Tandem Diabetes Care Inc (TNDM) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the Tandem Diabetes Care third-quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead.

    您好,感謝您的耐心等待。歡迎參加 Tandem Diabetes Care 2025 年第三季財報電話會議。(操作員說明)請注意,今天的會議正在錄音。現在我謹將會議交給今天的主講人,執行副總裁兼首席行政官蘇珊·莫里森女士。請繼續。

  • Susan Morrison - Executive Vice President, Chief Administrative Officer

    Susan Morrison - Executive Vice President, Chief Administrative Officer

  • Hello everyone, and welcome to Tandem’s third-quarter 2025 earnings call. Today’s discussion will include forward-looking statements.

    大家好,歡迎參加 Tandem 2025 年第三季財報電話會議。今天的討論將包含前瞻性陳述。

  • These statements reflect management’s expectations about future events, our product pipeline, development timelines, and financial performance and operating plans, and speak only as of today’s date. There are risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward-looking statements, which are described in our press release issued earlier today and under the risk factors portion of our most recent quarterly report on Form 10-Q.

    這些聲明反映了管理層對未來事件、我們的產品線、開發時間表、財務業績和營運計劃的預期,並且僅代表截至今日的情況。存在一些風險和不確定性,可能導致實際結果與我們在前瞻性聲明中預期或預測的結果存在重大差異,這些風險和不確定性已在我們今天早些時候發布的新聞稿以及我們最新的 10-Q 表格季度報告的風險因素部分中進行了描述。

  • Today’s discussion will also include references to both GAAP and non-GAAP financial measures. Please refer to our earnings release issued earlier today and available on the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure and other information regarding our use of non-GAAP financial measures.

    今天的討論還將包括對 GAAP 和非 GAAP 財務指標的參考。請參閱我們今天稍早發布的收益報告,該報告可在我們網站的投資者中心部分查閱,其中對這些指標與其最直接可比較的 GAAP 財務指標進行了調節,並提供了有關我們使用非 GAAP 財務指標的其他資訊。

  • John Sheridan, Tandem’s President and CEO, will be leading today’s call, and he’ll be joined by Lee Vosseller, Executive Vice President and Chief Financial Officer. Following their prepared remarks, the operator will open up the call for questions. Thanks in advance for limiting yourself to one question before getting back into the queue. I’ll now turn the call over to John.

    Tandem 的總裁兼執行長 John Sheridan 將主持今天的電話會議,執行副總裁兼財務長 Lee Vosseller 將與他一同出席。在發言結束後,主持人將開放提問環節。感謝您在重新排隊前只提一個問題。現在我將把電話交給約翰。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thank you, Susan. Good afternoon, everyone, and welcome to our call today. In the third quarter, we achieved significant strategic milestones and delivered record Q3 sales. This year has represented a period of transformation for Tandem, and we are doing the right thing to position our company for success. Our substantial progress is starting to become evident in our financial results and serves as a testament to our strategic vision, hard work, and the collective dedication of our entire team. There are three primary initiatives that we’ve been prioritizing to evolve our business, which will be the focus of my prepared remarks today. These include modernization of our commercial operations, driving innovation, and reshaping our business model. In the US, we are beginning to see measurable benefits from our commercial changes implemented throughout the year.

    謝謝你,蘇珊。各位下午好,歡迎參加我們今天的電話會議。第三季度,我們實現了重要的戰略里程碑,並取得了創紀錄的第三季銷售額。今年是 Tandem 的轉型期,我們正在採取正確的措施,使公司走向成功。我們的實質進展開始在財務表現中顯現出來,這證明了我們的策略遠見、辛勤工作以及整個團隊的共同奉獻。為了推動業務發展,我們優先考慮了三項主要舉措,這也是我今天發言的重點。這些措施包括商業營運現代化、推動創新以及重塑商業模式。在美國,我們開始看到全年實施的商業變革帶來了可衡量的利益。

  • We have redefined end-to-end processes, begun deploying new technology platforms, and restructured the organization to deepen our capabilities and to improve efficiencies. As a result, we’re beginning to see improved sales productivity and effectiveness and plan to build on this momentum in the coming quarter and years. Pump shipments for Q3 met our expectations with favorable underlying sales trends, and September was our strongest month of the quarter.

    我們重新定義了端到端流程,開始部署新的技術平台,並重組了組織結構,以增強我們的能力並提高效率。因此,我們開始看到銷售效率和效益有所提高,並計劃在接下來的一個季度和幾年裡保持這種勢頭。第三季泵浦出貨量符合預期,銷售趨勢良好,9 月是本季表現最好的一個月。

  • About two-thirds of our new customers continued to adopt our technology from multiple daily injections. We also continue to see a healthy mix of both t:slim X2 and Mobi adoption, highlighting the value of our portfolio approach in the highly segmented market. Outside of the US, our commercial transformation is focused on preparing for direct operations in Europe. We have executed well against our transition plans, and I’ve been impressed with the high caliber experienced people joining us.

    約三分之二的新客戶繼續採用我們的技術,每天多次注射。我們也繼續看到 t:slim X2 和 Mobi 的採用率保持健康平衡,這凸顯了我們在高度細分的市場中採用產品組合方法的價值。在美國以外,我們的商業轉型重點是為在歐洲開展直接業務做好準備。我們的過渡計畫執行得很順利,加入我們的都是高素質、經驗豐富的人才,這給我留下了深刻的印象。

  • Our direct sales initiatives will begin in the UK, Switzerland, and Austria in early 2026, with additional countries to follow later in the year. In some locations, we’ve already started to hire our sales reps. Many of these individuals currently sell our technology through a distributor, which helps support a smooth transition. Establishing direct international operations is a critical step to strengthen our financial position by accelerating sales growth and driving margin expansion.

    我們的直銷計畫將於 2026 年初在英國、瑞士和奧地利啟動,隨後將在今年稍後擴展到其他國家。在某些地區,我們已經開始招募銷售代表。目前,許多此類人士透過分銷商銷售我們的技術,這有助於實現平穩過渡。建立直接的國際業務是增強我們財務狀況的關鍵一步,它能夠加速銷售成長並推動利潤率擴張。

  • It’s also an opportunity to deepen our relationships with the European diabetes community and bring the benefits of Tandem’s incredible technology to more people living with diabetes worldwide. Our second business initiative is focused on driving innovation. We have several recent and upcoming launches, which deliver on our portfolio promise of expanding choice. For example, the potential for Mobi is still not fully unlocked.

    這也是加深我們與歐洲糖尿病界關係,並將 Tandem 的卓越技術帶給全球更多醣尿病患者的機會。我們的第二項業務措施著重於推動創新。我們近期和即將推出多款產品,兌現了我們擴大產品選擇範圍的承諾。例如,Mobi 的潛力尚未完全發揮出來。

  • We are awaiting FDA clearance for our Mobi Control app for Android, which is currently only available in iOS. Adding Android capability is an exciting opportunity as it significantly expands the worldwide addressable market. In addition, last week, we announced that t:slim X2 is now fully available with Abbott’s Freestyle Libre 3+ integration in the US, marking the first step in a broader global rollout. This integration has been in the early access phase of launch in the US over the past several months, with positive user feedback.

    我們正在等待 FDA 批准我們的安卓版 Mobi Control 應用,目前僅適用於 iOS 系統。添加安卓功能是一個令人興奮的機會,因為它能顯著擴大全球潛在市場。此外,上週我們宣布,t:slim X2 現已在美國全面上市,並與 Abbott 的 Freestyle Libre 3+ 系統集成,這標誌著其在全球範圍內更廣泛推廣的第一步。過去幾個月,該整合功能已在美國處於早期訪問階段,並獲得了積極的用戶回饋。

  • We’re excited to offer integration with Abbott’s latest generation sensor, as it provides even more CGM users access to the life-changing benefits of our Control-IQ+ algorithm. We are expanding the international rollout of our source cloud infrastructure, which supports both the expansion of Mobi outside the United States and enables iOS and Android mobile app applications for t:slim X2.

    我們很高興能夠與雅培最新一代感測器集成,因為這將使更多 CGM 用戶能夠享受我們 Control-IQ+ 演算法帶來的改變生活的好處。我們正在擴大源雲基礎設施的國際推廣,這既支援 Mobi 在美國以外的擴展,也支援 t:slim X2 的 iOS 和 Android 行動應用程式。

  • Our t:slim mobile app is now live in five countries, with another seven scheduled for deployment before the end of the year and the remaining to follow soon after. This is a milestone in bringing our data management solutions to users worldwide and a testament to the world-class capabilities we are building in this space. Lastly, we continue to receive positive feedback from people with type 2 diabetes who experienced real-world results similar to those in our study in the New England Journal of Medicine earlier this year. Control IQ Plus offers immediate and sustained improvement, even without carb counting and regardless of bolus strategy, including when people don’t bolus at all. Importantly, we’re seeing that insulin-dependent people using GLP-1s get even better outcomes when used with Control IQ Plus.

    我們的 t:slim 行動應用程式目前已在五個國家/地區上線,另有七個國家計劃在年底前部署,其餘國家/地區也將很快跟進。這是我們將資料管理解決方案帶給全球用戶的里程碑,也證明了我們在該領域正在建立的世界級能力。最後,我們不斷收到來自 2 型糖尿病患者的正面回饋,他們在現實生活中獲得了與我們今年稍早在《新英格蘭醫學雜誌》上發表的研究結果類似的療效。Control IQ Plus 可提供即時和持續的改善,即使不計算碳水化合物,也無論採用何種胰島素追加策略,包括完全不注射胰島素的情況。重要的是,我們發現,對於使用 GLP-1 的胰島素依賴型患者,當與 Control IQ Plus 一起使用時,可以獲得更好的治療效果。

  • In line with our expectations, t:slim X2’s screen display resonates strongly with the type 2 users, along with a 300-unit reservoir, as it reduces the frequency of cartridge changes, helping reduce the daily burden of diabetes. Following this positive feedback, we expanded our type 2 commercial efforts, moving from pilot to full promotion of Control IQ Plus for people with type 2 diabetes. The market is highly underpenetrated and requires development. We’re seeing evidence as the territories that participated in our pilot launch activities are now the most productive in bringing our technology to people with type 2. Serving this population is a focus for us because it offers meaningful longer-term growth opportunity, doubling our addressable market in the US. The third initiative driving our business transformation is shaping our business model to drive growth and improve gross margin and profitability.

    正如我們所預期的,t:slim X2 的螢幕顯示效果與 2 型糖尿病患者產生了強烈的共鳴,同時其 300 單位的儲液器也減少了更換藥筒的頻率,從而有助於減輕糖尿病患者的日常負擔。收到這些正面的回饋後,我們擴大了第 2 型糖尿病的商業推廣力度,從試點階段過渡到全面推廣 Control IQ Plus 給第 2 型糖尿病患者。市場滲透率極低,需要進一步開發。我們看到證據表明,參與我們試點推廣活動的地區,現在在將我們的技術帶給 2 型糖尿病患者方面最為高效。服務這群人是我們的重點,因為它提供了有意義的長期成長機會,使我們在美國的潛在市場翻了一番。推動我們業務轉型的第三項舉措是調整我們的業務模式,以推動成長並提高毛利率和獲利能力。

  • We have been identifying and implementing changes to increase efficiency through interoperations, greater automation, and the implementation of new processes and systems. A major focus of reshaping our business model has been our pursuit and advancement of a multi-channel reimbursement strategy. There are two key pharmacy-related accomplishments this quarter. First, we’ve successfully increased pharmacy benefit coverage for Tandem Mobi to more than 40% of US lives, a milestone we plan to build on in 2026. The next highlight is that we started selling t:slim X2 supplies to our large existing customer base through the pharmacy benefit in September. As you recall, we previously shared this is a goal for Q4, and it’s now off to a great start. Early uptake has been encouraging, with customers citing affordability, convenience, and simplified refills as the top reasons for switching to their pharmacy benefit.

    我們一直在尋找並實施變革,透過互通性、更高的自動化程度以及新流程和系統的實施來提高效率。重塑我們業務模式的一個重點是追求和推動多通路報銷策略。本季在藥學方面取得了兩項重要成就。首先,我們已成功將 Tandem Mobi 的藥品福利覆蓋範圍擴大到美國人口的 40% 以上,我們計劃在 2026 年在此基礎上繼續努力。下一個亮點是,我們從 9 月開始透過藥局福利向我們龐大的現有客戶群銷售 t:slim X2 耗材。如您所知,我們之前曾表示這是第四季度的目標,現在看來已經取得了良好的開端。早期的接受度令人鼓舞,顧客表示,價格實惠、方便快速、續藥流程簡化是他們選擇使用藥局福利的主要原因。

  • This supports our thesis that pharmacy access is not only more efficient for Tandem, but also more appealing to our customers. Operationalizing pharmacy access for new and existing customers required significant internal effort. We’ve assembled a skilled team of market access and pharmacy distribution leaders with experience across leading PBMs, pharma, and medtech organizations, enabling faster contracting and smooth implementation. Their expertise has accelerated this strategic shift, making our AID technology more affordable and accessible while establishing a scalable foundation for future growth. As you can see, we’ve meaningfully advanced our key initiatives in support of Tandem’s mission and financial goals. I want to thank our employees, as taking on these initiatives simultaneously has been quite an undertaking. The team’s efforts are making a positive impact and starting to yield tangible results, positioning Tandem as a continued global leader in diabetes care.

    這印證了我們的論點,即藥房管道不僅對 Tandem 而言效率更高,而且對我們的客戶也更具吸引力。為新舊客戶提供便利的藥局服務需要大量的內部投入。我們組建了一支由市場准入和藥品分銷領域的領導者組成的專業團隊,他們在領先的藥品福利管理機構、製藥公司和醫療技術公司擁有豐富的經驗,從而能夠更快地簽訂合約並順利實施。他們的專業知識加速了這一策略轉變,使我們的 AID 技術更加經濟實惠、更容易獲取,同時為未來的成長奠定了可擴展的基礎。如您所見,我們已在支持 Tandem 的使命和財務目標方面取得了實質進展,並推進了各項關鍵舉措。我要感謝我們的員工,因為同時開展這些專案確實是一項艱鉅的任務。團隊的努力正在產生積極影響,並開始取得實際成果,使 Tandem 繼續保持糖尿病護理領域的全球領先地位。

  • I’ll now turn the call over to Lee, who will expand on our third-quarter results and future expectations. Lee.

    現在我將把電話交給李,他將詳細介紹我們第三季的業績和未來預期。李。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Thanks, John. As a reminder, unless otherwise noted, the financial metrics I will be discussing today are on a non-GAAP basis. Reconciliations from GAAP to non-GAAP results can be found in today’s earnings release, as well as on the Investor Center portion of our website.

    謝謝你,約翰。再次提醒大家,除非另有說明,我今天將要討論的財務指標均為非GAAP指標。GAAP 與非 GAAP 結果的調整表可在今天的收益報告中以及我們網站的投資者中心部分找到。

  • Please note that 2025 sales and margins in the US are no longer impacted by the Tandem Choice program, which ended in 2024. 2025 continues to be a strong year for Tandem. With revenue of $249 million, we once again set record third-quarter sales. Our top-line outperformance was primarily driven by ASP increases on both pumps and supplies in the US, as well as favorable foreign currency dynamics. Another highlight of the quarter was our profitability, as our gross margin increased 3 percentage points year over year and adjusted EBITDA returned to positive.

    請注意,2025 年美國地區的銷售額和利潤率不再受 Tandem Choice 計劃的影響,該計劃已於 2024 年結束。 2025 年對 Tandem 而言仍將是強勁的一年。第三季營收達 2.49 億美元,再次創下銷售紀錄。我們營收的優異表現主要得益於美國泵浦和耗材的平均售價上漲,以及有利的外匯匯率波動。本季另一個亮點是我們的獲利能力,毛利率年增 3 個百分點,調整後 EBITDA 轉正。

  • In the US, third-quarter sales were approximately $176 million, marking our highest third quarter to date and our second highest quarter ever. Pricing was the primary contributor, providing significant benefit from both the DME and pharmacy channels. Notably, pricing alone increasingly contributed to year-over-year revenue growth this year, driving 2% growth in Q1, 4% in Q2, and 5% in Q3. This is due in part to the scaling of our pharmacy business to 5% of US sales this quarter.

    在美國,第三季銷售額約為 1.76 億美元,創下迄今為止最高的第三季紀錄,也是有史以來第二高的季度紀錄。價格是主要因素,DME 和藥局管道都帶來了顯著的收益。值得注意的是,今年價格因素對年收入成長的貢獻越來越大,第一季成長了 2%,第二季成長了 4%,第三季成長了 5%。部分是由於本季我們藥局業務的規模擴大到美國銷售額的 5%。

  • We are excited by the potential for future pharmacy contribution as we further expand into the channel. Pump shipments in the US were over 20,000. Consistent with our expectations, this was slightly down from Q2, following the pharmacy stocking benefit that we recognized in Q2. We continue to see strong demand for our portfolio of products, led by renewals from our large and loyal customer base.

    隨著我們進一步拓展該管道,我們對未來藥房業務的潛在貢獻感到興奮。美國泵出貨量超過 20,000 台。與我們的預期一致,這比第二季度略有下降,這是因為我們在第二季度看到了藥房庫存增加的好處。我們持續看到市場對我們產品組合的強勁需求,這主要得益於我們龐大而忠實的客戶群的續約。

  • Renewals continue to track to our historical capture rate of more than 70% of eligible customers within 18 months after warranty expiration. Turning to our performance outside the United States, we achieved $74 million in sales, delivering another record third quarter. Total international sales primarily increased year over year due to favorable movements in foreign currency exchange rates. Pump shipments were just over 9,000 as we continue our preparations to go direct in select European countries next year.

    續保率繼續保持我們以往的水平,在保固期結束後 18 個月內,超過 70% 的符合條件的客戶都能續保。再來看我們在美國以外的業績,我們實現了 7,400 萬美元的銷售額,再次創下第三季紀錄。國際銷售總額年增主要得益於外匯匯率的有利變動。水泵出貨量略高於 9,000 台,我們正繼續為明年在部分歐洲國家進行直接銷售做準備。

  • True market demand remained strong, with end-user pump placements growing double digits year over year. In addition to our strong worldwide sales performance, we also demonstrated significant margin improvement. Our Q3 gross margin of 54% increased approximately 3 percentage points year over year and increased approximately 2 percentage points compared to Q2. Like sales, this reflects meaningful benefit from higher ASPs.

    真正的市場需求依然強勁,終端用戶泵浦的安裝量較去年同期成長兩位數。除了全球銷售業績強勁外,我們的利潤率也顯著提高。第三季毛利率為 54%,年增約 3 個百分點,較第二季成長約 2 個百分點。與銷售額一樣,這反映了平均售價提高帶來的顯著收益。

  • The combination of price, channel benefit, and scaling reductions in Mobi costs underpin both our near and long-term gross margin goals. Turning to our operating cost structure, we continue to prioritize spending towards resources that will drive top-line growth, generate efficiency, and strengthen our competitive position. Operating expenses increased 4% year over year, primarily attributed to SG&A investments. The SG&A increase reflects commercial investments in sales infrastructure, including US Salesforce expansion, costs to support direct operations in Europe, and initiatives aimed at streamlining our operations.

    價格、通路優勢以及行動端成本規模化降低的結合,支撐著我們近期和長期的毛利率目標。就我們的營運成本結構而言,我們將繼續優先考慮將資金投入到能夠推動營收成長、提高效率和增強我們競爭地位的資源上。營運費用較去年同期成長 4%,主要歸因於銷售、管理及行政費用投資。銷售、一般及行政費用的增加反映了對銷售基礎設施的商業投資,包括美國 Salesforce 的擴張、支援歐洲直接營運的成本,以及旨在簡化我們營運的措施。

  • R&D costs declined year over year, a result of our commitment to investing in the development of highly innovative products for our customers while maintaining disciplined resource allocation and strategic portfolio management. We remain committed to enhancing efficiencies throughout the organization to strengthen our operating margin leverage. To further this initiative, we completed an organizational restructuring in the third quarter.

    由於我們致力於投資開發面向客戶的高創新性產品,同時保持嚴格的資源分配和策略性的產品組合管理,研發成本逐年下降。我們將繼續致力於提高整個組織的效率,以增強我們的營業利潤率。為了進一步推動這項舉措,我們在第三季完成了組織結構重組。

  • Our Q3 operating expenses include approximately $3 million in costs associated with this restructuring, which are expected to deliver financial benefits in the coming quarters. In addition, in recent years, we updated our incentive stock grant practices to more closely align with benchmarks, culminating in a $5 million reduction in non-cash stock-based compensation and costs compared to the prior year.

    我們第三季的營運支出包括與此重組相關的約 300 萬美元成本,預計將在未來幾季帶來財務收益。此外,近年來,我們更新了激勵性股票授予做法,使其與基準更加緊密地保持一致,最終與前一年相比,非現金股票薪酬和成本減少了 500 萬美元。

  • As a result of our top-line growth and cost optimization efforts, Q3 marked a return to positive adjusted EBITDA and free cash flow, and we ended the quarter with $319 million in total cash and investments. Looking at 2025 overall, we are on track to achieve double-digit growth at a milestone of $1 billion in worldwide sales. This includes US sales of approximately $700 million, assuming a seasonal pump shipment curve that is consistent with our 2024 experience, where nearly 30% of shipments occurred in the fourth quarter.

    由於營收成長和成本優化,第三季調整後 EBITDA 和自由現金流恢復為正,季末我們擁有 3.19 億美元的現金和投資總額。展望 2025 年,我們預計將實現兩位數成長,全球銷售額達到 10 億美元這一里程碑。這其中包括約 7 億美元的美國銷售額,假設泵浦的季節性出貨曲線與我們 2024 年的經驗一致,其中近 30% 的出貨量發生在第四季。

  • It also reflects greater strength from pricing as we capitalize on the launch of t:slim supplies with a pharmacy benefit. Outside the US, we anticipate sales of approximately $300 million. This represents 12% growth year over year, even with approximately $10 million in headwinds assumed for distributor inventory destocking and inventory buybacks in advance of taking certain markets direct in early 2026. We are reaffirming our 2025 gross margin expectation in the range of 53%-54% of sales, with Q4 expected to be an all-time gross margin record in the mid to high 50s. We are also reaffirming our adjusted EBITDA expectations of negative 5% of sales. As a reminder, our expectation was 3% prior to a change in treatment of an in-process research and development charge in the first quarter, which impacted adjusted EBITDA by 8 percentage points.

    這也反映出定價方面的優勢更加明顯,因為我們利用了帶有藥房福利的 t:slim 耗材的推出。在美國以外,我們預計銷售額約為 3 億美元。即使考慮到經銷商庫存去庫存和在 2026 年初直接進入某些市場之前回購庫存,預計會產生約 1000 萬美元的不利影響,這也代表著同比增長 12%。我們重申 2025 年毛利率預期為銷售額的 53%-54%,預計第四季毛利率將創歷史新高,達到 50% 至 50% 以上。我們也重申了對調整後 EBITDA 的預期,即銷售額的 -5%。提醒一下,在第一季對在研發開發費用的處理方式發生變化之前,我們的預期是 3%,這導致調整後的 EBITDA 下降了 8 個百分點。

  • We are focused on carrying our momentum from 2025 forward to the year ahead. We have a number of exciting opportunities across the P&L going into 2026, and while we are not providing guidance today, I would like to frame up some of the key baseline assumptions to think about for next year. In the US, we anticipate returning to new pump growth driven by MDI conversions from new product introductions and increased pharmacy access. Renewal opportunities from pumps sold in 2022 will be flat year over year at $80,000, but we still expect low double-digit sales growth based on the tail of customers who have not yet renewed from years past. Overall, more than 70% of our US sales are expected to be generated by recurring and predictable revenue streams of renewals and supplies from our install base of more than 300,000 customers.

    我們致力於將2025年的發展動能延續到未來一年。展望 2026 年,我們在損益方面有很多令人興奮的機會,雖然我們今天不提供業績指引,但我希望概述一些明年需要考慮的關鍵基準假設。在美國,我們預計隨著新產品的推出和藥房管道的增加,MDI轉換將推動新泵浦的成長,從而恢復到先前的水平。2022 年售出泵浦的續約機會將與去年持平,為 80,000 美元,但我們仍然預計,基於過去幾年尚未續約的客戶,銷售額將實現兩位數的低成長。總體而言,我們預計超過 70% 的美國銷售額將來自我們超過 30 萬客戶的安裝基礎所帶來的續訂和供應等經常性且可預測的收入流。

  • Additionally, the improved pricing we achieved this year foreshadows the value we can unlock with a multi-channel market access strategy. We have contracts with all the major PBMs and are positioned well for increasing pharmacy channel access. We are also focused on optimizing our operations for volumes at a larger scale. Our fourth quarter progress will provide valuable information to guide the level of benefit to come from channel mix assumptions in 2026, and we look forward to providing you with a more detailed update on our year-end earnings call. Turning to our international expectations, we anticipate driving further market expansion and increasing contribution from renewals, as well as growth from our direct operations that will scale across the year. We anticipate that nearly 15% of our international sales will be generated from direct market sales, up from less than 5% in 2025.

    此外,我們今年取得的定價改善預示著我們可以透過多通路市場准入策略釋放價值。我們與所有主要的藥品福利管理機構 (PBM) 都簽訂了合同,並且在擴大藥房管道准入方面處於有利地位。我們也致力於優化運營,以實現更大規模的生產。我們第四季度的進展將為指導 2026 年管道組合假設帶來的收益水平提供有價值的信息,我們期待在年終收益電話會議上向您提供更詳細的更新。展望國際市場,我們預期市場將進一步擴張,續約收入將增加,同時,全年直接業務的成長也將實現規模化發展。我們預計,到 2025 年,我們國際銷售額的近 15% 將來自直接市場銷售,而這一比例不到 5%。

  • The primary benefit of going direct will initially be from ASP uplift, which may be variable in each market. Generally, though, over the four-year life of a patient, ASPs are anticipated to be at least 30% higher in a direct market versus our current distributor pricing. 2026 is also positioned to be an exciting year for both gross and operating margin leverage. We anticipate another step function improvement in gross margins from the combined benefit of lower product cost as Mobi scales and pricing contribution. Our goal is to deliver gross margin of at least 60% in Q4 2026. We are also focused on driving continued adjusted EBITDA improvement compared to the initial 3% operational target we set for 2025, as well as positive free cash flow. In summary, as we continue to execute our strategy, I remain confident in achieving our financial objectives.

    直接銷售的主要好處最初將來自於平均售價的提升,但這在每個市場可能會有所不同。不過,整體而言,在患者四年的生命週期內,直接市場的平均售價預計至少比我們目前的經銷商定價高出30%。 2026年對於毛利率和營業利益率的提升來說,也有望成為令人振奮的一年。我們預計隨著 Mobi 規模擴大和定價策略的提升,產品成本降低,毛利率將進一步大幅提高。我們的目標是到 2026 年第四季實現至少 60% 的毛利率。我們也致力於推動調整後 EBITDA 持續改善,以實現我們最初設定的 2025 年 3% 的營運目標,並實現正的自由現金流。總之,隨著我們繼續執行我們的策略,我對實現我們的財務目標仍然充滿信心。

  • I’ll turn the call back to you, John.

    約翰,我把電話轉回給你。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thanks, Lee. To wrap up our prepared remarks, I have a few additional updates on our initiative to drive innovation throughout our product pipeline, which remains the most exciting in insulin therapy management. In the recent quarters, we have been refining our roadmap to best leverage our deep technology portfolio that we have developed through organic investments and key acquisitions. Starting with Mobi Tubeless, which transforms Mobi into the world’s first extended-wear patch pump with a novel new cartridge and infusion site, Mobi becomes a solution for people who want to go 100% tubeless, people who prefer to use traditional infusion sets, and people who want a choice in interchanging wear options. Our market research shows that offering a tubeless wear mode for Mobi significantly increases user preference. When implemented with extended wear, user preferences increase even higher.

    謝謝你,李。最後,我想就我們推動產品線創新的措施做一些補充說明,這仍然是胰島素治療管理領域最令人興奮的舉措。在最近幾個季度,我們一直在完善我們的發展路線圖,以充分利用我們透過內部投資和關鍵收購所建立的深厚技術組合。從 Mobi Tubeless 開始,Mobi 成為世界上第一款採用新型藥盒和輸注部位的長效佩戴貼片泵,Mobi 為想要 100% 無管輸液的人、喜歡使用傳統輸液裝置的人以及想要選擇更換佩戴方式的人提供了解決方案。我們的市場調查顯示,為 Mobi 提供無內胎配戴模式可顯著提高使用者偏好度。長時間配戴後,用戶偏好度會進一步提高。

  • We expect Mobi Tubeless to be our first commercial offering featuring extended wear technology. We have prioritized its launch ahead of SteadySet, our extended wear infusion set, based on the high level of market enthusiasm for extended wear patch pump. We are entering the final stages of Mobi Tubeless testing to support a 510(k) submission. Manufacturing scale-up activities are happening in parallel to reduce the time between clearance and the commercial launch in 2026. Rounding out our platform update, we have also been refining the design of our SIGGI patch pump, which we acquired from AMF Medical. Bringing SIGGI development to San Diego earlier this year produced a great outcome. The team identified opportunities to combine the best of our Mobi and SIGGI platforms together, creating development synergies, enabling further miniaturization, and enhancing competitive differentiation.

    我們預期 Mobi Tubeless 將成為我們首款採用延長配戴技術的商業產品。我們優先推出了這款產品,而不是我們的長效佩戴輸液裝置 SteadySet,因為市場對長效佩戴貼片泵表現出了極大的熱情。我們即將進入 Mobi Tubeless 測試的最後階段,以支援 510(k) 申請。為了縮短從獲得許可到 2026 年商業上市之間的時間,生產規模擴大活動正在同步進行。為了完善我們的平台更新,我們也改進了從 AMF Medical 收購的 SIGGI 貼片幫浦的設計。今年早些時候,SIGGI 的開發案在聖地牙哥取得了巨大成功。團隊發現了將我們的 Mobi 和 SIGGI 平台的優勢結合起來的機會,從而創造開發協同效應,實現進一步小型化,並增強競爭優勢。

  • We are excited about what this means for the SIGGI technology as part of our tubeless roadmap. From a commercial perspective, we anticipate marketing this pump as our next-generation Mobi, building on the growing brand recognition of this new product family. Finally, I want to acknowledge the work of our team and our partners at the University of Virginia’s Center for Diabetes Technology for their progress in developing fully closed-loop technology for Tandem pump platforms. Our vision for fully closed-loop is to give people the ability to interact with their pump as much or as little as they like. We remain committed to advancing these R&D efforts quickly, and our goal is to start a pivotal study for our new fully closed-loop algorithm next year.

    我們對這項技術作為我們無內胎輪胎髮展路線圖的一部分,對 SIGGI 技術所具有的意義感到非常興奮。從商業角度來看,我們計劃將這款幫浦作為我們的下一代 Mobi 產品進行推廣,以鞏固這個新產品系列不斷增長的品牌知名度。最後,我要感謝我們團隊以及維吉尼亞大學糖尿病技術中心的合作夥伴們,感謝他們在開發 Tandem 幫浦平台的全閉環技術方面取得的進展。我們對完全閉環系統的願景是,讓人們能夠根據自己的意願,與泵浦進行盡可能多的互動,或盡可能少的互動。我們將繼續致力於快速推進這些研發工作,我們的目標是明年啟動一項針對我們新的全閉環演算法的關鍵性研究。

  • In conclusion, we began this year focused on business transformation, and I am proud of the progress we are making that positions Tandem for future success. As we approach year-end, we have an energized commercial organization, growing product momentum, and a sharpened focus on our forward-looking roadmap. Tandem’s achievements this year reflect our strategic vision and deep commitment to innovation in diabetes care. We have made measurable progress in modernizing our commercial operations, driving innovation, and evolving our business model. Looking ahead, our focus remains on delivering meaningful solutions for people living with diabetes, fostering operational excellence, and positioning Tandem for continued leadership and success in the global market. We appreciate your ongoing support and look forward to sharing further progress in the future quarters. Thank you again for joining us today.

    總之,今年年初我們專注於業務轉型,我對我們的進展感到自豪,這些進展為 Tandem 未來的成功奠定了基礎。隨著年底臨近,我們的商業組織充滿活力,產品發展勢頭強勁,我們更加專注於前瞻性的發展路線圖。Tandem今年的成就體現了我們的策略願景和對糖尿病護理創新的堅定承諾。我們在商業營運現代化、推動創新和發展商業模式方面取得了顯著進展。展望未來,我們的重點仍然是為糖尿病患者提供有意義的解決方案,促進卓越運營,並使 Tandem 在全球市場繼續保持領先地位並取得成功。我們感謝您一直以來的支持,並期待在未來幾季與您分享更多進展。再次感謝您今天蒞臨。

  • Operator

    Operator

  • (Operator Instructions) Matt Miksic, Barclays.

    (操作說明)馬特·米克西奇,巴克萊銀行。

  • Matthew Miksic - Analyst

    Matthew Miksic - Analyst

  • Hey, thanks so much for taking the questions, and congrats on a really strong quarter. Wanted to get a sense of, as we head into next year, maybe just kind of a broad question in terms of cadence. I know you’re not going to, may not give much color today on 2026 outlook, although I’m sure you’ll get a lot of questions on it.

    嘿,非常感謝你回答這些問題,也恭喜你本季取得了非常優異的成績。想了解一下,隨著我們邁入明年,也許可以就節奏方面提出一個比較廣泛的問題。我知道你今天可能不會對 2026 年的前景做出太多評價,儘管我相信你會收到很多相關的問題。

  • I’ll ask mine around the idea of cadence. Some of the new products, the continued progression into pharmacy, some of the geographic initiatives that you’ve undertaken. Taking all those into account, can you maybe give us a sense of acceleration, catalysts, and sort of progressive growth throughout the year if you were to map it out today, steering clear of what the headline number will be. As I said, I’m sure you’re going to get more questions on that, but that color would be great. Thanks.

    我會問我的朋友們關於節奏的想法。一些新產品、持續進軍藥局領域、以及你們所進行的一些地域性舉措。考慮到所有這些因素,如果您今天來規劃全年的發展藍圖,能否向我們介紹加速成長、催化劑以及某種漸進式成長的趨勢,但不要透露最終的業績數字。正如我所說,我確信你會收到更多關於這個問題的提問,但那個顏色會很棒。謝謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Hey there, Matt. A lot to unpack there. Yeah, I think what I’ll do is I’ll kind of give you a sense of what the pipeline is going to look like, and then I’ll let Lee talk more about the pharmacy channel and some of the other initiatives that we’ve got going on. I think that you can tell from the call here that we are really trying to increase our focus on what really matters for the business.

    嗨,馬特。這裡面有很多資訊需要分析。是的,我想我會先向你們介紹一下產品線的大致情況,然後讓 Lee 更多地談談藥房管道以及我們正在進行的其他一些舉措。我認為從這次通話中可以看出,我們正在努力更加專注於對業務真正重要的事情。

  • Certainly, we are very excited about Mobi, and we think it really will be the workhorse for the company in the not-too-distant future. As we just explained in the call, we’re waiting to get the Mobi Android approval here before the end of the year. I think as you move into 2026, we’re going to be moving Mobi to OUS countries.

    當然,我們對 Mobi 非常興奮,我們認為它在不久的將來必將成為該公司的主力產品。正如我們在電話中解釋的那樣,我們正在等待 Mobi Android 在年底前獲得批准。我認為,到了 2026 年,我們將把 Mobi 推廣到美國以外的國家。

  • We intend to implement Freestyle Libre 3, and we also intend to implement the tubeless version of Mobi. I think when you think about that and when you include that with Control-IQ, I mean, that’s a powerful product, and I think it’s going to really significantly change the competitive dynamic that we face in the marketplace today.

    我們計劃實施 Freestyle Libre 3,我們也計劃實施 Mobi 的無內胎版本。我認為,當你考慮到這一點,再加上 Control-IQ 的功能,我的意思是,這是一款強大的產品,我認為它將真正顯著地改變我們今天在市場上面臨的競爭格局。

  • We’re certainly very excited about it, and I would say we feel very confident we’re going to make these things happen in 2026, and I think it’s going to have a market effect on the business. Lee, you want to talk a bit about the pharmacy work that we’re doing?

    我們對此感到非常興奮,而且我認為我們非常有信心在 2026 年實現這些目標,我認為這將對市場業務產生影響。李,你想談談我們正在做的藥局工作嗎?

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. I think to sum it up, just based on John’s comments, the way you can think about it is these are building across the year in 2026. A lot of them just began at full commercial rollout. A lot of things are in flight. We’re very excited with our pharmacy progress. There’s more to build on there.

    當然。總而言之,根據約翰的評論,你可以這樣理解:這些事情將在 2026 年全年逐步發生。其中許多產品才剛開始全面商業推廣。很多東西都在飛行中。我們對藥房的進展感到非常興奮。還有更多可以進一​​步探討的地方。

  • Our business transformation in the US that we’ve been investing in, we’re starting to see the green shoots from a productivity perspective coming out of our commercial team. A lot of these things are going to be coming to fruition and building across the year in 2026. That’s how you can think about the cadence.

    我們一直在投資美國的業務轉型,從生產力角度來看,我們的商業團隊已經開始看到積極的跡象。許多這樣的事情將在 2026 年逐步實現和發展。這就是你思考節奏的方式。

  • It also is not just the top line, but it flows down through the bottom line as well, because we will also begin to show more leverage across the year from these investments that we have made as we are generating the return on the top line. You can also expect seasonality, but the building of the margin expectations and the EBITDA expectations as the revenue grows.

    這不僅關乎營收,也關乎利潤,因為隨著我們為營收帶來回報,我們將在今年逐步展現出這些投資帶來的更大槓桿效應。季節性因素也會影響利潤率預期和 EBITDA 預期,但隨著營收的成長,利潤率預期和 EBITDA 預期也會隨之提高。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    拉里·比格爾森,富國銀行。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Excuse me. Good afternoon. Thanks for taking the question. Lee, I wanted to focus my question on price and the uplift you can get from the supplies going through the pharmacy. On price, the 5% benefit in Q3, where do you see that going in 2026?

    打擾一下。午安.感謝您回答這個問題。李,我想重點問的是價格以及透過藥局進貨可以獲得的提價。價格方面,第三季 5% 的收益,您認為到 2026 年價格走勢如何?

  • You’re launching the t:slim supplies in the pharmacy this quarter. Any incremental color on what the pricing uplift is and how long the transition will take? How do we think about your current supply revenue per user at about $1,000 going forward? Thanks for taking the question.

    您本季將在藥局推出 t:slim 用品。能否提供更多關於價格上漲幅度以及過渡期所需時間的具體資訊?您目前每用戶約 1000 美元的供應收入,我們該如何看待未來這項預期?感謝您回答這個問題。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. Thanks, Larry. It’s a good question. We obviously haven’t given a lot of color yet on how to think about it. One thing I’ll point out is that as we’ve seen price increases across this year and it’s been increasingly a contributor to our revenue growth, the balance of it was really from DME in the first half of the year, and in the third quarter, it flipped around and the balance of it’s coming from the pharmacy operations.

    當然。謝謝你,拉里。這是個好問題。顯然,我們還沒有詳細闡述應該如何思考這個問題。我想指出的一點是,雖然我們今年已經看到價格上漲,而且價格上漲對我們收入增長的貢獻越來越大,但上半年收入增長主要來自耐用醫療設備 (DME),而到了第三季度,情況發生了逆轉,收入增長主要來自藥房業務。

  • As we go into Q4, I think you can back in pretty easily into what we’re expecting from a pricing benefit on supplies. That’s probably a good way between Q3 and Q4, what you’re seeing to think about as a baseline as we step into 2026. As we accumulate more data and trends and information from our progress in the fourth quarter, the level of coverage that we expect to have as we step into the beginning of the year, when we give our guidance assumptions at the year-end earnings call, we can give a lot more color on how to think about that build. I would say what you’re seeing now is a solid baseline.

    進入第四季度,我認為大家可以輕易推斷出我們對供應價格上漲的預期。這可能是第三季和第四季之間的一個好時機,也是我們邁入 2026 年時應該考慮的基準。隨著我們從第四季度的進展中積累更多的數據、趨勢和信息,我們預計在進入年初時將達到更高的覆蓋水平,屆時我們將在年終財報電話會議上給出我們的指導假設,我們可以更詳細地說明如何看待這一發展。我認為你現在看到的是一個堅實的基礎。

  • Operator

    Operator

  • Chris Pasquale, Nephron Research.

    克里斯·帕斯誇萊,腎臟單位研究。

  • Christopher Pasquale - Analyst

    Christopher Pasquale - Analyst

  • Thanks. Lee, I wanted to follow up on the guidance and the comment around seasonality. A year ago, Q4 did not come together quite the way you guys expected, resulted in sales coming in below guidance. Can you just expand on what exactly you are assuming happens this time around? Is it similar to last year or a return to sort of what would have been normal in previous years?

    謝謝。李,我想就季節性方面的指導和評論做個後續跟進。一年前的第四季度,業績並沒有完全達到大家的預期,導致銷售額低於預期。能否詳細說明一下您認為這次具體會發生什麼事?今年的情況與去年類似,還是回歸到往年的正常狀態?

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Yes, thanks for the question, Chris. When we built the seasonal curve expectations for 2025, we absolutely factored in our experience in 2024, which, to your point, was a bit more muted at the end of the year than what we had seen in years past. What is underpinning, I guess I would say, the fourth-quarter shipments?

    是的,謝謝你的提問,克里斯。在製定 2025 年的季節性曲線預期時,我們絕對考慮到了 2024 年的經驗,正如您所說,2024 年底的情況比往年要溫和一些。我想說,支撐第四季出貨量的因素是什麼?

  • Last year, we saw about 30% of the full-year shipments landing in the fourth quarter. That is probably a good place to start for this year. Just the breakdown between new and renewal, you can still think about it as renewal being a little more than half. A lot of that step-up from Q3 to Q4 is really underpinned by the new renewal opportunities coming to market in the fourth quarter. I think that is a great starting point. Just to sum it all up, I would say very similar to what we saw in 2024.

    去年,我們看到全年出貨量約有 30% 是在第四季完成的。這或許是今年一個不錯的起點。單就新訂單和續訂訂單而言,你仍然可以認為續訂訂單略多於一半。第三季到第四季的成長很大程度上得益於第四季市場上出現的新續約機會。我認為這是一個很好的起點。總而言之,我認為與 2024 年我們看到的情況非常相似。

  • Operator

    Operator

  • Danielle Antalffy, UBS.

    Danielle Antalffy,瑞銀集團。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Hey, good afternoon, guys. Thanks so much for taking the question. Lee, thanks for the color on the renewal pumps. I guess just curious, I’m not sure if you guys can give any insights or clarity on what percentage renewals make pump shifts, given that shifts, excuse me, given that this was, I think you said, a historically high quarter. I don’t know if it’s easier to ask the question like percent that’s new patients to pump or new patients to Tandem pump versus renewals or what. I guess just trying to get a sense of what number of new patients have come on to Tandem in the last quarter. And that’s it for me.

    嘿,各位下午好。非常感謝您回答這個問題。李,謝謝你提供的翻新水泵的顏色資訊。我只是好奇,我不確定你們能否就續約率對油價波動的影響提供一些見解或解釋,因為,恕我直言,鑑於這是你們所說的歷史高季度。我不知道問這個問題是比較容易些,例如問新病患使用胰島素幫浦的百分比,還是新病患使用 Tandem 胰島素幫浦的百分比與續約患者百分比的百分比,或是其他什麼。我只是想了解一下上個季度有多少新患者加入了 Tandem。我的就講到這裡了。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. Thanks for the question, Danielle. Happy to take it. I would say the trends have remained consistent across each of the quarters this year where renewals have been a little bit more than half of the shipments. In the new start population, MDI conversions have been about two-thirds of the shipments.

    當然。謝謝你的提問,丹妮爾。樂意接受。我認為今年各季度的趨勢都保持一致,續訂量略高於出貨量的一半。在新開通的市場中,MDI轉換產品約佔出貨量的三分之二。

  • We did see continued pressure in the third quarter, and we expect again in the fourth quarter for new starts. That was factored into our updated guidance expectations we talked about last quarter where we said there would be a slight decline year over year. I will point back to all the opportunities that John laid out earlier from our initiatives between new product introductions, between pharmacy access, and just our commercial transformation really taking hold and taking root. We really expect to see a turnaround in that new start number and expect to return to growth in 2026.

    我們在第三季看到了持續的壓力,預計第四季將再次出現新的開局。這一點已納入我們上季更新的業績預期中,當時我們表示業績將比去年同期略有下降。我會回顧約翰之前提出的所有機會,包括我們推出新產品、拓展藥局管道以及商業轉型真正落地生根等措施。我們非常期待新車開工數量能夠出現好轉,並預計在 2026 年恢復成長。

  • Operator

    Operator

  • David Roman, Goldman Sachs.

    大衛羅曼,高盛集團。

  • David Roman - Analyst

    David Roman - Analyst

  • Hey, thanks for taking the question. You’ve got Jamie on for David today. Appreciated some of the building blocks you gave for 2026. I wanted to focus on the comments around returning to new pump growth driven by MDI conversions and just getting a sense of what you’re seeing in the market today, both in type one and type two, and how you’re expecting that to evolve both in terms of just market growth and competitive dynamics to get to that assumption that you’ve provided for 2026.

    嘿,謝謝你回答這個問題。今天傑米代替大衛上場。感謝您為2026年提供的一些基本要素。我想重點談談關於 MDI 轉換推動新泵成長回歸的評論,以及您目前在市場上看到的第一類和第二類泵的情況,以及您預計市場增長和競爭動態將如何發展,以達到您為 2026 年做出的假設。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thanks for the question. I would say that if you look at the basis of competition today, it’s changed dramatically over the last couple of years. I would say that form factors are a very important element of that, and so is market access. If you look at these transformational objectives that we’ve got going on right now, we’re certainly focused on increasing our presence in the pharmacy channel.

    謝謝你的提問。我認為,如果你觀察當今的競爭格局,你會發現它在過去幾年裡發生了巨大的變化。我認為外形尺寸是其中非常重要的因素,市場進入也是如此。如果你看看我們目前正在進行的這些變革性目標,我們當然專注於提高我們在藥局管道的影響力。

  • We certainly think that by doing that, you reduce the out-of-pocket for patients, and it’s easier for the physician to prescribe it. I think that getting to the pharmacy channel is something that we think will definitely positively affect our MDI uptake. At the same time, if you look at the innovation that we’ve got going on, we have things that are in the works. These things are on deck and are going to happen.

    我們當然認為,這樣做可以減少病人的自付費用,也方便醫生開處方。我認為,打入藥局通路肯定會對我們的 MDI 吸收率產生正面影響。同時,如果你看看我們正在進行的創新,我們還有一些專案正在籌備中。這些事情都在計劃之中,而且一定會發生。

  • I mean, as of right now, as I mentioned, we just got the Freestyle Libre 3 approval. That’s gone out broadly in the US. We expect to get Mobi Android approved here shortly. We have a number of other product-related feature enhancements that are going to really improve, I think, the competitive basis of Mobi in the marketplace. I think the combination of both of those really will affect MDI growth and get us to return to the point where we absolutely see growth in MDIs, and the company will go back to double-digit growth like we’ve seen consistently in the past.

    我的意思是,正如我剛才提到的,我們剛剛獲得了 Freestyle Libre 3 的批准。這件事在美國已經廣為流傳。我們預計很快就能在這裡獲得 Mobi Android 的批准。我們還有許多與產品相關的功能增強,我認為這些增強將真正提高 Mobi 在市場上的競爭力。我認為這兩件事結合起來確實會影響 MDI 的成長,使我們重新看到 MDI 的成長,公司也將恢復到過去一直保持的兩位數成長。

  • Operator

    Operator

  • Mike Kratky, Leerink Partners

    Mike Kratky,Leerink Partners

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Hi, everyone. Thanks for taking our questions, and congrats on the great quarter. I appreciate all the recent progress on gaining pharmacy traction. I think you mentioned over 40% of pharmacy coverage for Mobi. Can you just clarify how much of that 40% coverage you can actually get paid for in the pharmacy today, and what are the main milestones that can help bridge that gap, if any?

    大家好。感謝您回答我們的問題,並祝賀您本季業績斐然。我很欣賞近期在提升藥學影響力方面取得的所有進展。我想你有提到 Mobi 的藥品報銷比例超過 40%。您能否具體說明一下,目前在藥局實際可以獲得多少 40% 健保報銷,以及有哪些主要里程碑可以幫助彌補這一差距(如果有的話)?

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. Thanks for the question, Mike. The way to think about our pharmacy coverage is starting with we have contracts with all the major PBMs. The 40% we provide is really the payer lines that are attached to those contracts today. As you can expect, in any payer environment, some access is better than others. That is what we’ve been working on.

    當然。謝謝你的提問,麥克。看待我們的藥品福利,首先要從我們與所有主要藥品福利管理機構 (PBM) 簽訂合約這一事實開始。我們提供的 40% 實際上是目前與這些合約相關的付款方資金。正如你所預料的那樣,在任何支付方環境下,某些醫療服務途徑都會比其他途徑更好。這就是我們一直在努力的方向。

  • Across this year is improving our access both within the plans that we have and expanding that access through pull-through. As we think about pharmacy, it’s been a measured approach this year. There’s a lot to be ready for an organization of our size to be able to scale efficiently. There is a lot of operational aspects with how we take an order, how we fulfill an order, how we communicate with patients and physicians on the way this will work in the future. That’s what we’ve been doing in 2025 is shoring up access, preparing for us to step into 2026, and really push pharmacy at a much larger scale next year.

    今年我們將致力於改善現有計畫內的服務取得方式,並透過推廣活動擴大服務取得範圍。今年,我們在思考藥學問題時,採取了一種審慎的態度。對於我們這樣規模的組織來說,要高效擴展,需要做很多準備。我們從接受訂單、完成訂單,到與病人和醫生溝通未來運作方式,都涉及許多營運方面的問題。這就是我們在 2025 年所做的,鞏固准入管道,為我們進入 2026 年做好準備,並在明年真正更大規模地推動藥房發展。

  • Operator

    Operator

  • Matthew O'Brien, Piper Sandler.

    馬修·奧布萊恩,派珀·桑德勒。

  • Unidentified Participant

    Unidentified Participant

  • Hi there. This is Ana on for Matt. Thanks for taking the question. I guess I just wanted to ask specifically on the gross margin guide. I mean, there was some solid improvement in Q3, so that was good to see. You’re still guiding to 53-54% for the full year. You said mid to high 60s in the fourth quarter, which is a pretty meaningful step up. Just wondering sort of what’s baked into the assumptions there and what gets you to the full-year target. Thanks.

    你好呀。這是Ana替Matt主持節目。感謝您回答這個問題。我只是想具體問一下毛利率指南方面的問題。我的意思是,第三季確實有一些顯著的改善,這很好。您仍然預計全年收益率為 53-54%。你說第四季會達到60多分,這是一個相當大的進步。我只是想知道這些假設包含了哪些內容,以及是什麼讓你們實現了全年目標。謝謝。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. I appreciate the question. And so, just to confirm, the fourth quarter is expecting to be our all-time high, which is in the mid to high 50%. And that’s the launching point as we go into next year, where we usually see a modest step down. But by the end of next year, we expect to be at 60% in the fourth quarter.

    當然。感謝您的提問。因此,再次確認一下,第四季預計將創歷史新高,達到 50% 到 50% 的中高水平。這就是我們進入明年的起點,明年我們通常會看到小幅下滑。但到明年年底,我們預計第四季將達到 60%。

  • And so, what drives that step up this year? When you look at the drivers of our business that impact gross margin, the single biggest contributor has always been pumps, and it’s pumps in the US. And so, pumps come first. International has a little bit of pressure because of the pricing dynamics using distributors there. And then supplies have been the smallest contributor to gross margin. So, as pump sales become a bigger percent of our business, you usually see margin scale.

    那麼,今年推動這項進步的因素是什麼呢?當你審視影響我們業務毛利率的驅動因素時,你會發現最大的貢獻者一直是泵,而且是美國的泵。因此,泵是首要考慮的因素。國際市場由於透過分銷商進行定價,面臨一些壓力。其次,供應環節對毛利率的貢獻最小。因此,隨著泵浦銷售額在我們業務中所佔比例越來越大,通常會看到利潤率也隨之提高。

  • What I’ll add to that is, I would say the newer information is as we continue to penetrate pharmacy with our launch of t:slim supplies in the pharmacy channel. Think about the large install base that we have and being able to get that price appreciation. That’s also factored into contributing to our gross margin step-up in the fourth quarter of this year. We are really excited about what pharmacy can deliver for us as a business because I think you’re seeing measurable benefit already with just the small volumes that we’ve had. You can only imagine where this could go in the long term as we continue to broaden our access.

    我還要補充一點,最新的資訊是,隨著我們透過在藥局通路推出 t:slim 產品,我們將繼續滲透藥局市場。想想我們龐大的用戶基數,以及由此帶來的價格上漲。這也是我們今年第四季毛利率上升的因素。我們對藥局業務能為我們帶來的收益感到非常興奮,因為我認為即使我們目前的銷售量很小,也已經看到了可衡量的收益。不難想像,隨著我們不斷擴大服務範圍,這在長期內會發展成什麼樣子。

  • Operator

    Operator

  • Richard Newitter, Truist Securities.

    Richard Newitter,Truist Securities。

  • Unidentified Participant

    Unidentified Participant

  • Hi, it’s Felipe on for Ritz. Thanks for taking the question. Just on the pharmacy channel, you and a few of your competitors are entering the channel pretty quickly. I’m just trying to understand, or can you help us understand why we should or shouldn’t see more competitive rebetting strategies in the channel as more players enter? What are overall expectations for pricing in the channel over the long term? Thanks for taking the question.

    嗨,我是麗茲卡爾頓酒店的 Felipe。感謝您回答這個問題。光是在藥局管道,你和你的一些競爭對手就正在迅速進入這個管道。我只是想弄清楚,或者您能否幫助我們理解,隨著更多玩家的加入,我們是否應該或不應該在頻道中看到更多競爭性的再投注策略?從長遠來看,該通路的定價整體預期是什麼?感謝您回答這個問題。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Yeah, thanks, Felipe. When we think about this, this is something as we’ve looked at over the years. There was a time when durable pumps were not even accepted in the channel. There was also always the concern that when you get into the pharmacy channel in any category, there will be price erosion over time.

    是啊,謝謝你,費利佩。當我們思考這個問題時,我們會發現這是我們多年來一直在關注的事情。曾幾何時,耐用型幫浦甚至不被渠道商接受。人們一直擔心,無論哪個品類,一旦進入藥局管道,隨著時間的推移,價格都會不斷下降。

  • When we looked at our opportunity in the near term, for us, there is a significant step-up opportunity when you compare to DME to our base business today. It makes sense for us to enter into that category, especially with the access we think we can offer to patients with a lower out-of-pocket cost. In the long term, it could mean pricing pressure. For us, what we are doing is we are getting in, we are building a stable business off of it.

    當我們審視近期機會時,對我們而言,與我們目前的基礎業務相比,DME 領域存在著巨大的提昇機會。對我們來說,進入這個類別是有意義的,尤其是考慮到我們認為可以為患者提供自付費用較低的醫療服務。從長遠來看,這可能意味著價格壓力。對我們來說,我們正在做的就是進入這個領域,並在此基礎上建立一個穩定的業務。

  • We’re preparing for that possibility if we’re going to take full advantage of it in the near term as we enter that channel. I think with all of us in the channel together, we all hope to get that pricing premium to continue to support our margins in the long term. It is a risk, but it’s something that we think we can mitigate, and it’s worth going into despite that.

    如果我們要在近期內充分利用進入該管道的機會,我們就需要為此做好準備。我認為,我們通路內的所有人齊心協力,都希望獲得溢價,從而在長期內繼續支撐我們的利潤率。這確實存在風險,但我們認為可以降低風險,儘管如此,仍然值得嘗試。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • I’d also just say that when you look at the two pump competitors that are out there today, their volume in the pharmacy channel is very low and probably will be for a while. I think ultimately, I think it’s going to be Tandem and one of the large entities that have meaningful volume in the market. I think we’ll have to see how that dynamic plays out.

    我還要說,看看目前市面上的兩款幫浦競爭對手,它們在藥局通路的銷售量非常低,而且這種情況可能會持續一段時間。我認為最終勝出的會是 Tandem 以及市場上規模較大的實體之一。我認為我們得看看這種動態會如何發展。

  • Operator

    Operator

  • Joanne Wunsch, Citibank.

    Joanne Wunsch,花旗銀行。

  • Joanne Wunsch - Analyst

    Joanne Wunsch - Analyst

  • Thank you so much for taking the question. I want to go back to something that you said about SIGGI. And if I heard you correctly, you were calling it a next-generation Mobi. Maybe I just misunderstood that. But could you please sort of clarify how you think about launching that product into the market? And thank you.

    非常感謝您回答這個問題。我想回到你之前提到的關於SIGGI的事情。如果我沒聽錯的話,你剛剛稱它為下一代 Mobi。也許是我理解錯了。您能否具體說明一下您打算如何將該產品推向市場?謝謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Sure. I would start off by saying that Mobi Tubeless is going to be the first extended wear pump on the market. It is going to be a patch pump. We have done quite a bit of research on Mobi Tubeless, and it scored very well. I mean, availability of tubeless wear and Control-IQ provided meaningful uptake and user preference.

    當然。首先我想說的是,Mobi Tubeless 將成為市面上第一款長效耐用型氣筒。這將是一個臨時泵。我們對 Mobi Tubeless 進行了相當多的研究,它的分數非常高。我的意思是,無內胎輪胎和 Control-IQ 的普及帶來了顯著的市場接受度和使用者偏好。

  • With the implementation of extended wear capabilities, we also saw further increases in preference. I think that we are seeing this great enthusiasm for Mobi. As an extended wear product, it really gives us confidence that it is going to do very well in the marketplace. As we begin to see the design come together and based on this high level of enthusiasm, we believe that we only need one tubeless product on the market at a time.

    隨著延長配戴時間功能的實現,我們也看到消費者對它的偏好進一步提高。我認為我們看到了大家對 Mobi 的巨大熱情。作為一款長效配戴產品,它讓我們非常有信心在市場上取得成功。隨著設計逐漸成型,並且基於這種高度熱情,我們認為市場上一次只需要一款無內胎產品。

  • We absolutely plan to continue to invest in SIGGI’s development. On a forward-going basis, it’s best to think about it as the next-generation Mobi product and part of the growing brand and product for that family. We want to give Mobi room to run. I think it’s going to do very, very well.

    我們絕對會繼續投資SIGGI的發展。從長遠來看,最好將其視為下一代 Mobi 產品,以及該系列品牌和產品不斷發展壯大的一部分。我們希望給 Mobi 留出發展空間。我認為它會非常非常成功。

  • Operator

    Operator

  • Suraj Kalia, Oppenheimer & Co.

    蘇拉吉·卡利亞,奧本海默公司

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • John, one question for you and one for Lee, and I’ll pose them up front. John, you mentioned the fully closed-loop system. Obviously, it needs an input signal. I was curious if you could indicate which CGM or which camp are you leaning towards for the autonomous fully closed-loop system. Lee, for you, I just wanted to follow up on Danielle’s question, right? Please correct me if my math is wrong. US pump revs down 2% year over year, price 5% benefit. Am I right in thinking units were down 7%? I guess my real question then would be, if I look at patients that are switching or starting new from MDI versus repeat patients, how should we think about relative softness in these two buckets? Hopefully, my math is right, but please correct me if I’m not.

    約翰,我問你一個問題,問李一個問題,我先問出來。約翰,你提到了完全閉環系統。顯然,它需要一個輸入訊號。我很好奇您能否指出您傾向於哪種 CGM 或哪種陣營的自主全閉環系統。Lee,我只是想就Danielle提出的問題做個後續的解答,對吧?如果我的計算有誤,請指正。美國汽油產量年減 2%,價格上漲 5%。我理解的沒錯吧,銷量下降了7%?那麼,我真正的問題是,如果我比較從 MDI 轉用或首次使用 MDI 的患者和再次使用 MDI 的患者,我們應該如何看待這兩類患者的相對軟度呢?希望我的計算沒錯,但如果錯了請指正。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • I can tell you that when it comes to the fully closed-loop system, that it’s going to work with all of the CGMs that are currently integrated with our product. The CGMs are interoperable, and it’s really the fully closed-loop algorithm that matters. Our team is doing a great job, and we’ve got a great collaboration going on with UVA right now in the Center for Diabetes Technology.

    我可以告訴大家,就完全閉環系統而言,它將與目前整合到我們產品中的所有 CGM 配合使用。CGM 之間可以互通,真正重要的是完全閉環演算法。我們的團隊做得非常出色,目前我們正與維吉尼亞大學糖尿病技術中心進行良好的合作。

  • I would say that the partnership with UVA has been something that’s been ongoing. If you look back to 2016, it largely resulted in Control-IQ. We chose to work with UVA back then because they had the most amount of clinical data for an AID system at that point in time. The FDA was very, very familiar with the product as well. Today, we find ourselves in a very similar position.

    我認為與維吉尼亞大學的合作一直都在進行中。回顧 2016 年,其結果很大程度上是 Control-IQ。當時我們選擇與維吉尼亞大學合作,是因為他們在當時擁有最多的愛滋病防治系統臨床數據。美國食品藥物管理局(FDA)對產品也非常非常熟悉。今天,我們發現自己處境非常相似。

  • We’re working with UVA again, and we’re working with them to implement their fully closed-loop algorithm. Once again, their algorithm has the most amount of clinical data that’s out there, and it’s very familiar to the FDA. We’re working expeditiously to get the system ready for trial. As I said in the preparatory remarks, our plans are to implement the fully closed-loop pivotal study next year.

    我們再次與維吉尼亞大學合作,並與他們合作實施他們的完全閉環演算法。他們的演算法再次擁有最多的臨床數據,而且FDA對此非常熟悉。我們正在加緊工作,使系統做好試驗準備。正如我在準備發言中所說,我們的計劃是明年實施完全閉環的關鍵性研究。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • To your question on new pump starts. The way to think about it in the third quarter is, first of all, remind you that in the second quarter, we had a small stocking dynamic. If you normalize for that between Q2 and Q3, you would see pump shipments roughly flat, which is a normal seasonal trend. When you break it down between renewal and new pumps, we did see strong growth in renewal pumps as we have been demonstrating.

    關於您提出的新泵浦啟動問題。第三季要考慮的一點是,首先要提醒大家,第二季我們的庫存動態較小。如果將第二季和第三季之間的變化進行標準化處理,你會發現泵浦的出貨量大致持平,這是一個正常的季節性趨勢。如果將更新換代泵浦和新泵浦分開來看,正如我們所展示的那樣,我們看到更新換代泵浦實現了強勁成長。

  • As we expected, new pumps continue to be slightly pressured. When you further break down new pumps and focus on MDI conversions versus competitive conversions, the competitive conversions have been a large reason why we’ve seen some headwinds in new pump starts this year. One of the primary competitors that has been a big contributor, I would say, to our competitive conversions has started to retain more of their own customers and have less to share, I guess I would say.

    正如我們預期的那樣,新泵浦仍然會承受輕微的壓力。當你進一步細分新泵並關注 MDI 轉換與競爭性轉換時,競爭性轉換是今年新泵啟動出現一些不利因素的主要原因。我認為,對我們競爭轉換率造成很大影響的主要競爭對手之一,已經開始留住更多自己的客戶,而需要分享的客戶數量則越來越少。

  • At the end of the day, we are very focused on the MDI conversion part of the population. And we’ve already, I think you’ve heard many of the opportunities we’ve listed out that can really help drive and stimulate growth in MDI conversions as we look ahead.

    歸根究底,我們非常關注的是MDI轉換族群。我相信你們已經聽到了我們列出的許多機會,這些機會確實可以幫助推動和刺激 MDI 轉換的成長,並展望未來。

  • Operator

    Operator

  • Jason Bedford, Raymond James and Associates.

    Jason Bedford,Raymond James and Associates。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Elaine on for Jason. Thanks for taking the question. You had a nice beat outside the US, especially in supplies. Can you talk about what drove this strength there? Did you see any impact from stocking or preparing to go direct? Also, you talked about a $10 million headwind. Is that more weighted towards third quarter or the fourth quarter? Thank you.

    大家好,我是伊萊恩,替傑森為您報道。感謝您回答這個問題。你們在美國以外的市場表現不錯,尤其是在物資供應方面。您能談談是什麼造就了那裡的這種優勢嗎?庫存管理或準備直接銷售是否對您產生任何影響?另外,你也提到了1000萬美元的逆風。這主要集中在第三季還是第四季?謝謝。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. On our OUS performance this quarter, I would say underlying trends were pretty much in line with our expectations. The outperformance is mostly attributed to a few million dollars benefit from foreign currency dynamics that worked in our favor this quarter. To those underlying trends, what you’re seeing are the effect of what the distributors are ordering from us.

    當然。就我們本季的海外業務表現而言,我認為基本趨勢與我們的預期基本一致。業績優異主要歸功於本季外匯匯率波動為我們帶來的數百萬美元收益。在這些潛在趨勢的基礎上,你現在看到的是經銷商向我們訂購的產品所產生的影響。

  • When you see what happens in the end market, we actually showed low double-digit growth in our placements in the market. What’s being shipped out the door is being impacted somewhat, as you mentioned, by the transition to going direct. What we’ve seen across this year is some destocking from some of the distributors as they’re working down their inventory levels. That’s a part of the $10 million headwind we’ve factored into our expectations.

    當你看到終端市場的情況時,你會發現我們在市場上的份額實際上實現了兩位數的低成長。正如您所提到的,由於轉向直銷,出貨量確實受到了一定程度的影響。今年以來,我們看到一些分銷商正在進行去庫存化,以降低庫存水準。這是我們預期中已考慮在內,1000萬美元不利因素的一部分。

  • We expect to see a bit stronger impact from that in the fourth quarter as we near the actual launch in those markets and potentially have to enter into an inventory buyback situation. The underlying market dynamics are really strong outside the US. We look forward to taking some of these markets direct ourselves and being able to even further accelerate that growth looking ahead.

    我們預計,隨著產品在這些市場正式上市日期的臨近,第四季將會出現更強烈的反響,屆時我們可能不得不進行庫存回購。美國以外的市場基本面非常強勁。我們期待親自開拓其中一些市場,並在未來進一步加速成長。

  • Operator

    Operator

  • William Plovanic, Canaccird Genuity.

    威廉·普洛瓦尼克,加拿大天才。

  • William Plovanic - Equity Analyst

    William Plovanic - Equity Analyst

  • Great. Thanks. Good evening, and thanks for taking my question. I really wanted to dive into type two here. You’re one of two on the label with it. It’s been a big driver for one of your competitors. I know you’re just going to full launch. Is this something that you’re really waiting for Mobi Tubeless before you kind of go full out and see a bigger impact? Is this waiting for pharmacy, or is it you just got past the pilot phase and it’s only because you just got past the pilot phase?

    偉大的。謝謝。晚上好,感謝您回答我的問題。我真的很想深入探討第二種類型。你是標籤上僅有的兩個人之一。這曾是你們某個競爭對手的主要動力。我知道你們正準備全面啟動。你們真的在等 Mobi Tubeless 上市,才打算全力以赴,看看能不能產生更大的影響?這是在等待藥房批准,還是因為你們剛剛完成了試點階段,所以才這樣?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Okay, Bill. Thanks. I would say that we’re leveling.

    好的,比爾。謝謝。我認為我們正在趨於平衡。

  • William Plovanic - Equity Analyst

    William Plovanic - Equity Analyst

  • If I could also, what percent of new patient starts were type two this quarter? I don’t know if you shared that. Thanks. Sorry for interrupting.

    如果可以的話,請問本季新就診患者中,第二型糖尿病患者佔多少百分比?我不知道你是否分享過這件事。謝謝。不好意思打擾一下。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Okay. Yeah, sure. No problem. I would say that we’re certainly leveraging the lessons from the pilot. And there’s a lot of great information that comes back on our marketing training and the sales execution. But as you say, you’re right. We’ve kind of evaluated the performance of the pilots, and now we’re moving to full commercial launch.

    好的。當然可以。沒問題。我認為我們肯定會充分利用試點計畫的經驗教訓。而且,我們從行銷培訓和銷售執行中獲得了許多寶貴的資訊。但正如你所說,你是對的。我們已經對飛行員的表現進行了評估,現在我們正著手全面商業化推廣。

  • The pilot territories were very productive. I think that we’re getting very positive feedback from physicians and patients that they’re seeing the same experiences that we saw in our type 2 trial: immediate sustained results, the simplification of the bolus process, and their soon achievable with GLP-1 use. The preference so far, it’s leaning towards the screen displays and 300-unit reservoirs. T:slim X2 is, interestingly enough, the preference for most people. That’s fine. I think that that’s where we’re going to go.

    試辦地區產出很高。我認為我們從醫生和患者那裡得到了非常積極的回饋,他們看到了與我們在 2 型糖尿病試驗中看到的相同的體驗:立即獲得持續的效果、簡化推注過程,以及使用 GLP-1 很快就能實現這些效果。目前的偏好是傾向於螢幕顯示器和 300 單位的儲液罐。有趣的是,T:slim X2 是大多數人的首選。沒問題。我認為那就是我們要去的地方。

  • Market development is needed, and certainly we’re going to do that. I think having additional competitors out there doing market development at the same time is a positive thing for us. Pharmacy channel and tubeless are only going to improve the uptake. I think we’re going to start full blast here. It’s actually started. We started in the third quarter.

    市場開發是必要的,我們當然會這樣做。我認為,有更多競爭對手同時進行市場開發對我們來說是件好事。藥局管道和無內胎設計只會提高接受度。我認為我們要全力以赴了。實際上已經開始了。我們從第三季開始。

  • We’re continuing to move aggressively with the products that we’ve got on the marketplace. As we do access more of the pharmacy channel, we do get Mobi Tubeless. We think that’s going to also significantly improve our performance in that market. It doubles the size of the addressable market for us. We’re going to do everything we can to take advantage of that. I will say we haven’t said specifically what the number of starts that we have.

    我們將繼續積極推動已投放市場的產品。隨著我們更多地接觸到藥房管道,我們也獲得了 Mobi Tubeless。我們認為這將顯著提升我們在該市場的表現。這將使我們的潛在市場規模翻倍。我們將盡一切努力利用這一點。我想說的是,我們還沒有具體說明我們有多少次先發機會。

  • I’m not sure we’re going to talk about that specifically in the future either. Thanks.

    我不確定我們將來是否會專門討論這個問題。謝謝。

  • Operator

    Operator

  • Michael Polark, Wolfe Research.

    邁克爾·波拉克,沃爾夫研究中心。

  • Mike Polark - Equity Analyst

    Mike Polark - Equity Analyst

  • Hey, good afternoon. I want to just make sure I fully understand the updated comments on tubeless Mobi. I heard 510(k) submission entering final stages. I also heard commercial launch in 2026. If I were to assume you have 510(k) in by the end of the year, count six months, it’s kind of mid-year approval, 2H26 launch. Is that a reasonable way to think about it?

    嘿,下午好。我只是想確保我完全理解關於無內胎 Mobi 的最新評論。我聽說510(k)申請已進入最後階段。我還聽說將於 2026 年正式上市。假設您在年底前獲得 510(k) 批准,算上六個月,這相當於年中批准,2026 年下半年上市。這種思考方式合理嗎?

  • Two other pieces of this, I continue to hear the emphasis on extended wear. Is the best assumption that when this product comes to market, it will have the seven-day set exclusively? On manufacturing, ramping in parallel, the expectation is you will be ready for kind of big bang introduction when these other boxes get checked or still would be a process post-approval to ramp supply. Thank you.

    另外兩點,我一直聽到強調延長使用壽命。最合理的假設是,該產品上市時將只提供七天套裝嗎?在生產製造方面,同步增產的預期是,當其他條件都滿足時,就可以進行大規模的推出,或者在獲得批准後,仍需要一段時間來逐步增加供應。謝謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Yeah. I mean, I think we understand the importance of Mobi Tubeless in the marketplace. We think that product is going to really help us return to a very competitive position. As a result of that, I indicated in the prepared remarks, we are going to prioritize Mobi Tubeless over SteadySet. We are going to introduce Mobi Tubeless first with the extended wear.

    是的。我的意思是,我認為我們都明白 Mobi Tubeless 在市場上的重要性。我們認為這款產品將真正幫助我們重回極具競爭力的地位。因此,正如我在準備好的演講稿中所述,我們將優先考慮 Mobi Tubeless 而不是 SteadySet。我們將首先推出具有更長使用壽命的 Mobi Tubeless 輪胎。

  • It will have seven days when it does come to market. We will have SteadySet. I mean, we’re not deprioritizing SteadySet, but I think that you know that there’s a great deal of enthusiasm for Mobi Tubeless. It’s certainly going to drive business opportunity for us. I think if we work on one product versus two, we can get it to market faster. We know Mobi Tubeless is going to sell a lot of pumps.

    這款產品上市後將有七天的銷售期。我們將擁有 SteadySet。我的意思是,我們並沒有降低 SteadySet 的優先級,但我想您也知道大家對 Mobi Tubeless 抱有極大的熱情。這無疑將為我們帶來商機。我認為如果我們集中精力研發一款產品而不是兩款,就能更快地將其推向市場。我們知道 Mobi Tubeless 的氣泵銷售肯定會很好。

  • We think this is a really important initiative. We have not said specifically on the timing. We have said 2026, but I can guarantee you we are doing everything we can, as I just indicated, prioritizing it over other products to make sure we bring it to market as fast as possible. We think it is going to be a great product and really, again, differentiate Tandem in the marketplace again.

    我們認為這是一項非常重要的措施。我們尚未具體說明時間。我們說過會在 2026 年推出,但我可以向你們保證,正如我剛才所說,我們正在盡一切努力,優先考慮它而不是其他產品,以確保我們盡快將其推向市場。我們認為這將是一款很棒的產品,並且真的會再次讓 Tandem 在市場上脫穎而出。

  • Operator

    Operator

  • Jeff Johnson, Bayer

    傑夫約翰遜,拜耳

  • Unidentified Participant

    Unidentified Participant

  • Thank you. Good afternoon, guys. I think most of my questions have been answered. Maybe just back on the US pharmacy comments. There were 5% of revenues this quarter. Can you just remind us what the breakdown is, supplies versus pumps in that? I know you have the 40% lives under coverage for Mobi. Are you getting many pumps there?

    謝謝。下午好,各位。我覺得我的大部分問題都得到了解答。或許可以回到之前關於美國藥局的評論上來。本季營收佔比5%。能否請您簡單說明其中的構成,例如耗材和幫浦的構成?我知道你們為 Mobi 提供了 40% 的覆蓋率。你們那裡有很多泵嗎?

  • And Lee, I think you and I have talked in the past on the pharmacy side that some of your pharmacy contracts, even on the Mobi side, may not be straight pay-as-you-go models where you kind of take that four-year total price and just divide it by 48 months, that you might actually get more Mobi revenue upfront and more supplies over those 48 months. Just kind of maybe refresh us on what structure of some of those pharmacy contracts might look like with Mobi as well. Thank you.

    李,我想你我以前在藥房方面討論過,你們的一些藥房合同,即使是移動端的,可能也不是簡單的按需付費模式,即把四年的總價除以 48 個月,實際上你們可能會在前期獲得更多的移動端收入,並在 48 個月內獲得更多的供應。能否也幫我們回顧一下,Mobi 與藥局簽訂的一些合約的結構大概是什麼樣的?謝謝。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Yeah. Thanks for the questions, Jeff. Just to your comment about the 5% and where’s the balance, I would say that it’s all been Mobi so far, except we did introduce t:slim X2 supplies in the channel in September. It was a balance between pump and supplies before. It will start to lean more towards supplies as we look ahead into Q4 because there’s such a large opportunity with t:slim X2 with the large install base that we have.

    是的。謝謝你的提問,傑夫。關於您提到的 5% 以及餘額在哪裡,我想說到目前為止都是 Mobi,只是我們在 9 月份向渠道推出了 t:slim X2 耗材。以前需要在水泵和耗材之間取得平衡。展望第四季度,我們將開始更加重視供應,因為 t:slim X2 擁有龐大的裝機量,市場機會龐大。

  • It’ll start to lean in the other direction on the supply side. In terms of the reimbursement model, you have a good memory there. Our contracts today are pretty much all structured like a traditional DME reimbursement model. Not the price point necessarily, but how the breakdown is between pumps and supplies with reimbursement upfront for the pump and then ongoing reimbursement for the supplies.

    供應方面將開始向另一個方向傾斜。就報銷模式而言,你在這方面記憶力很好。我們目前的合約幾乎都採用傳統的DME報銷模式。不一定是價格,而是泵浦和耗材的細分方式,泵浦的費用可以預先報銷,耗材的費用可以持續報銷。

  • This hasn’t been a headwind for patient adoption because we have such a great ability to influence the out-of-pocket for the patients with copay assistance programs. We still get the same benefit with patients, and it’s keeping the same structure in place that we’ve been accustomed to with DME.

    這並沒有對患者接受治療造成阻礙,因為我們有能力透過共付額援助計畫來影響患者的自付費用。我們仍然能從患者身上獲得相同的益處,並且保持了我們一直以來在 DME 領域所習慣的相同結構。

  • As we look ahead, in order to get the maximum or the most optimal access on pharmacy, we are looking at other reimbursement models. We would consider anything from the DME-like model we have today all the way to a more pay-as-you-go model and anything in between, if you will. It’s something that we’ll share more in the future as we get more coverage and we talk about the expansion of our pharmacy program. For now, they are all that DME-like structure.

    展望未來,為了獲得最大或最佳的藥品取得途徑,我們正在研究其他報銷模式。我們會考慮從我們今天採用的類似DME的模式,到更傾向於按需付費的模式,以及介於兩者之間的任何模式。隨著我們獲得更多報道,並討論藥房計劃的擴展,我們將在未來分享更多相關資訊。目前,它們都具有類似DME的結構。

  • Operator

    Operator

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

    (操作員說明)特拉維斯·斯蒂德,美國銀行證券。

  • Stephanie Piazzolla - Analyst

    Stephanie Piazzolla - Analyst

  • Hi, this is Stephanie Piazzolla on for Travis. Thanks for taking the question. I just wanted to follow up on a comment that John made about getting back to the double-digit growth you’ve seen in the past and just wanted to clarify if that was referring to expectations for MDI patient growth next year specifically or over time and if that was US or worldwide comment. Thank you.

    大家好,我是Stephanie Piazzolla,替Travis為您報道。感謝您回答這個問題。我只是想就約翰關於恢復過去兩位數增長的評論做個後續說明,並想澄清一下,他指的是明年 MDI 患者增長的預期,還是指長期增長的預期,以及這是針對美國還是全球的評論。謝謝。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Yeah, thanks for the question, Stephanie. I’ll answer for John on that one. We have often said that our goal long-term is to have sustained double-digit growth with a dual focus on profitability. That is what John was referring to, not to any particular piece or part or period, but that is just what our financial goal is. We look forward with all these opportunities to demonstrate and execute on that looking ahead.

    是的,謝謝你的提問,史蒂芬妮。我會替約翰回答這個問題。我們常說,我們的長期目標是在獲利能力的雙重支撐下,實現兩位數的持續成長。約翰指的就是這個,不是指任何特定的部分或時期,而是指我們的財務目標。展望未來,我們期待利用這些機會來展示和實現這些目標。

  • Operator

    Operator

  • John Block, Stifel

    約翰·布洛克,斯蒂費爾

  • John Block - Analyst

    John Block - Analyst

  • Thanks and good afternoon. Lee, I have revenues up $25 million Q over Q for the fourth quarter and a similar amount for EBITDA. We’ll call it like roughly 100% drop through on the incremental revenue to get to the EBITDA margin guidance of negative 5%. On the fly math is always dangerous. That is where I’m sort of spitting out for the model to get to the billion and the negative 5% margin. It is a high drop through. I’m calculating the current drop through in the most recent quarter at impressive, 50-60%, but not 100%. Maybe if you could just bridge us. Obviously, you have the gross margin, but then what are some of the other things that we should think about? I’m guessing it is some of the restructuring that you alluded to on the call. Any color would be great. Thanks.

    謝謝,下午好。李,我這邊第四季的營收季增了 2,500 萬美元,EBITDA 也成長了類似的金額。我們將稱之為增量收入大約下降 100%,以達到 EBITDA 利潤率為 -5% 的預期目標。臨時進行的數學運算總是很危險的。這就是我為了讓模型達到十億和負 5% 的利潤率而得出的結果。這是一個高落差的滴水。我計算得出,最近一個季度的跌幅相當驚人,達到 50-60%,但不到 100%。也許如果你能幫我們搭橋就好了。顯然,毛利率是重要因素,但除此之外,我們還應該考慮哪些其他因素呢?我猜想這應該是你在電話會議中提到的一些重組措施。任何顏色都可以。謝謝。

  • Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

    Leigh Vosseller - Chief Financial Officer, Executive Vice President, Treasurer

  • Sure. Happy to take that. When you look at Q3 to Q4, the implied revenue step up, it’s mostly coming from the US business. As I mentioned earlier, there are the pump shipments stepping up in line with what we’ve typically seen seasonally. When you have more pump shipments, we generally see a higher gross margin.

    當然。樂意接受。從第三季到第四季來看,隱含收入有所成長,這主要來自美國業務。正如我之前提到的,泵浦的出貨量正在增加,這與我們通常在季節性情況下看到的情況一致。水泵出貨量越大,我們通常看到的毛利率就越高。

  • We have a particular assumption for price improvement on supplies in the fourth quarter as we’ve introduced t:slim into the pharmacy channel. That really benefits the gross margin, which is piece one. You already acknowledged that’s a nice step up. Dropping through to the bottom line, the incremental benefit is coming from that leverage we expect to see in our spending. As you mentioned, we did initiate a restructuring in the third quarter, which will yield benefit, but also just our entire commercial transformation that’s underway.

    我們對第四季度供應價格的改善有一個特別的假設,因為我們已將 t:slim 引入藥房管道。這確實有利於毛利率,這是第一點。你已經承認這是一個不錯的進步。歸根究底,增量收益來自於我們預期在支出方面看到的槓桿作用。正如您所提到的,我們在第三季啟動了重組,這將帶來好處,而且我們正在進行的整個商業轉型也將帶來好處。

  • Part of it was changing the shape of how we go to market and make ourselves more competitive. Part of that is how to streamline and automate and improve our processes internally for how we engage with patients and the pump orders and the supply orders and so on. We are beginning, we are expecting to start to see the benefit of that as we exit this year and going into 2026, we’ll build on that even further.

    部分原因是改變了我們進入市場的方式,使我們更具競爭力。其中一部分是如何簡化、自動化和改善我們內部與患者互動、幫浦訂單、耗材訂單等流程。我們已經開始,我們預計在今年結束、進入 2026 年之際,我們將開始看到這樣做的好處,並且我們將在此基礎上進一步發展。

  • Again, we’re very excited about what the future holds for us here, where we look forward to demonstrating this profitability improvement that everyone’s been waiting so eagerly for and continuing to drive the business in a positive way with all the new innovations, business model changes, and the transformation that we have going on right now.

    再次重申,我們對未來的發展前景感到非常興奮,我們期待著展現大家一直熱切期盼的盈利能力提升,並繼續透過所有新的創新、商業模式的改變以及我們目前正在進行的轉型,以積極的方式推動業務發展。

  • Operator

    Operator

  • Thank you. This concludes today’s question and answer session and conference call. Thank you for participating. You may now disconnect.

    謝謝。今天的問答環節和電話會議到此結束。感謝您的參與。您現在可以斷開連線了。