Tandem Diabetes Care Inc (TNDM) 2024 Q4 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 welcome to the Tandem Diabetes fourth-quarter and year-end 2024 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, Susan Morrison, executive Vice President and Chief Administrative Officer. Please go ahead.

    大家好,歡迎參加 Tandem Diabetes 2024 年第四季及全年業績電話會議。(操作人員指示)請注意,今天的會議正在錄音。現在我謹將會議交給你們的發言人,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 thanks for joining Tandem's fourth quarter and year-end 2024 earnings call. Today's discussion will include forward-looking statements. 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.

    大家好,感謝各位參加 Tandem 公司 2024 年第四季及全年財報電話會議。今天的討論將包含前瞻性陳述。這些聲明反映了管理層對未來事件、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有重大差異。

  • A list of factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is highlighted in our press release issued earlier today and under the risk factors portion and elsewhere in our most recent annual report on Form 10k.

    可能導致實際結果與任何前瞻性聲明所表達或暗示的結果存在重大差異的因素清單已在今天早些時候發布的新聞稿、風險因素部分以及我們最新的 10-K 表格年度報告的其他部分中進行了重點說明。

  • We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors.

    我們不承擔因新資訊、未來事件或其他因素而公開更新任何前瞻性聲明的義務。

  • Today's discussion will also include references to a number of GAAP and non-gap financial measures. Non-gap financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations.

    今天的討論也將涉及一些 GAAP 和非 Gap 財務指標。我們提供非缺口財務指標,旨在向投資者提供我們認為能夠反映我們核心經營績效和持續業務營運的資訊。

  • We believe these non-gap financial measures facilitate better comparisons of operating results across reporting periods.

    我們認為這些非缺口財務指標有助於更好地比較不同報告期間的經營績效。

  • Any non-gap information presented should not be considered as a substitution independently or superior to results prepared in accordance with GAAP. 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.

    任何非缺口資訊均不應被視為獨立於或優於依照公認會計原則編製的結果。有關這些指標與其最直接可比較的 GAAP 財務指標的調整表,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。

  • Participating on today's call are John Sheridan, Tandem's President and CEO Mark Navarra, executive Vice President and Chief Commercial Officer, and Lee Vossler, executive Vice President and Chief Financial Officer.

    參加今天電話會議的有 Tandem 總裁兼執行長 John Sheridan、執行副總裁兼商務長 Mark Navarra 以及執行副總裁兼財務長 Lee Vossler。

  • Following their prepared remarks, the operator will open the call for questions.

    在發言結束後,主持人將開放提問環節。

  • Thank you in advance for limiting yourself to one question before getting back in the queue. I'll now turn the call over to John.

    謝謝您提前限制自己只提一個問題,然後再重新排隊。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

  • Thanks, Susan, and thank you everyone for joining us on today's call.

    謝謝蘇珊,也謝謝大家今天參加我們的電話會議。

  • 2024 was a pivotal year for tandem, marked by an impressive 18% increase in worldwide sales. I am proud that we set new sales records both in the US and internationally while delivering industry leading customer satisfaction and expanding our portfolio of technology solutions.

    2024 年是 Tandem 的關鍵一年,全球銷售額實現了令人矚目的 18% 的成長。我感到自豪的是,我們在美國和國際上都創造了新的銷售記錄,同時實現了業界領先的客戶滿意度,並擴大了我們的技術解決方案組合。

  • The highlight of the year was the introduction of our category defining pump platform Tandem Mobi , which experienced continued growth throughout 2024 as awareness of our newest offering increased. Additionally, we implemented operational efficiencies that set the stage for sustained profitability in 2025 and beyond. These achievements were made possible thanks to the resilience, perseverance, and hard work of our employees.

    今年的亮點是推出了我們定義品類的泵浦平台 Tandem Mobi,隨著人們對我們最新產品的認識不斷提高,該平台在 2024 年持續成長。此外,我們也實施了營運效率提升措施,為2025年及以後的持續獲利奠定了基礎。這些成就的取得,離不開員工的韌性、毅力和辛勤工作。

  • Thank you, everyone, including our distributors, suppliers, clinical partners, for your continued dedication and efforts that contribute to furthering our mission.

    感謝各位,包括我們的經銷商、供應商、臨床合作夥伴,感謝你們的持續奉獻和努力,為推進我們的使命做出了貢獻。

  • Tandem now offers the most robust ecosystem and insulin therapy management in the world. With our flagship t:slim and Tandem Mobi, we provide the greatest choice in pump platforms. We offer customers a seamless cloud-based experience with our apps and operating system support and enable HCPs with our web-based data management platform TandemSource.

    Tandem 目前提供全球最強大的生態系統和胰島素治療管理。我們的旗艦產品 t:slim 和 Tandem Mobi 為用戶提供了最豐富的泵浦平台選擇。我們透過我們的應用程式和作業系統支持,為客戶提供無縫的雲端體驗,並透過我們基於網路的 TandemSource 資料管理平台,為醫療保健專業人員 (HCP) 提供支援。

  • We also integrate with multiple leading CGM sensors, and next month we will launch our third automated insulin delivery algorithm with Control-IQ plus.

    我們還與多家領先的 CGM 感測器集成,下個月我們將推出第三款自動胰島素輸注演算法 Control-IQ plus。

  • ControlIQ has long been considered the best automated insulin delivery algorithm with more than 240 million patient days of data logged in our system and 70 plus peer reviewed manuscripts and published abstracts. Over the past five years, it has provided immediate and sustained results across all patient populations.

    ControlIQ 長期以來被認為是最好的自動胰島素輸送演算法,我們的系統中記錄了超過 2.4 億個患者日的數據,並發表了 70 多篇同行評審的手稿和摘要。在過去的五年裡,它為所有患者群體帶來了立竿見影且持續的效果。

  • Now we're raising our own bar with a launch of Control IQ plus. Control IQ Plus offers superior glucose control and best in class outcomes by predicting, calculating, and adjusting insulin doses, including delivering automated collection correction bonuses.

    現在,我們透過推出 Control IQ plus 來提升我們自己的標準。Control IQ Plus 透過預測、計算和調整胰島素劑量,提供卓越的血糖控制和一流的效果,包括提供自動收集校正獎勵。

  • Driven by customer feedback, we have added new clinical features, such as an extended bolus lasting up to 8 hours and the option to set a temporary basal rate.

    在客戶回饋的推動下,我們增加了新的臨床功能,例如持續長達 8 小時的加壓注射和設定臨時基礎率的選項。

  • Activating Control IQ+ is easy. We have introduced a simple set of wizards that allows users to set it in accordance to AACE guidelines, switch it on, and witness immediate results. This is particularly beneficial to people coming from MDI.

    啟動 Control IQ+ 非常簡單。我們推出了一套簡單的嚮導,使用戶能夠按照 AACE 指南進行設置,將其打開,並立即看到結果。這對來自芒特迪瑟特學院(MDI)的人來說尤其有利。

  • In the US, customers also are now able to choose between English and Spanish. Control IQ Plus was originally approved for individuals with type 1 diabetes, age 2 and older. As highlighted in yesterday's press release, we're excited that it is now FDA cleared for people living with type 2 diabetes, 18 years and up.

    在美國,顧客現在也可以選擇英語或西班牙語。Control IQ Plus 最初獲準用於 2 歲及以上患有第 1 型糖尿病的人。正如昨天的新聞稿中所強調的,我們很高興該產品現在已獲得 FDA 批准,可用於 18 歲及以上患有 2 型糖尿病的人。

  • This more than doubles our addressable market in the United States, positioning us for significant long-term growth. This expanded label indication encompasses all insulin requiring people with type 2 diabetes and is based on a recently completed pivotal trial. This trial represents the first large-scale randomized control study of an automated insulin delivery system in more than 300 people with type 2 diabetes.

    這將使我們在美國的潛在市場規模擴大一倍以上,為實現顯著的長期成長奠定基礎。此次擴大適應症範圍涵蓋所有需要胰島素治療的第 2 型糖尿病患者,並基於最近完成的關鍵性試驗。這項試驗是首個針對 300 多名 2 型糖尿病患者進行的大規模隨機對照研究,旨在評估自動胰島素輸送系統的有效性。

  • Full study results will be presented at the International Conference of Advanced. Technologies and treatments for diabetes in Amsterdam next month.

    完整的研究結果將在國際先進技術大會上發表。下個月將在阿姆斯特丹舉辦糖尿病技術和治療研討會。

  • With Tandem's robust expanded portfolio, we also began executing a multi-channel pair strategy with the addition of the pharmacy channel, which we expect will ensure our best of class products are matched with ease of access and improved affordability.

    憑藉 Tandem 強大的擴展產品組合,我們也開始實施多通路組合策略,新增了藥房管道,我們期望這將確保我們一流的產品能夠更容易地獲取,並提高價格可負擔性。

  • We also began investing in important commercial initiatives to fortify our business fundamentals. And advanced our short and longer term sales and profitability goals. For instance, in the fourth quarter, we initiated recruitment efforts to support a strategic sales expansion and territory realignment, which took effect at the beginning of this year.

    我們也開始投資重要的商業項目,以鞏固我們的業務基本面。並推進了我們的短期和長期銷售及獲利目標。例如,在第四季度,我們啟動了招募工作,以支援策略性銷售擴張和區域重新調整,該調整於今年年初生效。

  • We identified opportunities to modernize the tools and systems used by our commercial teams, enhance their efficiency and effectiveness.

    我們發現了可以對銷售團隊使用的工具和系統進行現代化改造,以提高其效率和效力的機會。

  • Additionally, leveraging leveraging the robust performance of our OUS business and recognizing the vast potential within the markets we serve, we have begun a multi-year transition to direct commercial operations in select European countries.

    此外,憑藉我們海外業務的強勁表現,並認識到我們所服務市場的巨大潛力,我們已經開始在部分歐洲國家進行多年過渡,以開展直接商業運營。

  • Overall, 2024 was a successful year for Tandem with a return to growth. Importantly, we also initiated fundamental changes to key business processes, broadened market access options, and expanded organizational capabilities to accelerate revenue growth and profitability in 2025 and beyond.

    總體而言,2024 年對 Tandem 來說是成功的一年,公司恢復了成長勢頭。重要的是,我們也啟動了關鍵業務流程的根本性變革,拓寬了市場准入選擇,並擴大了組織能力,以加速2025年及以後的收入成長和獲利能力。

  • And taking a deeper look at the fourth quarter, there are many wins to celebrate. Outside the US, we delivered strong double-digit growth driven by demand for the t:slim pump platform.

    深入分析第四節,我們會發現有許多值得慶祝的勝利。在美國以外,我們實現了強勁的兩位數成長,這主要得益於對 t:slim 泵浦平台的需求。

  • In the US we saw strength from both t:slim and Tandem Mobi platforms and in key performance indicators, such as year over year growth in the customers coming from multiple daily injections and customers renewing from tandem once again.

    在美國,我們看到 t:slim 和 Tandem Mobi 平台都表現出強勁勢頭,關鍵績效指標也實現了同比增長,例如來自每日多次注射的客戶數量以及再次從 Tandem 續訂的客戶數量。

  • Our wins in that quarter also came with some challenges. The fourth quarter in the US did not come together as anticipated. We experienced more mutant seasonality in the last few weeks of the year, where historically, we have seen acceleration throughout December.

    我們在那個季度取得的勝利也伴隨著一些挑戰。美國第四季經濟情勢並未如預期般好轉。在今年的最後幾週,我們經歷了更反常的季節性變化,而歷史上,這種變化通常會在整個 12 月加速發生。

  • Additionally, shipping delays by carriers who did not deliver to customers before the end of the year as planned, impacted the timing of revenue reporting.

    此外,由於承運商未能按計劃在年底前向客戶交付貨物,導致發貨延誤,也影響了收入報告的時間。

  • Despite these factors, the underlying trends of our business remain strong and favorable.

    儘管存在這些因素,但我們業務的基本趨勢仍然強勁且有利。

  • I will now ask Mark to provide more additional detail on the commercial insights, Mark.

    現在我將請馬克提供更多關於商業見解的細節,馬克。

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Thank you, John. When I joined Tandem just over a year ago, we put a commercial strategy in place to maximize our portfolio of innovations, galvanize the customer experience and fortify our international efforts to become truly global. Our strategy remains fully intact and we achieved meaningful progress delivering on it in 2024 and most importantly, set ourselves up well for the longer term.

    謝謝你,約翰。一年多前我加入 Tandem 時,我們制定了一項商業策略,旨在最大限度地發揮我們的創新組合優勢,提升客戶體驗,並加強我們的國際業務,從而真正成為一家全球化公司。我們的策略依然完全不變,我們在 2024 年實現了這項策略,取得了實質進展,最重要的是,我們為長遠發展奠定了良好的基礎。

  • Starting with maximizing our portfolio, in 2024, we demonstrated our commitment to bringing new innovation to market with the launch of a new pump platform and multiple new CGM integrations. We also scaled TandemSource, which is now used by more than 90% of our US Prescribers and began offering it outside The United States. The expansion of our AID portfolio with The US Launch of Tandem Mobi was a particular highlight.

    從最大化我們的產品組合開始,我們在 2024 年透過推出新的泵浦平台和多個新的 CGM 集成,展現了我們致力於將創新帶入市場的決心。我們也擴大了 TandemSource 的規模,目前超過 90% 的美國處方醫生都在使用它,並且我們開始在美國以外提供它。隨著 Tandem Mobi 在美國的推出,我們擴大了援助計畫組合,這尤其令人矚目。

  • Mobi is an expansion to our portfolio, largely attracting customers who otherwise may not have selected Tandem. At half the size of t:slim, the same weight as two AA batteries and the size of an AirPod case, Mobi is defining a new category in AID technology.

    Mobi 是我們產品組合的擴展,主要吸引了原本可能不會選擇 Tandem 的顧客。Mobi 的體積只有 t:slim 的一半,重量與兩節 AA 電池相同,大小與 AirPods 充電盒相當,它正在定義 AID 技術的新類別。

  • Its tiny form factor coupled with mobile app operation and the flexibility to be worn as many as 20 different ways, including the ability to detach, provides patients with an entirely new value proposition and wearability backed by the best in class Control IQ.

    它小巧的外形,加上行動應用程式的操作,以及多達 20 種不同的佩戴方式(包括可拆卸),為患者提供了全新的價值主張和佩戴體驗,並由一流的 Control IQ 提供支援。

  • This new value proposition is attracting a younger population to AID therapy and earning MOBE excellent feedback from both healthcare providers and MOBE customers. This was reflected in DQ and A's recent survey where MOBE was rated number one in size, comfort and wear during physical activity.

    這項新的價值主張正在吸引更多年輕人接受愛滋病治療,並為 MOBE 贏得了醫療保健提供者和 MOBE 客戶的一致好評。DQ 和 A 最近的調查也反映了這一點,MOBE 在尺寸、舒適度和運動時的穿著體驗方面被評為第一名。

  • I am proud of the start to Mobi's launch, which we plan to continue building by amplifying awareness and trialing of this exciting technology, offering greater access and expected affordability through the pharmacy channel and by expanding its feature set.

    我為 Mobi 的推出開局感到自豪,我們計劃繼續推進這項令人興奮的技術的推廣和試用,透過藥房管道提供更便捷的購買管道和更實惠的價格,並擴展其功能集。

  • We also continue to have high expectations for our flagship t:slim pump, which has a strong fan base with both new and renewing customers. Its 300 unit cartridge, broad CGM and phone compatibility and all in one touchscreen use provide high satisfaction and allow for Tandem to meet different needs in the diabetes community. We now have more than 320,000 in warranty customers in The United States and the way we serve them is a differentiating factor for Tandem. As a result, we delivered double digit growth in renewal customers both sequentially and year over year, while delivering an industry leading customer satisfaction score.

    我們對旗艦產品 t:slim 水泵也依然寄予厚望,該產品擁有強大的粉絲基礎,深受新舊客戶的喜愛。其 300 個單位的藥盒、廣泛的 CGM 和手機相容性以及一體化觸控螢幕使用,提供了很高的滿意度,使 Tandem 能夠滿足糖尿病群體的不同需求。我們現在在美國擁有超過 32 萬名保固客戶,我們為他們提供服務的方式是 Tandem 的一個差異化因素。因此,我們的續約客戶數量實現了兩位數的環比和同比增長,同時客戶滿意度得分也達到了行業領先水平。

  • For the first time, Tandem won Seagrove's People Choice Award leading in four out of the eight categories surveyed including Favorite Pump. In DQ and A, Tandem had the highest Net Promoter Score outperforming all other competitors. This reflects our deep dedication and commitment to delivering a best in class customer experience. Turning to our business outside The US, where we now have more than 160,000 in warranty customers.

    Tandem 首次榮獲 Seagrove 人民選擇獎,在所調查的八個類別中領先四個,包括最受歡迎的泵。在DQ和A中,Tandem的淨推薦值最高,超過了所有其他競爭對手。這體現了我們致力於提供一流客戶體驗的堅定決心和不懈努力。再來看看我們在美國以外的業務,我們現在在美國擁有超過 16 萬名保固客戶。

  • Our consistent outperformance this year was driven by high demand for our t:slim X2 pump and under new international leadership, we advanced how we work with our distributor partners and strengthened our commercial capabilities. It's also a reflection of the large and underpenetrated nature of the countries we serve and the future opportunity in these regions.

    今年我們持續優異的業績得益於市場對我們 t:slim X2 泵的高需求,並且在新國際領導層的領導下,我們改進了與分銷合作夥伴的合作方式,並加強了我們的商業能力。這也反映了我們所服務國家的幅員遼闊、市場滲透率低以及這些地區未來的發展機會。

  • As we look to 2025 and beyond, we are well positioned to drive and scale our commercial strategy. The worldwide AID market has more competitors, larger sales forces and more insulin pump offerings than ever before. 2024 highlighted this as an opportunity to invest in foundational capabilities that we are capitalizing on for the year ahead to increase our share of voice, continue driving sales force and overall commercial effectiveness and improve how we service those markets.

    展望 2025 年及以後,我們已做好充分準備,推動和擴大我們的商業策略。全球輔助生殖技術(AID)市場競爭比以往任何時候都更加激烈,銷售團隊規模更大,胰島素幫浦產品種類也更加豐富。 2024 年凸顯了這個趨勢,也為我們提供了一個投資基礎能力建構的機會。我們將充分利用這些優勢,在未來一年提升市場份額,持續增強銷售團隊和整體商業效能,並改善我們服務這些市場的方式。

  • In The US, we have successfully executed a strategic realignment and expansion of our sales and clinical teams. This optimization enhanced efficiency while increasing our share of voice in high priority growth accounts. Tandem's technology is incredibly exciting and innovative and we recognize this is a promotionally sensitive market. So now is the time to invest selectively and responsibly to amplify our market presence and enhance both the customer and employee experience.

    在美國,我們已成功實施了銷售和臨床團隊的策略調整和擴張。這項優化提高了效率,同時增加了我們在高優先成長客戶的市場份額。Tandem 的技術非常令人興奮和創新,我們也意識到這是一個對促銷活動非常敏感的市場。因此,現在是時候進行有選擇、負責任的投資,以擴大我們的市場份額,並提升客戶和員工的體驗。

  • We have enhanced our structure, targeting strategy, modernized our practices and equip our teams with new capabilities and tools to drive commercial excellence. These initiatives were piloted with our field team in 2024 are now being rolled out and we expect to see increasing benefits starting in the latter half of this year.

    我們加強了組織結構和目標策略,改進了實踐方法,並為團隊配備了新的能力和工具,以推動商業卓越發展。這些措施於 2024 年在我們的實地團隊中進行了試點,現在正在推廣,我們預計從今年下半年開始將看到越來越多的效益。

  • Another exciting opportunity for Tandem is our scaling pharmacy channel initiatives. 2025 marks the first year that Tandem is able to offer multi channel durable medical equipment and pharmacy benefit plan coverage. Our team exceeded our market access goals for 2024 by signing multiple meaningful contracts with leading PBMs and we now have approximately 20% of US lives covered under pharmacy agreements for a mix of commercial and government lives.

    Tandem面臨的另一個令人振奮的機會是我們正在拓展的藥局通路計畫。 2025年將是Tandem首次能夠提供多通路耐用醫療設備和藥局福利計畫涵蓋的年份。我們的團隊透過與領先的藥品福利管理機構 (PBM) 簽署多項重要合同,超額完成了 2024 年的市場准入目標,目前我們已透過藥品協議覆蓋了大約 20% 的美國人口,其中包括商業保險和政府保險。

  • We believe this is a win for tandem and most importantly, a win for patients who previously stayed on multiple daily injections due to cost barriers. Driving scalable growth in pharmacy is a top priority for our business this year as we work to drive broader access and sustainable growth. Pharmacy is also strategically important as we increase our focus on supporting people living with Type two diabetes where cost is also a barrier.

    我們認為這對 Tandem 來說是一個勝利,更重要的是,這對以前因為費用問題而不得不每天多次注射的患者來說是一個勝利。今年,推動藥房業務的可擴展成長是我們業務的首要任務,我們將努力擴大服務覆蓋率並實現永續成長。隨著我們越來越重視為患有二型糖尿病的人們提供支持,藥房也具有重要的戰略意義,因為費用也是一個障礙。

  • To help drive change so that cost does not prevent people from getting the therapy they want and need, we are active in a coalition as well as industry efforts to establish a sustainable Medicare pathway to broaden coverage for people living with Type two.

    為了推動變革,使費用不會阻礙人們獲得他們想要和需要的治療,我們積極參與聯盟以及行業努力,以建立可持續的醫療保險途徑,擴大對二型糖尿病患者的覆蓋範圍。

  • Addressing the needs of the Type two insulin dependent population is a strategic imperative for Tandem and one that provides long term growth opportunities. With Control IQ+ Type two indication now FDA cleared, the size of our addressable market has doubled.

    滿足二型胰島素依賴族群的需求是 Tandem 的策略要務,也是能夠提供長期成長機會的舉措。隨著 Control IQ+ 的 II 型適應症獲得 FDA 批准,我們的潛在市場規模翻了一番。

  • As a reminder, more than 30,000 people with Type two use Tandem's technology today and we've seen this success without any dedicated marketing or sale efforts. Our recently completed randomized clinical trial will serve as a powerful foundation for promotion post clearance, highlighting key differentiators that set us apart in this market.

    需要提醒的是,目前已有超過 30,000 名二型糖尿病患者使用 Tandem 的技術,而我們取得這樣的成功並沒有進行任何專門的市場營銷或銷售工作。我們最近完成的隨機臨床試驗將為上市後的推廣奠定強有力的基礎,突顯我們在這個市場中脫穎而出的關鍵差異化優勢。

  • We also recognize the needs of this population can be different than people living with Type one and we are committed to serving them with tailored solutions. We will soon begin Type two pilot launch activities that will scale based on our key performance indicators.

    我們也認識到,這部分人群的需求可能與患有第 1 型糖尿病的人不同,我們致力於為他們提供量身定制的解決方案。我們很快就會啟動第二類試點啟動活動,並根據我們的關鍵績效指標進行規模化調整。

  • Turning to our business outside The United States, we are continuing to scale our presence in the countries we serve. Historically, our sales have been exclusively through distributors. In 2024, we began laying the groundwork to expand our international presence by onboarding new talent to our regional and in country commercial teams, while continuing partnerships with our in region distributors.

    展望我們在美國以外的業務,我們正在繼續擴大在我們服務國家的市場份額。從歷史上看,我們的銷售一直都是透過經銷商進行的。2024 年,我們開始為擴大國際業務奠定基礎,透過向我們的區域和國家商業團隊吸收新人才,同時繼續與我們在區域內的經銷商建立合作關係。

  • To build upon this model and drive further growth, we are preparing to initiate direct sales, training and customer support in select European countries starting in 2026, acknowledging that such transitions can cause some disruption, we are working closely with the distributors to minimize impact for all parties involved, particularly prescribers and Tandem pump users.

    為了鞏固這一模式並推動進一步成長,我們正準備從 2026 年開始在部分歐洲國家進行直接銷售、培訓和客戶支援。我們意識到這種轉變可能會造成一些混亂,因此我們正在與經銷商密切合作,以最大限度地減少對所有相關方的影響,特別是對處方醫生和 Tandem 泵用戶的影響。

  • This is a natural step in our maturation as a med tech company and one that is intended to strengthen our financial position by accelerating sales growth and driving margin expansion. It's also an opportunity to gain greater direct insights and deepen relationships within the European diabetes community, which is a priority for us as we build out our teams to support local efforts and establish global leadership.

    這是我們作為一家醫療技術公司走向成熟的自然步驟,旨在透過加速銷售成長和推動利潤率擴張來增強我們的財務狀況。這也是一個獲得更直接的見解並加深與歐洲糖尿病界關係的機會,這對我們來說是一個優先事項,因為我們正在組建團隊以支持當地工作並確立全球領導地位。

  • As you can see, we have entered a transformational phase for our commercial organization and for Tandem. These steps are critical as we continue to maximize our portfolio, expand our addressable market, increase our competitiveness both near and long term and improve the lives of people with diabetes worldwide.

    正如你所看到的,我們的商業組織和 Tandem 公司都已進入轉型階段。這些步驟至關重要,因為我們將繼續最大限度地擴大我們的產品組合,擴大我們的目標市場,提高我們近期和長期的競爭力,並改善全世界糖尿病患者的生活。

  • I'd now like to turn the call over to Lee to share some more information on our Q4 results and expectations for 2025. Lee?

    現在我想把電話交給李,讓他分享更多關於我們第四季業績和2025年預期方面的資訊。李?

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

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

  • Thanks, Mark. As a reminder, unless otherwise noted, the financial metrics I'll 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,馬克。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準則下的指標。GAAP 與非 GAAP 結果的調整表可在今天的盈利報告中以及我們網站的投資者中心部分找到。

  • Annual worldwide sales were the highest ever at $910 million which was an increase of 18% year over year. We also achieved record fourth quarter sales of $252 million It was the largest in our history and the second quarter in a row of greater than 20% growth over the prior year.

    全球年度銷售額達9.1億美元,創歷史新高,較去年同期成長18%。第四季銷售額也創下歷史新高,達到 2.52 億美元,這是我們史上最高的季度銷售額,也是連續第二季比上年增長超過 20%。

  • This sales performance was driven largely by a strong double digit increase in pump shipments. Starting with color on The US Market, in the fourth quarter, we shipped more than 24,000 pumps and generated sales of $184 million representing 13% year over year growth. On a full year basis, sales were $642 milion Pump shipments of nearly $81,000 for the year increased 10% due largely to the Mobi launch and strong retention of our customers through renewal purchases, while pump sales increased 13%.

    這項銷售業績主要得益於泵浦出貨量兩位數的強勁成長。從美國市場的彩色泵開始,第四季我們出貨超過 24,000 台泵,銷售額達 1.84 億美元,年增 13%。全年銷售額為 6.42 億美元。泵浦的年出貨量接近 8.1 億美元,成長了 10%,這主要歸功於 Mobi 的推出以及客戶透過續訂購買的強勁留存率,而泵浦的銷售額成長了 13%。

  • This differential is due to improvements in average selling prices benefiting from continued price increases and favorable mix within the DME channel across the year. We are now consistently seeing nearly 40% of our US Pump and supply business through direct contracts versus 36% a year ago. When looking at our sources of business during the year, we continue to see positive trends into the fourth quarter.

    這一差異是由於平均售價的提高,而平均售價的提高得益於全年DME通路內價格的持續上漲和有利的產品組合。現在,我們近 40% 的美國泵浦及耗材業務都是透過直接合約完成的,而一年前這一比例為 36%。回顧全年的業務來源,我們發現第四季依然保持著正面的發展趨勢。

  • Renewals and new starts from MDI conversions are two key metrics that are foundational to meeting our long term growth objectives, and we delivered on both fronts. Renewals continue to meet historically high retention rates on pace for consistent achievement of 70% capture within 18 months of warranty expiration.

    續約和 MDI 轉換帶來的新開通是實現我們長期成長目標的兩個關鍵指標,我們在這兩方面都取得了成功。續保率繼續保持歷史高位,預計在保固期到期後的 18 個月內持續實現 70% 的續保率。

  • Renewals were the greatest driver of pump growth, but we're exiting 2024 encouraged by our trajectory with Mobi driving more MDI users to pump therapy. MDI conversions in 2024 grew double digits and made up greater than 60% of our new starts overall.

    續約是泵浦成長的最大驅動力,但我們對 2024 年的發展軌跡感到鼓舞,Mobi 將更多 MDI 使用者推向泵浦治療。2024 年 MDI 轉換率實現了兩位數成長,占我們新開工總量的 60% 以上。

  • Q4 also marked the conclusion of our Tandem Choice program, which as previously discussed was an opportunity for eligible t:slim X2 customers to switch to Mobi upon its availability earlier this year.

    第四季度也標誌著我們的 Tandem Choice 計劃的結束,正如之前討論的那樣,該計劃為符合條件的 t:slim X2 用戶提供了一個在今年早些時候 Mobi 可用時切換到 Mobi 的機會。

  • As a reminder, reported pump shipments and non GAAP financials do not include any impact from the program. There were essentially three stages of this program. On a GAAP basis, we deferred a portion of the sale for each eligible X2 customer over the course of approximately 18 months prior to selling Mobi.

    需要提醒的是,已公佈的泵浦出貨量和非GAAP財務資料均未包含該計劃的任何影響。該計劃基本上分為三個階段。根據 GAAP 準則,我們在出售 Mobi 之前,將每位符合資格的 X2 客戶的部分銷售款項遞延了大約 18 個月。

  • Upon launching Mobi this year, we ceased deferring any portion of X2 sales and began recognizing sales and cost of goods sold with each individual election to switch to Mobi. Now that the program is complete, we captured all remaining X2 sales deferrals in the fourth quarter totaling $30 million For further details on the GAAP accounting for this program, please refer to the accounting policy discussion in our 10-K's.

    今年推出 Mobi 後,我們停止遞延 X2 銷售的任何部分,並開始在每次選擇切換到 Mobi 時確認銷售額和銷售成本。現在該計劃已完成,我們在第四季度確認了所有剩餘的 X2 銷售遞延款項,總計 3000 萬美元。有關該計劃的 GAAP 會計處理的更多詳細信息,請參閱我們 10-K 文件中的會計政策討論。

  • Turning to our results outside The United States, we shipped approximately 40,000 pumps for the full year and grew sales to $268 million which is a 39% increase year over year. In the fourth quarter, we shipped approximately 10,000 pumps and grew sales 48% to $68 million

    再來看看我們在美國以外的業績,我們全年出貨約 40,000 台泵,銷售額增長至 2.68 億美元,年增 39%。第四季度,我們出貨了約1萬台泵,銷售額成長48%,達到6,800萬美元。

  • \Similar to The US, our OUS pump and supply sales benefited both from volume and price increases. The majority of our pump sales continued to be driven by customers new to Tandem with strong demand for teslam X2. Renewals will begin to offer more meaningful contribution in 2025.

    與美國類似,我們的 OUS 水泵和耗材銷售也受益於銷售量和價格的雙重成長。我們的大部分泵浦銷售仍由 Tandem 的新客戶推動,他們對 teslam X2 的需求強勁。續約將在 2025 年開始發揮更有意義的作用。

  • Moving on to margin performance, our 2024 gross margin was 51% consistent with 2023, while absorbing headwinds associated with the Mobi launch. As expected with scaling volumes, Mobi pump manufacturing costs per unit continue to improve across the year and will begin to benefit gross margin as we enter 2025.

    接下來談談利潤率表現,我們 2024 年的毛利率為 51%,與 2023 年持平,同時吸收了與 Mobi 上線相關的不利因素。隨著產量的擴大,Mobi 水泵的單位製造成本在年內持續改善,並將於 2025 年開始提高毛利率,正如預期的那樣。

  • This positive contribution from Mobi will build in the coming years and become more meaningful as we increase the mix of Mobi pumps we are selling. Additional leverage will come from Mobi cartridge scaling in 2026 and beyond as the size of the ordering install base is expected to grow. Gross margins also benefited from favorable ASPs across all products.

    未來幾年,Mobi 的積極貢獻將會不斷增強,隨著我們銷售的 Mobi 水泵產品組合的增加,這種貢獻的意義也會更加重大。隨著訂購安裝基礎規模預計在 2026 年及以後擴大,Mobi 墨水匣的規模擴張將帶來額外的槓桿作用。毛利率也受益於所有產品有利的平均售價。

  • For the full year of 2024, our adjusted EBITDA margin was consistent with 2023 at negative 1% of sales, which included increased spending year over year to support the Mobi launch and clinical trials for new products and indications. The adjusted EBITDA margin also reflects initial investments to commence the expansion of our footprint in The US as well as build infrastructure to support direct operations outside The US.

    2024 年全年,我們調整後的 EBITDA 利潤率與 2023 年持平,為銷售額的 -1%,其中包括為支持 Mobi 的上市以及新產品和適應症的臨床試驗而逐年增加的支出。調整後的 EBITDA 利潤率也反映了為擴大我們在美國的業務規模而進行的初始投資,以及為支持美國以外地區的直接運營而建設的基礎設施。

  • Even with these investments, 2024 marked a return to positive free cash flow, which is early evidence of our dedication to improved financial strength in the coming year. We ended the year with $438 million in total cash and investments and are confident in our ability to support key operating and non operating commitments in 2025, including debt repayment of convertible notes due and final AMF purchase obligations.

    即使進行了這些投資,2024 年也標誌著自由現金流恢復為正,初步證明了我們致力於在未來一年提高財務實力的決心。截至年底,我們擁有 4.38 億美元的現金和投資總額,我們有信心在 2025 年履行關鍵的營運和非營運承諾,包括償還到期可轉換票據的債務和最終的 AMF 購買義務。

  • Turning to guidance, with Tandem Choice behind us, we are returning to GAAP guidance for 2025, which will be most directly comparable to the non GAAP results we provided in 2024. Worldwide sales are expected to be in the range of $997 million to just over $1 billion or 10% to 11% growth year over year. This contemplates the impact of certain factors that are critical to meeting our long term sales ambitions that may create some level of disruption in the near term.

    展望未來,隨著 Tandem Choice 專案的完成,我們將恢復 2025 年的 GAAP 業績指引,這將與我們 2024 年提供的非 GAAP 業績指引最為直接可比。全球銷售額預計在 9.97 億美元至略高於 10 億美元之間,年增 10% 至 11%。這考慮了某些對我們實現長期銷售目標至關重要的因素的影響,這些因素可能會在短期內造成一定程度的干擾。

  • In The US, our sales for 2025 are expected to be in the range of $725 million to $730 million or growth of 13% to 14%. We anticipate another strong performance with renewals from increased warranty expirations, predictable and growing supply sales and mid single digit growth in new pump starts. This growth in new pump starts will be driven by continued traction with Mobi and other new product innovations. We will continue to vigorously pursue improved market access for our expanded Type two label in the Medicare population, expecting only modest contribution in the meantime.

    預計到 2025 年,我們在美國市場的銷售額將在 7.25 億美元至 7.3 億美元之間,成長 13% 至 14%。我們預計,隨著保固到期數量的增加,續約業務將持續成長,供應銷售穩定成長,新泵浦啟動量也將實現中等個位數的成長,因此業績將再次強勁成長。新泵浦啟動量的成長將得益於 Mobi 的持續發展勢頭以及其他新產品創新。我們將繼續積極尋求改善我們擴大的二類標籤在聯邦醫療保險人群中的市場准入,但預計在此期間只能取得有限的貢獻。

  • The sales force expansion and realignment that we just completed in the US have the potential to create disruption in the near term and was factored into our expectations. Our move into the pharmacy channel is important for addressing affordability concerns and we have a strong start with approximately 20% of covered lives under contract. We have not included material benefit from pricing or volume at this time.

    我們剛剛在美國完成的銷售團隊擴張和重組可能會在短期內造成混亂,這一點已納入我們的預期。我們進軍藥局通路對於解決價格負擔能力問題至關重要,而且我們已經取得了良好的開端,約有 20% 的參保人簽訂了合約。目前我們尚未將價格或銷售量帶來的實質收益納入考量。

  • We will continue to gather and assess data related to new product adoption and channel utilization to inform updates to our guidance in upcoming quarters. As a reminder, both pump and supply shipments typically reflect seasonal patterns across the quarters, which is associated with insurance dynamics in The US.

    我們將繼續收集和評估與新產品採用和通路利用相關的數據,以便為未來幾季的業績指引更新提供依據。需要提醒的是,泵浦和耗材的出貨量通常反映出季度間的季節性模式,這與美國的保險動態有關。

  • For example, first quarter pump shipments typically decline from the fourth quarter by 25% to 30%. Accordingly, sales for the first quarter are expected to be in the range of $144 million to $147 million representing 10% to 12% growth year over year.

    例如,第一季泵浦的出貨量通常比第四季下降 25% 至 30%。因此,預計第一季銷售額將在 1.44 億美元至 1.47 億美元之間,年增 10% 至 12%。

  • The remainder of 2025 is expected to follow historical seasonal patterns where both pump and supply sales scale up across the year. Sales outside The US for 2025 are expected to grow 2% to 4% to a range of $272 million to $277 millionThis reflects the tremendous market expansion opportunity ahead balanced with the potential for disruption as we prepare to go direct in select European countries. Our sales assumptions factor in $15 million to $20 million of potential headwinds later in the year as we navigate this transition ahead of our planned 2026 launch.

    預計 2025 年剩餘時間將遵循歷史季節性模式,即全年泵浦和供應銷售額都將逐步成長。預計 2025 年美國以外地區的銷售額將成長 2% 至 4%,達到 2.72 億美元至 2.77 億美元。這反映了未來巨大的市場擴張機會,同時也反映了在我們準備在部分歐洲國家開展直銷業務時可能出現的市場動盪。我們的銷售預期考慮到今年稍後可能會面臨 1500 萬至 2000 萬美元的潛在不利因素,因為在我們計劃於 2026 年推出產品之前,我們需要應對這一轉型。

  • In the first quarter, we anticipate minimal disruption and therefore expect sales of $75 million to $77 million from strength in these markets. We expect to demonstrate our greatest progress in recent years in both growth and adjusted EBITDA margins. While I have outlined today certain investments we are making for growth, we have meaningful efficiency initiatives underway through greater automation, process improvement and increased use of technology to support our customers.

    第一季度,我們預計不會受到太大影響,因此預計這些市場的強勁表現將帶來 7,500 萬美元至 7,700 萬美元的銷售額。我們預計在成長和調整後 EBITDA 利潤率方面都將取得近年來最大的進步。雖然我今天概述了我們為促進成長而進行的一些投資,但我們正在透過提高自動化程度、改進流程和更多地使用技術來開展有意義的效率提升計劃,以更好地支持我們的客戶。

  • The savings expected to be generated will allow us to fund the commercial investments while expanding margins. We expect gross margin to be approximately 54% for the full year and 51 in the first quarter, including minimal anticipated impact of tariffs, driving towards our long term target of 65% where Mobi will be the greatest contributor.

    預計節省的資金將使我們能夠為商業投資提供資金,同時擴大利潤率。我們預計全年毛利率約為 54%,第一季毛利率約為 51%,其中關稅的影響預計微乎其微,這將推動我們實現 65% 的長期目標,其中 Mobi 將是最大的貢獻者。

  • Adjusted EBITDA margins are expected to improve to approximately 3% of sales for the year or an improvement of four percentage points from 2024 with the low in the first quarter at approximately negative 6% of sales. I'll now hand the call back to John for closing remarks.

    預計全年調整後 EBITDA 利潤率將提高至銷售額的約 3%,比 2024 年提高 4 個百分點,第一季最低點約為銷售額的 -6%。現在我將把電話交還給約翰,請他作總結發言。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thanks, Lee. Alongside our operational and commercial strategies to propel business growth, we are unwavering in our dedication to innovation and focus on new technologies that will bring the greatest benefits to our people with diabetes.

    謝謝你,李。除了推動業務成長的營運和商業策略外,我們也堅定不移地致力於創新,專注於能夠為糖尿病患者帶來最大利益的新技術。

  • In 2025, we will further expand our portfolio by launching new technology solutions. First is our integration with FreeStyle Libre three plus with t:slim followed by Mobi and then next is introduction of Android app for control for Mobi. Additionally, I am thrilled to announce that we have already submitted Mobi for CE Mark and are on track to launch it outside The Us.

    2025年,我們將透過推出新的技術解決方案進一步擴展我們的產品組合。首先是我們將 FreeStyle Libre 3 Plus 與 t:slim 集成,然後是 Mobi,接下來是推出用於控制 Mobi 的 Android 應用程式。此外,我很高興地宣布,我們已經向消費者提交了 Mobi 的 CE 認證申請,並正按計劃在美國以外地區推出該軟體。

  • By the end of the year. The international launch of TandemSource currently underway will enable the scaling of Mobi's global expansion. Another key regulatory filing to highlight is our initial FDA submission for our steady set and fusionset. We are pursuing a three day indication as a first step in our regulatory strategy for longer wear times with additional filings to support our product targets.

    到年底。TandemSource 目前正在進行國際發布,這將使 Mobi 的全球擴張規模得以擴大。另一個值得關注的重要監管文件是我們首次向 FDA 提交的穩定器和融合器申請。我們正在推進三天適應症的研發,作為我們監管策略的第一步,以實現更長的佩戴時間,並會提交更多文件來支持我們的產品目標。

  • Our commitment to innovation and growth also extends beyond 2025. We are enhancing the features of both t:slim and Mobi platforms. For t:slim, it's continuing to keep our flagship platform modern and competitive. For Mobi, we are prioritizing the development of a tubeless infusion site that offers even more wearability options, which will be the next significant pump enhancement available within our portfolio. Beyond that, we plan to further expand our portfolio with a third pump platform, Sigi.

    我們對創新和發展的承諾也延續到2025年以後。我們正在增強 t:slim 和 Mobi 平台的功能。對 t:slim 而言,這意味著要繼續保持我們旗艦平台的現代化和競爭力。對於 Mobi,我們優先開發無管輸液部位,提供更多配戴選擇,這將是我們產品組合中下一個重要的幫浦增強功能。除此之外,我們還計劃透過推出第三個幫浦平台 Sigi 來進一步擴展我們的產品組合。

  • Sigi is an ergonomic and rechargeable patch pump. We are beginning to accelerate its development in San Diego, leveraging the expertise of our advanced pump development team and we are excited to bring this differentiated technology to the market.

    Sigi 是一款符合人體工學的充電式貼片式吸乳器。我們正在聖地牙哥加快這項技術的研發,利用我們先進的泵浦研發團隊的專業知識,我們很高興能將這項差異化技術推向市場。

  • We remain steadfast in our commitment to offer the best performing fully closed loop algorithm with industry leading outcomes and minimal user burden. To further this goal, we recently signed a multi year collaboration agreement with the University of Virginia Center for Diabetes Technology to advance research and development efforts on fully closed loop insulin delivery systems. This exciting collaboration will build on ongoing research as we continue our successful partnership to deliver new innovations.

    我們始終堅定不移地致力於提供性能最佳的全閉環演算法,以實現業界領先的成果並最大限度地減少用戶負擔。為了進一步實現這一目標,我們最近與維吉尼亞大學糖尿病技術中心簽署了一項多年合作協議,以推進全閉環胰島素輸送系統的研究和開發工作。這項令人興奮的合作將建立在持續的研究基礎上,我們將繼續保持成功的合作關係,帶來新的創新成果。

  • As you can see, 2025 is positioned to be full of tremendous opportunity for Tandem. The strengths that have driven meaningful growth for us in the past are once again in place today. These include having a differentiated portfolio of technology solutions, our industry leading customer service and our best in class automated insulin delivery algorithm.

    如您所見,2025 年對 Tandem 來說將是充滿巨大機會的一年。過去推動我們實現有意義成長的優勢,如今再次發揮作用。這些優勢包括:我們擁有差異化的技術解決方案組合、業界領先的客戶服務以及一流的自動化胰島素輸送演算法。

  • These drivers coupled with our actions underway to fortify, strengthen and grow our business include our expanded sales force with modernized tools and systems, increased pharmacy channel access, scaling growth into Type two, preparation for direct sales in Europe and the most exciting pipeline in diabetes. Each of these is an exciting opportunity independently.

    這些驅動因素,加上我們正在採取的鞏固、加強和發展業務的行動,包括擴大銷售團隊並採用現代化工具和系統、增加藥房管道、擴大二型糖尿病業務的成長、為在歐洲進行直接銷售做準備,以及糖尿病領域最令人興奮的產品線。這些本身都是令人興奮的機會。

  • Together they position us for near and longer term profitable growth as we create new possibilities for people living with diabetes. Thank you for supporting Tandem through this exciting transformation. Operator, would you please open the call for questions?

    它們共同為我們實現近期和長期的獲利成長奠定了基礎,同時為糖尿病患者創造了新的可能性。感謝您在Tandem經歷這段激動人心的轉型時期給予的支持。接線生,請開啟問答環節好嗎?

  • Operator

    Operator

  • Thank you. (Operator Instructions)

    謝謝。(操作說明)

  • Matthew Blackman with Steel.

    馬修布萊克曼與鋼鐵人。

  • Mathew Blackman - Analyst

    Mathew Blackman - Analyst

  • Good afternoon, everybody. Thanks for taking my question. Lee, I was going to give you a multi part question. Apologies that we're starting off like that. But I was hoping to get you to if you could quantify, I think you called out 4Q shipping delays.

    大家下午好。謝謝您回答我的問題。李,我本來打算問你一個包含多個部分的問題。很抱歉我們以這種方式開始。但我希望你能能量化一下,我想你之前提到過第四季度的發貨延遲問題。

  • Can you quantify that for us and whether that was on both the pumps and the supply side? And then also the December trends being softer, just any thoughts there on why and to the extent you want to give us some commentary beyond obviously the 1Q guidance, how things are looking in early '25 on that front? And then on the guidance, I just want to confirm, I think I heard it, but is Type two baked in there? Is Libre baked in there? It didn't sound like it.

    您能否為我們量化一下,並說明這種情況是否同時發生在抽水站和供水系統兩方面?此外,12 月的趨勢也較為疲軟,您對此有何看法?除了第一季的業績指引之外,您能否就 2025 年初的業績展望做一些評論?關於指導意見,我想確認一下,我好像聽到了,但其中是否包含了二型糖尿病的內容?Libre是烘焙食品嗎?聽起來不像。

  • And just any clarification on what's in there and what would be potentially upside? I'll leave it at that. Thank you.

    請問裡面都包含哪些內容,以及潛在的成長潛力是什麼?我就說到這兒吧。謝謝。

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

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

  • Thanks, Matt. Certainly a lot packed into that question. So I think I will start with a few comments on the fourth quarter.

    謝謝你,馬特。這個問題確實包含了很多資訊。所以我想先就第四季談幾點看法。

  • And so to your point, asking about where the shortfall came from, the majority of it really came from the fact that we saw a muted seasonal curve in the in December. So if you think about the last few weeks, and as we normally look at seasonal trends, and not only grows across the quarters, but even across the weeks within the fourth quarter.

    所以,關於你提到的短缺來自哪裡,大部分短缺實際上是由於我們在 12 月看到了較為平緩的季節性曲線。所以,如果你回顧過去幾週,就像我們通常觀察季節性趨勢一樣,不僅在各個季度之間增長,甚至在第四季度內的幾週內也增長。

  • December was still by far the largest shipment month we had for the year. It was really just those last few weeks that fell short, and it showed growth year over year. And so the comment about the shipping delays, it was a contributor. It was not the most meaningful, but it was important just to call out compounding, what we were seeing at the end of the year.

    12月仍然是我們全年出貨量最大的月份。真正表現不佳的只是最後幾週,但總體而言,它比去年同期有所增長。所以,關於出貨延遲的評論,也是一個促成因素。雖然這並非最有意義的,但重要的是要指出複利效應,也就是我們在年底看到的情況。

  • And we did take those considerations or take those into consideration as we thought about how to set the guidance for 2025 none of it took away from our enthusiasm, or confidence in continuing to grow the market. We still saw great strength in NDI. We still saw great traction with our renewal opportunities, and those are the fundamental key performance indicators that we expect to drive the business going forward.

    我們在考慮如何制定 2025 年的指導方針時,確實考慮到了這些因素,但這絲毫沒有減弱我們對繼續發展市場的熱情和信心。我們仍然看到NDI的強勁實力。我們的續約業務依然取得了巨大成功,這些都是我們期望推動業務未來發展的關鍵績效指標。

  • Operator

    Operator

  • Steve Lichtman with Oppenheimer.

    史蒂夫·利希特曼與奧本海默公司合作。

  • Steve Lichtman - Analyst

    Steve Lichtman - Analyst

  • Thank you evening guys. I guess for for my one question wanted to touch on pharmacy, a lot of progress, that you noted there. Can you talk about the next steps for that initiative, any 2025 goals on coverage you can share and you know how you see, now that you're at that 20% mark, how you see that playing out here in the in the coming quarters.

    謝謝各位晚上好。我想問的一個問題是,關於藥學,正如您所提到的,藥學領域取得了很大的進步。您能否談談該計劃的下一步計劃?能否分享一下 2025 年的覆蓋率目標?現在你們已經達到了 20% 的目標,你們認為在接下來的幾個季度裡,這一目標將如何實現?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thanks for the question, Steve. I'll take that one. So, yes, I think we're really focused on pharmacy. We recognize that out of pocket cost matters and we're really pleased with the strong progress we're making in the pharmacy. This year is the first year that we can offer multi channel DME and pharmacy benefit plan coverage.

    謝謝你的提問,史蒂夫。我選那個。是的,我認為我們確實非常專注於藥學領域。我們認識到自付費用很重要,我們對藥房取得的顯著進展感到非常滿意。今年是我們首次能夠提供多通路耐用醫療設備和藥品福利計劃保障。

  • And the good news is we now have patients receiving product through the pharmacy. It's a really important step. It's a win for Tandem, certainly because we believe it allows us to offer better access and experience and we do think it will help us with our win rate with both healthcare professionals and patients. But it's obviously a huge win for patients, right, because those that have been on MDI and haven't been able to go on good cost barriers, it's been something we've been focused on. So yes, we've signed multiple contracts with leading PBMs.

    好消息是,現在患者可以透過藥局獲得產品。這是非常重要的一步。這對 Tandem 來說無疑是一次勝利,因為我們相信這能讓我們更好地提供便利的訪問和體驗,而且我們認為這將有助於提高我們在醫療保健專業人員和患者中的成功率。但這對患者來說顯然是一個巨大的勝利,對吧?因為對於那些一直在使用 MDI 但無法獲得良好費用保障的患者來說,這正是我們一直關注的問題。是的,我們已經與多家領先的藥品福利管理公司簽訂了合約。

  • That translates to roughly 20% of covered lives across various lines of business, both commercial and government. And we're activating our co pay assistance capability as well to serve that market. So we have those plans obviously pulled through that with our field teams and for this year driving scale and efficiency in the pharmacy remains a top priority.

    這意味著在商業和政府等各個行業中,約有 20% 的受保人受到保險保障。我們同時也啟動共同支付援助計劃,以服務該市場。因此,我們已經制定了這些計劃,並與我們的現場團隊一起落實到位。今年,提高藥局的規模和效率仍然是我們的首要任務。

  • Operator

    Operator

  • Brooks O'Neil with Lake Street Capital Markets.

    布魯克斯·奧尼爾,來自湖街資本市場公司。

  • Brooks O'Neil - Analyst

    Brooks O'Neil - Analyst

  • Hey, good afternoon, guys. This is Erin on the line for Brooks. Thanks for taking my question. You, you've mentioned in the past that the Mobi pump compared to TSE in the long term will be, roughly 10 to 15% lower manufacturing costs and the cartridge being about roughly 20%. Can we expect to see some meaningful margin improvement from those conversions this year, recognizing the guide does call for margin improvement, but, just looking to digest that a little bit. Thanks guys.

    嘿,各位下午好。這是艾琳在布魯克斯的電話那頭。謝謝您回答我的問題。您之前提到過,從長遠來看,與 TSE 相比,Mobi 泵的製造成本大約會降低 10% 到 15%,而墨盒的成本大約會降低 20%。我們能否期待今年這些轉換率能帶來一些實質的利潤率提升?雖然指南確實要求提高利潤率,但我們還是想再仔細消化一下。謝謝各位。

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

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

  • Sure. Thanks for the question, Aaron. So you do have it correct in terms of the ultimate at scale, lower manufacturing costs for Mobi compared to t:slim. As we built up this year, we were facing headwinds with Mobi having that higher per unit cost mostly because of the overhead that we were absorbing. But I can say as we exited 2024 and going into 2025, the pump itself will start to become accretive.

    當然。謝謝你的提問,亞倫。所以,就規模化生產而言,你的說法是正確的,Mobi 的製造成本比 t:slim 更低。今年發展過程中,我們遇到了一些不利因素,Mobi 的單位成本較高,主要是因為我們承擔了較高的管理費用。但我可以肯定地說,隨著我們告別 2024 年進入 2025 年,經濟泵本身將開始變得有利可圖。

  • And that's part of the contribution to the margin improvement in 2025. The cartridges on the other hand still have a way to go before they scale up enough to start showing that benefit, which will begin in 2026. And so this is a multi year margin expander for us, but everything that we're seeing we're absolutely on the right track to achieving those targets for the Mobi pump.

    這也是2025年利潤率提高的部分原因。另一方面,墨盒距離大規模生產並開始展現其優勢還有很長的路要走,而這一優勢要到 2026 年才會開始顯現。因此,這將為我們帶來多年的利潤成長,但我們目前看到的一切都表明,我們絕對走在實現 Mobi 水泵目標的正確道路上。

  • Operator

    Operator

  • Matt Miksic with Barclays.

    馬特·米克西奇(Matt Miksic)就職於巴克萊銀行。

  • Matt Miksic - Analyst

    Matt Miksic - Analyst

  • Thanks so much for taking the question and congrats on a really great finish despite the the ebbs and flows that you mentioned in December. So I wanted to ask a question about you mentioned some of the additional new product innovations that kind of baked into your guidance for this year. So maybe highlight what some of those are. And then also one of the questions we get often is without putting a finer point on the arrival of SIgi is kind of the pathway of Sigi. It's going to use, I suppose, the current algorithms Control IQ plus now, but maybe what other hoops and hurdles that it has to get through in order to get to market?

    非常感謝您回答這個問題,也祝賀您儘管經歷了您提到的12月份的起伏,但仍然取得了非常出色的成績。所以我想問一個問題,您提到了一些額外的新產品創新,這些創新也融入了您今年的指導方針中。所以,或許可以重點介紹其中的一些內容。此外,我們經常被問到的一個問題是,如果不更詳細地說明 SIgi 的到來,那就是 SIgi 的發展路徑。我想它會使用目前的 Control IQ Plus 演算法,但為了推向市場,它或許還需要克服哪些其他障礙和困難?

  • Does that involve a large clinical trial? Maybe just some high level background on what the pathway is to bring Sigi eventually to The US? Thanks so much.

    這是否需要進行大規模臨床試驗?或許可以簡單介紹一下將 Sigi 最終引入美國的途徑?非常感謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Good thing, Matt. Well, first of all, we're really excited about the launch of Control IQ and that's going to be happening here in a matter of weeks. And it has enhancements to the algorithm that sort of the usability of the product personalization and also it will enable children two years and older to start to use Control IQ as well as people who have Type two. So very excited about that. I'd say following Control IQ plus we intend to implement FreeStyle Libre three on t:slim and that then will be followed on to Mobi.

    幸好如此,馬特。首先,我們對 Control IQ 的發布感到非常興奮,它將在幾週內在這裡發布。它還對演算法進行了改進,提高了產品個性化的可用性,並且使兩歲及以上的兒童以及患有二型糖尿病的人能夠開始使用 Control IQ。對此我感到非常興奮。我想說,繼 Control IQ Plus 之後,我們打算在 t:slim 上實現 FreeStyle Libre 3,然後將其移植到 Mobi 上。

  • And then we also are working on the Android version for Mobi, which will be available in this year as well. So all we feel very good about these. We think that they're going to be meaningful improvements to the sort of the appeal of the products and drive significant revenue growth opportunities in the market. In addition to that, we're also rolling out Tandem Source and Mobile OUS, which we're excited about. And I think that that's been happening now and I think that we're going to be going country by country as we get into the year.

    此外,我們也正在開發 Mobi 的 Android 版本,該版本也將在今年推出。所以我們對這些都感覺非常好。我們認為這些改進將顯著提升產品的吸引力,並為市場帶來巨大的收入成長機會。除此之外,我們還將推出 Tandem Source 和 Mobile OUS,對此我們感到非常興奮。我認為這種情況現在已經發生了,而且我認為隨著今年的進行,我們將逐一進行考察。

  • We did also, as I mentioned, file for CE Mark for MOBE. And so certainly there's uncertainty that comes along with the MDR certifications in Europe, they've gotten more complex over time. But we would expect to hopefully have that on the market OUS before the end of the year. So those are a lot that's a lot going on here for the 2025 and we think it's really meaningful progress and I think it's our commitment to innovation. The question is about Sigi.

    正如我之前提到的,我們也為 MOBE 申請了 CE 標誌。因此,歐洲的 MDR 認證確實存在不確定性,而且隨著時間的推移,它們變得越來越複雜。但我們預計,希望在年底前能將該產品推向美國境外市場。所以,2025 年有很多事情正在發生,我們認為這是真正有意義的進步,我認為這是我們對創新的承諾。問題是關於Sigi的。

  • Sigi is going to be an ACE pump, so it's going to be interoperable. And so just like t:slim and Mobi, once it's approved as an interoperable pump, we can use any of our approved algorithms on it and we would intend to do that. And so, it's still a little ways away. So any enhancements that happen to Control IQ or any additional improvements we make to algorithms in the meantime will be available on Sigi as soon as it does come to market. I hope that answers your question.

    Sigi 將是一款 ACE 泵,因此它將具有互通性。因此,就像 t:slim 和 Mobi 一樣,一旦它被批准為可互通的泵,我們就可以在上面使用我們任何已批准的演算法,我們也打算這樣做。所以,距離目標還有一段距離。因此,Control IQ 的任何增強功能,或我們在此期間對演算法進行的任何額外改進,都將在 Sigi 上市後立即在 Sigi 上提供。希望我的回答能解答你的疑問。

  • Operator

    Operator

  • David Roman with Goldman Sachs.

    David Roman,任職於高盛集團。

  • Unidentified Participant

    Unidentified Participant

  • Good afternoon. This is Phil on for David, thank you for taking the question. I thought I'd go to the OUS business, some solid outperformance in 4Q versus your guidance. But if I do the math, even if adjusting for the direct to the distributor to direct transition that's contemplated, it still represents some slowing year over year trying to adjust out some of the 2023 one time distributor in France. I guess the question is what's contemplated in the underlying there with renewal becoming a more meaningful part of the opportunity?

    午安.這裡是菲爾,替大衛回答問題,謝謝你回答這個問題。我想去看看 OUS 業務,第四季業績遠超您的預期。但如果我計算一下,即使考慮到正在考慮的從直接分銷商到直接銷售的過渡,這仍然代表著逐年放緩,試圖調整一些 2023 年法國一次性分銷商的影響。我想問題在於,在更新成為更有意義的機會的一部分的過程中,背後究竟蘊含著什麼?

  • Is there maybe some expectation for slowing ahead of the Mobi rollout and launch OUS? Thanks for taking the question.

    在 Mobi 系統推出和 OUS 上線之前,是否有可能出現速度放緩的情況?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, Phil. I'll acknowledge first, there have been a lot of moving parts in our business outside The US. Over the past couple of years and in 2025 as well.

    當然。謝謝你,菲爾。首先我要承認,我們在美國以外的業務涉及很多方面。過去幾年以及 2025 年都是如此。

  • But I'll say from the perspective of the market, it's still vastly under penetrated and we've been demonstrating great strength and traction. If you think about where our business has been coming from in the past few years, it's really almost all new customers to tandem. And so renewals only began to be a contribution in 2025.

    但從市場角度來看,這個市場滲透率仍然很低,我們已經展現了強大的實力和發展動能。如果你想想我們過去幾年的業務來源,你會發現幾乎全部都是新客戶。因此,續約直到 2025 年才開始成為一項貢獻。

  • And so we do anticipate there will be disruption this year as we execute on this transition to going direct in preparation for 2026. But outside of that, we feel very strongly about our opportunity in those markets and we'll continue to push forward there.

    因此,我們預計今年在執行向直接發行過渡以準備 2026 年的過程中會出現一些混亂。但除此之外,我們對在這些市場的機會充滿信心,我們將繼續在這些市場努力前進。

  • And so as we start the year, we're always thoughtful when we put our guidance into place about what the risks and opportunities are for the business and putting more weight to the risks and this is true for the whole worldwide business. And that's reflected in how we built the guide for 2025 for OUS, but we do believe there's a great opportunity for us to grow.

    因此,在新的一年伊始,我們在製定指導方針時總是深思熟慮,考慮業務面臨的風險和機遇,並更加重視風險,這對於整個全球業務都是如此。這一點也體現在我們為 OUS 制定 2025 年發展指南的方式上,但我們確實相信我們有很大的發展機會。

  • Operator

    Operator

  • Chris Pascal with Nephron Research.

    Chris Pascal,來自 Nephron Research。

  • Chris Pasquale - Analyst

    Chris Pasquale - Analyst

  • Thanks. I wanted to ask about the US sales force expansion and clarify how far along you are in that process today and how we should think about the timing of any potential disruption associated with that. And then given the news about Type two, does this give you the coverage that you need to really capitalize on that opportunity and call on the primary care physicians who manage a lot of those patients or you're going to need to do more to really get at that opportunity?

    謝謝。我想詢問一下美國銷售團隊擴張的情況,並澄清一下目前該進程進展到什麼程度,以及我們應該如何看待與此相關的任何潛在幹擾的時間安排。鑑於目前關於第二型糖尿病的消息,這是否能為您提供所需的保障,讓您真正抓住這個機會,聯繫那些管理大量此類患者的初級保健醫生?或者您還需要做更多工作才能真正抓住這個機會?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Mark, why don't you take that?

    馬克,你為什麼不拿走?

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • A a lot for the question. There's a couple of questions in there. So, yes, I mean, when we step back, we felt like it was the appropriate time to selectively invest in the field force expansion, just based on the potential of the portfolio. Also just looking at what competition is doing with their sales forces. We know this market is a promotionally sensitive market and frankly we had realigned in several years.

    這個問題回答得很多。裡面有幾個問題。所以,是的,我的意思是,當我們回顧過去時,我們覺得現在是根據投資組合的潛力,有選擇地投資於現場人員擴張的合適時機。同時,也要關注競爭對手在銷售團隊方面的措施。我們知道這個市場對促銷活動非常敏感,坦白說,我們已經在幾年內調整了策略。

  • So the realignment will do create optimization and efficiencies as you get through a realignment process. And then the expansion is clearly going to give us some boost in increasing our share of voice. And what's important here is this has been allow us to really call on the right high growth HCPs, the ones where we believe have the greatest potential and growth opportunity as we've missed some of those or haven't called on them in the prior years.

    因此,在重組過程中,重組確實會帶來最佳化和效率提升。而此次擴張顯然將有助於我們提高市場佔有率。重要的是,這使我們能夠真正聯繫到合適的、高成長的醫療保健專業人員,那些我們認為具有最大潛力和成長機會的醫療保健專業人員,因為我們錯過了其中一些,或者在前幾年沒有聯繫過他們。

  • So and the realignment and expansions allows us to really go deeper in each of those more high potential accounts. Now in terms of disruption, I mean, this was very front and center and we did this expansion in quarter four.

    因此,透過重新調整和擴張,我們可以真正深入研究每一個高潛力客戶。就顛覆性創新而言,我的意思是,這非常突出,我們在第四季度進行了擴張。

  • So we start this year right now with higher share voice. We are completed in the expansion about 95%- plus there. So it's live. And we are very intentional on how we went about this to ensure that we minimize disruption. In quarter four, the field teams were focused on selling and so there was no impact to Q4.

    所以,我們今年伊始就擁有了更高的市佔率。擴建工程已完成約 95% 以上。直播開始了。我們非常謹慎地處理此事,以確保將幹擾降到最低。第四季度,銷售團隊專注於銷售,因此對第四季沒有造成影響。

  • And we've got a really good experienced team on board that knows how to manage realignments and expansions. And so that continues to serve us well now into the second month of the year. I'll try to comment on the future sales force expansion.

    我們擁有一支非常優秀的、經驗豐富的團隊,他們知道如何管理重組和擴張。因此,這項措施在現在到今年第二個月仍然對我們很有幫助。我會盡量就未來銷售團隊的擴張發表一些看法。

  • I think, hey, we continuously evaluate share voice needs, what competition is doing in line with our growth and profitability goals. For now in Type two, we're really primarily focused on those high insulin prescribers.

    我認為,我們會不斷評估市場佔有率需求,以及競爭對手的動向,以符合我們的成長和獲利目標。目前,在二型糖尿病領域,我們主要關注的是那些大量使用胰島素的醫生。

  • Think of this more than those and endo like PCPs. But what is very important is we designed this sales force restructure and alignment. It's designed with the Type two expansion in mind as well as as we expand in pharmacy. So down the road, we can easily scale up over time if we want to put more share of voice into primary care. But for the time being, we're focused on the immediate core market.

    想想這些,而不是那些和內分泌科醫生之類的PCP。但非常重要的是,我們設計了這次銷售團隊重組和調整。它的設計考慮到了二型糖尿病的擴張,以及我們在藥房的擴張。因此,從長遠來看,如果我們想讓基層醫療擁有更大的話語權,我們可以隨著時間的推移輕鬆擴大規模。但就目前而言,我們專注於眼前的核心市場。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo

    拉里·比格爾森,富國銀行

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Good afternoon. Thanks for taking the question. Hey John, I wanted to focus on the Type two launch and opportunity in the US. So the mid single digit growth in new starts, how much is contemplated from Type two?

    午安.感謝您回答這個問題。嘿,約翰,我想重點談談美國第二類疫苗的上市和市場機會。因此,新開工量實現個位數中段成長,第二類專案預計能帶來多少成長?

  • How long is the pilot going to last, John? And Type two, I think about 5% to 10% of new starts today for you guys. For Pod, it's 30% now. Is there any reason your percent of new starts from Type two can't increase to 30% in the next few quarters? Thanks.

    約翰,試播集會持續多久?至於第二種類型,我認為今天你們這裡新開的病例大約佔 5% 到 10%。Pod 目前是 30%。未來幾季,你們第二類新啟動專案的比例為何不能提升到 30%?謝謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Yes. Let me go ahead and just kick it off and I'm going to hand it over to Lee and Mark to add some insights from their perspective. First thing I want to do about Type two is I want to thank the FDA because this was a stressful time for them as you might imagine. And I think they did a great job of getting this through their system. And those guys are just as committed to helping people with diabetes as we are.

    是的。讓我先拋磚引玉,然後把麥克風交給 Lee 和 Mark,讓他們從各自的角度補充一些見解。關於二型糖尿病,我首先要感謝美國食品藥物管理局(FDA),因為正如你所能想像的那樣,這對他們來說是一段壓力很大的時期。我認為他們在通過他們的系統方面做得非常出色。他們和我們一樣,都致力於幫助糖尿病患者。

  • So just hats off to them. That being said, as you said, Larry, it's a large underpenetrated market. It's about 5% penetrated in the US, essentially doubles our addressable market. And the great thing about Control IQ is it brings the same benefits that people with Type one have experienced to the Type two community.

    所以,我真要向他們致敬。話雖如此,正如你所說,拉里,這是一個滲透率很低的大型市場。目前該產品在美國的滲透率約為 5%,這實際上使我們的潛在市場翻了一番。Control IQ 最棒的地方在於,它將 1 型人格障礙患者所體驗到的益處帶給了 2 型人格障礙患者群體。

  • And I think that as we've seen it over the last couple over the last year or so as we've done marketing research, we're finding that people who have type two are more willing to consider pump therapy. And so in the past, we might have said that we can get from 5% maybe to 15%. I think that with this the new smaller, easier to use technology in the market, we think we can get to over 25% in the next three point five years. So, I think that with that, I think I'll let Mark talk a little bit more about our go to market strategy and we'll go from there. Mark, I think you're on mute.

    而且我認為,正如我們在過去一年左右的時間裡進行市場調查所看到的那樣,我們發現患有二型糖尿病的人更願意考慮使用胰島素幫浦治療。所以過去我們可能會說,我們可以達到 5% 到 15% 的水平。我認為,隨著市場上這種體積更小、更易於使用的新技術的出現,我們認為在未來三年半內,市場份額可以達到 25% 以上。所以,我想接下來就讓馬克再多談談我們的市場進入策略,我們再從那裡開始討論。馬克,我覺得你靜音了。

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Thank you. I just will echo the gratitude and the excitement we have about being able to scale our impact in Type two diabetes. And you know, we'll soon, you know, in this quarter in March begin our Type two pilot launch activities and, you know, we'll scale that based on how things go and based on various performance KPIs.

    謝謝。我只想再次表達我們對能夠擴大在二型糖尿病領域的影響的感激和興奮之情。你知道,我們很快就會在本季度,也就是三月份,開始我們的第二類試點啟動活動,並且,你知道,我們將根據情況和各種績效KPI來擴大規模。

  • As I mentioned earlier, we're going to target, you know, high insulin prescribers. A big focus is going to be around activating and expanding the pharmacy channel, recognizing how important that is for Type one and Type two and work to establishing a sustainable Medicare pathway to broaden coverage.

    正如我之前提到的,我們將重點放在那些大量開胰島素處方的醫生。重點將放在活化和擴大藥房管道上,認識到這對一型和二型糖尿病患者的重要性,並努力建立可持續的醫療保險途徑以擴大覆蓋範圍。

  • There is naturally a lot of market development work in this particular category of Type two. So we've recognized with our other industry partners, we have our work cut out for us. That's going to take some time to develop the market and to ensure that we've got really good long term growth potential. But we're excited to roll out the results we will be presenting next month in Amsterdam, ATTD. We're really excited about unveiling those results.

    第二類產品這個特定類別自然有許多市場開發工作要做。因此,我們和其他產業夥伴都意識到,我們還有很多工作要做。開發市場需要一些時間,以確保我們有良好的長期成長潛力。但我們很高興能夠公佈下個月在阿姆斯特丹舉行的 ATTD 大會上將要展示的研究成果。我們非常興奮地向大家公佈這些結果。

  • And then of course, all the follow on medical communication, clinical training and so forth that comes along with it. So, you know, we have a big year ahead of us. And the last thing I think we'll say is that we do recognize that the population needs here in type two are different from type one. We're approaching it and we're committed to serving this population with tailored solutions.

    當然,還有隨之而來的所有後續醫療溝通、臨床訓練等等。所以,你知道,我們未來一年將面臨巨大的挑戰。最後我想說的是,我們確實認識到第二類人群的需求與第一類人群的需求不同。我們正在著手解決這個問題,並致力於為這個群體提供量身定制的解決方案。

  • Operator

    Operator

  • Shagun Singh with RBC.

    Shagun Singh 與 RBC 合作。

  • Shagun Singh - Analyst

    Shagun Singh - Analyst

  • Great. Thank you so much for taking the question. I wanted to touch on the 2025 guidance and I appreciate you guys have those base case guidance philosophy. You've factored in some of the headwinds, but is it possible for you to share maybe a range of outcomes like given that you have Type two, you have the OUS renewal opportunity, Libre integration, the pharmacy channel where you're making progress? Anything you can share on the range of outcomes or to help us really put that into those opportunities into perspective for 2025 would be helpful.

    偉大的。非常感謝您回答這個問題。我想談談 2025 年的指導意見,我很欣賞你們這些基本情況的指導理念。你已經考慮到了一些不利因素,但你能否分享一下可能出現的各種結果,例如,考慮到你患有二型糖尿病,你有機會獲得 OUS 續簽,Libre 整合,以及你在藥房渠道取得的進展?如果您能分享一些關於各種結果的信息,或者幫助我們真正從 2025 年的角度看待這些機遇,那將非常有幫助。

  • Thank you.

    謝謝。

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

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

  • Sure. Happy to take the question. So from a guidance perspective, to your point, we looked very closely at what are the predictable recurring revenue streams to start. And obviously renewals have been something that we have a consistent track record with that will already just because of the new opportunities in 2025 create a step up in growth. Consistency in our supply sales from our very large installed base of over 480,000 people.

    當然。樂意回答這個問題。所以從指導的角度來看,正如您所說,我們非常仔細地研究了哪些是可預測的經常性收入來源,以便啟動專案。顯然,續約一直是我們擁有良好記錄的事情,而僅僅因為 2025 年的新機遇,就將帶來成長的飛躍。我們擁有超過 48 萬用戶的龐大裝置量,因此供應銷售穩定。

  • And then when we thought about the new factors, if you want to call it, are the new product and feature introductions that we have in 2025, we're super excited about all of these opportunities Type two, the new products, the pharmacy initiatives. But some of these are really multi year contributors and we're just getting started. Mark just talked about the pilot for Type two. Pharmacy was at a very beginning phase, really building out the infrastructure and just testing the waters there, if nothing else here in the first quarter at least. And so from a guidance perspective, we factored in modest contribution from those in 2025.

    然後,當我們考慮新的因素時,如果你願意這麼稱呼的話,那就是我們在 2025 年推出的新產品和新功能,我們對所有這些機會都感到非常興奮,第二類機會,新產品,藥房計劃。但其中有些人是多年的長期貢獻者,而我們才剛起步。馬克剛才談到了二型機的試運轉情況。藥局業務還處於起步階段,主要在建設基礎設施,試探市場反應,至少在第一季是如此。因此,從指導的角度來看,我們考慮了 2025 年的適度貢獻。

  • And so what's important, I think, is it really is the impact it could have on new starts for Tandem and we factored in about a mid single digit growth in new starts year over year, in the US, I should say in particular.

    所以我認為,真正重要的是它對 Tandem 新業務啟動的影響,我們考慮到了新業務啟動量每年大約會有中等個位數的成長,尤其是在美國。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • And Shagun, this is not unusual. We've done this in the past where we were pressing hard to get these systems into the market and to benefit from them. But until we have evidence and understand exactly how they're going to affect us, we're going to take a more conservative position.

    沙貢,這並不罕見。我們過去也曾這樣做過,當時我們努力將這些系統推向市場並從中獲利。但是,在獲得證據並確切了解它們將如何影響我們之前,我們將採取更保守的立場。

  • Operator

    Operator

  • Matthew Taylor with Jeffrey.

    馬修泰勒和傑弗裡。

  • Unidentified Participant

    Unidentified Participant

  • Good afternoon, guys. This is also Matt on for Matt Taylor. We wanted to ask a little bit about the integration with Libre users, especially those not on the pump. So maybe if you can help us understand how that launch has progressed thus far and maybe the kind of momentum you're seeing about it and maybe how you think about this from a guidance perspective in terms of it being a driver of your new starts next year?

    下午好,各位。這也是馬特為馬特泰勒主持的節目。我們想了解 Libre 用戶(特別是那些不使用胰島素幫浦的用戶)的整合情況。所以,您能否幫助我們了解一下該專案目前的進展情況,以及您看到的良好勢頭,並從指導角度考慮,您認為該專案能否推動您明年的新專案啟動?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Thanks. Yes. We have Libre two integrated today with t:slim and we're working on bringing Libre three to market here in the relatively near future. I think that the availability of the product is going to be it will be shipped on new pumps and it also be made available to people who currently own pumps through a software upgrade. Right now though, if you look at the installed base in the US for Freesite Liberty three, there's roughly 300,000 or 400,000 people who have who use the system, use the sensor that have Type one who don't use pumps.

    謝謝。是的。目前我們已經將 Libre 2 與 t:slim 集成,並且我們正在努力在不久的將來將 Libre 3 推向市場。我認為該產品的供應方式是:它將隨新泵一起發貨,同時也將透過軟體升級的方式提供給目前擁有泵的用戶。不過,就目前而言,如果你看一下美國 Freesite Liberty 3 的安裝基數,大約有 30 萬到 40 萬人使用該系統,使用 1 型感測器,但不使用水泵。

  • And so I would say that there is a large market development opportunity to collaborate with Abbott as we bring this technology to market and we see the benefits. So if you look out over time, we've said we can get upwards of close to a million people using our technology and these 400,000 people in the US.

    因此,我認為與雅培合作將這項技術推向市場並帶來益處,存在著巨大的市場開發機會。所以從長遠來看,我們說過,我們可以讓近一百萬人使用我們的技術,而這四十萬人就在美國。

  • Represent a big part of that. And so we will be working closely with Abbott and our own sales team to make sure that we take advantage of that.

    這其中有很大一部分是原因。因此,我們將與雅培公司和我們自己的銷售團隊密切合作,確保我們充分利用這一優勢。

  • Operator

    Operator

  • Mike Kratkey with Leering Partners.

    Mike Kratkey,來自 Leering Partners。

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Hi, everyone. Thanks for taking our questions. Maybe just to go back to an earlier one on understanding the dynamics of the fourth quarter. I think you mentioned the unexpected timing of revenue reporting in the fourth quarter, but it looks like the guidance for 1Q is still down about over 20% at the midpoint in the US.

    大家好。謝謝您回答我們的問題。或許應該回顧一下先前關於理解第四季動態的文章。我想你提到了第四季度營收報告發佈時間出乎意料的情況,但看起來美國第一季的業績預期仍然比預期中位數下降了20%以上。

  • So was there anything specific that fundamentally contributed to that December weakness that you saw? And I think you mentioned that there was no impact to your 4Q sales from the sales force realignment. So just wanted to clarify what's giving you the confidence that that's the case.

    那麼,你認為導致12月份疲軟的具體因素有哪些呢?我想你之前也提到過,銷售團隊重組對第四季的銷售額沒有產生任何影響。所以我想弄清楚是什麼讓你確信情況就是這樣。

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

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

  • Mark, would you like to talk about the commercial environment a bit in the fourth quarter going into first?

    馬克,你能否談談第四季到第一季的商業環境?

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Yes, of course. Happy to Lee. And thanks for the question, Mike. So, yes, I mean, as John and Lee both pointed to some of the things that happened in Q4, I mean, there was a little bit of a muting on the seasonality. I think I step back and I reflect on the full year.

    是的當然。很高興認識李。謝謝你的提問,麥克。是的,我的意思是,正如約翰和李都指出的第四季度發生的一些事情一樣,季節性因素有所減弱。我想我會退後一步,回顧整整一年。

  • And there are some macro factors that I think we continue to observe that continue to be a challenge. I mentioned out of pocket costs for patients and how important it is to make these accessible. And so that's really underscored the importance for us to strengthen our position in pharmacy. And so I think that played into some parts of it. I think overall from a competitive standpoint, I think we recognize that first of all, this is like a super large under penetrated growth market.

    而且,我認為我們持續觀察到的一些宏觀因素仍然構成挑戰。我提到了患者需要自付的費用,以及讓這些費用變得可負擔的重要性。因此,這更加凸顯了我們加強在藥學領域地位的重要性。所以我認為這在某種程度上影響了結果。我認為從競爭的角度來看,我們首先要認識到,這是一個規模龐大但滲透率極低的成長市場。

  • There's going to be some entrance here and there. And we continue to see kind of two large competitors, a new one that's been scaling. But we feel good. We feel like we're holding our own. And as Lee mentioned, despite December, I mean, it was still a really good, I think, month.

    這裡那裡會有一些入口。我們看到兩大競爭對手,以及一家正在快速擴張的新競爭對手。但我們感覺很好。我們感覺自己還能應付。正如李所提到的那樣,儘管十二月不太順利,但我認為它仍然是一個非常好的月份。

  • In fact, it was like the largest shipment month we had all year and with really sizable growth versus last year's December in 2023. So the underlying fundamentals we feel good about it was a record quarter, helping year over year and quarter over quarter growth. We really like what we're seeing on the MDI side and of course from a renewal perspective.

    事實上,這是我們全年出貨量最大的一個月,與去年 2023 年 12 月相比,成長幅度相當可觀。因此,我們看好的基本面是,本季創下歷史新高,這有助於實現同比增長和環比增長。我們非常滿意 MDI 方面的情況,當然,從更新的角度來看也是如此。

  • Operator

    Operator

  • Danielle and Antalffy with UBS.

    Danielle 和 Antalffy 與瑞銀集團合作。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Hey, good afternoon guys. Thanks so much for taking the question. Just to follow-up on the Type two opportunity, just curious, so I appreciate there's still a lot of market development to happen and you guys are going to pilot this and all that. But just curious about and by the way, congrats on getting that approval. How to think about what's important to a Type two patient based on the small percentage of patients that you have on pump today and some of the market research you've already done from a feature perspective, time and range versus pharmacy versus footprint of the pump, flexibility, etcetera.

    嘿,各位下午好。非常感謝您回答這個問題。關於第二類機會,我只是想進一步了解一下,我知道還有很多市場開發工作要做,你們也會進行試點等等。只是好奇問問,順便恭喜你獲得批准。如何根據目前使用胰島素幫浦的二型糖尿病患者比例較小,以及您已經從功能角度進行的一些市場調查,來思考二型糖尿病患者最重視的是什麼,例如輸液時間和範圍與藥房、胰島素幫浦佔地面積、靈活性等等。

  • And also, how a patient utilizes that pump? Is it pretty in line with what you see from type one like 20, three 60 five? Or is there some different adoption patterns we should be or utilization, excuse me, patterns we should be considering? Thank you so much.

    還有,病人是如何使用這個幫浦的?它和您從第一種類型(例如 20、3、60、5)中看到的情況是否相當一致?或者,我們是否應該考慮一些不同的採用模式,或者,抱歉,是使用模式?太感謝了。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Mark, I'll just kick that off and hand it over to you. But I would just say that a couple of things are important to people with Type one. First of all, I think it's the simplicity of the system. It really does have to be easy to use. Discretion is another very important factor, so therefore it needs to be small and convenient.

    馬克,我這就開始,然後交給你。但我只想說,對於患有第 1 型糖尿病的人來說,有兩件事很重要。首先,我認為是系統的簡潔性。它確實必須易於使用。隱蔽性是另一個非常重要的因素,因此它需要小巧便捷。

  • And I think the financial elements are something that we need to deal with. So I think that when you look at this, we've got Mobi. It is small. It's convenient. We're moving into the pharmacy channel.

    我認為財務問題是我們需要解決的。所以我覺得,當你審視這一切時,我們會發現我們有了 Mobi。它很小。很方便。我們正在進軍藥局渠道。

  • It is addressing some of the out of pocket expenses that the Type two community will have to deal with. And I think that we feel pretty well positioned to take advantage of this marketplace, and I think we're going to kick off this pilot and learn a lot more. But I think it's one of those opportunities that we think it's giant for us and we're excited to be on it. Mark, you want to add anything to that?

    它旨在解決二型糖尿病患者群體需要承擔的一些自付費用。我認為我們已經做好充分準備,能夠充分利用這個市場,我認為我們將啟動這個試點項目,並從中學習到更多東西。但我認為這是一個對我們來說意義重大的機會,我們很高興能參與其中。馬克,你還有什麼要補充的嗎?

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Yeah, thanks John. I think you know. The only thing I would add is that we're going to two points is that from a portfolio perspective, what we feel good about is that we can offer choice and that is one similarity between type one and type two is that not one size fits all.

    謝謝你,約翰。我想你知道的。我唯一要補充的是,我們要談兩點,從投資組合的角度來看,我們感到滿意的是我們可以提供選擇,而第一類和第二類之間的一個共同點是,沒有一種模式適合所有人。

  • And that we through our market research recognize that there are unique segments in type one, but also in type two. And in some cases, type two really favor a larger reservoir with 300 units of insulin and they like the onscreen compatibility and use of t:slim. Others we know were going to really like Mobi because of its small form factor and its versatile wear. So I think we feel good about being able to offer that choice.

    我們透過市場調查發現,第一類產品中存在獨特的細分市場,第二類產品中也存在獨特的細分市場。在某些情況下,二型糖尿病患者喜歡容量較大的胰島素儲液罐(300 單位胰島素),他們也喜歡 t:slim 的螢幕相容性和使用體驗。我們知道其他人也會非常喜歡 Mobi,因為它體積小巧,佩戴方式多樣。所以我覺得我們很欣慰能夠提供這樣的選擇。

  • And as we load up more CGM integration on Mobi, we believe that's going to be equally important. The other point I'd say is that you know, we have a lot of experience working with Type two. As I think we've shared before, we've got about 30,000 people living with Type two using our technology today. And so we've got great experience training them, working with them. We understand some of the important nuances to deliver compelling and effective training.

    隨著我們在 Mobi 上加載更多 CGM 整合功能,我們認為這一點同樣重要。我想說的另一點是,我們有很多與二型人格障礙患者合作的經驗。正如我們之前分享過的,目前大約有 3 萬名患有二型糖尿病的人正在使用我們的技術。因此,我們在培訓他們、與他們共事方面累積了豐富的經驗。我們了解一些重要的細節,能夠提供引人入勝且有效的訓練。

  • And we're naturally looking at how to scale that, digitize it, modernize it, and make it the best experience possible.

    我們自然會考慮如何擴大規模、數位化、現代化,並使其成為最佳體驗。

  • Operator

    Operator

  • Jason Bedford with Raymond James.

    Jason Bedford 與 Raymond James 合作。

  • Jayson Bedford - Analyst

    Jayson Bedford - Analyst

  • Good afternoon. Just maybe on the pharmacy, the 20% of lives is bigger than I thought. So I guess my question is, how does this impact the P&L and your guidance in 2025? Meaning, is it a driver of revenue growth? Does it impact margins? Or is it just a little early right now?

    午安.或許在藥房,那20%的生命比我想像的還要多。所以我想問的是,這會對2025年的損益表和業績指引產生什麼影響?也就是說,它是否是營收成長的驅動因素?這會影響利潤率嗎?或者現在是不是還太早?

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

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

  • Thanks for the question, Jason. So I'll start by saying we're very pleased with the progress we've already made acquiring these contracts coming into the year. And we're still in the very early stages. And so from a guidance perspective, we have only factored in very modest contribution from a volume and an ASP perspective. But I think that's the point as we look forward, this complements our channel strategy and will help us drive towards meeting our future profitability goals.

    謝謝你的提問,傑森。首先我想說,我們對今年以來在獲取這些合約方面取得的進展感到非常滿意。我們目前仍處於非常早期的階段。因此,從指導的角度來看,我們只考慮了銷售量和平均售價方面非常有限的貢獻。但我認為,展望未來,這正是關鍵所在,它將完善我們的通路策略,並幫助我們實現未來的獲利目標。

  • And I think most importantly, overcome the affordability question for many patients. So the 60% of people in the Type one not using pumps today, there's a cost sensitivity there and this gives us that opportunity to really lower that out of pocket cost and drive more people to pump therapy.

    而且我認為最重要的是,要解決許多患者的經濟承受能力問題。因此,目前有 60% 的 1 型糖尿病患者未使用胰島素泵,這其中存在成本敏感性,而這給了我們一個真正降低自付費用並促使更多人使用胰島素泵治療的機會。

  • Operator

    Operator

  • William Plovanic, Canaccord Genuity

    威廉‧普洛瓦尼克,Canaccord Genuity

  • William Plovanic - Analyst

    William Plovanic - Analyst

  • Great. Thanks. Good evening. Thanks for taking my question. I want to go back to the pharmacy.

    偉大的。謝謝。晚安.謝謝您回答我的問題。我想再去一趟藥局。

  • You've been signing these contracts. I think one of the questions I get is, how does this impact cash flow? Typically, if with the Pay We Go product, you'll get you have a capital piece. Do you get paid that capital piece up front or is that smoothed over the length of the contract? And then, so how is this going to impact your free cash flow?

    你一直在簽署這些合約。我覺得我常被問到的問題之一是,這會對現金流產生什麼影響?通常情況下,如果您選擇「先買後付」產品,您將獲得一部分本金。那筆資金是一次性付清,還是在合約期間內分期支付?那麼,這將如何影響你的自由現金流呢?

  • And how are you thinking about longer term, just the business in general? I mean, I see it seems like as you're crossing that chasm into positive free cash flow, you're taking the opportunity to transition the international business, realign the US sales force, kind of like turning '25 into a transition year. Is this just taking the incremental free cash available and investing in the business now for leverage in the future?

    那麼,您對長遠發展,也就是整個業務的發展,有什麼想法呢?我的意思是,我覺得你似乎正在跨越那道鴻溝,實現正自由現金流的同時,也藉此機會轉型國際業務,重組美國銷售團隊,有點像把 2025 年變成一個過渡年。這是否只是利用現有的額外自由現金流,對企業進行投資,以便將來獲得更大的槓桿效應?

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

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

  • Yes, yes. Couple of really good questions. I can touch on the pharmacy very quickly. The pharmacy gives us the opportunity to think about our business model and our structure and how reimbursement may work. At this point, the volume we've anticipated is very small and there's no change to the business model that we have in place.

    是的,是的。幾個非常好的問題。我可以很快地談談藥房的情況。藥局讓我們有機會思考我們的商業模式、組織結構以及報銷機制。目前,我們預期的交易量非常小,我們現有的商業模式沒有任何改變。

  • So, bottom line, no cash flow impact with the contracts that we kicked off right now. And then to your point on the long term of the business, and this is more generally about cash flow, there are very important things that we need to do to set up the business appropriately to drive that long term growth to meet our ambitions for growing top line.

    所以,總而言之,我們目前啟動的合約不會對現金流產生任何影響。至於您提到的業務長期發展問題,以及更普遍意義上的現金流問題,我們需要做一些非常重要的事情來妥善安排業務,以推動長期成長,從而實現我們提高營收的目標。

  • Again, we are always looking for ways to make those investments but fund them in other ways with cost saving initiatives. And so as we turn the corner to being free cash flow positive again this year, we look forward to the opportunity to be able to make these investments that will have multi year benefit for the organization. We also have initiatives in place so that we can show a bit of leverage in 2025 even in this investment year.

    我們一直在尋找進行這些投資的方法,但希望透過其他方式,例如採取節約成本的措施,來為這些投資提供資金。因此,隨著我們今年再次實現自由現金流為正,我們期待有機會進行這些投資,這些投資將為公司帶來多年的收益。我們也制定了一些舉措,以便即使在今年的投資年,我們也能在 2025 年展現出一定的影響力。

  • Operator

    Operator

  • Mike Polark with Wolf Researcher

    麥克·波拉克與狼研究員

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Good afternoon. Just one model question. I appreciate the 2025 guidance comment mid single digit growth expectation for new US pumpers.

    午安.僅舉一例。我很欣賞您對 2025 年美國新幫浦市場實現個位數中等成長的預期。

  • We all stab at this number, but we had interested if you're willing to comment on 2024 US new pumpers. What was the growth rate either for the full year or in the fourth quarter?

    我們都對這個數字進行猜測,但我們很想知道您是否願意對 2024 年美國新泵送者發表評論。全年或第四季的成長率是多少?

  • Thank you for taking the questions.

    感謝您回答這些問題。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Sure, great question, Mike. And so what I can share about new pumpers, so we've often talked about our sources of growth being renewal and new pumpers, and within new pumpers we often break it down into NDI and competitive conversions.

    當然,問得好,麥克。關於新客戶,我可以分享一些資訊。我們經常談到,我們的成長來源是客戶更新和新客戶,而在新客戶中,我們通常將其細分為 NDI 和競爭對手轉換。

  • Our focus is purely on MDI conversions. 2024 was a year where we knew, we anticipated, and we saw that competitive conversions would start to decline purely because the op. CUNY was declining, and so our focus is driving the growth of the business through the NDI conversions. NDI did return to growth in the second quarter, each of the quarters Q2, Q3, and Q4, and it was double digit growth year over year. And so that's one of the key underpinnings as we thought about the 2025 guide, in building, in that build up.

    我們只關注 MDI 的轉換率。 2024 年,我們預料到競爭轉換率會開始下降,這完全是因為營運成本的增加。CUNY 的業務正在下滑,因此我們的重點是透過 NDI 轉換來推動業務成長。NDI在第二季度恢復成長,第二季、第三季和第四季均實現成長,並且較去年同期成長兩位數。因此,這是我們在構思 2025 年指南、建構和建構過程中最重要的基礎之一。

  • Operator

    Operator

  • Matthew O'Brien with Piper Sandler.

    馬修·奧布萊恩和派珀·桑德勒。

  • Matthew O'Brien - Analyst

    Matthew O'Brien - Analyst

  • Afternoon, thanks for taking the question. It's a two parter as well. I just want to be clear about a couple of things that you've said on the call. The Q4 end of year impact that you saw, I'm just wondering if that wasn't competitive specifically with another durable pump company in the market with a good product there, the halo effect that's probably happening on the patch pump side of things.

    下午好,謝謝您回答這個問題。它也是分為兩部分的。我只想澄清一下你在電話裡提到的一些事情。我看到的第四季末的影響,我只是在想,這是否是因為市場上另一家耐用泵公司擁有優秀的產品而造成的競爭,以及補片泵方面可能出現的光環效應。

  • Is that something you saw in Q4 that's lingering here somewhat into Q1 and could impact the full year? And then secondly, the guide, Lee, if I look at the number of additional pump sales you need to make this year, I know there'll be a little bit more bump from the renewal cycle, but it's also at a time you've got a restructured sales force where that didn't go well for one of your CGM partners recently. And it just is assuming a big, big ramp in the back half of the year especially that I think a lot of folks are going to be concerned about you being able to hit without getting a massive tailwind from Type 2s and a massive tailwind on the pharmacy side. So how do we get comfortable you can do all that again with a restructured sales force? Thanks.

    這是您在第四季度觀察到的,並且延續到第一季度,可能會對全年產生影響的現象嗎?其次,Lee,如果我看一下你今年需要增加的泵銷量,我知道續約週期會帶來一些增長,但與此同時,你的銷售團隊也進行了重組,而最近你的一個 CGM 合作夥伴在這方面做得併不好。而且,假設今年下半年出現大幅成長,我認為很多人會擔心,如果沒有第二型糖尿病患者和藥劑師的巨大助力,你是否能夠取得成功。那麼,我們該如何確信,在重組銷售團隊後,你們還能再次做到這一切呢?謝謝。

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

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

  • Sure. Great question, Matt. I'll keep it back. Mark may want to chime into it. So first of all, from the sales force expansion perspective and the impact on 2025, we did anticipate there could be disruption.

    當然。問得好,馬特。我會把它藏起來。馬克或許也想發表一下意見。首先,從銷售團隊擴張的角度來看,以及對 2025 年的影響,我們確實預料到可能會出現一些混亂。

  • No matter how well you plan or execute, there can be a little bit of turbulence initially as people are going out and meeting their docs and getting acquainted with their new territories and realignments. I'd mark and speak to how diligent we were in how we are executing on this. But we factored in, in the beginning of the year that it could be a bit more disruptive.

    無論你的計劃和執行多麼周全,最初都可能會有一些動盪,因為人們要出去與醫生見面,熟悉新的領域和重新調整後的安排。我會重點表揚並說明我們在執行這項工作時是多麼認真負責。但我們在年初就考慮到,這可能會造成更大的干擾。

  • And so to that point, on the ramp across the year, it's partially seasonality, taking into consideration the impact we saw at the end of 2024 with a little bit muted seasonality really in just the last few weeks of the year, but also assuming that these with the territory realignments and the expansion, we'll start to see more productivity as they get to the back half of the year. And so to that Q4 softness, I would say, there's a myriad of factors that contributed.

    因此,就全年而言,這部分是季節性的,考慮到我們在 2024 年底看到的影響,季節性確實在年底的最後幾周有所減弱,但也假設隨著區域重新調整和擴張,隨著下半年到來,我們將開始看到更高的生產力。因此,我認為造成第四季疲軟的原因有很多。

  • It's hard to pinpoint a single one. It wasn't it has been across the year an increasingly competitive environment. Mark mentioned the macro factors we've seen across recent years, more and more people becoming sensitive to cost, use of high deductible plans and such. There are so many things, but I can't say if there's any one thing that turned on a dime in those last few weeks. It just was a little bit more muted than what we've seen in the past.

    很難具體指出是哪一個。過去一年來,競爭環境日益激烈。馬克提到了近年來我們看到的一些宏觀因素,例如越來越多的人對成本變得敏感,使用高免賠額計劃等等。有很多事情,但我不能說在過去的幾周里,有沒有任何事情發生了翻天覆地的變化。與我們過去看到的相比,這次的氣氛稍微低調一點。

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Yes, I would just say that nothing changed competitively throughout the year. I mean, it was basically it was static and I think that we held our own. Certainly, there's a lot of competition, but I think we held our own.

    是的,我想說的是,這一年裡,競爭格局沒有任何改變。我的意思是,基本上比賽是靜態的,我認為我們表現得還不錯。當然,競爭非常激烈,但我認為我們表現得還不錯。

  • Operator

    Operator

  • Josh Jennings with TD Cowen

    喬許詹寧斯與TD Cowen

  • Joshua Jennings - Analyst

    Joshua Jennings - Analyst

  • Hi, good evening. I wanted to ask on the Type two indication. I guess first just to ask you your views on the basal opportunity. Is that in play with the current label? Or do you need to show more data for Control IQ to be approved there and for you to take advantage of that opportunity?

    您好,晚上好。我想諮詢一下關於二型適應症的問題。我想先問問您對基礎治療機會的看法。這與目前的標籤有關嗎?或者,您是否需要提供更多數據才能讓 Control IQ 獲得批准,並讓您抓住這個機會?

  • And maybe just touch on type two coverage for tendon pumps, where it stands and when it will be full? Thanks a lot.

    或許還可以簡單談談肌腱幫浦的二類保險覆蓋情況,目前的狀況以及何時才能全面覆蓋?多謝。

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Yes. Josh, the approval we got was for type two diabetes in general for insulin use with type two using our algorithm. And so it involves it's all insulins and it's all manners in which insulin can be delivered either through basal bolus. So it's all there. And so, I think basal only is something that's not necessarily an area we're focused on.

    是的。Josh,我們獲得的批准是針對二型糖尿病患者使用胰島素治療二型糖尿病的,使用的是我們的演算法。因此,它涉及所有胰島素,以及所有可以透過基礎胰島素、餐前胰島素等方式輸送胰島素的方法。所以一切都在那裡。因此,我認為基礎免疫力並非我們關注的重點領域。

  • But if we decide to, then we can do that with this album. Lee, you want to just comment on?

    但如果我們要這麼做,那麼我們可以透過這張專輯來實現。李,你想就此發表一下看法嗎?

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

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

  • Sure. The Type two coverage. And so I'll say first and foremost, from a commercial perspective, there it's pretty much the same coverage as it would be for a Type one. So there aren't any real limitations from a Type two perspective. From a Medicare perspective, there's still some onerous requirements.

    當然。第二種類型的保險。因此,首先我要說的是,從商業角度來看,它的覆蓋範圍與 Type 1 幾乎相同。所以從第二類角度來看,並沒有什麼真正的限制。從聯邦醫療保險的角度來看,仍然存在一些繁瑣的要求。

  • And we are engaged and working actively with other industry players in order to get changes made with that national coverage determination, which has been received by CMS and is on the docket for review. We just don't yet have any color today on when they will actually get to it. So we are working hard to pursue that improved coverage overall.

    我們正在積極與其他行業參與者合作,以期對國家醫療保險覆蓋範圍決定進行修改。該決定已提交給 CMS,目前正在進行審查。目前我們還無法確定他們何時才能真正著手處理此事。因此,我們正在努力追求整體上更好的覆蓋範圍。

  • Operator

    Operator

  • Jeff Johnson with Baird.

    Jeff Johnson 與 Baird 合作。

  • Jeff Johnson - Analyst

    Jeff Johnson - Analyst

  • Hey, thank you. Good afternoon, guys. Congrats on the Type two coverage. I wanted to focus another question there, which I apologize. I know a lot of the questions have been on Type two.

    嘿,謝謝。下午好,各位。恭喜您獲得二型糖尿病保險。我原本想在那裡提出另一個問題,對此我深感抱歉。我知道很多問題都跟第二類有關。

  • But I've really been trying to game this out. And John, I'd love to hear your thoughts or anyone else's thoughts. If I look over the last two point five years up until six months ago, both you and your biggest AID competitor essentially were off label for Type two.

    但我一直在努力仔細推敲這件事。約翰,我很想聽聽你的想法,或是其他人的想法。如果我回顧過去兩年半的時間,直到六個月前,你和你最大的 AID 競爭對手基本上都是在進行二型糖尿病的超適應症用藥。

  • And I think during that time, as best I can break out numbers, you guys were winning about 25% share of the Type two new starts that were coming in, the other company winning maybe 75%. Now when you're both going to be on label, do you think those shares shift, I think a rising tide is going to help everybody, but do you think that 25%, 75% split or maybe my math's off a little bit, but somewhere in there, does that share shift or does the share shift at all now that you're both going to be competing on label and how is it different if you're both on label versus maybe six, nine months ago when you were both off label?

    我認為在那段時間裡,根據我所能統計的數據,你們贏得了大約 25% 的二類新啟動市場份額,而另一家公司可能贏得了 75%。現在你們兩個都要簽約唱片公司了,你覺得唱片份額會改變嗎?我覺得整體收益上漲對大家都有好處,但你覺得25%、75%的份額分配(或者我的計算可能有點偏差)會改變嗎?或者說,現在你們兩個都要簽約唱片公司了,份額會有任何變化嗎?如果你們兩個都簽了唱片公司,和六個月前、九個月前你們倆都還沒簽約的時候相比,有什麼不同?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Yes. The first thing I'll say is what I mentioned a moment ago and that is that certainly as new technology comes to market, it's smaller, it's more convenient to use and the therapy benefits are substantial. We believe more and more people are coming to market.

    是的。首先我要說的就是我剛才提到的,隨著新技術的出現,它體積更小、使用更方便,而且治療效果也更顯著。我們相信越來越多的人會進入市場。

  • So the opportunity is big and I think the penetration is bigger than we had thought it was in the past. I would say when it comes to Type two and on the competition in the marketplace, it really comes back to the pipeline, market access and the things that we're working on.

    所以機會很大,而且我認為市場滲透率比我們過去預想的還要高。我認為,就二型糖尿病和市場競爭而言,關鍵在於研發管線、市場准入以及我們正在努力的方向。

  • And so I would anticipate that we're very confident in our pipeline and we think it's going to be more competitive as more of these features and systems comes to market. So I think that, I think we're going to begin to take more share on Type two and in Type one.

    因此,我預計我們對我們的產品線非常有信心,並且我們認為隨著更多此類功能和系統推向市場,競爭將會更加激烈。所以我認為,我們將開始在第二類和第一類市場佔據更大的份額。

  • Operator

    Operator

  • Travis Steed with Bank of America.

    特拉維斯·斯蒂德,美國銀行。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Hey, thanks for taking the question. I did want to ask on the gross margin ramp over in the course of 2025, I think it's 51% in Q1 and 54% for the full year, just if there's any other additional color on that. And then the impetus for why doing the sales force expansion now, I don't know if there was a specific reason why now is the time to do it, if it was related to Type two or if it's what you're seeing in the competitive environment. And if you're calling on more primary care doctors or if it's all kind of just focused on deeper with the endos?

    嘿,謝謝你回答這個問題。我想問一下關於 2025 年毛利率成長的情況,我認為第一季是 51%,全年是 54%,請問這方面還有其他補充資料嗎?至於為什麼現在要擴大銷售隊伍,我不知道是否有具體的原因,也不知道是因為第二種原因,還是因為競爭環境的緣故。如果你要聯絡更多的初級保健醫生,或者所有治療都集中在更深入的內分泌治療上呢?

  • John Sheridan - President, Chief Executive Officer, Director

    John Sheridan - President, Chief Executive Officer, Director

  • Yes. Thanks for the question, Travis. I'll start with the gross margin and turn it over to Mark from the commercial expansion perspective. For gross margin, what you typically see in, again, I'll say, the normal year is that gross margin improves across the quarters as pump sales ramp in the US, with pumps being the highest gross margin contributor.

    是的。謝謝你的提問,崔維斯。我先從毛利率說起,然後從商業擴張的角度交給馬克分析。就毛利率而言,通常情況下,我再說一遍,正常年份的情況是,隨著美國泵浦銷量的成長,毛利率會逐季提高,而泵浦是毛利率貢獻最大的產品。

  • In 2025, in particular, we have probably the added benefit of Mobi scaling up across the year. So as we sell more and more Mobi pumps, that will also provide even greater contribution to the margin. So we're starting the year at 51%. And I think I'd like to point out that that's flat to what we just demonstrated in the fourth quarter when usually we take a bit of a step back in Q1 for gross margin. So we're at a new starting point for the year and confident in our ability to deliver on that.

    尤其是在 2025 年,我們可能會迎來 Mobi 在一年內不斷擴大規模的額外好處。因此,隨著我們銷售的 Mobi 水泵越來越多,這將對利潤率做出更大的貢獻。所以今年年初我們的佔比是 51%。我想指出的是,這與我們剛剛在第四季度展示的情況持平,而通常情況下,我們在第一季的毛利率會略有下降。所以,我們今年迎來了一個新的起點,並且對我們實現目標的能力充滿信心。

  • So Mark?

    那麼,馬克?

  • Unidentified Corporate Representative

    Unidentified Corporate Representative

  • Yes. Thanks, Travis, for the question. I think the timing was right for us to do this at the end of last year and set up ourselves for 2025. I think it's a combination of factors of timing. I mean, number one is that we do think the portfolio has got a lot of potential.

    是的。謝謝特拉維斯的提問。我認為去年底是我們做這件事的合適時機,可以為2025年做好準備。我認為這與時機等多種因素有關。我的意思是,第一點是我們認為該投資組合具有很大的潛力。

  • We're really excited about what we can offer with our technology. And the market is promotionally sensitive. We know that, we've done our research, we understand it. And there is an efficiency play here too. We haven't realigned in several years.

    我們對利用我們的技術所能提供的產品感到非常興奮。而且市場對促銷活動非常敏感。我們知道這一點,我們已經做過調查,我們理解它。這裡也存在著提高效率的問題。我們已經好幾年沒有進行調整了。

  • And what that sort of means is that the marketplace has grown and changed tremendously over the last few years. And for us to recut territories and alignment creates greater efficiency for our sales teams, gives them better workload balance, they have better reach and frequency and can just really concentrate on those high potential accounts, but it's really important. And then secondly, we believe we needed some extra share voice in order to compete and continue in this current market within the US. And alongside that is also new tools and capabilities.

    這意味著,在過去幾年裡,市場發生了巨大的成長和變化。重新劃分銷售區域和調整銷售策略,可以提高銷售團隊的效率,更好地平衡工作量,擴大銷售範圍和頻率,讓他們能夠真正專注於那些高潛力客戶,這真的非常重要。其次,我們認為我們需要一些額外的市場份額才能在美國當前的市場中競爭並繼續發展。同時,還有新的工具和功能。

  • It's not just about sales force expansion. As John mentioned, we've been piloting a number of different tools to better understand and segment HCPs and help enrich our messaging, new selling tools. And so, again, we feel good starting this year where we have stronger share of voice. We know exactly where to go, what to say, how to say it with a bunch of high impact tools that really can support the field.

    這不僅是銷售團隊擴張的問題。正如約翰所提到的,我們一直在試用多種不同的工具,以便更好地了解和細分醫療保健專業人員,並幫助豐富我們的訊息傳遞和新的銷售工具。所以,我們再次感到欣慰,因為今年我們擁有了更大的話語權。我們非常清楚該去哪裡,該說什麼,該怎麼說,並且擁有一系列能夠真正支援該領域的高效工具。

  • Operator

    Operator

  • Thank you. I'm showing no further questions in the queue at this time.

    謝謝。目前隊列中沒有其他問題了。

  • Thank you all for part thank you all for participating. This concludes today's program. You may now disconnect.

    感謝大家的參與。今天的節目到此結束。您現在可以斷開連線了。