Tandem Diabetes Care Inc (TNDM) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to Tandem Diabetes Care First Quarter 2023 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President, Chief Administrative Officer. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 Tandem Diabetes Care 2023 年第一季度收益電話會議。 （操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人，執行副總裁兼首席行政官蘇珊·莫里森。請繼續。

Hello, everyone, and welcome to Tandem's First Quarter Earnings Call for 2023. We'd like to remind everyone that today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, product development time lines 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. 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 10-K, quarterly report on Form 10-Q and in our other SEC filings. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or other factors.

大家好，歡迎參加 Tandem 2023 年第一季度收益電話會議。我們想提醒大家，今天的討論將包括前瞻性陳述。這些陳述反映了管理層對未來事件、產品開發時間表以及財務業績和運營計劃的預期，並且僅代表截至今天的情況。存在風險和不確定性，可能導致實際結果與我們前瞻性陳述中預期或預計的結果存在重大差異。我們今天早些時候發布的新聞稿以及我們最新年度報告的風險因素部分和其他地方強調了一系列可能導致實際結果與任何這些前瞻性陳述所表達或暗示的結果存在重大差異的因素。 10-K 表、10-Q 表的季度報告以及我們向 SEC 提交的其他文件中的報告。我們不承擔公開更新任何前瞻性陳述的義務，無論是由於新信息、未來事件還是其他因素。

Today's discussion will also include references to a number of GAAP and non-GAAP financial measures. Non-GAAP 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. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP 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, quarterly report on Form 10-Q and the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure.

今天的討論還將涉及一些公認會計原則和非公認會計原則財務指標。提供非公認會計準則財務指標是為了向我們的投資者提供我們認為能夠反映我們核心經營業績並反映我們持續業務運營的信息。我們相信這些非公認會計準則財務指標有助於更好地比較不同報告期間的經營業績。所提供的任何非 GAAP 信息不應被視為獨立替代或優於根據 GAAP 準備的結果。請參閱我們的收益發布、10-Q 表季度報告以及我們網站的投資者中心部分，了解這些指標與其最直接可比的 GAAP 財務指標的對賬情況。

Today's call participants include John Sheridan, our President and CEO. Brian Hansen, our Executive Vice President and Chief Commercial Officer; and Leigh Vosseller, our Executive Vice President and Chief Financial Officer. Following their prepared remarks, we'll open up the call for questions. Thank you in advance for limiting yourself to one question before getting back into the queue. John, you're welcome to begin.

今天的電話會議參與者包括我們的總裁兼首席執行官約翰·謝里登 (John Sheridan)。 Brian Hansen，我們的執行副總裁兼首席商務官；以及我們的執行副總裁兼首席財務官 Leigh Vosseller。在他們準備好的發言之後，我們將開始提問。提前感謝您在回到隊列之前將自己限制在一個問題上。約翰，歡迎你開始。

Thanks, Susan, and thank you, everyone, for joining us on today's call. We're coming out of the first quarter with confidence about our ability to achieve our key operational and commercial goals we set for this year. We continue to expand the insulin pump market while capturing competitive share and grow the number of Tandem customers purchasing a t:slim once again. This is a meaningful achievement in a highly competitive environment and a testament to our talented employees and our #1 rated t:slim X2 with Control-IQ technology.

謝謝蘇珊，也謝謝大家參加今天的電話會議。第一季度結束後，我們對實現今年設定的關鍵運營和商業目標的能力充滿信心。我們繼續擴大胰島素泵市場，同時獲得競爭性份額，並再次增加購買 t:slim 的 Tandem 客戶數量。這是在競爭激烈的環境中取得的一項有意義的成就，也是對我們才華橫溢的員工和採用 Control-IQ 技術的排名第一的 t:slim X2 的證明。

Internally, our teams continue to prepare for the launch of multiple new products in 2023. I'll talk more about each of these later in my comments. But overall, there's an enthusiasm at Tandem as we approach being able to offer another wave of innovative products to the diabetes community. With these launches, we'll be building upon our reputation for offering high-quality products and services that reduce the burden of diabetes management. We set our high bar with our easy-to-use t:slim X2 with Control-IQ technology. It continues to deliver outstanding clinical and quality of life improvements across a wide range of ages and demographics of people living with type 1 diabetes. This was recently highlighted in multiple publications, including the New England Journal of Medicine and Diabetes Technology and Therapeutics.

在內部，我們的團隊繼續為 2023 年推出多種新產品做準備。我將在稍後的評論中詳細討論其中的每一個產品。但總體而言，當我們能夠向糖尿病社區提供另一波創新產品時，Tandem 充滿了熱情。通過這些產品的推出，我們將鞏固我們提供高質量產品和服務以減輕糖尿病管理負擔的聲譽。我們通過採用 Control-IQ 技術的易於使用的 t:slim X2 設定了高標準。它繼續為不同年齡和人口統計的 1 型糖尿病患者帶來顯著的臨床和生活質量改善。最近，包括《新英格蘭醫學雜誌》和《糖尿病技術與治療學》在內的多種出版物都強調了這一點。

The amount of positive data we are amassing for our market-leading AID capabilities is unrivaled. The New England Journal publication was the third time our t:slim was featured in the journal. This time focusing on the benefits of our Control-IQ technology for very young children. Diabetes Technology and Therapeutics recently published a meta-analysis of 3 randomized Control-IQ trials that demonstrated the immediate and sustained clinical benefit of our system. What this meta-analysis shows is that regardless of age, people with the highest baseline hemoglobin A1c and the lowest time in the range experienced the greatest benefit, which is important as we work to bring the benefits of our technology to more people living with diabetes.

我們為市場領先的 AID 能力積累的積極數據數量是無與倫比的。 《新英格蘭雜誌》是我們的 t:slim 第三次在該雜誌上發表專題報導。這次重點關注我們的 Control-IQ 技術對幼兒的好處。糖尿病技術和治療最近發表了 3 項隨機 Control-IQ 試驗的薈萃分析，證明了我們的系統具有直接和持續的臨床益處。這項薈萃分析表明，無論年齡如何，具有最高基線血紅蛋白 A1c 和該範圍內時間最短的人都會獲得最大的益處，這對於我們努力將我們的技術的好處帶給更多醣尿病患者來說非常重要。

Our technology is not only making a positive clinical impact, but we are also making a positive impact on the environment. By choosing a t:slim pump our customers have kept more than 20 million batteries out of landfills since 2012. This is an important part of our longer-term product strategy as we look forward to similar environmental benefits from our future product offerings. Is this kind of performance and impact, combined with the customer experience our teams provide that sets Tandem apart and allows us to continue growing our installed base, 3 years following the launch of Control-IQ.

我們的技術不僅對臨床產生積極影響，而且對環境也產生積極影響。通過選擇 t:slim 泵，自 2012 年以來，我們的客戶已使超過 2000 萬個電池不再被填埋。這是我們長期產品戰略的重要組成部分，因為我們期待未來的產品能夠帶來類似的環境效益。這種性能和影響力，再加上我們團隊提供的客戶體驗，使 Tandem 脫穎而出，並使我們能夠在 Control-IQ 推出 3 年後繼續擴大我們的安裝基礎。

I'd now like to ask Brian and Leigh to spend a few minutes talking about our performance in the first quarter, the broader commercial environment and our expectations for the remainder of the year. Brian?

我現在想請 Brian 和 Leigh 花幾分鐘談談我們第一季度的業績、更廣泛的商業環境以及我們對今年剩餘時間的預期。布萊恩？

Thanks, John. In my role, I get to spend quite a bit of time with healthcare providers and their patients and their personal stories they share quickly put into perspective why our t:slim X2 insulin pump is rated #1. It's #1 in terms of overall satisfaction, #1 in terms of clinical outcomes, #1 in ease of use and #1 in reducing burden. There is also a broad acknowledgment that Control-IQ technology continues to be best-in-class. Our automated correction bolus feature, customized profiles, superior overnight control and ability to disconnect continue to be strong selling features. This is why over the past several years, including into Q1 of this year, approximately half of our new customers report adopting insulin pump therapy for multiple daily injections, demonstrating that we are furthering our long-term goal to expand the insulin pump market.

謝謝，約翰。在我的角色中，我花了相當多的時間與醫療保健提供者及其患者以及他們分享的個人故事快速了解為什麼我們的 t:slim X2 胰島素泵被評為第一。它在總體滿意度方面排名第一，在臨床結果方面排名第一，在易用性方面排名第一，在減輕負擔方面排名第一。人們還廣泛承認 Control-IQ 技術仍然是同類最佳的。我們的自動校正推注功能、定製配置文件、卓越的隔夜控制和斷開連接能力仍然是強大的銷售功能。這就是為什麼在過去幾年中，包括今年第一季度，我們大約一半的新客戶報告採用胰島素泵療法進行每日多次注射，這表明我們正在進一步推進擴大胰島素泵市場的長期目標。

As we look at the broader commercial environment, the start to the year was largely consistent with what we've seen exiting 2022. While there were pressures associated with the competitor's new product launch in the United States, which created noise and delayed decision-making. The experience we've gained selling in this environment will benefit us in the back half of this year. Our sales team is excited about the increasing number of in-person diabetes education and advocacy events and our clinical specialists are training more patients in person, which our customers report as a very positive experience. These interactions with our team contribute to overall customer satisfaction which remains high for our technology and our services. It's why we've not seen a change in our modest attrition rate over the past few years. We monitor this in multiple ways, including through the incredible amount of therapy data regularly uploaded by our customers through our t:connect platform and renewal purchases.

當我們審視更廣泛的商業環境時，今年的開局與 2022 年結束時的情況基本一致。儘管競爭對手在美國推出新產品帶來了壓力，這造成了噪音並延遲了決策。我們在這種環境下獲得的銷售經驗將使我們在今年下半年受益。我們的銷售團隊對越來越多的面對面糖尿病教育和宣傳活動感到興奮，我們的臨床專家正在親自培訓更多的患者，我們的客戶認為這是一次非常積極的體驗。與我們團隊的這些互動有助於提高客戶的整體滿意度，這對於我們的技術和服務來說仍然很高。這就是為什麼我們在過去幾年中沒有看到我們適度的員工流失率發生變化。我們通過多種方式對此進行監控，包括通過我們的客戶通過我們的 t:connect 平台和續訂購買定期上傳的大量治療數據。

In fact, the number of repeat customers purchasing a new pump from Tandem once again increased meaningfully in Q1. It's also encouraging based on renewal opportunity this year is significantly higher than 2022 and continues to climb over the next few years in line with our historical pump shipments. The impact of the U.S. economic environment has also been consistent over the past several quarters. The more comprehensive payment plans now available to our customers have helped address this pressure, but it has also highlighted that there are some misconceptions held by patients and positions about the affordability of insulin pump therapy through the DME channel. Our data shows, on average, the cost for a direct Tandem customer is less than $50 monthly for our system and nearly 1/3 pay 0 out of pocket for the pump itself.

事實上，第一季度購買 Tandem 新泵的回頭客數量再次顯著增加。這也令人鼓舞，因為今年的續約機會明顯高於 2022 年，並且根據我們歷史上的泵出貨量在未來幾年繼續攀升。美國經濟環境的影響在過去幾個季度也一直持續。現在為我們的客戶提供的更全面的付款計劃有助於緩解這一壓力，但它也凸顯出患者對通過 DME 渠道進行胰島素泵治療的負擔能力存在一些誤解和立場。我們的數據顯示，平均而言，Tandem 直接客戶的系統成本每月不到 50 美元，近 1/3 的客戶為泵本身支付 0 費用。

Our commercial team is focused on driving customer awareness of these facts to counter the perception of cost as a barrier to choosing the t:slim X2 for pump therapy. Outside the United States, there isn't the same pricing sensitivity as most people are covered under government healthcare plans where little or no additional payments are required to adopt pump therapy. Related to our international scaling activity, we continue to work through the logistics of the inventory transition to our European distribution center, which was largely done in the first quarter. We've now onboarded our distributors in France and Germany, which are 2 of the largest countries we serve. And once completed in the second quarter, this European distribution center will support roughly 70% of our sales outside the United States. We're already hearing positive feedback from our distribution partners that is easing the supply chain process. We now serve approximately 25 countries worldwide and in 2023, we'll be focused on bringing the benefits to more people living with diabetes in those countries.

我們的商業團隊致力於提高客戶對這些事實的認識，以消除成本作為選擇 t:slim X2 用於泵療法的障礙的看法。在美國以外的地區，價格敏感性不一樣，因為大多數人都享受政府醫療保健計劃，採用泵療法只需很少或不需要額外付款。與我們的國際擴張活動相關，我們繼續致力於將庫存轉移到歐洲配送中心的物流工作，這主要是在第一季度完成的。我們現在已經在法國和德國建立了經銷商，這是我們服務的兩個最大的國家。一旦第二季度竣工，這個歐洲配送中心將支持我們在美國以外地區約 70% 的銷售額。我們已經從分銷合作夥伴那裡聽到了積極的反饋，這些反饋正在簡化供應鏈流程。我們現在為全球大約 25 個國家提供服務，到 2023 年，我們將致力於為這些國家的更多醣尿病患者帶來好處。

As we have noted, most of these countries are only 10% to 20% penetrated, which presents an exciting longer-term opportunity. Overall, we continue to be mindful of our competition and will capitalize on the valuable knowledge we have gained so far to inform our commercial strategy as they expand their launches worldwide. We remain excited about the t:slim X2 system we offer today as well as the future technology right around the quarter. We are starting to receive customer and healthcare provider inquiries about Mobi and their early signs of anticipation building, reinforcing conviction and our strategy of offering a true portfolio of pumps to meet the needs of more people living with diabetes.

正如我們所指出的，這些國家中的大多數只有 10% 到 20% 的滲透率，這提供了一個令人興奮的長期機會。總體而言，我們將繼續關注我們的競爭，並將利用我們迄今為止獲得的寶貴知識，在他們在全球範圍內擴大產品發佈時為我們的商業戰略提供信息。我們對今天提供的 t:slim X2 系統以及本季度的未來技術仍然感到興奮。我們開始收到客戶和醫療保健提供商有關 Mobi 的詢問，以及他們建立預期、強化信念的早期跡象，以及我們提供真正的泵產品組合以滿足更多醣尿病患者需求的戰略。

With that, I will now turn the call over to Leigh.

現在，我將把電話轉給 Leigh。

Thank you, Brian. As a reminder, unless otherwise noted, the financial metrics I'll be discussing today are on a non-GAAP basis. Reconciliations to GAAP can be found in today's earnings release as well as on the Investor Center portion of our website. Worldwide sales in the first quarter were $171 million, which was in line with the high end of our expectations and excludes the deferral associated with the U.S. Tandem Choice program that launched in late 2022.

謝謝你，布萊恩。提醒一下，除非另有說明，否則我今天將討論的財務指標均基於非公認會計原則。您可以在今天的收益報告以及我們網站的投資者中心部分找到 GAAP 的調節表。第一季度的全球銷售額為 1.71 億美元，符合我們預期的上限，並且不包括與 2022 年底啟動的美國 Tandem Choice 計劃相關的延期。

Nearly half our sales were driven by 23,000 pump shipments. There were multiple unique factors in the quarter resulting in year-over-year comparisons that are not necessarily reflective of the progress of our business, such as the impact on sales of the ongoing operational transition to our European distribution center. Beginning with our results in the U.S., total sales were $133 million. We experienced typical seasonal trends in our first quarter performance associated with the insurance deductible resets. For example, the average sequential decline for pump shipments in the U.S. historically was approximately 30%. In the first quarter of 2023, the decline was 28% as we shipped 17,000 pumps. While the majority of these shipments were to new customers, renewals also provided a meaningful contribution in the quarter with strong growth year-over-year. We maintained the improvements we saw last year in our renewal rates on an increased number of new opportunities, which underscores our high customer satisfaction.

我們近一半的銷售額來自 23,000 台泵的出貨量。本季度有多個獨特因素導致了同比比較，這些因素不一定反映我們業務的進展，例如正在進行的向歐洲配送中心的運營過渡對銷售的影響。從我們在美國的業績開始，總銷售額為 1.33 億美元。我們在第一季度的業績中經歷了與保險免賠額重置相關的典型季節性趨勢。例如，美國泵出貨量歷來平均環比下降約 30%。 2023 年第一季度，我們的泵出貨量為 17,000 台，下降了 28%。雖然這些出貨量大部分是發給新客戶的，但續訂也為本季度做出了有意義的貢獻，同比增長強勁。我們保持了去年在新機會數量增加的續約率方面的改進，這凸顯了我們的高客戶滿意度。

Turning to supplies. We saw an increase in both our cartridges and infusion set sales in line with growth in our in-warranty installed base to approximately 300,000 people at the end of the first quarter. Similar to pumps and our historical experience, we saw insurance-related seasonality in the first quarter impacting customer ordering patterns. Overall, our direct mix of business in the U.S. and therefore, our pricing was consistent with 2022 at approximately 35% of sales. We are reaffirming our non-GAAP sales expectations in the U.S. for the full year in the range of $650 million to $660 million based on our current referral trends for new customers and strong renewal rates. We assume that sales will increase across the quarters and that the year will be back-end loaded due to normal seasonality.

轉向供應。我們的藥筒和輸液器銷量均有所增長，與第一季度末保修期內安裝人數增長至約 300,000 人一致。與泵和我們的歷史經驗類似，我們看到第一季度與保險相關的季節性因素影響了客戶的訂購模式。總體而言，我們的業務直接混合在美國，因此我們的定價與 2022 年保持一致，約為銷售額的 35%。根據我們當前的新客戶推薦趨勢和強勁的續訂率，我們重申全年在美國的非 GAAP 銷售額預期在 6.5 億至 6.6 億美元之間。我們假設各個季度的銷售額都會增加，並且由於正常的季節性因素，全年將出現後端負載。

Considering the sequential step-up from Q1 to Q2, historical trends show a great deal of variability. The bottom end of the range has been a low double-digit increase over Q1, which is a good starting point for how to think about this year as customers anticipate new product launches from our partners, competitors and even our own Mobi launch.

考慮到從第一季度到第二季度的連續上升，歷史趨勢顯示出很大的可變性。與第一季度相比，該範圍的底部出現了兩位數的低增長，這是一個很好的起點，可以讓我們思考今年的情況，因為客戶預計我們的合作夥伴、競爭對手甚至我們自己的 Mobi 發布的新產品。

Outside the U.S., our sales in the first quarter were $38 million. We shipped approximately 6,000 pumps bringing our estimated in-warranty customer base outside the United States to 130,000 people. This is a 30% increase in the number of our customers outside the U.S. compared with Q1 of last year. A big focus for our internal operations and supply chain team in the quarter was the continued transition to utilization of the European distribution center that Brian discussed. This is a positive move for our business, reducing logistical supply chain challenges strengthening international distributor relations and bringing closer correlation between our pump shipments and pump placements on patients.

在美國以外，我們第一季度的銷售額為 3800 萬美元。我們運送了大約 6,000 台泵，使美國以外的保修期內客戶群達到 130,000 人。與去年第一季度相比，我們美國以外的客戶數量增加了 30%。本季度我們內部運營和供應鏈團隊的一大重點是繼續過渡到利用布萊恩討論的歐洲配送中心。這對我們的業務來說是一個積極的舉措，減少了物流供應鏈的挑戰，加強了國際分銷商關係，並使我們的泵運輸和患者泵放置之間的相關性更緊密。

The first quarter impact of this transition was approximately $18 million, reflected in our pump and supply sales. Although we have substantially completed the onboarding of the participating market, we anticipate approximately $7 million of remaining sales headwinds in the second quarter based on current distributor inventory levels. These pressures were partially offset in the first quarter by pricing benefit from the actual mix of the ordering countries. Consistent with our previously provided guidance, our full year expectations for OUS business are in the range of $235 million to $240 million.

這一轉變對第一季度的影響約為 1800 萬美元，反映在我們的泵和供應銷售中。儘管我們已經基本完成了參與市場的啟動，但根據當前的分銷商庫存水平，我們預計第二季度仍將面臨約 700 萬美元的剩餘銷售阻力。這些壓力在第一季度被訂購國家實際組合的定價優勢所部分抵消。與我們之前提供的指引一致，我們對 OUS 業務的全年預期在 2.35 億美元至 2.4 億美元之間。

Turning to margins. Our gross margin in the first quarter was in line with our expectations at 50% of sales. Similar to our experience in recent quarters, we benefited from higher average selling prices and reduced manufacturing costs which were offset by unfavorable product mix. While our supplies gross margin modestly improved over last year, our growing installed base of customers drove the proportion of lower-margin supply sales higher overall. Additionally, the impact of lower sales and higher costs associated with raw materials acquired in early 2022 further pressure gross margin. Those higher material costs combined with greater freight costs reduced gross margin by 1 percentage point. We anticipate that these higher inventory costs will be materially behind us in the second half of this year and maintain our expectations of approximately 52% gross margin for the full year.

轉向邊緣。第一季度毛利率佔銷售額的 50%，符合我們的預期。與我們最近幾個季度的經歷類似，我們受益於平均銷售價格的提高和製造成本的降低，但不利的產品組合抵消了這些成本。雖然我們的供應毛利率比去年略有改善，但我們不斷增長的客戶群推動了低利潤供應銷售的比例總體上更高。此外，2022 年初採購的原材料銷量下降和成本上升的影響進一步令毛利率承壓。較高的材料成本加上較高的運費使毛利率下降了 1 個百分點。我們預計，這些較高的庫存成本將在今年下半年大幅消失，並維持我們對全年毛利率約 52% 的預期。

From an operating expense perspective, we continue to diligently manage spending, prioritize investments in future growth opportunities and pursue additional measures to create efficiencies within the organization. In relation to those efforts, we recognized a onetime $79 million charge for our in-process R&D associated with the closing of the AMF Medical acquisition as well as $3 million in cash and noncash severance costs in the quarter. Beyond these unique items, our increase in Q1 baseline spending compared to the fourth quarter was primarily associated with ongoing operational costs related to our recent acquisitions and Mobi development scale-up costs.

從運營費用的角度來看，我們繼續努力管理支出，優先投資於未來的增長機會，並採取其他措施來提高組織內的效率。與這些努力相關的是，我們確認了與完成 AMF Medical 收購相關的一次性研發費用 7,900 萬美元，以及本季度的 300 萬美元現金和非現金遣散費。除了這些獨特的項目之外，與第四季度相比，我們第一季度基準支出的增加主要與我們最近的收購和 Mobi 開發規模擴大成本相關的持續運營成本有關。

When excluding the onetime transactions as well as depreciation, amortization and noncash stock-based compensation, our adjusted EBITDA margin was negative 12%. This was in line with our expectations, particularly in light of the sales impact of the European distribution center transition. We anticipate that our adjusted EBITDA margin will improve in the second quarter to negative mid-single digits with a return to positive margins in the second half of the year when the distribution center transition is complete. Therefore, we are maintaining our expectations for adjusted EBITDA to be in the range of 5% to 6% on a full year basis.

當排除一次性交易以及折舊、攤銷和非現金股票補償時，我們調整後的 EBITDA 利潤率為負 12%。這符合我們的預期，特別是考慮到歐洲配送中心轉型對銷售的影響。我們預計，調整後的 EBITDA 利潤率將在第二季度改善至負中個位數，並在下半年配送中心過渡完成後恢復為正利潤率。因此，我們維持全年調整後 EBITDA 在 5% 至 6% 範圍內的預期。

We closed the quarter with total cash and investments of $520 million. Notably, we utilized $69 million in cash for the closing of the AMF Medical acquisition in the first quarter, but remain in a strong balance sheet position. To summarize our 2023 outlook, which is provided on a non-GAAP basis, our worldwide sales are estimated to be in the range of $885 million to $900 million, including sales outside the United States of $235 million to $240 million. Our gross margin expectation is approximately 52% and adjusted EBITDA is estimated to be in the range of 5% to 6% of sales. Our noncash P&L charges for stock compensation, depreciation and amortization are expected to be approximately $115 million, of which $95 million is associated with stock comp and $20 million with depreciation.

本季度結束時，我們的現金和投資總額為 5.2 億美元。值得注意的是，我們在第一季度使用了 6900 萬美元現金來完成對 AMF Medical 的收購，但資產負債表狀況依然強勁。總結我們基於非公認會計原則提供的 2023 年展望，我們的全球銷售額預計在 8.85 億至 9 億美元之間，其中美國以外的銷售額為 2.35 億至 2.4 億美元。我們的毛利率預期約為 52%，調整後的 EBITDA 預計在銷售額的 5% 至 6% 範圍內。我們用於股票補償、折舊和攤銷的非現金損益費用預計約為 1.15 億美元，其中 9500 萬美元與股票補償相關，2000 萬美元與折舊相關。

As a reminder, unless otherwise stated, the financial metrics I discussed today are on a non-GAAP basis. Please refer to our earnings release and the Investor Center portion of our website for a reconciliation to the most directly comparable GAAP financial measure.

提醒一下，除非另有說明，我今天討論的財務指標都是基於非公認會計原則的。請參閱我們的收益發布和我們網站的投資者中心部分，以了解與最直接可比的公認會計準則財務指標的對賬。

I will now turn the call back to John.

我現在將把電話轉回給約翰。

Thanks, Leigh. Delivering on innovation is what drove Tandem to its leadership position in insulin therapy management. We are committed to continue doing so by serving the varying needs and preferences of people living with diabetes, the majority of whom use multiple daily injections today. This requires a true portfolio of solutions that center around simplification and delivering choice. This means choice in features, choice and device form factor and choice in how users can wear and operate their pump. We'll continue delivering on this vision in 2023 as we plan for our upcoming new product introductions.

謝謝，利。創新推動 Tandem 在胰島素治療管理領域取得領先地位。我們致力於繼續這樣做，滿足糖尿病患者的不同需求和偏好，其中大多數人目前每天進行多次注射。這需要一個真正以簡化和提供選擇為中心的解決方案組合。這意味著功能、設備外形尺寸的選擇以及用戶佩戴和操作泵的方式的選擇。在計劃即將推出的新產品時，我們將在 2023 年繼續實現這一願景。

Our goal starting this fall is for the t:slim X2 to be the first FDA-cleared insulin pump integrated with multiple CGM sensors. Choice of more than one CGM is not only a differentiator, it's a true realization of interoperability and opens the door for more people to adopt our technology. This empowers users to make the best sensor decision for their needs and preferences. Our t:slim X2 pump in the market are capable of being remotely updated to integrate with Dexcom's G7 and Abbott's Freestyle Libre sensors. These no-cost software updates will be offered to all X2 users within their warranty period. We find that launching our products in a metered fashion provides the best experience for our healthcare providers, customers and internal teams. The key phases, including starting with internal walkabout testing, followed by scaling availability in the United States and debt internationally.

從今年秋天開始，我們的目標是讓 t:slim X2 成為首款經 FDA 批准的集成多個 CGM 傳感器的胰島素泵。選擇多個 CGM 不僅是一種差異化因素，而且是互操作性的真正實現，並為更多人採用我們的技術打開了大門。這使用戶能夠根據自己的需求和偏好做出最佳的傳感器決策。我們市場上的 t:slim X2 泵能夠遠程更新，以與 Dexcom 的 G7 和 Abbott 的 Freestyle Libre 傳感器集成。這些免費軟件更新將在保修期內提供給所有 X2 用戶。我們發現，以計量方式推出我們的產品可以為我們的醫療保健提供者、客戶和內部團隊提供最佳體驗。關鍵階段包括從內部步行測試開始，然後擴大在美國的可用性和國際債務。

We've been working closely with Dexcom to finalize our Control-IQ integration with G7 and to coordinate its launch. Walkabout testing has been taking place and launch will scale across the upcoming months, followed by our international rollout. We've also been working diligently on the integration of Abbott's Freestyle Libre 2 and Libre 3 sensors. Walkabout testing using Libre 2 is also underway. And we plan to start a scaled launch in the U.S. in the third quarter with Libre 3 as a fast follow up. We believe this path will allow Libre customers to enjoy the benefits of our Control-IQ technology as we finalize the integration with Libre 3.

我們一直與 Dexcom 密切合作，以完成 Control-IQ 與 G7 的集成並協調其發布。 Walkabout 測試已經進行，發布將在接下來的幾個月內進行擴展，隨後我們將在國際範圍內進行推廣。我們還一直致力於雅培 Freestyle Libre 2 和 Libre 3 傳感器的集成。使用 Libre 2 的 Walkabout 測試也在進行中。我們計劃第三季度在美國開始大規模發布，并快速跟進 Libre 3。我們相信，隨著我們最終完成與 Libre 3 的集成，這條道路將使 Libre 客戶能夠享受到我們的 Control-IQ 技術的優勢。

Outside the United States, we intend to launch directly with the Libre 3 sensor as the implementation path aligns with our target launch timing. The next new technology we are preparing to launch the following FDA clearance is a Tandem Mobi system. As a reminder, the Mobi pump is about half the size of the t:slim and operated by a smartphone through a mobile application. It's designed to expand our portfolio of diabetes solutions and offer people greater choice in how they wear and operate their pump. Our dialogue with the agency remains constructive as we work through the process of FDA review and responding to questions. In the meantime, we continue to prepare for its launch in the second half of the year.

在美國境外，我們打算直接使用 Libre 3 傳感器進行發布，因為實施路徑與我們的目標發佈時間一致。我們準備在 FDA 批准後推出的下一項新技術是 Tandem Mobi 系統。提醒一下，Mobi 泵的大小約為 t:slim 的一半，並通過智能手機通過移動應用程序進行操作。它旨在擴展我們的糖尿病解決方案組合，並為人們在如何佩戴和操作泵方面提供更多選擇。在我們完成 FDA 審查和回答問題的過程中，我們與該機構的對話仍然是建設性的。同時，我們也在繼續為下半年的上線做準備。

As you can see, we are making great progress with our future products in addition to the strength that we offer in our t:slim X2 today. We have historically introduced new diabetes technologies at an industry-leading pace. So it's particularly noteworthy that we will be bringing multiple new products to market in the coming months. Our employees are extraordinary. And I'd like to express our thanks to everyone for your efforts in making both Tandem and our technology offerings positively different. We remain confident in our ability to achieve our goals for the year which focuses on successful executing our business plan, supporting our customers and building shareholder value.

正如您所看到的，除了我們今天在 t:slim X2 中提供的優勢之外，我們在未來的產品方面也取得了巨大的進步。我們歷來以行業領先的速度推出新的糖尿病技術。因此，特別值得注意的是，我們將在未來幾個月內將多種新產品推向市場。我們的員工非常出色。我想對大家表示感謝，感謝你們為使 Tandem 和我們的技術產品變得與眾不同而付出的努力。我們對實現今年目標的能力仍然充滿信心，這些目標的重點是成功執行我們的業務計劃、支持我們的客戶和創造股東價值。

With that, I'd like to ask the operator to open the call up for questions.

就此，我想請接線員打開電話詢問問題。

(Operator Instructions) And our first question is from Matt Miksic with Barclays.

（操作員說明）我們的第一個問題來自巴克萊銀行的馬特·米克西奇（Matt Miksic）。

Congrats on a really solid quarter here. So maybe, John, if you could describe this the walkabout process and the sort of the ramp-up of the integration that you talked about, a little bit different than the sort of clearance and launch cadence that we're used to. And then I just have one follow-up.

祝賀這個季度的表現非常強勁。所以，約翰，如果你能描述一下你所說的步行過程和集成的加速過程，這可能與我們習慣的許可和啟動節奏有點不同。然後我只有一個後續行動。

Sure. Well, the sequence of release is really going to follow the sequence of the FDA approvals for both Dexcom and Abbott. So Dexcom will be first, and then that will be followed by Abbott. And as I said in the prepared remarks, we conduct this walkabout testing really to help us understand and optimize system performance and customer experience. It's followed by a scaled launch, which is going to happen in the upcoming months. And we would expect to see meaningful -- a meaningful number of customers using the t:slim G7 in the third quarter.

當然。嗯，發布順序實際上將遵循 FDA 批准 Dexcom 和 Abbott 的順序。所以 Dexcom 將是第一，然後是 Abbott。正如我在準備好的發言中所說，我們進行這種步行測試實際上是為了幫助我們了解和優化系統性能和客戶體驗。隨後將在未來幾個月內進行大規模發布。我們預計第三季度將有大量客戶使用 t:slim G7。

So I think that when it comes to the international launch, it will follow the U.S. launch. It will occur on a country-by-country basis for G7, and it will commence relatively -- in a relatively short time frame after the U.S. launch starts. When it comes to the Abbott product, we're also in the walkabout testing phase right now, and that scaled launch process is going to be delayed a little bit compared to Dexcom. It will happen in the third quarter. And so I think that it will happen in the third quarter, we would see meaningful numbers of people using the system as we enter the fourth quarter.

所以我認為當談到國際發佈時，它將跟隨美國的發布。它將在 G7 中逐個國家進行，並且將在美國啟動後相對較短的時間內開始。就 Abbott 產品而言，我們現在也處於步行測試階段，與 Dexcom 相比，規模化的發布過程將稍微延遲一些。這將在第三季度發生。因此，我認為這將在第三季度發生，進入第四季度時，我們將看到大量使用該系統的人。

That's great. And one follow-up, if I could, John. We talked about this process. And we pick up on this a little bit when we talk to clinicians and how they're seeing patient choice kind of enter new patients considering the 2 leading closed-loop systems out there in the market. It seems to have kind of stabilized in sort of a 60%, 70% of new patients may be flowing to the other system in the very anecdotal checks that we've performed. But what's your sense? I mean is it sort of crested? Is it stable? Is there anything else coming up in the narrative and dialogue that clinicians are having with patients that gives us a sense of what the environment is like at the moment?

那太棒了。如果可以的話，還有一個後續行動，約翰。我們討論了這個過程。當我們與臨床醫生交談以及他們如何看待患者選擇進入新患者時，我們會考慮到市場上兩種領先的閉環系統。根據我們進行的軼事檢查，情況似乎已經穩定下來，60%、70% 的新患者可能會流向另一個系統。但你的感覺是什麼？我的意思是它有點冠冕嗎？穩定嗎？臨床醫生與患者進行的敘述和對話中是否還有其他內容可以讓我們了解當前的環境？

Yes, Matt, I think you're right. I think we sort of see the situation as having stabilized. There still is pressure for sure but it's not any better, it's not any worse. So it has been entering this year. I think we probably expect to see the pressure for another quarter or 2 until we start to see the benefits of these new technologies, new ways of innovation come to market in the second half. And so we would agree with your characterization.

是的，馬特，我認為你是對的。我認為我們認為局勢已經穩定下來。壓力肯定還是有的，但沒有好轉，也沒有更糟。於是就進入了今年。我認為我們可能預計還會再經歷一兩個季度的壓力，直到我們開始看到這些新技術和新創新方式在下半年上市的好處。所以我們同意你的描述。

One moment for our next question. And our next question is from Steven Lichtman with Oppenheimer.

請稍等一下我們的下一個問題。我們的下一個問題來自史蒂文·利奇曼和奧本海默。

So just one question and then just one quick clarification just in terms of making -- it looks like you're making nice progress on the integration with the CGM that is not embedded in guidance, right? Any sort of contribution you get in the latter part of the year. That's just a clarification. And then just going back, Brian, to some of your comments about some of the experiences you've learned in terms of competing with the newer products in the market and that could help you in the back half of the year. Can you talk a little bit more about what that means I think you had talked a little bit about the pricing dynamics and some clarifications there. If you can clarify what you mean by that and what you'll be putting in place?

因此，只有一個問題，然後只是在製作方面進行一個快速澄清 - 看起來您在與未嵌入指南中的 CGM 集成方面取得了很好的進展，對吧？您在今年下半年獲得的任何形式的貢獻。這只是一個澄清。然後，布萊恩，回到您對您在與市場上的新產品競爭方面所學到的一些經驗的評論，這可能會對您在今年下半年有所幫助。您能多談談這意味著什麼嗎？我認為您已經談過一些有關定價動態的問題並進行了一些澄清。您能否澄清您的意思以及您將採取的措施？

Sure. So Leigh, you want to catch the first.

當然。所以Leigh，你想抓住第一個。

Sure. I'll start by confirming that we do not have any new product contribution in the guidance for this year.

當然。首先我要確認的是，我們今年的指南中沒有任何新產品貢獻。

And to my piece, I commented earlier that first quarter was a lot like fourth quarter. The environment is pretty stable right now from a COVID perspective. We're not seeing those challenges, maybe a few staffing challenges. So now we sit with some of the economic pressures. And I think we've addressed those very well. And obviously, the competitive piece as part of the prepared remarks is something that we see. I wouldn't say most of our conversations with our healthcare providers start with the strength of Control-IQ and the support that they get from the Tandem team. And then we take a look at that 6- or 9-month window now that the competitive product has been available on the market.

在我的文章中，我早些時候評論說第一季度很像第四季度。從新冠疫情的角度來看，目前的環境相當穩定。我們沒有看到這些挑戰，也許還有一些人員配置方面的挑戰。所以現在我們面臨著一些經濟壓力。我認為我們已經很好地解決了這些問題。顯然，我們已經看到了作為準備好的評論一部分的競爭性文章。我不會說我們與醫療保健提供者的大部分對話都是從 Control-IQ 的實力以及他們從 Tandem 團隊獲得的支持開始的。然後，既然競爭產品已經上市，我們就看看 6 或 9 個月的窗口期。

Those patients are coming back to the endocrinologists with feedback, and we can see how they're doing. The physicians can see how they're doing, and again, it highlights the strength of our product and to some extent, the strength of their products. We feel very good about our offering and continue to lean into the size, the touchscreen, the ability to disconnect all the features that folks have liked, and our team has done a tremendous job there.

這些患者帶著反饋回到內分泌科醫生處，我們可以看到他們的情況如何。醫生可以看到他們的表​​現，這再次凸顯了我們產品的優勢，在某種程度上也凸顯了他們產品的優勢。我們對我們的產品感覺非常好，並繼續關注尺寸、觸摸屏、斷開人們喜歡的所有功能的能力，我們的團隊在這方面做得非常出色。

So anytime there is a product introduction like that, it takes a little while to kind of play out and that pent-up demand and early excitement, but I think we're moving into a more stable environment now going into Q2 and the rest of the year.

因此，每當有這樣的產品推出時，都需要一段時間才能發揮作用，以及被壓抑的需求和早期的興奮，但我認為我們正在進入一個更穩定的環境，現在進入第二季度和剩下的時間那一年。

Great. Thanks.

偉大的。謝謝。

One moment for our next question. And our next question is from Chris Pasquale with Nephron Research.

請稍等一下我們的下一個問題。我們的下一個問題來自 Nephron Research 的 Chris Pasquale。

John, one question on Mobi and then one just on the model. Are you expecting any slowdown in pump shipments as Mobi gets closer to the finish line here. You talked about anticipation starting to build we have seen in the past when you guys have launched new products, a bit of an air pocket in front of that. Is that contemplated in your outlook for the year?

約翰，一個關於 Mobi 的問題，然後一個關於模型的問題。隨著 Mobi 接近終點線，您是否預計泵的出貨量會放緩？你談到了過去當你們推出新產品時我們看到的預期開始建立，在這之前有點像空氣袋。您對今年的展望是否考慮到了這一點？

I'll take that one, Chris. Yes, we -- any time a new products introduced into the market, whether it's a competitive product or our own product, we tend to see noise in advance of it. It's usually the strongest in the time from when FDA approval comes around that time frame up until the product actually released on the market. So when we look at the cadence of how sales will spread across the year, we're taking that into consideration, which is part of the reason when we talk about the sequential step-up into Q2, when we think that noise might begin, we're cautioning you just start on the end of the low double-digit step-up, which is the low end of the range that we've seen historically.

我要那個，克里斯。是的，每當有新產品進入市場時，無論是競爭產品還是我們自己的產品，我們往往會提前看到噪音。通常是從 FDA 批准該時間範圍內到產品實際投放市場期間的最強時間。因此，當我們考慮全年銷售分佈的節奏時，我們會考慮到這一點，這也是當我們談論進入第二季度的連續升級時的部分原因，當我們認為噪音可能會開始時，我們警告您，請從低兩位數升壓的末尾開始，這是我們歷史上看到的範圍的低端。

Okay. That's helpful. And then just looking at the international pump revenue this quarter, there was a pretty big delta between pumps shipped and the revenue you guys recognized there seem to imply a step-up in ASP. Is that just because of mix? Or is there another dynamic happening there related to the distribution center?

好的。這很有幫助。然後看看本季度的國際泵收入，泵的發貨量和你們所認識到的收入之間存在相當大的差異，這似乎意味著平均售價的上升。難道只是因為混合嗎？或者是否存在與配送中心相關的其他動態？

It actually is related to the distribution center, but it is a price benefit. So if you think about the sales headwind that we saw was within particular countries. And so it was a different mix of ordering countries within the quarter than what we would see on a normalized basis which gave us that price benefit this quarter. It's not something to that I would model in or expect to continue for the future.

它實際上與配送中心有關，但它是價格優勢。因此，如果您考慮一下我們在特定國家/地區看到的銷售逆風。因此，本季度內訂購國家的組合與我們在正常化基礎上看到的不同，這給我們帶來了本季度的價格優勢。這不是我會模仿或期望在未來繼續下去的東西。

One moment for our next question. Our next question comes from Brooks O'Neil with Lake Street Capital Markets.

請稍等一下我們的下一個問題。我們的下一個問題來自湖街資本市場的布魯克斯·奧尼爾。

So the last few product innovations you guys have delivered have largely been delivered through the free software download and I know we're anticipating that for the integration with G7 and Libre products. How do you view the impact to your revenue line from those free software download versus the impact you might anticipate from Mobi which is a complete new form factor?

因此，你們交付的最後幾個產品創新大部分是通過免費軟件下載交付的，我知道我們預計與 G7 和 Libre 產品集成。您如何看待這些免費軟件下載對您的收入線的影響以及您可能預期的全新外形的 Mobi 的影響？

I'm going to say that -- Hi Brooks, first of all, how are you doing? I would say that.

我要說的是——嗨布魯克斯，首先，你好嗎？我會這樣說。

I am doing much (inaudible).

我正在做很多事情（聽不清）。

We expect to see -- good. We expect to see favorable revenue impact from the G7 launch. It's a brand-new form factor. It's got a faster start-up time. I've talked to people who are using it and it really is -- people really do like it. So we think that there's going to be a positive impact, as Leigh mentioned. We also think that it could help us with renewals to have people renew sooner. So that's all good.

我們期望看到——很好。我們預計 G7 的推出將帶來有利的收入影響。這是一種全新的外形。它的啟動時間更快。我和正在使用它的人交談過，確實如此——人們真的很喜歡它。所以我們認為這將會產生積極的影響，正如 Leigh 提到的那樣。我們還認為，讓人們更快地續訂可以幫助我們續訂。所以這一切都很好。

I think that Abbott when you think about Abbott, there's quite a large number of people with type 1 that are using the Abbott sensors that are not using pump therapy today. So that may represent even a bigger opportunity than what we see with the Dexcom. I do think that when we bring Mobi to market, it's a brand-new form factor. It's going to be controlled by the mobile app. It's got the discretion and the ease of use, just the simplicity of interacting with a system that's on a mobile app. We think that's going to have a positive effect on sales. I think that all 3 of them are going to have a positive effect. And I think that probably, we will see some effect in the latter part of this year. But the good news about 2024 as we get the full benefit of these products, including Tandem source, which we haven't talked much about, through the entire year of 2024.

我認為 Abbott 當你想到 Abbott 時，有相當多的 1 型患者正在使用 Abbott 傳感器，但目前沒有使用泵療法。因此，這可能代表著比 Dexcom 更大的機會。我確實認為，當我們將 Mobi 推向市場時，它會是一種全新的外形。它將由移動應用程序控制。它具有謹慎性和易用性，與移動應用程序上的系統交互非常簡單。我們認為這將對銷售產生積極影響。我認為這三者都會產生積極的影響。我認為，我們可能會在今年下半年看到一些效果。但關於 2024 年的好消息是，我們在 2024 年全年都能充分受益於這些產品，包括 Tandem 源，我們對此沒有太多討論。

One moment for our next question. Our next question is from Larry Biegelsen with Wells Fargo.

請稍等一下我們的下一個問題。我們的下一個問題來自富國銀行的拉里·比格爾森 (Larry Biegelsen)。

This is Nathan Treybeck on for Larry. Can you talk about how new starts trended in Q1 relative to renewal and the underlying drivers? And I guess what you're seeing in April so far?

這是拉里的內森·特雷貝克 (Nathan Treybeck)。您能否談談第一季度新開工相對於更新的趨勢以及潛在的驅動因素？我猜到目前為止您在四月份看到了什麼？

Sure. So the way this quarter shaped up, as John and Brian both said, it was pretty stable, I would say, in consistent with the type of environment we were seeing in the fourth quarter. So as we came into the year, we anticipated that overall pump shipments in the U.S. would follow typical sequential trends, which is a decline of about 30%. And in this quarter, indeed, the decline was about 28% for new and renewal. Renewal pumps are continuing to grow to be a bigger piece of the pumps that we ship, but new pump starts are actually still the majority there. And so I would say the if the dynamics are the same and that we've seen consistent strong renewals even in the light of this environment, and new pumps is where we have seen the pressure. But as we've talked about, we still firmly believe we have the best product out there, and we continue to fight for that new market share.

當然。因此，正如約翰和布萊恩所說，本季度的情況非常穩定，我想說，與我們在第四季度看到的環境類型一致。因此，進入今年，我們預計美國泵的整體出貨量將遵循典型的連續趨勢，即下降約 30%。事實上，本季度新的和續訂的下降幅度約為 28%。更新泵在我們運送的泵中所佔的比重正在不斷增長，但實際上新啟動的泵仍然佔大多數。因此，我想說的是，如果動態相同，並且即使在這種環境下，我們也看到了持續強勁的更新，而新泵就是我們看到壓力的地方。但正如我們所說，我們仍然堅信我們擁有最好的產品，並且我們將繼續爭取新的市場份額。

Great. And if I could just follow up. In terms of new competition, so your competitor recently got approval for their 780G pump in the U.S. How are you thinking about the competitive landscape once that this is on the market?

偉大的。如果我能跟進的話。在新的競爭方面，您的競爭對手最近在美國獲得了其 780G 泵的批准。您如何看待該產品上市後的競爭格局？

Well, we've been competing against that product now in OUS countries for many quarters. And while we know that once the product does come to market, as I said sometime this summer, we expect them to step up promotion. But we think we have a better product. We think we have the confidence and trust of the endo community in the States. And when you look at the new device, it's certainly a better device, but it's still the same form factor, and it has a sensor that requires fingersticks.

嗯，我們現在在美國國家/地區與該產品競爭已有多個季度了。雖然我們知道，正如我今年夏天的某個時候所說，一旦產品確實上市，我們預計他們會加大促銷力度。但我們認為我們有更好的產品。我們認為我們得到了美國內鏡社區的信心和信任。當你看到新設備時，它肯定是一個更好的設備，但它的外形尺寸仍然相同，並且它有一個需要指尖刺痛的傳感器。

So while there's new competitive products in the market, first of all, it's not a surprise. We've been expecting this for a while. And it hasn't changed our conviction. We remain confident in our ability to hit our goals for the year even with this coming to market midyear.

因此，儘管市場上出現了新的競爭產品，但首先，這並不令人意外。我們對此已經期待了一段時間了。這並沒有改變我們的信念。即使這款產品在年中上市，我們仍然對實現今年目標的能力充滿信心。

One moment for our next question. Our next question comes from Danielle Antalffy with UBS.

請稍等一下我們的下一個問題。我們的下一個問題來自瑞銀集團的 Danielle Antalffy。

I just have 2 questions, if I could. One, on the competitive environment. And that's really around what's factored in. I mean, I think we were all a little surprised about the recent product approval from one of the major competitors. So what's factored into the guide there? And then my second question, I'll just ask it now. And John, you did touch on this a little bit, but just trying to think about the opportunity that exists here with Libre integration, given the size of their installed base. And obviously, it's a smaller installed base or they have less market share, I should say, in type 1. But is this something that you think could be an inflection driver and sort of change the tide here back to accelerating growth? Or is this more muted? I mean, how should we be thinking about this? I appreciate it's not in '23 numbers, but as we look at '24, et cetera.

如果可以的話，我只有兩個問題。一、關於競爭環境。這確實是考慮因素。我的意思是，我認為我們都對最近獲得主要競爭對手之一的產品批准感到有點驚訝。那麼指南中包含哪些因素呢？然後我的第二個問題，我現在就問。約翰，你確實談到了這一點，但只是想考慮一下 Libre 集成中存在的機會，考慮到他們的安裝基礎的規模。顯然，我應該說，在類型 1 中，安裝基數較小，或者市場份額較小。但這是否是您認為可能成為拐點驅動因素並在某種程度上改變趨勢回到加速增長的東西？或者這更低調？我的意思是，我們應該如何思考這個問題？我很欣賞它不是在 23 號數字中，而是在我們查看 24 號數字時，等等。

Sure. Thanks for the questions, Danielle. I'll take the first one about what's factored in the guidance in relation to the competitive environment. We do always when a new product is being introduced factoring that there will be noise in the market. And in fact, we have been anticipating, I guess, you would say, the approval of this product now for a year or 2. So it's something that we've always assumed could be just right around the corner.

當然。謝謝你的提問，丹妮爾。我將討論第一個關於與競爭環境相關的指導因素的因素。當新產品推出時，我們總是會考慮到市場上會出現噪音。事實上，我想，你會說，我們已經期待該產品獲得批准一兩年了。所以我們一直認為它可能指日可待。

And so now we have more certainty about the timing. And so as we look into Q2, we think it will be noisy, which is why when we look at our historical range of how Q1 usually transitions into Q2, we expect to be on the low end of that in the low double digits in terms of sequential growth with that kind of noise that's coming in the market and also add to it that there's going to be conversations people who might be waiting for G7 to be available on the pump as well as people starting to talk about Mobi. And so that's what we've thought about from a competitive perspective and the noise that could come this year.

所以現在我們對時間安排有了更多的確定性。因此，當我們研究第二季度時，我們認為它會很嘈雜，這就是為什麼當我們查看第一季度通常如何過渡到第二季度的歷史範圍時，我們預計會處於低兩位數的低端隨著市場上出現的這種噪音，連續增長的趨勢也隨之而來，此外，人們可能會等待 G7 的上市，也會開始談論 Mobi。這就是我們從競爭角度考慮的問題以及今年可能出現的噪音。

Danielle, regarding Libre, I think the first thing to say that's important is that we're all about providing choice. And we are not engaged in any of the competitive sort of competition between the sensor companies. All we're trying to do is provide a device that has a choice of sensors so that people who have a natural tendency to choose Dexcom can and if they have an interest in Abbott, they can do that also.

Danielle，關於 Libre，我認為首先要說的是，我們致力於提供選擇，這一點很重要。我們並沒有參與傳感器公司之間的任何競爭。我們想做的就是提供一種可以選擇傳感器的設備，這樣那些自然傾向於選擇 Dexcom 的人就可以選擇，如果他們對 Abbott 感興趣，他們也可以這樣做。

But that being said, there -- as we understand it, there's approximately 300,000 people who have type 1 in the U.S. that use the Abbott sensor. And so certainly, that becomes an opportunity for us to take advantage of that community. If we even get 30% or 35% penetration with that community, there's -- it's 100,000 people that are potential candidates for pump therapy. So I think that there is a big opportunity with the Abbott device, and I think it's also larger outside the United States. So we look at it as a growth driver that's going to -- it's really an important growth driver that allows us to get to the numbers we've talked about in 2027 time frame. So it's an important part of our pipeline going forward.

但話雖如此，據我們了解，美國大約有 300,000 名 1 型糖尿病患者使用 Abbott 傳感器。當然，這成為我們利用該社區的機會。如果我們在該社區的滲透率達到 30% 或 35%，那麼就有 100,000 人是泵療法的潛在候選人。所以我認為雅培設備有很大的機會，而且我認為它在美國以外的地區也更大。因此，我們將其視為一個增長動力，這確實是一個重要的增長動力，使我們能夠在 2027 年的時間範圍內達到我們所討論的數字。因此，這是我們未來管道的重要組成部分。

One moment for our next question. Our next question comes from Matt Taylor with Jefferies.

請稍等一下我們的下一個問題。我們的下一個問題來自杰弗里斯的馬特·泰勒。

I just wanted to follow up on that line of thinking about the Abbott opportunity. And John, you just mentioned 30% to 35%. Have you done market research on the percentage of people that could convert? Or how do you think about the opportunity overall for them to convert to MDIs and they haven't done that previously. And your opportunity within that?

我只是想繼續思考雅培機會。約翰，你剛才提到了 30% 到 35%。您是否對可以轉化的人數百分比進行過市場調查？或者您如何看待他們轉換為計量吸入器的總體機會，而他們以前從未這樣做過。你的機會在其中嗎？

Yes. And as I said, I think that there's about 300,000. And if you look at the current penetration rate of pump therapy in the U.S., it's about 35%. So in my mind, that kind of defines as a starting point. We certainly are going to have to sell to them, help convince them of the benefits of pump therapy and just work the process. But I think that when we set a goal for ourselves, I think that's a reasonable starting point. And I think as they become more and more familiar with the benefits of pump therapy, connected up to a sensor that they're comfortable with. We think that represents a significant opportunity for growth in the upcoming couple of years.

是的。正如我所說，我認為大約有 30 萬。如果你看一下泵療法目前在美國的滲透率，大約為 35%。所以在我看來，這就是一個起點。我們當然必須向他們推銷產品，幫助他們相信泵療法的好處，然後完成整個過程。但我認為，當我們為自己設定目標時，我認為這是一個合理的起點。我認為，隨著他們越來越熟悉泵療法的好處，連接到他們熟悉的傳感器。我們認為這代表著未來幾年的重要增長機會。

Maybe just one call. I mean that makes sense. Could you help us think about the time frame that you would expect some of those folks to convert? And what are the key factors? And whether they're converting quarter 1 or quarter 6 after the integration?

也許只是一個電話。我的意思是這是有道理的。您能否幫助我們考慮一下您期望其中一些人轉變的時間範圍？關鍵因素是什麼？整合後他們是否會在第一季度或第六季度進行轉換？

I think that the -- I think it's going to -- it's not going to be overnight for sure. I think there's definitely going to be a selling process, pro promotion, co-marketing process that's going to have to happen. But I think that it does represent a large opportunity for us. And I think it's something that our sales force is excited to get involved in.

我認為，我認為這肯定不會在一夜之間發生。我認為肯定會有一個銷售流程、專業促銷、聯合營銷流程。但我認為這對我們來說確實是一個巨大的機會。我認為我們的銷售團隊很高興參與其中。

One moment for our next question. Our next question comes from Matthew O'Brien with Piper Sandler.

請稍等一下我們的下一個問題。我們的下一個問題來自馬修·奧布萊恩和派珀·桑德勒。

And this one's for Leigh. And I guess it does have 2 parts. It's not a singular question. But Leigh, is there any demonstrable change as far as MDI patients or competitive conversions you wanted to call out in the quarter? And then more importantly, as I look at the model here, and you guys are sticking with the U.S. number for the full year and based on your commentary, which I think you said low double digits off of what you just put up in the U.S. when I do that math, I'm getting like 42% of the full year number is which you should generate in the first half. Historically, it's been -- last year, it was 47%. The year before that, it was 44%. So it's just a big ramp in the back half of the year with a competitor making more noise in the space, not including Mobi et cetera.

這是給Leigh的。我猜它確實有兩個部分。這不是一個單一的問題。但是 Leigh，就 MDI 患者而言，或者您想在本季度呼籲的競爭性轉變方面，是否有任何明顯的變化？更重要的是，當我查看這裡的模型時，你們堅持使用全年的美國數據，並根據你們的評論，我認為你們所說的數據比你們剛剛在美國發布的數據低了兩位數。當我進行數學計算時，我得到全年數字的 42% 是您應該在上半年生成的。從歷史上看，去年這一比例是 47%。前一年，這一比例為 44%。因此，這只是今年下半年的一個巨大的增長，競爭對手在該領域發出了更多的聲音，不包括 Mobi 等。

I mean, why are you confident to be able to get back to -- get up to 650 even at the low end of the range? I mean, can you really walk us through how you get there?

我的意思是，為什麼您有信心能夠回到 650，即使是在該範圍的低端？我的意思是，你真的能告訴我們你是如何到達那裡的嗎？

Sure. Thanks for the questions, Matt. I'll start with the first one on how new pumpers broke down. It again remained consistent at that 50-50 mix of about 50% coming from MDI and 50% from competitive conversions. So no change in those dynamics there today. But again, just to remark that renewals are becoming a much bigger contribution to our pump shipments every quarter. And that leads to the second part of your question about the U.S. this year and why we're so confident in the back half.

當然。謝謝你的提問，馬特。我將從第一個開始，介紹新泵浦如何發生故障。它再次保持在 50-50 的比例不變，其中約 50% 來自 MDI，50% 來自競爭性轉換。所以今天這些動態沒有改變。但再次強調一下，續約對我們每個季度的泵出貨量做出了更大的貢獻。這就引出了你關於今年美國的問題的第二部分，以及為什麼我們對下半年如此有信心。

First, I would say 2022 probably isn't a good comp for how the first half and second half split, just based on the dynamics across the year, it was a much healthier environment in the first half than it was in the second half. And so a 40-60 split isn't too unusual for what we've seen in our history. And this year, the conviction comes from the fact that partially more of our business is coming from recurring revenue streams. So more like 60% this year, which is higher than what we've seen in the past when you factor in the supply sales stream that we see from our large installed base as well as renewals growing pretty significantly. If we look 4 years ago, there were about 50,000 people. They bought Tandem pumps in the U.S., up from 30,000 the year before. And those have a strong seasonal scale to them.

首先，我想說，2022 年可能不是一個很好的上半年和下半年劃分的比較，僅根據全年的動態，上半年的環境比下半年要健康得多。因此，對於我們歷史上所見過的情況來說，40-60 的分裂並不罕見。今年，我們的信念來自於這樣一個事實：我們的部分業務更多來自經常性收入流。所以今年更像是 60%，這比我們過去看到的要高，當你考慮到我們從我們龐大的安裝基礎中看到的供應銷售流以及相當顯著增長的續訂時。如果我們看看 4 年前，大約有 5 萬人。他們在美國購買了 Tandem 泵，而去年的數量為 30,000 個。這些都具有很強的季節性特徵。

So when you just think about normal seasonality, you think about the predictability of renewals coming and the predictability of supplies. It seems pretty normal for us to be able to achieve that kind of year, and we have a high level of conviction in doing that.

因此，當您只考慮正常的季節性時，您就會考慮續訂的可預測性和供應的可預測性。能夠實現這樣的目標對我們來說似乎很正常，而且我們對此充滿信心。

One moment for our next question. Our next question comes from Jayson Bedford with Raymond James.

請稍等一下我們的下一個問題。我們的下一個問題來自傑森·貝德福德和雷蒙德·詹姆斯。

Just may be a couple of questions. They're probably more -- to Leigh. On international, the historical kind of sequential dynamics are kind of all over the place. You called out the $7 million expected impact from the distributor dynamic this year in 2Q. Any direction you can give us on international revenue in 2Q?

可能只是幾個問題。對於Leigh來說，他們可能更重要。在國際上，歷史性的連續動態比比皆是。您指出今年第二季度分銷商動態預計將產生 700 萬美元的影響。您能給我們關於第二季度國際收入的任何指示嗎？

So I think, Jayson, the way to look at it is -- we gave a headwind that hit us in the fourth quarter of about $6 million. It was about $18 million in Q1. So when you add those back, I mean considering there's still a little bit of variability in there because we haven't fully transitioned, that gets you to almost what I would call a normalized run rate type of number. So you can use that to think about what to build off as you look forward for our OUS business. We're still very excited about the opportunities there with -- we have new product introductions that come outside the U.S., and there's a lot of excitement about Control-IQ. And so there's still great growth opportunity there. It's just we need to work through these headwinds here in the near term.

所以我認為，傑森，看待這個問題的方法是——我們在第四季度遇到了大約 600 萬美元的逆風。第一季度約為 1800 萬美元。因此，當您將這些添加回來時，我的意思是考慮到其中仍然存在一些可變性，因為我們還沒有完全過渡，這使您幾乎可以得到我所說的標準化運行率類型的數字。因此，當您期待我們的 OUS 業務時，您可以用它來思考要構建什麼。我們仍然對那裡的機會感到非常興奮——我們在美國以外推出了新產品，而且 Control-IQ 也令人興奮不已。因此那裡仍然存在巨大的增長機會。只是我們需要在短期內克服這些不利因素。

Okay. And just the up low double-digit comment that you've made here, that was related to the U.S. business, right?

好的。您在這裡發表的兩位數的低評論，與美國業務有關，對吧？

Yes. Thanks for asking that for clarification. It's U.S. pump shipments which is what I'm really referring to. When we look at our traditional seasonal patterns there, that seems like a good place to think about the starting point for Q2 of this year.

是的。感謝您要求澄清。我真正指的是美國泵的出貨量。當我們審視那裡的傳統季節性模式時，這似乎是思考今年第二季度起點的好地方。

Okay. Okay. And then just to true up kind of the apples-to-apples comparison here. I appreciate the 430,000 in-warranty user comment. What was the in-warranty installed base exiting '22? Just want to make sure we're comparing the installed base on an apples-to-apples basis.

好的。好的。然後只是為了真實地進行同類比較。我感謝 430,000 條保修期內用戶的評論。 22 年保修期內安裝量是多少？只是想確保我們是在同類的基礎上比較安裝基礎。

Sure. It was off the top. I think was about 420,000. There's one thing I'd like to point out there. I think it's a question I've gotten a number of times is how they translate that installed base number into what is an ordering base number and/or how do view attrition. And that installed base number that we provide is intended to be representative of who is in warranty in any given period. And while I think it's a good directional tool for modeling supplies, so looking at renewal opportunities, it's not the way to measure attrition because it's straight math. So as you add new people into the warranty base and you drop off people whose warranties have expired. That's not how the ordering patterns work.

當然。它已經脫離了頂部。我想大約是420,000。我想指出一件事。我認為我多次遇到的一個問題是他們如何將安裝基數轉換為訂購基數和/或如何查看損耗。我們提供的安裝基數旨在代表在任何給定期限內處於保修期內的人員。雖然我認為它是建模供應的一個很好的方向性工具，所以在考慮更新機會時，這不是衡量消耗的方法，因為它是直接的數學。因此，當您將新人員添加到保修庫中時，您就會丟棄保修已過期的人員。這不是排序模式的工作原理。

We have people who have stopped using the pump in-warranty. We have many people who use the pump out of warranty. So it's not necessarily a way to think about attrition, but it is good directionally for modeling, like I said, supplies and thinking about renewal opportunities.

我們有人在保修期內停止使用泵。我們有很多人使用超出保修期的泵。因此，這不一定是考慮消耗的方法，但它對於建模（就像我說的）、供應和考慮更新機會很有方向性。

And your comment is you don't believe it's (inaudible).

你的評論是你不相信這是（聽不清）。

Jayson, I'm going to need to ask you to jump back in the queue.

傑森，我需要請你插回到隊列中。

One moment for our next question. (Operator Instructions) Our next question comes from Joanne Wuensch with Citi.

請稍等一下我們的下一個問題。 （操作員說明）我們的下一個問題來自花旗銀行的 Joanne Wuensch。

I'm just going to get my head around season 2 is the only thing difference between that and the previous season, the addition of G7 and Libre 3. And then part of that is, so you'll be going to market with Mobi as well as t:slim 2, how does your sales force sort of decide which one it's selling on which day?

我只想了解第二季與上一季之間的唯一區別，即添加了 G7 和 Libre 3。然後其中一部分是，因此您將使用 Mobi 作為營銷工具以及 t:slim 2，您的銷售人員如何決定在哪一天銷售哪一款產品？

So Joanne, I just want to be sure I understand. Right now, we have t:slim X2 on the market. And we are going to add the capability for G7 and Libre 2 and 3 to t:slim X2. So we will be providing a software update to the current installed base so that they can actually update, can use these new sensors as they come to market. We are also working on the t:slim X3, which is a technology upgrade to t:slim X2 and that's something that's going to be coming out here in the near future. And it's essentially just to make sure that we just preserve the life of the t:slim product because it's been on the market for about 10 years right now.

所以喬安妮，我只是想確保我理解。目前，我們有 t:slim X2 上市。我們將為 t:slim X2 添加 G7 和 Libre 2 和 3 的功能。因此，我們將為當前安裝的基礎提供軟件更新，以便他們可以實際更新，可以在這些新傳感器上市時使用它們。我們還在開發 t:slim X3，它是 t:slim X2 的技術升級版，並將在不久的將來推出。本質上只是為了確保我們能夠保持 t:slim 產品的使用壽命，因為它現在已經上市大約 10 年了。

So there's a number of technology upgrades that will enhance the capability, microprocessing skills, I think our capabilities as well. But I just want to be sure I understand the question when you're asking. I'm not sure if I did.

因此，有許多技術升級將增強能力、微處理技能，我認為我們的能力也是如此。但我只是想確保我理解你問的問題。我不確定我是否做到了。

Yes, you did. I probably didn't say it as clearly as you answered it. But t:slim 3 is coming out at the end of this year also. I'm just trying to get my head around how many new things you're talking about in the second half of the year?

是的，你做到了。我可能沒有說得像你回答的那麼清楚。但 t:slim 3 也將在今年年底推出。我只是想弄清楚你在下半年談論了多少新事物？

Well, right now, we have 4 new products. We have Tandem Source, which is something we really haven't talked about that much. And that's coming out here in the relatively near future. As we talked about the 2 sensor integrations, we expect to start scaling launch here in the near future with G7, and we'll start the scaling launch of that in the third quarter. And then we're waiting for approval on Mobi.

嗯，現在我們有 4 個新產品。我們有 Tandem Source，這是我們還沒有談論太多的東西。這將在不久的將來出現。正如我們討論的 2 個傳感器集成一樣，我們預計在不久的將來會在 G7 上開始擴展發布，我們將在第三季度開始擴展發布。然後我們正在等待 Mobi 的批准。

And so there's really 4 products that we're looking at happening here in the fourth -- sorry, the third and fourth quarter of this year. Tandem t:slim X3 is it's out in time. It will be the next product but we haven't been specific about when it's going to be available to the marketplace. But it's out there probably 12 to 18 months from now.

因此，我們確實希望在第四季度推出 4 款產品——抱歉，是今年第三季度和第四季度。 Tandem t:slim X3 及時上市了。它將是下一個產品，但我們尚未具體說明何時將其推向市場。但它可能會在 12 到 18 個月後發布。

One moment for our next question. Our next question comes from Matthew Blackman with Stifel.

請稍等一下我們的下一個問題。我們的下一個問題來自 Matthew Blackman 和 Stifel。

I've got one clarification question for Leigh and then a bigger picture question. Maybe, Leigh, just to start, I'm not sure if we're doing the math right, and you gave us some different metrics to play with at this time. But on renewals, was the 1Q number something approaching 5,000 pumps, something in that neighborhood. Just any help there. And then I guess a sort of a follow-up question, and this is probably for John and/or Brian. I was hoping you'd give us some sense of your strategy in a primary care channel. There's obviously still some opportunity in endo offices, but it seemed to be a large still untapped cohort of type 1 and type 2 intensive that use PCPs. I know today, you target high-prescribing insulin docs and that capture some of the opportunity, but do you need to go deeper and broader than that? And if so, what could that look like? And frankly, why wouldn't that be an initiative that you'd be starting now, if you aren't already. Thank, there's a lot on their, I apologize.

我要向 Leigh 提出一個澄清問題，然後再提出一個更宏觀的問題。也許，Leigh，首先，我不確定我們的數學計算是否正確，而您此時給了我們一些不同的指標供我們使用。但在續約方面，第一季度的泵數量接近 5,000 台，就在那個街區。那裡有任何幫助。然後我猜想有一個後續問題，這可能是針對約翰和/或布萊恩的。我希望您能讓我們了解您在初級保健渠道中的策略。顯然，內科診所仍然存在一些機會，但似乎還有大量尚未開發的使用 PCP 的 1 型和 2 型密集型人群。我知道今天，您的目標是高處方胰島素醫生，並抓住了一些機會，但您是否需要比這更深入、更廣泛？如果是這樣，那會是什麼樣子？坦率地說，如果您還沒有開始的話，為什麼不現在就開始呢？謝謝，他們的內容太多了，我很抱歉。

Yes. So I'll give you a quick response to the renewals question. The information that we've shared is that renewals continue to be strong. And so what's important to note is that the rate at which we convert customers when the warranties expire, it was consistent again this quarter with last year, even first quarter. So comparing a healthier environment to what we're seeing today, which is a little bit more challenged, but it says a lot about our own customers and how they really want to -- they really want to stick with their product. They love the product, they love our customer service and everything that we offer.

是的。因此，我將快速答复您續訂問題。我們分享的信息是續訂繼續強勁。因此，值得注意的是，保修期滿後我們轉換客戶的速度，本季度與去年甚至第一季度再次保持一致。因此，將更健康的環境與我們今天所看到的環境進行比較，這更具挑戰性，但它充分說明了我們自己的客戶以及他們真正想要的方式——他們真的想堅持使用他們的產品。他們喜歡我們的產品，喜歡我們的客戶服務以及我們提供的一切。

In terms of the number -- another piece of information that might be useful. I mentioned the sequential decline for pump shipments from the fourth quarter to the first quarter, it was approximately the same for both the renewal population and the new population. And so renewals are becoming a bigger percent of what we ship each quarter, and we expect that to continue throughout the year as the number of opportunities grow. But new pumpers will still be the majority. And so hopefully, that's a little bit of information to help you understand the renewals trajectory.

就數量而言——另一條可能有用的信息。我提到從第四季度到第一季度水泵出貨量連續下降，更新人口和新增人口大致相同。因此，續訂量在我們每個季度發貨量中所佔的比例越來越大，並且隨著機會數量的增加，我們預計這一情況將在全年持續下去。但新泵浦仍將佔大多數。希望這些信息可以幫助您了解續訂軌跡。

Brian, why don't you take the question on primary care physicians?

布萊恩，你為什麼不回答關於初級保健醫生的問題呢？

Yes. We definitely do see primary care physicians where there is a desire to interact with a pump company like Tandem. And I would say all of our territories have a certain percentage of PCPs that they do call on. We work very closely with our CGM partners as well who have moved into that space more aggressively. And when they start to get inquiries about pump therapy or the opportunity to work with their patients, they pull us into several of those meetings.

是的。我們確實看到初級保健醫生希望與 Tandem 這樣的泵公司進行互動。我想說的是，我們所有的地區都有一定比例的 PCP 需要他們的幫助。我們還與 CGM 合作夥伴密切合作，他們更積極地進入了這一領域。當他們開始詢問有關泵療法或與患者合作的機會時，他們會邀請我們參加其中的幾次會議。

And as physicians become more comfortable with that, we certainly will spend time with anyone who is interested in learning more about pump therapy, explaining to their patients and quite frankly, getting trained on it and support them just like we would in endocrinology office. But clearly, the majority of our time is spent in our big diabetes education centers where we see the type 1s predominantly sitting as we start to look at type 2 more aggressively in the future with Control-IQ and our future products, that becomes probably a bigger piece of our strategy to grow in the primary care space.

隨著醫生對此越來越適應，我們當然會花時間與任何有興趣了解泵療法的人一起，向他們的患者解釋，坦率地說，接受培訓並為他們提供支持，就像我們在內分泌科辦公室一樣。但顯然，我們的大部分時間都花在我們的大型糖尿病教育中心，在那裡我們看到 1 型糖尿病主要是坐著的，而我們開始通過 Control-IQ 和我們未來的產品更積極地研究 2 型糖尿病，這可能會成為我們戰略的更大一部分是在初級保健領域發展。

One moment for our next question. Our next question comes from Joshua Jennings with TD Cowen.

請稍等一下我們的下一個問題。我們的下一個問題來自 TD Cowen 的 Joshua Jennings。

Wanted to ask about the cost per month for patient for pumps is less than $50. Does that include the expenses related to CGM and the accessories or confusion sets within the DME channel? And can patients access infusion sets in reservoir and CGMs using their pharmacy benefit and pair them with Tandem pump t:slim X2 through the DME channel? I have one follow-up.

想詢問患者每月的泵費用是否低於 50 美元。這是否包括與 CGM 和 DME 通道內的配件或混亂集相關的費用？患者是否可以利用其藥房福利使用儲液器和 CGM 中的輸液器，並通過 DME 通道將它們與 Tandem 泵 t:slim X2 配對？我有一個後續行動。

I'll take that one. Yes. So the infusion sets cartridges are only available through the DME channel today. And that $50 or less per month does not factor in the CGM portion of their therapy is just strictly the pump is spread out over time as well as the infusion sets and cartridges necessary to operate the system.

我會接受那個。是的。因此，輸液器盒目前只能通過 DME 渠道購買。每月 50 美元或更少的費用並不包括治療中的 CGM 部分，嚴格來說，泵以及操作系統所需的輸液器和藥筒隨著時間的推移而分散。

Can Tandem patients access their CGM through their pharmacy benefit instead of the DME to cut down on costs for the CGM?

Tandem 患者能否通過藥房福利而不是 DME 獲得 CGM，以降低 CGM 成本？

Absolutely. They have a choice if they want to get it in conjunction with their pump supplies or they can separate those 2 and get those through the pharmacy channel. If their benefits allow it, it works for them, there's no hesitation to do that if available for them.

絕對地。他們可以選擇是否要將其與泵供應結合起來，或者可以將這兩者分開並通過藥房渠道獲得。如果他們的福利允許，這對他們有用，如果可以的話，他們會毫不猶豫地這樣做。

Great. And then just on checking with endocrinologists and the very positive feedback, clearly, as you're all well aware of the Control-IQ algorithm, sometimes we get feedback on just cross-trial comparisons being challenging. So my question is, one, can you just remind us of the road map of enhancing the Control-IQ algorithm go? And then how are you thinking about investing in a head-to-head trial against your competition? Would that be worthwhile to kind of formally put the stake in the ground at the Control-IQ algo was the premier solution?

偉大的。然後，只要與內分泌學家核實並得到非常積極的反饋，顯然，正如你們都清楚 Control-IQ 算法一樣，有時我們會得到關於交叉試驗比較具有挑戰性的反饋。所以我的問題是，第一，您能否提醒我們增強 Control-IQ 算法 go 的路線圖？那麼您如何考慮投資與您的競爭對手進行正面交鋒的試驗？是否值得正式將 Control-IQ 算法作為首要解決方案落地？

Yes, sure. We are and have been since 2015, significantly expanding our internal capabilities to develop algorithms, and we have been working on it since that time. 2015 was when we first establish the relationship with [TypeZero]. And I think that we established that relationship because we didn't have the capabilities initially. But certainly, we have been since then. And we continue to work with a number of universities and other institutions to just improve the knowledge and to run clinical studies and just get -- just better feedback on the performance and ideas on where we ought to be heading.

是的，當然。自 2015 年以來，我們一直在顯著擴展我們開發算法的內部能力，從那時起我們就一直致力於此。 2015年是我們第一次與[TypeZero]建立關係的時候。我認為我們建立這種關係是因為我們最初不具備這種能力。但可以肯定的是，從那時起我們就一直如此。我們繼續與許多大學和其他機構合作，以提高知識並開展臨床研究，並獲得關於我們應該走向何方的績效和想法的更好反饋。

So I will say that, as you know, we probably have our second clinical study underway right now to evaluate certain features for Control-IQ. We would -- we expect that, that's going to inform a pivotal study that would be run sometime next year. And that study would be -- what would be required to get clinical approval for that next-generation system. The -- I think some of the key features that we've talked about in the past have just been simplification of the bolus workflow personalization. And then just -- there's a number of things that I think we can do to just improve the overall experience and potentially make the algorithm more aggressive. So that's what we're working on right now. And I think that as we get closer to define a pivotal study, we'll talk more about what the specifics are.

所以我想說，正如您所知，我們現在可能正在進行第二項臨床研究，以評估 Control-IQ 的某些功能。我們預計，這將為明年某個時候進行的一項關鍵研究提供信息。該研究將是——獲得下一代系統的臨床批准需要什麼。我認為我們過去討論過的一些關鍵功能只是推注工作流程個性化的簡化。然後，我認為我們可以做很多事情來改善整體體驗，並有可能使算法更加積極。這就是我們現在正在努力的事情。我認為，當我們越來越接近定義一項關鍵研究時，我們將更多地討論具體細節。

In addition to that, we are working on, I will call it, Control-IQ 1.5. And this is an algorithm that's going to enable a broader cross-section of people with big larger body mass and also the younger children that have smaller body masses to use the system, and there will be a few features that are going to be available in that, and that will be available in a relatively short period of time, probably sometime next year. But most of the work that we're focused on right now is really on Control-IQ 2.0. And we're also looking beyond that. I mean certainly, we are working towards ultimately getting a fully closed-loop system, but that's going to be out in time.

除此之外，我們正在開發（我將其稱為 Control-IQ 1.5）。這種算法將使更廣泛的體重較大的人以及體重較小的年幼兒童能夠使用該系統，並且將提供一些功能並且將在相對較短的時間內提供，可能是明年的某個時候。但我們現在關注的大部分工作實際上都集中在 Control-IQ 2.0 上。我們的目光也不僅僅局限於此。我的意思是，我們正在努力最終建立一個完全閉環的系統，但這將會及時實現。

Great. And then any ambitious to hold support or invest in the head-to-head trial with competitive technologies?

偉大的。那麼，是否有雄心勃勃地支持或投資具有競爭性技術的頭對頭試驗？

I think, Joshua, right now, there's just a lot of clinical data out there. And I think we feel like clinical data stands for itself, and it's strong. And I think we compete quite well both from the sort of the clinical information as well as the real-world data. So at this point in time, I don't think we see the need to do that. And I think that when you talk to people about it, they certainly agree with us that our device is the best on the market.

我認為，約書亞，現在只有很多臨床數據。我認為我們覺得臨床數據不言而喻，而且很強大。我認為我們在臨床信息和現實數據方面都具有很好的競爭力。因此，目前，我認為我們沒有必要這樣做。我認為，當你與人們談論這個問題時，他們肯定同意我們的觀點，即我們的設備是市場上最好的。

One moment for our next question. Our next question comes from Travis Steed with Bank of America Securities.

請稍等一下我們的下一個問題。我們的下一個問題來自美國銀行證券公司的 Travis Steed。

This is [Stephanie Tazil] on for Travis. Heard the clarification on the U.S. pump shipments up low double digits next quarter, but wanted to see how we should think about overall Q2 revenue on a sequential basis. The Street is at $215 million. So wanted to see if you had any thoughts there. And then on the Q2 EBITDA margin guide of negative mid-single digits previously, it seems like it would be flat in Q2. So I was wondering if that's gotten worse versus before? And if so, why?

這是特拉維斯的[斯蒂芬妮·塔齊爾]。聽到關於下季度美國泵出貨量增長低兩位數的澄清，但想知道我們應該如何按順序考慮第二季度的整體收入。華爾街的估值為 2.15 億美元。所以想看看你是否有什麼想法。然後，根據此前第二季度 EBITDA 利潤率為負中個位數的指引，第二季度似乎將持平。所以我想知道情況是否比以前更糟？如果是這樣，為什麼？

Thanks for the question, Stephanie. So starting with sales worldwide in Q2. I think it was very important to get the information about where we think U.S. pump shipments trend because that's one of the biggest drivers, which is I would expect a softer expectation than what people have right now. And it's really an anticipation that the market could be noisy in the second quarter, but we think it's temporary. It's really just ahead of some really exciting products that are around the corner for us. And until the newest competitive product starts coming out to market, which we feel will compete effectively against.

謝謝你的提問，斯蒂芬妮。所以從第二季度的全球銷售開始。我認為了解我們認為美國泵出貨量趨勢的信息非常重要，因為這是最大的驅動因素之一，我預計人們的預期會比現在更溫和。人們確實預計第二季度市場可能會很混亂，但我們認為這只是暫時的。它確實領先於我們即將推出的一些非常令人興奮的產品。直到最新的競爭產品開始上市，我們認為這些產品將有效地與之競爭。

The other piece that I think is really important to understand about the expectations for Q2 is how the distribution center transition outside the U.S. is impacting the year. So originally, I had given the guidance that it's $25 million for the year and only said heavily in the first quarter. So now I think it's important to take note that, that $7 million will be a headwind in the second quarter, which I think also will often expectations from where they are today. And so I think we want to be cautious as we step into Q2 and the environment that we're in. But we feel like everything that we're talking about, they're all just temporary items, and we feel convicted that we can achieve the second half after what we see in the second quarter.

我認為了解第二季度預期非常重要的另一件事是美國以外的配送中心轉型對今年的影響。所以最初，我給出的指導是今年 2500 萬美元，只是在第一季度才大量說了。因此，現在我認為重要的是要注意，700 萬美元將是第二季度的阻力，我認為這也經常是人們對目前狀況的預期。因此，我認為，當我們進入第二季度和我們所處的環境時，我們要保持謹慎。但我們覺得我們正在談論的一切，它們都只是臨時項目，我們確信我們可以在我們第二季度看到的情況之後，實現了下半場的目標。

To your question about the EBITDA. A lot of that is just translating what's happening from the OUS market. So as you think about the sales trajectory, we're closely managing costs, but it's really the sales that are influencing what EBITDA looks like. What it looked like in the first quarter and what we expect it to look like in the second quarter. So once we get past that transition, EBITDA to start to track more closely to pump sales across the year. And so we do fully expect to be back to positive in the third quarter and for the back half of the year.

關於您關於 EBITDA 的問題。其中很多只是翻譯了 OUS 市場發生的情況。因此，當您考慮銷售軌跡時，我們正在密切管理成本，但實際上影響 EBITDA 的是銷售。第一季度的情況以及我們預計第二季度的情況。因此，一旦我們度過了這一轉變，EBITDA 將開始更密切地跟踪全年的泵銷售情況。因此，我們確實完全期望第三季度和今年下半年能夠恢復正值。

One moment for our next question. Our next question comes from Alex Nowak with Craig-Hallum.

請稍等一下我們的下一個問題。我們的下一個問題來自亞歷克斯·諾瓦克和克雷格·哈勒姆。

One is just the latest on the back and forth that the FDA and the Mobi submission. Has there been any questions that have been raised, kind of soft (inaudible) clock? Have you moved into labeling discussions? Just where does that stand?

其中之一隻是 FDA 和 Mobi 提交的最新文件。是否有人提出過任何問題，例如軟（聽不清）時鐘？您是否已開始進行標籤討論？那到底在哪裡呢？

We're having a constructive dialogue with them right now. It's -- I would say that there's -- it's a -- we're at a point where we're responding to questions and we're actually in the process of answering some questions, which, in some cases, take time because there might be additional testing and things like that, that's going on. I would say it's constructive. And I think that it's basically encouraging that we see a lot more activity from the FDA in the last couple of quarters, right, as we've said in the past, though, it's difficult to predict exactly when we would expect to get approval. And so the organization is preparing that that's going to happen in the second half of this year, and it will take us roughly a quarter to have the device on the market from the time we actually received the clearance.

我們現在正在與他們進行建設性對話。我想說的是，我們現在正在回答問題，我們實際上正在回答一些問題，在某些情況下，這需要時間，因為可能會進行額外的測試和類似的事情，這正在進行中。我想說這是有建設性的。我認為，在過去的幾個季度中，我們看到 FDA 開展了更多的活動，這基本上是令人鼓舞的，正如我們過去所說，儘管很難準確預測我們預計何時獲得批准。因此，該組織正在準備在今年下半年實現這一目標，從我們實際收到許可之日起，我們大約需要四分之一的時間才能將該設備推向市場。

Okay. That makes sense. And then in the past, you've talked about the operating cost base that, well, I guess, if you look at the operating cost base, you have doubled that size of the expense lines versus 2021, but the revenues hasn't doubled. Now I know a lot has been happening the last 2 years, but you're also getting ready for a lot of new product enhancements coming. So I mean, how should we start thinking about efficiencies and margins over the next couple of quarters, next year or so when these new products come online? Should a lot of that start to drop to the bottom line. And just help me get back to this free cash flow positive territory that we're pretty close at but now we're a little bit further away.

好的。這就說得通了。然後在過去，你談到了運營成本基礎，好吧，我想，如果你看看運營成本基礎，你會發現與 2021 年相比，費用線的規模增加了一倍，但收入並沒有增加一倍。現在我知道過去兩年發生了很多事情，但您也正在為即將到來的許多新產品增強功能做好準備。所以我的意思是，當這些新產品上線時，我們應該如何開始考慮未來幾個季度、明年左右的效率和利潤？如果其中很多開始下降到底線。請幫助我回到自由現金流正值領域，我們已經非常接近，但現在我們還有些遙遠。

Right. So I'll start just the first half of this year is in orally pressured by this transition that we're seeing outside the U.S. So that's one of the biggest pressure points that preventing us from being positive on an EBITDA line for this past quarter and this upcoming quarter. What it takes is we're prudently managing our spending. So we're looking very closely at where we're putting our dollars, where are the right places to make investments and where -- and more importantly, can we find the efficiencies, not only for right now, but for the longer term.

正確的。因此，我將從今年上半年開始，我們在美國以外地區看到的這種轉變面臨著口頭壓力。因此，這是阻止我們在上個季度對 EBITDA 線保持積極態度的最大壓力點之一，這個即將到來的季度。我們需要的是謹慎管理我們的支出。因此，我們正在密切關注我們將資金投入到哪裡、哪裡是合適的投資地點以及哪裡——更重要的是，我們能否找到效率，不僅是目前的效率，而且是長期的效率。

So we continue to focus closely on a lot of our customers facing services that we offered moving to more automated or digital solutions. And that's where Tandem Source as a new product will really come into play. And not only will be very helpful from the physician perspective and the efficiency it can create in their practices but also internally and how we can offer patients something that's more like a retail experience as opposed to a lot of the -- today with the required human interaction. And so as we look forward, that's one of our biggest opportunities for the longer term to create efficiencies within the operating expense line to help us drive those margins up. And we still remain confident that we can achieve our long-term objectives there.

因此，我們繼續密切關注我們提供的許多客戶面臨的服務，轉向更加自動化或數字化的解決方案。這就是 Tandem Source 作為新產品真正發揮作用的地方。這不僅從醫生的角度及其在實踐中創造的效率非常有幫助，而且在內部以及我們如何為患者提供更像零售體驗的東西，而不是今天的許多所需的人力相互作用。因此，展望未來，從長遠來看，這是我們最大的機會之一，可以在運營費用範圍內提高效率，幫助我們提高利潤率。我們仍然對實現我們的長期目標充滿信心。

And we have our final question comes from Mike Polark with Wolfe Research.

最後一個問題來自 Wolfe Research 的 Mike Polark。

I have a question about this kind of emerging, bring your own sensor paradigm. Do you have any early flavor for whether Control-IQ algorithm performs similarly with the Dexcom products as Libre? Or are you sorting that out now? And kind of if you could speculate what's the future state of this? Are the pumps and sensors indifferent? Or might there be some quality and performance variances that you eventually know about in 1, 2, 3 years?

我對這種新興的、帶上你自己的傳感器範例有一個疑問。您是否對 Control-IQ 算法與 Dexcom 產品（如 Libre）的性能是否相似有任何初步了解？或者你現在正在解決這個問題嗎？如果你能推測一下未來的情況會怎樣？泵和傳感器是否無關緊要？或者您最終會在 1、2、3 年內了解到一些質量和性能差異？

I think that we've carefully evaluated the Abbott sensor, and I think we feel very confident that it will perform very well with Control-IQ. We will -- we plan on using the sensor data as soon as we initiate the sensor session to power the system and to actually inform Control-IQ. So we have confidence that the system is going to work well. I think it just comes down to personal preferences. I mean some people prefer 1 sensor over the other. And I think that it just gives people a choice. I mean, what's going to happen is there will simply just be a touchscreen on the system, and you'll be able to choose whichever sensor you prefer. And I think that's the idea here is just to give people a choice.

我認為我們已經仔細評估了 Abbott 傳感器，並且我認為我們非常有信心它能夠與 Control-IQ 配合使用，表現非常出色。我們計劃在啟動傳感器會話後立即使用傳感器數據來為系統供電並實際通知 Control-IQ。因此，我們有信心該系統將運行良好。我認為這只是取決於個人喜好。我的意思是有些人更喜歡一個傳感器而不是另一個。我認為這只是給人們一個選擇。我的意思是，將會發生的情況是系統上只有一個觸摸屏，您將能夠選擇您喜歡的任何傳感器。我認為這裡的想法只是為了給人們一個選擇。

And a boring follow-up. Reporting change supplies now instead of infusion sets and cartridges. Is that permanent? Or will there be a breakout in some other materials? And if not, why the change?

還有無聊的後續。現在報告更換耗材，而不是輸液器和藥筒。那是永久的嗎？或者其他一些材料會不會有突破？如果不是，為什麼要改變？

Sure. You're right. We did make that change this quarter. And frankly, the relationship between cartridges and infusion has been so consistent that it seemed like an unnecessary level of detail. So the way it has been tracking, you can usually see that infusion set sales run about 2x to 2.5x cartridge sales, and it really just follows the use pattern of the patient. So there's not a lot of variation there.

當然。你說得對。我們本季度確實做出了改變。坦率地說，墨盒和輸液之間的關係是如此一致，以至於它看起來像是不必要的細節。因此，按照它的跟踪方式，您通常可以看到輸液器的銷量大約是藥筒銷量的 2 倍到 2.5 倍，而且它實際上只是遵循患者的使用模式。所以那裡沒有太多變化。

And this concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。