行隆乳。因此我們相信,微創(包含 Mia 與 Preserve)確實有機會帶動品類成長。我認為在「透明化」方面的興趣正在提升——不僅是對 Preserve 與 Mia,也包括對隆乳本身更開放、更多關注;我們覺得自己在其中扮演很重要的角色。

  • Operator

    Operator

  • Sam Eiber, BTIG.

    Sam Eiber,BTIG。

  • Sam Eiber - Equity Analyst

    Sam Eiber - Equity Analyst

  • Hi, good morning. Thanks for taking the questions here. Maybe I can stay on Preserve for a moment. Peter, would love your thoughts on if you think Preserve can eventually become standard of care over traditional breast augmentation at least here in the US. And maybe you can help explain why Preserve is something that beyond the tools is something that can only be done with Motiva, whether it's the implant surface, whether it's the low complication rates. Would love if you can explain that in a little bit more detail. Thank you.

    嗨,早安。謝謝讓我提問。我想先在 Preserve 上多停留一下。Peter,我很想聽聽你的看法:你是否認為 Preserve 最終能在美國至少取代傳統隆乳,成為標準治療(standard of care)?另外也請你協助說明,為什麼 Preserve 除了工具之外,還有一些只能用 Motiva 才能做到的要素——不論是植入物表面、或是較低的併發症率等。希望你能更詳細解釋一下。謝謝。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yeah. I mean, I think in terms of the minimally invasive and Preserve, not only in the US, but I think globally, it really makes sense. If you look at our different types of procedures, surgical procedures, everything is minimally invasive. And I think bringing that technology and that capability, I think it's -- I think patients, that's what they're looking for. I mean it's very clear what the benefits are for patients, smaller scars, quicker recovery, minimal anesthesia, which is very important for a number of women. So it really has the opportunity to be a significant growth driver, but it's the standard of care, I think, in the industry.

    是的。我的意思是,就微創與 Preserve 而言,不只在美國,我認為在全球其實都很合理。你看各種不同的手術類型,幾乎所有外科手術都在走向微創。我認為把這項技術與能力帶進來——我想病人要的就是這個。對病人的好處非常明確:疤痕更小、恢復更快、麻醉需求更少,這對許多女性非常重要。因此它確實有機會成為重要的成長驅動因素,也會成為產業的標準治療。

  • And I think in some respects, because of the lack of innovation we've seen in the US prior to our entry, I think a lot of the category is behind. So we do believe that, that's going to be more standardized in the industry. And I think it's really our innovation with the unique implants that we have is very specific and beneficial for this type of procedure. And we'll continue to look at and continue to drive innovation that really shapes the category. And I think this is just the starting point for us.

    而且我認為在某些方面,由於我們進入美國市場之前所看到的創新不足,這個品類其實是落後的。所以我們確實相信,這將在產業中變得更標準化。我也認為,我們以獨特植入物所帶來的創新,對這類手術非常特定且有利。我們會持續尋找並推動能夠形塑品類的創新。我認為這只是我們的起點。

  • Operator

    Operator

  • Mason Carrico, Stephens.

    Mason Carrico,Stephens。

  • Mason Carrico - Equity Analyst

    Mason Carrico - Equity Analyst

  • Hey, guys. Thanks for taking the question here. I assume that most, if not all, Preserve users were already Motiva users. But I was curious to hear if that launch is actually to increased conversation or maybe even conversion of accounts that previously hadn't adopted Motiva. Maybe just a simpler question is, do you think that launch could actually accelerate the onboarding of new accounts moving forward?

    嗨,各位。謝謝讓我提問。我假設大多數、甚至全部的 Preserve 使用者原本就是 Motiva 使用者。但我想了解的是,這次上市是否真的增加了對話,或甚至讓先前尚未採用 Motiva 的客戶開始轉換。換個更簡單的問法:你認為這次上市是否可能加速未來新客戶的導入(onboarding)?

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • So Mason, I mean, we're pretty early in the launch, but what we've seen outside the US is that the minimally invasive, specifically Preserve, has brought in a number of new accounts for us in our direct markets in Western Europe. So it has had that benefit, bringing new technology, bringing a new procedure, I think, has really resulted in our ability to drive account growth in a lot of our Western European markets.

    所以 Mason,我的意思是,我們上市還算早期,但我們在美國以外看到的是,微創——特別是 Preserve——在西歐我們的直營市場帶來了不少新客戶。因此它確實有這樣的效益:帶來新技術、帶來新術式,我認為這確實讓我們在許多西歐市場得以推動客戶成長。

  • In the US, I mean, it's still early. I believe you're going to see the same type of trend in the US, but we're kind of in month 2 right now, and there's significant demand with the accounts that we do have, and it's very -- we're very focused on getting the training done. But I do believe, to your question, I think it has the potential to drive, certainly account acquisition.

    在美國方面,現在還早。我相信你會在美國看到同樣的趨勢,但我們目前大概才第 2 個月,現有客戶的需求非常顯著,而我們也非常專注在完成訓練。不過我確實認為,回到你的問題,它有潛力推動、當然也包括客戶獲取(account acquisition)。

  • Operator

    Operator

  • Caitlin Roberts, Canaccord Genuity.

    Caitlin Roberts,Canaccord Genuity。

  • Caitlin Cronin - Equity Analyst

    Caitlin Cronin - Equity Analyst

  • Hi, congrats on the quarter and thanks so much for taking the questions. Just a quick one. Have you added all the reps that you plan to add for Preserve in the US? And just appreciate the guidance on MIS, but could you break out potentially Preserve and Mia? And any updates on the timeline for you guys to bring Ergo2 into the US and eventually Mia?

    嗨,恭喜本季表現,也非常感謝讓我提問。我只有一個簡短問題:你們是否已在美國為 Preserve 補齊所有計畫增聘的業務代表?另外,謝謝你們對 MIS 的指引,但你們能否把 Preserve 與 Mia 分開拆分說明?以及你們將 Ergo2 帶進美國、並最終導入 Mia 的時程是否有更新?

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yeah, so thanks, Caitlin. The split between the Preserve and Mia, a bulk of that is really driven by Preserve is the key driver for us. We expect that to be a significant growth driver for us moving forward. And as it relates to Ergo2, I mean, we -- currently, we've had good discussions with the FDA. We're trying to really align on what the appropriate regulatory requirements are for us to get that approved with the FDA. But we don't see that as a significant driver for us until probably around 2028. I mean, we have a lot of growth opportunities as it relates to Preserve currently.

    是的,謝謝你,Caitlin。關於 Preserve 與 Mia 的拆分,其中大部分其實是由 Preserve 驅動;Preserve 是我們的關鍵驅動因素。我們預期它將在未來成為我們重要的成長引擎。至於 Ergo2,我們目前與 FDA 有良好的討論。我們正努力就適當的法規要求與 FDA 對齊,以便取得核准。但我們不認為它會在大約 2028 年之前成為我們的重要驅動因素。我的意思是,就 Preserve 而言,我們目前有很多成長機會。

  • As you asked, I mean, we are expanding our sales force. Currently, we're at 50 reps, but we're going to continue to expand that opportunistically when there's a geographical opportunity, but also more importantly, getting the right talent. I think we've been very successful in what I consider to be a best-in-class organization. And in this industry, bringing over high-quality sales reps that have the established relationship, and that makes a big impact, and we've been able to do that.

    如你所問,我們正在擴編銷售團隊。目前我們有 50 位業務代表,但只要有地理區域上的機會,我們會持續以機會式方式擴編;更重要的是要找到合適的人才。我認為我們在打造我所稱的同級最佳(best-in-class)組織方面非常成功。在這個產業中,延攬具高品質、且已建立客戶關係的業務代表會帶來很大影響,而我們也做到了。

  • Operator

    Operator

  • Joanne Wuensch, Citibank.

    Joanne Wuensch,Citibank。

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • Good morning, and thank you for taking the question. I've got a big picture one. What are you seeing in the macroeconomic environment? And specifically, I'm concerned or thoughtful of the consumer and the impacts to the Middle East as it might relate either to sales or resin or oil prices or anything on the bigger landscape would be helpful. Thank you so much.

    早安,謝謝讓我提問。我有一個較宏觀的問題:你們在總體經濟環境中看到了什麼?特別是,我在意或關注消費者端,以及中東局勢可能帶來的影響——不論是對銷售、樹脂或油價,或任何更大範圍的面向;若能分享會很有幫助。非常感謝。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yes. Thanks, Joanne. I think that's a great question. I mean, obviously, that's top of mind for anybody that's running a company. And I think as you look at what's going on in the Middle East, I think, first off, just looking at the Middle East, as we highlighted in the prepared remarks, it represents 5% of our total sales. Not surprising in Q1, we didn't have any orders. But we are -- we do have orders in the system in Q2, and we expect to be shipping to the Middle East this quarter. So there is some demand there.

    是的。謝謝你,Joanne。我認為這是個很好的問題。我的意思是,顯然這是任何經營公司的人都會放在心上的議題。我想就中東正在發生的事情而言,首先,單看中東市場——如同我們在事先準備的發言中提到的——它占我們總銷售的 5%。在第一季沒有任何訂單並不令人意外。但我們在第二季的系統中已有訂單,我們預期本季會出貨到中東。因此那裡仍有一些需求。

  • But I think the key question is what you highlighted, what is the potential overall macro impact? And so far, Joanne, we have not seen an impact on the global demand for the number of procedures. And that's something that we're going to continue to closely monitor.

    但我認為關鍵問題是你所強調的:整體宏觀層面的潛在影響是什麼?截至目前,Joanne,我們尚未看到對全球手術量需求造成影響。這也是我們將持續密切監測的事項。

  • As it relates to areas in terms of cost, I think we've seen some -- and I can let Sandra answer this, but we've seen some impact in terms of outward freight. There has not been an impact in terms of our silicone costs because those are locked in for the full year. So I would say, in general, we haven't seen a significant impact, but that's something we're going to monitor very closely. Sandra?

    就成本相關的面向而言,我認為我們看到了一些——我可以讓Sandra來回答——但我們在對外運輸費用方面看到了一些影響。至於我們的矽膠成本則沒有受到影響,因為那部分已鎖定全年。因此我會說,整體而言我們尚未看到顯著影響,但這是我們會非常密切監控的。Sandra?

  • Cassandra Harris - Senior Vice President, Chief Financial Officer

    Cassandra Harris - Senior Vice President, Chief Financial Officer

  • I think Peter hit it. We're seeing some initial surcharges on outbound freight. But at this time, we've been able to navigate through and hold our margin profile. Our silicon provider, we recently have locked in volumes, and we have a contract with them through the end of the year. And we'll monitor the situation and look to protect our margins with any type of price as it progresses.

    我想Peter已經說到重點了。我們在出貨的對外運費上看到一些初期的附加費。不過目前我們仍能因應並維持我們的毛利結構。我們的矽膠供應商方面,我們最近已鎖定供貨量,並且與對方簽有合約至年底。我們會持續監測情勢,並在情況發展時,透過任何形式的價格措施來保護我們的利潤。

  • Operator

    Operator

  • Allen Gong, JPMorgan.

    Allen Gong,摩根大通(JPMorgan)。

  • Allen Gong - Analyst

    Allen Gong - Analyst

  • Hi, Tim. Thanks for the question. I just had a quick one on the guidance and just the momentum that you're seeing. You talked about how orders are up 30% from 4Q to 1Q. I guess first quick one, is that a US comment? And also, given that kind of momentum, how should we feel about the cadence for the balance of the year, particularly what you're seeing in the second quarter given the reiterated guide or guide just to beat in the first quarter?

    嗨,Tim。謝謝讓我提問。我只有一個關於財測與你們所看到動能的簡短問題。你提到訂單從第四季到第一季成長了30%。我想先快速確認一下:這是指美國市場嗎?另外,在這樣的動能之下,我們應該如何看待今年剩餘期間的節奏,特別是第二季你們所看到的情況?因為你們重申了指引,或是第一季只是要超越指引?

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yes. Allen, I'll kick it off. But just to clarify that, I mean, when we talk about the orders, that was specific to the US. We're -- as we highlighted in the prepared remarks, we're increasing the number of accounts, but also we're increasing the utilization rate as the surgeons work through their schedule. So it's a combination, and it's reflected in the average daily orders. So we see very strong momentum going into Q2 as well. And -- but that's not just in the US I think in overall, globally in a lot of markets, we've -- the demand has been stable.

    是的。Allen,我先回答。先澄清一下:我們談到的訂單成長,是特指美國市場。正如我們在事先準備的發言中所強調的,我們一方面在增加客戶帳戶數,另一方面也在外科醫師逐步排程的過程中提高使用率。因此這是兩者的組合,並反映在平均每日訂單上。所以我們也看到進入第二季的動能非常強。而且——這不僅限於美國,我認為整體而言,在全球許多市場,我們看到需求一直相當穩定。

  • And I think the one outstanding question that we had going into as we're managing the business like a lot of different companies is what's the impact of the Middle East. And as I mentioned before, it is a small part of our business. We do have orders in the system for Q2. So there is demand there. And we have not seen the impact in terms of global demand, but that's something we're going to monitor. So based on that, gave us the comfort to raise the guidance. We had a strong Q1, and then we're off to a good start in Q2. So that gave us the comfort around that.

    我認為在我們經營業務、像許多公司一樣管理各種變數時,唯一尚待釐清的問題是中東的影響。如我先前提到的,那只占我們業務的一小部分。我們在系統中已有第二季的訂單,因此那裡仍有需求。我們尚未看到對全球需求的影響,但這是我們會持續監測的。基於此,也讓我們更有信心上調指引。我們第一季表現強勁,第二季開局也不錯,因此讓我們對此更有把握。

  • Operator

    Operator

  • Matt Taylor, Jefferies.

    Matt Taylor,Jefferies。

  • Matthew Taylor - Equity Analyst

    Matthew Taylor - Equity Analyst

  • I wanted to follow up on the silicon supply comments. I know that this year, the contract is set in stone. But could you address the potential for cost increases beyond that? Maybe give us an update on how negotiations are going and when we could expect an update?

    我想追問一下關於矽膠供應的評論。我知道今年合約已經確定不變。但你們能否談談之後成本上升的可能性?也請更新一下談判進展,以及我們何時可能看到進一步更新?

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Yeah. Thanks, Matt. It's a good question. I mean, we have a very good relationship with NuSil. I mean, it goes back for a number of years. And obviously, as we continue to grow as a company, we become a more valuable customer to NuSil. And we've had very productive conversations with NuSil. I mean, we consider them very good partners. In fact, that we've aligned or we agreed on volume commitments for this year, just about a month ago. So the prices are locked in for this year. We've made that commitment. Obviously, that's an increase in volume versus last year.

    好的,謝謝,Matt。這是個好問題。我們與NuSil的關係非常好,合作已經有很多年。顯然,隨著我們公司持續成長,我們也成為NuSil更有價值的客戶。我們與NuSil的對話非常有成效,我們把他們視為非常好的合作夥伴。事實上,大約一個月前我們才就今年的供貨量承諾達成一致。因此今年的價格已鎖定,我們也做出了該承諾。當然,這個供貨量相較去年是增加的。

  • And we've started conversations around a long-term agreement. And there's interest on the NuSil side to have an agreement as well as for us to have an agreement 5 years or more. And a lot of the conversations are less about pricing. It's much more about co-development work. They're interested in exclusivity with us and looking at the length of the agreement. Generally around the price is more volume driven. But the conversations are very productive. And as I mentioned before, we are -- continue to be a bigger part of their business. And they've been good partners for us in the past, and we expect that to continue moving forward. So we haven't finalized the conversation, the discussions on the agreement, but there's strong intent to have a very -- a long-term agreement for -- with NuSil.

    同時我們也已開始就長期協議進行討論。NuSil方面也有意願簽訂協議,我們也希望能簽訂5年或更長的協議。許多討論重點較少在價格,更多是在共同開發工作。他們對與我們的獨家合作有興趣,也在討論協議期限。一般而言,價格更多是由供貨量所驅動。但目前對話非常有建設性。正如我先前提到的,我們持續成為他們業務中更重要的一部分。他們過去一直是我們很好的合作夥伴,我們也預期未來會持續如此。所以我們尚未完成協議的討論與定案,但雙方都有強烈意願與NuSil建立一份非常——一份長期的合作協議。

  • Operator

    Operator

  • Mike Matson, Needham & Co.

    Mike Matson,Needham & Co.。

  • Michael Matson - Analyst

    Michael Matson - Analyst

  • I just wanted to ask one on the refinancing. So by our math, it seems like without the additional $35 million draw, there could be a slight increase in interest expense of maybe like $1 million a year. Is that right?

    我想問一個關於再融資的問題。按我們的計算,如果沒有額外提用3,500萬美元,利息費用可能會小幅增加,大概每年增加約100萬美元。是這樣嗎?

  • Cassandra Harris - Senior Vice President, Chief Financial Officer

    Cassandra Harris - Senior Vice President, Chief Financial Officer

  • Yeah. Thanks, Mike. So yes, so on the new debt agreement, we've increased it from $225 million. And the current draw is $265 million. There is a lower interest rate at 8.75%. There's ability to PIK, which gives us some near-term cash availability, which we take. So net-net-net, there is neutral to slightly up on the increase in the availability of the funds with the lower interest rate and then the exercise of the PIK.

    是的,謝謝,Mike。沒錯,在新的債務協議下,我們把額度從2.25億美元提高,而目前的提用金額是2.65億美元。利率較低,為8.75%。同時也可以選擇PIK(利息資本化支付),這讓我們在短期內有更多現金可用,我們也會採用。因此整體來看,在資金可用額度增加、利率下降以及採用PIK的情況下,淨效果大致持平到略為上升。

  • Operator

    Operator

  • Anthony Petrone, Mizuho Group.

    Anthony Petrone,瑞穗集團(Mizuho Group)。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thanks. One for Sandra, just on gross margin here, guidance 71.2% to 72.2%. How much of that is just kind of a reflection of Preserve at higher prices? And have you baked in an FDA clearance for reconstruction and just what that can bring to the table in terms of gross margin momentum?

    謝謝。我有一題想問Sandra,關於毛利率指引71.2%到72.2%。其中有多少只是反映Preserve以較高價格銷售?另外,你們是否已將重建適應症的FDA核准納入假設?以及這可能為毛利率動能帶來什麼貢獻?

  • Cassandra Harris - Senior Vice President, Chief Financial Officer

    Cassandra Harris - Senior Vice President, Chief Financial Officer

  • Yes, Anthony, good question. So our gross margin improvement, and we do expect that it will continue to contribute is the growth of the US With the US business being a direct account, it improves our margin profile, and you're seeing that in our numbers. And then obviously, with OUS being further along in the journey on minimally invasive, its growth in the direct business and then the launch of minimally invasive in the US, that also is a big contributor to the margin.

    是的,Anthony,這是個好問題。我們毛利率的改善,而且我們預期會持續貢獻,主要來自美國業務的成長。由於美國業務是直營客戶(direct account),因此能改善我們的毛利結構,你也在我們的數字中看到了。此外,隨著美國以外(OUS)在微創旅程上走得更前面,其直營業務的成長,以及微創在美國的上市,這也對毛利率有很大的貢獻。

  • So as we look forward, we do expect that we will continue to improve that margin based upon the mix of that business, both US and OUS as well as the minimally invasive. And at this juncture, we do not -- we can't necessarily time the FDA approval. So we've made no assumptions in regard to reconstruction.

    因此展望未來,我們確實預期毛利率將會持續改善,主要取決於業務組合,包括美國與美國以外(OUS),以及微創產品的占比。在目前這個時間點,我們無法精準掌握FDA核准的時程。因此,我們並未就重建適應症做任何假設。

  • Operator

    Operator

  • Ladies and gentlemen, that is all the time we have for questions today. I will now turn the call back over to Peter Caldini for closing remarks.

    各位女士、先生,今天的提問時間到此為止。接下來我將把電話交回給Peter Caldini作結語。

  • Fillipo Caldini - Chief Executive Officer, Director

    Fillipo Caldini - Chief Executive Officer, Director

  • Thank you, everybody, for joining the call this morning. I appreciate the time and really having everybody get to hear more about the progress we're making with Establishment Labs. As we highlighted or as I highlighted in the commentary, it's a great opportunity. I hope to see at some of the events, but also please take us up on the offer about visiting us in Costa Rica, and you really get an opportunity to really see the uniqueness of this company and the strengths that we have and just to build that partnership. So thanks again, everybody, for joining the call, and look forward to seeing you soon. Thank you.

    謝謝各位今天早上參加電話會議。我很感謝大家的時間,也很高興大家能更深入了解我們在Establishment Labs所取得的進展。正如我們——或我在評論中所強調的,這是一個很好的機會。我希望能在一些活動上見到各位;也請大家接受我們的邀請,來哥斯大黎加拜訪我們,你們將有機會親眼看到這家公司獨特之處、我們的優勢,以及如何建立這樣的合作夥伴關係。再次感謝各位參與本次電話會議,期待很快與各位見面。謝謝。

  • Operator

    Operator

  • Thank you, sir. Ladies and gentlemen, that concludes this event. Thank you for attending, and you may now disconnect your lines.

    謝謝您,先生。各位女士、先生,本次活動到此結束。感謝各位出席,現在可以掛線。