Allurion Technologies Inc (ALUR) 2025 Q1 法說會逐字稿

Hello and welcome to the Allurion first quarter earnings call. (operator instructions)

您好，歡迎參加 Allurion 第一季財報電話會議。（操作員指令）

I would now like to turn the conference over to Tara Brady. You may begin.

現在我想將會議交給塔拉·布雷迪。你可以開始了。

Good morning and thank you for joining us. Earlier today, Allurion Technologies Inc. Issued a press release announcing financial results for the quarter ended March 31, 2025 and provided a business update.

早安，感謝您加入我們。今天早些時候，Allurion Technologies Inc. 發布了一份新聞稿，宣布了截至 2025 年 3 月 31 日的季度財務業績，並提供了業務更新。

You can access a copy of the announcement on the company's website at investors.allurion.com. With me on the call today is Shantanu Gaur, founder and Chief Executive Officer.

您可以在公司網站 investors.allurion.com 上查看該公告的副本。今天與我一起參加電話會議的是創辦人兼執行長 Shantanu Gaur。

Before we begin, I would like to inform you that the comments mentioned on today's call contain forward-looking statements within the meaning of federal securities laws. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our Securities and Exchange Commission filings, including our annual report on Form 10K filed on March 27, 2025.

在我們開始之前，我想通知您，今天電話會議上提到的評論包含聯邦證券法所定義的前瞻性陳述。由於某些風險和不確定性，實際結果可能與明示或暗示的結果有重大差異。這些風險和不確定性在我們提交給美國證券交易委員會的文件中進行了詳細描述，包括我們於 2025 年 3 月 27 日提交的 10K 表年度報告。

Our SEC filings can be found through our company website at investors.allurion.com or the SEC's website.

您可透過我們公司網站 investors.allurion.com 或美國證券交易委員會 (SEC) 網站查閱我們的 SEC 文件。

Investors are cautioned not to place undue reliance on such forward-looking statements, and Allurion undertakes no obligation to publicly update or release any revisions to these forward-looking statements.

敬請投資人不要過度依賴此類前瞻性陳述，Allurion 不承擔公開更新或發布這些前瞻性陳述的任何修訂的義務。

Please note that this conference call is being recorded. It will be available for audio replay on our website under the events and presentation section on our investor relations page shortly after the conclusion of this call.

請注意，本次電話會議正在錄音。本次電話會議結束後不久，我們將在網站的投資者關係頁面的活動和演示部分提供音訊重播。

In addition to the company's GAAP results, management will also provide supplementary results on a non-gap basis.

除了公司的 GAAP 結果外，管理層還將提供非差距基礎上的補充結果。

Please refer to the press release issued today in the accompanying supplementary financial data tables for a detailed reconciliation of GAAP and non-gap results, which can be accessed from the investor relations section of the company's website.

請參閱今天發布的新聞稿中隨附的補充財務資料表，以了解 GAAP 和非差距結果的詳細對賬，可從公司網站的投資者關係部分存取。

And with that, I will turn it over to Shantanu.

現在，我將把發言權交給 Shantanu。

Good morning everyone and thank you for joining us as we kick off an exciting 2025 for Allurion, a year we expect to be rich in catalysts. We were pleased to deliver the first quarter in line with expectations, setting us up to deliver on the year ahead. First quarter revenue of $5.6 million was achieved on adjusted operating expenses of $10.1 million a decrease in expense of 45% compared to the prior year.

大家早安，感謝大家加入我們，開啟 Allurion 令人興奮的 2025 年，我們預計這一年將充滿催化劑。我們很高興第一季的業績符合預期，這為我們來年取得的成績做好了準備。第一季營收為 560 萬美元，調整後的營運費用為 1,010 萬美元，與前一年相比減少了 45%。

Adjusted net operating loss of $5.9 million narrowed by 48% compared to prior year, and gross margin expanded to 75% compared to 73% in the prior year and 45% in the previous quarter.

調整後淨營業虧損 590 萬美元，較前一年縮小 48%，毛利率擴大至 75%，而上年度為 73%，上季為 45%。

Our financial results reflect increased efficiency as we move toward profitability, with expenses continuing to reduce, gross margin expanding, and operating loss narrowing.

我們的財務結果反映出我們在邁向獲利的過程中效率不斷提高，費用持續減少，毛利率不斷擴大，經營虧損不斷縮小。

As we have stated previously, we have a new vision for the future of Allurion. That vision begins with our plan for 2025, which is built around 5 pillars. First, a new commercial plan focused on key geographies with deeper penetration within these geographies and a business to business to consumer or B2B2C direct sales model versus a direct to consumer or DTC marketing model.

正如我們之前所說，我們對 Allurion 的未來有了新的願景。這個願景始於我們的 2025 年計劃，該計劃圍繞著五大支柱構建。首先，新的商業計劃重點關注關鍵地區，在這些地區進行更深入的滲透，並採用企業對企業對消費者或 B2B2C 直銷模式，而不是直接面向消費者或 DTC 行銷模式。

Second, gaining FDA approval for the Allurion balloon and preparing for US launch. Third, achieving profitability for the ex US business by the end of 2025. Fourth, scaling our now proven AI product platform and leveraging a variety of new business models. And fifth, resuming commercialization in France.

第二，獲得FDA對Allurion氣球的批准，並準備在美國推出。第三，到2025年底實現美國以外業務的獲利。第四，擴展我們現已驗證的人工智慧產品平台並利用各種新的商業模式。第五，恢復在法國的商業化。

Thus far in 2025, I am extremely proud of our team for the significant progress we have made across all five pillars.

到 2025 年為止，我為我們的團隊在五大支柱上取得的重大進展感到非常自豪。

Regarding our new commercial plan, our first quarter results speak to the efficiency of our B2B2C model. We piloted several aspects of the B2B2C model in clinics in Europe in the first quarter and observed over 40% growth quarter over quarter and year over year, giving us confidence in the model as we expand its implementation globally.

關於我們的新商業計劃，我們的第一季業績證明了我們的 B2B2C 模式的效率。我們在第一季在歐洲的診所試行了 B2B2C 模式的幾個方面，並觀察到環比和同比增長超過 40%，這讓我們對該模式在全球範圍內的實施充滿信心。

In the 1st quarter, we also filled several open positions in our direct markets and will continue to attract top talent in the 2nd quarter. We expect revenues to ramp as the year progresses, as the use of our B2B2C model expands and our enhanced sales team on boards.

在第一季度，我們還填補了直接市場的幾個空缺職位，並將在第二季度繼續吸引頂尖人才。我們預計，隨著時間的推移，隨著 B2B2C 模式的擴展和銷售團隊的增強，收入將會增加。

As part of our new commercial plan, we are increasingly leaning in to the areas Allurion products, either our entire program or just our AI powered virtual care suite, intersect with GLP-1 therapy.

作為我們新商業計劃的一部分，我們越來越傾向於 Allurion 產品（無論是我們的整個計劃還是僅僅是我們的 AI 驅動的虛擬護理套件）與 GLP-1 療法交叉的領域。

In addition to the combination of the Allurion program with low doses of GLP-1s, which I will provide an update on later in the call, we are seeing a number of different approaches being taken by clinicians organically that combine Allurion with normal doses of GLP-1s.

除了將 Allurion 方案與低劑量 GLP-1 結合（我將在稍後的電話會議中提供最新資訊）之外，我們還看到臨床醫生有機地採用了多種不同的方法，將 Allurion 與正常劑量的 GLP-1 結合。

As we announced yesterday, we presented two abstracts at the European Congress on Obesity that touch on this.

正如我們昨天宣布的那樣，我們在歐洲肥胖大會上提交了兩份涉及這一問題的摘要。

In one study of 138 patients who were prescribed GLP-1s with normal dose escalation and used our VCSs through which they received behavioral support and had changes in lean body mass track, lean body mass increased by 6.1% and muscle mass increased by 6.4%, while fat mass decreased by 10.2%. In another study of 60 patients who were treated with the Allurion balloon and semaglutide with a normal dose escalation, the average reduction in total body weight was 21.2%, with improvement in LDL cholesterol, triglycerides, and hemoglobin A1C after 10 months.

在一項針對 138 名患者的研究中，這些患者被處方了正常劑量遞增的 GLP-1，並使用了我們的 VCS，透過 VCS 他們獲得了行為支持，並且瘦體重軌跡發生了變化，瘦體重增加了 6.1%，肌肉質量增加了 6.4%，而脂肪質量減少了 10.2%。在另一項針對 60 名接受 Allurion 球囊和司美格魯肽治療且劑量正常增加的患者的研究中，總體重平均減輕了 21.2%，10 個月後 LDL 膽固醇、三酸甘油酯和糖化血紅蛋白 A1C 得到改善。

This approach led to outcomes similar to those achieved with bariatric surgery without the risks inherent to surgery.

這種方法可獲得與減重手術類似的結果，但不存在手術固有的風險。

While we believe that the best option for most patients seeking higher weight loss is likely a combination of the Allurian program with a low dose of GOP-1s, these studies speak to the versatility of Allurian's product portfolio.

雖然我們認為對於大多數尋求更高減肥效果的患者來說，最好的選擇可能是將 Allurian 方案與低劑量的 GOP-1 相結合，但這些研究證明了 Allurian 產品組合的多功能性。

The first study supports our thesis that even at normal doses of GLP-1s, Allurion's virtual care suit can be useful in driving better weight loss outcomes and maintaining muscle compared to what patients can achieve using GLP-1s alone.

第一項研究支持了我們的論點：即使在正常劑量的 GLP-1 下，與患者單獨使用 GLP-1 相比，Allurion 的虛擬護理套裝也可以有助於實現更好的減肥效果並保持肌肉。

The second study describes an option that may be attractive for patients with severe obesity who are seeking an alternative to bariatric surgery and may be more willing to tolerate the higher side effects observed with normal dose escalation.

第二項研究描述了一種可能對嚴重肥胖患者有吸引力的選擇，這些患者正在尋求減肥手術的替代方案，並且可能更願意忍受正常劑量增加所觀察到的更嚴重的副作用。

Commercially, we believe this versatility will open new doors for us that will ultimately drive higher balloon and software revenues. Regarding our path to FDA approval, we recently completed our pre-PMA meeting with FDA where we presented our top line results from audacity. We were very pleased with FDA's openness to considering additional analyses that addressed the control group performance we observed in audacity.

從商業角度來看，我們相信這種多功能性將為我們打開新的大門，最終將帶來更高的氣球和軟體收入。關於我們獲得 FDA 批准的途徑，我們最近完成了與 FDA 的 PMA 前會議，在會上我們展示了 Audacity 的頂級成果。我們非常高興 FDA 願意考慮進行額外的分析來解決我們在 Audacity 中觀察到的對照組的表現。

We believe these analyses will further underscore the strength of our data and overall application. We were very encouraged by FDA's feedback and we very much look forward to completing our PMA submission, which we expect will occur by the end of June, and working collaboratively with FDA toward an approval.

我們相信這些分析將進一步強調我們的數據和整體應用的優勢。FDA 的回饋讓我們深受鼓舞，我們非常期待完成 PMA 提交，預計將於 6 月底完成，並與 FDA 合作獲得批准。

Regarding our path to profitability, we believe our first quarter results demonstrate the increased efficiency of our business following the restructuring we implemented at the end of 2024. With the financing we conducted in the first quarter along with our continued discipline in our cash use, we ended the first quarter with cash and cash equivalents of $20 million which provides the company the runway we believe we need to achieve our FDA approval, profitability, and other milestones that could generate significant value for shareholders.

關於我們的獲利之路，我們相信，第一季的業績證明了我們在 2024 年底實施重組後業務效率的提高。透過我們在第一季進行的融資以及我們對現金使用的持續約束，我們在第一季結束時擁有 2000 萬美元的現金和現金等價物，這為公司提供了我們認為獲得 FDA 批准、盈利能力和其他里程碑所需的跑道，這些里程碑可以為股東創造巨大價值。

Looking forward to the rest of the year, our direct exposure to tariffs is negligible. As many of the Allurion balloon and almost all of its components are manufactured in the US, and we do not expect any impact on gross margin from tariffs for the balance of the year.

展望今年剩餘時間，我們直接受到的關稅影響可以忽略不計。由於 Allurion 氣球的大部分零件及其幾乎所有組件都是在美國製造的，我們預計今年餘下的時間內關稅不會對毛利率產生任何影響。

We are maintaining our guidance of revenues of approximately $30 million with a reduction in operating expenses of approximately 50% compared to 2024.

我們維持約 3,000 萬美元的收入預期，與 2024 年相比，營運費用減少約 50%。

Turning now to our digital product, with the shortages of compounded GLP-1s now officially over, we have started to build out Allurion meds to offer brand name GLP-1s. We have performed pilot work with pharmacy partners that offer these medications at low and high doses and are in discussions to perform a more complete integration later this year.

現在轉向我們的數位產品，隨著複合 GLP-1 短缺的正式結束，我們已經開始打造 Allurion 藥物來提供品牌 GLP-1。我們已經與提供低劑量和高劑量這些藥物的藥房合作夥伴進行了試點工作，並正在討論在今年稍後進行更全面的整合。

We believe that having brand name GOP-1s available through Allurion meds could be an attractive option for US patients, especially at lower doses in combination with the Allurion balloon with over 40% of adults in the US with obesity and 9% with severe obesity, we believe the combination approach could become the standard of care when Allurion balloon launches in the United States.

我們相信，透過 Allurion 藥物獲得品牌 GOP-1 可能對美國患者來說是一個有吸引力的選擇，特別是與 Allurion 球囊聯合使用較低劑量時，美國超過 40％ 的成年人患有肥胖症，9％ 患有嚴重肥胖症，我們相信當 Allurion 球囊在美國推出時，聯合療法可能成為治療標準。

Finally, we are making good progress in treating patients in France again. We have re-engaged clinics, retrained providers, and are now in the final phases of updating our collateral to reactivate placements. We look forward to providing further updates on this in future calls.

最後，我們在法國再次救治病人的工作取得了良好進展。我們已經重新聘用了診所，重新培訓了服務提供者，目前正處於更新抵押品以重新激活安置的最後階段。我們期待在未來的電話會議中提供有關此問題的進一步更新。

Before I turned over to Tara, I want to provide an update on our vision for the future of obesity care that I shared on our last call and how we believe Allurion can bring this vision to reality and have a significant positive impact for shareholders in 2025 and beyond. We believe that combining the Allurion program with low dose GLP-1s could become a new standard of care for obesity. By combining the two approaches, our initial data indicate that patients can achieve sustained weight reduction of greater than 20%.

在將麥克風交給塔拉之前，我想先介紹一下我在上次電話會議上分享的關於肥胖護理未來的願景，以及我們如何相信 Allurion 能夠將這一願景變為現實，並在 2025 年及以後為股東帶來重大的積極影響。我們相信，將 Allurion 計劃與低劑量 GLP-1 結合可以成為肥胖症治療的新標準。透過結合這兩種方法，我們的初步數據表明患者可以實現超過 20% 的持續減重。

While maintaining muscle mass and increasing long-term adherence to GLP-1 therapy, driven in part by the fewer side effects experienced at lower doses, this trifecta losing weight, keeping it off, and maintaining muscle is what we call metabolically healthy weight loss.

在維持肌肉質量和增加對 GLP-1 療法的長期依從性的同時，部分原因是低劑量時副作用較少，這種減肥、維持體重和維持肌肉的三重奏就是我們所說的代謝健康減肥。

The science behind our focus on muscle, use of low doses of GLP-1, and long-term engagement to enable behavior change is clear and continues to be elucidated at physiological, cellular, and psychological levels.

我們關注肌肉、使用低劑量 GLP-1 以及長期參與以實現行為改變背後的科學原理是明確的，並且在生理、細胞和心理層面上繼續得到闡明。

First, from a physiological perspective, muscle mass is crucial for driving weight loss and weight maintenance. Compared to fat, muscle burns 2times to 3 times more energy per kilo at rest, and during exercise, increased muscle leads to increased energy expenditure.

首先，從生理角度來看，肌肉質量對於減重和維持體重至關重要。與脂肪相比，肌肉在靜止狀態下每公斤燃燒的能量是脂肪的2到3倍，而在運動過程中，肌肉的增加會導致能量消耗的增加。

Muscle is also the primary site for glucose storage, removing it from the blood, leading to increased insulin sensitivity and less fat storage. Muscle also releases myokines during exercise, which increase satiety, reduce appetite, and actually stimulate release of endogenous GLP-1.

肌肉也是儲存葡萄糖的主要部位，它將葡萄糖從血液中移除，從而提高胰島素敏感性並減少脂肪儲存。肌肉在運動時也會釋放肌動蛋白，增加飽足感、減少食慾，並實際上刺激內源性 GLP-1 的釋放。

Second, from a cellular perspective, high doses of GLP-1 stimulate pathways that lead to protein degradation and inhibit pathways that lead to protein synthesis, leading to a breakdown of muscle and muscle wasting. Using lower doses of GLP-1 in combination with the Allurian balloon mitigates these effects without impacting overall weight reduction. Further, as discussed on the previous call, the combination of the Allurian balloon with GLP-1s is highly synergistic, as the Allurian balloon primarily works by inducing satiety and GLP-1s work by reducing hunger, two mechanisms of action that are distinct at the cellular and molecular level.

其次，從細胞角度來看，高劑量的 GLP-1 會刺激導致蛋白質降解的途徑，並抑制導致蛋白質合成的途徑，從而導致肌肉分解和肌肉萎縮。使用較低劑量的 GLP-1 與 Allurian 球囊組合可減輕這些影響，而不會影響整體減肥效果。此外，正如上次電話會議所討論的那樣，Allurian 球囊與 GLP-1 的結合具有高度協同作用，因為 Allurian 球囊主要透過誘導飽腹感起作用，而 GLP-1 透過減少飢餓感起作用，這兩種作用機制在細胞和分子層面上是不同的。

Third, from a psychological perspective, behavior change is key for weight maintenance and takes time.

第三，從心理學角度來看，行為改變是維持體重的關鍵，而且需要時間。

Adopting new eating behaviors typically takes 2months to 3 months, and it usually takes 6 months for these behaviors to become second nature. Data from the National Weight Control Registry, which studies individuals who have successfully maintained a weight loss of at least GBP30 for at least a year, clearly indicates that maintaining weight loss for 1 year significantly improves the chances to sustain long-term behavior change.

養成新的飲食習慣通常需要 2 到 3 個月，而這些行為成為第二天性通常需要 6 個月。國家體重控制登記處的研究對像是那些成功維持至少 30 英鎊減重並持續至少一年的個人，其數據清楚地表明，維持一年的減重可以顯著提高維持長期行為改變的機會。

While we have already reported out retrospective data on the combination approach, we now intend to launch a prospective trial, the details of which I am pleased to share today. The trial will be conducted across 3 obesity centers of excellence in Europe and will enroll subjects with a BMI greater than 30.

雖然我們已經報告了組合療法的回顧性數據，但我們現在打算啟動一項前瞻性試驗，我很高興今天分享其細節。該試驗將在歐洲 3 個肥胖卓越中心進行，招募 BMI 大於 30 的受試者。

Subjects will receive the Allurion balloon and will start 0.25 mg semaglutide 30 days after a balloon placement. Semaglutide dose will increase over the subsequent 11 months to a maximum of 1.0 milligrams.

受試者將接受 Allurion 球囊治療，並在球囊植入 30 天後開始服用 0.25 毫克司美格魯肽。司美格魯肽的劑量將在接下來的 11 個月內增加到最高 1.0 毫克。

For reference, standard dosing for samagnotide typically reaches between 1.7 milligrams and 2.4 milligrams, so the maximum dose that will be used in this study is approximately half body weight, muscle mass, and compliance with some of the tide will be evaluated throughout the study using the Allurion scale and Allurion virtual care suite.

作為參考，沙馬諾肽的標準劑量通常在1.7毫克至2.4毫克之間，因此本研究中使用的最大劑量約為體重的一半，肌肉質量和對部分潮汐的依從性將在整個研究過程中使用Allurion量表和Allurion虛擬護理套件進行評估。

Subjects will receive lifestyle modification and behavior change counseling through the Allurion app with the site selected and the protocol now drafted, we will begin the process to seek IRB approvals to conduct the trial, and expect enrollment to start by the end of this year. We are extremely excited to begin this clinical program. We believe that if successful and validated in larger sample sizes, this combination protocol could become a new standard of care for the treatment of obesity.

受試者將透過 Allurion 應用程式接受生活方式調整和行為改變諮詢，選擇站點並起草協議，我們將開始尋求 IRB 批准進行試驗，並預計在今年年底前開始招生。我們非常高興開始這個臨床計畫。我們相信，如果成功並在更大的樣本量中得到驗證，這種組合方案可能成為治療肥胖症的新標準。

I will now turn the call over to Tara Brady, our interim Chief Financial Officer, Tara.

現在我將把電話轉給我們的臨時財務長 Tara Brady。

Thank you, Shantanu. Our revenue for the first quarter of 2025 was $5.6 million compared to $9.4 million for the same period in 2024. The year over year decrease in revenue was primarily due to the temporary suspension of sales in France, as well as lower investments in sales and marketing.

謝謝你，Shantanu。我們 2025 年第一季的營收為 560 萬美元，而 2024 年同期的營收為 940 萬美元。收入年減主要是因為法國的銷售暫停以及銷售和行銷投資減少。

Gross profit for the first quarter was $4.2 million or 75% of revenue, compared to $6.9 million or 73% of revenue for the same period in 2024 and 45% compared to the fourth quarter of 2024. The increase in gross profit was driven by increased manufacturing efficiencies resulting from the restructuring initiative implemented in the 4th quarter of 2024.

第一季毛利為 420 萬美元，佔營收的 75%，而 2024 年同期為 690 萬美元，佔營收的 73%，與 2024 年第四季相比為 45%。毛利的成長得益於 2024 年第四季實施的重組計畫所帶來的製造效率的提高。

Sales and marketing expenses for the first quarter were $3.6 million compared to $6.1 million for the same period in 2024. The reduction in expense is primarily driven by increased operating efficiency and the restructuring initiatives implemented during the 4th quarter of 2024, which refocused spends on more efficient channels.

第一季的銷售和行銷費用為 360 萬美元，而 2024 年同期為 610 萬美元。費用的減少主要得益於營運效率的提高和 2024 年第四季實施的重組舉措，這些舉措將支出重新集中在更有效率的管道上。

Research and development expenses for the first quarter were $2.6 million compared to $5.7 million for the same period in 2024. The reduction was primarily driven by reduced costs related to the[ II] trial and restructuring initiatives implemented during the fourth quarter of the year. General and administrative expenses for the first quarter were $5.2 million compared to $6.4 million for the same period in 2024.

第一季研發費用為 260 萬美元，而 2024 年同期為 570 萬美元。成本減少的主要原因是今年第四季實施的試驗和重組措施相關成本的降低。第一季的一般及行政費用為 520 萬美元，而 2024 年同期為 640 萬美元。

Adjusted general and administrative expenses or $3.8 million excluding one-time financing costs of $1.4 million. The reduction year over year was primarily driven by the restructuring initiative implemented during the 4th quarter of 2024.

調整後的一般及行政開支為 380 萬美元，不包括 140 萬美元的一次性融資成本。年比下降主要是由於 2024 年第四季實施的重組措施。

Loss from operations for the first quarter was $7.3 million compared to $11.4 million for the same period in 2024. Adjusted laws from operations was $5.9 million excluding one-time financing costs of $1.4 million.

第一季營業虧損為 730 萬美元，而 2024 年同期為 1,140 萬美元。調整後的營運法律費用為 590 萬美元，不包括 140 萬美元的一次性融資成本。

The reduction was driven by restructuring initiatives implemented during the 4th quarter and expansion and growth margin year over year. As of March 30, 2025, we had cash in cash equivalents of $20.4 million.

減少的原因是第四季度實施的重組措施以及年擴張和成長利潤率。截至 2025 年 3 月 30 日，我們的現金等價物為 2,040 萬美元。

I will now turn the call back over to Shantanu Gaur.

現在我將電話轉回給 Shantanu Gaur。

Thanks, Tara. We are excited by the start to 2025, clearly demonstrating that we have restructured our business to run more efficiently while still fulfilling a massive unmet medical need around the world. We are making solid progress against our 5 point plan for 2025, and with our pre-PMA meeting now behind us, see a clear path to completing our PMA and advancing our application toward FDA approval. The prospective clinical data we intend to collect on the combination of a loan with GLP-1 therapy could define a new standard of care in obesity management, and we are excited about its potential in our existing markets and once approved, the US market. With our sales team growing and new B2B2C strategy coming to life globally, we believe we are putting Allurion on a path to profitable, sustainable growth.

謝謝，塔拉。我們對 2025 年的開始感到興奮，這清楚地表明我們已經重組了業務，以實現更有效率的運營，同時仍然滿足全球大量未滿足的醫療需求。我們正在按照 2025 年的 5 點計劃取得堅實進展，並且隨著我們的 PMA 前會議結束，我們看到了完成 PMA 和推進我們的申請獲得 FDA 批准的明確途徑。我們打算收集的有關貸款與 GLP-1 療法相結合的預期臨床數據可能會定義肥胖管理的新護理標準，我們對其在現有市場以及一旦獲得批准的美國市場的潛力感到興奮。隨著我們銷售團隊的不斷壯大以及新的 B2B2C 策略在全球範圍內的實施，我們相信 Allurion 正走上盈利、可持續增長的道路。

We believe that if executed correctly, this strategy could lead to significant Accretion of shareholder value with millions of patients entering the funnel and being treated with the Allurion program.

我們相信，如果正確執行，這項策略將使數百萬患者進入管道並接受 Allurion 計劃的治療，從而顯著增加股東價值。

Would that operator, please open up the call for questions.

請接線生打開電話，以便提問。

Jason Wittes, Roth Capital Partners.

傑森‧維特斯，羅斯資本合夥人。

Hi, thanks for taking the questions. Lots of lots of positive things going on this quarter. Maybe to start, can you give any indication in terms of what some of the trends that are going on regionally, whether that be Middle East or Europe, ex France, of course, in terms of momentum, especially with the new change in marketing strategy.

你好，謝謝你回答這個問題。本季發生了很多積極的事情。首先，您能否介紹一下區域內正在發生的一些趨勢，無論是中東還是歐洲（當然不包括法國），就發展勢頭而言，尤其是在行銷策略發生新變化的情況下。

Yes, thanks for thanks for the question, Jason. What we're seeing regionally is really following the expansion of our B2B2C marketing strategy, specifically in territories where there are two phenomena going on. One, tore markets from a GLP-1 perspective are creating some tailwinds for us with patients who have previously tried GLP-1s now re-entering the funnel. Looking for an alternative, but also with the launch of our focus on metabolically healthy weight loss and the combination of the balloon with a low dose of GLP-1s, we're starting to see that in markets where GLP-1s are available, that they are being combined organically with the Allurion balloon.

是的，謝謝你的提問，傑森。我們在區域上看到的其實是我們 B2B2C 行銷策略的擴張，特別是在出現兩種現象的地區。首先，從 GLP-1 的角度來看，裂痕市場正在為我們創造一些順風，而以前嘗試 GLP-1 的患者現在重新進入通路。在尋找替代方案的同時，隨著我們開始關注代謝健康減肥以及球囊與低劑量 GLP-1 的結合，我們開始看到在有 GLP-1 的市場中，它們與 Allurion 球囊有機地結合在一起。

The second phenomenon is really the expansion of our direct sales force as we hire. New sales reps specifically in our direct markets in Europe, they will take some time to onboard, but as they do on board, we start to see an acceleration in new account openings and also going deeper into some of our existing accounts. So as the year progresses, we expect those two trends to continue, and that's why we expect revenues to steadily ramp as the year goes on.

第二個現像是，隨著我們招募人才，我們的直銷團隊實際上也在擴大。特別是在我們歐洲直接市場的新銷售代表，他們需要一些時間來適應，但隨著他們的適應，我們開始看到新帳戶開設速度加快，並且對我們的一些現有帳戶的了解也更加深入。因此，隨著時間的推移，我們預計這兩種趨勢將會持續下去，這就是為什麼我們預期收入將隨著時間的推移而穩定成長。

And can I ask also about the trial with GLP ones did you state how long you think it might take, how many patients and those type of things in terms of how we should be thinking about when we can see some data from that trial.

我還可以問一下關於 GLP 試驗的問題嗎？您是否說明過您認為可能需要多長時間、需要多少名患者以及諸如此類的事情，就我們應該如何考慮何時可以看到該試驗的一些數據而言。

Yes, we expect enrollment in that study to begin this year, probably in the latter half of this year, and with a 1 year follow up, those patients will be going through the combination therapy for most of 2026. We are still considering whether or not to. In some interim looks into the data and are also finalizing the size of the study, but we're expecting the study to be at least 75 subjects across multiple sites in Europe, but we may increase the size, especially if the enrollment demand is there.

是的，我們預計該研究的招募將於今年開始，可能是在今年下半年，經過一年的跟踪，這些患者將在 2026 年的大部分時間接受聯合治療。我們仍在考慮是否要這樣做。在一些中期研究中，我們對數據進行了調查，並最終確定了研究規模，但我們預計該研究將涉及歐洲多個地點的至少 75 名受試者，但我們可能會增加規模，特別是如果有入學需求的話。

Okay, that's helpful and that maybe one last question relates to that. With that in terms of the arms, are you considering doing an arm with the AI suite alone and with the AI suite and combination of the balloon and GLP-1s, or have you, is there any thought about how that in terms of how you might design the arms for this trial?

好的，這很有幫助，也許最後一個問題與此有關。就試驗臂而言，您是否考慮過只使用 AI 套件和使用 AI 套件以及氣球和 GLP-1 的組合來設計試驗臂，或者您是否考慮過如何為這次試驗設計試驗臂？

With this trial in particular, our goal is to validate what we have seen previously in our retrospective work with a prospective study with all of the data that is available now with diet and exercise controls and all the data that we have with patients who are just using the Allurion virtual care Suite with or without GLP-1s, we actually have a lot of data, historical data to compare this prospective. Against and so for now we're moving forward with the single arm prospective trial design and we're going to use a lot of the historical data that we have at our fingertips as comparators. That will do two things. One, it will accelerate the execution of the study, but it will also make it much more efficient to run, which ties into one of our goals for this year is to accelerate our path to profitability. So we'll have plenty of data here to compare our results against.

特別是透過這次試驗，我們的目標是透過前瞻性研究來驗證我們先前在回顧性研究中看到的結果，該研究利用目前有關飲食和運動控制的所有數據以及我們掌握的所有使用 Allurion 虛擬護理套件（無論是否使用 GLP-1）的患者的數據，我們實際上擁有大量數據和歷史數據來比較這一前瞻性研究。因此，目前我們正在推動單臂前瞻性試驗設計，並將使用我們掌握的大量歷史資料作為比較對象。這將起到兩點作用。一方面，它將加速研究的執行，但也會使其運作更加高效，這與我們今年的目標之一即加速獲利目標相吻合。因此，我們將有大量數據可供與我們的結果進行比較。

Okay, thank you. And one last small question, that's just the gross margin had a nice rebound here. Is this kind of the gross margin we can anticipate for the rest of the year? Or is there further improvements?

好的，謝謝。最後一個小問題，那就是毛利率在這裡出現了良好的反彈。這是我們今年剩餘時間可以預期的毛利率嗎？或者還有進一步的改進嗎？

Yes, for the first quarter we were very pleased with the margin expansion. It was driven by some of the restructuring and reorganization that we did in the second half of 2024, but also part of this was driven by increased efficiency on the manufacturing floor as well through some of the new initiatives that we launched during calendar year 2024.

是的，對於第一季的利潤率擴張，我們感到非常滿意。這是由我們在 2024 年下半年進行的一些重組和改組所推動的，但部分原因也是透過我們在 2024 日曆年推出的一些新舉措提高了製造車間的效率。

As the year goes on. We expect, margins to remain in that ballpark we will obviously ramp revenues as the year goes on, which may also increase the margin profile, especially in the second half of the year. But for now on a go forward basis I would say what we did in the 1st quarter, we should be in that same ballpark for the remainder of the year.

隨著時間的流逝。我們預計利潤率將保持在這個水平，隨著時間的推移，我們的收入顯然會增加，這也可能會提高利潤率，特別是在今年下半年。但就目前而言，從未來發展來看，我想說，我們在第一季所取得的成績，應該會在今年剩餘時間內維持同樣的水準。

Got it, thanks. I'll jump back. Thank you very much

明白了，謝謝。我會跳回去。非常感謝

Josh Jennings, TD Cowan.

喬許‧詹寧斯 (Josh Jennings)，TD Cowan。

Hi, good morning. Thanks for taking the question.

嗨，早安。感謝您回答這個問題。

I was I was hoping to just get a better handle on the pre-PMA meeting and just the path from here. I think you called out that that there will be some further analysis of the control group. Any more specifics you can share just in terms of The last remaining steps before you submit that final module if you're around mid year.

我希望能夠更好地掌握 PMA 前會議以及從這裡開始的進程。我認為您曾提到將對對照組進行進一步分析。如果您在年中左右，您可以分享有關提交最終模組之前最後剩餘步驟的更多細節嗎？

Yes, thanks for the question, Josh. We were very pleased with that pre-PMA meeting with the FDA and just to provide a little bit more color on some of the things that we discussed. We presented the preliminary data from Audacity to the FDA, and as you may recall, one of the issues that we highlighted when we announced the top line results was the performance of the control group. And as we've done more analysis on the data and as we've shared some of that analysis with FDA, it's becoming clear that part of the control group performance was really driven by the statistical methods. That we were using in order to impute the missing data in the control subjects and some of the methods that we had been using may introduce some bias into the results that doesn't necessarily need to be there.

是的，謝謝你的提問，喬希。我們對與 FDA 舉行的 PMA 前會議感到非常高興，並為我們討論的一些事情提供了更多細節。我們向 FDA 提交了 Audacity 的初步數據，您可能還記得，我們​​在宣布頂線結果時強調的問題之一是對照組的表現。隨著我們對數據進行更多分析並與 FDA 分享部分分析結果，很明顯，對照組的表現部分是由統計方法驅動的。我們用它來估算對照組的缺失數據，而我們一直在使用的某些方法可能會為結果帶來一些不必要的偏差。

And so with our conversation with FDA, we were actually very pleased to see their receptivity to alternative methods that we can use to analyze that control. Group data that puts us in a much stronger position compared to our pre-specified endpoints. So that was, we were very encouraged by that conversation and that really paves the way for us to complete our clinical study report and module number 4 on the timeline that we discussed in the call.

因此，透過與 FDA 的對話，我們非常高興地看到他們願意接受我們可以用來分析控制的替代方法。與我們預先指定的端點相比，群組資料使我們處於更有利的地位。所以，那次談話讓我們非常受鼓舞，這確實為我們按照通話中討論的時間表完成臨床研究報告和模組 4 鋪平了道路。

So I think, moving forward we will have, I believe, a much more accurate representation of that control group performance which is our Allurion balloon patients should reflect favorably on the overall data. And as a reminder too, we were very pleased with the performance of our Lauran balloon subjects in the study and through our further analysis, their performance has remained unchanged, so we are moving in the right direction, I believe, in terms of completion of the report and getting the PMA into FDA.

因此我認為，展望未來，我們將對對照組的表現有更準確的描述，我們的 Allurion 球囊患者應該對整體數據有正面的影響。另外提醒一下，我們對研究中的 Lauran 球囊受試者的表現非常滿意，透過進一步分析，他們的表現保持不變，因此我相信，在完成報告和將 PMA 提交給 FDA 方面，我們正朝著正確的方向前進。

I appreciate those details and just a follow-up question on that. I mean, is there, are there any analysis to be performed around higher levels of GOP one use in the control arm, or is that just not obtainable?

我很感謝這些細節，並且只是想就此提出一個後續問題。我的意思是，是否有針對對照組中使用更高水平的 GOP 進行分析，或者這根本無法獲得？

Right now there's, a few variables that we've identified that could have been leading to that overperformance in the control group GLP-1s ones being one of them. But what's interesting about these analyses that we've performed is really no matter what was driving some of that control group overperformance, it really doesn't matter in terms of how the missing data is imputed and so whatever was driving that final outcome for the control subjects, we can actually through alternative statistical methods potentially. Correct for all of that, which puts us much more in line with our pre-specified end points. So we're very pleased with how that analysis is going and you know in addition to the solid safety profile that we had in the audacity trial, we're feeling very good about this upcoming submission to FDA.

目前，我們已經確定了一些變量，這些變量可能導致對照組 GLP-1 表現優異，其中之一就是。但是，我們進行的這些分析的有趣之處在於，實際上無論是什麼原因導致了對照組的過度表現，對於如何估算缺失數據而言，這實際上並不重要，因此，無論是什麼原因導致了對照組的最終結果，我們實際上都可以透過其他統計方法來找到答案。所有這些都是正確的，這使我們更加符合我們預先指定的終點。因此，我們對分析的進展非常滿意，而且您知道，除了我們在 Audacity 試驗中獲得的可靠安全性之外，我們對即將提交給 FDA 的申請也感到非常滿意。

Excellent. It's great to hear about the moving forward with the trial for the program and low those GLP-1s . I was hoping to just hear from you about the current algorithm that your centers, adopters of the Allurion balloon and BCS are following. Are you seeing?

出色的。很高興聽到該計劃的試驗正在取得進展並降低 GLP-1 的含量。我希望了解你們的中心、Allurion 氣球的採用者和 BCS 所遵循的當前演算法。你看到了嗎？

Centers adopt and realizing the synergies of the program plus low or normal dosing GOP ones already and could that be a base of registry data that can also that will also accrue to help support this combo therapy approach you're moving forward with.

各中心已經採用並實現了該計劃與低劑量或正常劑量 GOP 方案的協同作用，這可以作為註冊數據的基礎，這些數據也將不斷積累，以幫助支持您正在推進的這種組合治療方法。

Yes, it's a very good question, Josh. We're seeing this happen organically in the field, and in fact, the retrospective data that we presented a few months ago was a result of low dose GLP-1s being used in combination with Lauran organically by one of our physician partners in Italy. I was actually on the phone yesterday with one of our physician partners in Mexico who told me that he is opening up a new branch to his clinic that is going to focus on prescribing GLP-1s. He feels like that's going to do two things, and he's a bariatric surgeon by training. He feels like that's going to bring more patients into the front door, but also. He knows that as patients escalate their GLP-1 dose, their adherence drops, they have side effects, and they want to go back down to a low dose, which of course will impact their overall weight loss, and he's well positioned to plug in the Allurion balloon into those patients as part of his treatment algorithm.

是的，這是一個非常好的問題，喬希。我們在該領域看到了這種情況的自然發生，事實上，幾個月前我們提出的回顧性數據是義大利一位醫生合作夥伴將低劑量 GLP-1 與 Lauran 有機結合使用的結果。實際上，昨天我剛剛與我們在墨西哥的一位醫生合作夥伴通了電話，他告訴我，他正在為他的診所開設一個新的分支機構，專注於開立 GLP-1 處方。他認為這會產生兩個效果，而且他是一名受過訓練的減肥外科醫生。他覺得這不僅會吸引更多的病人前來就診，而且。他知道，隨著患者增加 GLP-1 劑量，他們的依從性會下降，並產生副作用，因此他們會希望恢復到低劑量，這當然會影響他們的整體減肥效果，因此他很適合將 Allurion 球囊插入這些患者體內，作為其治療演算法的一部分。

So, we're seeing it happen in markets where GLP1s have matured, and that's what gives us confidence that this prospective trial that we are doing is going to speak to a lot of physicians around the world who are probably doing something very similar in their practice on a go forward basis, even after this prospective trial is done, one of the strengths of the virtual care suite is that Physicians and their teams can Allurion in the virtual care suite the treatment regimen that they are using. So for a patient who gets the Allurion balloon, if that patient starts on a low dose GLP-1 with a check of a box, the physician and their team can put into our system that the patient has started Semaglutide or Tirzepatide at a dose which then allows us globally to track this performance.

因此，我們看到它在 GLP1 已經成熟的市場中發生，這讓我們有信心，我們正在進行的這項前瞻性試驗將與世界各地的許多醫生交流，他們可能在未來的實踐中做著非常類似的事情，即使在這項前瞻性試驗完成後，虛擬護理套件的優勢之一是醫生和他們的團隊可以在虛擬護理套件中使用 Allurion 來治療他們正在使用的治療方案。因此，對於使用 Allurion 球囊的患者，如果該患者開始使用低劑量 GLP-1 並勾選一個方框，醫生及其團隊就可以將患者已開始使用 Semaglutide 或 Tirzepatide 的劑量輸入我們的系統，這樣我們就可以在全球範圍內跟踪這種表現。

So, I suspect that there's going to be a lot of this combination therapy happening in the field, and we will have that data at our fingertips through the virtual care suite, but also through some of these more structured clinical studies and registries that we can launch in the future.

因此，我認為該領域將會大量採用這種聯合療法，我們將透過虛擬護理套件輕鬆獲取這些數據，同時也可以透過我們將來可以啟動的一些更結構化的臨床研究和登記冊來獲取這些數據。

Understood. And just one last one, I think you've already addressed this, but just to Make sure we understand the layers of I guess sequential revenue performance to get you to the full year guidance. I mean all the all the work you've done on the commercial reorganization and the strategy, commercial strategy on a go forward basis seems sound, but maybe just help us think through the cadence of the improvement in sales over the next couple quarters in 2025 and include just how you see the recovery in France going. Thanks so much.

明白了。最後一個問題，我想你已經提到過這個問題，但只是為了確保我們理解連續收入表現的各個層面，以便為你提供全年指導。我的意思是，您在商業重組和策略方面所做的所有工作，從前進的角度來看商業策略似乎是合理的，但也許只是幫助我們思考 2025 年接下來幾季銷售成長的節奏，包括您如何看待法國的復甦。非常感謝。

Thank you, Josh. So when it comes to the rest of this year, we expect to see a steady increase in revenue as the year goes on. That's really being driven by onboarding of new sales team members, much of which is happening this quarter and at the end.

謝謝你，喬希。因此，展望今年剩餘時間，我們預計收入將隨著時間的推移穩步增長。這實際上是由新銷售團隊成員的加入所推動的，其中大部分將在本季度和末進行。

And on board. (inaudible)

並在船上。（聽不清楚）

Thank you. Good morning. A couple of questions about the prospective combo study. I guess the first question, any estimate of what you plan to spend for the study?

謝謝。早安.關於未來組合研究的幾個問題。我想第一個問題是，您預計這項研究要花多少錢？

Yes, thanks for the question, Keay. As I mentioned earlier, one of our goals is to increase and accelerate our path to profitability. And one of the nice parts about this prospective study is that we can leverage our existing patient flow, commercial patient flow, leverage our existing clinics that are using GLP-1s in combination with the program, and also leverage the lower cost of GLP-1s overseas compared to the US.

是的，謝謝你的提問，Keay。正如我之前提到的，我們的目標之一是增加並加速我們的獲利之路。這項前瞻性研究的優點之一是，我們可以利用現有的患者流量、商業患者流量、利用與該計劃結合使用 GLP-1 的現有診所，還可以利用海外與美國相比 GLP-1 的較低成本。

So we actually don't expect this prospective trial to have any material. Impact on our budget or overall expenses and some of that expense will hit in 2025 and some of it will hit in 2026. So because the study is going to, between enrollment and actual execution will take 1years to 2 years, we'll also be able to space out that expense over time. So we're not providing a specific number at this point, but all I can say is we feel comfortable about funding it with our existing budget.

所以我們其實並不期望這次預期的試驗能產生任何成果。對我們的預算或總體支出的影響，部分支出將在 2025 年產生，部分支出將在 2026 年產生。因此，由於這項研究從招募到實際執行將需要 1 到 2 年的時間，我們也可以隨著時間的推移分攤這筆費用。因此，我們目前不會提供具體的數字，但我可以說的是，我們對於用現有預算來資助它感到滿意。

Okay and from a regulatory perspective, as far as expanded label, is that part of the strategy or is it simply by doing a prospective study, having that data, it would support a marketing effort to utilize the combination with low dose GLP-1s as opposed to an end goal of an expanded label to that same effect.

好的，從監管角度來看，就擴大標籤而言，這是策略的一部分嗎？還是僅僅透過進行前瞻性研究，獲得這些數據後，就可以支持行銷活動，利用與低劑量 GLP-1 的組合，而不是以擴大標籤為最終目標來達到相同的效果。

In the short term, Keay I think it's more about the commercial implications of a study like this and providing physicians additional comfort that this is a valid strategy. As I mentioned previously, a lot of this is already happening organically amongst physicians who are doing both the Allurion and GLP-1s, and this study will, I think, provide a bit of a cherry on top in terms of validating that approach. That being said, what we do believe that this study will also allow us to do is start the conversation with regulators and with payers about the. Of combination therapy, both from the perspective of increased clinical outcomes or improved clinical outcomes, longer term weight loss, improved muscle mass maintenance, but also the health economic implications of this type of approach, as you can imagine, GLP-1s at high doses cost a lot of money and are bleeding a lot of payers dry, whether they are commercial payers or even self-insured employers.

從短期來看，Keay，我認為這更多的是關於此類研究的商業意義，並讓醫生更加放心，這是一個有效的策略。正如我之前提到的，許多這樣的情況已經在使用 Allurion 和 GLP-1 的醫生中自然而然地發生，我認為這項研究將在驗證這種方法方面錦上添花。話雖如此，我們確實相信這項研究也能讓我們與監管機構和付款人展開對話。對於聯合治療，無論是從增加臨床結果或改善臨床結果、長期減肥、改善肌肉質量維持的角度來看，還是從這種方法的健康經濟影響的角度來看，正如您所想像的，高劑量的 GLP-1 花費很多錢，並且正在榨乾很多付款人，無論他們是商業付款人還是自我保險的雇主。

And so I believe that as we get closer to the US market with some of this data in hand, it could provide a very compelling option for payers who are struggling to cope with the high cost of GLP-1 therapy and also regulators who are looking for additional options for treating patients with obesity. So I do think in the long term this data could be very useful for that, but in the short term we're really focused on the commercial and clinical impact at our existing centers.

因此我相信，隨著我們掌握這些數據並逐漸接近美國市場，它可以為那些難以應對 GLP-1 療法高昂成本的付款人以及那些正在尋找治療肥胖症患者其他選擇的監管機構提供一個非常有吸引力的選擇。因此我確實認為從長遠來看這些數據可能非常有用，但從短期來看我們真正關注的是現有中心的商業和臨床影響。

Okay, thanks.

好的，謝謝。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

Hey guys, thanks for taking my question. I'm on for Matt Taylor. Could you talk about the procedure growth in the quarter, and maybe procedure growth ex France if you have that, and. I guess any trends you're seeing in Q2 on that procedure growth since the tariff announcements, I know you said there's not a material impact on costs, but are you seeing any impact on the procedures there?

嘿夥計們，謝謝你們回答我的問題。我支持馬特泰勒。您能否談談本季的流程成長情況，以及法國以外的流程成長（如果有的話），以及。我想，自從關稅公告發布以來，您在第二季度看到了該流程增長的任何趨勢，我知道您說這對成本沒有實質影響，但您是否看到那裡的流程受到任何影響？

Thanks for the question. When it comes to procedure growth, now that inventory levels have really normalized globally, procedures and our top line revenue are moving in lockstep with one another. And so quarter over quarter we see stability in procedure volume X France in certain territories. We're seeing some growth in procedure volume and in other territories that were more dependent on that DTC marketing that we were doing in the early part of 2024, we're starting to see a recovery in procedure volume, but on a go forward basis we'll really just be reporting out our top line revenue numbers, which will give you an indication of how procedure volume is trending.

謝謝你的提問。就流程成長而言，現在全球庫存水準已經真正正常化，流程和我們的營業收入正在同步成長。因此，與上一季相比，我們發現某些地區的 X 法國的手術量保持穩定。我們看到程式量有所成長，在 2024 年初更依賴 DTC 行銷的其他地區，我們開始看到程式量復甦，但在未來，我們實際上只會報告我們的頂線收入數字，這將讓您了解程式量的趨勢。

And when it comes to France in particular, we do expect that, in the second half of the year we'll start seeing some placements, not nearly at the volume as they were in the second half of 2024, but they will add to our overall global procedure volume. When it comes to tariffs and their impact on our business, yes, as I mentioned, we don't expect any impact on our gross margin as a result of tariffs.

特別是在法國，我們確實預計，今年下半年我們將開始看到一些安置，雖然數量遠不及 2024 年下半年，但它們將增加我們全球的整體程序量。談到關稅及其對我們業務的影響，是的，正如我所提到的，我們預計關稅不會對我們的毛利率產生任何影響。

And in Europe and elsewhere we really haven't seen an impact of from a macro perspective, it's something that we're tracking very closely, obviously, but again, when it comes to the actual ground level impact of these tariffs on consumers who are interested in weight loss, we see the impact being fairly minimal here.

在歐洲和其他地方，我們確實沒有看到從宏觀角度來看的影響，顯然，我們正在密切關注這一問題，但當談到這些關稅對有意減肥的消費者的實際影響時，我們認為其影響相當小。

Okay, all right, that's very clear. Thank you. And you mentioned the additional analysis, the FDA was that due to any concerns that the balloon wouldn't be approved without the additional analysis, or is that just kind of normal in the process?

好的，好的，這很清楚。謝謝。您提到了額外的分析，FDA 是否擔心如果沒有額外的分析，氣球不會獲得批准，還是這只是流程中的正常現象？

No, it wasn't due to any additional concerns. It was actually just due to the further analysis that we did after seeing the top line data internally and also after presenting that data to FDA, they actually invited some of these additional analyses that frankly, work in our favor in terms of that second pre-specified endpoint. So we're very pleased that that door was opened and And that we have that flexibility. We were very pleased with the overall results of the trial to begin with from a safety perspective and also from a balloon performance perspective and now that we have an additional analysis that we can do when it comes to the control group, I think it just, further strengthens and underscores the quality of the study and the quality of the data. So we're feeling very good about the outcome there and what it means for the rest of the process with the FDA.

不，這並不是由於任何其他擔憂。這實際上只是因為我們在內部看到頂線數據後進行了進一步的分析，並且在將這些數據提交給 FDA 後，他們實際上邀請進行一些額外的分析，坦率地說，就第二個預先指定的終點而言，這些分析對我們有利。因此，我們很高興這扇門被打開了，而且我們擁有了這種靈活性。首先，從安全性和球囊表現的角度來看，我們對試驗的整體結果非常滿意，現在我們可以對對照組進行額外的分析，我認為這進一步加強和強調了研究的品質和數據的品質。因此，我們對該結果以及它對 FDA 其餘流程的意義感到非常滿意。

Okay, awesome. One final question is just on the AI powered virtual care suite, impressive study results from yesterday where you combined with the GLP-1s. Could you talk about when you'd expect those virtual care suit revenues to be material, yeah, when you expect that to ramp up and be material to the top line.

好的，太棒了。最後一個問題是關於人工智慧虛擬護理套件，昨天與 GLP-1 結合的研究結果令人印象深刻。您能否談談您預計這些虛擬護理套裝收入何時會變得重要，是的，您預計什麼時候會增加並對營業收入產生重要影響。

Yes, it's a good question. The data that we presented at the European Congress on Obesity, I think, really just underscores the versatility of the program. We were able to show that in combination with normal dose GLP-1s, our VCS can power higher weight loss results. It can also power better muscle mass maintenance and in fact muscle mass improvement as a percentage of body composition. And then when you combine Allurion BCS and balloon with high dose GLP-1s, you get excellent weight loss. Obviously in those patients they may actually experience the side effects of high doses and may not be on that high dose therapy for very long, but in the short term at least you get to results for patients with severe obesity that are similar to what they could achieve with bariatric surgery without, as we mentioned, the risks of bariatric surgery.

是的，這是個好問題。我認為，我們在歐洲肥胖大會上展示的數據確實強調了該計劃的多功能性。我們已經證明，與正常劑量的 GLP-1 結合，我們的 VCS 可以帶來更好的減肥效果。它還可以促進更好地維持肌肉質量，事實上提高肌肉質量在身體組成中所佔的百分比。然後，當您將 Allurion BCS 和球囊與高劑量 GLP-1 結合使用時，您會獲得顯著的減肥效果。顯然，這些患者實際上可能會經歷高劑量的副作用，並且可能不會長期接受高劑量治療，但至少在短期內，嚴重肥胖患者可以獲得與減肥手術相似的治療效果，而且如我們所提到的，沒有減肥手術的風險。

What we really see from a software perspective is the US most likely being the bigger contributor of our software revenue ramp.

從軟體角度來看，我們真正看到的是美國很可能成為我們軟體收入成長的最大貢獻者。

We do have clinics overseas, large chains that are using the virtual care suite to manage all of their different weight loss patients, whether they're getting GOP-1s, our balloon, or bariatric surgery, but I really believe the bigger uptake. Going to be in the US, especially when we combine the virtual care suite with our ability in the US to prescribe GLP-1s through the Allurion meds platform. So I don't expect there to be a material contribution to our revenue from software this year or early next year, but as we start ramping in the US, I do believe it can become a more meaningful part of our business.

我們確實在海外設有診所，大型連鎖機構正在使用虛擬護理套件來管理所有不同的減肥患者，無論他們接受的是 GOP-1、我們的球囊還是減肥手術，但我確實相信更大的應用範圍。我們將在美國開展業務，特別是當我們將虛擬護理套件與我們在美國透過 Allurion 藥物平台開立 GLP-1 的能力結合時。因此，我並不期望今年或明年初軟體會對我們的收入產生實質的貢獻，但隨著我們開始在美國擴張，我相信它會成為我們業務中更有意義的一部分。

All right, great. Thanks for taking my question.

好的，太好了。感謝您回答我的問題。

This concludes the question and answer session. I'll turn the call to Shantanu for closing remarks.

問答環節到此結束。現在請 Shantanu 致閉幕詞。

Thank you very much, operator. As we close our call today, I'd just like to extend my thanks and gratitude to everyone who's joining us today, particularly all my fellow Allurion who are on the call, who are building Allurion 2.0 side by side with me and our loyal shareholders, of course who have backed us. For many years now, your unwavering belief in our mission and our commitment to our company have really set us up for success. So we look forward to updating all of you on the progress that we make over the next several months. Thank you everyone for joining and have a great day.

非常感謝，接線生。在我們今天的電話會議結束之際，我只想向今天參加會議的每個人表示感謝和感激，特別是所有參加電話會議的 Allurion 同事，他們與我和我們忠實的股東並肩打造 Allurion 2.0，當然，他們也支持我們。多年來，您對我們的使命的堅定信念以及我們對公司的承諾確實為我們的成功奠定了基礎。因此，我們期待在未來幾個月向大家通報我們所取得的進展。感謝大家的參與並祝福大家有個愉快的一天。

This concludes today's conference call. Thank you for joining. You may now disconnect.

今天的電話會議到此結束。感謝您的加入。您現在可以斷開連線。