德康醫療 (DXCM) 2022 Q1 法說會逐字稿

(Operator Instructions) As a reminder, today's conference is being recorded.

（接線員指示）提醒各位，今天的電話會議將進行錄音。

I will now turn the call over to Mr. Kevin Sayer. Sir, you may begin.

現在我將把電話交給 Kevin Sayer 先生。先生，您可以開始。

Thank you, operator. We apologize for being a bit late today. We've had some difficulties with our conference call service provider here, but we're up and running now. And we're excited to talk about a good quarter.

謝謝你，接線員。我們為今天稍微晚了一點致歉。我們在這裡的電話會議服務供應商方面遇到了一些困難，但現在已經恢復運作。我們也很高興能談談一個表現不錯的季度。

I'm going to turn it over to Sean. Sean?

我把時間交給 Sean。Sean？

Thank you, and welcome to Dexcom's First Quarter 2022 Earnings Call. Our agenda begins with Kevin Sayer, Dexcom's Chairman, President and CEO, who will summarize our recent highlights and ongoing strategic initiatives, followed by a financial review and outlook from Jereme Sylvain, our Chief Financial Officer.

謝謝各位，歡迎參加 Dexcom 2022 年第一季財報電話會議。我們的議程將由 Dexcom 董事長、總裁兼執行長 Kevin Sayer 先行，總結近期亮點與持續推動的策略性計畫，接著由我們的財務長 Jereme Sylvain 進行財務回顧與展望。

Following our prepared remarks, we will open the call up for your questions. (Operator Instructions) Please note that there are also slides available related to our first quarter performance on the Dexcom Investor Relations website on the Events and Presentations page.

在我們的準備發言之後，我們將開放提問。（接線員指示）另請注意，Dexcom 投資人關係網站的「活動與簡報」頁面也提供與第一季表現相關的投影片。

With that, let's review our safe harbor statement. Some of the statements we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs and expectations about future events, strategies, competition, products, operating plans and performance.

接下來，我們先回顧安全港聲明。我們在今天電話會議中所做的部分陳述可能構成前瞻性陳述。這些陳述反映管理層對未來事件、策略、競爭、產品、營運計畫與績效的意圖、信念與預期。

All forward-looking statements included in this presentation are made as of the date hereof based on information currently available to Dexcom, are subject to various risks and uncertainties and actual results could differ materially from those anticipated in the forward-looking statements.

本簡報中所包含的所有前瞻性陳述均以本簡報日期為準，係基於 Dexcom 目前可得資訊作出，並受各種風險與不確定性影響，實際結果可能與前瞻性陳述中所預期者有重大差異。

The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in Dexcom's annual report on Form 10-K, most recent quarterly report on Form 10-Q and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this presentation or to conform these forward-looking statements to actual results.

可能導致實際結果與任何此等前瞻性陳述所明示或暗示內容產生重大差異的因素，已詳載於 Dexcom 的 Form 10-K 年度報告、最近一期 Form 10-Q 季度報告及其他向美國證券交易委員會提交的文件中。除法律要求外，我們不承擔在本簡報日期後更新任何此等前瞻性陳述，或使該等前瞻性陳述與實際結果一致的義務。

Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP and cash-based results. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP.

此外，在本次電話會議中，我們將就非 GAAP 與以現金為基礎的結果，討論若干未依 GAAP 編製的財務衡量指標。除非另有說明，所有財務指標之提及均以非 GAAP 基礎呈現。此額外資訊之呈現不應被視為可單獨解讀，亦不應被視為可替代依 GAAP 編製之結果，或優於依 GAAP 編製之結果。

Please refer to the tables in our earnings release and the slides accompanying our first quarter earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure.

請參閱我們的財報新聞稿中的表格，以及隨第一季財報簡報附上的投影片，以取得這些衡量指標與其最直接可比較之 GAAP 財務衡量指標之調節表。

Now I will turn it over to Kevin.

現在我把時間交給 Kevin。

Thank you, Sean, and thank you, everyone, for joining us. Today, we reported strong first quarter results with organic revenue growth of 22% over the first quarter of 2021 or 23% on a constant currency basis.

謝謝你，Sean，也謝謝各位的參與。今天我們公布了強勁的第一季業績，與 2021 年第一季相比，有機營收成長 22%，若以固定匯率計算則成長 23%。

Demand for Dexcom CGM remains very high globally across all of our customer segments. We've also seen a nice rebound in customer growth throughout the first quarter with new customer starts ramping after the Omicron wave and ultimately meeting our expectations for the quarter. As many of you know, we have significantly scaled our business to drive demand and greatly expand the number of people with diabetes that we can serve globally.

Dexcom CGM 的需求在全球各客戶區隔仍然非常強勁。我們也看到第一季客戶成長明顯回升；在 Omicron 疫情波過後，新客戶啟用量加速成長，最終達到我們對本季的預期。各位都知道，我們已大幅擴大業務規模，以帶動需求並大幅擴展我們在全球可服務的糖尿病患者人數。

This scale goes beyond manufacturing capacity, extending to the efficiencies that we can bring as we serve customers and clinicians. Our relentless focus on meeting the needs of our customers continues to be validated in our results.

這樣的規模不僅體現在製造產能，也延伸到我們在服務客戶與臨床醫師時所能帶來的效率。我們持續專注於滿足客戶需求，而這一點也在我們的業績中不斷獲得驗證。

In the first quarter, our Net Promoter Scores for G6 remained near record levels, with customers also indicating that the strategies and tools that we've implemented are simplifying their experiences with Dexcom. The teams have driven several innovations that may not always draw the attention of our investors, but they are critically important to the experience of our customers. For example, our customers rely on Dexcom to make dozens of decisions each day and, therefore, a reliable supply of Dexcom CGM is critically important.

第一季，我們 G6 的淨推薦值（Net Promoter Score）維持在接近歷史新高的水準；客戶也表示，我們所導入的策略與工具正在簡化他們使用 Dexcom 的體驗。團隊推動了多項創新，這些創新未必總能引起投資人的注意，但對客戶體驗至關重要。舉例來說，客戶每天仰賴 Dexcom 做出數十項決策，因此 Dexcom CGM 的穩定供應極其重要。

In the first quarter, we established new records for on-time shipping for commercial orders and timing of replacement systems at 99.7% and 99.9%, respectively. We are especially proud of this result given the challenges of current global supply chain dynamics. Product supply should never be on the minds of our customers, and our operations team is making sure that this is the case. These efforts are delivering results in our performance as both retention and utilization levels have steadily improved since the launch of G6, reflecting a competitive strength as we engage with clinicians and payers on the value of our CGM systems. Building on this momentum, we are thrilled to now be underway with the initial launch of our G7 CGM system.

第一季，我們在商業訂單準時出貨與更換系統時效方面分別創下 99.7% 與 99.9% 的新紀錄。考量到當前全球供應鏈動態所帶來的挑戰，我們對此成果尤其自豪。產品供應不應成為客戶需要操心的事情，而我們的營運團隊正確保確實如此。這些努力也反映在我們的表現上：自 G6 上市以來，留存率與使用率水準持續改善，並在我們與臨床醫師及支付方溝通 CGM 系統價值時，展現出競爭優勢。在此動能之上，我們很興奮目前已開始進行 G7 CGM 系統的初期上市。

G7 builds upon the best-in-class G6 experience with a form factor that is 60% smaller with the reduced environmental footprint, a streamlined set of experience, including a 30-minute warm-up time, an improved app experience with CLARITY integrated into the core app. And all of this with accuracy that improves upon the reliable performance that is a hallmark of Dexcom's CGM technology.

G7 在同級最佳的 G6 體驗基礎上再進一步：外型尺寸縮小 60%，環境足跡更低；體驗流程更精簡，包括 30 分鐘暖機時間；並提供更佳的 App 體驗，將 CLARITY 整合至核心 App 中。同時，其準確度也優於 Dexcom CGM 技術一貫可靠表現的水準。

Following the receipt of CE Mark for G7 in March, we initiated our limited launch of G7 in the U.K. in the subsequent weeks. During this brief window, we are assessing the functionality of the sensor and app in the real world and gathering initial feedback from our users, which has been very positive so far. Our plan is to extend the G7 launch to a steady cadence of additional international markets over the remainder of 2022 with a growing impact to our overall sensor mix in the second half of the year.

在 3 月取得 G7 的 CE 認證後，我們於接下來數週在英國啟動 G7 的有限度上市。在這段短暫期間，我們正在評估感測器與 App 在真實世界中的功能表現，並蒐集使用者的初步回饋；截至目前回饋非常正面。我們的計畫是在 2022 年剩餘期間，以穩定節奏將 G7 推向更多國際市場，並在下半年對我們整體感測器產品組合帶來日益增加的影響。

In the U.S., our 510(k) submission for the G7 sensor, receiver and Android and iOS apps remains under review. We are in the traditional back and forth that comes with these processes. And we appreciate the FDA's ongoing attention to their view even as they juggle a very busy schedule. In the meantime, the teams are busy preparing for a seamless transition once G7 is available. This includes preliminary discussions with payers to drive market access, where possible in advance of approval. It includes significant preparations from our operations team to add incremental G7 lines in advance of the loss to support the expected ramp in demand. And it includes ongoing work with our insulin delivery partners to ensure that we are progressing towards the goal of connected pump and insulin pen systems that are integrated with our latest sensor technology.

在美國，我們針對 G7 感測器、接收器以及 Android 與 iOS App 的 510(k) 申請仍在審查中。我們正處於此類流程一貫的往返溝通階段。我們也感謝 FDA 在行程非常繁忙的情況下，仍持續投入審視。與此同時，團隊正忙於為 G7 可供使用後的無縫轉換做準備，包括在可能且於核准前的情況下，與支付方進行初步討論以推動市場准入；也包括由營運團隊進行大量準備，在上市前增加額外的 G7 產線，以支援預期的需求爬升；並包括與胰島素給藥合作夥伴持續合作，確保我們朝向「與最新感測器技術整合的連網胰島素幫浦與胰島素筆系統」之目標持續推進。

As we progress with the launch of G7, we continue to pursue creative solutions to expand access to our CGM technology and bring the value of real-time CGM to people who previously faced limited options for diabetes management. Beyond G7, we recently introduced Dexcom ONE in Spain, which is the newest of our direct markets and will launch Dexcom ONE in the U.K. shortly. These represent the first dual product markets for Dexcom, bringing 2 excellent options for real-time CGM to customers and their respective health systems of these countries.

在推進 G7 上市的同時，我們也持續尋求創新解決方案，以擴大 CGM 技術的可近性，並將即時 CGM 的價值帶給過去在糖尿病管理上選擇有限的人群。除了 G7 之外，我們最近在西班牙（我們最新的直營市場）推出 Dexcom ONE，並將於近期在英國推出 Dexcom ONE。這些將成為 Dexcom 首批「雙產品」市場，為客戶及其所在國家的醫療體系提供兩種優質的即時 CGM 選擇。

We expect this dual product strategy to significantly expand the number of people with reimbursed access to our CGM technology, broadening our growth opportunity in these countries as well as additional countries where we plan to bring Dexcom ONE in the future.

我們預期此雙產品策略將大幅擴增可獲得給付的 CGM 技術使用人數，進一步拓展我們在這些國家以及未來計畫導入 Dexcom ONE 的其他國家的成長機會。

And geographic expansion is only 1 element of the significant growth opportunity ahead for Dexcom.

而地理版圖擴張只是 Dexcom 未來龐大成長機會中的一個面向。

In the first quarter, we were also pleased to receive Device designation from the FDA for the CGM system that we are working to develop for use in the hospital setting. The breakthrough designation represents the FDA's recognition of Dexcom's potential to offer a more effective solution for glucose management and patient outcomes in the hospital relative to the current standard of care. This recognition is designed to expedite the regulatory pathway as we continue to build evidence for the safety and impact of Dexcom CGM in the inpatient setting.

第一季，我們也很高興獲得 FDA 對我們正在開發、用於醫院場域之 CGM 系統的「突破性醫療器材」指定。此突破性指定代表 FDA 認可 Dexcom 有潛力相較於目前的標準照護，為醫院中的血糖管理與病患預後提供更有效的解決方案。此項認可旨在加速法規審查途徑，讓我們在持續建立 Dexcom CGM 於住院病人場域之安全性與影響力證據的同時，能更快推進。

As you can see, we have a busy year plan as we navigate some of the most exciting launches in Dexcom history and build out the foundation of growth for years to come. The foundation for long-term growth emerges from the core values that motivate us and the noble mission that our employees embrace to drive greater health outcomes throughout the world.

如您所見，隨著我們推進 Dexcom 歷史上一些最令人振奮的產品上市計畫，並為未來多年的成長奠定基礎，我們今年的規劃相當繁忙。長期成長的基礎源自於驅動我們的核心價值，以及我們員工所擁抱的崇高使命，進而在全球推動更佳的健康成果。

Along those lines, we are pleased to publish our third annual sustainability report shortly after the conclusion of the first quarter. This report demonstrates our commitment to our stakeholders and details some great progress in our reporting efforts, including the publication of our first SASB index, which is the reporting framework we find to be most preferred among our stakeholders.

基於上述方向，我們很高興在第一季結束後不久發布我們第三份年度永續報告。本報告展現我們對利害關係人的承諾，並詳述我們在揭露工作上的一些重大進展，包括發布我們第一份 SASB 指數；SASB 是我們認為在利害關係人之間最受偏好的報導框架。

We also added updates to our efforts to drive access to our CGM technology globally via a comprehensive strategy that involves product differentiation, leveraging scale and demonstrating robust clinical outcomes. And we enhanced our disclosures around the composition of our workforce, employee engagement metrics, climate-related disclosure. And we are still early in our journey, and these updates provide just a glimpse of the many things that made Dexcom a company that I am truly proud to lead.

我們也更新了推動全球取得我們 CGM 技術的相關工作，透過一套全面性策略，涵蓋產品差異化、運用規模優勢，以及展現強健的臨床成果。同時，我們也強化了對於員工組成、員工投入度指標以及氣候相關揭露的資訊披露。我們仍處於旅程的早期階段，而這些更新僅是讓大家一窺眾多使 Dexcom 成為一家令我真正引以為傲、並很榮幸領導的公司之諸多面向。

With that, I will turn it over to Jereme for a review of the first quarter financials. Jereme?

接下來，我把時間交給 Jereme，請他回顧第一季財務表現。Jereme？

Thank you, Kevin. As a reminder, unless otherwise noted, the financial metrics presented today will be discussed on a non-GAAP basis. Reconciliations to GAAP can be found in today's earnings release as well as on our IR website.

謝謝你，Kevin。提醒各位，除非另有說明，今天所呈現的財務指標將以非 GAAP 基礎進行討論。與 GAAP 的調節表可在今日的財報新聞稿以及我們的投資人關係（IR）網站上查閱。

For the first quarter of 2022, we reported worldwide revenue of $629 million compared to $505 million for the first quarter of 2021, representing growth of 25% on a reported basis and 26% on a constant currency basis. Organic revenue, which excludes non-CGM revenue related to last year's acquisition of our distributor in Australia and New Zealand, was 22% or 23% on a constant currency basis.

2022 年第一季，我們全球營收為 6.29 億美元，較 2021 年第一季的 5.05 億美元成長；以報告基礎計算成長 25%，以固定匯率計算成長 26%。有機營收（不含去年收購澳洲與紐西蘭經銷商所帶來的非 CGM 營收）成長 22%，以固定匯率計算則為 23%。

U.S. revenue totaled $451 million for the first quarter compared to $381 million for the first quarter of 2021, representing growth of 18%. As Kevin mentioned, we saw a nice reacceleration of new customer starts over the course of the quarter, coinciding with improved access to health care providers for sales force as the impact of Omicron waned.

美國第一季營收合計 4.51 億美元，較 2021 年第一季的 3.81 億美元成長 18%。如 Kevin 所提到的，我們在本季期間看到新客戶啟用數明顯再加速，這與 Omicron 影響消退後，業務團隊更容易接觸醫療照護提供者的情況相呼應。

Our team continues to do a great job expanding the Dexcom prescriber base and making sure that these clinicians are aware of the Dexcom stories and the benefits of our system, leaving us well positioned to extend new customer growth, both now and well into the future.

我們的團隊持續在擴大 Dexcom 的開立處方醫師基礎方面表現出色，並確保這些臨床醫師了解 Dexcom 的故事與我們系統的效益，使我們在延續新客戶成長方面具備良好態勢，不僅是現在，也包括未來很長一段時間。

International revenue grew 43%, totaling $178 million for the first quarter. Organic revenue growth, which excludes the non-CGM revenue related to our distributor acquisition, was 33% for the first quarter. These international results include approximately $6 million of unfavorable impact from foreign currency or approximately 4% impact to our international growth result for the quarter.

國際營收成長 43%，第一季合計 1.78 億美元。有機營收成長（不含與經銷商收購相關的非 CGM 營收）第一季為 33%。這些國際結果包含約 600 萬美元的外匯不利影響，約對本季國際成長結果造成 4% 的影響。

We continue to see very good international momentum as we broaden our commercial footprint. This includes the recently announced expansion of our Dexcom ONE rollout that Kevin mentioned as well as additional access wins that have expanded our addressable market beyond the improvements that we achieved in 2021. As we mentioned earlier this year, following the successful launch of Dexcom ONE late last year, we saw 2 of the 4 regions we serve to establish reimbursement starting in the first quarter. We've also secured reimbursement for Dexcom ONE in Spain in conjunction with our launch this month and are hopeful to have Dexcom ONE added to the U.K. drug tariff shortly.

隨著我們擴大商業版圖，國際市場動能持續非常強勁。這包括 Kevin 提到的、近期宣布擴大 Dexcom ONE 推出範圍，以及其他取得給付/准入的成果，將我們的可服務市場進一步擴大，超越我們在 2021 年所達成的改善。如我們今年稍早所提到的，在去年底 Dexcom ONE 成功上市後，我們所服務的 4 個區域中已有 2 個自第一季起建立了給付。我們也在本月於西班牙上市的同時取得 Dexcom ONE 的給付，並希望 Dexcom ONE 很快能被納入英國藥品給付清單（drug tariff）。

In Canada, we secured provincial coverage for people with type 1 diabetes in Ontario. With this addition, Dexcom has now established coverage for 7 provinces, representing greater than 93% of the Canadian population. Our first quarter gross profit was $398.1 million or 63.3% of revenue compared to 68.1% of revenue for the first quarter of 2021.

在加拿大，我們在安大略省為第一型糖尿病患者取得省級給付。隨著這項新增，Dexcom 目前已在 7 個省建立給付，涵蓋超過 93% 的加拿大人口。我們第一季毛利為 3.981 億美元，約占營收 63.3%，相較之下 2021 年第一季毛利率為 68.1%。

Our first quarter gross margin reflects the traditional step down that we see from our fourth quarter, as we see a greater mix of pharmacy revenue and less contribution from our DME customers with high deductible health plans.

我們第一季毛利率反映了從第四季到第一季常見的季節性下滑，原因在於藥局通路營收占比提高，以及來自高自付額健康保險方案之 DME 客戶的貢獻降低。

We also took a write-off of some obsolete G5 inventory in the quarter as Australia, previously the largest remaining G5 market in the world, as it added G6 to its CGM subsidy as of March. With this update, we are now able to fully transition the Australian market to G6, something our customers have long awaited. That impact, combined with a onetime impact related to facility damage, impacted our gross margin for the quarter by 100 basis points.

本季我們也認列部分過時的 G5 庫存報廢，因為澳洲先前是全球最大的 G5 剩餘市場，而其自 3 月起已將 G6 納入 CGM 補助。隨著此更新，我們現在能將澳洲市場全面轉換至 G6，這是我們客戶長久以來所期待的。該影響再加上一項與設施損壞相關的一次性影響，使本季毛利率受到 100 個基點的影響。

Our teams are doing a good job leveraging our significant volume growth and operational efficiencies to offset the inflationary environment, allowing us to remain on track our full year margin expectations as we continue to advance our G7 launch.

我們的團隊正有效運用顯著的出貨量成長與營運效率，來抵銷通膨環境的影響，使我們在推進 G7 上市的同時，仍能維持全年毛利率目標的進度。

Operating expenses were $347.8 million for Q1 of 2022 compared to $297.5 million in Q1 of 2021. Despite ongoing investments in our commercial infrastructure, including the final quarter that includes incremental impact from our U.S. sales force expansion in 2021 as well as preparation for G7 launch and pre-commercial G7 development costs that remained in our R&D expense, we still saw first quarter operating expenses as a percentage of sales decrease by 360 basis points compared to the first quarter of 2021.

2022 年第一季營業費用為 3.478 億美元，較 2021 年第一季的 2.975 億美元增加。儘管我們持續投資商業基礎建設，包括 2021 年美國業務團隊擴編所帶來增量影響的最後一季，以及為 G7 上市做準備、且仍計入研發費用的 G7 上市前開發成本，我們仍看到第一季營業費用占銷售額的比例較 2021 年第一季下降 360 個基點。

Operating income was $50.3 million or 8% of revenue in the first quarter of 2022 compared to $46.4 million or 9.2% of revenue in the same quarter of 2021. With the Q1 channel mix dynamic offsetting the operating leverage we continue to drive across the business.

2022 年第一季營業利益為 5,030 萬美元，約占營收 8%；相較之下，2021 年同季為 4,640 萬美元，約占營收 9.2%。其中，第一季通路組合的變化抵銷了我們持續在全公司推動的營運槓桿效益。

Adjusted EBITDA was $112.4 million or 17.9% of revenue for the first quarter compared to $94.4 million or 18.7% of revenue for the first quarter of 2021. Net income for the first quarter was $32.3 million or $0.32 per share. We remain in great financial position as we closed the first quarter with approximately $2.7 billion of cash and cash equivalents. This gives us the flexibility to support our ongoing organic growth investments, including the scale-up of our Malaysia manufacturing facility and global commercial infrastructure, while also being opportunistic to look at strategic options that accelerate our long-term growth potential through either our ventures unit or M&A.

第一季調整後 EBITDA 為 1.124 億美元，約占營收 17.9%；相較之下，2021 年第一季為 9,440 萬美元，約占營收 18.7%。第一季淨利為 3,230 萬美元，或每股 0.32 美元。我們的財務狀況依然非常穩健，第一季結束時持有約 27 億美元的現金及約當現金。這使我們能靈活支持持續的有機成長投資，包括馬來西亞製造廠的擴產以及全球商業基礎建設，同時也能把握機會，透過我們的創投部門或併購（M&A）評估可加速長期成長潛力的策略選項。

Turning to guidance. We are pleased to be in a position to reaffirm our full year 2022 guidance for revenue and margin. This includes total revenue of between $2.82 billion and $2.94 billion. Gross profit margins of approximately 65%, operating margins of approximately 16% and adjusted EBITDA margins of approximately 25%. This guidance continues to factor in our strong customer growth momentum for our CGM platform, whether that is G6, Dexcom ONE or G7 with approximately $15 million to $20 million of incremental currency headwinds versus our previous expectations. We are focused on meeting the complex operating environment and global inflationary pressures head on, with our teams committed to driving efficiencies and operating leverage for our shareholders.

接著談展望。我們很高興能夠重申 2022 全年營收與利潤率指引。這包括總營收介於 28.2 億至 29.4 億美元之間；毛利率約 65%，營業利益率約 16%，以及調整後 EBITDA 利潤率約 25%。此指引仍納入我們 CGM 平台強勁的客戶成長動能，無論是 G6、Dexcom ONE 或 G7，同時也反映相較於先前預期額外約 1,500 萬至 2,000 萬美元的匯率逆風。我們將正面迎戰複雜的營運環境與全球通膨壓力，團隊也致力於為股東推動效率提升與營運槓桿。

With that, I will pass it back to Kevin.

接下來我把時間交回給 Kevin。

Thanks, Jereme. As you can tell, there is no shortage of exciting things underway at Dexcom, and we look forward to providing updates as they come throughout the course of the year.

謝謝你，Jereme。如各位所見，Dexcom 正在進行的令人振奮事項不勝枚舉，我們也期待在今年的進程中，隨時向各位提供最新進展。

I would now like to open up the call for Q&A. Sean?

現在我想開放電話會議進入問答環節。Sean？

Thank you, Kevin. (Operator Instructions) Operator, please provide the Q&A instructions.

謝謝你，Kevin。（接線員指示）接線員，請提供問答說明。

(Operator Instructions) The first question in the queue comes from Jeff Johnson.

（接線員指示）隊列中的第一個問題來自 Jeff Johnson。

I tend to focus on your top line, but, Jereme, I think I want to start maybe on a gross margin question, if I could. With the gross margin down to 480 basis points, it looks like G&A was up about $16 million year-over-year. I'm assuming that was largely driven by the G7 new manufacturing lines, if you could just confirm that? Obviously, you broke up the 100 basis points on the Australia write-off and the facility issue. That would still put gross margin down about 100 basis points year-over-year adjust for all those factors. Is that just some of those channel mix headwinds? Is there any other core pricing issues going on? Or what else is impacting on that other 100 basis points seems to be left over in my math?

我通常會聚焦在你們的營收端，但 Jereme，如果可以的話，我想先從毛利率的問題開始。毛利率下滑到 480 個基點，看起來 G&A 年增約 1,600 萬美元。我猜這主要是由 G7 新製造產線所帶動的，你能否確認一下？另外，你們也拆解了澳洲沖銷與廠房問題合計 100 個基點。即便如此，把這些因素都調整回去後，毛利率仍年減約 100 個基點。那只是一些通路組合的不利因素嗎？還是有其他核心定價方面的問題？或是還有什麼在影響，因為照我的計算似乎還剩下那 100 個基點沒有解釋到？

Sure. Yes, no problem. And I can certainly give you some of the context in terms of that impact. There's a couple of other smaller pieces of gross margin. So we'll first recap. We had about 50 bps associated with the impact we had at our facility, and that will be recovered via insurance on the balance of the year. So that's certainly a temporal thing.

當然。是的，沒問題。我也可以提供一些關於影響的背景說明。毛利率裡還有幾個較小的項目。我們先回顧一下：我們的廠房事件大約影響了 50 個基點，而這部分在今年剩餘期間會透過保險理賠回收，所以這確實是暫時性的因素。

We certainly talked about the G5 and, again, that's a temporal thing as well as we have more folks on G6, that certainly will bode well for the balance of the year on margin.

我們也確實談到過 G5，而同樣地，這也是暫時性的；隨著更多人員轉到 G6，這對今年剩餘期間的毛利率表現肯定會有正面幫助。

The other couple of pieces in there. There were some impacts associated with onetime use sensors. These are warranty sensors. It's actually a good thing. They expired, and they expired because our warranty rates continue to come down. And so for the quarter, certainly, we had to take a charge for those. But for the balance of the year, we expect our warranties to do better. That was about 50 bps as well. So some of that is the equation you're looking at.

另外還有幾個部分。其中有一些影響與一次性使用感測器有關。這些是保固用感測器。其實這是件好事：它們到期了，而之所以到期，是因為我們的保固率持續下降。因此在本季，我們確實需要為此提列一次性費用。但在今年剩餘期間，我們預期保固表現會更好。這部分大約也是 50 個基點。所以你在看的那個差異，部分就來自這裡。

And there was a little bit of an impact of currency as it flows through. There's about 30 or 40 basis points of currency as you push that through. The remainder of that, and this will push you above the 65% number, is associated with mix and we talked a little bit about it in the prepared remarks. As more and more of the mix in Q1 is tilted towards pharmacy and more folks go through the pharmacy, there's a little bit of pressure as you have less DME in the first quarter.

另外，匯率在傳導過程中也有一點影響。匯率帶來大約 30 到 40 個基點的影響。剩下的部分（這會讓你推算的數字高於 65%）則與產品/通路組合有關，我們在事先準備的講稿裡也稍微提到。由於第一季的組合越來越偏向藥局通路、更多人透過藥局取得產品，因為第一季 DME（耐用醫療設備）占比相對較少，所以會帶來一些壓力。

We expect that to normalize over the balance of the year, and that's historically why you had that step back. As more and more goes to the pharmacy in the first quarter, you just get a little bit of a dynamic from that point of view from a gross margin perspective. But nothing pricing wise. Nothing that would expect us to change the full year. In fact, that's why we reiterated the full year gross margin. We certainly expect to get there.

我們預期這在今年剩餘期間會回歸正常，而這也是歷來你會看到那種回落的原因。第一季更多轉向藥局通路時，從毛利率角度就會出現一些動態變化。但在定價方面沒有問題；也沒有任何會讓我們改變全年展望的因素。事實上，這也是我們重申全年毛利率指引的原因。我們確實有信心達成。

The next question in queue is from Danielle Antalffy.

下一位排隊提問的是 Danielle Antalffy。

Just, Kevin, I'm curious, we've done a lot of work recently on CGM and adoption beyond the Type 1 patient population. And I've got to I say, one of the things that has been very surprising is that they're still -- even with the Endo community, some holdouts on Type 2s and whether the burden of therapy offsets the benefit you get from the CGM. And I know this is a high-level question, but I guess I'm just curious about what you think the right strategy is to get those people over the hump here? You have data. You have coverage for non-insulin intensive Type 2. So where to from here with these types of folks, which, I'm surprised, quite frankly, exists at all, but they do, I guess.

Kevin，我很好奇，我們最近在 CGM 以及其在第一型糖尿病患者族群以外的採用方面做了很多研究。我得說，其中一個非常令人意外的點是，即使在內分泌科社群裡，對於第二型（患者）仍然有一些保留者，質疑治療負擔是否抵銷了 CGM 帶來的效益。我知道這是個高層次的問題，但我想了解你認為要讓這些人跨過這道門檻，正確的策略是什麼？你們有數據，也有針對非胰島素密集治療的第二型的給付覆蓋。那接下來要怎麼推進、面對這類人？老實說，我很驚訝這種情況竟然還存在，但看起來確實存在。

Well, we could take the rest of the call time, Danielle, and talk about this because it's something we talk about a lot. Let's get to the starting point, and that's the evidence. The fact is over and over again, every single time we use CGM and run a study in this patient group, people have much better outcomes than they had before.

Danielle，我們甚至可以用接下來整段電話會議的時間來談這件事，因為這是我們經常討論的主題。先從起點談起，也就是證據。事實是，一次又一次，每當我們在這個病患族群使用 CGM 並進行研究時，他們的結果都比以前好得多。

Getting the data from CGM absolutely changes people's lives and their view of their health, and they make changes because they have feedback that gives them something exactly as to what they should do.

從 CGM 取得數據，確實會改變人們的生活以及他們對健康的看法；他們會做出改變，因為這些回饋能非常明確地告訴他們該做什麼。

We also need to remember that this group of patients, this Type 2 patient who is not on insulin, most of them don't see endocrinologists or people that are always in the diabetes community, they see their primary care doctors. So we have to come up with a set of tools. It will make it very easy for that position and for this whole group to engage with CGM.

我們也需要記得，這一群未使用胰島素的第二型患者，多數並不看內分泌科醫師或總是在糖尿病社群裡的醫療人員，他們看的是家庭醫師/基層照護醫師。因此我們必須提出一套工具，讓那個職位（基層照護醫師）以及整個族群都能非常容易地使用並參與 CGM。

Let's take another look at some of the dynamics going on here. CGM, over time, the cost of CGM has come down, but the cost of these drugs has not come down. The cost of these drugs is very high. What a great way to titrate a new GLP-1 then to have somebody with a CGM to say, "Hey, this is helping you. This is the right dose. This isn't the correct dose." It's going to play a vital role in that space, and it's going to be a very cost-effective solution for patients in that space, and it's going to be cost-effective for all the payers.

再來看看這裡的一些動態。隨著時間推移，CGM 的成本已經下降，但這些藥物的成本並沒有下降；藥物成本非常高。要如何更好地調整（titrate）一個新的 GLP-1 劑量？讓病人配戴 CGM 會是很棒的方法，因為可以說：「嘿，這對你有幫助。這是正確的劑量。這不是正確的劑量。」它在那個領域會扮演關鍵角色，對那個領域的病人而言會是非常具成本效益的解決方案，對所有支付方也會具成本效益。

We need to continue to push for reimbursement. Things really don't grow until they're covered, but we have some very aggressive plans with our partners in the other programs. We have plans of our own. And quite honestly, the feedback we get from the individuals who do get coverage for this, like I said, it's phenomenal. And none of them write me an e-mail or none of them say, "I'm doing better because I'm on a new drug." They attribute their improved health to the CGM and the information that they have and the changes they've been able to make.

我們需要持續推動給付/報銷。很多事情在被納入給付之前都不會真正成長，但我們與合作夥伴在其他計畫上有一些非常積極的規劃；我們自己也有計畫。坦白說，我們從那些已獲得此項給付的人那裡得到的回饋——就像我說的——非常驚人。而且沒有人寫 e-mail 給我、也沒有人說：「我變好是因為我用了新藥。」他們把健康改善歸功於 CGM、歸功於他們獲得的資訊，以及因此能做出的改變。

So we remain bullish on this, but it does take time. I remember the first ride along I ever did when I came here years ago, and I asked every doctor I visited, when you put a patient on CGM only after they've been on a pump for a few years because they're not serious about diabetes unless they wear a pump. We'll look how that's changed. We can change the other equation too. We just need a little more time and a little more evidence.

所以我們對此仍然非常樂觀，但這確實需要時間。我還記得多年前我剛來這裡時第一次跟著業務拜訪（ride along），我問我拜訪的每一位醫師：你們為什麼只在病人使用胰島素幫浦幾年後才讓他們用 CGM，因為除非他們戴著幫浦，否則就不算是認真對待糖尿病。看看這件事後來改變了多少。我們也能改變另一個等式；只是需要多一點時間與多一點證據。

Yes. And when we read the study, Danielle, will certainly understand the questions you're asking out there. If you were winded the results you got from that, say, 2 or 3 to 4 years ago, it would have been a much different outcome as well. And I think you're just seeing that the recognition of this technology over time moves. But we do have to move people off of preconceived notions or the questions around the advancement of technology through education and awareness.

是的。而且當我們閱讀那份研究時，Danielle，我們也會完全理解你在外界所提出的那些問題。如果你把你從那份研究得到的結果放在例如 2、3 到 4 年前來看，結果也會非常不同。我認為你看到的是，市場對這項技術的認知會隨時間推進而改變。但我們確實必須透過教育與提升認知，讓人們擺脫先入為主的觀念，或對技術進步的疑慮。

So it's a continued focus there. And again, it all kind of aligns to all the work we did last year around expanding the sales force, direct-to-consumer advertising, really getting that education and awareness out there. We have to continue to do that, and that should help us over time.

因此我們會持續聚焦在這裡。而且同樣地，這也與我們去年所做的所有工作相互呼應：擴大銷售團隊、進行面向消費者的廣告投放，真正把教育與認知推廣出去。我們必須持續這麼做，長期來看應該會幫助我們。

And the next question in the queue comes from Robbie Marcus.

下一位排隊提問的是 Robbie Marcus。

Maybe if I can ask, in the U.S. business in fourth quarter, you talked about how you had difficulty accessing primary care channel. First quarter growth in the U.S. came in a little lighter than we would have expected. Maybe just talk about trends there and then conversely talk about some of the early responder trends and feedback you're getting on G7 in Europe?

我想請教一下，在美國業務方面，你們在第四季提到難以觸及基層照護通路。第一季美國的成長略低於我們原先的預期。能否談談那裡的趨勢？另外，也請相對地談談你們在歐洲對 G7 的一些早期回應者趨勢，以及你們目前收到的回饋？

Sure. Yes, I'll take the U.S. question, Robbie, and then Kevin can certainly cover the early feedback on G7. So in the U.S., and we talked a little bit about this as we kind of rounded out the year last year, in December -- certainly, in December, we saw the impact of Omicron and that continued pretty heavily into January in terms of getting out there and getting in front of prescribers. And so as you kind of look through the quarter, the way the quarter worked out was you had a kind of a lower January.

當然。是的，Robbie，我先回答美國的問題，接著 Kevin 當然可以談談 G7 的早期回饋。所以在美國，我們在去年年底收尾時也稍微談到過這點，在 12 月——確實，在 12 月我們看到了 Omicron 的影響，而且在 1 月仍然相當明顯，特別是在外出拜訪並直接與開立處方的醫師接觸方面。因此，當你回顧整個季度時，這一季的走勢是 1 月相對偏低。

And as the quarter progressed, each month got a little bit better as things really opened up. And so what we saw was exactly that is January was a bit tough. February was better and March was even better than that. And so the momentum continues in the right way, and that's the way I think we think about it. And so it played out a little bit how we expect when we gave guidance a little bit better as we're kind of coming out a little bit about the top end of at least where we thought the quarter was going to run.

而隨著季度推進，隨著情況真正開放，每個月都稍微好一些。所以我們看到的正是如此：1 月有點艱難，2 月更好，3 月又比 2 月更好。因此動能持續朝正確方向前進，我認為我們就是這樣看待的。整體表現也大致符合我們的預期；在我們給出指引時，實際結果略優一些，因為我們正逐步走出、至少接近我們原先認為本季可能落在的區間上緣。

But that momentum you're seeing, I think, is pretty common to what we've seen and heard in the market. It's also what we've seen as we've been getting in front of these positions. In terms of the experience in the U.K. on the G7 launch, Kevin?

但你看到的那股動能，我認為與我們在市場上看到、聽到的情況相當一致。這也符合我們在與這些醫師接觸時所觀察到的。至於英國 G7 上市的經驗，Kevin？

Yes. We're early on, Robbie, but the feedback has been exactly what we expected has been phenomenal. As you start with product features, size is the first thing everybody sees and even the smaller size of the applicator, lesser materials, size on the body, the half hour warm-up, people love the app being much different than what we've had before is being very well accepted and very easy to use, setup as much easier and much more friendly.

是的。我們還在早期階段，Robbie，但回饋完全如我們預期，表現非常出色。從產品特點來看，尺寸是大家第一眼就注意到的；不論是更小的施用器尺寸、材料用量更少、機身尺寸，以及半小時的預熱時間，大家都很喜歡。App 與我們以往的版本差異很大，接受度非常高，也非常容易使用；設定流程也容易得多、友善得多。

So far so good with the limited launch. Everybody is very happy who's on our products so far. And we continue to gather feedback and then we'll take the feedback we get and incorporate anything we hear that would be valuable into the full launch when we roll it out later this year.

到目前為止，有限度上市的情況一切順利。到目前為止使用我們產品的人都非常滿意。我們也會持續蒐集回饋，並把我們聽到、認為對全面上市有價值的內容納入考量，等到今年稍晚全面推廣時一併導入。

The next question in the queue comes from Jayson Bedford.

下一個排隊提問的是 Jayson Bedford。

Nice job on making this call work. So my question is, typically, you commented on unit volume I don't think I've heard that this quarter. So can you maybe, Jereme, talk about the interplay between volume growth and rev growth this quarter, both U.S. and international? .

這通電話會議能順利進行做得很好。我的問題是：通常你們會評論出貨量（unit volume），但我想這一季我沒有聽到。Jereme，你能否談談本季出貨量成長與營收成長之間的互動關係，包含美國與國際市場？

Sure. Yes. So I think you saw it play out about the same way you saw it in prior quarters. And as we kind of make that migration that's happening, our unit volume growth was in the low 40s. And so as you kind of draw that correlation to what happened last quarter, it's about a similar correlation, which is about what you would have expected, right, as we're going into this year of the final major migration to the pharmacy as well as annualizing some of the OU.S. access wins that we got.

當然。是的，我認為你看到的走勢與前幾季大致相同。隨著我們正在進行的那個轉換（migration），我們的出貨量成長在 40% 出頭。因此，若你把它與上一季做對照，相關性大致相近，基本上也符合你的預期，對吧？因為我們正進入今年，將完成最後一波主要轉換到藥局通路，同時也把我們在美國以外（OU.S.）取得的一些通路准入勝利（access wins）進行年度化（annualizing）。

In terms of the split, U.S./OU.S., we really don't break it out. However, you generally know that there's price -- there's channel mix and pricing in both of those. And so as you talk about the growth numbers, the unit volume numbers are generally higher than that, and it's generally pretty proportionate. That's generally where we sit today. And for the balance of the year, clearly, we have not changed on what we expect those headwinds to be. So hopefully that helps low 40% unit volume growth.

至於美國/美國以外（U.S./OU.S.）的拆分，我們確實不會細分揭露。不過你通常也知道，兩邊都存在價格——也就是通路組合（channel mix）與定價的影響。因此當你談成長數字時，出貨量的成長通常會高於營收成長，而且大致上是相當成比例的。這就是我們目前大致所處的位置。至於今年剩餘期間，我們對於預期會面臨的那些逆風（headwinds）也沒有改變。所以希望這能回答你的問題：出貨量成長在 40% 出頭。

The next question comes from Matthew O'Brien.

下一個問題來自 Matthew O'Brien。

Here in the U.S., just to follow up a bit more on the U.S. commentary, I think people are expecting a little bit more in Q1, understanding Omicron was a little bit of a headwind, but your 55%, 60% penetrated of Type 1s. Consumer confidence is dropping like a rock. You're getting into some of the people that have been more hesitant to get on to CGM so far. So is there a risk that the domestic business could see a little bit more softness than expected throughout the course of this year or even into next year as those factors really kind of start to pile up?

在美國這邊，延續你們對美國市場的評論再追問一下：我想大家原本預期 Q1 會更好一些，理解 Omicron 是一點逆風，但你們在第一型糖尿病（Type 1）族群的滲透率已達 55%、60%。消費者信心正在急速下滑。你們也正在觸及一些到目前為止對使用 CGM 較為猶豫的人。所以，是否存在風險：國內業務在今年甚至明年，隨著這些因素逐漸累積，可能會比預期更疲弱一些？

Matt, I appreciate the question. We do not feel that way at all. With respect to the U.S. population, again, Jereme hit unit volume growth. Our unit volume growth was outstanding this quarter, and our new patient numbers, once we got past the Omicron wave early in the quarter, our new patient adds were very, very strong. And we finished where we plan to finish for the quarter in general. So we did not feel that softness at all.

Matt，謝謝你的問題。我們完全不這麼認為。就美國族群而言，Jereme 剛提到出貨量成長；我們本季的出貨量成長非常亮眼。而且在本季初度過 Omicron 波段之後，我們新增病患數非常、非常強勁。我們整體也如計畫在本季結束時達到預期水準。所以我們完全沒有感受到那種疲弱。

And with respect to confidence, people have never had more confidence in our product than they have in G6 right now. As I said earlier, our customer satisfaction scores are better than they've ever been. Patients are very satisfied with Dexcom. As we look at further penetration in this marketplace, there are some very significant catalysts coming as well on the Type 1 side, and they'll also be more applicable to Type 2 intensive users as well.

至於信心方面，市場對我們產品的信心從未像現在對 G6 這麼高。如我先前所說，我們的客戶滿意度分數是歷來最佳。病患對 Dexcom 非常滿意。當我們進一步提升在這個市場的滲透率時，在第一型（Type 1）端也有一些非常重要的催化劑即將到來，而且對第二型重度使用者（Type 2 intensive users）也會更適用。

You look at our integrated partners with Tandem and with 5 Omnipod 5 on the horizon and then you look at a G7 product for those who aren't on pumps because we won't be integrated with those pumps immediately out of the gate, but a G7 product for our MDI patients that is a much, much better experience than what we have now. And when we have now is world-class, we don't lack for being bullish at all right now here in the U.S. We think we're in a good spot.

你看看我們與 Tandem 的整合夥伴關係，以及即將推出的 Omnipod 5；再看看針對那些未使用幫浦的人所提供的 G7 產品——因為我們不會在一開始就立刻與那些幫浦完成整合——但對於我們的 MDI 病患而言，G7 的使用體驗會比我們現在好非常、非常多。而我們現在的產品已是世界級，我們在美國市場目前完全沒有任何不看好的理由。我們認為我們處在很好的位置。

The next question comes from Joanne Wuensch.

下一個問題來自 Joanne Wuensch。

Thank you for pulling this off. I ask you what's included in your guidance? You've got Dexcom ONE going out the door in different regions. You've got G7 outside the United States and in the United States in the back half of the year, I would assume. How do you think about putting all those factors into your guidance?

謝謝你們把這件事完成。我想問：你們的指引（guidance）包含了哪些內容？你們正在不同地區推出 Dexcom ONE。你們也會在美國以外推出 G7，並且我猜在今年下半年於美國推出。你們如何把所有這些因素納入指引的考量？

Sure. So we've got a little bit of all. So what we do generally in our guidance is we look at multiple different scenarios. And so we have Dexcom ONE in various country launches, timed to different times. It helps us align where that guidance should ultimately sit. We also have a G7 launch outside the U.S. as well as in the U.S. at various times throughout the course of the year that helps us understand the impact. And we run various scenarios to make sure that under all of these scenarios, whether it's G7 or G6 or Dexcom ONE, that we make sure that we're putting out reasonable guidance around what we can achieve. And again, we'll always try to outperform it.

當然。我們把各種因素都納入一些。一般而言，我們在制定指引時會看多種不同情境。因此，Dexcom ONE 會在不同國家分階段上市、時間點各不相同，這有助於我們校準指引最終應落在的位置。我們也規劃了在美國以外以及在美國於一年中不同時間點推出 G7，這也幫助我們理解其影響。我們會跑各種情境，確保在所有情境下——不論是 G7、G6 或 Dexcom ONE——我們都能提出合理、可達成的指引。而且一如既往，我們會努力超越它。

So the way to think about it is, is there's various difference in all of them ultimately play in to kind of coming up with a guidance number we feel comfortable coming out with. And let me give you an example about that. G7 comes out great. It can be an extra catalyst, but you still have to remember G6 is an incredible product that's going to be connected to Omnipod 5, as Kevin previously referenced. So there's some catalysts there.

所以可以這樣理解：各種情境之間的差異，最終都會納入我們提出一個我們覺得有把握的指引數字。讓我舉個例子：如果 G7 推出後表現非常好，它可能成為額外的催化劑，但你也要記得，G6 是一個非常出色的產品，並且會如 Kevin 先前提到的，與 Omnipod 5 連接整合。因此那裡也有一些催化因素。

Dexcom ONE is certainly interesting. And when you win tenders, that can ultimately drive it, knowing when exactly you'll win those tenders. Sometimes it's hard to pick because we have various different scenarios that play in. So a little bit of all of it is the way to think about it, and we expect to be able to hit guidance irrespective of the timing of a lot of these launches to the extent the launches fall the right way, we certainly hope to outperform.

Dexcom ONE 當然也很有意思。而當你贏得標案（tenders）時，最終可能會帶動成長；但要精準掌握你何時會贏得這些標案，有時很難判斷，因為我們會把各種不同情境都納入考量。所以整體而言，就是把所有因素都納入。並且我們預期，不論這些上市時點如何，只要上市推進的方向合理，我們都有能力達成指引；若進展更順利，我們當然希望能超越。

The next question comes from Mathew Blackman.

下一個問題來自 Mathew Blackman。

You mentioned the growing prescriber base, anything you're willing to share on the size of the prescriber base and in particular, the percent that primary care physicians comprised of that base today versus prior to the sales force expansion? Just anything to help us frame the progress of that newer call point?

你提到處方醫師基礎正在成長；你是否願意分享一下處方醫師基礎的規模？特別是，與銷售團隊擴編之前相比，目前其中基層照護醫師（primary care physicians）所占的百分比是多少？任何能幫助我們理解這個較新的拜訪對象（call point）進展的資訊都可以。

Sure. Yes. So I'd say, while we haven't necessarily sized it and I don't think we're ready to size it exactly today, it has grown dramatically. Like I think we've had, it's doubled over the past, call it, 18 months, and it continues to grow faster. In fact, we expect it to grow another sizable portion this year as our folks call on more. In terms of the mix, it is predominantly primary care physicians at this point.

當然。是的。所以我會說，雖然我們不一定已經精確量化，而且我想我們今天也還沒準備好給出確切規模，但它確實大幅成長。我認為在過去大約 18 個月裡，它已經翻倍，而且仍在更快成長。事實上，隨著我們的團隊拜訪更多醫師，我們預期今年還會再成長相當可觀的一部分。就組成來看，目前主要仍以基層照護醫師為主。

When you think about the endocrinologists over -- across the United States, there's about 6,600 endocrinologists across the United States, and we call on tens of thousands of prescribers. And so you can probably get a feel for how many we're calling on. The larger prescribers still in the endocrinologist community. So that still is where we spend a good chunk of our time. But at this point, due to the expansion of the sales force, we are calling on more primary care physicians than we are in endocrinologists.

如果你看美國的內分泌科醫師——全美大約有 6,600 位內分泌科醫師，而我們拜訪的是數以萬計的處方醫師。因此你大概可以感受到我們拜訪的規模。較大的處方量仍然在內分泌科社群裡，所以我們仍把相當一部分時間投入在那裡。但目前由於銷售團隊擴編，我們拜訪的基層照護醫師已經多於內分泌科醫師。

The next question comes from Larry Biegelsen.

下一個問題來自 Larry Biegelsen。

Just wanted to focus on G7. So Kevin, I know you can't predict the FDA, but how are you feeling about having approval of G7 in the U.S. by ADA? Is it still plausible? And with the G6 launch, we saw a pretty big inflection when you launched that in the U.S. Do you think we could see something similar with G7?

我想聚焦在 G7。Kevin，我知道你無法預測 FDA，但你對於在 ADA 之前於美國取得 G7 核准的把握如何？這仍然有可能嗎？另外在 G6 上市時，我們看到你們在美國上市後出現相當大的拐點（inflection）。你認為 G7 也可能出現類似情況嗎？

Larry, thanks for asking. Let's go back a little bit on G7. Remember, this is a global launch for us, not just a U.S. one. Our limited launch right now in the U.K. is going on. We have seen mark there. U.K. will be our first launch as we roll out internationally. And then we roll out to other countries after that as we go through the local approval and filing process. So we're on track with our international plans.

Larry，謝謝提問。我們先回顧一下 G7。請記得，這對我們而言是全球上市，而不只是美國上市。我們目前在英國的有限度上市正在進行中，我們已經看到那裡的表現。英國將是我們國際推廣的第一個上市市場。之後我們會在完成各地的核准與申報流程後，陸續推進到其他國家。所以我們的國際計畫進度如期。

One of the things we've learned over the years is we really don't give dates as far as when we think things are going to be approved. And we are in our back and forth time with the FDA. We applaud them for spending as much time as they have an effort during a busy time with us in getting this done. And we're confident we'll have a meaningful U.S. launch of G7 this year. Approval more than likely will come after ADA knowing what we know and what we see today, and we're comfortable with that. We are also comfortable that there are no showstoppers in the things we're discussing with them. We are having a very good dialogue and look forward to that launch.

我們多年來學到的一件事是：對於我們認為何時會獲准，我們真的不會給出日期。目前我們正與 FDA 進行來回溝通。我們也肯定他們在繁忙期間仍投入大量時間與心力，協助我們完成這件事。我們有信心今年會在美國進行一個具規模且有意義的 G7 上市。就我們目前所知與所見，核准很可能會在 ADA 之後到來，而我們對此也感到安心。我們同樣也相信，我們與他們討論的事項中沒有任何「致命阻礙」（showstoppers）。我們的對話非常順暢，也期待這次上市。

As far as a bolus with G7, you're absolutely right. We do believe this is going to be a great product launch for us and will lead to more people using CGM. I think it's important that everybody remember, we're in a different time now with respect to reimbursement particularly with the time it will take this into the pharmacy channel. So as you start lining things up, once you have approval, you file with CMS to get reimbursement that takes some time and the pharmacy contracts take some time.

至於 G7 是否會帶來一波推升（bolus），你說得完全正確。我們確實相信這會是一次很棒的產品上市，並帶動更多人使用 CGM。我認為大家要記得的是：就給付（reimbursement）而言，我們現在所處的時點不同了，特別是導入藥局通路所需的時間。因此當你開始把事情排程起來，一旦取得核准，你需要向 CMS 申請給付，這需要一些時間，而藥局合約也需要一些時間。

So we will launch the product and absolutely seek to get reimbursement and approval every place we can as quick as we can and even some prelaunch where we can do that. We have those efforts going on as well. So this will roll out as quickly as we can do it. We're optimistic we'll get approved, but more than likely after ADA.

所以我們會推出產品，並且絕對會在所有可行的地方，盡快爭取給付與核准；在可行之處，我們也會在上市前就先行推動。我們也正在進行這些工作。因此我們會以我們能做到的最快速度推進。我們對獲准保持樂觀，但更可能是在 ADA 之後。

And the next question comes from Marie Thibault.

下一個問題來自 Marie Thibault。

I want to ask here on Dexcom ONE as you expand that launch. I'm curious who is appealing to how these early users are hearing about it? And who is telling them about how it's being positioned versus the G-Series?

我想問一下 Dexcom ONE，隨著你們擴大上市，我很好奇它吸引的是哪些人？這些早期使用者是如何得知這個產品的？又是誰向他們介紹、以及它相對於 G 系列是如何被定位的？

Yes. This is Kevin. I'll take that. Our first users in the [both] countries, this is all an e-commerce effort. This has e-commerce platform with some advertising from us. But by and large, our e-commerce platform has reached these people. That's how they've heard about it and have paid cash for this product on their own. As far as positioning right now, Dexcom ONE is positioned for insulin users, but it's not positioned for those who are going to integrate with another device or even share data with others. It's a simplified version of our product for that type of use.

是的。我是 Kevin，我來回答。我們在這兩個國家的第一批使用者，完全是透過電商（e-commerce）推動的。我們有電商平台，也有一些我們投放的廣告。但整體而言，是我們的電商平台觸及了這些人。他們就是這樣得知產品資訊，並自行以現金購買。就目前的定位而言，Dexcom ONE 是為胰島素使用者而設，但不針對需要與其他裝置整合、甚至與他人分享資料的使用者。它是針對那類使用情境的簡化版產品。

In the other countries that we rolled out, as Jereme said earlier, we're involved in the tender process. In Spain, we have reimbursement for Dexcom ONE in Spain. In many of the European markets, there is a positioning of what you would call high-risk pool and then another pool of insulin using patients. We have always played very well on the high-risk pool with these patients because of our connectivity, our accuracy and our performance. And that is a higher price point within those geographies as well.

在我們推廣到的其他國家，如 Jereme 先前所說，我們參與了招標（tender）流程。在西班牙，我們的 Dexcom ONE 已取得給付。在許多歐洲市場，通常會有你可以稱之為「高風險族群」（high-risk pool）的定位，另外還有一個胰島素使用患者的族群。我們一直在高風險族群表現很好，因為我們的連線能力、準確度與效能。而在那些地區，這也對應到較高的價格帶。

With Dexcom ONE, we now have access to the other patients. And again, the qualification of those patients varies tender to tender and country to country. But it gives us a much larger playing field -- our playing field is going to be expanded anywhere between 80% and 90% in some of these countries where we launched Dexcom ONE is a dual product. So that's why we're doing it, and that's what we believe. So expanding into new geographies with the product with the e-commerce platform, but also expanding our reach and making available to more people.

有了 Dexcom ONE，我們現在能觸及其他患者。同樣地，患者的資格條件會因招標案而異、也會因國家而異。但它讓我們的可競爭範圍大幅擴大——在某些我們推出 Dexcom ONE 的國家，當我們以雙產品策略運作時，我們的市場範圍將擴大約 80% 到 90%。這就是我們這麼做的原因，也是我們所相信的方向。因此，我們一方面透過電商平台把產品帶進新的地理市場，另一方面也擴大觸及範圍，讓更多人可以使用。

The next question comes from Travis Steed.

下一個問題來自 Travis Steed。

Just wanted a little bit more color on the basal-only population and the conversations that you guys are having with payers. I'm hearing more and more patients in that population getting entrance coverage. So just kind of curious is that what you're seeing on your end as well in conversations with Medicare moving along?

我想再多了解一些關於僅使用基礎胰島素（basal-only）族群，以及你們與支付方（payers）之間的對話。我聽到越來越多這個族群的患者開始獲得入門型的給付（entrance coverage）。想請教你們那邊是否也看到同樣情況？以及與 Medicare 的討論是否也在推進？

Yes. So I'll start -- thanks for the question, and welcome back. I'll start with the CMS conversation. So certainly, we have the discussions. And that's a process that takes a little bit more time, but it is some and that's where the significance of the basal population resides. And we are working with CMS to look at what that opportunity looks like. And so we'll be making progress there over the course of the year. And as we have more and more information, we'll certainly share it.

是的。我先開始——謝謝你的問題，也歡迎回來。我先談 CMS 的部分。我們確實在進行討論。那是一個需要多一點時間的流程，但這個族群的主要意義與規模確實是在 basal 族群。我們正與 CMS 一起評估這個機會的樣貌。因此我們會在今年內持續推進；當我們掌握更多資訊時，也一定會分享。

In terms of the insurance coverage and the population on the commercial side, there are some insurance carriers that do cover it. It's a little sparse in between. There are some that folks kind of get access to it through some edits or forms around those lines around insulin use without look backs. And so there are folks that are getting access to it. However, it is very, very light penetration at this point in that space.

就商業保險端的承保與族群而言，確實有一些保險公司會承保，但整體仍相對零星。有些人可能透過某些編輯規則（edits）或表單等機制取得使用權限，例如針對胰島素使用不做回溯（look backs）之類的條件。因此確實有人能取得使用。但目前在那個領域的滲透率仍非常、非常低。

And so -- but those conversations are going. We are having the similar conversations that we talked about having with CMS. We are having those with commercial payers, and we'll continue to have those over time because we have shown and certainly with our MOBILE study was an obvious game changer that people on CGM do better. And I think that the insurance companies as well as CMS are starting to see it. So more updates to come over time as we get those coverages, and we'll share those certainly those that are significant in the future.

所以——但這些對話正在進行。我們與商業支付方的對話，與我們先前提到和 CMS 的對話類似，而且我們會隨時間持續推進，因為我們已經證明——尤其是我們的 MOBILE 研究很明顯地改變了局面——使用 CGM 的人表現更好。我認為保險公司以及 CMS 也開始看見這一點。隨著我們取得這些承保，後續會逐步更新；未來若有重要的承保進展，我們也一定會分享。

And the next question comes from Steven Lichtman.

下一個問題來自 Steven Lichtman。

I wanted to ask on the intensive Type 2 patient population in the U.S. where penetration still meaningfully trails Type 1. With the coverage efforts you've made over the past few years, are you seeing momentum pick up in this group? And what's your outlook for where penetration can go over time? .

我想請教美國需要密集治療的第二型糖尿病患者族群，目前的滲透率仍明顯落後於第一型。過去幾年你們在給付覆蓋方面做了許多努力，你們是否看到這個族群的動能正在加速？另外，對於滲透率隨時間推進可能達到的水準，你們的展望是什麼？

Yes. This is Kevin. I'll take that. Obviously, we are getting very good coverage in that segment. That population, again, Medicare covers that, and that is really our fastest-growing patient segment right now. We're doing very well in these Type 2 patients. Hence, the reason for expansion of the sales force and calling on more primary care physicians.

是的。我是 Kevin。我來回答。很明顯地，我們在那個區隔正取得非常好的給付覆蓋。那個族群同樣由 Medicare 承保，而那也確實是我們目前成長最快的病患區隔。我們在這些第二型病患上表現非常好。因此，我們才會擴編銷售團隊，並拜訪更多基層照護醫師。

As far as penetration in that population, their needs for CGM data are equal to those in our Type 1 population, and we believe not only is CGM going to be successful there, but we'll be successful there with our pump partners as well through our integrated systems. So I -- many years ago, I have said 80% penetration for CGM in the Type 1 world and even people from our own company kind of gave me a funny look. I don't see that as being a problem over time. If you're going to be intensively using insulin, there is no reason to not treat yourself with CGM. It is just a much better tool. So I believe that penetration get every bit as high as the Type 1 population without any question.

至於該族群的滲透率，他們對 CGM 數據的需求與我們第一型族群同樣高；我們相信 CGM 不僅會在那裡成功，我們也會透過整合式系統，與我們的胰島素幫浦合作夥伴一起在那裡取得成功。所以我——很多年前我就說過，在第一型領域 CGM 的滲透率可以到 80%，甚至我們公司內部也有人用有點奇怪的眼神看我。我不認為長期來看這會是問題。如果你要密集使用胰島素，就沒有理由不使用 CGM 來管理自己。它就是一個更好的工具。所以我相信，那個族群的滲透率毫無疑問可以達到與第一型族群一樣高。

And then the last question in the queue comes from Margaret Kaczor.

接著，隊列中的最後一個問題來自 Margaret Kaczor。

I just wanted to focus on completely different opportunity that we haven't talked too much about, but you guys mentioned in the prepared remarks. You have a lot of data that you've gathered in the hospital for inpatient use of CGM during COVID. You have breakthrough status. So could you just talk to us about what's the next steps in that market clearly a meaningful opportunity for you, but maybe some market education, some market development work needs to be done? So what are you guys focused on this year? And what should we look out for progress there? .

我想把焦點放在一個完全不同、我們還沒談太多的機會，但你們在事先準備的發言中有提到。你們在 COVID 期間，針對住院病人使用 CGM，在醫院端累積了大量數據。你們也有突破性（breakthrough）資格。所以能否談談這個市場接下來的步驟？這顯然對你們是個很有意義的機會，但可能需要做一些市場教育與市場開發工作。今年你們的重點是什麼？我們應該關注哪些進展指標？

Thank you for the question. This is definitely a passion of mine going way back to my early days in diabetes therapy back in '90s. One of the things we've done this year, we've hired a general manager for our hospital business, a very experienced executive who spent a lot of time here, and we're starting to build a full team around him in that organization. We're running clinical studies right now to show how the product performs in the hospital environment. And we've had numerous discussions with the FDA.

謝謝你的問題。這確實是我長期以來的熱情所在，可以追溯到我在 90 年代早期從事糖尿病治療的時候。今年我們做的一件事是：我們為醫院業務聘請了一位總經理，他是一位非常資深的主管，在這個領域投入了很多時間；我們也正在以他為核心，在該組織周圍建立完整團隊。我們目前正在進行臨床研究，以展示產品在醫院環境中的表現。我們也與 FDA 進行了多次討論。

I think for us the key here is to get the sensing technology and the performance of the sensor validated and verified that it will be approved and usable in that environment. And the feedback we've gotten certainly during the pandemic has been very, very positive for those facilities that did use CGM.

我認為對我們而言，關鍵在於讓感測技術與感測器的效能獲得驗證與確認，確保它能在那樣的環境中獲得核准並可用。而我們在疫情期間收到的回饋非常、非常正面——尤其是那些確實使用了 CGM 的醫療機構。

Once we do that and validate the product performance just from a technical perspective, then it becomes a question of what does that product look like? What does it connect to? And what is the distribution channel and business model look like? And that's why we haven't experienced CGM and the team built out here. We know how much better things work in a hospital if you have continuous data.

一旦我們從技術角度完成這些工作並驗證產品效能，接下來就會變成：那個產品會長什麼樣子？它要連接到什麼系統？以及通路與商業模式會是什麼樣子？這也是為什麼我們在這裡建立了具備 CGM 經驗的團隊。我們知道，如果在醫院裡能取得連續數據，很多事情會運作得更好。

I've had several experiences where people have told me about having their fingers stuck every 30 minutes without diabetes in a postsurgical order in an ICU, and it drives them crazy when they know they could be on CGM. As you look at the number of hospitalizations and the number of people hospitalized with diabetes and cardiovascular wards, in particular, the CGM opportunity here is vast.

我有過好幾次經驗，有人告訴我，他們在加護病房（ICU）術後醫囑下，即使不是糖尿病患者，也每 30 分鐘就要被扎手指一次；當他們知道其實可以用 CGM 時，這真的讓人抓狂。當你看看住院人次，以及因糖尿病與心血管病房（特別是心血管病房）而住院的人數，這裡的 CGM 機會非常龐大。

The questions we need to answer, business model, product configuration, ease of use, outcomes, all those things. And we have a great team that can put that data together for us. So we're very optimistic and bullish about it over time. I do appreciate the question though. Hopefully, we'll have you some more information over the course of the year.

我們需要回答的問題包括：商業模式、產品配置、易用性、臨床結果（outcomes）等等。我們有一個很棒的團隊可以為我們整理並建立這些數據。所以我們對長期發展非常樂觀、也非常看多。也很感謝你的提問。希望在今年接下來的時間裡，我們能提供你更多資訊。

We have one question in the queue from Frank Pinal.

隊列中有一個問題來自 Frank Pinal。

Just one on FX really quickly. Seeing a few companies at this point raise their forward FX headwind expectations for the next 2 to 3 quarters, and I'm wondering to what degree is that -- are you baking in FX? What's in there now? Could we see that challenge to the lower end of the guide?

我想很快問一個關於外匯（FX）的问题。到目前為止，我看到有幾家公司上調了未來 2 到 3 個季度的外匯逆風預期。我想了解你們在多大程度上已把外匯因素納入考量？目前指引裡包含了什麼？這個挑戰是否可能把結果推向指引區間的下緣？

Yes. Thanks for the question, Frank. And I think you'll see it in our prepared remarks, we do expect $15 million to $20 million of FX headwinds, but we kept our guide the same. And so the way to think about it is we think we can grow through that in the current period.

是的。謝謝你的問題，Frank。我想你會在我們事先準備的發言中看到，我們確實預期外匯逆風約為 1,500 萬到 2,000 萬美元，但我們維持指引不變。你可以這樣理解：我們認為在目前期間，我們有能力在這個逆風之下仍然成長。

And so as you do the math for the full year, if you include the impact, the incremental impacts of headwind versus a 15% to 20% guide, it's a 16% to 21% guide. So that should give you some comfort that, yes, there are headwinds associated with currency. Yes, we do believe we can grow through it. And so a currency-adjusted growth rate certainly would reflect that. So call it $15 million to $20 million on the year, but it doesn't change our full year guide.

因此，如果你把全年做個計算，若把外匯影響納入，與 15% 到 20% 的指引相比，等同於 16% 到 21% 的指引。這應該能讓你更安心：是的，匯率確實帶來逆風；是的，我們相信可以在逆風中成長。因此，以固定匯率（currency-adjusted）計算的成長率會反映這一點。全年大約是 1,500 萬到 2,000 萬美元，但不會改變我們的全年指引。

And sir, we have no further questions in the queue. Do you have any closing remarks? .

先生，目前隊列中沒有其他問題了。您有任何結語要補充嗎？

Yes. This is Kevin. I absolutely do. We appreciate all of you for hanging with us today. Obviously, to say things have been a little hectic here would be an understatement. But as always, we get through it.

有的。我是 Kevin。我當然有。我們感謝各位今天一路參與。很顯然，要說這裡最近有點忙亂，那還算是輕描淡寫。但一如既往，我們會挺過去。

I just -- if you look at this quarter, again, $110 million in organic growth, volume increases in the low 40%, great new patient numbers post the Omicron scare. Dexcom ONE launched in Spain, launch announced in the U.K. CE Mark for G7, limited launch for G7 in the U.K., continued G7 progress in the U.S., continued scale in our business, positive momentum on the operating leverage side. There's not a whole lot more we could do.

我只是——如果你看這一季，再次強調，有機成長 1.10 億美元、出貨量成長在 40% 出頭，Omicron 驚嚇過後新增病患數表現很棒。Dexcom ONE 已在西班牙上市、並在英國宣布上市；G7 取得 CE Mark；G7 在英國進行有限上市；G7 在美國持續推進；我們的業務持續擴大規模；營運槓桿面也有正向動能。基本上，我們能做的也不多了。

Times cannot be better and more hectic than here at Dexcom right now. We appreciate everybody's support and all the fine people who make this possible. Thanks, everybody, and have a great day.

在 Dexcom，現在的情況是前所未有的好，同時也前所未有的忙亂。我們感謝大家的支持，也感謝所有讓這一切成真的優秀同仁。謝謝大家，祝各位有美好的一天。

Thank you, ladies and gentlemen. This concludes today's teleconference. Thank you for participating. You may now disconnect.

謝謝各位女士、先生。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。