MiniMed Group Inc (MMED) 2025 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the MiniMed fourth quarter and fiscal year 2026 financial results conference call. (Operator Instructions) Please be advised, today's conference is being recorded.

    大家好,感謝您稍候。歡迎參加 MiniMed 2026 會計年度第四季暨全年財務業績電話會議。(接線員指示) 請注意,今天的會議將被錄音。

  • I would now like to hand the conference over to your speaker today, Ryan Weispfenning, Head of MiniMed Investor Relations. Please go ahead.

    現在我想把會議交給今天的講者——MiniMed 投資人關係主管 Ryan Weispfenning。請開始。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Hello, everyone, and thanks for joining us today for our fiscal '26 fourth-quarter earnings webcast. I'm Ryan Weispfenning, Vice President and Head of MiniMed Investor Relations. Joining me today are Que Dallara, Chief Executive Officer; and Chad Spooner, Chief Financial Officer. Today's program will last no longer than 45 minutes so that we may complete the call before the market opens.

    各位好,感謝今天參加我們 2026 會計年度第四季財報網路直播。我是 Ryan Weispfenning,MiniMed 投資人關係副總裁暨主管。今天與我一同出席的有執行長 Que Dallara,以及財務長 Chad Spooner。今天的議程不會超過 45 分鐘,以便我們在開盤前結束本次電話會議。

  • Earlier this morning, we issued a press release discussing our results and containing several financial schedules. We also posted an earnings presentation to our website that provides additional details on our performance. Both can be accessed on our website at investors.minimed.com.

    今天稍早,我們發布新聞稿說明本次業績,並附上多份財務附表。我們也在網站上發布了財報簡報,提供更多關於我們表現的細節。兩者皆可於 investors.minimed.com 查閱。

  • During today's program, many of the statements we make may be considered forward-looking statements, which are subject to risks and uncertainties, and actual results may differ materially from those projected in any forward-looking statement. Please take a moment to review the cautionary statements regarding forward-looking statements, including in our earnings press release and the presentation.

    在今天的議程中,我們所做的許多陳述可能構成前瞻性陳述,該等陳述受風險與不確定性影響,實際結果可能與任何前瞻性陳述所預測者有重大差異。請花點時間閱讀有關前瞻性陳述的警示聲明,包括我們的財報新聞稿與簡報中的相關內容。

  • Additional information concerning factors that could cause our actual results to differ is contained in the filings we make with the SEC, and we do not undertake to update any forward-looking statement or any of the information contained in this.

    關於可能導致實際結果與預期不同的因素之更多資訊,載於我們向美國證券交易委員會(SEC)提交的文件中;我們不承擔更新任何前瞻性陳述或本文所含任何資訊的義務。

  • In this presentation, we reference organic revenue growth, a non-GAAP financial measure. A reconciliation to the most directly comparable GAAP financial measure is included in today's earnings press release.

    在本簡報中,我們提及有機營收成長(organic revenue growth),此為一項非 GAAP 財務衡量指標。與最直接可比的 GAAP 財務衡量指標之調節表已包含於今天的財報新聞稿中。

  • With our organic revenue growth and adjusted EBITDA margin guidance, we do not provide reconciliations to comparable GAAP measures because certain items in these forward-looking non-GAAP measures cannot be predicted without unreasonable effort.

    就我們的有機營收成長與調整後 EBITDA 利潤率(adjusted EBITDA margin)指引而言,我們不提供與可比 GAAP 指標的調節,因為這些前瞻性非 GAAP 指標中的某些項目若不付出不合理的努力,無法預測。

  • We operated as part of Medtronic until our IPO in early March. Our GAAP financial statements were therefore prepared on a carve-out basis and include certain historical cost allocations from Medtronic for centralized support functions.

    在 3 月初首次公開發行(IPO)之前,我們一直作為美敦力(Medtronic)的一部分營運。因此,我們的 GAAP 財務報表係以分拆(carve-out)基礎編製,並包含美敦力就集中式支援職能所分攤的若干歷史成本。

  • We refer to certain financial information for MiniMed on a standalone basis. This replaces those Medtronic historical cost allocations with the expected run rate cost structure for standalone MiniMed. This information also eliminates the impact of certain incremental non-recurrent costs. These non-GAAP standalone financial measures are included to provide consistency and comparability while evaluating operational performance on a run rate standalone basis for reporting periods after MiniMed's fiscal year 2026.

    我們亦以獨立公司(standalone)基礎呈列 MiniMed 的若干財務資訊。此作法以 MiniMed 獨立營運時預期的常態化成本結構(run rate cost structure),取代美敦力的歷史成本分攤。此資訊亦排除若干新增的一次性、非經常性成本之影響。納入這些非 GAAP 的獨立公司財務衡量指標,旨在於評估 MiniMed 2026 會計年度之後各報導期間、以常態化獨立營運基礎之營運表現時,提供一致性與可比性。

  • A reconciliation of these stand-alone non-GAAP financial measures to their most directly comparable GAAP financial measures is included in today's earnings presentation. With that, over to you, Que.

    上述獨立公司非 GAAP 財務衡量指標與其最直接可比之 GAAP 財務衡量指標的調節表,已包含於今天的財報簡報中。接下來交給你,Que。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • Thank you, Ryan, and good morning, everyone. It's good to be speaking with you today on our first earnings call as a stand-alone, publicly traded MiniMed.

    謝謝你,Ryan,各位早安。很高興在 MiniMed 成為獨立上市公司後的第一場財報電話會議與各位交流。

  • Before we go into the details, let me start with who we are and why we exist. MiniMed exists to give people living with insulin-dependent diabetes more time in range, more freedom from the daily grind of managing their condition, and more time to simply live their lives.

    在進入細節之前,我先談談我們是誰,以及我們為何存在。MiniMed 的存在,是為了讓依賴胰島素的糖尿病患者有更多時間維持在目標範圍內(time in range)、更能擺脫每日管理病況的繁瑣負擔,並有更多時間單純地過生活。

  • We do that today for 659,000 pump users around the world through the most complete, most clinically validated automated insulin delivery platform available anywhere. That has been our North Star for more than 40 years.

    目前,我們透過全球最完整、臨床驗證最充分的自動化胰島素輸注(automated insulin delivery)平台,為全球 659,000 名胰島素幫浦使用者提供服務。這一直是我們 40 多年來的北極星目標。

  • We went public in early March. The week after, we received CE mark for the Instinct sensor made by Abbott with the MiniMed 780G a year ahead of schedule. And the week after that, we received FDA clearance for MiniMed Flex two quarters ahead of expectations.

    我們在 3 月初上市。隔週,我們提前一年取得由 Abbott 製造、可搭配 MiniMed 780G 的 Instinct 感測器 CE 認證。再隔一週,我們又提前兩個季度取得 MiniMed Flex 的 FDA 核准。

  • For fiscal '26, we had record revenue crossing the $3 billion threshold for the first time, with another year of high single-digit growth. These milestones reflect the acute focus we've had on driving pipeline execution over the last few years.

    在 2026 會計年度,我們營收創新高,首次突破 30 億美元門檻,並再度實現高個位數成長。這些里程碑反映了我們過去幾年在推動產品管線執行上的高度專注。

  • In Q4, we finished fiscal '26 strong, and we're carrying that momentum into fiscal '27. Our Q4 revenue growth was driven by continued strength in international markets and sequential pump adoption momentum in the US. New sensors were a meaningful driver throughout the entire second-half.

    在第四季,我們強勁收官 2026 會計年度,並將這股動能延續至 2027 會計年度。第四季營收成長主要來自國際市場的持續強勁表現,以及美國市場幫浦採用率的連續改善動能。新款感測器在整個下半年都是重要的成長驅動因素。

  • Let me address US performance directly. Growth of 1.5% in Q4 was below our initial expectations, and I want to be clear about what drove it. FDA clearance of MiniMed Flex came six months early. This is clearly positive news for us and a significant milestone, but it did create a short-term dynamic where some customers who were close to a pump decision chose to wait for the new system. That's a timing issue, not a demand issue.

    我想直接談談美國市場的表現。第四季 1.5% 的成長低於我們最初的預期,我想清楚說明其原因。MiniMed Flex 的 FDA 核准比預期早了六個月。這對我們而言顯然是正面消息,也是重要里程碑,但也造成短期效應:部分原本接近做出幫浦購買決策的客戶選擇等待新系統。這是時點問題,而非需求問題。

  • MiniMed Flex is the most substantial hardware and software pump update in a decade, and we're excited with what we're hearing in the market about Flex's launch later this month.

    MiniMed Flex 是十年來在硬體與軟體方面最重大的幫浦更新,我們對於本月稍晚 Flex 上市後市場回饋所傳來的訊息感到振奮。

  • In addition to Flex, we pulled forward two more launches. The MiniMed 780G with Instinct starts rolling out internationally later this month, giving our international pump users more sense of choice. And MiniMed Go, our smart MDI system for the 15 million people worldwide on multiple daily injections, launched in Europe earlier this year and in the US just this week.

    除了 Flex 之外,我們也提前推進另外兩項產品上市。搭載 Instinct 的 MiniMed 780G 將於本月稍晚開始在國際市場逐步推出,讓我們的國際幫浦使用者有更多選擇。此外,MiniMed Go——我們為全球 1,500 萬名採用每日多次注射(MDI)的患者打造的智慧 MDI 系統——已於今年稍早在歐洲上市,並於本週剛在美國上市。

  • And it is these three products that underpin our confidence in our fiscal '27 growth. Behind these three, the pipeline is just as exciting: MiniMed Fit, our next-generation patch pump, and Vivera, our fully closed-loop algorithm for type 1 and type 2, both on track for clearance next year.

    而正是這三項產品,支撐了我們對 2027 會計年度成長的信心。在這三項產品之後,我們的產品管線同樣令人振奮:MiniMed Fit——我們的下一代貼片式幫浦(patch pump),以及 Vivera——我們針對第一型與第二型糖尿病的全閉環(fully closed-loop)演算法,兩者皆按計畫於明年取得核准。

  • Now looking at Q4 in more detail, starting with international. As I mentioned earlier, our international business delivered a strong quarter, growing 12% organic, an acceleration from Q3. Increased Simplera availability drove a high-single-digit sequential increase in new pump sold or NPS and a 100-basis-point sequential increase in CGM attachments.

    現在更深入看看第四季,先從國際市場開始。如我先前提到,我們的國際業務在本季表現強勁,有機成長 12%,較第三季加速。Simplera 供應量提升,帶動新售出幫浦數(NPS)較前一季增加高個位數,並帶動連續血糖監測(CGM)搭載率較前一季提升 100 個基點。

  • On a year-over-year basis, NPS were down mid-single-digits. Primarily due to a tough comparison in Q4 of last year. That period benefited from the initial launch of Simplera, which drove a meaningful acceleration in NPS and set a high baseline.

    以年對年來看,NPS 下降中個位數。主要是因為去年第四季的比較基期較高。當時受惠於 Simplera 的初期上市,顯著推升 NPS 成長並建立了較高的基準。

  • We delivered strong international growth even before the Instinct sensor entered these markets. The EU Instinct launch opens up the MiniMed 780G to more than 4.5 million Abbott sensor users on insulin-intensive therapy, a population we haven't been able to reach until now.

    即使在 Instinct 感測器進入這些市場之前,我們的國際成長就已相當強勁。歐盟 Instinct 的上市,將使 MiniMed 780G 能觸及超過 450 萬名採用胰島素密集治療的 Abbott 感測器使用者——這是我們過去一直無法觸及的人群。

  • Turning to the US, with the context on overall US performance that I covered earlier, let me walk you through two components, CGM and pumps, because the underlying dynamics in each tell an important story about where this business is heading.

    接著談美國市場。基於我先前對美國整體表現所提供的背景,我將帶各位看兩個組成部分:CGM 與幫浦,因為兩者各自的底層動態,對於這項業務的走向提供了重要訊息。

  • US CGM revenue grew high single-digits in Q4, our first full quarter with both Simplera and Instinct available. Since launching both sensors in Q2, US CGM attachment has increased by mid-single-digit percentage points. More of our pump users are using our sensors. And that's the full stack working. When the sensor and pump are designed together, powered by our SmartGuard algorithm, patients use them together.

    美國 CGM 營收在第四季成長高個位數,這是我們同時提供 Simplera 與 Instinct 後的第一個完整季度。自第二季推出兩款感測器以來,美國 CGM 搭載率已提升中個位數的百分點。更多幫浦使用者正在使用我們的感測器。這就是完整堆疊(full stack)發揮作用。當感測器與幫浦是共同設計,並由我們的 SmartGuard 演算法驅動時,病患就會一起使用它們。

  • And that creates a durable, recurring revenue stream that compounds over time. Our new sensor offerings are also bringing new patients to MiniMed. US NPS were up year over year and up mid-single-digits sequentially, a leading indicator of where US revenue is heading.

    而這會創造一個可持續、可重複的經常性營收來源,並隨時間複利成長。我們新的感測器產品也正為 MiniMed 帶來新病患。美國 NPS 年增,且季比提升中個位數百分點,這是美國營收走向的領先指標。

  • And here's why I'm confident about fiscal '27. Sensors were the setup. MiniMed Go and Flex are the follow-through. MiniMed Go launched two weeks ago. Providers can prescribe directly from their EMR to MiniMed Pharmacy and the product is shipped directly to patients.

    這也是我對 27 財年充滿信心的原因。感測器是鋪陳。MiniMed Go 與 Flex 則是後續推進。MiniMed Go 於兩週前上市。醫療提供者可直接透過其 EMR 將處方開立至 MiniMed Pharmacy,產品並直接配送到病患手中。

  • Pre-orders for MiniMed Flex started this week and we will begin shipping in a couple of weeks. I have been out in the field extensively at key accounts, meeting with clinical teams, the reps, the patients, and the excitement is real. Flex is sleek and discreet and half the size of 780 with a 300-unit reservoir and app-based control. Now combined with two great sensor options, this is the product people have been waiting for.

    MiniMed Flex 的預購本週已開始,我們將在幾週內開始出貨。我近期在第一線於多個關鍵客戶處密集走訪,與臨床團隊、業務代表及病患會面,現場的興奮感是真實的。Flex 外型俐落且低調,體積只有 780 的一半,配備 300 單位儲液槽並可透過 App 控制。如今再結合兩種優秀的感測器選項,這就是大家一直在等待的產品。

  • To that end, let me turn to the pipeline because this is where I believe the long-term investment thesis for MiniMed becomes visible. We are in the middle of a complete portfolio transformation. Within 18 months, a person living with diabetes will be able to choose MiniMed at every stage of their journey. Smart pen, patch, or durable pump, all using the smarts of the same closed-loop algorithm, the same app, all within the same ecosystem, one company, every option.

    基於此,讓我談談產品研發管線,因為我相信 MiniMed 的長期投資論點在這裡會變得清晰可見。我們正處於完整產品組合轉型的中段。在 18 個月內,糖尿病患者將能在其旅程的每個階段都選擇 MiniMed。智慧筆、貼片式或耐用型幫浦,全部使用同一套閉環演算法的智慧、同一個 App、同一個生態系統之內;一家公司,所有選項。

  • I want to be clear about what this moment represents. This is the third generation of MiniMed. The first was defined by our pioneering insulin pump therapy. The second by our 780G and SmartGuard, the most clinically validated AIG system in the world.

    我想清楚說明這個時刻代表什麼。這是 MiniMed 的第三代。第一代以我們開創性的胰島素幫浦治療為標誌。第二代則以我們的 780G 與 SmartGuard 為代表,這是全球臨床驗證最充分的 AIG 系統。

  • The third era, the one we're building right now, gives patients the products they have been asking for, a durable pump that is half the size of 780 with a 300-unit reservoir; a patch pump with a 300-unit reservoir and up to seven days of wear; a smart MDI system for the millions of people not ready for pump therapy; and a fully closed-lib algorithm that ties it all together. We believe this will completely reshape how the market thinks about MiniMed.

    第三個時代,也就是我們正在打造的這個時代,將提供病患一直以來所要求的產品:一款體積為 780 一半、配備 300 單位儲液槽的耐用型幫浦;一款配備 300 單位儲液槽且可佩戴長達七天的貼片式幫浦;一套面向數百萬尚未準備好使用幫浦治療人群的智慧 MDI 系統;以及一套將一切串聯起來的全閉環演算法。我們相信這將徹底重塑市場對 MiniMed 的看法。

  • Let me go deeper on the products that will define our next chapter. First, with MiniMed Flex, our ECP, or early commercial pilot, is underway. We started taking pre-orders this week and expect to launch Flex with integration to Simplera Sync sensor later this month, followed by Flex integrated with InSync in our second quarter. Similar to 780G, we are working on making Flex available through pharmacy, and we will update you as the year progresses.

    讓我更深入說明將定義我們下一篇章的產品。首先,就 MiniMed Flex 而言,我們的 ECP(早期商業試點)正在進行中。我們本週開始接受預購,並預期於本月稍晚推出與 Simplera Sync 感測器整合的 Flex,接著在第二季推出與 InSync 整合的 Flex。與 780G 類似,我們正努力讓 Flex 可透過藥局通路取得,並將在今年進展過程中向各位更新。

  • In international market, we submitted Flex for clearance this last quarter, and we are expecting CE mark approval by the end of the calendar year with MiniMed Go, our smart MDI solution, launched in Europe in late February and began its US launch last week.

    在國際市場方面,我們於上一季已提交 Flex 申請核准,並預期在本曆年年底前取得 CE 認證;同時 MiniMed Go(我們的智慧 MDI 解決方案)已於 2 月下旬在歐洲上市,並於上週開始在美國上市。

  • With MiniMed Fit, our differentiated patch pump, we expect to submit to FDA by this fall with commercial launch next calendar year.

    就 MiniMed Fit(我們具差異化的貼片式幫浦)而言,我們預期在今年秋季前向 FDA 提交申請,並於下一個曆年進行商業化上市。

  • We've also made great progress on manufacturing and expect to have an initial capacity to serve 20,000 patients at launch, and we are scaling production capacity quickly. And Vivera, our fully closed-loop algorithm for type 1 and type 2 showed impressive feasibility data at ATTD in March. On average, users met ADA guidelines for time in range with no user input whatsoever, meaning no need to bolus, or make no announcements.

    我們在製造方面也取得重大進展,預期在上市時具備可服務 20,000 名病患的初始產能,並正快速擴增產能。此外,Vivera(我們針對第 1 型與第 2 型糖尿病的全閉環演算法)在 3 月 ATTD 上展示了令人印象深刻的可行性數據。平均而言,使用者在完全不需任何使用者輸入的情況下即可達到 ADA 的目標範圍內時間指引,亦即無需追加胰島素(bolus),或不必進行任何宣告。

  • We started enrollment in our US pivotal for Vivera in February. We have already completed around 50% of the targeted enrollment and remain on track for launch next calendar year.

    我們於 2 月啟動 Vivera 在美國的關鍵性試驗收案。目前已完成約 50% 的目標收案,並仍按計畫於下一個曆年上市。

  • With that, I'll turn it to Chad to walk through the Q4 financials and fiscal '27 guidance.

    接下來我把時間交給 Chad,請他說明第四季財務表現與 27 財年指引。

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • Thanks, Que. Q4 revenue was $837 million, up 8.7% organic, driven by 12.2% growth in international markets. US growth was 1.5%, driven by the short-term dynamics that Que covered earlier.

    謝謝你,Que。第四季營收為 8.37 億美元,有機成長 8.7%,主要由國際市場 12.2% 的成長所帶動。美國成長 1.5%,主要受 Que 先前提到的短期動態所驅動。

  • Our global growth was driven by our recurring revenue streams, CGM, and consumables, which make up 80% of our business. CGM grew mid-teens and consumables grew mid-single-digits.

    我們的全球成長主要由經常性營收來源所帶動,包括 CGM 與耗材,兩者合計占我們業務的 80%。CGM 成長中十位數百分比,耗材成長中個位數百分比。

  • For fiscal 2026, we had record revenue crossing the $3 billion threshold for the first time with an overall 8% organic growth. Growth was led by international, where we grew 11.2%.

    在 2026 財年,我們營收創新高,首次突破 30 億美元門檻,整體有機成長 8%。成長由國際市場領軍,國際市場成長 11.2%。

  • By product line, our recurring revenue streams from CGM and consumables drove our fiscal year growth, the same dynamic that we saw in Q4. CGM grew low double-digits in fiscal '26 as we launched new sensors around the globe.

    按產品線來看,來自 CGM 與耗材的經常性營收來源推動了本財年的成長,這與我們在第四季看到的動態相同。在 26 財年,隨著我們在全球推出新感測器,CGM 成長低十位數百分比。

  • Q4 adjusted stand-alone EBITDA was $154 million, growing 32%, 2 times reported revenue growth. As a percent of revenue, adjusted standalone EBITDA was 18.4%, an increase of 220 basis points versus Q4 fiscal '25, with 380 basis points of improvement coming from SG&A and R&D.

    第四季調整後獨立 EBITDA 為 1.54 億美元,成長 32%,為已揭露營收成長率的 2 倍。以營收百分比計,調整後獨立 EBITDA 為 18.4%,較 25 財年第四季提升 220 個基點,其中 380 個基點的改善來自 SG&A 與 R&D。

  • Walking through the Q4 P&L. Our adjusted stand-alone gross margin was 58.6%, an increase of 40 basis points versus the fourth quarter last year. This was driven by continued manufacturing efficiencies and an FX benefit offset by higher Simplera mix, which currently has lower margin than that of our legacy and Instinct sensors.

    接著說明第四季損益表。我們的調整後獨立毛利率為 58.6%,較去年第四季提升 40 個基點。這主要受持續的製造效率提升與匯率利多所帶動,但部分被 Simplera 產品組合占比提高所抵銷;Simplera 目前的毛利率低於我們的既有(legacy)與 Instinct 感測器。

  • Q4 adjusted standalone SG&A was 33.9% of revenue, an improvement of 140 basis points versus Q4 fiscal '25. As part of our MiniMed operating system, we have a robust productivity project funnel across the business. We executed on these transformation projects to drive efficiencies. Q4 adjusted standalone R&D was 11.6% of revenue. R&D spend was down $4 million from last year, driven by lower clinical and operations R&D spend as our new products launch.

    第四季調整後獨立 SG&A 占營收比為 33.9%,較 25 財年第四季改善 140 個基點。作為我們 MiniMed 營運系統的一部分,我們在全公司範圍內建立了強健的生產力專案管線。我們執行這些轉型專案以提升效率。第四季調整後獨立 R&D 占營收比為 11.6%。R&D 支出較去年減少 400 萬美元,主要因新產品上市使臨床與營運相關 R&D 支出降低。

  • For full-year fiscal '26, adjusted stand-alone EBITDA was $482 million, growing 27% or 2 times the rate of reported revenue growth. As a percent of revenue, adjusted stand-alone EBITDA was 15.6%, an increase of 160 basis points year over year with 350 basis points of improvement coming from SG&A and R&D.

    就 26 財年全年而言,調整後獨立 EBITDA 為 4.82 億美元,成長 27%,為已揭露營收成長率的 2 倍。以營收百分比計,調整後獨立 EBITDA 為 15.6%,年增 160 個基點,其中 350 個基點的改善來自 SG&A 與 R&D。

  • Fiscal '26 adjusted stand-alone gross margin was 59.2%, a 50 basis point increase versus fiscal '25. Driven by better conversion, material productivity and FX, offset by the mix impact from higher Simplera volume. Fiscal '26 adjusted standalone SG&A was 35.2% of revenue, an improvement of 200 basis points versus last year. Similar to what I just discussed in Q4, the transformation projects delivered efficiencies and significant operating leverage throughout the fiscal '26.

    26 財年調整後獨立毛利率為 59.2%,較 25 財年提升 50 個基點。主要受轉換率提升、材料生產力與匯率因素帶動,但部分被 Simplera 出貨量提高所造成的產品組合影響所抵銷。26 財年調整後獨立 SG&A 占營收比為 35.2%,較去年改善 200 個基點。如同我剛才在第四季所提到的,轉型專案在 26 財年帶來效率提升,並在整個年度提供顯著的營運槓桿。

  • And fiscal '26 adjusted standalone R&D was 13.6% of revenue, a decrease of 150 basis points versus the prior year, driven by lower clinical and operations R&D spend as our new products launch. That said, R&D on dollar basis increased by $11 million year over year.

    而 26 財年調整後獨立 R&D 占營收比為 13.6%,較前一年下降 150 個基點,主要因新產品上市使臨床與營運相關 R&D 支出降低。不過,以金額計算,R&D 較去年增加 1,100 萬美元。

  • From a cash and debt perspective, we start at the time of IPO with $350 million of cash in the balance sheet and no long-term debt. We ended the quarter with $298 million in cash and no long-term debt. This cash balance was ahead of our expectations as we focus on delivering good cash management.

    從現金與負債的角度來看,我們在 IPO 時點的資產負債表上有 3.5 億美元現金,且沒有長期負債。本季末我們的現金為 2.98 億美元,且沒有長期負債。由於我們專注於良好的現金管理,這一現金餘額高於我們的預期。

  • Turning to our key business metrics, we intend to provide you with new pumps sold, or NPS, and global CGM attachment rates on a quarterly basis.

    接著談我們的關鍵業務指標,我們計畫按季度向各位提供新售出幫浦數(NPS)以及全球 CGM 配戴率。

  • These metrics track the unique growth opportunities at MiniMed, first through the sale of pumps and then the associated recurring CGM revenue. Q4 NPS was $42,000, down low single-digits year over year, given the two dynamics that Que discussed, the US Flex early clearance this quarter and the international Simplera launch last year.

    這些指標反映 MiniMed 的獨特成長機會:首先透過幫浦銷售,其次是相關的經常性 CGM 收入。第四季 NPS 為 42,000,年減低個位數百分比,原因是 Que 提到的兩個因素:本季美國 Flex 提前取得核准,以及去年國際市場 Simplera 的上市。

  • On a sequential basis, Q4 NPS was up 740 basis points from Q3. We had robust sequential NPS increases in both US and international as our new CGM sensor launches drove increased sales of our MiniMed 780G pump systems.

    以季比來看,第四季 NPS 較第三季上升 740 個基點。隨著我們新款 CGM 感測器上市帶動 MiniMed 780G 幫浦系統銷售增加,美國與國際市場的 NPS 皆出現強勁的季比成長。

  • Q4 CGM attachment rate was 68%, up 100 basis points from Q3 and an increase of 500 basis points year over year. We expect our CGM attachment rate to continue to trend upwards as nearly every new MiniMed pump user is using our CGMs to get the benefit of our SmartGuard automation.

    第四季 CGM 配戴率為 68%,較第三季上升 100 個基點,且年增 500 個基點。我們預期 CGM 配戴率將持續上升,因為幾乎每位新的 MiniMed 幫浦使用者都在使用我們的 CGM,以獲得 SmartGuard 自動化的效益。

  • Turning to the full fiscal year, we sold 145,000 new pumps in fiscal '26. Stable versus a prior year, but grouped every quarter sequentially, including 26% higher NPS in the second-half of the fiscal year than the first half.

    再看整個會計年度,我們在 2026 會計年度售出 145,000 台新幫浦。與前一年度持平,但若按季度依序觀察,包括會計年度下半年 NPS 較上半年高出 26%。

  • The fiscal '26 average CGM attachment rate was 66%, an increase of 700 basis points versus a prior year. Like NPS, our CGM attachment rate increased sequentially every quarter in fiscal '26.

    2026 會計年度平均 CGM 配戴率為 66%,較前一年度提升 700 個基點。與 NPS 類似,我們的 CGM 配戴率在 2026 會計年度每一季皆呈現季比提升。

  • Regarding our global pump users, we intend to update you on this metric on an annual basis. We ended fiscal '26 with 659,000 global pump users, an increase of 4% year over year. This was driven by increasing NPS as we went through the year and reducing attrition.

    關於我們的全球幫浦使用者數,我們計畫按年度更新此指標。我們在 2026 會計年度結束時的全球幫浦使用者為 659,000 人,年增 4%。這主要由於我們在年度進程中 NPS 持續提升,以及流失率下降所帶動。

  • Let me talk about our readiness as a standalone company, in particular how the TSA exits are progressing. We have approximately 160 TSAs with Medtronic, and we have dedicated teams working with Medtronic, and we are confident that we will exit these TSAs in the timelines that we've established, most of which will occur in calendar 2027.

    我想談談我們作為一家獨立公司的準備情況,特別是 TSA 退出的進展。我們與美敦力約有 160 項 TSA,我們有專責團隊與美敦力合作,並且有信心能在既定時程內退出這些 TSA,其中大多數將發生在 2027 年曆年。

  • Next, let's cover our outlook for the full year of fiscal 2027. We expect organic revenue growth of approximately 10%, which includes 1% to 1.5% from the extra week. This is consistent with management's expectations at the time of our IPO.

    接下來,我們說明 2027 會計年度全年的展望。我們預期有機營收成長約 10%,其中包含額外一週帶來的 1% 至 1.5%。這與我們 IPO 時管理層的預期一致。

  • There are three large product launches that give us confidence in this growth outlook. MiniMed Flex in the US, MiniMed Go expanding globally, and the continued global rollout of the Instinct and Simplera sensors.

    有三項大型產品上市讓我們對此成長展望更有信心。美國的 MiniMed Flex、MiniMed Go 的全球擴張,以及 Instinct 與 Simplera 感測器持續在全球推廣。

  • For Q1, including the extra week benefit, we expect organic growth to be well above Q4. Excluding the extra week, we expect Q1 growth to be roughly similar to Q4. In the US, we expect faster growth in Q4, and over the course of the fiscal '27, US growth will be accelerating given the pull forward of the Flex launch.

    就第一季而言,包含額外一週的效益,我們預期有機成長將明顯高於第四季。若排除額外一週,我們預期第一季成長大致與第四季相近。在美國,我們預期第四季成長更快;而在 2027 會計年度期間,隨著 Flex 上市帶來的提前拉貨效應,美國成長將加速。

  • For fiscal '27, we expect adjusted EBITDA margin of approximately 16% with the improvement driven by OpEx leverage, in line with management's expectations at the time of IPO. We plan to leverage our global sales and marketing infrastructure to continue driving strong growth and margin expansion. We also expect to benefit from our strong product pipeline, including common platform components and software to deliver R&D leverage. And we also expect continued efficiencies from our support functions.

    在 2027 會計年度,我們預期調整後 EBITDA 利潤率約為 16%,改善主要來自營運費用(OpEx)槓桿,與 IPO 時管理層的預期一致。我們計畫運用全球銷售與行銷基礎設施,持續推動強勁成長與利潤率擴張。我們也預期受惠於強勁的產品管線,包括共用平台元件與軟體,以帶來研發(R&D)槓桿。此外,我們也預期支援職能將持續提升效率。

  • As we look at our quarterly EBITDA cadence, typically the margin starts below the annual amount and grows as we grow throughout the year. You saw this in fiscal '26, and we'd expect a similar cadence in fiscal '27. For Q1 fiscal '27, we'd expect adjusted EBITDA margin to be a couple hundred basis points greater than the adjusted stand-alone EBITDA margin in Q1 of fiscal '26 and to grow throughout the year to reach our 16% annual outlook.

    就季度 EBITDA 的節奏而言,通常利潤率會從低於全年水準開始,並隨著全年成長而逐步提高。你們在 2026 會計年度已看到這點,我們預期 2027 會計年度也會有類似節奏。對於 2027 會計年度第一季,我們預期調整後 EBITDA 利潤率將比 2026 會計年度第一季的調整後獨立 EBITDA 利潤率高出約兩百個基點,並在全年逐步提升,以達成我們 16% 的全年展望。

  • While we don't provide specific guidance on our KPIs, we do expect that as we roll out our new pump systems and sensors, we will continue to see growth in both NPS and CGM attachment rates. For more details on our guidance, see the guidance slide in our earnings presentations.

    雖然我們不對 KPI 提供具體指引,但我們確實預期,隨著新幫浦系統與感測器的推廣,NPS 與 CGM 配戴率都將持續成長。關於指引的更多細節,請參閱我們財報簡報中的指引投影片。

  • Que, back to you.

    Que,交還給你。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • Thanks, Chad. We're excited by the growth opportunities on the top and bottom line that Chad just laid out. We are already entering the year with meaningful momentum.

    謝謝,Chad。我們對 Chad 剛才所說明的營收端與獲利端成長機會感到振奮。我們在進入新年度時就已具備顯著動能。

  • As a reminder, we share with you several pieces of new news today. MiniMed Go launched in the US last week. Instinct will launch in Europe later this month. We started taking pre-orders for MiniMed Flex in the US this week and will be shipping later this month. And this morning, we announced an extension of our partnership with Abbott to commercialize a dual glucose ketone sensor designed to integrate with our MiniMed smart dosing systems.

    提醒各位,我們今天分享了幾項最新消息。MiniMed Go 已於上週在美國上市。Instinct 將於本月稍晚在歐洲上市。我們本週已在美國開始接受 MiniMed Flex 的預購,並將於本月稍晚出貨。此外,今天早上我們宣布延長與 Abbott 的合作夥伴關係,共同商業化一款雙重葡萄糖-酮體感測器,該感測器設計用於與我們的 MiniMed 智慧給藥系統整合。

  • And our pipeline with Fit and Vivera reflects a roadmap that spans near-term execution and long-term AID leadership. The AID market remains dramatically underpenetrated. The type 2 opportunity is still in its early innings, and the millions of patients still on MDI represent a runway that would define this category for years to come. We are building to serve all of them, and as we do, we expect this will create value for patients, their caregivers, and physicians, and this will translate to value for our shareholders.

    而我們與 Fit 與 Vivera 的產品管線,反映了一條兼顧短期執行與長期 AID 領導地位的路線圖。AID 市場目前仍嚴重滲透不足。第二型糖尿病的機會仍在早期階段,而仍在使用 MDI 的數百萬名患者代表著一條跑道,將在未來多年定義這個品類。我們正打造能力以服務所有這些族群;在此過程中,我們預期將為患者、其照護者與醫師創造價值,並進一步轉化為股東價值。

  • I do want to say something about our team. This past year, we separated from a parent company, executed an IPO, and kept launching products and delivering for patients all at the same time. Everyone executed multiple complex initiatives, and I'd like to thank our team for their commitment and dedication.

    我確實想談談我們的團隊。過去一年,我們從母公司分拆、完成 IPO,同時仍持續推出產品並為患者交付成果。每個人都執行了多項複雜的計畫,我想感謝團隊的投入與奉獻。

  • We know where we're headed. We'll keep you updated as we get there.

    我們知道我們要前往的方向。在抵達的過程中,我們會持續向各位更新進展。

  • Right, let's go to Q&A. Operator.

    好,接下來進入問答。接線員。

  • Operator

    Operator

  • (Operator Instructions) Travis Steed, Bank of America Securities.

    (接線員指示) 美國銀行證券(Bank of America Securities)的 Travis Steed。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Hey, congrats on your first earnings call as a public company. I maybe first wanted to ask about pumpship came in above three, the new start metrics were really strong, but the pump revenues were light versus what we've modeled. I know you talked about.

    嗨,恭喜你們作為上市公司召開第一次財報電話會議。我可能先想問一下,幫浦出貨量高於 3(的水準),新啟用指標非常強勁,但幫浦營收相較我們模型預估偏弱。我知道你們提到過。

  • Maybe some delays ahead of Flex, but trying to understand how that impacts the model and just trying to understand some of the dynamics there on the pump shipments versus the pump revenue and delays around Flex?

    可能是 Flex 上市前的一些延遲,但我想了解這如何影響模型,以及想更清楚幫浦出貨量相對於幫浦營收的某些動態,以及 Flex 相關延遲的情況?

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • Thanks, Travis. You said it right. It's really about the timing issue of Flex. I mean, customers make rational decisions, and some chose to wait for the new system. We obviously have a lot of patients that like buttons, and they don't want to have a phone controlling their pump. And so we saw that. It was really great to see that both the year over year in the US and sequential growth.

    謝謝,Travis。你說得沒錯。這主要是 Flex 的時點問題。我的意思是,客戶會做出理性的決策,有些人選擇等待新系統。我們顯然有很多患者喜歡按鍵操作,他們不希望用手機來控制幫浦。所以我們看到了這種情況。很高興看到美國市場無論是年比,還是季比成長都表現良好。

  • And so if you look at the second-half versus the first half. It's quite dramatic in terms of that leading indicator. I think in terms of revenue, it was very consistent with what we expected.

    因此,如果你看下半年相較於上半年。就那個領先指標而言,變化相當明顯。我認為就營收來看,與我們的預期非常一致。

  • I think where US was under our initial expectations is actually driven by, I would say, a weaker first half from pump, and that obviously translates to consumable and CGM revenue in the second-half. So think of it that way, but it really is a timing issue. We just started taking pre-orders yesterday for Flex. And it's extremely robust demand that we see already.

    我認為美國市場低於我們最初預期的部分,實際上是因為我會說,幫浦在上半年表現較弱,而這顯然會反映到下半年的耗材與CGM營收。所以可以這樣理解,但這確實是時點問題。我們昨天才剛開始接受Flex的預購。而我們目前看到的需求非常強勁。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Okay, thank you. Next question. Thanks, Travis. Next question, please, Kevin.

    好的,謝謝。下一個問題。謝謝你,Travis。下一題,Kevin,麻煩。

  • Operator

    Operator

  • David Roman, Goldman Sachs.

    David Roman,高盛。

  • David Roman - Analyst

    David Roman - Analyst

  • Thank you. Good morning, everybody. I wanted just to start with maybe connecting some of the dots here across your exit rate performance, your guidance and the commentary queue that you made around the product momentum expected in FY27. So as I look at the guidance of about 8.5% to 9%, excluding the extra week.

    謝謝。各位早安。我想先從把幾個點串起來開始:你們的退出率(exit rate)表現、你們的指引,以及你們對FY27預期產品動能的評論。因此,當我看你們約8.5%到9%的指引(不含多出的一週)。

  • And then the 8% you did in '26, but also the higher exit rate, as you look at the operational drivers in '27, there do look to be a number of factors that get better in this fiscal year around product launch momentum, Instinct integration, etc. So maybe you could just help us think through.

    再加上你們在'26做到了8%,以及更高的退出率;當你看'27的營運驅動因素時,確實看起來有不少因素會在本會計年度改善,例如產品上市動能、Instinct整合等等。所以也許你們可以幫我們一起思考一下。

  • Your guidance basis for FY27, how you're thinking about puts and takes, maybe is there a degree of conservatism in here, and how we connect the pieces between the underlying fundamental drivers and how you're setting the outlook here?

    你們FY27指引的基礎、你們如何看待利多與利空(puts and takes),這裡面是否帶有一定程度的保守性,以及我們如何把基本面驅動因素與你們在此設定的展望連結起來?

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • Hey, David, this is Chad. I'll start and then you might add a little bit of color. But the first thing that I would like to say is that what we have set forward, we think is a plan that we're confident we can achieve. When you look at the way we thought about the business before all these, we call it pull-ins of product lines, these things were in our forecast just later in the year. And so we're getting to them sooner.

    嗨,David,我是Chad。我先開始,然後你可能再補充一些細節。但我首先想說的是,我們提出的計畫,我們認為是一個我們有信心可以達成的計畫。當你回頭看我們在這些(我們稱之為)產品線提前導入(pull-ins)之前對業務的規劃,這些事情原本就在我們的預測裡,只是發生在更晚的時間點。而現在我們只是更早做到。

  • And what we're looking forward to is actually showing execution and the results and then reevaluating at that point in time. But we think that the plan right now is a very solid plan that we're confident that we can hit is the way that we think about it. So the product launches, and if you think even about Flex, we always had that in there.

    而我們期待的是,實際展現執行力與成果,然後在那個時間點再重新評估。但我們認為目前的計畫是一個非常扎實、我們有信心可以達標的計畫,這就是我們的看法。所以產品上市,如果你甚至想到Flex,我們一直都把它納入規劃之中。

  • And so as Que talked about it being a timing, there's always a gap between announcing and that patient-customer waiting period, it has just shifted forward a little bit. So we think fundamentally the model is still intact from that perspective and the numbers are good. We feel actually super excited about the opportunities given how much we've brought these product launches in for the year and achieving our numbers.

    因此,正如Que提到這是時點問題,從宣布到病患/客戶等待的期間之間總是會有落差,只是現在整體往前移了一點。所以我們認為從這個角度看,基本上模型仍然完整,數字也不錯。我們其實對這些機會感到非常興奮,因為我們把這些產品上市時程大幅提前到今年,並且仍能達成我們的數字。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • And David, I think, look, you've covered the space. I think you're going to see that not just for us, but the industry, when something new comes in, it typically takes a couple of quarters. Patients can't just get an appointment the next day with their endo. They're going to have to go in and see them. We've got to drive awareness. So we're very encouraged with what we're seeing.

    而且David,我想,你也長期追蹤這個領域。我認為你會看到的不只是我們,整個產業也是如此:當有新產品進來時,通常需要幾個季度。病患不可能隔天就能約到他們的內分泌科醫師(endo)。他們得去看診。我們也必須提升認知度。所以我們對目前看到的情況非常受到鼓舞。

  • We've touched over 8,000 providers as part of the flex launch. We've done more than almost 300 events. So we're seeing a lot of demand, but, people have to get appointments. They've got to go see their endo. And so typically, we see this play out in two quarters. Remember that in Q1, we're going to have flex with Simplera for, call it, five or six weeks.

    作為Flex上市的一部分,我們已經接觸超過8,000位醫療提供者。我們舉辦了將近300場活動以上。所以我們看到很多需求,但人們必須先約到門診。他們得去看他們的內分泌科醫師。因此通常我們會看到這在兩個季度內逐步展開。記住,在Q1,我們的flex搭配Simplera大概只有五到六週。

  • Q2 will be the first quarter where we'll have both sensors integrated. And so that's the buildup. And what we're trying to signal is the US, we are, very confident that this progression, you'll see it go through the year, and obviously, things emerge, we'll update you. But that's how we see the year unfold.

    Q2將會是第一個我們能同時整合兩款感測器的季度。所以這就是逐步累積的過程。而我們想傳達的是,在美國市場,我們對這樣的進展非常有信心,你會看到它在一年中逐步推進;當然如果有新情況出現,我們會更新你們。但這就是我們看待今年發展的方式。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thanks, David. We'll go to the next question, please, Kevin.

    謝謝你,David。Kevin,請進下一個問題。

  • Operator

    Operator

  • Joanne Wuensch, Citi.

    Joanne Wuensch,花旗。

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • Good morning and congratulations also on your first quarter out. So I want to just pause on the sensor dynamic and I'm curious how we should or think about the difference between Simplera, Instinct, and now the dual analyte sensor joining the mix and how you think about positioning the three of them and do you have a preference financially? Thank you.

    早安,也恭喜你們第一季的表現。我想先停一下談感測器的動態,我很好奇我們應該如何看待Simplera、Instinct,以及現在加入組合的雙分析物(dual analyte)感測器之間的差異;你們如何定位這三者?在財務上你們有偏好嗎?謝謝。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • So let me start, maybe so I can answer the financial question. I think what we're trying to do, Joanne, is really offer choice between Simplera and Instinct. So let's talk about that, because those are in market today. I think we're excited about the dual ketone, glucose sensor, but that's not yet commercially available. It's been approved on T-Mark, but we're still waiting for FDA approval.

    那我先開始,或許我可以回答財務面的問題。Joanne,我認為我們想做的是在Simplera與Instinct之間提供選擇。所以我們先談這個,因為這兩款目前都已在市場上。我想我們對雙酮體、葡萄糖感測器感到很興奮,但它目前還沒有商業化上市。它已在T-Mark獲准,但我們仍在等待FDA核准。

  • And the reason for the choice is with Simplera being a seven-day set, it really lines up with our seven-day infusion set. And so there are a lot of people who like to have a weekly routine. And so we offer that. There's some other, I would say relatively minor differences between the two sensors. And of course with Instinct being a 15-day sensor that helps people who like longer wear. And the simplicity of that.

    而提供選擇的原因是,Simplera是七天更換一次,這與我們的七天輸注組(infusion set)非常契合。所以有很多人喜歡每週固定的例行節奏。因此我們提供這個選項。兩款感測器之間還有一些其他我會說相對較小的差異。當然,Instinct是15天感測器,能幫助偏好更長配戴時間的人。以及那種簡便性。

  • And we're seeing that in the numbers. People like Sinclair, they like Instinct, they're both easy to insert, but it fits into people's lifestyle in a different way. And it's very consistent with our objective, which is to offer a portfolio that really meets the patient where they are, wherever they are on the journey, whether that's with a smart MDI system with MiniMed Go or a durable pump system with Flex and then in the future a patch option.

    而我們也在數據上看到這點。人們喜歡Simplera,也喜歡Instinct;兩者都容易插入,但它以不同方式融入人們的生活型態。這也非常符合我們的目標:提供一個產品組合,真正能在病患所處的位置滿足他們——無論他們在旅程中的哪個階段;不論是搭配MiniMed Go的智慧MDI系統,或是搭配Flex的耐用型幫浦系統,未來還會有貼片式(patch)選項。

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • And from a financial preference standpoint, Joanne, from the sensors that are available today, because as Que said on the Ketone sensor, that's a ways out before we'll have more details on the financials there. Between Instinct and Simplera and Legacy sensor and Instinct, we've said are comparable from a revenue and a margin standpoint, and Simplera has a lower gross margin, but it doesn't mean that we have a preference towards one versus the other because as we continue to scale up Simplera and in 2027, we're going to have. Significantly more than we had in prior years, which for us is great because it gives unconstrained demand internationally where Simplera has been selling quite a bit and we need it for our products.

    而就財務偏好而言,Joanne,就目前可取得的感測器來說——因為如Que所說,酮體感測器距離上市還有一段時間,我們之後才會有更多財務細節——在Instinct與Simplera之間,以及傳統(Legacy)感測器與Instinct之間,我們曾說過它們在營收與毛利率方面相近;Simplera的毛利率較低,但這不代表我們偏好其中之一,因為隨著我們持續擴大Simplera的規模,在2027年我們將會有。

  • That's the way we look at it. So we've priced in, we've modeled in the increase of Simplera for fiscal '27. And for the expanded usage as well of Instinct. But we don't say we have a financial preference. We let the patients choose, and we've got modeled and we think are appropriate margins for the different products.

    我們就是這樣看待的。因此,我們已把Simplera在'27會計年度的增加量納入定價與模型之中。也把Instinct使用擴大納入模型。但我們不會說我們有財務上的偏好。我們讓病患自行選擇,而我們也已在模型中納入並認為各產品有其適當的毛利率。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thank you, Joanne. Next question, please, Kevin.

    謝謝你,Joanne。Kevin,請下一題。

  • Operator

    Operator

  • Steve Lichtman, William Blair.

    Steve Lichtman,William Blair。

  • Steven Lichtman - Equity Analyst

    Steven Lichtman - Equity Analyst

  • Thank you. Good morning, everyone. Just wondering again on the FY27 outlook, as you look at the 10% organic growth, any additional color you can provide on, say, US versus OUS and around that 10% segment growth, which should be higher in your mind versus maybe a little lower? Thanks.

    謝謝。各位早安。我想再請教一次 FY27 的展望:當你們看待 10% 的有機成長時,能否再多提供一些說明,例如美國(US)相較於美國以外(OUS),以及在約 10% 的分部成長中,哪些分部在你們看來應該會更高、哪些可能會稍低?謝謝。

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • Hi, Steve. Thanks for the question. As we don't give specific guidance on regions or by products, to give a little color, the way that I would really think about it is OUS will continue to have strong growth throughout the year. You can look at historical execution and we don't see changes to that. And the US, as I referenced before, you're going to see a continued acceleration, right?

    嗨,Steve。謝謝你的問題。由於我們不會針對各地區或各產品提供具體指引,若要補充一些色彩,我會這樣看:美國以外(OUS)今年將持續維持強勁成長。你可以參考我們過往的執行表現,我們不認為那會有變化。至於美國(US),如我先前提到的,你會看到持續加速,對吧?

  • The metrics that we look at as we look at those NPS and the growth that we've seen in the second-half of the NPS is a leading indicator of what we're going to see for the growth going throughout the year. So the US, we've seen that acceleration in the second-half for the NPS on which it grew.

    我們觀察的指標,包括 NPS,以及我們在下半年看到的 NPS 成長,這是我們預期全年成長走勢的領先指標。因此在美國,我們已經看到下半年 NPS 的加速成長。

  • And the second-half versus the first. And so it'll be progression. Q1 obviously will be much more than you saw in Q4, but recognize that Flex has four to six weeks of selling in Q1. So that as we get into Q2, we've got a full quarter of Flex with Simplera and then we start to introduce Instinct, so you get even more benefit from that. And then Q3, you've got a full quarter of both of those.

    相較於上半年。因此會呈現逐季推進。第一季顯然會比你在第四季看到的高很多,但也請注意,Flex 在第一季只有四到六週的銷售期。因此到了第二季,我們就有一整季的 Flex 搭配 Simplera,接著開始導入 Instinct,你會從中獲得更多效益。到了第三季,兩者都會有完整一季的貢獻。

  • Sensors with flex. So that's why we see that progressive growth in the US throughout the year as way I think about it.

    感測器搭配 Flex。所以這就是為什麼我會認為美國今年會呈現逐步走高的成長。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thanks, Steve. Next question, please, Kevin.

    謝謝你,Steve。Kevin,請下一題。

  • Operator

    Operator

  • Pito Chickering, Deutsche Bank.

    Pito Chickering,德意志銀行(Deutsche Bank)。

  • Pito Chickering - Research Analyst

    Pito Chickering - Research Analyst

  • Hey, guys. Thanks for taking the question. I just wanted to follow-up, just from a modeling perspective, to help quantify the comments around the fourth quarter softness in the US pumps due to fit launching, for the timing of the launch in the US pump revenue cadence. Any quantification of how we should be modeling the US pump cadence launch throughout '27 as you think about the launch coming up soon? Thanks.

    嗨,各位。謝謝讓我提問。我想從建模角度追問一下,幫助量化你們提到的美國幫浦在第四季因 Fit 上市而出現的疲軟,以及這對美國幫浦營收節奏、上市時點的影響。就你們認為即將到來的上市而言,我們應該如何量化並建模 2027 年美國幫浦上市後的營收節奏?謝謝。

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • The way that we don't really talk specifically on a product by product line level, but what you can think about is there's a couple 100 basis points right in the US from this Flex.

    我們通常不會在單一產品線層級做非常具體的說明,但你可以這樣理解:在美國,這個 Flex 帶來的影響大約是幾個百分點(數百個基點)。

  • The timing shift. Some of it is people said, hey, we're going to wait for the unit. Some said, hey, we'll go on 7AG and we'll use your Flex Forward program. So it's hard to quantify the exact amount of that. But what we can see and what you can measure is, as I said before, the NPS growth and the cadence momentum there, right? And so that's what we're looking at from a how do we see the slowdown in the US for the fourth quarter and accelerating.

    時點的移轉。有些人說:「我們會等那台新機。」也有人說:「我們先用 7AG,並使用你們的 Flex Forward 計畫。」所以很難精確量化到底是多少。但我們能看到、也能衡量的是,如我先前所說,NPS 的成長以及那裡的節奏動能,對吧?因此,從我們的角度,是用這些來看第四季美國放緩、以及後續加速的情況。

  • And as Que said, what we're seeing already, we've just started this week taking early orders. So we're excited about where we see that growth coming in the US the way that we always like to talk about the business is a full portfolio, though, because we have the US, and as we balance the US growing with Flex, we have consistent performance in OUS as well, and we're expecting some strong performance there as well as we get Instinct and even before.

    另外如 Que 所說,我們已經看到一些跡象——我們本週才剛開始接受早期訂單。所以我們對於美國的成長前景感到興奮。我們一向喜歡用「完整產品組合」來談業務,因為我們有美國市場;在美國因 Flex 成長的同時,我們在美國以外(OUS)也有穩健表現,而且我們也預期那邊會有強勁表現,隨著 Instinct 推出,甚至在那之前就會看到。

  • Before we expected. So we're going to continue to see the OUS as well. So I like to think of our business as a whole complete, the US and OUS driving two-thirds of the top-line and we've got new products coming in both.

    比我們原先預期的更早。因此我們也會持續看到 OUS 的表現。我喜歡把我們的業務視為一個完整整體:美國與美國以外(OUS)合計驅動約三分之二的營收,而兩邊都有新產品即將推出。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • And I think just in terms of the ramp and maybe color on the commercial activities, our early commercial pilots under way, we have. Several 100 patients already wearing the device. You can check out the social media. It's extremely easy for them to use. We are looking forward to launching big time at ADA. And as I mentioned earlier today, we will be shipping Flex with Simpera later this month. It just takes time.

    另外就爬坡進度以及商業活動的補充說明,我們的早期商業試點已在進行中。目前已經有數百位病患在配戴這個裝置。你們可以看看社群媒體。對他們來說使用起來非常容易。我們很期待在 ADA 進行大規模上市推廣。而且如我今天稍早提到的,我們將在本月稍晚開始出貨 Flex 搭配 Simpera。這需要一些時間。

  • And then we're at Instinct. Then you've got Medicare. And then, of course, we've submitted Flex with the E mark and we expect at the end of the year. So it's all part of the, as the year goes by, this is going to be strengthening. And we already see it in the, as we said, the key indicator, which is the new pump sold leading indicator.

    接著是 Instinct。然後是 Medicare。當然,我們也已提交 Flex 的 E mark(歐盟 CE 標誌)申請,並預期在年底取得。因此,隨著年度推進,這整體動能會持續增強。而且我們已經在關鍵指標上看到了——如我們所說,新售出的幫浦數量是領先指標。

  • Pito Chickering - Research Analyst

    Pito Chickering - Research Analyst

  • Great. Thanks so much.

    很好。非常感謝。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thank you, Pito. Next question, please, Kevin.

    謝謝你,Pito。Kevin,請下一題。

  • Operator

    Operator

  • Daniel Markowitz, Evercore ISI.

    Daniel Markowitz,Evercore ISI。

  • Daniel Markowitz - Analyst

    Daniel Markowitz - Analyst

  • Hey guys, congrats on the first quarter at the gate and it's great to hear all the timing updates. It all sounds great. So ahead of the OUS Instinct launch, I wanted to ask if there are any early learnings to share from Instinct US.

    嗨,各位,恭喜第一季開局表現不錯,也很高興聽到所有時程更新。聽起來都很棒。在 OUS 的 Instinct 上市之前,我想請問是否能分享一些 Instinct 在美國的早期觀察?

  • In terms of maybe how big a percent of new CGM starts Instinct is demanding, and if you're seeing any trends in the Simplera installed base, if patients have any appetite to switch or anything else to call out. Thanks for taking the question.

    例如,Instinct 在新的 CGM 起始使用者中大約占比多少;以及你們是否在 Simplera 的既有裝機基礎中看到任何趨勢,例如病患是否有意願轉換,或其他值得一提的重點。謝謝讓我提問。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • Yeah, thanks for the question. I think what we're seeing is obviously most of the switching happening from our legacy sensor, Guardian 3 and Guardian 4 to Simplera anti-Instinct.

    好的,謝謝你的問題。我想我們看到的情況是,切換主要是從我們的舊款感測器 Guardian 3 與 Guardian 4,轉到 Simplera 以及 Instinct。

  • And I think as we mentioned in the prior quarters.

    而且我想如我們在前幾季提到的。

  • The new sensors not only have driven up CGM attachment because of the power of our algorithm, but increasingly bringing new patients to MiniMed. We have a lot of new stuff coming from MBI. We are also seeing competitive switches and, of course, patients coming out of warranty. And that's why you see the second-half pump shipment growth be so substantially higher than the first half. And so that's the pattern we continue to see.

    新感測器不僅因為我們演算法的強大而提升了 CGM 的搭載率,也愈來愈多地把新病患帶進 MiniMed。我們也有很多新的動能來自 MBI。我們同時也看到競品轉換,當然也有保固到期的病患。這也是為什麼你會看到下半年幫浦出貨成長顯著高於上半年。而這就是我們持續看到的模式。

  • As I said, last quarter was the first full quarter of having both sensors in the market. We have also increased Simplera capacity. We tripled it in Q4. And so we're starting to see really unconstrained demand coming through in international as well, and that's also driving additional pump growth. Because as we have a very large install base.

    如我所說,上季是兩款感測器同時在市場上的第一個完整季度。我們也提升了 Simplera 的產能。我們在第四季把它提高到三倍。因此我們開始看到國際市場也出現真正不受供給限制的需求,這也在帶動額外的幫浦成長。因為我們擁有非常龐大的裝機基礎。

  • And so when you have something new like sensors, you can't just give it we would grow faster. We just gave it to all new patients. But of course, we have to take care of our install base. And so we effectively were on a bit of an allocation strategy, which I think muted a bit of the new pump sold metric in Europe, just really managing the install base, trying to keep everybody happy. But now that instinct's coming in really a couple of weeks in Europe. Unconstrained, Sinclair, we're expecting that, again, the critical metric of new pumps sold to continue to grow.

    因此,當你有像感測器這樣的新東西時,你不能只是把它發出去,否則我們會成長得更快。我們只是把它提供給所有新病患。但當然,我們必須照顧我們的既有裝機基礎。因此我們實際上採取了一點配給策略,我認為這在歐洲稍微壓抑了「新幫浦銷售」這個指標,因為我們真的在管理既有裝機基礎,努力讓每個人都滿意。但現在那個限制在歐洲大概幾週內就會解除,Sinclair。在不受限制的情況下,我們預期同樣地,關鍵指標「新幫浦銷售」將持續成長。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thanks, Daniel. I think we've got time for two more questions here before the bottom of the hour. So we'll take the next question, please, Kevin.

    謝謝你,Daniel。我想在半點前我們還有時間再問兩個問題。所以請進行下一個問題,Kevin。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    Larry Biegelsen,富國銀行(Wells Fargo)。

  • Lawrence Biegelsen - Analyst

    Lawrence Biegelsen - Analyst

  • Good morning. Thanks for taking the question. Que, congrats on the IPO here. Que, just what needs to be done on MiniMed fit before the fall 2026 FDA submission? And on CGM, it's 50% of revenue carrying the growth. Attachment rate looks like it was up, I think, about 500 basis points year over year in Q4. Is that the way we should think about next year, and where can that go over time? Thank you.

    早安。謝謝讓我提問。Que,恭喜這次 IPO。Que,關於 MiniMed fit,在 2026 年秋季向 FDA 送件之前,還需要完成哪些工作?另外在 CGM 方面,它占營收的 50% 並帶動成長。我看 Q4 的搭載率(attachment rate)似乎年增約 500 個基點。我們應該用這種方式來看明年的走勢嗎?長期來看還能提升到什麼程度?謝謝。

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • So to answer your big question, we are tracking extremely well, and our goal is not just to submit and get an approval. Our goal is to have a successful launch next year with our patch AID system. So obviously we're working on the submission itself that is on track.

    針對你的主要問題,我們的進度追蹤得非常好,我們的目標不只是送件並取得核准。我們的目標是在明年以我們的貼片式 AID 系統成功上市。所以很明顯地,我們正在進行送件本身的工作,而且一切都在軌道上。

  • We're also working on manufacturing. I think that. We mentioned at least 20,000 patients at launch, and we are already expanding capacity to take on more patients next year. So we feel very good about it. We're one of the few companies telling you what our initial production capacity is going to be.

    我們也在做製造端的準備。我想。我們提到上市時至少可支援 20,000 名病患,而我們已在擴充產能,以便明年承接更多病患。所以我們對此感覺非常好。我們是少數幾家會告訴你初期生產產能會是多少的公司之一。

  • So it is all about gearing to launch and getting fit through the pharmacy channel.

    所以重點就是為上市做準備,並透過藥局通路把 fit 做到位。

  • With respect to the attachment rate, I think the way we think about it is, over the last few years, we've demonstrated that the second-generation algorithm, 780 with SmartGuard, and now Flex with SmartGuard, is extremely powerful with the five-minute order correction, the new detection technology really driving outcomes with less effort.

    至於搭載率,我們的看法是:過去幾年我們已證明第二代演算法,也就是具備 SmartGuard 的 780,以及現在具備 SmartGuard 的 Flex,憑藉每五分鐘一次的劑量校正、新的偵測技術,確實非常強大,能以更少的投入帶來更好的結果。

  • And so, really, what we see is every order for our AID systems come with our CGM consumable. And we see that pattern continuing, which is why you see this very steady growth of CGM attachment. It's an important metric with respect to how it drives revenue.

    因此,實際上我們看到的是,每一筆我們 AID 系統的訂單都會搭配我們的 CGM 耗材。而我們也看到這個模式會持續下去,這就是為什麼你會看到 CGM 搭載率非常穩定地成長。就其如何帶動營收而言,這是一個重要指標。

  • So we're not concerned about that at all. What really we are focused on now is growing that new pump-sold metric with these new launches. And so as we get that metric up, the CGM attachment will continue. So you want to add anything?

    所以我們對此完全不擔心。我們現在真正聚焦的是,透過這些新產品上市來拉升「新幫浦銷售」這個指標。因此當我們把這個指標拉上來時,CGM 的搭載也會持續。你要補充什麼嗎?

  • Chad Spooner - Chief Financial Officer, Executive Vice President

    Chad Spooner - Chief Financial Officer, Executive Vice President

  • Yeah, and I would just say, Larry, your math is good and the continuous rate of improvement is a good assumption that we've seen historically. And how high can we go as we continue to sell the new AID systems, everyone is going to be on our CGMs. So you can see that in the future getting into the 90 percentile range, right, globally. With steady progression in the US and internationally.

    對,我只想說,Larry,你的計算沒錯,而持續改善的速度用作假設也很合理,因為我們歷史上確實看到如此。而隨著我們持續銷售新的 AID 系統,大家都會使用我們的 CGM,所以我們能提升到多高?你可以看到未來在全球範圍內進入 90% 這個區間,對吧。並且在美國與國際市場都會穩步推進。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Thank you. Thanks, Larry. We've got time for one more question, Kevin. Let's go to our last question, please.

    謝謝。謝謝你,Larry。我們還有時間再問最後一個問題,Kevin。請進行最後一個問題。

  • Operator

    Operator

  • Marie Thibault, BTIG.

    Marie Thibault,BTIG。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Hey, great. Thanks for squeezing me in and congrats on everything you've done to get to this point. I wanted to ask about MiniMed Go here. How are you thinking about the initial uptake trajectory, given this is effectively a new patient segment for MiniMed with these MDI users and likely requires a different commercial strategy? So any details on the trajectory as well as what you're doing to establish formulary access and reimbursement coverage?

    嗨,太好了。謝謝讓我插進來,也恭喜你們一路做到這一步所完成的一切。我想問一下 MiniMed Go。鑑於這對 MiniMed 來說,面向的是一個新的病患族群——這些 MDI 使用者——而且可能需要不同的商業策略,你們如何看待初期採用(uptake)的成長軌跡?所以想請你們分享一些軌跡細節,以及你們正在做什麼來建立處方集(formulary)准入與給付報銷覆蓋?

  • Que Dallara - Chief Executive Officer, Director Nominee

    Que Dallara - Chief Executive Officer, Director Nominee

  • So with respect to the US, MiniMedGo, we launched actually just last week. It's gone incredibly well, but as you said, Marie, this is a new category. We have started a dedicated primary care sales team. We think this will help reach patients early in the funnel, but it does require market development. From a reimbursement standpoint, we actually are pretty well positioned. We have great reimbursement for our CGM's intent, as has been in market for a while.

    就美國而言,MiniMedGo 我們其實是上週才剛上市。進展非常順利,但如你所說,Marie,這是一個新類別。我們已成立一支專門的基層醫療(primary care)銷售團隊。我們認為這將有助於在漏斗前端更早接觸病患,但確實需要市場開發。從給付報銷的角度來看,我們其實處於相當有利的位置。我們的 CGM 給付非常好,而且這項產品已在市場上有一段時間。

  • This MiniMedGo system now brings all of that together. So from an access standpoint, we feel pretty good about where we stand commercially on it.

    而這套 MiniMedGo 系統現在把這一切整合在一起。所以就准入而言,我們對其商業面的現況感到相當有信心。

  • But it does require market education, and that's why we have this dedicated primary care team out in force now, really driving up demand. And we're already seeing orders come through, a lot of excitement. On this therapy option.

    但它確實需要市場教育,這也是為什麼我們現在派出這支專門的基層醫療團隊全力推進,真正把需求拉上來。而我們已經看到訂單進來,大家非常興奮。對於這個治療選項。

  • Ryan Weispfenning - Vice President and Head of Investor Relations

    Ryan Weispfenning - Vice President and Head of Investor Relations

  • Okay. Thank you, Marie. And for those analysts that we didn't get to this morning, we're happy to connect with you later today. I want to thank everyone who joined us today. We appreciate your interest and support in MiniMed. We look forward to connecting with you on our Q1 earnings call, if not sooner, as part of our outreach here during the quarter. So with that, have a great rest of your day.

    好的。謝謝你,Marie。至於今天早上我們沒來得及回答的分析師,我們很樂意在今天稍晚再與各位聯繫。我要感謝今天加入我們的每一位。我們感謝各位對 MiniMed 的關注與支持。我們期待在第一季財報電話會議上與各位再度交流;若不是更早,也會在本季的對外溝通活動中與各位保持聯繫。那麼,祝各位今天剩下的時間愉快。

  • Operator

    Operator

  • Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect and have a wonderful day.

    謝謝各位女士、先生。今天的簡報到此結束。您現在可以斷線,祝您有美好的一天。