德康醫療 (DXCM) 2015 Q4 法說會逐字稿

Welcome to the DexCom fourth-quarter and full-year 2015 earnings release conference call. My name is Bianca and I will be your operator for today. (Operator Instructions) Please note that this conference is being recorded.

歡迎參加 DexCom 2015 年第四季與全年財報發布電話會議。我是 Bianca，今天將擔任您的接線員。(接線員指示) 請注意，本次會議將被錄音。

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

現在我將把電話交給本次會議主持人 Kevin Sayer 先生。先生，您可以開始了。

Thank you very much and welcome to our fourth-quarter 2015 and full-year 2015 earnings call. We'll start with our safe harbor statement from Steve Pacelli. Steve?

非常感謝，歡迎各位參加我們 2015 年第四季與 2015 全年財報電話會議。我們先請 Steve Pacelli 宣讀安全港聲明。Steve？

Thanks, Kevin. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans, and performance and speak only as of the date hereof.

謝謝，Kevin。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、營運計畫與績效的預期，且僅截至本日有效。

These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under risk factors and elsewhere in our annual report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC. We undertake no obligation to update publicly or revise these forward-looking statements for any reason.

這些前瞻性陳述涉及多項風險與不確定性。可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單，已在我們的 Form 10-K 年度報告、Form 10-Q 季度報告，以及其他向 SEC 提交的報告之風險因素與其他章節中詳述。我們不承擔因任何原因公開更新或修訂這些前瞻性陳述的義務。

Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash-based operating results. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. 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，我們將討論若干未依 GAAP 編製、與我們以現金為基礎之營運結果相關的財務資訊。提供此非 GAAP 資訊旨在增進您對我們目前財務表現的整體理解。此額外資訊之呈現不應被孤立看待，亦不應作為依 GAAP 編製之結果的替代，或被視為優於依 GAAP 編製之結果。

Kevin?

Kevin？

Thank you, Steve. Joining me today are Jess Roper, our Chief Financial Officer, and Steve Pacelli, our Executive Vice President of Strategy and Corporate Development. Before I turn the call over to Steve to review our detailed financial results, let me start off with some highlights.

謝謝你，Steve。今天與我一同出席的還有我們的財務長 Jess Roper，以及策略與企業發展執行副總裁 Steve Pacelli。在我把電話交給 Steve 以檢視更詳細的財務結果之前，我先分享幾項重點。

At the JPMorgan healthcare conference in January, we announced estimated Q4 and full-year 2015 revenue of approximately $129 million and $400 million, respectively. We actually ended the quarter at a record $131 million and ended the year at $402 million. To put this into perspective, our 2015 revenue of $402 million is a tenfold increase over our full-year 2010 product revenue of $40 million.

在 1 月的摩根大通醫療健康大會上，我們公布 2015 年第四季與全年營收估計分別約為 1.29 億美元與 4.00 億美元。實際上，我們第四季以創紀錄的 1.31 億美元作收，全年則為 4.02 億美元。為了讓各位更有概念，我們 2015 年 4.02 億美元的營收，相較於 2010 年全年產品營收 4,000 萬美元，成長了 10 倍。

And what we did not disclose at JPMorgan, but I'm pleased to announce today, is that for Q4 2015, we are profitable on a GAAP basis. We also grew our global installed base to an estimated 140,000 to 150,000 patients, almost doubling the size of our worldwide patient base during 2015. Needless to say, we're quite pleased with our 2015 performance.

另外，在摩根大通大會上我們未揭露、但我很高興今天宣布的是：2015 年第四季我們在 GAAP 基礎下已實現獲利。我們也將全球裝機基礎擴大至估計 14 萬至 15 萬名患者，幾乎在 2015 年將全球患者基礎規模翻倍。不用說，我們對 2015 年的表現相當滿意。

More from me later. I'll now turn the call over to Steve.

稍後我會再補充更多。現在我把電話交給 Steve。

Thanks, Kevin. DexCom reported revenue of $131 million for the fourth quarter of 2015 compared to $84 million for the same quarter in 2014, a $47 million or 55% increase. Sequentially, revenue for Q4 of 2015 increased $26 million, up 24% from the prior quarter.

謝謝，Kevin。DexCom 2015 年第四季營收為 1.31 億美元，相較 2014 年同季的 8,400 萬美元，增加 4,700 萬美元，增幅 55%。以季對季來看，2015 年第四季營收較前一季增加 2,600 萬美元，成長 24%。

As we guided at JPMorgan, for fiscal 2016, we expect revenue to range from $540 million to $565 million, reflecting growth of approximately 35% to 40% versus 2015. Also, while we do not provide specific quarterly guidance, I remind investors that the first quarter is traditionally a seasonally slow quarter for our business as annual insurance deductibles reset and flexible spending accounts are largely unfunded.

如同我們在摩根大通大會所指引，2016 會計年度我們預期營收將介於 5.40 億至 5.65 億美元，反映相較 2015 年約 35% 至 40% 的成長。此外，雖然我們不提供特定季度指引，但我要提醒投資人，第一季傳統上是我們業務的季節性淡季，因為年度保險自付額會重置，且彈性支出帳戶多半尚未到位。

As we look to close out February, however, I'm pleased to report that our pipeline of new patient opportunities is larger than it has ever been. I also remind investors that in years past, including in 2015, approximately 40% to 45% of our revenue was generated in the first half of the year and 55% to 60% was generated in the second half. And we do not view 2016 any differently.

然而，隨著我們即將結束 2 月，我很高興報告，我們新患者機會的管線規模已達到歷來最大。我也提醒投資人，過去幾年（包括 2015 年），我們約有 40% 至 45% 的營收來自上半年，55% 至 60% 來自下半年。我們對 2016 年的看法並無不同。

Our fourth-quarter gross profit totaled just over $91 million, generating a gross margin of 70% compared to a gross profit of $59 million and gross margin of 70% for the same quarter in the prior year. We are now at the upper end of our gross margin targets on our existing product platform.

我們第四季毛利合計略高於 9,100 萬美元，毛利率為 70%，相較前一年同季毛利 5,900 萬美元、毛利率同為 70%。以現有產品平台而言，我們目前已處於毛利率目標區間的上緣。

We remind investors that our gross margin on hardware could be slightly lower for a period of time due to the introduction of the G5 Mobile transmitter, which has a shorter useful life and a lower ASP, which impact overall gross margin. We also note that we recorded a charge in Q4 relating to a potential increase in warranty expense resulting from an important customer notification we have issued related to the speaker component in our handheld receiver.

我們提醒投資人，由於導入 G5 Mobile 發射器（其使用壽命較短且平均售價 ASP 較低），硬體毛利率在一段時間內可能會略為下降，進而影響整體毛利率。我們也指出，第四季我們認列了一筆費用，與我們就手持式接收器中的喇叭元件所發布的一項重要客戶通知相關，該通知可能導致保固費用增加。

Going forward, gross margin will be impacted slightly in 2016 due to costs associated with our manufacturing capacity expansion project. But as we guided at JPMorgan, for full year 2016, we expect gross margin to range from 67% to 70%, with Q1 being down, of course, sequentially on lower volumes due to the seasonality.

展望未來，2016 年毛利率將因我們製造產能擴充專案相關成本而略受影響。但如同我們在摩根大通大會所指引，2016 全年我們預期毛利率將介於 67% 至 70%；當然，由於季節性導致出貨量較低，第一季毛利率將較前一季下滑。

Some final thoughts on our revenues and our gross profits. Our mix between durable and consumable products remains steady, at approximately 30% durable and 70% consumable. Pricing has remained consistent, with the ASP for sensors within a range of $70 to $75 per sensor and the ASP for our hardware approximately $800 to $850 per starter kit, with receiver ASPs at approximately $400 to $425, G4 PLATINUM transmitter ASPs approximately $400 to $425, and G5 Mobile transmitter ASP at approximately $400 to $425 for two G5 Mobile transmitters.

最後補充一些關於營收與毛利的看法。耐久財與耗材產品的組合維持穩定，約為 30% 耐久財、70% 耗材。定價維持一致：感測器 ASP 約落在每個感測器 70 至 75 美元；硬體 ASP 約為每套入門套組 800 至 850 美元，其中接收器 ASP 約 400 至 425 美元，G4 PLATINUM 發射器 ASP 約 400 至 425 美元，而 G5 Mobile 發射器 ASP 約為 400 至 425 美元（兩個 G5 Mobile 發射器）。

We continue to expect quarter-to-quarter variability within these ASP ranges stemming from our ever-changing payer mix, including direct DME contracts, third-party DME contracts, and pharmacy contracts.

我們仍預期在上述 ASP 區間內，季度之間會出現波動，原因在於我們的付款方組合持續變動，包括直接 DME 合約、第三方 DME 合約以及藥局合約。

Finally, our international business continued to perform, generating $16 million in revenue during the quarter. Consistent with prior years due to our US seasonality, our international sales as a percentage of total revenue is slightly lower in Q4. However, on an annualized basis, growth in our international business is keeping pace with our domestic business.

最後，我們的國際業務持續表現良好，本季創造 1,600 萬美元營收。由於美國市場的季節性因素，與往年一致，第四季國際銷售占總營收的比重略低。然而，以年化基礎來看，我們國際業務的成長與國內業務大致同步。

Blended ASPs for our OUS products are approximately 20% lower than our US business. And we remind investors that sensor utilization OUS is lower, primarily due to the cash pay nature of the business. Finally, we note that much of our European business continues to be G4 PLATINUM, as we launched G5 Mobile in only five key geographies during the fourth quarter.

我們 OUS（美國以外）產品的混合 ASP 約比美國業務低 20%。我們也提醒投資人，OUS 的感測器使用率較低，主要因為該業務多為自費性質。最後我們指出，我們在歐洲的多數業務仍以 G4 PLATINUM 為主，因為我們僅在第四季於五個關鍵地區推出 G5 Mobile。

Research and development expense totaled $29 million for Q4 of 2015 compared to $22 million in Q4 of 2014 with the increase due primarily to additional payroll-related costs and expenses related to work on our near-term product pipeline, particularly with respect to our next-generation insertion system and work in our advanced product pipeline, including expenses associated with our Google Life Sciences, now Verily, partnership.

2015 年第四季研發費用合計 2,900 萬美元，相較 2014 年第四季的 2,200 萬美元增加；增加主要來自額外的薪酬相關成本，以及我們近期產品管線工作的相關費用，特別是下一代插入系統的開發，以及先進產品管線的工作（包括與 Google Life Sciences（現為 Verily）合作夥伴關係相關的費用）。

Selling, general, and administrative expense totaled $61 million in Q4 of 2015 compared to $36 million during the same quarter in 2014, with the increase primarily due to year-over-year increases in headcount in our sales organization, including both field sales and internal sales support staff, as well as a ramp in marketing expenses in connection with our DTC awareness campaigns, initial investment in our OUS expansion efforts, and investment in our IT infrastructure.

2015 年第四季銷售、一般及行政費用合計 6,100 萬美元，相較 2014 年同季的 3,600 萬美元增加；增加主要來自我們銷售組織人力編制的年對年成長（包括外勤銷售與內部銷售支援人員），以及與我們 DTC（直接面向消費者）認知宣導活動相關的行銷費用提升、對 OUS 擴張工作的初期投資，以及對 IT 基礎設施的投資。

Our net income for the fourth quarter of 2015 totaled $1.5 million, which included $27 million in non-cash expenses, centered primarily in non-cash share-based compensation expense across all functional areas of our business. Absent these non-cash charges, cash-based net income was $29 million for Q4, representing 22% of revenue, a 55% increase over cash-based net income in Q4 2014 of $19 million.

我們2015年第四季的淨利合計為150萬美元，其中包含2,700萬美元的非現金費用，主要為涵蓋我們業務所有職能領域的非現金股份基礎薪酬費用。若排除這些非現金費用，以現金為基礎的淨利在第四季為2,900萬美元，占營收22%，較2014年第四季的1,900萬美元現金基礎淨利成長55%。

Earnings per share for the quarter totaled $0.02. With respect to our balance sheet, we ended the fourth quarter with $115 million in cash and marketable securities.

本季每股盈餘合計為0.02美元。就資產負債表而言，我們在第四季末持有1.15億美元的現金及有價證券。

Before I turn the call over to Kevin, I would like to remind investors of the color around our OpEx spend for 2016 that we provided at JPMorgan. With our anticipated growth rates and robust near-term and long-term product pipeline, we expect a typical year-over-year increase in our normalized cash-based operating expenses of approximately 20% to 25% or approximately $50 million.

在我把電話會議交給Kevin之前，我想提醒投資人我們在摩根大通（JPMorgan）所提供的、關於2016年營運費用（OpEx）支出的補充說明。在我們預期的成長率以及強勁的短期與長期產品研發/上市管線帶動下，我們預期經常性、以現金為基礎的營運費用年增幅通常約為20%至25%，或約5,000萬美元。

In addition, we expect additional cash-based expenditures of approximately $40 million in 2016 as we focus on four key incremental strategic initiatives, including our Verily partnership, expanded manufacturing capacity, international expansion, and investment in our advanced data platform. We also expect our non-cash expenses to increase, particularly our share-based compensation expense. For example, if our stock price is between $60 and $65, our estimated share-based compensation expense would be between $110 million and $115 million for 2016. Nonetheless, we expect a continued increase in cash-based net income year over year.

此外，隨著我們聚焦四項關鍵的新增策略性計畫（包括與Verily的合作、擴充製造產能、國際擴張，以及投資先進資料平台），我們預期2016年將增加約4,000萬美元的現金基礎支出。我們也預期非現金費用將增加，尤其是股份基礎薪酬費用。例如，若我們股價介於60至65美元之間，我們估計2016年的股份基礎薪酬費用將介於1.10億至1.15億美元。儘管如此，我們預期以現金為基礎的淨利仍將持續逐年成長。

With that, I'll turn the call back to Kevin for a business update.

接下來，我把電話會議交回給Kevin，請他提供業務最新進展。

Thank you, Steve. We had a very exciting 2015. We introduced the G4 PLATINUM with Share, apps to enable CGM display on the Apple Watch. We entered into an extremely exciting collaboration with the life sciences team at Verily and we launched our G5 Mobile CGM system both in the US and in Europe. All on top of a $143 million or 55% year-over-year increase in sales and a $37 million or 103% year-over-year increase in cash-based net income.

謝謝你，Steve。2015年對我們而言非常令人振奮。我們推出了可分享（Share）的G4 PLATINUM，以及可在Apple Watch上顯示CGM的應用程式。我們與Verily的生命科學團隊展開極具吸引力的合作，並在美國與歐洲同步推出G5 Mobile CGM系統。此外，我們的銷售額增加1.43億美元、年增55%，以現金為基礎的淨利增加3,700萬美元、年增103%。

I'd like to start off with a few words about our G5 commercial launch. Our G5 Mobile system is the first and only CGM system approved by the FDA for both adults and children as young as two years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. Response in the diabetes community for mobile connectivity has been exceptional and our perspective patient pipeline is at an all-time high.

我想先談幾點關於G5的商業上市。我們的G5 Mobile系統是第一個、也是唯一一個獲FDA核准、適用於成人及最小至2歲兒童的CGM系統，可將葡萄糖數據直接傳送至智慧型手機，讓使用者不必再攜帶獨立的接收器。糖尿病社群對行動連線的反應非常熱烈，我們的潛在病患管線也創下歷史新高。

Because connectivity is such a major advance, we made the decision to launch this new platform on a worldwide basis, unlike prior generations, which were initially launched either in the US or selected European geographies. Not only did we add a record number of new patients in the fourth quarter, but we also fulfilled a significant obligation to patients entitled to a free upgrade to the G5 Mobile platform.

由於連線是一項重大進展，我們決定以全球同步方式推出這個新平台；不同於以往世代產品通常先在美國或部分歐洲地區上市。我們不僅在第四季新增病患數創下新高，也履行了對有資格免費升級至G5 Mobile平台之病患的重大義務。

The ramp of this launch has been much steeper than any platform change we have attempted and has really stretched our organization. While moving CGM directly to the phone has been extremely well accepted, it has added a new level of complexity to our customer support functions.

這次上市的爬坡速度比我們以往任何一次平台更換都更陡峭，確實讓我們的組織承受很大壓力。雖然將CGM直接移到手機上獲得高度接受，但也為我們的客戶支援職能增加了新的複雜度層級。

While all Dexcom receivers are configured exactly the same way, all mobile phones are not. Our tech support calls have increased in volume and duration and have become much more complex. And as with any product launch, we have quickly identified some changes to enhance the G5 Mobile experience and we are moving quickly to file and implement these enhancements.

雖然所有Dexcom接收器的設定方式完全相同，但並非所有手機都一樣。我們的技術支援來電在數量與通話時間上都增加，且變得更為複雜。而如同任何產品上市，我們很快就辨識出一些可提升G5 Mobile體驗的變更，並正迅速推進申報與導入這些強化。

We plan to launch the Android version of the G5 Mobile later this year and note that the Android follow application is already available. We also plan to submit and possibly launch an enhanced version of our G5 Mobile app to provide for additional features and functionality, such as insulin onboard data obtained from our pump partners. Once again, iOS will be first, followed by Android.

我們計畫在今年稍晚推出G5 Mobile的Android版本，並請注意Android的Follow（追蹤）應用程式已可使用。我們也計畫提交、並可能推出強化版的G5 Mobile應用程式，以提供更多功能，例如從我們的幫浦合作夥伴取得的胰島素在體（insulin onboard）數據。同樣地，iOS將先行，之後才是Android。

Our G5 Mobile product in Europe not only introduced connectivity to this market, but the CE Mark G5 Mobile is the first ever continuous glucose monitor that does not require confirmatory fingersticks when making treatment decisions, although a minimum of two fingersticks a day remain necessary for calibration. We continue to believe that CGM will ultimately be the standard of care in diabetes management. And we see a clear path to the day when the only reason to take a fingerstick will be to calibrate a sensor or for a safety check to ensure proper sensor performance.

我們在歐洲推出的G5 Mobile產品不僅為該市場帶來連線功能；此外，取得CE Mark的G5 Mobile更是史上第一款在做出治療決策時不需要以指尖採血進行確認的連續血糖監測器，儘管每天仍至少需要兩次指尖採血以進行校準。我們仍然相信，CGM最終將成為糖尿病管理的標準照護。我們也清楚看到一條路徑：未來指尖採血的唯一理由將是校準感測器，或作為安全檢查以確保感測器運作正常。

Now I'd like to say a bit about our marketing initiatives in the fourth quarter. We told the investment community during our last earnings call that we would commence our initial direct-to-consumer, or DTC, campaigns in connection with our G5 Mobile launch. And I'm pleased to report that these programs commenced in Q4.

接下來我想談談我們第四季的行銷計畫。在上一次財報電話會議中，我們曾向投資界表示，將配合G5 Mobile上市啟動我們初期的直接面向消費者（DTC）行銷活動。我很高興報告，這些計畫已於第四季開始執行。

We delivered over 200 million targeted impressions in Q4, including diabetes print publications; digital ads on social media sites, blogger sites, and endemic search sites; targeted rich media and digital video content ads; in-office advertising to top insulin prescribing endocrinology and primary care offices; newly diagnosed patient information packets; and we participated in a very large number of diabetes events.

我們在第四季投放超過2億次精準觸及（targeted impressions），涵蓋糖尿病平面刊物；社群媒體網站、部落客網站與垂直搜尋網站上的數位廣告；精準投放的互動式多媒體與數位影音內容廣告；在開立胰島素處方量最高的內分泌科與基層醫療診所進行院內廣告；新診斷病患資訊包；以及我們參與了大量的糖尿病相關活動。

Our digital advertising efforts drove 2.5 times the pharma industry average for click-through rates, producing over 475,000 landing page hits in Q4 and led to double the unique visits to our website in 2015 versus 2014. The campaign helped generate our highest month-to-month growth in lead generation. And it has continued into Q1, when we typically see a drop off in lead generation at the start of the new year. Needless to say, we expect to continue this campaign into 2016.

我們的數位廣告推動的點擊率達到製藥產業平均的2.5倍，第四季帶來超過475,000次落地頁（landing page）點擊，並使2015年網站不重複訪客數較2014年增加一倍。該活動也促成我們最高的月對月潛在客戶（leads）成長。而且活動延續到第一季；通常在新年開始時，我們會看到潛在客戶開發下滑。不用說，我們預期將在2016年持續此行銷活動。

Now I'll talk a bit about reimbursement. We continue our work to simplify and expand access for our patients and we still maintain that moving our products to the pharmacy channel is our future. We entered into several key pharmacy contracts in 2015, including United Healthcare and Anthem. In doing so, we learned that entering into a pharmacy contract is just the beginning and not without administrative pitfalls.

接下來我談一下給付（reimbursement）。我們持續努力簡化流程並擴大病患的可近性，同時我們仍認為將產品移轉至藥局通路（pharmacy channel）是我們的未來方向。我們在2015年簽訂了數個關鍵藥局合約，包括United Healthcare與Anthem。在此過程中，我們了解到簽訂藥局合約只是開始，且並非沒有行政上的陷阱。

A couple of examples include inconsistent application of preauthorization policies and failure of specific plans to move reimbursement from DME to pharmacy in a timely manner. As we look at 2016, we expect to increase our efforts to secure additional regional and national payer contracts and move a much more significant piece of our business to the pharmacy.

例如：事前授權（preauthorization）政策的適用不一致，以及部分特定方案未能及時將給付從耐用醫療設備（DME）轉移至藥局通路。展望2016年，我們預期將加大力度以取得更多區域性與全國性付款方（payer）合約，並把更大比例的業務移轉至藥局通路。

There has been some noise in the investment community regarding our Medicare plans. I would like to take this opportunity to clarify. We are approaching Medicare from three separate paths: judicial, administrative, and legislative.

投資界對於我們的Medicare計畫有一些雜音。我想藉此機會加以澄清。我們正從三條不同路徑推進Medicare：司法、行政與立法。

We have very little control over the judicial path, but more and more patient activists are jumping on the bandwagon. And we understand that they are independently pursuing appeals with many of the administrative law judges declaring the beneficiary should be covered for CGM.

對於司法路徑我們能掌控的很少，但越來越多病患倡議者加入行動。我們也了解到，他們正獨立向多位行政法官提出上訴，而許多行政法官裁定受益人應獲得CGM給付。

Two bills remain in the legislature and may get approved. There are 219 bipartisan cosponsors in the House and Senate, and while moving legislation is not easy, the amount of support and advocacy shown for these bills demonstrates a national desire and help serve as a catalyst for action.

目前仍有兩項法案留在立法程序中，且可能獲得通過。眾議院與參議院共有219位跨黨派共同提案人；雖然推動立法並不容易，但這些法案所展現的支持與倡議力度，顯示全國性的需求，並有助於成為促成行動的催化劑。

Finally, the first hurdle on the administrative path is the non-adjunctive or dosing claim, which I will discuss momentarily. Discussion with CMS on this front remains active and we have by no means abandoned the administrative path. I'm also pleased to report at the recent AACE consensus conference on CGM this past weekend -- that's the American Association of Clinical Endocrinologists -- a diverse cross-section of diabetes care thought leaders, including scientific and medical societies, patient advocacy groups, government, insurance, and pharmaceutical and medical device manufacturers came together to advocate for expanded use of continuous glucose monitoring in the management of diabetes.

最後，行政途徑上的第一個障礙是非輔助（non-adjunctive）或胰島素劑量（dosing）適應症主張，我稍後會討論。我們與 CMS 在這方面的討論仍在進行中，我們絕對沒有放棄行政途徑。我也很高興報告，上週末在近期的 AACE（美國臨床內分泌醫師協會）CGM 共識會議上，糖尿病照護領域多元的意見領袖橫跨科學與醫學學會、病友倡議團體、政府、保險，以及製藥與醫療器材製造商齊聚一堂，共同倡議在糖尿病管理中擴大連續血糖監測的使用。

The key conclusions concerning CGM use in diabetes include the following: robust data support for the benefits of CGM in many people with diabetes, particularly those with Type 1 diabetes. Technological advances have improved reliability and accuracy of CGM, as is very evident with our systems.

關於糖尿病 CGM 使用的關鍵結論包括以下幾點：大量且扎實的數據支持 CGM 對許多糖尿病患者的益處，尤其是第一型糖尿病患者。技術進步已提升 CGM 的可靠性與準確性，這在我們的系統上表現得非常明顯。

Use of CGM has reduced hypoglycemia while improving control of blood glucose, ensuring patient safety. Data also suggests that CGM provides benefit in patients with Type 2 diabetes on intensive insulin therapy. Studies are needed to demonstrate the value of CGM technology in other patient populations. And finally, access should be expanded to all patient populations with proven benefits. What a great outcome for the diabetes community.

使用 CGM 已在改善血糖控制的同時降低低血糖發生，確保病患安全。數據也顯示，對於接受強化胰島素治療的第二型糖尿病患者，CGM 亦可帶來益處。仍需要研究來證明 CGM 技術在其他病患族群中的價值。最後，應將可及性擴大到所有已證實能受益的病患族群。這對糖尿病社群而言是非常好的成果。

Turning to our product pipeline, we continue to make progress on our advanced sensor technologies. We plan to launch both a new receiver and a new insertion system for G5 Mobile in the US before year end. Clinical trials for the new insertion system are underway and are more rigorous than we had originally anticipated.

談到我們的產品研發管線，我們在先進感測器技術上持續取得進展。我們計畫在年底前於美國為 G5 Mobile 同時推出新的接收器與新的插入系統。新的插入系統臨床試驗正在進行中，且比我們原先預期更為嚴謹。

With respect to Gen 6, after a series of pre-submission meetings with the FDA, we will submit our IDE in the next two weeks and plan to commence a pivotal study in the second quarter. We will provide you with a more detailed timeline in our next call after the IDE is approved.

就第六代（Gen 6）而言，在與 FDA 進行一系列送件前會議後，我們將在未來兩週內提交 IDE，並計畫於第二季啟動關鍵性研究。在 IDE 獲准後，我們會在下一次電話會議中提供更詳細的時程。

We are also working closely with our artificial pancreas partners to incorporate Gen 6 into their research and clinical studies as soon as possible, providing us with a very robust data set on the performance of this product. Once again, for those of you not familiar with this technology, the G6 sensor will have a reduced calibration scheme -- one per day after startup -- driven with a completely new advanced algorithm platform. And the labeled indication of up to 10 days of sensor life.

我們也正與人工胰臟合作夥伴密切合作，盡快將 Gen 6 納入其研究與臨床試驗，讓我們能取得關於此產品表現的非常強健的數據集。再次說明，對於不熟悉此技術的各位，G6 感測器將採用降低校正的方案——啟用後每天一次——並由全新的先進演算法平台驅動。且標示適應症為感測器壽命最長可達 10 天。

Overall performance should be better than G5 Mobile, even with a reduced calibration scheme and an extended wear. The Gen 6 product will also leverage the new applicator and receiver technologies that we expect to complete this year.

整體表現應優於 G5 Mobile，即使在降低校正頻率與延長配戴時間的情況下亦然。Gen 6 產品也將運用我們預期今年完成的新型施用器與接收器技術。

Activities related to an FDA-approved insulin dosing claim continue and we remain confident that we can obtain a dosing claim during the second half of this year. In fact, much activity is expected during the next several weeks and we will provide you with much more clarity on our next earnings call.

與 FDA 核准的胰島素劑量（dosing）適應症主張相關的工作仍在持續進行，我們仍有信心能在今年下半年取得劑量適應症。事實上，未來幾週預期會有許多進展，我們將在下一次財報電話會議中提供更明確的說明。

We continue to study sensors with no calibration requirements. The G6 platform, with its new sensor chemistry and new algorithm, is our first step in this area. The innovation we have seen with our advanced sensor technologies give us tremendous confidence that calibrations can be completely eliminated in the future, certainly for those patients not practicing intensive insulin therapy. Much of the uncertainty here relates to the regulatory pathway and labeling for these products that have no calibrations.

我們持續研究不需要校正的感測器。G6 平台憑藉其新的感測器化學與新演算法，是我們在此領域的第一步。我們在先進感測器技術上看到的創新，讓我們對未來能完全取消校正充滿信心，至少對於未採行強化胰島素治療的患者而言更是如此。此處的不確定性多與無需校正產品的法規途徑與標示（labeling）相關。

With respect to our pump partners, J&J and Tandem continue to report positive results from their integrated pump offerings with G4 PLATINUM. And we believe all of our pump partners are making excellent progress on the development of more advanced integrated systems.

就我們的幫浦合作夥伴而言，J&J 與 Tandem 持續回報其與 G4 PLATINUM 整合式幫浦產品的正面成果。我們也相信所有幫浦合作夥伴在更先進整合系統的開發上都取得了極佳進展。

Finally, on the product pipeline front, our partnership with Verily is going extremely well. Verily has completed a first-generation transmitter and is beginning to test its performance with both G5 and G6 sensors. Initial results have been very promising and launch of our first combined product appears very, very much on schedule.

最後，在產品研發管線方面，我們與 Verily 的合作進展非常順利。Verily 已完成第一代發射器，並開始以 G5 與 G6 感測器測試其效能。初步結果相當令人鼓舞，我們首款聯合產品的上市看起來非常、非常符合進度。

On the international front, as Steve stated earlier, we are accelerating our investment in the international markets this year. Subject to negotiation of some final details, we will establish a European headquarters in Scotland and will begin to expand the European team on all fronts. We believe that reimbursement could come in some of the larger countries in Europe this year and we need to be ready to capitalize on this opportunity.

在國際市場方面，如 Steve 先前所述，我們今年正加速對國際市場的投資。在若干最終細節完成協商的前提下，我們將在蘇格蘭設立歐洲總部，並將在各方面開始擴編歐洲團隊。我們相信今年歐洲部分較大的國家可能會取得給付（reimbursement），我們需要做好準備以把握這個機會。

We've also added a very senior executive to focus on international expansion in Canada, Central and South America, and Asia. We will begin to build this team up as well.

我們也新增了一位資深高階主管，專注於加拿大、中南美洲與亞洲的國際擴張。我們也將開始建立並擴充這支團隊。

Before I open the call up to questions, I'd like to spend a few minutes on competition. Let's start with Abbott and the Libre. First, the Libre is not a CGM. We have long said that one of the key benefits we provide to our patients is best-in-class accuracy combined with proactive alerts and alarms, particularly at night. We also now provide the ability to share data with caregivers to add an extra layer of patient safety.

在我開放提問之前，我想花幾分鐘談談競爭。先從 Abbott 與 Libre 談起。首先，Libre 並不是 CGM。我們長期以來一直強調，我們為患者提供的關鍵價值之一，是同級最佳的準確度結合主動式提示與警報，尤其是在夜間。我們現在也提供與照護者分享數據的能力，為病患安全再加上一層保障。

Some would have you believe that patients suffer from alarm fatigue and would prefer to go without alarms. That is certainly not the case with our system, but might be the case with other, less accurate sensor systems, where false alerts can occur up to 50% of the time.

有些人會讓你相信患者會出現警報疲勞，並且寧可不要警報。在我們的系統上絕非如此，但在其他準確度較低的感測器系統上可能會發生，因為誤報的比例可能高達 50%。

Regardless, our system is customizable. Patients can choose to silence their high and low alarms to their liking, except for the critical fixed low glucose alarm our system provides when the patient cross a dangerously low threshold of 55 milligrams per deciliter.

無論如何，我們的系統可客製化。患者可依自身偏好選擇將高、低血糖警報靜音，但有一項例外：當患者跨越危險的低血糖門檻——每分升 55 毫克——時，我們系統提供的關鍵固定低血糖警報無法關閉。

And with respect to alerts alarms in the future, we intend to provide patients with even greater flexibility and better performance to get more out of their CGM systems. The Libre simply can't compete when it comes to system performance, especially as it relates to hypoglycemia detection. At the ATD conference a few weeks back, a clinician summed up the value of Libre. He said: Libre provides patients with a nice path to the product they really need -- CGM.

至於未來的提示與警報，我們打算提供患者更高的彈性與更佳的效能，以便從其 CGM 系統中獲得更多價值。Libre 在系統效能方面根本無法競爭，尤其是在低血糖偵測上。在幾週前的 ATD 會議上，一位臨床醫師總結了 Libre 的價值。他說：Libre 為患者提供了一條不錯的路徑，通往他們真正需要的產品——CGM。

Shifting to Medtronic, Medtronic recently announced they would forgo the launch of the 640G in the US in favor of the 670G with a new sensor. Since we haven't seen any meaningful performance data on the 670G and their new sensor, I reserve comment on this future system. I will only remind investors that when Medtronic launched the 530G back in the fall of 2013, its published accuracy data was similar to that of our G4 PLATINUM system. The actual field performance has not been close to that of G4 PLATINUM, even before our software 505 algorithm update.

轉到 Medtronic，Medtronic 近期宣布將放棄在美國推出 640G，改為推出搭載新感測器的 670G。由於我們尚未看到 670G 及其新感測器任何具實質意義的效能數據，我暫不評論這套未來系統。我只想提醒投資人，當 Medtronic 在 2013 年秋季推出 530G 時，其公布的準確度數據與我們的 G4 PLATINUM 系統相近。但實際的現場表現與 G4 PLATINUM 相去甚遠，即便在我們更新 505 軟體演算法之前也是如此。

Since the launch of 530G, according to dQ&A, an independent source, our CGM market share has gone from the mid- to upper-60% range to approximately 76% at the end of 2015. The patient community has spoken. Accurate, reliable, connected CGM is the most important product offering in diabetes treatment today.

自 530G 上市以來，根據獨立來源 dQ&A 的資料，我們的 CGM 市占率已從 60% 中段到高段提升至 2015 年底約 76%。患者社群已經表態。準確、可靠、可連線的 CGM，是當今糖尿病治療中最重要的產品供給。

I'll now open the call up for Q&A.

我現在開放問答（Q&A）。

(Operator Instructions) Ben Andrew, William Blair.

(接線員指示) Ben Andrew，William Blair。

Thanks for taking the questions. First question from me is talk about what all you can do with G5 mobile, the application. You talked about adding insulin onboard as a feature, but can you add algorithms and start to do some predictive things with this version? Or are we looking further out before you start to incorporate more sophisticated things between simple kind of data presentation?

感謝讓我提問。我第一個問題是想談談你們在 G5 mobile 這個應用程式上能做哪些事情。你們提到會加入「胰島素在體內（insulin onboard）」作為一項功能，但在這個版本中是否也能加入演算法並開始做一些預測性的功能？還是說在你們開始把更精密的功能加入、超越單純的資料呈現之前，還需要再往後一段時間？

We can do a lot of those things, Ben. The question is what do we do timing-wise versus the G6, which we are going to, as I said earlier, submit the IDE on. We can move technologies into that or put them in the other product and we evaluate that as we go.

Ben，我們可以做很多這類事情。問題在於時程上要怎麼安排，相較於 G6——如我先前所說，我們將提交 IDE。我們可以把技術移到那邊，或是放在另一個產品裡，我們會在推進過程中持續評估。

So for today, we're planning on keeping the G5 Mobile app similar to what it is and adding a few features to enhance it without adding a bunch of advanced algorithm and prediction. Most of that is scheduled for G6 at this point.

所以就目前而言，我們的規劃是讓 G5 Mobile app 大致維持現狀，並加入少數功能來強化體驗，但不會加入大量進階演算法與預測功能。目前大部分這類功能都排在 G6 上。

And those would be PMA supplements, is that right?

那那些會是 PMA 補充申請（supplements），對嗎？

It will all be included in the original G6 filing. The G6 is a full PMA because it's a new sensor.

那些都會包含在原始的 G6 送件中。G6 會是一個完整的 PMA，因為它是新的感測器。

Okay.

好的。

I would just add some of that algorithm development is not exactly linked to a sensor. We've talked in the past about not tying ourselves down to G5, G6, G7 iterations. Some of the algorithm work that's going on is kind of independent of the specific sensor platform.

我再補充一點：部分演算法開發並不一定要和感測器綁在一起。我們過去談過，不希望把自己綁死在 G5、G6、G7 的迭代上。目前進行中的一些演算法工作，某種程度上是獨立於特定感測器平台的。

Yes.

是的。

Got it. And then Kevin, you alluded to the fact there's a lot that's going to happen in the next few weeks. Is that conducting clinical trials, kind of moving things forward in terms of having gotten some clarity on the dosing claim requirements with the Agency?

了解。接著 Kevin，你提到接下來幾週會有很多事情發生。那是指進行臨床試驗、以及在與主管機關釐清劑量宣稱（dosing claim）要求後，推動相關工作往前走嗎？

And then in a related question, is there some fundamental reason that the FDA wouldn't approve kind of a near-term product or anybody's product without a calibration stick? I mean, how high is that hurdle for them?

另外一個相關問題是：FDA 是否有什麼根本性的原因，會不批准短期內的產品——或任何人的產品——在沒有校正棒（calibration stick）的情況下上市？也就是說，對他們而言這個門檻有多高？

I don't have an answer to that last question, Ben. We're studying that rigorously as we prepare our future product offerings, particularly our Google product offerings we intend to launch here out a couple years.

Ben，最後那個問題我沒有答案。我們正在嚴謹地研究這件事，為我們未來的產品供應做準備，特別是我們打算在未來幾年推出的 Google 產品。

With respect to the dosing claim, we've had activity going on for a long time. And that activity is heating up and we are going to get some clarity on things over the next few weeks. I am not going to go into detail as what those are, but by the time we get to the next call, we should have a very clear path on the non-adjunctive claim to present to you guys.

至於劑量宣稱，我們已經進行相關工作很長一段時間了。而且這些活動正在升溫，我們會在接下來幾週對一些事情取得更明確的方向。我不會詳細說明那些是什麼，但等到下一次電話會議時，我們應該能向各位提出一條非常清楚的路徑，說明非輔助（non-adjunctive）宣稱。

Okay. And then last question for me: do you expect -- and one of the features on G6 of the 10-day time frame. Would that have a shut-off feature at this point? Is that kind of the threshold, Kevin? Thank you.

好的。我最後一個問題：你們預期——G6 的其中一項特點是 10 天的使用期限。在目前的規劃下，會有自動關閉（shut-off）功能嗎？Kevin，這是否就是那個門檻？謝謝。

You know what, I'm not going to answer that. We've considered shut-off features all the way back to 7 Plus. So we'll take that into consideration and give more color on Gen 6 as it gets closer to market.

你知道嗎，我不打算回答這個問題。我們早在 7 Plus 時期就已經考慮過關閉功能。所以我們會把這點納入考量，並在第六代（Gen 6）更接近上市時提供更多說明。

Mike Weinstein, JPMorgan.

Mike Weinstein，JPMorgan。

Good afternoon. So let me follow up the commentary you made about the first quarter, seeing less seasonality potentially this quarter than you have in prior years. Can you give us a little bit more than that?

下午好。我想追問你對第一季的評論：你提到本季可能比過去幾年看到的季節性更不明顯。你能再多說一點嗎？

I think what Steve said is our new patient pipeline is more robust than it's ever been. With respect to seasonality and patient reorders, Mike, it's very much the same as it's always been. And it will be sequentially down, as we said at the conference in early January. I believe we used number of 15%; it's approximately down 15% from what it's been. And that's very consistent with what it's been in other years. So while we have more patients in the pipeline, that growth is necessary to have the quarter that we expect to have.

我想 Steve 的意思是，我們的新病患管線比以往任何時候都更強。至於季節性與病患回購（reorders），Mike，基本上和以往一樣。而且如同我們在一月初的會議上所說，會呈現季對季下滑。我記得我們用的數字是 15%；大約會比之前下滑 15%。這與其他年度的情況非常一致。所以雖然我們的管線中有更多病患，但要達到我們預期的季度表現，這樣的成長是必要的。

Right. And the part that feels like it's a bit different is the new patient flow -- is that what you're saying?

了解。那看起來比較不同的部分是新病患流入——你是這個意思嗎？

We're saying that that's where our big increase is coming in the first quarter up to this point in time, yes.

是的，我們的意思是，截至目前第一季最大的增量來源就是新病患。

Okay.

好的。

Mike, remember: 70% of our business is consumables and those are largely reorder patients. So those patients who stocked up in Q4 typically aren't reordering yet.

Mike，請記得：我們 70% 的業務是耗材，而那主要來自回購病患。因此，那些在第四季囤貨的病患，通常還沒到再次下單的時間。

Exactly, right. I know there's a timing to when they reload, if you will, on their CGMs.

沒錯。我知道他們補貨——如果可以這麼說——他們的 CGM 是有時間點的。

Yes.

是的。

Exactly.

完全同意。

And then G6, just the IDE study, obviously you have to have some more conversations there with the FDA. But typically, what do those -- historically what do those look like and what's the follow-up period on them?

接著談 G6，關於 IDE 研究，你們顯然還需要和 FDA 再多談一些。但通常這類研究——從歷史經驗來看——大概會是什麼樣子？以及它們的追蹤期通常多長？

Our IDE submissions typically get approved very quickly, Mike, because we have had a number of discussions with the Agency before we submit them. So they're seeing something that they're expecting.

Mike，我們的 IDE 送件通常很快就會獲准，因為在提交之前我們已經和主管機關進行過多次討論。所以他們看到的是他們預期會看到的內容。

I can tell you, as the IDE stands now and we'll give more explicit detail on the next call, this will be the most rigorous study we have ever attempted by a long ways. And so while the FDA is very cooperative as far as getting things through and helping us, they are not making it easier to get CGMs approved. So this will be a very rigorous study once we get it out there and get it going. But it's -- it will be filed very soon and we hope to start in the second quarter.

我可以告訴你，就目前 IDE 的規劃而言——我們會在下一次電話會議提供更明確的細節——這將是我們迄今為止嘗試過最嚴謹的研究，遠遠超過以往。因此，雖然 FDA 在推進流程與協助我們方面非常合作，但他們並沒有讓 CGM 的核准變得更容易。所以一旦我們把研究推出去並啟動，這會是一項非常嚴謹的研究。不過——我們很快就會送件，並希望在第二季開始。

Okay. And then there was obviously some discussion this quarter about the pathway to CMS reimbursement. Do you just want to comment on that, Kevin, while we have you?

好的。另外，本季顯然也有一些討論是關於取得 CMS 給付的途徑。Kevin，趁你在線上，你要不要對此再評論一下？

I think we've said all we've got. And we need this non-adjunctive claim to get to CMS. That's really our first step on the administrative side and the FDA has been very helpful. It's been a very active interactive discussion. And as I said on Ben's question as well, we'll have a lot of color on that next quarter because a lot of things are coming to a head here as far as Agency discussions.

我想我們已經把能說的都說了。我們需要這個非輔助（non-adjunctive）宣稱，才能推進到 CMS。那確實是我們在行政面上的第一步，而 FDA 也非常有幫助。這一直是非常積極、互動式的討論。而且如同我在回答 Ben 的問題時也提到的，下一季我們會提供更多細節，因為就主管機關的討論而言，很多事情接下來都會到一個關鍵點。

Understood. Okay, I'll let some others jump in. Thanks, guys.

了解。好的，我讓其他人加入提問。謝謝各位。

Brooks West, Piper Jaffray.

Brooks West，Piper Jaffray。

Thanks for taking the questions. Kevin or Steve, I wanted to follow-up on your competitive comments and explore a little bit on where your new patients are coming from. And a couple of questions, I guess. What is the mix you're seeing from existing or people who have some familiarity with managing their diabetes? And I'm curious mix between pumpers and manual dose patients. What's your new patient mix?

謝謝讓我提問。Kevin 或 Steve，我想延續你們對競爭的評論，並進一步了解你們的新病患來源。我想有幾個問題。你們看到的組成中，既有病患或對糖尿病管理已有一定熟悉度的人占比如何？另外我也好奇，使用胰島素幫浦的病患與手動劑量（manual dose）病患之間的比例。你們的新病患組合是什麼？

And then I think there's a perception out there that you've been stealing patients from Medtronic for some time. And maybe if they are able to get a better product out, that might slow you down. I wonder if you would comment on that dynamic as well?

然後我想外界有一種看法，認為你們一段時間以來一直在從美敦力那邊「搶」病患。也許如果他們能推出更好的產品，可能會讓你們的成長放緩。我想請你也評論一下這種競爭態勢？

Sure. Let's talk about the mix first and then I'll comment on the Medtronic comment. So our mix has historically run somewhere in the neighborhood of 60% to 65% pumpers and the balance MDI patients. I would say we've started to see a slight shift in favor of MDI patients.

當然。我們先談產品組合，然後我再回應關於美敦力的評論。我們的組合歷來大約是 60% 到 65% 的胰島素幫浦使用者，其餘則是 MDI（多次每日注射）病患。我會說我們已開始看到些微轉變，對 MDI 病患更有利。

And I would also tell you that if you ask this same question in a couple years from now, the hope and the plan is that that balance would shift. That you probably see something more like 60% MDI patients and 40% pumpers. Frankly, more reflective of what the -- this is in the US, in particular -- more reflective of what the US base would look like.

我也想說，如果你在兩三年後再問同樣的問題，我們的希望與計畫是這個比例會改變。你可能會看到更像是 60% 的 MDI 病患、40% 的幫浦使用者。坦白說，這會更能反映——這裡特別指美國——美國的基礎市場結構應該長什麼樣子。

As for stealing Medtronic patients, I would say that the further -- couldn't be further from the truth. Our patients are generally -- the vast majority are new to CGM therapy. We do have some handful of patients who choose to wear a Medtronic pump, but who also wear a Dexcom sensor.

至於說我們在搶美敦力的病患，我會說這——完全不是事實，差得很遠。我們的病患一般而言——絕大多數都是 CGM（連續血糖監測）治療的新使用者。我們確實有少數病患選擇使用美敦力的幫浦，但同時也配戴 Dexcom 的感測器。

But I would say in our portion of that 60% to 65% of our base who are also insulin pumpers, the vast majority of those are wearing an Animas, an Insulet, or Tandem pump, not a Medtronic pump. And the short answer is no, we are not in any way stealing patients from Medtronic as a big growth driver for the Company.

但我會說，在我們基礎用戶中那 60% 到 65% 同時也是胰島素幫浦使用者的部分，絕大多數使用的是 Animas、Insulet 或 Tandem 的幫浦，而不是美敦力的幫浦。簡短的答案是：不，我們絕不是以從美敦力那邊搶病患作為公司成長的主要驅動力。

We get a few.

我們會拿到一些。

Yes.

是的。

Okay, that's helpful. And then I wonder, as you guys have spent more time with the Google team or the Verily team, if you could share not so much product details, but learnings on the type of device that might be appropriate for the Type 2 or broader market. And I wonder if your perception of that market opportunity has evolved since you started that collaboration. Thanks.

好的，這很有幫助。接著我想問，隨著你們與 Google 團隊或 Verily 團隊相處更久，能否分享一些不是產品細節、而是關於哪種類型的裝置可能適合第二型或更廣泛市場的學習與洞見。我也想知道，自從你們開始這項合作以來，你們對該市場機會的看法是否有所演變。謝謝。

Brooks, our perception continues to evolve and we're doing a lot of market research. The one thing that we've learned about this market is it's not going to do us any good just to display a number and say here you go. That we're going to have to really give patients the ability to learn from the system that we provide and provide interactive suggestions like okay, you exercised today. Look how much better you did.

Brooks，我們的看法仍在持續演變，我們也正在做大量的市場研究。我們對這個市場學到的一件事是：僅僅顯示一個數字然後說「給你」對我們沒有任何幫助。我們必須真正讓病患能從我們提供的系統中學習，並提供互動式建議，例如：好，你今天運動了。看看你的表現好多少。

And that's the type of system and interface that we're going to develop to address that market again, which is different than what we have now. Just flashing a number on the screen isn't going to be enough, particularly for those that aren't using insulin. I would maintain that intensive insulin-using Type 2 patients can have the exact same experience as our Type I patients have today.

而這就是我們將要開發、用來切入該市場的系統與介面類型；再次強調，這與我們目前的產品不同。只是在螢幕上閃一個數字是不夠的，特別是對那些不使用胰島素的人。我仍然認為，密集使用胰島素的第二型病患，可以擁有與我們第一型病患今天相同的體驗。

So it's been a very interactive process. I would tell you with the Google guys, in particular -- or Verily as they're called now -- their fresh approach to things, coming from a non-medical device industry, has been refreshing for us and caused us to think very differently.

所以這一直是一個高度互動的過程。我會說，特別是 Google 的夥伴——或者他們現在叫 Verily——他們從非醫療器材產業帶來的全新思維，對我們而言很新鮮，也促使我們用非常不同的方式思考。

Conversely, there's some things about medical devices that we've taught them, particularly with respect to PMA filings, that they weren't as aware of either. It has really been a wonderful partnership and we think it's going to produce amazing results over time.

反過來說，關於醫療器材也有一些事情是我們教他們的，特別是在 PMA 申請方面，他們原本也沒有那麼了解。這確實是一個很棒的合作夥伴關係，我們認為隨著時間推進，它會產生令人驚豔的成果。

Great. Thanks, guys.

很好。謝謝各位。

Kyle Rose, Canaccord.

Kyle Rose，Canaccord。

Thank you very much and congrats on a great quarter. I just wanted to see -- it sounds like the early stages of the Google-Verily partnership are going well. Want to see if you could just remind us what the specific milestones are expected there. I think two to three years for the first product.

非常感謝，也恭喜你們交出很棒的一季。我想確認一下——聽起來 Google-Verily 合作的早期進展很順利。想請你們提醒我們那邊預期的具體里程碑是什麼。我記得第一個產品大概是兩到三年。

And then also, is it still fair to expect that we won't see any impact or any contribution from that partnership on the current pipeline, you know, the G6 or the receiver?

另外，是否仍然可以合理預期，我們不會在目前的產品管線上看到任何影響或貢獻，例如 G6 或接收器？

This is Kevin. I think the first pass product won't really affect the G6 sensor because it's going to start the trials, like I said, in the second quarter. Over time, Google Electronics could very much be incorporated into a future transmitter offering if that improves technological performance and reduces costs. So we could conceivably use their electronics in some future configuration of G6 in addition to the specific Google products.

我是 Kevin。我認為第一版產品不會真正影響 G6 感測器，因為它會如我所說在第二季開始試驗。隨著時間推進，如果能提升技術表現並降低成本，Google 的電子技術很可能會被納入未來的發射器方案中。因此，除了特定的 Google 產品之外，我們也可能在未來某種版本的 G6 中採用他們的電子元件。

As far as contributing to our earnings or our sales, certainly nothing in 2016. And more than likely nothing in 2017. I think that that really starts off in 2018 when we launch our first product.

至於對我們獲利或銷售的貢獻，2016 年當然不會有。而且很可能 2017 年也不會有。我認為真正會在 2018 年開始，當我們推出第一個產品時。

The milestones are really two big ones: there's our first-generation product, which we're working on. But our second-generation product, which we're also working on with Verily, and the second-generation product we've shown pictures of that's (technical difficulty) CGM transmitter literally into a Band-Aid size electronics configuration that a patient can peel off and throw away that would be very cost-effective. And that's the end game here. That's what we're shooting for every day because we know that's what patients want.

里程碑主要有兩個大的：第一是我們正在開發的第一代產品。但第二個是我們也正與 Verily 一起開發的第二代產品；我們已展示過照片的第二代產品，是把（技術問題）CGM 發射器字面上整合到像 OK 繃大小的電子配置中，病患可以撕下來就丟掉，而且成本會非常具競爭力。這就是我們的最終目標。這是我們每天努力的方向，因為我們知道這就是病患想要的。

Great. And then can you just remind us on what -- the launch of the new receiver this year, can you just remind us on what the changes are with the new generation? And then it also sounds like the timeline for the insertion product may be a little later than expected. Is that fair to think of as a back-half-of-the-year event there or just how that impacts anything. And then that's it. Thank you.

很好。另外，今年推出的新接收器，你能否提醒我們新一代有哪些變更？還有，聽起來插入裝置（insertion product）的時程可能會比預期晚一些。這樣理解是否合理——會是在下半年發生的事件嗎？或是它會如何影響其他事情。就這些。謝謝。

The insertion system will definitely be a back-of-the-year event and it's important that we explain a little bit. When we switch to the new insertion system, we are changing everything we do. We've used the current insertion system since we started way back when. That's been our insertion system since our first product was launched.

插入系統肯定會是在年底前後、也就是下半年的事件，而且我們需要稍微解釋一下。當我們切換到新的插入系統時，我們正在改變我們所做的一切。我們從很久以前開始就一直使用目前的插入系統。自從我們第一個產品上市以來，它就是我們的插入系統。

So when we change to the new insertion system, we don't take this lightly. We are going to swap out every mold; we're going to have to change our manufacturing assembling processes and everything. This is the biggest change operationally we've ever undertaken. So it will be a back-half-of-the-year event, the insertion system, and more than likely it will be a phased launch as we do that.

所以當我們改用新的插入系統時，我們不會掉以輕心。我們將更換每一個模具；我們必須改變製造與組裝流程以及所有事情。這是我們在營運上所進行過的最大變革。因此插入系統會是下半年的事件，而且很可能會採分階段推出。

But our feedback has been remarkable on the system because it's basically peel the tape, put it on your skin, push a button, and you are done. Patients, really, really love that.

但我們收到對這套系統的回饋非常驚人，因為它基本上就是撕開膠帶、貼在皮膚上、按一下按鈕，就完成了。病患真的、真的很喜歡。

With respect to the new receiver, it will be a touchscreen device. That is still a Dexcom-configured receiver and it will have a patient interface much more similar to the G5 Mobile app. And so it's designed to have a better patient experience and interface. It's also designed to be more durable and to be very durable with respect to patient wear and dropping receivers and stuff like that. So we're looking forward to getting that product out there. Patients will very much like it.

關於新的接收器，它將會是一款觸控式裝置。它仍然是 Dexcom 設定的接收器，並且會有一個與 G5 Mobile 應用程式更為相似的病患介面。因此它的設計是為了提供更好的病患體驗與介面。它也被設計得更耐用，特別是針對病患配戴、接收器掉落之類的情況要非常耐用。所以我們很期待把這個產品推出到市場。病患會非常喜歡它。

Great. Thank you very much.

很好。非常感謝。

Jayson Bedford, Raymond James.

Jayson Bedford，Raymond James。

So wondering if you could talk a bit more about what you're seeing in terms of the G5 launch. We are four to five months into it here. Curious if you're seeing more interest from Type 2s. Are you seeing more compliant utilization, seeing a lower attrition rate? Just anything would be helpful.

想請你再多談一點你們在 G5 上市方面看到的情況。我們現在已經進入第 4 到第 5 個月。好奇你們是否看到第二型糖尿病患者的興趣增加。你們是否看到更遵從的使用情況、較低的流失率？任何資訊都會很有幫助。

Steve, you want to take a crack and then I --

Steve，你要先說說看，然後我——

Yes. I mean, no, I mean, I would tell you that obviously the biggest benefit is certainly connectivity directly to your phone. The patients love not having to carry a separate receiver and have the convenience of having it on their phone. That together with the Share platform, which as you know we launched with the G4 PLATINUM system, by continuing to have that ability to share data with caregivers.

是的。我的意思是，當然，最大的好處顯然是能直接連線到你的手機。病患很喜歡不必再攜帶一個獨立的接收器，而是方便地在手機上就能看到。再加上 Share 平台——如你所知，我們在 G4 PLATINUM 系統時就推出了——能持續具備與照護者分享資料的能力。

I would say we continue to see and I would -- just looking at some of the initial data on our direct-to-consumer campaigns, we're certainly seeing success in driving awareness at the patient level, more so than at the clinician level. So we're really continuing to see -- we've said in prior quarters that the biggest driver for our growth has been patients referring to other patients -- patients, parents of patients, and caregiver or loved ones. We are continuing to see that and I think our DTC campaigns are really adding to that push.

我會說我們持續看到——我也會說——從我們一些面向消費者的初期行銷活動數據來看，我們確實在提升病患端的認知方面看到成效，且比臨床醫師端更明顯。所以我們真的持續看到——我們在前幾季也說過，我們成長最大的驅動因素是病患轉介其他病患——病患、病患的父母，以及照護者或親友。我們仍然持續看到這種情況，我認為我們的 DTC（直接面向消費者）活動確實在加強這股推力。

But no, I think the launch has gone great. As Kevin mentioned in the prepared remarks, we've learned a lot about going directly to a consumer device, like a mobile phone. And there are some challenges there and we've got some things that we're going to work on over the next several quarters. But by and large, the reception has been remarkable.

但不，我認為這次上市進展得非常好。正如 Kevin 在事先準備的講稿中提到的，我們從直接走向像手機這樣的消費性裝置學到了很多。而這裡面確實有一些挑戰，我們接下來幾季會針對一些事情持續改善。但整體而言，市場反應非常出色。

You know, I'd just add, Jayson, with respect to Type 2 patients, that's as much a function of reimbursement coming as it is going to the phone.

你知道，我再補充一下，Jayson，關於第二型糖尿病患者，這在很大程度上取決於給付（reimbursement）是否到位，而不只是是否連到手機。

Yes, yes, yes.

是的，是的，是的。

But as far as appealing to patients, I would tell you we are appealing to a broader base of patients by going to a phone. Not just those necessarily, as Steve said, the physicians would recommend and push them there. But it would also appeal to those when they hear about it and see things in our DTC campaigns going hey, if this goes to my phone, I might be interested in this. So I think we are appealing to a broader base of patients.

但就吸引病患而言，我會說我們透過連到手機，正在吸引更廣泛的病患族群。不僅僅是那些——如 Steve 所說——由醫師建議並推動使用的病患。當他們聽到、看到我們 DTC 活動的內容時，也會覺得「嘿，如果這能連到我的手機，我可能會有興趣」。所以我認為我們正在吸引更廣泛的病患基礎。

Okay. I realize you're not going to quantify it, but are you seeing a lower attrition rate with this device?

好的。我知道你們不會量化，但你們是否看到這個裝置的流失率更低？

You know, it's too early. It's absolutely too early. And we do have our jet zooming over, as it does in every earnings call, so I'll let the jet go by. It's too early to tell. The product hasn't been out that long and we, as we do in every fourth quarter, ship so much the last month of that quarter.

你知道，現在還太早。真的還太早。而且我們的噴射機又在頭上呼嘯而過，就像每次財報電話會議一樣，所以我先讓噴射機飛過去。現在還太早下結論。產品上市時間還不長，而且我們也像每年第四季一樣，在該季最後一個月出貨量非常大。

We'll certainly have the tools to get a better indication of utilization and patient retention, as all this data is coming to our servers. And we are starting to build the analytics platforms to really go after and analyze this and build the business cases to understand our business better, much better -- much, much better with all the data coming to the servers. I think we'll provide more clarity in the future; don't have a lot yet.

我們當然會有工具來更好地判斷使用情況與病患留存，因為所有這些資料都會傳到我們的伺服器。而我們也開始建立分析平台，真正去深入分析這些資料，並建立商業案例，以更好地理解我們的業務——在所有資料都進到伺服器之後，會好很多、好非常多。我想未來我們會提供更清楚的資訊；目前還沒有太多。

Okay. And then just maybe to follow up on the pharmacy, do you think this avenue has stimulated more demand for the device? Or is the real benefit still largely a convenience factor for those existing users?

好的。那再追問一下藥局通路，你認為這個途徑是否刺激了對該裝置的更多需求？還是說真正的好處主要仍是對既有使用者而言的便利性？

I don't think we have broad enough coverage to stimulate a bunch of benefit in the pharmacy channel. I think in most cases what happens is we'll approach healthcare professionals and say we have great coverage under these plans where's there's pharmacy benefit. Do you have a lot of patients who have pharmacy benefit who could use this?

我不認為我們目前有足夠廣泛的給付覆蓋，能在藥局通路帶來大量的效益。我想多數情況下，我們會去找醫療專業人員並說：在這些有藥局給付（pharmacy benefit）的計畫下，我們有很好的覆蓋。你是否有很多具備藥局給付、可能適合使用這個的病患？

And we'll get a few patients who do it, but by and large, again, as a lot of our demand is coming directly from patients, they see an ad. They're not seeing you can get it at your pharmacy. They are seeing what this system does for you and your life and how it enables you to better manage your diabetes.

然後我們會有少數病患透過這種方式使用，但整體而言——再一次——由於我們很多需求是直接來自病患，他們看到廣告。他們看到的不是「你可以在藥局買到」。他們看到的是這個系統如何改善你的生活、以及如何讓你更好地管理糖尿病。

All right, thanks. I'll jump back in queue.

好的，謝謝。我回到隊列後面。

Danielle Antalffy, Leerink Partners.

Danielle Antalffy，Leerink Partners。

Thanks so much for taking the question and congrats again on such an awesome year. I was wondering -- I wanted to ask you guys about CMS and how do think about the size of that patient population that could open up, if you do get coverage there?

非常感謝讓我提問，也再次恭喜你們有這麼精彩的一年。我想問——我想請教你們關於 CMS，你們如何看待如果在那裡獲得給付，可能會開放出來的病患族群規模？

Yes, so we don't have great data, but the estimates that we've seen range from kind of on the low end like 15% of the Type 1s in the US and I've seen as high as 25%. So there's certainly, you know, no matter how you slice it, if you think there is 1.3 million to 1.5 million Type 1s -- and you're looking at hundreds of thousands of Type I patients who are in the Medicare age population.

是的，所以我們沒有非常好的數據，但我們看到的估計值大概從較低端的美國第一型糖尿病患者約 15%，到我也看過高達 25%。所以無論你怎麼切分來看，如果你認為第一型糖尿病患者有 130 萬到 150 萬人——那你看到的是數十萬名處於 Medicare 年齡層的第一型糖尿病患者。

And then the other -- you know, we think the big opportunity with Medicare over time is the intensively well-managed Type 2s. Because as Type 2s progress in their disease state, they move from starting out trying to manage with diet and exercise maybe at a younger age, but by the time they reach the Medicare age population, many of them have progressed to the point where they're taking not only a long-acting insulin, but they are taking mealtime insulin injections as well. At that point in time, they become perfect candidates for CGM.

然後另外——你知道，我們認為 Medicare 隨時間推進最大的機會在於那些被密集且良好管理的第二型糖尿病患者。因為第二型糖尿病患者隨著病程進展，可能在較年輕時先從飲食與運動嘗試管理開始，但到了 Medicare 年齡層時，許多人已進展到不僅使用長效胰島素，還會在用餐時注射胰島素。在那個時間點，他們就成為 CGM 的完美候選人。

The other fact that we know that over time, people who have had Type I diabetes for a long number of years develop a condition called hypoglycemia unawareness. They actually lose the ability to detect an oncoming hypoglycemic episode. So again, this happens in folks over a long period of time.

我們也知道另一個事實是，隨著時間推移，罹患第一型糖尿病很長一段時間的人，會發展出一種稱為「低血糖無感」（hypoglycemia unawareness）的狀況。他們實際上會失去偵測即將發生低血糖發作的能力。所以同樣地，這通常發生在長期病程的患者身上。

And so you start to think about people who have lived with Type 1 and are now entering the Medicare age. These are the same folks that may be having that issue with hypoglycemia unawareness. So we think there's a great opportunity for those patients as well. So it is an exciting potential catalyst for us.

因此你開始去思考，那些與第一型糖尿病共存、如今正進入 Medicare 年齡層的人。這些人也可能正面臨低血糖無感的問題。所以我們認為對這些病患而言也有很大的機會。因此這對我們來說是一個令人振奮的潛在催化劑。

Absolutely; that's great. Thanks for the color. And I was wondering if you guys could give any color on how to think about the cadence of potential products coming out of the Verily collaboration with Google. And sort of what the first go at a product might look like and what you ultimately hope to get to?

當然；那很棒。謝謝你提供的補充說明。我想請教各位，能否再補充說明一下，該如何看待與 Google 的 Verily 合作可能推出產品的節奏。以及第一款產品大概會是什麼樣子，還有你們最終希望達到的目標是什麼？

Yes. So we've always said that we've agreed to do a minimum of two products with Google. We've always said that the first product is really a -- it's going to leverage, frankly, much of the technology that we already have today. So some of the Gen 6 sensor technologies, some of the more advanced algorithms that we have. Some of the initial prototype miniaturized electronics and batteries and things that Google kind of brought to the table when we first started talking about working together.

是的。我們一直都說，我們已同意與 Google 至少合作開發兩款產品。我們也一直說，第一款產品其實——坦白講——會大量運用我們目前已經擁有的技術。例如部分第六代（Gen 6）感測器技術、我們的一些更先進的演算法。以及 Google 在我們一開始討論合作時帶來的一些初期原型的微型化電子元件與電池等。

It's really that second-generation product that we've shown in some of the slide presentations that begins to look more like a tiny bandage on the skin. Certainly will continue to pierce the skin, but looking at really taking cost out of the system, making it truly minimally, so minimally invasive for patients that there be -- really we've eliminated all the objections to wearing it. That doesn't come until the second product, which is probably four or five years away.

真正是我們在一些簡報投影片中展示過的第二代產品，外觀開始更像貼在皮膚上的小型敷貼。當然仍會持續穿刺皮膚，但重點在於真正降低系統成本，讓它對病患而言侵入性極低、低到——我們基本上消除了配戴它的所有反對理由。那要到第二款產品才會實現，而那大概還要四到五年。

Okay, great. Thank you.

好的，很棒。謝謝。

Doug Schenkel, Cowen and Company.

Doug Schenkel，Cowen and Company。

Hi. This is Ryan Blicker on for Doug. Thanks for taking my questions. So I wanted to follow up on the awareness point you guys talked about earlier. Historically, you've cited patient and provider awareness of CGM as one of the biggest hurdles to broader adoption. Can you give us an update on where that stands today relative to maybe 12 months ago?

嗨。我是代替 Doug 的 Ryan Blicker。謝謝讓我提問。我想追問一下你們先前提到的「認知度」議題。過去你們曾指出，病患與醫療提供者對 CGM 的認知度是更廣泛採用的一大障礙。能否更新一下，與大約 12 個月前相比，目前的情況如何？

And how should we think about the recent AACE guidelines you mentioned, your DTC campaign, and other initiatives? How will that impact 2016?

以及我們該如何看待你們提到的近期 AACE 指南、你們的 DTC（直接面向消費者）行銷活動，以及其他倡議？這些將如何影響 2016 年？

This is Kevin. Obviously, we'll certainly use the recent AACE guidelines in our campaigns. Nothing could be more compelling than saying the physician group who takes care of you recommends that most of you should use CGM. So we will absolutely use that and we're thrilled with those guidelines.

我是 Kevin。很明顯地，我們一定會在行銷活動中運用近期的 AACE 指南。沒有什麼比「照護你的醫師團體建議你們大多數人應該使用 CGM」更有說服力。所以我們絕對會使用這點，而且我們對這些指南感到非常振奮。

With respect to patient awareness, I think it's increased dramatically. Just look at the new patient adds we had this year. As we said in our prepared remarks, we pretty much doubled the size of our patient base in 2015. It took us from 2005 to 2014 to get to one point and we doubled it in a year. Or at least came pretty close to doubling it in 12 months. So obviously, awareness is rising rapidly in the patient community and the physician community, because you can't bring the patients in without healthcare provider support. So I think our efforts to increase awareness have worked very well across the board.

就病患認知度而言，我認為已大幅提升。看看我們今年新增的新病患數就知道。如同我們在事先準備的發言中所說，我們在 2015 年幾乎把病患基礎規模翻倍。我們從 2005 年到 2014 年才達到一個水準，而我們在一年內就把它翻倍。或者至少在 12 個月內非常接近翻倍。所以很明顯，病患社群與醫師社群的認知度都在快速上升，因為沒有醫療提供者的支持，你不可能把病患帶進來。因此我認為我們提升認知度的努力在各方面都非常奏效。

And the reason those increasing -- that increasing awareness has worked is because the product does. It really delivers what we promised with respect to accuracy and performance. And it changes and saves lives. So you have a case where a product has met expectations and people are willing to sign up for another experience.

而之所以——這種認知度提升之所以有效——是因為產品確實做到了。就準確度與效能而言，它確實交付了我們承諾的成果。而且它改變並拯救生命。所以你會看到一個情況：產品達到預期，人們也願意再加入、再體驗一次。

Okay, that's helpful. And you talked about the reimbursement landscape for intensively managed Type 2s in the US. Can you give us any update or color on what progress has been made there over the past year, acknowledging it still does remain pretty limited? Any color would be helpful.

好的，這很有幫助。另外你們談到美國對於密集管理的第二型糖尿病患者的給付環境。能否更新或補充說明一下過去一年在這方面取得了哪些進展——也理解目前仍相當有限？任何補充都會很有幫助。

It's still pretty limited. We have some plans who have agreed to cover the Type 2 intensively managed patients. We need more data. When it's all said and done, we need more data here.

目前仍相當有限。我們有一些保險計畫已同意給付第二型、密集管理的患者。我們需要更多數據。說到底，我們在這裡需要更多數據。

That is what came out of the AACE consensus, that we definitely see benefit there, but we need more data.

這也是 AACE 共識所指出的：我們確實看到那裡有益處，但我們需要更多數據。

We got to have more data. So we'll plan some studies in that population.

我們必須要有更多數據。所以我們會規劃在那個族群做一些研究。

Okay, thank you.

好的，謝謝。

James Franciscone, Morgan Stanley.

James Franciscone，Morgan Stanley。

Thanks for taking the question. I was wondering if you could give us a little bit more detail on Europe and the reimbursement -- development of reimbursement there. In particular, are there two or three countries that you'd highlight that are closest to gaining reimbursement? And in those countries, you know, what's the process or timing for getting reimbursement or what are the milestones that we should be looking for?

謝謝讓我提問。我想請你們再多談一些歐洲以及那邊的給付——給付發展的細節。特別是，有沒有兩到三個國家你們會點名，認為最接近取得給付？在那些國家，取得給付的流程或時程是什麼，或我們應該關注哪些里程碑？

Yes, it's a great question. So I'll tell you: we have reimbursement today in Sweden, we have Switzerland, and The Netherlands. And honestly, Sweden is one of our largest countries, which is -- probably shouldn't be, considering the number of people. There's only 6 or 8 million people in the country.

是的，這是個好問題。我可以告訴你：我們目前在瑞典有給付，在瑞士也有，荷蘭也有。坦白說，瑞典是我們最大的國家市場之一——考量人口數，可能不應該這麼大。那個國家只有 600 萬或 800 萬人口。

What we're seeing involves -- it's seeing some positive signs in Germany. So we are hoping that -- the three key ones for this year to look for would be Germany, the UK, and France. Whether we get all three is still an unknown, but I would expect to see at least one, if not potentially a couple of them. Those are pretty sizable markets. I mean, Germany and the UK in particular are the largest markets -- would be the largest markets for us in Europe.

我們看到的情況是——在德國出現一些正向跡象。所以我們希望——今年要關注的三個關鍵國家會是德國、英國與法國。是否能三個都拿到仍是未知數，但我預期至少會看到其中一個，甚至可能一到兩個。這些都是相當大的市場。我的意思是，尤其德國與英國會是歐洲對我們而言最大的市場。

So that's what's driving this need to make some additional investment. Really, we've said it before -- we'd feel pretty stupid if we got reimbursement in Germany, France, and the UK and didn't have the resources to be able to support new patient additions over there. So we're taking a look at beefing up some -- you know, opening the headquarters, as Kevin mentioned. And then beefing up some additional DexCom resources in Europe.

所以這也驅動了我們需要做一些額外投資。我們之前也說過——如果我們在德國、法國和英國拿到給付，卻沒有資源去支援那邊新增病患，我們會顯得很愚蠢。所以我們正在評估加強一些——你知道的，如 Kevin 提到的，設立總部。然後在歐洲增補更多 DexCom 的資源。

Okay. So you'd be disappointed then if in at least one of those three countries CGM was not paid for by the end of the year?

好的。所以如果到年底這三個國家中至少有一個沒有為 CGM 付費，你們就會感到失望？

Yes, that's fair.

是的，這樣說合理。

That's fair, that's fair.

合理，合理。

I think we'd like to see at least one of the three. Yes.

我想我們希望至少看到三者之一。是的。

Okay, okay. And then we talked a little bit on the call today about insulin-dependent Type 2s. Is there anything that you're doing today from a clinical trial perspective or technology perspective to develop the data to support use in that population?

好的，好的。另外，我們今天的電話會議也稍微談到胰島素依賴型的第二型糖尿病患者。在臨床試驗或技術面，你們目前是否有做任何事情來建立數據，以支持在該族群的使用？

You know -- this is Kevin. It's going to take a clinical study and a large clinical study more than anything else. We have some studies that are being run where there are some Type 2 patients who are insulin-dependent and there are subsets of populations in many of our studies. We are going to have to run some bigger ones to develop a better data set and show the payers.

你知道——我是 Kevin。最重要的是需要一項臨床研究，而且是一項大型臨床研究。我們目前正在進行的一些研究中，確實包含部分胰島素依賴的第二型患者，他們在我們許多研究中屬於某些子族群。我們將必須再做一些更大型的研究，以建立更好的數據集並向支付方證明。

Another thing that we've proposed and will pursue with our reimbursement team, we'll go to payers directly and maybe offer to do some things in their population to show the cost effectiveness of this. But those programs really haven't been developed. They're just a lot -- a lot of them are at the idea stage and we'll crystallize those and be a little more aggressive throughout the year.

我們提出的另一件事，而且也會與我們的給付團隊一起推進的，是我們會直接去找付款方，或許提出在他們的族群中做一些事情，以證明這項方案的成本效益。但那些計畫其實還沒有真正被建立起來。它們只是很多——很多都還停留在構想階段，我們會把這些想法具體化，並在今年內採取更積極的作法。

Okay, that's helpful. And then just one more on DTC and then I'll get back in queue. Is there some way to think about how much you've invested in DTC to date and how you view the returns on that investment? And, you know, whether you're going to be scaling it up or waiting and seeing?

好的，這很有幫助。接著再問一個關於 DTC 的問題，然後我就回到排隊。有沒有什麼方式可以理解你們迄今在 DTC 上投入了多少，以及你們如何看待這項投資的回報？還有，你知道，你們是打算擴大規模，還是先觀望？

We are certainly going to run it through the first two quarters of this year and then we will go back and analyze the returns on that. We obviously know how much we've spent. We also know how much we've increased the leads that we've generated through our digital media, and the increase has been absolutely wonderful. We're very pleased with that.

我們當然會在今年前兩個季度持續執行，之後再回頭分析其回報。我們當然知道自己花了多少。我們也知道透過數位媒體所產生的潛在客戶（leads）增加了多少，而這個增幅非常出色。我們對此非常滿意。

So at the end of probably about a nine-month period, we'll step back and analyze and decide where we go from here. But so far, the results have been great.

所以在大概九個月的期間結束時，我們會退一步做分析，並決定接下來怎麼走。但到目前為止，結果非常好。

Okay, great. Thanks for taking the questions, guys.

好的，很棒。謝謝各位回答問題。

Anthony Petrone, Jefferies.

Anthony Petrone，Jefferies。

Thanks. Maybe just a quick follow-up on the OUS reimbursement. Would you expect stocking orders ahead in anticipation, say, of a reimbursement approval in Germany, UK, and France? And then a couple of follow-ups.

謝謝。也許快速追問一下海外（OUS）的給付。你們是否預期會在例如德國、英國、法國的給付核准之前，先出現為了預期核准而提前下的備貨訂單？然後我還有幾個追問。

No, we don't intend to do that.

不，我們不打算那樣做。

Great. And then maybe just looking ahead to Android. Maybe walk us through sort of timing on that. I think it's a 2016 event and considering that there are multiple Android manufacturers. I mean, how significant is a G5 Android launch when you consider that it will open up -- it opens additional channels on the iPhone?

了解。接著也許談談 Android 的展望。能否帶我們走一下大概的時程？我想這會是 2016 年的事件，而且考量到 Android 製造商很多。我的意思是，當你考慮到它會開啟——它在 iPhone 之外開啟更多通路時，G5 的 Android 上線有多重要？

Android is certainly an important -- I mean, I'm an Android user myself. Android is certainly important to us. The question is really one of once we file, how long does the FDA take to review. We think even with our anticipated filing timeline that it is certainly plausible that it will be a 2016 launch.

Android 當然很重要——我是說，我自己也是 Android 使用者。Android 對我們確實很重要。真正的問題在於我們一旦送件後，FDA 需要多久時間審查。我們認為即使以我們預期的送件時程來看，2016 年上市當然是有可能的。

You know, in terms of numbers of patients, it's actually interesting. We know today -- and frankly, we've talked long and hard about the price of CGM and where we think pricing needs to go over the long haul. We find that the vast majority of our users today, the vast majority of hits we get on our website and otherwise, are from iOS users.

你知道，就病患數量而言其實很有意思。我們今天知道——坦白說，我們也長時間深入討論過 CGM 的價格，以及我們認為長期而言定價需要走向哪裡。我們發現目前我們的使用者絕大多數、我們網站以及其他管道收到的絕大多數點擊，都是來自 iOS 使用者。

So while we know Android is important, we know that iOS is and will remain to be much more important in terms of a platform. It's also a much more stable platform. It's a much more locked-down platform, so it's certainly easier for us to deal with that platform out of the gate before we go to Android.

所以雖然我們知道 Android 很重要，但我們也知道 iOS 在平台的重要性上更高，而且未來仍會更重要。它也是一個更穩定的平台。它的封閉性更高，因此對我們來說，在一開始先處理這個平台、再轉向 Android，確實更容易。

Yes. All that being said, we will have to pick some phones to talk to. We cannot possibly talk to all of them. And I think when we offer the Android platform, I think it will be a tremendous benefit to our patients because I have gotten a few not-so-happy letters from patients saying I would love to use your system, but I'm not ever going to do it until you get me an Android phone.

是的。話雖如此，我們必須挑選一些手機來進行連線。我們不可能跟所有機型都對接。而且我認為當我們提供 Android 平台時，對病患會是很大的好處，因為我收到過幾封不太高興的病患來信，說他們很想用我們的系統，但在我們讓它支援 Android 手機之前，他們永遠不會用。

So I think it will be a great benefit in another -- you know, when you grow at the rates we grow at, every positive event is just a catalyst that helps you continue to perform. And I think this will fall right into that bucket.

所以我認為這會帶來很大的助益；另外——你知道，當你以我們這樣的成長速度在成長時，每一個正面事件都只是推動你持續表現的催化劑。我想這也會正好落在那一類。

Maybe just a quick one there would be, I mean, I would assume maybe Samsung would be the direction? And are you sort of working with manufacturers at this point or is that just something that you'll decide later on down the road?

也許在這裡快速問一下，我的意思是，我猜可能會朝 Samsung 的方向？你們目前有在和製造商合作嗎，還是這只是你們之後才會再做決定的事情？

We've certainly worked and talked with several Android manufacturers to learn the intricate parts of those phones. I can tell you they are all not the same, even though they all run the Android operating system. We've learned that their interaction with the Bluetooth LE interface may differ a bit from phone to phone.

我們確實已經與幾家 Android 製造商合作並交流，以了解那些手機的細節。我可以告訴你，它們並不都一樣，即使它們都跑 Android 作業系統。我們也了解到，它們與 Bluetooth LE 介面的互動，可能會因手機而略有不同。

And that's one of the reasons we've taken so long to get this app filed. We want to make sure it works consistently across the board over those platforms which we choose to support.

而這也是我們花了這麼久才把這個 App 送件的原因之一。我們想確保在我們選擇支援的那些平台上，它能夠一致且穩定地運作。

Great, thanks.

很好，謝謝。

(Operator Instructions) Erik Shoger, Northcoast Research.

（接線員指示）Erik Shoger，Northcoast Research。

Just wanted to ask a question about the -- piggyback on some of the OUS questions. I guess you said there won't be any real stocking orders that you'll see, but what sort of ramp would you expect once you do get approval in a country like Germany or France or the UK? I mean, seemingly there's a lot of pent-up demand there. How would you expect that to progress?

我想問一個問題，算是延伸一些海外（OUS）問題。我想你剛才說不會看到任何真正的備貨訂單，但一旦你們在像德國、法國或英國這樣的國家拿到核准後，你們預期會出現什麼樣的爬坡（ramp）？我的意思是，那裡看起來有很多被壓抑的需求。你們預期會如何發展？

We're not going to speculate. We're not going to speculate on that at this time. It still remains to be seen how broad is the reimbursement when we get the language, what's the pricing look like. There's a whole bunch of factors that we are still not fully aware of. So we're not going to speculate at this point.

我們不會做推測。我們目前不會對此做推測。等我們拿到文字內容後，給付範圍到底有多廣、定價看起來如何，仍有待觀察。還有一大堆因素我們仍未完全掌握。所以我們此刻不會推測。

You know, Erik, and I'll go back to what we said back in the pediatric days. Everybody said what kind of boost are we going to see from pediatrics? Obviously, we've gotten a boost because we've been growing above our projected rates of 35% to 40%. But in all reality, you've got to get things like this to continue to grow a business the way that we are. So it just kind of falls into line. And we expect it, we've planned for it, and we'll deal with it.

你知道，Erik，我會回到我們在兒科那段時間說過的話。大家都問兒科會帶來多大的推升？很顯然，我們確實得到了一些推升，因為我們的成長率高於我們原先預估的 35% 到 40%。但實際上，你必須要有這類事情，才能讓企業持續以我們目前的方式成長。所以它就是順勢而為、符合整體脈絡。我們預期會發生、也已經為此做了規劃，並且會去因應。

Okay. I guess that kind of leads to my other question is as it relates to the guidance, I mean, obviously like you said, you need things like this to continue to grow at the rate you have. Does your current guidance as it stands now must not assume much changes internationally?

好的。我想這也引出我另一個問題，關於財測（guidance）。我的意思是，正如你所說，你需要這類事情才能以你們目前的速度持續成長。你們目前的財測在現階段看起來，應該沒有假設國際市場會有太多變化吧？

We are not going to comment on our guidance. Our guidance is $540 million to $565 million and we'll stick with that.

我們不會評論我們的財測。我們的財測是 5.40 億美元到 5.65 億美元，我們會維持這個說法。

Okay. Maybe one last one as it relates to the AACE consensus statements. I think a big part of their requests from the industry was better data on economic benefits of CGM. And I think -- correct me if I'm wrong -- the DIaMonD study that you're working on will have -- provide some nice data there? Is there anything else that you're working on that might address those data requests?

好的。最後再問一個，關於 AACE 的共識聲明。我想他們對產業的一大部分要求，是要有更多關於 CGM 經濟效益的更好數據。而且我想——如果我沒記錯——你們正在進行的 DIaMonD 研究會有——會提供一些很好的數據？你們還有在做其他事情，可能可以回應那些數據需求嗎？

The DIaMonD study is our biggest data requests that we have coming up. We should have data from that study available in the second half of 2016 to help drive this message. And that will be good for us. There's also a very large study in Sweden going on using CGM and we should very good data on those patients as well.

DIaMonD 研究是我們即將面臨的最大資料需求之一。我們應該能在 2016 年下半年取得該研究的資料，以協助推動這項訊息。這對我們會很有利。另外，瑞典也正在進行一項使用 CGM 的非常大型研究，我們也應該能取得那些患者非常好的資料。

So we'll have some CGM cost data out with those two studies. I think all medical devices are going to have to fall into this category more than we have in the past to justify our existence. And the beauty of ours is we know that we win. We absolutely know that you're going to save money if you use CGM. Just avoiding one hypoglycemic event where you're hospitalized saves the system $15,000 to $20,000. And for a number of our patients, those events happen frequently.

因此，透過這兩項研究，我們將會有一些 CGM 的成本資料出爐。我認為所有醫療器材都將比過去更需要落入這個範疇，來證明我們存在的正當性。而我們的優勢在於，我們知道自己會勝出。我們非常確定，只要使用 CGM 就能省錢。僅僅避免一次需要住院的低血糖事件，就能為體系節省 15,000 到 20,000 美元。而對我們的一些患者而言，這類事件發生得相當頻繁。

And then obviously, the A1C reduction and the reduction of complications, which is tougher to measure because it takes a longer period of time. But all those things happen. So we are very confident we can build a very good cost-effective case with CGM.

然後很明顯地，A1C 的降低以及併發症的減少——這比較難衡量，因為需要更長的時間。但這些事情都會發生。因此，我們非常有信心能用 CGM 建立一個非常好的成本效益論證。

Okay. I'll agree with you there. Thanks, guys.

好的。我同意你的看法。謝謝，各位。

Jeff Johnson, Robert W Baird.

Jeff Johnson，Robert W Baird。

So Kevin, maybe I could follow up on that DIaMonD comment you just made there. Any evolution in the way you're thinking about kind of CGM first? It seems like some of that cost data is even suggesting CGM cost savings bigger, even when it's paired with just MDI over pumping. So just any updated thoughts there?

Kevin，我想就你剛才提到的 DIaMonD 再追問一下。你們對於「CGM 優先」這種思路有沒有任何演進？看起來有些成本資料甚至顯示，即使只搭配 MDI（多次每日注射）而不是搭配胰島素幫浦，CGM 的成本節省更大。所以想聽聽你們是否有更新的想法？

Well, both CGM and insulin pumps add cost to the system. Anything you add for treatment adds cost. What we believe we can show in the DIaMonD study is those patients who are multiple daily injections can achieve very good results with their multiple daily injections and using the CGM.

嗯，CGM 和胰島素幫浦都會增加體系成本。你在治療上增加任何東西都會增加成本。我們相信在 DIaMonD 研究中可以證明：那些採用多次每日注射的患者，透過多次每日注射並使用 CGM，也能達到非常好的結果。

Then we go to the additional benefit and additional cost savings if we had a new insulin delivery methodology to the system. And look, we're all going to be fighting for dollars over time in reimbursement. We want to be the first choice. We want to position CGM to be the first thing that the physicians pick and the payers pick to intensively manage people who are using intensive insulin therapy.

接著，如果我們為體系引入新的胰島素輸送方式，就會帶來額外效益與額外的成本節省。而且坦白說，隨著時間推移，在給付上我們都會為了資金而競爭。我們希望成為第一選擇。我們希望把 CGM 定位成醫師與支付方在強化管理使用強化胰島素治療的人群時，會優先選擇的第一項工具。

Because we believe it's most important. It's most important that they know their glucose values. And then whatever they choose to do after that certainly will be a function of payers, clinicians, and everybody else. But it's our job to position CGM first. And we believe it is the most important tool.

因為我們相信它最重要。最重要的是讓他們知道自己的葡萄糖數值。之後他們要選擇做什麼，當然會取決於支付方、臨床醫師以及其他所有人。但把 CGM 放在第一位是我們的工作。而我們相信它是最重要的工具。

Yes, understood. That's helpful; thank you. And then Steve, maybe a question for you or for Jess just on the gross margin guidance for 2016. Any kind of gating comments you can make? You know, I know obviously the revenue lower in the first half versus the second half will influence that a little bit. You're talking about some higher tech support in that. Should we think about gross margins ramping throughout the year? Is that the best way to set up our models here as we go forward?

是的，了解。這很有幫助，謝謝。接著 Steve，我想問你或 Jess 一個關於 2016 年毛利率指引的問題。你們能否提供一些關鍵限制因素（gating）的說明？我知道很明顯上半年營收低於下半年會對此有些影響。你們也提到會有較高的技術支援成本。我們是否應該預期毛利率會在全年逐步走升？這是否是我們接下來建立模型時最好的假設方式？

Yes, that's fair. I mean, Q1 is just going to be sequentially down because of lower revenues, right? That's the biggest gating factor in Q1. And then, again, as we ramp Gen 5 over the year, you're going to see a little bit of pressure on the overall gross margin because the gross margin on the G5 we are shipping two transmitters effectively for the price of one versus G4. So you'll see a little pressure there.

是的，這樣理解合理。我的意思是，第一季會因為營收較低而呈現季比下滑，對吧？這是第一季最大的關鍵限制因素。然後同樣地，隨著我們在全年推升第 5 代（Gen 5），你會看到整體毛利率有一點壓力，因為我們出貨 G5 時，實際上是以一個的價格出兩個發射器，相較於 G4。所以你會看到那裡有些許壓力。

And then there'll be some costs that roll into COGS with respect to the new expanded manufacturing facility that could have a little bit of an impact. But anyways, we're not talking -- we've guided 67% to 70%. We're not going to see a -- there's not a meaningful impact.

另外，與新擴建製造設施相關的一些成本會轉入銷貨成本（COGS），可能也會有一點影響。但不管怎樣，我們的指引是 67% 到 70%。我們不會看到——不會有顯著的影響。

Not meaningful variations throughout the year? You think quarter by quarter, we should be kind of plus or minus?

所以全年各季之間不會有顯著波動？你認為按季來看，我們大概就是上下小幅波動？

Yes, with the caveat that Q1 will be a little down.

是的，但要補充一點：第一季會稍微偏低。

Exactly. All right, thanks, guys.

沒錯。好，謝謝各位。

We have no further questions at this time. I'd like to turn the call over back to Mr. Kevin Sayer for closing remarks.

目前沒有進一步的問題。我想把電話會議交回給 Kevin Sayer 先生作結語。

Thank you very much and we appreciate everybody's participation today. Reflecting back, 2015 was really an amazing year for this Company. The things that we've done, the advances we've made in technology, in connectivity and reimbursement, in moving to the pharmacy, and our partnership with Verily are going to shape the future the future of the diabetes industry for a very, very long time. And our future could not be brighter.

非常感謝，也感謝大家今天的參與。回顧來看，2015 年對本公司而言確實是令人驚豔的一年。我們所做的事情、在技術、連結性與給付方面的進展、轉向藥局通路，以及我們與 Verily 的合作夥伴關係，將在非常、非常長的時間內塑造糖尿病產業的未來。而我們的前景再光明不過。

I got a recent note from a patient and he wrote and he said that first of all, he said I can't imagine as a parent how any child could be managed without this system. And he said you have turned the treatment of my son's diabetes from my worst nightmare to simply an annoying headache.

我最近收到一位患者的留言，他寫道，首先他說，身為父母，我無法想像沒有這套系統要如何管理任何孩子的病情。他說，你們把我兒子的糖尿病治療，從我最可怕的夢魘，變成只是惱人的頭痛。

Now while we're happy that we could move him out of the nightmare category, annoying headache just isn't good enough. We're going to get rid of the headache, too, and we're going to make people's life better and continue to grow the business. Thanks, everybody, and have a great week.

現在，雖然我們很高興能把他從夢魘那一類移出來，但「惱人的頭痛」仍然不夠好。我們也會把頭痛一併消除，讓人們的生活變得更好，並持續成長業務。謝謝大家，祝各位本週愉快。

Thank you, ladies and gentlemen. This concludes today's conference. 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。