Insulet Corp (PODD) 2023 Q3 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation Third Quarter 2023 Earnings Call. (Operator Instructions) As a reminder, this conference call is being recorded.

    女士們、先生們,下午好,歡迎參加 Insulet Corporation 2023 年第三季財報電話會議。 (操作員說明)謹此提醒,本次電話會議正在錄音。

  • I would now like to turn the conference over to your host, Deborah Gordon, Vice President, Investor Relations.

    現在我想將會議交給東道主、投資者關係副總裁黛博拉·戈登 (Deborah Gordon)。

  • Deborah R. Gordon - VP of IR

    Deborah R. Gordon - VP of IR

  • Thank you. Good afternoon and thank you for joining us for Insulet's Third Quarter 2023 Earnings Call. With me today are Jim Hollingshead, President and Chief Executive Officer; and Lauren Budden, our Interim Chief Financial Officer and Treasurer.

    謝謝。下午好,感謝您參加 Insulet 的 2023 年第三季財報電話會議。今天與我在一起的有總裁兼執行長 Jim Hollingshead;以及我們的臨時財務長兼財務主管 Lauren Budden。

  • Both the replay of this call and the press release discussing our quarterly results and our guidance will be available on the Investor Relations section of our website. Also on our website is our third quarter supplemental earnings presentation. We encourage you to reference that document for a summary of key metrics and business updates.

    本次電話會議的重播以及討論我們季度業績和指導的新聞稿將在我們網站的投資者關係部分提供。我們的網站上還有我們的第三季補充收益演示。我們鼓勵您參考該文件以獲取關鍵指標和業務更新的摘要。

  • Before we begin, we would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and could materially differ from current expectations. Please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such statements.

    在我們開始之前,我們想通知您,Insulet 在本次電話會議中所做的某些陳述可能具有前瞻性,並且可能與當前的預期有重大差異。請參閱我們向 SEC 提交的文件中的警示性聲明,以了解此類聲明固有局限性的詳細說明。

  • We'll also discuss non-GAAP financial measures with respect to our performance, namely adjusted gross and operating margins, adjusted EBITDA and constant currency revenue, which is revenue growth, excluding the effect of foreign exchange. These measures align with what management uses as supplemental measures in assessing our operating performance, and we believe they are helpful to investors, analysts and other interested parties as measures of our operating performance from period to period.

    我們還將討論與我們的績效相關的非公認會計準則財務指標,即調整後的毛利率和營業利潤率、調整後的 EBITDA 和固定貨幣收入(即收入成長,不包括外匯影響)。這些指標與管理階層在評估我們的經營績效時所使用的補充指標一致,我們相信它們對投資者、分析師和其他利害關係人作為衡量我們不同時期經營績效的指標很有幫助。

  • Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year reported basis with the exception of revenue growth rates, which will be on a year-over-year constant currency basis.

    此外,除非另有說明,所有有關美元和百分比變化的財務評論均將以同比報告為基礎,但收入增長率除外,收入增長率將以同比固定貨幣為基礎。

  • With that, I'll turn the call over to Jim.

    這樣,我就把電話轉給吉姆。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Deb. Good afternoon and thank you for joining us. Q3 was another strong quarter for Insulet with rapid growth and achievement of many strategic milestones. Thanks to our global team's execution, dedication and focus, we are on track to complete another transformational year and enter 2024 with significant momentum.

    謝謝,黛布。下午好,感謝您加入我們。第三季度是 Insulet 的另一個強勁季度,實現了快速成長並實現了許多戰略里程碑。由於我們全球團隊的執行力、奉獻精神和專注力,我們有望完成另一個轉型年,並以強勁勢頭進入 2024 年。

  • On today's call, I want to do 3 things: discuss our financial results and market traction, provide an update on our continuing progress in clinical and market access work and review key developments in our innovation pipeline.

    在今天的電話會議上,我想做三件事:討論我們的財務表現和市場吸引力,提供我們在臨床和市場准入工作方面持續進展的最新情況,並回顧我們創新管道的關鍵進展。

  • Our third quarter revenue exceeded our expectations with total Omnipod growth of over 27%, including U.S. growth of 35%. We also achieved total company growth of 25%. These are remarkable results, especially coming in the context of our strong prior year comparables. As a result, we raised guidance once again for the full year.

    我們第三季的營收超出了我們的預期,Omnipod 總營收成長超過 27%,其中美國成長了 35%。我們也實現了 25% 的公司整體成長。這些都是令人矚目的成果,尤其是在我們去年的可比業績強勁的背景下。因此,我們再次上調了全年指引。

  • Performance was driven primarily by the huge success of Omnipod 5, our revolutionary automated insulin delivery system. It is gratifying to see the positive impact Omnipod 5 is having as it continues to simplify and improve the lives of people with diabetes, and we are only in the early innings.

    性能主要得益於我們革命性的自動化胰島素輸送系統 Omnipod 5 的巨大成功。我們很高興看到 Omnipod 5 所產生的正面影響,因為它不斷簡化和改善糖尿病患者的生活,而我們只處於早期階段。

  • Q3 represented the anniversary of the U.S. launch of our Omnipod 5 platform. Omnipod 5 is the only FDA-cleared, fully disposable, pod-based AID system, and it continues to transform diabetes management. Its simplicity, ease of use, widespread and affordable access and improved real-world outcomes have made Omnipod 5 the leading AID offering on the market. With the added benefits of U.S. pharmacy channel access, pay-as-you-go model and an easy onboarding pathway, Omnipod 5 makes it simple and efficient for health care practitioners, patients and payers to conveniently prescribe, access and afford our breakthrough technology.

    第三季是我們在美國推出 Omnipod 5 平台的週年紀念。 Omnipod 5 是唯一一款經 FDA 批准、完全一次性、基於 Pod 的 AID 系統,它不斷改變糖尿病管理。 Omnipod 5 的簡單性、易用性、廣泛且經濟實惠的存取以及改進的現實結果使 Omnipod 5 成為市場上領先的 AID 產品。憑藉美國藥房通路准入、即用即付模式和輕鬆入門途徑的額外優勢,Omnipod 5 使醫療保健從業者、患者和付款人能夠簡單高效地方便地開處方、獲取和支付我們突破性技術的費用。

  • We are now also beginning the global rollout of Omnipod 5 in our international markets, starting with the U.K. this past June. With one full quarter under our belts in the U.K., we are seeing very strong early adoption. In Q3, Omnipod 5 drove accelerated new customer starts in the U.K., taking revenue growth to almost 45% year-over-year and driving approximately 70% sequential growth in new customer starts. It's a strong early sign of the global power of Omnipod 5 to transform diabetes care.

    我們現在也開始在國際市場上全球推廣 Omnipod 5,今年 6 月先在英國推出。在英國已經有整整一個季​​度的時間,我們看到了非常強勁的早期採用率。第三季度,Omnipod 5 推動了英國新客戶數量的加速成長,營收年增近 45%,並推動新客戶數量較上季成長約 70%。這是 Omnipod 5 改變糖尿病護理的全球力量的強烈早期跡象。

  • During Q3, we also commenced the rollout of Omnipod 5 in Germany in August, and early momentum is exciting. Based on these results, we are confident that Omnipod 5 will emerge as the market-leading offer everywhere it is available.

    在第三季度,我們還在 8 月開始在德國推出 Omnipod 5,早期勢頭令人興奮。基於這些結果,我們相信 Omnipod 5 將成為市場領先的產品。

  • The success of Omnipod 5 led to another outstanding quarter of new customer starts both in the U.S. and globally. In the U.S., Omnipod 5 continue to represent the vast majority of our new customer starts in Q3, and customer retention remains strong. In the U.S. in Q3, Omnipod new customer starts coming from multiple daily injections and legacy tubed pumps was an estimated 80-20 percentage split, which is in line with our historical mix.

    Omnipod 5 的成功帶動了美國和全球新客戶數量又一個出色的季度成長。在美國,Omnipod 5 繼續代表第三季新客戶的絕大多數,且客戶保留率仍然很高。在美國,第三季度,Omnipod 新客戶開始來自於每日多次注射,而傳統管式幫浦的比例估計為 80-20%,這與我們的歷史組合相符。

  • Omnipod was specifically designed for individuals on MDI and as expected, we are driving pump penetration across all age groups in both the type 1 and type 2 markets while also growing our share, positioning Insulet as a leader in these markets. We estimate that we are the clear leader in bringing customers into the market from MDI.

    Omnipod 專為使用MDI 的個人而設計,正如預期的那樣,我們正在推動泵在1 型和2 型市場中所有年齡段的滲透率,同時也擴大我們的份額,將Insulet 定位為這些市場的領導者。我們估計,在將客戶引入 MDI 市場方面,我們無疑是領先者。

  • In addition to growing awareness of Omnipod and high product demand among patients, a growing number of HCPs are writing scripts for it. In Q3, we saw another increase in prescribers, growing to over 17,000, up from over 15,000 in Q2. In a market where there are 7,000 to 8,000 endocrinologists, this shows the broad appeal and ease of prescription of Omnipod 5. Importantly, this extensive reach is critical to access patients who are not seen at the high-volume pump-prescribing clinics that historically defines the pump market.

    除了患者對 Omnipod 的認識不斷提高和產品需求旺盛之外,越來越多的 HCP 正在為其編寫腳本。在第三季度,我們看到處方醫生數量再次增加,從第二季度的 15,000 多人增加到 17,000 多人。在擁有7,000 至8,000 名內分泌科醫生的市場中,這顯示了Omnipod 5 的廣泛吸引力和處方便利性。重要的是,這種廣泛的覆蓋範圍對於接觸那些在歷史上定義的大容量泵處方診所看不到的患者至關重要幫浦市場。

  • Omnipod 5's broad appeal is also evidenced by the growing number of scripts that these HCPs write for our system. Omnipod loyalty amongst Podders has been a hallmark of our brand for many years, and it is great to see the growing demand and confidence amongst the prescribing HCPs. In fact, an increasing number tell us that when given the choice, their patients overwhelmingly choose Omnipod.

    這些 HCP 為我們的系統編寫的腳本數量不斷增加也證明了 Omnipod 5 的廣泛吸引力。多年來,Podders 對 Omnipod 的忠誠度一直是我們品牌的標誌,很高興看到處方 HCP 的需求和信心不斷增長。事實上,越來越多的人告訴我們,當有選擇時,他們的患者絕大多數選擇 Omnipod。

  • Our results in Q3 also strengthen our conviction that we'll be able to reach the millions of people with type 2 diabetes who need insulin therapy as a part of their care. In the quarter, Omnipod adoption in the type 2 market continued at a steady pace with type 2 patients representing approximately 20% of our U.S. new customer starts. These new customer starts come from across our Omnipod portfolio of products, demonstrating the clear benefits that our products offer the type 2 population.

    第三季的結果也堅定了我們的信念,我們將能夠惠及數百萬需要胰島素治療作為護理一部分的 2 型糖尿病患者。本季度,Omnipod 在 2 型市場的採用繼續穩步推進,2 型患者約占美國新客戶的 20%。這些新客戶來自我們的 Omnipod 產品組合,展示了我們的產品為 2 型人群帶來的明顯好處。

  • Omnipod DASH continues to be the leading insulin pump offer with an indication for use in the type 2 market. While we can't yet market Omnipod 5 for type 2, the obvious underlying demand for AID in the type 2 market is encouraging. And we look forward to bringing Omnipod 5 to these customers once we complete our pivotal trial and secure an extension to our existing indication for use.

    Omnipod DASH 仍然是領先的胰島素幫浦產品,適用於 2 型市場。雖然我們還無法銷售適用於 2 型的 Omnipod 5,但 2 型市場對 AID 的明顯潛在需求令人鼓舞。我們期待在完成關鍵試驗並確保擴展現有的使用適應症後,將 Omnipod 5 帶給這些客戶。

  • And to that end, we are very excited to announce that we have reached our enrollment goal this week in our U.S. type 2 pivotal study. As a reminder, this is a study of up to 400 participants with a 13-week protocol comparing Omnipod 5 to participants' previous therapy. The feedback from HCPs and study participants continues to be very strong and strengthens our confidence that Omnipod 5 will have a big impact in the critically underserved population of type 2 patients who require insulin. We will provide further updates as the trial progresses.

    為此,我們非常高興地宣布,我們本週已達到美國 2 型關鍵研究的入組目標。提醒一下,這是一項針對多達 400 名參與者的研究,為期 13 週,將 Omnipod 5 與參與者先前的治療進行比較。來自 HCP 和研究參與者的回饋仍然非常強烈,這增強了我們的信心,即 Omnipod 5 將對服務嚴重不足的需要胰島素的 2 型患者群體產生重大影響。隨著試驗的進展,我們將提供進一步的更新。

  • I'd like to make a few comments about the ongoing debate about the impact of GLP-1s on our markets. As we've made clear, we regard the GLP-1 class of drugs as an important innovation for people with type 2 diabetes, and they have been indicated for use in type 2 diabetes for several years. These drugs help many of the same patients we aim to help, and we applaud their innovation.

    我想就有關 GLP-1 對我們市場影響的持續爭論發表一些評論。正如我們已經明確表示的,我們認為 GLP-1 類藥物是針對 2 型糖尿病患者的一項重要創新,多年來它們已被證明可用於治療第 2 型糖尿病。這些藥物幫助了許多我們想要幫助的患者,我們對他們的創新表示讚賞。

  • Further, as a reminder, we believe GLP-1s do not materially impact our end markets. They are not indicated for use in type 1 diabetes, which is an autoimmune disorder, and there is no apparent mechanism for them to impact the course of type 1 as a condition. Likewise, there is no apparent mechanism for GLP-1 drugs to alter the underlying progression of beta cell decline that is characteristic of type 2 diabetes.

    此外,提醒一下,我們認為 GLP-1 不會對我們的終端市場產生重大影響。它們不適用於第 1 型糖尿病(一種自體免疫疾病),也沒有明顯的機制可以影響第 1 型糖尿病的病程。同樣,GLP-1 藥物沒有明顯的機制來改變第 2 型糖尿病特徵性 β 細胞衰退的潛在進展。

  • Last month, we published a short slide presentation going into these issues in more detail. This week, we published an update to those slides based upon data that was recently presented at EASD. In a large retrospective study of 23,000 users of semaglutide, the evidence presented suggests 3 important conclusions.

    上個月,我們發布了一個簡短的幻燈片演示,更詳細地討論了這些問題。本週,我們根據最近在 EASD 上發布的數據發布了這些幻燈片的更新。在一項針對 23,000 名索馬魯肽使用者進行的大型回顧性研究中,所提供的證據提出了 3 個重要結論。

  • First, semaglutide has almost identical impact on glycemic control as liraglutide in terms of the magnitude and duration of A1c reduction. Second, this real-world evidence shows a very clear relationship between dose adherence and glycemic control, such that only the most adherent users receive the level of benefit that has been demonstrated in more controlled clinical settings. Finally and importantly, weight loss and the persistence of weight loss for semaglutide users in this study was demonstrated to be independent of glycemic control.

    首先,就 A1c 降低的幅度和持續時間而言,索馬魯肽對血糖控制的影響與利拉魯肽幾乎相同。其次,這個現實世界的證據表明劑量依從性和血糖控制之間存在非常明確的關係,因此只有最堅持的使用者才能獲得在更受控制的臨床環境中所證明的益處水平。最後也是重要的是,本研究中索馬魯肽使用者的體重減輕和體重減輕的持續性被證明與血糖控制無關。

  • In short, real-world evidence shows that patients using semaglutide continue to have their diabetes progress with limited or no incremental duration of effect over previous drugs, and type 2 diabetes continues to progress even with weight loss. For those who are interested in more detail, we refer you to our updated presentation, which is available on the Insulet Investor page.

    簡而言之,現實世界的證據表明,使用索馬魯肽的患者的糖尿病繼續進展,但與先前的藥物相比,其作用持續時間有限或沒有增加,並且即使體重減輕,2 型糖尿病也會繼續進展。對於對更多詳細資訊感興趣的人,我們建議您參閱我們更新的演示文稿,該演示文稿可在 Insulet Investor 頁面上找到。

  • These data reinforce our existing view. Because the underlying disease continues to progress, most people with type 2 diabetes will eventually need to incorporate insulin into their therapy. Insulet is incredibly well positioned to serve these customers as they progress in their condition and need to add first basal and then intensive insulin into their treatment.

    這些數據強化了我們既有的觀點。由於潛在疾病持續進展,大多數第 2 型糖尿病患者最終需要將胰島素納入治療中。 Insulet 非常適合為這些客戶提供服務,因為他們的病情有所進展,需要在治療中先添加基礎胰島素,然後添加強化胰島素。

  • We are already winning in this market, and we continue to have strong conviction that people with type 2 diabetes represent a large and underserved population. We are continuing our efforts to bring the full power of a broad portfolio of insulin delivery options, including Omnipod DASH, Omnipod 5 and Omnipod GO, which I will come back to in a few moments.

    我們已經在這個市場上取得了勝利,我們仍然堅信 2 型糖尿病患者代表著龐大且服務不足的人群。我們正在繼續努力,充分利用廣泛的胰島素輸送選項組合的全部功能,包括 Omnipod DASH、Omnipod 5 和 Omnipod GO,我稍後會談到這些。

  • In addition to our type 2 pivotal trial, we are progressing several additional clinical initiatives. We are pleased to have completed the protocol with the last participant in our randomized controlled trial using Omnipod 5 with Dexcom's G6. We're in the process of analyzing and preparing the data, which we expect to show the clear benefits of Omnipod 5 therapy over non-AID systems.

    除了我們的 2 型關鍵試驗之外,我們還正在進行其他幾項臨床措施。我們很高興使用 Omnipod 5 和 Dexcom G6 與隨機對照試驗的最後一位參與者完成了協議。我們正在分析和準備數據,我們希望這些數據能顯示 Omnipod 5 療法相對於非 AID 系統的明顯優勢。

  • We are also making great progress with the RADIANT study, which is our Libre 2 integration trial, for which we began enrollment in September. Clinicians have remarked about the simplicity and ease of transition for MDI users to Omnipod 5 in the outpatient setting, including in regions where it is often the norm for AID therapy to occur in the hospital for days due to the complexity of existing tubed pump offerings. We are excited that our integration with Abbott's Libre 2 sensor has advanced to the point where study participants are using the system. Both of these studies will provide the evidence we need to drive pricing and market access initiatives as we launch Omnipod 5 across our international markets.

    我們在 RADIANT 研究方面也取得了巨大進展,這是我們的 Libre 2 整合試驗,我們於 9 月開始入組。臨床醫生表示,MDI 使用者在門診環境中可以簡單輕鬆地過渡到 Omnipod 5,包括在由於現有管式幫浦產品的複雜性而通常需要在醫院進行數天 AID 治療的地區。我們很高興我們與 Abbott Libre 2 感測器的整合已經發展到研究參與者正在使用該系統的程度。當我們在國際市場上推出 Omnipod 5 時,這兩項研究都將為我們提供推動定價和市場准入計畫所需的證據。

  • I'd now like to turn to 3 key areas of innovation for us: expanding the Omnipod 5 platform, moving upstream in the type 2 market with Omnipod GO and driving the future of AID with our advanced algorithm program. The widespread success of Omnipod 5 makes it easy to forget that the current version of our offering is in some ways our minimum viable product. In order to achieve the full promise of the platform, our aim is to expand on customer choice both for phone control and for CGM use.

    我現在想談談我們的 3 個關鍵創新領域:擴展 Omnipod 5 平台、利用 Omnipod GO 在 2 類市場中向上游發展,以及利用我們先進的演算法程式推動 AID 的未來。 Omnipod 5 的廣泛成功使人們很容易忘記我們產品的當前版本在某些方面是我們的最低可行產品。為了實現該平台的全部承諾,我們的目標是擴大客戶對電話控制和 CGM 使用的選擇。

  • In that context, we are excited to have received FDA clearance for our 510(k) for the Omnipod iOS app. This is another major innovation milestone for Insulet, and iOS is one of the most requested features from our customers. We are thrilled to have the opportunity to provide the iOS option to our existing Omnipod 5 customer base as well as future customers. Because the iOS app represents a completely new software platform, we expect to begin a U.S. limited market release in early 2024. And upon successful completion, we will make iOS for Omnipod 5 broadly available as soon as possible.

    在這種背景下,我們很高興針對 Omnipod iOS 應用程式獲得 FDA 510(k) 批准。這是 Insulet 的另一個重大創新里程碑,而 iOS 是我們客戶最需要的功能之一。我們很高興有機會為現有的 Omnipod 5 客戶群以及未來的客戶提供 iOS 選項。由於 iOS 應用程式代表了一個全新的軟體平台,我們預計將於 2024 年初開始在美國有限市場發布。成功完成後,我們將盡快廣泛提供 Omnipod 5 的 iOS。

  • With regard to CGM, our efforts to expand our sensor integrations with our partners, Dexcom and Abbott, continue to steadily progress. I've already mentioned our progress with Libre sensor integration in the context of our European trial. We are also hard at work to complete our integration with Dexcom's G7 sensor, and we are excited to announce that we are planning for a limited market release of Omnipod 5 plus G7 also in early 2024.

    在 CGM 方面,我們與合作夥伴 Dexcom 和 Abbott 擴大感測器整合的努力繼續穩步推進。我已經在歐洲試驗中提到了我們在 Libre 感測器整合方面取得的進展。我們也正在努力完成與 Dexcom G7 感測器的集成,我們很高興地宣布,我們計劃也在 2024 年初在市場上有限發布 Omnipod 5 加 G7。

  • Omnipod 5 is the market-leading offer. And with these coming innovations, we are confident we will be able to maintain and extend that leadership.

    Omnipod 5 是市場領先的產品。透過這些即將到來的創新,我們有信心能夠維持並擴大這一領先地位。

  • A key innovation effort that moves us upstream from AID is Omnipod GO, which is designed to radically simplify the initiation of basal insulin therapy for people who need to start insulin as their type 2 diabetes progresses. Even small penetration into this market will meaningfully contribute to our long-term growth trajectory. We have commenced the commercial pilot for Omnipod GO in the U.S., which includes HCPs that we don't typically call on who are new to Omnipod, most of whom who are primary care physicians.

    Omnipod GO 是推動我們從 AID 向上游邁進的一項關鍵創新工作,它旨在從根本上簡化那些隨著 2 型糖尿病進展而需要開始使用胰島素的患者的基礎胰島素治療的啟動過程。即使對這個市場的滲透很小,也會對我們的長期成長軌跡做出有意義的貢獻。我們已經在美國開始了 Omnipod GO 的商業試點,其中包括我們通常不會拜訪的 HCP,他們是 Omnipod 的新手,其中大多數是初級保健醫生。

  • Our commercial pilot is providing us with the opportunity to present Omnipod GO and also to educate PCPs on all of our Omnipod offerings. Although early in our pilot, PCPs are telling us that Pod therapy is much easier than pump therapy. As a result, these HCPs want to learn about the entire Omnipod portfolio. We expect both Omnipod GO and Omnipod DASH to make the treatment pathway far easier for these type 2 patients. Learnings from our ongoing Omnipod GO commercial pilot will help us to refine our plans for commercialization in 2024.

    我們的商業試點為我們提供了展示 Omnipod GO 以及向 PCP 介紹我們所有 Omnipod 產品的機會。儘管在我們試驗的早期,PCP 告訴我們 Pod 療法比泵療法容易得多。因此,這些 HCP 希望了解整個 Omnipod 產品組合。我們預期 Omnipod GO 和 Omnipod DASH 將使這些 2 型患者的治療途徑變得更容易。從我們正在進行的 Omnipod GO 商業試點中獲得的經驗將幫助我們完善 2024 年商業化計劃。

  • We are continuing to progress work on our next-generation AID algorithm with our EVOLUTION feasibility trial, which we began earlier in the year and which is being conducted in New Zealand. The goal of this feasibility study is to test potential enhancements to the Omnipod 5 algorithm in order to further drive simplicity of use. We've been able to launch this study very early in the life cycle of our AID offerings specifically because of the unique aspects of Omnipod 5, both because the on-market algorithm is highly effective and because of our ability to gather actual usage data from essentially the entire population of Omnipod 5 users. We expect that cloud connectivity for -- of Omnipod 5, coupled with our data sciences capabilities, will allow us to materially accelerate our algorithm development efforts over time.

    我們正在透過 EVOLUTION 可行性試驗繼續推進下一代 AID 演算法的工作,該試驗於今年早些時候開始,目前正在紐西蘭進行。本可行性研究的目標是測試 Omnipod 5 演算法的潛在增強功能,以進一步簡化使用。我們能夠在 AID 產品生命週期的早期啟動這項研究,特別是因為 Omnipod 5 的獨特之處,既因為市場上的演算法非常有效,也因為我們能夠從以下位置收集實際使用數據:基本上是Omnipod 5使用者的全部群體。我們預計 Omnipod 5 的雲端連接,再加上我們的數據科學能力,將使我們能夠隨著時間的推移實質地加速我們的演算法開發工作。

  • Finally, an important update on our intellectual property portfolio, which is a key asset enabling our continued growth. In August, we filed a suit in the U.S. against EOFlow and other affiliated parties to stop the misappropriation of Insulet's proprietary trade secrets. Last month, after requesting preliminary relief and obtaining some initial evidence, the court granted our request for a preliminary injunction against EOFlow, which prohibits EOFlow from manufacturing, marketing or selling to any new customer any product that we designed, developed or manufactured using or relying on Insulet's trade secrets.

    最後,我們的智慧財產權組合的重要更新,這是實現我們持續成長的關鍵資產。 8 月,我們在美國對 EOFlow 和其他關聯方提起訴訟,以阻止盜用 Insulet 的專有商業機密。上個月,在請求初步救濟並獲得一些初步證據後,法院批准了我們對EOFlow 發出初步禁令的請求,該禁令禁止EOFlow 製造、行銷或向任何新客戶銷售我們使用或依賴設計、開發或製造的任何產品關於 Insulet 的商業秘密。

  • The court also extended the prior injunction issue to restrain EOFlow from disclosing to any third party information that contains, derives from or incorporates Insulet's confidential information. In granting Insulet's motion, the court found "very substantial, indeed, strong evidence of misappropriation" and "that Insulet is likely to succeed on the merits of its trade secrets claim."

    法院還擴大了先前的禁令問題,以限制 EOFlow 向任何第三方披露包含、源自或包含 Insulet 機密資訊的資訊。在批准 Insulet 的動議時,法院發現“非常實質性、確實有力的盜用證據”,並且“Insulet 很可能因其商業秘密主張的優點而勝訴”。

  • We have invested considerable resources over many years developing our Omnipod products, and we are confident we have a clear lead technically and in terms of scalability. We will continue to vigorously defend our IP to protect those investments.

    多年來,我們投入了大量資源來開發 Omnipod 產品,我們相信我們在技術和可擴展性方面擁有明顯的領先優勢。我們將繼續大力捍衛我們的智慧財產權,以保護這些投資。

  • In closing, we completed another outstanding quarter, and we have sustained momentum across our business. We are enjoying continued rapid growth in the U.S. type 1 market, and we're seeing accelerating adoption in our international markets where Omnipod 5 is launched. We are also seeing continued growth in the type 2 market across our Omnipod offerings. We are excited about the catalysts coming in 2024 with iOS functionality, CGM integrations and Omnipod GO that unlock a lot of market growth for many years to come. I want to thank our entire Insulet global team for their engagement and hard work as we continue to drive our mission to simplify life for the millions of people with diabetes around the world.

    最後,我們又完成了一個出色的季度,我們的業務保持了持續的成長勢頭。我們在美國 1 型市場持續快速成長,並在推出 Omnipod 5 的國際市場上看到其採用速度加快。我們也看到 Omnipod 產品的 2 類市場持續成長。我們對 2024 年 iOS 功能、CGM 整合和 Omnipod GO 的催化劑感到興奮,這些催化劑將在未來許多年釋放大量市場成長。我要感謝我們整個 Insulet 全球團隊的參與和辛勤工作,因為我們將繼續推動我們的使命,為世界各地數百萬名糖尿病患者簡化生活。

  • Before I turn the call over to Lauren, I want to welcome and congratulate her on her role as our Interim CFO and Treasurer. Lauren is our Chief Accounting Officer and has been with Insulet for close to 5 years. She has long been a key member of our finance team and has contributed significant value to the company and to shareholders during her tenure with us. We are thrilled to have Lauren in this role to support our continued execution of our strategic priorities.

    在將電話轉給勞倫之前,我想歡迎並祝賀她擔任我們的臨時財務長和財務主管。 Lauren 是我們的首席會計官,在 Insulet 工作近 5 年。她長期以來一直是我們財務團隊的關鍵成員,在我們任職期間為公司和股東貢獻了巨大的價值。我們很高興勞倫擔任這一職務,以支持我們繼續執行我們的戰略重點。

  • With that, I will turn the call over to Lauren.

    這樣,我會將電話轉給勞倫。

  • Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

    Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

  • Thanks so much, Jim. It's an honor to serve as interim CFO. As Jim shared, Insulet achieved another quarter of robust growth, financial performance and strategic progress. We once again delivered strong global new customer starts, fueled by huge demand for Omnipod 5 in the U.S. And we are seeing a very nice uptick in new customer starts in the international markets where we launched Omnipod 5.

    非常感謝,吉姆。擔任臨時財務長是我的榮幸。正如吉姆分享的那樣,Insulet 又實現了一個季度的強勁成長、財務表現和策略進展。在美國對 Omnipod 5 龐大需求的推動下,我們再次實現了強勁的全球新客戶成長。在我們推出 Omnipod 5 的國際市場上,我們看到新客戶成長非常強勁。

  • As a result of our growing customer base, we delivered 25% revenue growth in Q3, finishing above the high end of our guidance range. Our outperformance was driven by global Omnipod growth of over 27%. On a reported basis, for total revenue, foreign currency was a 180 basis point tailwind compared to Q3 last year. U.S. Omnipod revenue growth was 35% and exceeded our guidance range.

    由於我們不斷成長的客戶群,我們在第三季實現了 25% 的營收成長,高於我們指導範圍的上限。我們的優異表現是由全球 Omnipod 成長超過 27% 所推動的。根據報告,就總收入而言,與去年第三季相比,外匯帶來了 180 個基點的推動力。美國 Omnipod 營收成長 35%,超出了我們的指導範圍。

  • Revenue growth continues to be driven by our annuity-based model and growing U.S. pharmacy volume. This includes an increase in volume contribution from Omnipod 5 and Omnipod DASH and the related premium for Pods in the U.S. pharmacy. Pharmacy channel access continues to be a competitive advantage, and we remain focused on driving increased volume through this channel, which in Q3 represented between 90% and 95% of our total U.S. volume.

    我們的年金模式和不斷增長的美國藥房銷售繼續推動收入成長。這包括 Omnipod 5 和 Omnipod DASH 銷售貢獻的增加以及美國藥房 Pod 的相關溢價。藥房管道的准入仍然是一種競爭優勢,我們仍然專注於透過該管道增加銷量,該管道在第三季度占我們美國總銷量的 90% 至 95%。

  • Omnipod 5 ramp dynamics resulted in an estimated net tailwind of approximately $10 million, which is in line with what we expected for Q3 guidance. As a reminder, since our launch, we have realized a recurring net volume benefit from new customers as well as from Omnipod customers converting to Omnipod 5, many of whom received their starter kits and first refill orders in the quarter, plus some initial stocking in retail pharmacies. Our estimates have been net of those Omnipod 5 customers who skipped an order in the period.

    Omnipod 5 的斜坡動態預計帶來約 1000 萬美元的淨收益,這與我們對第三季度指導的預期一致。提醒一下,自從我們推出以來,我們已經意識到新客戶以及轉換為Omnipod 5 的Omnipod 客戶帶來了經常性的淨銷量收益,其中許多人在本季度收到了入門套件和首次補充訂單,再加上一些初始庫存零售藥局。我們的估計已扣除在此期間跳過訂單的 Omnipod 5 客戶。

  • In Q3, as we expected, the volume benefit from conversions has been normalizing and was therefore immaterial as the majority of our existing customers already switched to Omnipod 5. Going forward, we expect continued benefit from the 2 script dynamics as we drive Omnipod 5 new customer starts.

    在第三季度,正如我們預期的那樣,轉換帶來的銷售收益已經正常化,因此並不重要,因為我們的大多數現有客戶已經轉向Omnipod 5。展望未來,隨著我們推動Omnipod 5 新的發展,我們預計將繼續受益於2 個腳本動態客戶啟動。

  • In Q3, U.S. attrition and global utilization remained stable. International Omnipod revenue increased 8%, which was above our expectations. Growth was primarily driven by continued strong adoption of Omnipod DASH and, to a smaller degree, incremental benefit from our Omnipod 5 launch in the U.K., which drove a notable increase in new customer starts. These benefits were partially offset by slightly higher attrition as we continue to be impacted by AID competition, including lower distributor orders.

    第三季度,美國的損耗和全球利用率保持穩定。 International Omnipod 營收成長 8%,超出我們的預期。成長主要得益於 Omnipod DASH 的持續強勁採用,以及在較小程度上得益於我們在英國推出的 Omnipod 5 帶來的增量收益,這推動了新客戶數量的顯著增加。由於我們繼續受到 AID 競爭(包括分銷商訂單減少)的影響,因此人員流失率略有上升,部分抵消了這些收益。

  • On a reported basis, foreign currency was a 720 basis point tailwind over the prior year. Drug Delivery revenue declined 27%, which was slightly below our guidance range due to a lower forecast from our partner. Gross margin was 67.8%, up over 1,200 basis points and included income of $1.9 million due to lower estimated costs associated with the medical device corrections we announced last year when we took a charge of approximately $37 million in Q3 last year. Excluding both, gross margin increased 120 basis points to 67.3% in Q3 of this year. This exceeded our expectations due to favorable manufacturing costs and higher-than-expected revenue.

    根據報告,外幣匯率較前一年上漲 720 個基點。由於我們的合作夥伴的預測較低,藥物輸送收入下降了 27%,略低於我們的指導範圍。毛利率為67.8%,成長超過1,200 個基點,其中包括190 萬美元的收入,這是由於我們去年宣布的醫療設備修正相關的估計成本較低,當時我們在去年第三季度收取了約3700 萬美元的費用。剔除兩者後,今年第三季的毛利率成長了 120 個基點,達到 67.3%。由於有利的製造成本和高於預期的收入,這超出了我們的預期。

  • The year-over-year increase in adjusted gross margin was primarily driven by improved manufacturing efficiency and a premium from volume growth in the pharmacy channel. These increases were partially offset by expected higher production costs as U.S. manufacturing continues to ramp and become a larger portion of our total production.

    調整後毛利率的年增率主要是由於製造效率的提高以及藥品通路銷售成長的溢價所推動的。這些成長部分被預期更高的生產成本所抵消,因為美國製造業持續成長並占我們總產量的更大比例。

  • Operating expenses were up year-over-year, in line with our expectations, as we invested in our business to support our strong growth trajectory. Adjusted operating margin was 12.2% and adjusted EBITDA was 19.1%. Both exclude the favorable medical device correction adjustment of $1.9 million and were above our expectations due to higher-than-anticipated revenue and gross margin.

    由於我們投資業務以支持強勁的成長軌跡,營運費用較去年同期成長,符合我們的預期。調整後營業利益率為 12.2%,調整後 EBITDA 為 19.1%。兩者均排除了有利的 190 萬美元醫療器材修正調整,並且由於高於預期的收入和毛利率而高於我們的預期。

  • Turning to cash and liquidity. We ended the quarter with $685 million in cash and the full $300 million available under our credit facility. This strong financial position gives us the flexibility to invest in our innovation pipeline and other key areas of our organization in order to build on our foundation for long-term sustainable growth.

    轉向現金和流動性。本季結束時,我們擁有 6.85 億美元的現金,以及我們信貸額度下可用的全額 3 億美元。這種強大的財務狀況使我們能夠靈活地投資於我們的創新管道和組織的其他關鍵領域,從而為長期可持續成長奠定基礎。

  • Now turning to our 2023 outlook. For the full year, we are raising our expectations for total Omnipod revenue growth to a range of 29% to 30% and total company revenue growth to a range of 26% to 27%. For U.S. Omnipod, we are increasing our revenue growth outlook to a range of 37% to 38%. This increase is primarily driven by continued strong Omnipod 5 adoption stemming from consecutive strong new customer starts and, to a lesser extent, ongoing conversions from other Omnipod products as well as from recurring revenue from Omnipod DASH and the benefits of our pay-as-you-go model in the pharmacy channel.

    現在轉向我們的 2023 年展望。對於全年,我們將 Omnipod 總營收成長預期上調至 29% 至 30%,公司總收入成長至 26% 至 27%。對於美國 Omnipod,我們將營收成長前景提高至 37% 至 38%。這一成長主要是由於Omnipod 5 的採用率持續強勁,這源於連續強勁的新客戶開始,在較小程度上,來自其他Omnipod 產品的持續轉換,以及Omnipod DASH 的經常性收入和我們按使用付費的好處-去藥房渠道的模型。

  • As a reminder, Q4 of last year was the first full quarter of Omnipod 5 sales, contributing to a tougher comparison in the fourth quarter of this year. The prior year included the 2-script benefit, which was in large part due to the accelerated pace of customer conversions in the second half of 2022. It also included retail channel stocking.

    提醒一下,去年第四季是 Omnipod 5 銷售的第一個完整季度,這使得今年第四季的比較更加困難。上一年包括 2 腳本收益,這在很大程度上是由於 2022 年下半年客戶轉換速度加快。它還包括零售通路備貨。

  • For International Omnipod, we are raising the low end of our guidance range and now expect 9% to 10% growth. On a reported basis, we estimate a favorable foreign currency impact of approximately 100 basis points. We expect growth will be driven by ongoing Omnipod DASH adoption as well as the benefit from our Omnipod 5 launches in the U.K. and Germany partially offset by AID competitive headwinds.

    對於 International Omnipod,我們正在提高指導範圍的下限,目前預計將成長 9% 至 10%。根據報告,我們估計有利的外匯影響約為 100 個基點。我們預計成長將由 Omnipod DASH 的持續採用以及我們在英國和德國推出的 Omnipod 5 所帶來的收益推動,但 AID 的競爭阻力部分抵消了這一優勢。

  • As a reminder, given the nature of our annuity model, we expect Omnipod 5 to more meaningfully contribute to our growth rate in the second half of 2024. For Drug Delivery, we are reaffirming our guidance range of a 45% to 50% decline.

    提醒一下,考慮到我們年金模型的性質,我們預計Omnipod 5 將在2024 年下半年對我們的成長率做出更有意義的貢獻。對於藥物輸送,我們重申我們的指導範圍為下降45% 至50 %。

  • Turning to 2023 gross margin. We are raising our adjusted gross margin expectations to a range of 66% to 67% and expect to achieve the midpoint of this range. The increase from our prior guide is driven by improved manufacturing costs as well as higher-than-expected revenue, including favorable mix.

    轉向2023年的毛利率。我們將調整後的毛利率預期提高至 66% 至 67% 的範圍,並預計達到該範圍的中點。與我們先前的指南相比,這一成長是由製造成本的改善以及高於預期的收入(包括有利的組合)所推動的。

  • Although certain headwinds that we experienced during 2023 will carry over into next year, we expect to see further gross margin improvement in 2024. We now expect adjusted operating margin in the range of 9% to 10% given our revenue and gross margin outperformance. We remain committed to margin expansion and anticipate leveraging our investments in 2024 and beyond.

    儘管我們在2023 年經歷的某些不利因素將延續到明年,但我們預計2024 年毛利率將進一步改善。鑑於我們的收入和毛利率表現出色,我們現在預計調整後的營業利潤率將在9%至10% 範圍內。我們仍然致力於擴大利潤率,並預計在 2024 年及以後利用我們的投資。

  • Turning to our fourth quarter 2023 revenue guidance. We expect total Omnipod and total company growth of 22% to 25%. For U.S. Omnipod, we expect growth of 28% to 31%. Even with the challenging comp due to the Omnipod 5 full market release in August of last year, our new customer start momentum and the benefits of our annuity model continue to fuel our revenue growth, including strong expected sequential dollar growth in Q4.

    轉向我們的 2023 年第四季營收指引。我們預計 Omnipod 總量和公司總量將成長 22% 至 25%。對於美國 Omnipod,我們預計將成長 28% 至 31%。儘管由於去年 8 月 Omnipod 5 全面上市而導致競爭比較激烈,但我們的新客戶啟動勢頭和年金模型的優勢繼續推動我們的收入增長,包括第四季度強勁的預期連續美元增長。

  • For International Omnipod, we expect growth of 5% to 8%. On a reported basis, we estimate a favorable foreign exchange impact of approximately 300 basis points. Finally, we expect Q4 Drug Delivery revenue to be approximately $3 million to $5 million due to timing of production and orders.

    對於 International Omnipod,我們預計將成長 5% 至 8%。根據報告,我們估計有利的外匯影響約為 300 個基點。最後,由於生產和訂單的時間安排,我們預計第四季度的藥物輸送收入約為 300 萬至 500 萬美元。

  • We have sustained momentum across our business, and we are poised for another strong year in 2024. While we will provide formal 2024 guidance on our Q4 call in February, I will provide some color now on how we are thinking about 2024 given the strong momentum we see in the business.

    我們的業務保持持續成長勢頭,並準備在2024 年迎來又一個強勁的一年。雖然我們將在2 月份的第四季度電話會議上提供正式的2024 年指導,但考慮到強勁的勢頭,我現在將提供一些關於我們如何看待2024 年的資訊我們在商業中看到。

  • We anticipate another year of large dollar growth in 2024 even with the significant volume benefits realized in 2023 from our Omnipod 5 ramp. For U.S. Omnipod, we expect a growth rate within the mid-20% range, fueled by Omnipod 5 and its strong pace of new customer starts as well as our annuity model and pharmacy channel access.

    儘管我們的 Omnipod 5 產量在 2023 年實現了顯著的銷售效益,但我們預計 2024 年將是美元大幅成長的一年。對於美國 Omnipod,我們預計其成長率將在 20% 左右,這得益於 Omnipod 5 及其新客戶啟動的強勁步伐以及我們的年金模式和藥房管道准入。

  • For international, we expect continued growth with Omnipod DASH and more meaningful growth towards the second half of the year from our recent Omnipod 5 launches in the U.K. and Germany. We expect continued headwinds in the countries where we do not yet have Omnipod 5 to partially offset this growth. All in, that puts us somewhere in the high single digits for the year with the second half of the year accelerating to a range of high single digits to low double digits. For Drug Delivery, we expect to see a decline, and at the high end of the forecast, we expect the decline to be lower than in 2023.

    對於國際市場,我們預計 Omnipod DASH 將持續成長,並且我們最近在英國和德國推出的 Omnipod 5 將在下半年實現更有意義的成長。我們預計,在我們尚未擁有 Omnipod 5 的國家/地區,持續的阻力將部分抵消這一成長。總而言之,這使我們今年處於高個位數,下半年加速達到高個位數到低兩位數的範圍。對於藥物輸送,我們預計會下降,並且在預測的高端,我們預計下降幅度將低於 2023 年。

  • In conclusion, we delivered another quarter of solid financial performance, and we further positioned Insulet for continued momentum through the end of this year and beyond. As we continue to capitalize on the global market opportunity and invest in innovation, we're poised for another strong year of customer base growth and revenue growth. Opportunities of this magnitude are few and far between, and we are very well positioned to drive long-term value creation for our shareholders.

    總之,我們又一個季度實現了穩健的財務業績,並進一步使 Insulet 在今年年底及以後保持持續成長勢頭。隨著我們繼續利用全球市場機會並投資於創新,我們將迎來另一個客戶群成長和收入成長強勁的一年。如此巨大的機會很少見,我們完全有能力為股東創造長期價值。

  • With that, operator, please open the call for questions.

    那麼,接線員,請打開提問電話。

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from Robbie Marcus from JPMorgan.

    (操作員說明)我們的第一個問題來自摩根大通的 Robbie Marcus。

  • Rohin Kirit Patel - Analyst

    Rohin Kirit Patel - Analyst

  • This is Rohin on for Robbie. Congrats on a really nice quarter. So there are several exciting developments you outlined on deck for 2024 just between CGM integration, iOS launch and continued international expansion. And thanks for providing that color on those preliminary targets for next year as well. My question is more related to how we should think about the growth contribution from each of these tailwinds next year and the puts and takes and what's assumed in those preliminary targets that you outlined.

    這是羅辛為羅比代言的節目。恭喜您度過了一個非常美好的季度。因此,您概述了 2024 年在 CGM 整合、iOS 發布和持續國際擴張之間的幾項令人興奮的發展。感謝您為明年的初步目標提供了這種顏色。我的問題更涉及到我們應該如何考慮明年這些順風車對成長的貢獻、看跌期權和你概述的初步目標中的假設。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Rohin. We're really excited about the growth catalysts that we have coming. We've obviously got great momentum continuing to drive really strong demand and new customer starts in the market, really well positioned. And we're very excited about getting into the limited market releases for both iOS and G7 early in the year and also really excited about continuing progress with the Libre integration. So we think they do drive continued growth for us.

    謝謝,羅欣。我們對即將到來的成長催化劑感到非常興奮。顯然,我們擁有巨大的動力,繼續推動市場的強勁需求和新客戶的出現,處於非常有利的位置。我們對今年年初進入 iOS 和 G7 的有限市場版本感到非常興奮,也對 Libre 整合的持續進展感到非常興奮。因此,我們認為它們確實推動了我們的持續成長。

  • And in terms of the guide, we haven't really guided on the number for that. It's really in our color. But we do think it opens up a lot of potential growth for us across the board. They're all important. And I wouldn't want to necessarily weigh one over the other, so we think they all drive catalyst.

    就指南而言,我們還沒有真正指導這個數字。這確實是我們的顏色。但我們確實認為它為我們帶來了全面的潛在成長。它們都很重要。我不想權衡其中一個,所以我們認為它們都是催化劑。

  • But I'll ask Lauren and Deb if they want to add any color to that.

    但我會問勞倫和黛布是否想為此添加任何色彩。

  • Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

    Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

  • Sure. Thanks, Jim. So yes, we have factored them in. But given our annuity model, as Jim said, it's not expected to be a meaningful contribution. And we're just entering in LMR in the beginning of the year.

    當然。謝謝,吉姆。所以,是的,我們已經將它們考慮在內。但正如吉姆所說,考慮到我們的年金模型,預計這不會是一個有意義的貢獻。我們今年年初剛進入 LMR。

  • Operator

    Operator

  • Our next question comes from Larry Biegelsen from Wells Fargo.

    我們的下一個問題來自富國銀行的拉里·比格爾森。

  • Charles F. Ellson - Associate Equity Analyst

    Charles F. Ellson - Associate Equity Analyst

  • This is Charles on for Larry. First, congrats on the nice quarter. And I just wanted to ask, forgive me if you said this already. Did you say new patient starts were a record worldwide? Did I hear that right? And then I got a quick follow-up.

    這是查爾斯替補拉里。首先,恭喜這個美好的季度。我只是想問,如果你已經這麼說了,請原諒我。您是否說過新增患者數創下了全球紀錄?我沒聽錯吧?然後我得到了快速跟進。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • New customer starts were really strong, not quite a record. And so second, we're not -- we don't want to get in the table ranking all of our quarters all the time, but it was our second-highest quarter ever of new customer starts, just coming in behind. Q2 was kind of a blowout quarter for us in new customer starts where everything hit on every cylinder. So really happy with the new customer starts, but not quite a record.

    新客戶的增加確實很強勁,但還沒有達到創紀錄的水平。其次,我們不想一直在所有季度的排名表中,但這是我們有史以來新客戶數量第二高的季度,只是排在後面。第二季度對我們來說是新客戶啟動的井噴季度,一切都在全力以赴。對新客戶的開始感到非常滿意,但不是一個記錄。

  • Charles F. Ellson - Associate Equity Analyst

    Charles F. Ellson - Associate Equity Analyst

  • Okay. And just a quick follow-up. Wondering if you might be able to give an update on the search for a new CFO. What exactly are you looking for there? And I wonder if you could give a possible time line you might hope to have an announcement there.

    好的。只是快速跟進。想知道您是否能夠提供有關尋找新財務長的最新資訊。您到底想在那裡找什麼?我想知道您是否可以給出一個可能的時間表,您可能希望在那裡發佈公告。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Sure, Charles. First of all, we're really happy to have Lauren in the chair. She's been with us for a long time. She's such a great contributor to the company and to our senior finance team and really blessed to have somebody of Lauren's caliber to step in, in this interim.

    當然,查爾斯。首先,我們很高興勞倫擔任主席。她和我們在一起已經很久了。她對公司和我們的高階財務團隊做出了巨大的貢獻,並且非常幸運能在這段時間內有像勞倫這樣有能力的人介入。

  • And we're conducting a search. We're just out of the market now with the search. We've written the spec. And I don't really want to talk about the characteristics and so on that we're looking for. We think that the CFO job here is a really fun job. We have internal candidates who are really strong, including Lauren, and early look at the market looks really promising. We want to move as quickly as we can because we want to get to some stability there. But we're very confident we'll get the right person in the role.

    我們正在進行搜索。我們現在剛剛退出市場並進行搜尋。我們已經寫好了規範。我真的不想談論我們正在尋找的特徵等等。我們認為這裡的財務長工作是一份非常有趣的工作。我們有非常強大的內部候選人,包括勞倫,而且早期的市場觀察看起來非常有前途。我們希望盡快採取行動,因為我們希望在那裡實現一定的穩定。但我們非常有信心找到合適的人選來擔任這個職位。

  • Operator

    Operator

  • Our next question comes from Stephanie Piazzola from Bank of America.

    我們的下一個問題來自美國銀行的史蒂芬妮·皮亞佐拉。

  • Stephanie Laura Piazzola - Associate

    Stephanie Laura Piazzola - Associate

  • Congrats on a good quarter. I wanted to ask more about margins, which were really strong in the quarter and throughout the year have been showing improvement each quarter. So appreciate the revenue color you gave on 2024. But if there's any color you could share on margins for next year, that would be helpful. Maybe any of the puts and takes to consider there?

    恭喜季度表現良好。我想更多地了解利潤率,該季度的利潤率非常強勁,而且全年每個季度都在改善。因此,感謝您給出的 2024 年收入顏色。但如果您可以分享明年利潤率的任何顏色,那將會有所幫助。也許有什麼需要考慮的地方?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Stephanie. I'll turn to Lauren on that. Go ahead -- sorry, Lauren. Go ahead, go ahead.

    謝謝,斯蒂芬妮。我會向勞倫求助。繼續吧——對不起,勞倫。來吧,來吧。

  • Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

    Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

  • So we're not providing guidance today. But just a little color, we are committed to expanding our margins. We're thrilled that we increased gross margins for the full year of '23 to 66% to 67%. And we are also very thrilled that we increased the high end of our operating margin guidance range as well. So we're very focused on increasing those, and we would expect that trend to continue going forward as well.

    所以我們今天不提供指導。但只要一點點顏色,我們就致力於擴大我們的利潤。我們很高興我們將 23 年全年的毛利率提高到 66% 至 67%。我們也非常高興我們也提高了營業利潤指導範圍的上限。因此,我們非常注重增加這些,我們預計這種趨勢也將繼續向前發展。

  • Operator

    Operator

  • Our next question comes from Jayson Bedford from Raymond James.

    我們的下一個問題來自雷蒙德詹姆斯的傑森貝德福德。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • This is Jayson on for Jayson. So big picture, have the physician or user discussions changed with greater GLP adoption? I'm just wondering if you changed your marketing strategy in any way? And then just quickly, as a related follow-up, can we assume that the year-over-year growth in new type 2 users was higher than your overall U.S. Omnipod growth?

    這是傑森代表傑森。總體而言,隨著 GLP 的廣泛採用,醫師或使用者的討論是否發生了變化?我只是想知道您是否以任何方式改變了行銷策略?然後,作為相關的後續行動,我們是否可以假設新型 2 用戶的同比增長高於美國 Omnipod 的整體成長?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • So no, we haven't changed our marketing message at all. Omnipod 5 and Omnipod DASH are so effective in insulin delivery. The pilot with Omnipod GO is -- we're learning a lot. It's going well. And GLP-1s are out there. GLP-1 has been indicated for some time in the market. And so we haven't changed our messaging.

    所以不,我們根本沒有改變我們的行銷訊息。 Omnipod 5 和 Omnipod DASH 在胰島素輸送方面非常有效。 Omnipod GO 的試點是-我們學到了很多東西。進行得順利。 GLP-1 就在那裡。 GLP-1 在市場上出現了一段時間。所以我們沒有改變我們的訊息。

  • I think that we continue to learn about GLP-1s. And if we need to adapt our messaging, we will. But we haven't had to change our messaging. We continue to obviously have a lot of success. Can you remind me of the second part of your question there, Jayson?

    我認為我們會繼續了解 GLP-1。如果我們需要調整我們的訊息傳遞,我們會的。但我們不必改變我們的訊息傳遞。顯然,我們繼續取得了很大的成功。傑森,你能提醒我你問題的第二部分嗎?

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • Type 2 -- it looked like type 2 was strong just in terms of type 2 adoption. Can I assume that it grew faster? If I just look at the number of type 2s added in 3Q this year versus last year, it feels like it's faster than overall Omnipod growth. If there's a way to bless that assumption, that would be great.

    類型 2-就類型 2 的採用而言,類型 2 看起來很強大。我可以假設它成長得更快嗎?如果我只看今年第三季與去年相比增加的 2 型數量,感覺它比 Omnipod 的整體成長還要快。如果有一種方法可以支持這個假設,那就太好了。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • I'm not sure I would jump to that split. Go ahead, Lauren.

    我不確定我會跳到那個分裂。來吧,勞倫。

  • Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

    Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

  • I was just going to say it grew about the same.

    我只是想說它成長得差不多。

  • Operator

    Operator

  • Our next question comes from Patrick Wood from Morgan Stanley.

    我們的下一個問題來自摩根士丹利的帕特里克·伍德。

  • Patrick Andrew Robert Wood - Former Research Analyst

    Patrick Andrew Robert Wood - Former Research Analyst

  • I'm just curious like big picture, not about '24, just slightly longer term, how the launch in the U.K., and I mean, I guess, some of what's around Germany, how you're thinking the time line to returning to double-digit growth OUS could look. And is there anything you're seeing in those markets that would sort of prohibit you from reaccelerating as Omnipod 5 pushes through that region?

    我只是好奇大局,而不是 24 年,只是稍微長遠一點,在英國如何推出,我的意思是,我猜,德國周圍的一些事情,你如何考慮返回的時間線OUS 有望實現兩位數增長。當 Omnipod 5 進軍該地區時,您在這些市場中是否看到了一些阻礙您重新加速的因素?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks. Yes, we're so excited about getting Omnipod 5 into multiple markets in Europe. As we said -- as we detailed in the prepared remarks, the U.K. launch is going really well. Germany is strong out of the gate.

    謝謝。是的,我們非常高興能夠將 Omnipod 5 打入歐洲的多個市場。正如我們所說,正如我們在準備好的演講中詳細說明的那樣,英國的發布進展非常順利。德國隊門外實力強勁。

  • In direct answer to your question, we don't see any barriers to driving really strong and robust growth where we launch Omnipod 5. And I think I said in the prepared remarks, we're very confident it's going to be a leading offer wherever we're able to put it in the market. So it's such a great solution, it's so easy for customers to use. It drives such great real-world results. And as we get more evidence and we can drive access conversations, we're also confident we can get a price premium for the value that Omnipod 5 creates. And so we're all systems -- full speed ahead in getting into our international markets with OP5.

    在直接回答你的問題時,我們認為在我們推出Omnipod 5 的過程中,推動真正強勁和穩健的增長沒有任何障礙。我想我在準備好的評論中說過,我們非常有信心它無論在哪裡都會成為領先的產品我們能夠將其推向市場。所以這是一個非常棒的解決方案,客戶使用起來非常簡單。它在現實世界中取得瞭如此出色的成果。隨著我們獲得更多證據並推動訪問對話,我們也有信心為 Omnipod 5 創造的價值獲得溢價。因此,我們都是系統 - 透過 OP5 全速進入國際市場。

  • Operator

    Operator

  • Our next question comes from Jeff Johnson from Baird.

    我們的下一個問題來自貝爾德 (Baird) 的傑夫·約翰遜 (Jeff Johnson)。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • Nice quarter. Jim, maybe if I could pin you down on a little bit more detail on the sensor integration side. So with LMR on G7 integration in the U.S. early in the year, I know it's going to depend on what you see in the field, what the feedback is and all that. But just generally, do we tend to think of LMRs, I could go back and check my notes, I guess, on O5. Is that like a 3-month LMR and then a full launch? Or just how to think about that?

    不錯的季度。吉姆,也許我可以為您提供有關感測器整合的更多細節。因此,隨著 LMR 今年年初在美國進行 G7 整合,我知道這將取決於您在現場看到的情況、反饋等等。但一般來說,我們是否傾向於考慮 LMR,我想我可以回去檢查我的筆記,我想是在 O5 上。這是否類似於 3 個月的 LMR,然後全面發布?或只是如何思考這個問題?

  • And then on the L2 front, obviously, you gave some updates internationally. How should we think about the time line L2 in the U.S.? And L3, OUS and U.S., any updates there at all? Just once L2 comes out integration, is it a 6-month or is it a year? How far down the road might we see L3?

    然後,在 L2 方面,顯然,您在國際上提供了一些更新。我們該如何看待美國的L2時間線? L3、OUS 和 U.S. 有任何更新嗎? L2出來整合後,是6個月還是一年?沿著這條路走多遠我們可以看到 L3?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Yes. Thanks, Jeff. I'll go in reverse order. We're not providing additional guidance on timing for the Libre family of sensors at this point. We do feel good about the integration we have going with our RADIANT trial. And the customer experience on the RADIANT -- which is the Libre 2 integration that we're doing in Europe. The customer experience on the RADIANT trial has been terrific. And so we're very bullish on that. And obviously, to be in trial with that system, we have to have a working integration. So we're bullish on that, but we're not ready to provide timing on Libre for any specific markets at this moment.

    是的。謝謝,傑夫。我會按照相反的順序來。目前,我們不提供有關 Libre 系列感測器計時的額外指導。我們確實對 RADIANT 試驗的整合感到滿意。 RADIANT 上的客戶體驗-這是我們在歐洲進行的 Libre 2 整合。 RADIANT 試用的客戶體驗非常棒。所以我們非常看好這一點。顯然,要試用該系統,我們必須進行有效的整合。因此,我們對此持樂觀態度,但目前我們還沒有準備好為任何特定市場提供 Libre 的時間表。

  • On the LMR question, it's a great question. We don't -- we think of LMRs as exercises to test hypotheses and make sure the system is working the way we want it to. So we don't actually put a time line on it. We put a set of conditions on it. And so as we get into market with LMR, we'll see what we see.

    關於 LMR 問題,這是一個很好的問題。我們不認為 LMR 是測試假設的練習,並確保系統按照我們希望的方式運作。所以我們其實並沒有設定時間表。我們對其提出了一系列條件。因此,當我們進入 LMR 市場時,我們將會看到我們所看到的結果。

  • Obviously, we wouldn't be going into LMR with the G7 integration if we weren't confident that the system was working as expected. But with all of these things, you have to get the product out in a while to see how it performs. And so we'll get the LMR out there and we'll move as quickly as we can, and we're really excited about bringing that G7 integration to market.

    顯然,如果我們對系統按預期工作沒有信心,我們就不會將 LMR 與 G7 整合。但面對所有這些事情,你必須花一段時間才能把產品拿出來看看它的表現如何。因此,我們將推出 LMR,並儘快採取行動,我們對將 G7 整合推向市場感到非常興奮。

  • Operator

    Operator

  • Our next question comes from Matt Taylor from Jefferies.

    我們的下一個問題來自傑富瑞 (Jefferies) 的馬特泰勒 (Matt Taylor)。

  • Matthew Charles Taylor - Equity Analyst

    Matthew Charles Taylor - Equity Analyst

  • I guess I wanted to ask you more about your efforts in type 2. Obviously, you're having some good success there today with 20% coming into the fold and that being a consistent level over time, a healthy level. But I guess my question is, as you get the, hopefully, additional indications and are able to market, do you expect the proportion of type 2s to increase in the future? Maybe offer some thoughts on where that could go to. And also, could that even further broaden the prescriber base once you have that?

    我想我想更多地詢問您在類型2 方面所做的努力。顯然,您今天在這方面取得了一些良好的成功,有20% 的人加入,並且隨著時間的推移,這是一個穩定的水平,一個健康的水平。但我想我的問題是,當您希望獲得更多適應症並能夠上市時,您預計 2 型的比例未來會增加嗎?也許可以提供一些關於可以去往何處的想法。而且,一旦有了這個,是否可以進一步擴大處方者基礎?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Matt. Those are both great questions. First thing I'll say is we're so strong in type 1, all right? So our offering in type 1 is bringing so many customers into the market from MDI that we expect to continue to drive penetration to the type 1 market and bring those customers who are currently not on a technology-based solution onto Pod therapy. And so -- and therefore, that portion of the growth will continue. We're very bullish on growing MDI in type 1.

    謝謝,馬特。這些都是很好的問題。我首先要說的是,我們在第一類方面非常強大,好嗎?因此,我們的 1 型產品將如此多的客戶從 MDI 引入市場,我們希望繼續推動 1 型市場的滲透,並將目前尚未採用基於技術的解決方案的客戶引入 Pod 療法。因此,這部分成長將持續下去。我們非常看好 1 類 MDI 的成長。

  • Type 2 is a massively underpenetrated market. And we've been through the numbers on this a couple of times. And it's in our deck that we put up, our investor deck that shows the market size for type 2 -- the progression of type 2 disease. But we've got 30-some-odd million people diagnosed with type 2 in the U.S. who then progress on the basal and then on to intensive insulin therapy. Right now, there are about 2.5 million people in the U.S. market who need intensive insulin as a part of their type 2 diabetes care. And they're just really underpenetrated as a market for pump therapy overall, and therefore, for Pod therapy. And we're very, very bullish on that.

    類型 2 是一個滲透率嚴重不足的市場。我們已經看過這方面的數據好幾次了。我們在投資者平台上展示了​​ 2 型疾病的市場規模—2 型疾病的進展。但在美國,有超過 30 萬人被診斷出患有第 2 型糖尿病,隨後接受基礎胰島素治療,然後接受強化胰島素治療。目前,美國市場上約有 250 萬人需要強化胰島素作為第 2 型糖尿病照護的一部分。作為泵療法的整體市場,它們的滲透率確實很低,因此對於 Pod 療法也是如此。我們對此非常非常樂觀。

  • So if you think about -- we'll continue to penetrate type 1. Type 2 is actually a larger end market for intensive insulin therapy than type 1. So the proportion -- I do think, to your point, the proportion will probably swing as we're able to get the indication for use and drive adoption in the market. But the numbers will go up. The total adoption number of customers will go up on both fronts.

    因此,如果你考慮一下——我們將繼續滲透1 型。2 型實際上是比1 型更大的強化胰島素治療終端市場。所以這個比例——我確實認為,就你的觀點而言,這個比例可能會波動因為我們能夠獲得使用指示並推動市場採用。但數字將會上升。客戶的總採用數量將在這兩個方面都有所增加。

  • Operator

    Operator

  • Our next question comes from Matthew O'Brien from Piper Sandler.

    我們的下一個問題來自 Piper Sandler 的 Matthew O'Brien。

  • Phillip Paul Dantoin - Research Analyst

    Phillip Paul Dantoin - Research Analyst

  • This is Phil on for Matt. Congrats on the quarter. Just Wayde or Jim, as we think about the key growth factors for the business being on the volume side of things, the ratio of MDI to conversions has marched from 50-40 to now 80-20 in the U.S. Are you seeing any kind of slowdown in your ability to convert competitive pumpers? Also, if you could provide that same ratio in OUS given the launch there. What does that MDI-to-conversion ratio look like in Europe?

    這是菲爾替馬特發言。恭喜本季。就 Wayde 或 Jim 而言,當我們考慮業務的關鍵成長因素在於數量方面時,美國的 MDI 與轉換率的比率已從 50-40 上升到現在的 80-20。您是否看到任何類型的變化?您轉化有競爭力的泵手的能力下降了嗎?另外,如果您可以在 OUS 中提供相同的比率(鑑於在那裡發布)。歐洲的 MDI 轉換率是多少?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Phil. The Q3 doesn't look hugely different from Q2 in terms of the mix of components of where customers are coming from. The only difference was -- and if I just back up, I'll go into the weeds for a second, I apologize for going into the weeds. When we talk about sources of customers, whether it's type 1, type 2, MDI competitive conversion, we have different sources of data that allow us to estimate that, including voluntary -- so when a customer enrolls on Omnipod, they will tell us where they're coming from usually. So it's voluntary information. It's not 100% data capture, and what that means is there's a little bit of an estimation kind of range on those things.

    謝謝,菲爾。就客戶來源的組成部分而言,第三季看起來與第二季沒有太大不同。唯一的區別是——如果我後退,我會進入雜草區一會兒,我為進入雜草區而道歉。當我們談論客戶來源時,無論是類型1、類型2、MDI 競爭性轉換,我們都有不同的資料來源可以讓我們進行估計,包括自願的— 因此,當客戶在Omnipod 上註冊時,他們會告訴我們在哪裡他們通常來自。所以這是自願訊息。這不是 100% 的數據捕獲,這意味著這些事情存在一些估計範圍。

  • And so Q3 compared to Q2 didn't look all that different. The only thing that looked different enough for us to change the number was competitive conversions went -- as you said, last quarter, we said it was 75-25. In this quarter, we said 80-20. But even that, in terms of total number and range of estimate, was not that huge a change.

    因此,第三季與第二季相比,看起來並沒有太大不同。唯一看起來不同的事情足以讓我們改變這個數字,那就是競爭性轉換——正如你所說,上個季度,我們說是 75-25。在本季度,我們說80-20。但即便如此,就總數和估計範圍而言,變化也不算太大。

  • And we've been really happy with competitive conversions over the course of the launch of Omnipod 5. We're really clear at launch that the number, the volume of people converting from tubed pumps was a pleasant surprise for us. And we sustained that for a long time and probably a little longer on balance, kind of above historical trends of 80-20, sustained it for a little bit longer than we thought. So it's not really a surprise for us to get back to this 80-20 mix.

    在 Omnipod 5 推出的過程中,我們對具有競爭力的轉換感到非常滿意。我們在發佈時就非常清楚,從管式泵轉換的人數對我們來說是一個驚喜。我們維持了很長一段時間,整體來說可能更長一點,高於 80-20 的歷史趨勢,維持它的時間比我們想像的要長一點。因此,我們回到 80-20 的組合並不感到意外。

  • And what it means is we continue to bring -- we're the clear market leader in bringing customers from MDI on to -- you could talk about, again, the broad category of AID, but on to AID Pod therapy on Omnipod 5. We're the clear market leader in bringing MDI into the market, and we're still taking share out of the installed base of tubed pumps.

    這意味著我們將繼續帶來——我們是讓客戶從 MDI 轉向——你可以再次談論 AID 的廣泛類別,但在 Omnipod 5 上的 AID Pod 療法。在將MDI 引入市場方面,我們是明顯的市場領導者,並且我們仍在從管式泵的安裝基礎上奪取份額。

  • And so we don't really see anything in the data. And out in the market, we see a lot of promotional activity. But we haven't -- our field is not really reporting any move that's making it harder for us in any way to convert people off of their tubed pump experience because Omnipod 5, and for that matter, Omnipod DASH, are so compelling. So that's maybe a long kind of more in-the-weeds answer than you're looking for, but that's how we see it.

    所以我們在數據中看不到任何東西。在市場上,我們看到很多促銷活動。但我們還沒有——我們的領域並沒有真正報告任何讓我們更難以任何方式讓人們放棄管式幫浦體驗的舉措,因為 Omnipod 5 以及 Omnipod DASH 是如此引人注目。所以這可能是一個比你想要的更長的、更雜亂的答案,但這就是我們的看法。

  • On the European side of the question, it's -- I think we're going to see that different market by market. And in fact, in the U.K., what we see is different hospital by hospital. So in some instances, the NHS trust hospitals are tilting more towards new customer starts with Omnipod 5. And in some cases, they're tilting more towards upgrading from Omnipod DASH as a mix on balance more conversion than new customers start. A little bit of that is driven by physician preference and a little bit of that is driven by the hospital budget for the year.

    在問題的歐洲方面,我認為我們將看到不同的市場。事實上,在英國,我們看到的是不同的醫院。因此,在某些情況下,NHS 信託醫院更傾向於新客戶開始使用Omnipod 5。而在某些情況下,他們更傾向於從Omnipod DASH 進行升級,因為總體而言,轉換率高於新客戶開始使用。其中一部分是由醫生偏好驅動的,另一部分是由當年醫院預算所驅動的。

  • And so I think we'll see -- and I think it will look a little different in Germany, and I think it will look a little different as we get into other countries. As a reminder, the contracting in Europe locks everybody into a contract. So in the U.S., we're in the pharmacy channel. It's easy to convert from a tubed pump on to Omnipod 5. In most of the European markets, whether you're on an Omnipod DASH or you're on a tubed pump, you're locked into a contract for a period of time.

    所以我想我們會看到——我認為在德國它看起來會有點不同,而且我認為當我們進入其他國家時它看起來也會有點不同。提醒一下,歐洲的合約將每個人都鎖定在合約中。所以在美國,我們在藥局通路。從管式泵轉換到 Omnipod 5 很容易。在大多數歐洲市場,無論您使用 Omnipod DASH 還是管式泵,您都必須遵守一段時間的合約。

  • And so for example, in the U.K., it's at the discretion of the hospital to upgrade somebody to an Omnipod 5. And so that market behavior will look a little bit different market by market. What we do know is that Omnipod 5 is just -- the pent-up demand for Omnipod 5 in our European markets is really strong, and you can see the results already in the U.K.

    例如,在英國,醫院可以自行決定是否將某人升級到 Omnipod 5。因此,不同市場的市場行為會略有不同。我們所知道的是,歐洲市場對 Omnipod 5 被壓抑的需求非常強勁,您可以在英國看到結果。

  • Operator

    Operator

  • Our next question comes from Margaret Kaczor from William Blair.

    我們的下一個問題來自威廉·布萊爾的瑪格麗特·卡佐爾。

  • Malgorzata Maria Kaczor Andrew - Partner & Research Analyst

    Malgorzata Maria Kaczor Andrew - Partner & Research Analyst

  • I wanted to talk a little bit about Omnipod GO. I think you had mentioned that you're maybe seeing some pull-through in sales for the whole Omnipod family even early on. So is there any more detail around what you're seeing and how that relates maybe to the long-term commercial opportunity of a patient per account basis or however you look at it? And then as a follow-up, which I'll sneak through, as you think about 2024 guidance, are you assuming any of that benefit from that pull-through direct sales from Omnipod GO?

    我想談談 Omnipod GO。我想您曾經提到過,您可能會在早期看到整個 Omnipod 系列的銷售出現一些成長。那麼,您所看到的情況是否有更多細節,以及這與每個帳戶的患者的長期商業機會有何關係,或者您如何看待它?然後,作為後續行動,當您考慮 2024 年指導時,我將偷偷介紹一下,您是否認為 Omnipod GO 的拉動式直接銷售會帶來任何好處?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Margaret. I'll do them in reverse order. We haven't put anything formally into the guide out of the Omnipod GO pilot, and we're still planning -- so this is not even yet a limited market release. It's a commercial pilot. And so we haven't tried to quantify that or include any of it into the color that Lauren provided or the guide.

    謝謝,瑪格麗特。我會按照相反的順序做。我們尚未將任何內容正式納入 Omnipod GO 試點指南中,而且我們仍在計劃中,因此這還不是有限的市場發布。這是一名商業飛行員。因此,我們沒有嘗試量化這一點,也沒有將其中的任何內容納入勞倫提供的顏色或指南中。

  • The pilot, the -- I'm really pleased that we're piloting it in the way we are because we are doing exactly what we wanted, which is we're learning a lot. And it's, I would say, kind of a pleasant surprise as we get into these PCP practices and talk to them about the offering that not only do they recognize the target patient profile for Omnipod GO as we characterize it. But as we explain Omnipod GO and they see the ease of use of Omnipod GO, they ask us about the broader product portfolio. And I don't think we anticipated that, that would be happening.

    試點,我真的很高興我們以現在的方式進行試點,因為我們正在做我們想要的事情,我們學到了很多東西。我想說,當我們深入這些 PCP 實踐並與他們討論該產品時,他們不僅認識到我們所描述的 Omnipod GO 的目標患者概況,這是一個令人驚訝的驚喜。但當我們解釋 Omnipod GO 並且他們看到 Omnipod GO 的易用性時,他們向我們詢問更廣泛的產品組合。我認為我們沒有預料到會發生這種情況。

  • And so it's -- and what it tells us is that Omnipod therapy genuinely is so simple to use that it should open up the conversation in primary care. What we're using the pilot for is to figure out what are the mechanics of that, right? So what does it look like? How many reps? What's the call pattern? What's in the bag? And we're testing things like the target patient profiles and things like that. And so I continue to think of it as early days, but the learnings from the pilot have been really, really productive for us as we think about how to approach type 2 patients in the primary channel.

    事實就是這樣——它告訴我們的是,Omnipod 療法確實使用起來非常簡單,應該會在初級保健中開啟對話。我們使用試點的目的是弄清楚其機制是什麼,對吧?那麼它是什麼樣子的呢?代表多少次?呼叫模式是什麼?包包裡面有什麼?我們正在測試諸如目標患者概況之類的東西。所以我仍然認為它還處於早期階段,但是當我們思考如何在主要管道中接觸 2 型患者時,從試驗中學到的經驗對我們來說非常非常有成效。

  • Operator

    Operator

  • Our next question comes from Joanne Wuensch from Citigroup.

    我們的下一個問題來自花旗集團的 Joanne Wuensch。

  • Unidentified Analyst

    Unidentified Analyst

  • This is actually Anthony on for Joanne. Just a quick easy one here. I just want to confirm the $10 million this quarter that was associated with the Omnipod 5 ramp dynamics. I just want to confirm that was the tailwind. And then, are you providing any guidance on what this number could be next year, whether it's a tailwind or a headwind?

    這其實是安東尼為喬安妮代言的。這裡只是一個快速簡單的。我只想確認本季與 Omnipod 5 斜坡動態相關的 1000 萬美元。我只是想確認那是順風。然後,您是否就明年這個數字可能會是多少提供任何指導,無論是順風還是逆風?

  • Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

    Lauren Budden - Group VP, CAO, Controller & Interim CFO and Treasurer

  • Yes. So the $10 million is the double script phenomenon. And what's different now is that conversions is really a small component of that. So it's really immaterial. So going forward, we expect the double script phenomenon to continue, but it's really just part of our normal growth rate going forward on new customer starts.

    是的。所以1000萬美元就是雙腳本現象。現在不同的是,轉換其實只是其中的一小部分。所以這真的無關緊要。因此,展望未來,我們預計雙腳本現象將持續下去,但這實際上只是我們新客戶啟動正常成長率的一部分。

  • Operator

    Operator

  • Our next question comes from William Plovanic from Canaccord Genuity.

    我們的下一個問題來自 Canaccord Genuity 的 William Plovanic。

  • Caitlin Cronin - Associate

    Caitlin Cronin - Associate

  • This is Caitlin Cronin on for Bill. Congrats on a great quarter. Just to dig into U.S. competition a little bit more, it seems like there's been a few new entrants into the market this year and updates and potentially some early next year. How are you thinking about kind of the competitive landscape for tubed pumps and then also kind of for patch pumps in development going forward?

    我是比爾的凱特琳·克羅寧。恭喜您度過了一個出色的季度。為了更深入了解美國的競爭情況,今年似乎有一些新進業者進入該市場,並進行了更新,明年初可能還會出現一些更新。您如何看待管式幫浦的競爭格局以及未來開發中的貼片幫浦的競爭格局?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • We're very confident in our competitive position. Omnipod 5 with G6 sensor is the best AID offering on the market. And what we see coming in competitor pipelines -- we think nothing in competitor pipelines is as good as Omnipod 5 with G6. And so -- and it doesn't mean that there won't be competition. As I said earlier, we see our competitors out, there's a lot of promotional activity around from some of our competitors. So we see that out in the world. We haven't really seen it impact our results at this point.

    我們對自己的競爭地位非常有信心。配備 G6 感測器的 Omnipod 5 是市場上最好的 AID 產品。我們在競爭對手的產品線中看到的情況 - 我們認為競爭對手的產品線中沒有什麼比帶有 G6 的 Omnipod 5 更好。所以——這並不意味著不會有競爭。正如我之前所說,我們看到我們的競爭對手出局,我們的一些競爭對手進行了許多促銷活動。所以我們在世界上看到了這一點。目前我們還沒有真正看到它對我們的結果產生影響。

  • Now competition always, I think -- first of all, I think competition is great for business. It helps everybody learn and develop better products, and it helps customers have better experience, which is what we're all trying to do. And so we know there's going to be competition. We know our competitors continue to try to innovate, but we're very, very confident in our competitive position and our growth profile. And that's why we're so excited about the growth catalysts we have coming in 2024.

    我認為現在競爭總是存在的——首先,我認為競爭對商業來說是件好事。它幫助每個人學習和開發更好的產品,幫助客戶獲得更好的體驗,這也是我們都在努力做的事情。所以我們知道將會有競爭。我們知道我們的競爭對手正在繼續嘗試創新,但我們對我們的競爭地位和成長前景非常非常有信心。這就是為什麼我們對 2024 年出現的成長催化劑如此興奮。

  • As to patch pump companies, there's patch pumps -- we're the leader in patch pump. There's not really a viable patch pump competitor that we see on the horizon. And so that's another reason that we're very, very bullish on our position and expect to continue to lead the market.

    至於貼片幫浦公司,有貼片幫浦——我們是貼片幫浦的領導者。我們目前還沒有看到真正可行的貼片幫浦競爭對手。因此,這是我們非常非常看好我們的立場並期望繼續引領市場的另一個原因。

  • Operator

    Operator

  • Our next question comes from Mike Kratky from Leerink Partners.

    我們的下一個問題來自 Leerink Partners 的 Mike Kratky。

  • Michael Holden Kratky - Research Analyst

    Michael Holden Kratky - Research Analyst

  • So regarding the ongoing [SECURE] pivotal trial for Omnipod 5, how are you thinking about how that could impact the commercial opportunity for this product over the next few years? And what are the other main drivers that you expect to increase penetration within the insulin-intensive type 2 patients that remain so underpenetrated?

    那麼,關於正在進行的 Omnipod 5 的 [SECURE] 關鍵試驗,您如何看待這將如何影響該產品在未來幾年的商業機會?您預計在胰島素密集型 2 型患者中提高滲透率的其他主要驅動因素是什麼?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks for the question. We're very excited about the [SECURE] trial. And as I said in our prepared comments, we've completed the goal for recruitment. And so just to be clear what that means, that trial is designed to be up to 400 patients, but it has a minimum number of patients that are required. And so we crossed over the hurdle for the minimum number of patients. And the way to think about that is that it derisks the trial from an enrollment point of view.

    謝謝你的提問。我們對 [SECURE] 試驗感到非常興奮。正如我在準備好的評論中所說,我們已經完成了招募目標。因此,為了明確這意味著什麼,該試驗設計為最多 400 名患者,但它有所需的最低患者數量。這樣我們就跨過了患者數量最少的障礙。思考這個問題的方法是,從入組的角度來看,它會降低試驗的風險。

  • So we now are certain to have enough patients to successfully complete the trial. Enrollment is still open. So we'll continue to enroll some patients for the next little while because it's always better to have more patients in the trial rather than fewer. But -- so the trial is derisked operationally now with enough patients in to get powered results that we need. And we'll continue the trial.

    所以我們現在肯定有足夠的患者來成功完成試驗。報名仍開放。因此,我們將在接下來的一段時間內繼續招募一些患者,因為試驗中的患者越多越好,而不是更少。但是,現在該試驗已經消除了操作風險,有足夠的患者參與以獲得我們需要的強大結果。我們將繼續審判。

  • And then it's a 13-week protocol. Once the last patient is in, they'll complete the 13-week protocol. We'll gather the data, we'll clean the data, we'll prepare submission and so on. And then it will be in the hands of the FDA. And that will be a huge unlock for us in the type 2 space.

    然後是一個為期 13 週的方案。一旦最後一名患者入院,他們將完成為期 13 週的治療方案。我們將收集資料、清理資料、準備提交等等。然後它將掌握在 FDA 的手中。這對於我們在 2 類領域來說將是一個巨大的解鎖。

  • We're already the market leader in type 2 with Omnipod DASH. Omnipod DASH has had an indication for use in type 2 for some time. And we've been promoting Omnipod DASH for type 2 this year. And you can see the results already. So if you saw quarter-over-quarter, DASH actually did really well in the quarter, a little bit better than last quarter in terms of percent of revenue. And that's clearly because, as we're out talking to physicians about type 2 patients and Pod therapy, we're driving growth in type 2.

    我們已經憑藉 Omnipod DASH 成為 2 類市場的領導者。 Omnipod DASH 已顯示用於 2 型有一段時間了。今年我們一直在推廣 2 型 Omnipod DASH。您已經可以看到結果了。因此,如果你看一下季度環比,你會發現 DASH 在本季度的表現實際上非常好,就收入百分比而言,比上季度要好一些。這顯然是因為,當我們與醫生討論 2 型患者和 Pod 療法時,我們正在推動 2 型患者的成長。

  • We also know -- even though we cannot promote Omnipod 5 because it does not yet have an indication for use, we do know that AID for people with type 2, and specifically Omnipod 5 AID for people with type 2, has very high appeal and physicians are writing it off label even though we're not promoting it.

    我們也知道,儘管我們無法推廣 Omnipod 5,因為它還沒有使用跡象,但我們確實知道針對 2 型患者的 AID,特別是針對 2 型患者的 Omnipod 5 AID,具有非常高的吸引力,並且即使我們不提倡它,醫生也會將其註銷。

  • And so when you take those 2 things together, the success of Omnipod DASH in the type 2 market, the obvious pent-up demand for Omnipod 5 in the type 2 market, once we get the indication for use with a successful result from the SECURE trial, we think it will unlock massive growth for us.

    因此,當您將這兩件事放在一起時,一旦我們從 SECURE 獲得成功結果並獲得使用指示,Omnipod DASH 在 2 型市場中的成功以及 2 型市場中對 Omnipod 5 明顯被壓抑的需求試驗,我們認為它將為我們帶來巨大的成長。

  • That will come in the endocrinology channel. That's what we also think type 2 growth can come out of the PCP channel, which is why we're piloting Omnipod GO in the PCP channel because it extends our reach upstream for type 2 patients as they initiate insulin therapy with a basal offering. And then as they progress, they will already be on an Omnipod offering, and they should pretty seamlessly progress onto either Omnipod DASH or Omnipod 5.

    這將來自內分泌頻道。這也是我們認為 2 型成長可以來自 PCP 管道的原因,這就是我們在 PCP 管道中試驗 Omnipod GO 的原因,因為它擴展了我們對 2 型患者的上游影響力,因為他們開始使用基礎胰島素治療。然後,隨著他們的進步,他們將已經使用 Omnipod 產品,並且他們應該非常無縫地進步到 Omnipod DASH 或 Omnipod 5。

  • Operator

    Operator

  • Our next question comes from Steven Lichtman from Oppenheimer.

    我們的下一個問題來自奧本海默的史蒂文·利希特曼。

  • Steven Michael Lichtman - MD & Senior Analyst

    Steven Michael Lichtman - MD & Senior Analyst

  • So you mentioned earlier, you're clearly moving your prescriber base past high-volume endos. Do you need to expand sort of your feet on the street meaningfully as this prescriber base continues to grow? Or are you seeing leverage opportunities from your current team?

    所以你之前提到過,你顯然正在將你的處方者基礎轉移到大容量內視鏡治療上。隨著處方者基礎的不斷增長,您是否需要有意義地擴大在街頭的影響力?或者您從目前團隊中看到了利用機會?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Great question, Steve. And I would say 2 things on that front. The first one is we are considering expanding feet on the street, and that's part of the Omnipod GO commercial pilot, to figure out how many feet on the street we need to get the reach that we want.

    好問題,史蒂夫。我想在這方面說兩件事。第一個是我們正在考慮擴大街道上的英尺數,這是 Omnipod GO 商業試點的一部分,以計算我們需要在街道上增加多少英尺才能達到我們想要的覆蓋範圍。

  • The other thing is we get a lot of leverage out of DTP. And so a lot of the physicians that are writing for us don't necessarily have a rep calling on them right now. And what's happening is our DTP advertising often reaches physicians, by the way. So they often see the product through our online media or maybe on the TV ad, but patients go in and ask for Omnipod into those practices that we don't necessarily have a call routine with. So we're getting leverage in that way already. And then we will consider adding feet on the street, as you say, as appropriate over the coming quarters.

    另一件事是我們從 DTP 中獲得了很大的優勢。因此,許多為我們撰寫文章的醫生現在不一定有代表來拜訪他們。順便說一句,我們的 DTP 廣告經常接觸到醫生。因此,他們經常透過我們的線上媒體或電視廣告看到該產品,但患者會進去要求 Omnipod 參與那些我們不一定有通話例程的實踐。所以我們已經以這種方式獲得了影響力。然後,正如您所說,我們將考慮在未來幾季酌情在街上增加人潮。

  • Operator

    Operator

  • Our next question comes from Chris Pasquale from Nephron.

    我們的下一個問題來自 Nephron 的 Chris Pasquale。

  • Christopher Thomas Pasquale - Partner & Senior Research Analyst

    Christopher Thomas Pasquale - Partner & Senior Research Analyst

  • I just want to follow up on the O5 type 2 opportunity. How are you thinking about the time line for FDA approval? And then also for presentation of that data -- because it sounds like there's also already a fair amount of off-label interest. And it would seem like perhaps the data presentation itself could be a catalyst to spur even more interest before you actually get the labeling.

    我只是想跟進 O5 2 類機會。您如何看待 FDA 批准的時間表?然後還要展示這些數據——因為聽起來已經有相當多的標籤外興趣。在您真正獲得標籤之前,數據呈現本身似乎可能會成為激發更多興趣的催化劑。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Great questions, Chris. First, on timing, we haven't announced a formal time line on getting to an FDA clearance out of the [SECURE] trial, but it's fairly easy to do the math. I think the last patient will probably be in no later than the end of the calendar year, a 13-week protocol, analyze the data, do a filing. So I think it's safe to say that we'll be filing with the FDA in '24 for sure for clearance. And then we'll see what happens in terms of -- each of those steps can have a plus or minus on the time line on them. But we expect to file next year for that.

    很好的問題,克里斯。首先,在時間上,我們尚未宣布獲得 FDA 批准 [SECURE] 試驗的正式時間表,但計算起來相當容易。我認為最後一位患者可能會在不遲於日曆年年底的情況下進行為期 13 週的治療方案,分析數據,進行歸檔。因此,我認為可以肯定地說,我們將在 24 年向 FDA 提交申請,以確保獲得批准。然後我們將看看會發生什麼——每個步驟都可以在時間線上有一個加號或減號。但我們預計明年會為此提交申請。

  • In between now and then, there's a couple of things that are -- in terms of data on the study. We have published data out of our type 2 feasibility trial. And as we've referred to that in the context of the GLP-1 news that what we do see in -- out of our feasibility data is that the patients in that smallest trial who were also on GLP-1s actually did better on Omnipod 5 than patients not on GLP-1s and for reasons that we explained in the slides that we posted last quarter and that we've updated this week.

    從現在到那時,就研究數據而言,有一些事情是這樣的。我們已經發布了 2 類可行性試驗的數據。正如我們在 GLP-1 新聞中提到的那樣,我們確實從可行性數據中看到,在那個最小的試驗中,也使用 GLP-1 的患者實際上在 Omnipod 上表現更好5 比未服用GLP -1 的患者高,原因我們在上季度發布的幻燈片中進行了解釋,並在本週進行了更新。

  • And so GLP-1s make the body more sensitive to insulin, and they reduce the required dose. And so the combination of the 2 actually ends up with a better outcome for patients, which is interesting. And along those lines, we anticipate that we will have a large number, just about half, plus or minus, of the current enrollees in that trial are already on either an SGLT2 or a GLP-1. And so we anticipate being able to report out on subsets of the trial. That may happen -- it may happen before the FDA filing, it may happen after, but we anticipate being able to do some kind of scientific reporting on that as well during 2024.

    因此,GLP-1 使身體對胰島素更加敏感,並且減少了所需的劑量。因此,兩者的結合實際上最終會為患者帶來更好的結果,這很有趣。沿著這些思路,我們預計該試驗的當前參與者中將有大量(大約一半左右)已經在使用 SGLT2 或 GLP-1。因此,我們預計能夠報告試驗的子集。這可能會發生——可能發生在 FDA 備案之前,也可能發生在 FDA 備案之後,但我們預計在 2024 年期間也能夠對此進行某種科學報告。

  • Operator

    Operator

  • Our next question comes from Marie Thibault from BTIG.

    我們的下一個問題來自 BTIG 的 Marie Thibault。

  • Marie Yoko Thibault - MD and Medical Technology and Digital Health Analyst

    Marie Yoko Thibault - MD and Medical Technology and Digital Health Analyst

  • Congrats on the iOS clearance. Just a quick one here on that. When might we see the G7 Omnipod 5 integrated with iOS as well, just all the latest generation?

    恭喜您獲得 iOS 許可。在此簡單介紹一下。我們什麼時候才能看到 G7 Omnipod 5 也與 iOS 集成,而且只是最新一代?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • We haven't guided the timing on that, Marie. You can imagine that, that's a very urgent matter for us to get to. But we'll do first things first. And so we'll get into LMR with iOS, which will be a G6 offering initially. And we'll get into LMR with G7, and then the 2 systems will come together after that.

    我們還沒有指導時間,瑪麗。你可以想像,這對我們來說是一件非常迫切的事。但我們會先做重要的事情。因此,我們將進入 iOS 的 LMR,最初將是 G6 產品。我們將與 G7 一起進入 LMR,然後這兩個系統將結合在一起。

  • Operator

    Operator

  • Our next question comes from Josh Jennings from TD Cowen.

    我們的下一個問題來自 TD Cowen 的 Josh Jennings。

  • Joshua Thomas Jennings - MD & Senior Research Analyst

    Joshua Thomas Jennings - MD & Senior Research Analyst

  • Congratulations on another strong quarter. Wanted to follow up on Steve's question on the expanding prescriber base. Any chance you can help us think through the penetration into the 7,000 to 8,000 U.S. endocrinologists? And then of the additional prescribers, I guess, if you're almost fully penetrated there, 7,000 to 9,000, are those -- some of those nurse practitioners and endocrinology practices? Are they PCPs? Maybe just help us better understand where you're getting this prescriber expansion outside of endocrinology.

    祝賀又一個強勁的季度。想跟進史蒂夫關於擴大處方者基礎的問題。您有機會幫助我們思考對 7,000 至 8,000 名美國內分泌科醫生的滲透嗎?然後,我想,如果你幾乎完全了解那裡的其他處方者,7,000 到 9,000 名,是那些——其中一些執業護士和內分泌科實踐者?他們是 PCP 嗎?也許只是幫助我們更了解內分泌學以外的處方擴展。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Josh. I'll provide -- we don't have perfect data on the specifics of your question, but we're very well penetrated with endocrinologists. We know that some of those prescribers are nurse practitioners and other care extenders in endo practices. And then we know that some of the writers are PCPs or PAs attached to nonspecialist practices as well. But I don't think -- I mean, I'll turn to Lauren and/or Deb to see if we have other color than that. That's the color I think we have.

    謝謝,喬許。我會提供——我們沒有關於你的問題的具體細節的完美數據,但我們對內分泌學家的了解非常深入。我們知道,其中一些處方者是執業護理師和內視鏡治療中的其他護理延伸者。然後我們知道一些作者也是從事非專業實踐的 PCP 或 PA。但我不認為——我的意思是,我會向勞倫和/或黛布求助,看看我們是否還有其他顏色。我想這就是我們的顏色。

  • Deborah R. Gordon - VP of IR

    Deborah R. Gordon - VP of IR

  • No. This is Deb. That's the color that we have, Jim. It's great because what we are seeing is we're seeing increases from all aspects. We're seeing increasing prescribers from endos, increasing prescribers from HCPs. And it's great that we also have PCPs that are becoming aware of the system and prescribing it. So we look at the trend data, and we see it increasing over the last quarter, and it's been great. So we'll see where it goes from there.

    不,這是黛布。這就是我們的顏色,吉姆。這很棒,因為我們看到的是各個方面的成長。我們看到越來越多的內科醫生開出處方,越來越多的醫生開出處方。很高興我們也有 PCP 開始了解該系統並開立處方。因此,我們查看趨勢數據,我們看到它在上個季度增加,而且非常棒。所以我們將看看它從那裡走向何方。

  • Operator

    Operator

  • Our next question comes from Danielle Antalffy from UBS.

    我們的下一個問題來自瑞銀集團的 Danielle Antalffy。

  • Danielle Joy Antalffy - Analyst

    Danielle Joy Antalffy - Analyst

  • Congrats on a really strong quarter. I guess my one question is a question I ask a lot, and that's around the primary care physician population here and just sort of what Insulet is doing to ensure that they're appropriately servicing that prescribing base because they do own the majority of the type 2, so really executing upon that once you do get the Omnipod 5 type 2 indication. And is it going to require you to add to the sales force? Or do you think you have enough to get to all the high-prescribing physicians?

    恭喜這個季度的強勁表現。我想我的一個問題是我經常問的一個問題,這與這裡的初級保健醫生群體有關,而Insulet 正在做的事情就是確保他們為處方基地提供適當的服務,因為他們確實擁有大多數這種類型的藥物2,因此,一旦您獲得 Omnipod 5 類型 2 指示,就真正執行該操作。是否需要您增加銷售隊伍?或者你認為你有足夠的錢去看所有高處方醫生嗎?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thanks, Danielle. Primary care physicians are really important in the type 2 patient journey, absolutely. And a couple of things that we're doing there. One is that's a main -- that's one of the main objectives of our Omnipod GO commercial pilot. We really want to understand better than we do right now kind of in person, what's going on in the primary care channel. And so the Omnipod GO commercial pilot has allowed us to get into a number of primary practices, present a target patient population to them, which we're finding is ringing true for them for the GO offering.

    謝謝,丹妮爾。初級保健醫生在第 2 型患者治療過程中確實非常重要,這是絕對的。我們正在那裡做一些事情。一是這是主要的——這是我們 Omnipod GO 商業試點的主要目標之一。我們真的想比現在更了解初級保健管道的情況。因此,Omnipod GO 商業試點使我們能夠進入許多主要實踐,向他們展示目標患者群體,我們發現這對他們的 GO 產品來說是真實的。

  • And as I said earlier, it's really allowing us to see that primary practices don't know much often about our portfolio products. And once we get in there, they're very interested in our full portfolio, including Omnipod DASH. And of course, we're not indicated for Omnipod 5, so we're not promoting it there. But it's giving us an opportunity to talk about the whole portfolio.

    正如我之前所說,這確實讓我們看到主要實踐並不經常了解我們的投資組合產品。一旦我們進入那裡,他們對我們的完整產品組合非常感興趣,包括 Omnipod DASH。當然,我們沒有指定 Omnipod 5,因此我們不會在那裡推廣它。但這給了我們一個討論整個投資組合的機會。

  • And out of the pilot, we'll develop a better approach or find approach for how to commercialize into primary care. And there are several other options. The other thing that we see is that our DTP advertising -- or sorry, direct-to-patient, direct-to-consumer-type advertising and our social media does tend to reach into the primary channel. So physicians often see that media and patients often see the media and walk into their physicians and ask about it. So we're getting leverage in that way as well. And I agree with you, we need to really service type 2 patients. We need to find them where they are, and very often where they are as in the primary channel.

    在試點之外,我們將開發更好的方法或找到如何將初級保健商業化的方法。還有其他幾種選擇。我們看到的另一件事是,我們的 DTP 廣告——或者抱歉,直接面向患者、直接面向消費者的廣告和我們的社交媒體確實傾向於進入主要管道。所以醫生常常看到媒體,病人也常常看到媒體走進他們的醫生那裡詢問。所以我們也以這種方式獲得影響力。我同意你的觀點,我們需要真正為 2 類患者提供服務。我們需要在他們所在的地方找到他們,而且通常是在他們所在的地方,就像在主要管道中一樣。

  • Operator

    Operator

  • Our last question today will come from Matt Miksic from Barclays.

    今天我們的最後一個問題將來自巴克萊銀行的馬特·米克西奇。

  • Matthew Stephan Miksic - Research Analyst

    Matthew Stephan Miksic - Research Analyst

  • So maybe just, if you could, with sort of the thinking of entering the basal market potentially on the other side of this, just give us a sense of your expectations there in terms of is this sort of attaching with relationships with patients potentially as they move into a more insulin-intensive clinical needs. Or is this a portion of that market that you feel -- I'm speaking beyond the sort of out-of-pocket interest that you've seen so far.

    因此,如果可以的話,也許您有可能在另一方面進入基礎市場的想法,請讓我們了解您的期望,即與患者的關係是否可能與他們建立聯繫。進入更密集的胰島素臨床需求。或者這是您所感受到的市場的一部分——我所說的超出了您迄今為止所看到的那種自付費用的興趣。

  • But is there a portion of that market that you think is particularly attractive and maybe the size around that? Just sort of an update on your view as to what is that opportunity in addition, of course, being very large compared to the insulin-intensive opportunity?

    但您認為該市場的一部分特別有吸引力,或者其規模是否特別大?只是更新一下您對這個機會的看法,當然,與胰島素密集型機會相比,這個機會非常大?

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Yes. Thanks, Matt. There are at least 3 million patients in the U.S. who are on basal-only therapy. Some people say 4 million, so let's call it 3 million to 4 million people on basal-only insulin therapy who have type 2 diabetes in the U.S. Really only a small penetration in that market helps meaningfully with our growth trajectory because our aim is to not only serve those patients but to introduce the Omnipod family of products to them such that when their disease progresses, which is essentially inevitable. As their disease progresses, we have a relationship with them. We're helping with the therapy early, and then we stay -- they stay with us, we stay with them as their disease progresses.

    是的。謝謝,馬特。美國至少有 300 萬名患者僅接受基礎治療。有人說400 萬,所以我們稱之為300 萬至400 萬僅接受基礎胰島素治療的美國2 型糖尿病患者。實際上,該市場的一小部分滲透率對我們的成長軌跡有重大幫助,因為我們的目標是不只為這些患者提供服務,但向他們介紹 Omnipod 系列產品,以便當他們的疾病進展時,這本質上是不可避免的。隨著他們的疾病進展,我們與他們建立了關係。我們儘早幫助治療,然後我們留下來——他們和我們在一起,隨著他們的疾病進展,我們和他們在一起。

  • The target patient population there is -- there's a lot of people there and there's a lot of offerings in there. There's people on MDI. We've been asked before and we're conscious of the fact that the insulin companies are looking to launch once-a-week insulins, which will be a type of therapy in that market. We think there's a lot of room in that market for different offerings. And for us, there's some clear benefits that we bring to market with Omnipod GO, which include there's no needles. So there's a very significant percentage of patients who don't want to do an injectable therapy because they don't like needles.

    那裡的目標患者群體——那裡有很多人,那裡有很多產品。有人在 MDI 上。我們之前曾被問過,我們意識到胰島素公司正在尋求推出每週一次的胰島素,這將成為該市場的一種治療方法。我們認為該市場有很大的空間容納不同的產品。對我們來說,我們透過 Omnipod GO 為市場帶來了一些明顯的好處,其中包括沒有針頭。因此,有很大比例的患者因為不喜歡針頭而不想進行注射治療。

  • And then the other thing is people forget to take their care. They forget to take their insulin. And so we think that we solve both of these problems for both patients and their physicians, and that's what we're testing out in our commercial pilot.

    另一件事是人們忘記照顧自己。他們忘記服用胰島素。因此,我們認為我們可以為患者及其醫生解決這兩個問題,這就是我們在商業試點中測試的內容。

  • So we think there is a meaningful market there for us for Omnipod GO with basal-only therapy. And importantly, we think when we get to those patients and help them early in their patient journey, we can help them throughout their patient journey. And eventually, many of them will end up on Omnipod DASH or Omnipod 5. And so that's the theory of the case. It's both and. It's a meaningful market for us as a basal market. And it's early customer acquisition, if you think about it that way, early in the patient life cycle, which helps us to acquire those patients much further upstream.

    因此,我們認為純基礎療法的 Omnipod GO 有一個有意義的市場。重要的是,我們認為,當我們接觸到這些患者並在患者旅程的早期階段幫助他們時,我們就可以在整個患者旅程中為他們提供幫助。最終,其中許多將最終使用 Omnipod DASH 或 Omnipod 5。這就是案例的理論。兩者都是和。作為基礎市場,這對我們來說是一個有意義的市場。如果你這樣想的話,這是早期客戶獲取,在患者生命週期的早期,這有助於我們在更上游的地方獲取這些患者。

  • Operator

    Operator

  • I'm showing no further questions at this time. I would like to turn the conference back to Jim Hollingshead for closing remarks.

    我目前沒有提出任何進一步的問題。我想請吉姆‧霍林斯黑德 (Jim Hollingshead) 致閉幕詞。

  • James R. Hollingshead - President, CEO & Director

    James R. Hollingshead - President, CEO & Director

  • Thank you, everybody, for joining us today. We're really excited to have delivered another outstanding quarter for Insulet with our Omnipod family of products, clearly driving growth and have great momentum in the type 1 market both in the U.S. and now excited internationally as we've launched Omnipod 5 in the U.K. and Germany and are on track to deliver in other international markets. Clearly leading the market in type 2, which is a very exciting development for us.

    謝謝大家今天加入我們。我們非常高興能夠透過我們的Omnipod 系列產品為Insulet 帶來另一個出色的季度業績,這明顯推動了成長,並且在美國1 型市場上擁有巨大的勢頭,現在我們在英國推出了Omnipod 5,這在國際上也令人興奮。和德國,並有望在其他國際市場上交付。明顯領先 2 類市場,對我們來說是一個非常令人興奮的發展。

  • I want to thank all of our Insulet employees for their dedication and for their focus on mission because it's helped us to get out and continue to reach all the people out there that we've reached, helping them simplify their lives with diabetes. There are millions of people around the world that we intend to help, and we're well on track to do that.

    我要感謝所有 Insulet 員工的奉獻精神和對使命的專注,因為這幫助我們走出去並繼續接觸我們所接觸到的所有患者,幫助他們簡化糖尿病患者的生活。我們打算幫助世界各地數百萬人,而且我們正在順利實現這一目標。

  • Thanks, everybody, for joining us today, and have a good evening.

    謝謝大家今天加入我們,祝大家晚上愉快。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.

    女士們、先生們,今天的會議到此結束。感謝您的參與,祝您有美好的一天。你們都可以斷開連線。