德康醫療 (DXCM) 2017 Q1 法說會逐字稿

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  • Operator

    Operator

  • Welcome to the DexCom First Quarter 2017 Earnings Release Conference Call. My name is Danielle, and I will be your operator for today's call. (Operator Instructions) Please note that this conference is being recorded.

    歡迎參加 DexCom 2017 年第一季財報發布電話會議。我叫 Danielle,將擔任今天電話會議的接線員。(接線員指示) 請注意,本次會議將被錄音。

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

    我現在把電話交給 Kevin Sayer。Sayer 先生,您可以開始了。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you, Danielle, and welcome, everyone, to DexCom's First Quarter 2017 Earnings Call. We'll start with our safe harbor statement from Steve Pacelli.

    謝謝你,Danielle,也歡迎各位參加 DexCom 2017 年第一季財報電話會議。我們先請 Steve Pacelli 宣讀我們的安全港聲明。

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Thanks, Kevin. Some of the statements that 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. All forward-looking statements included in this presentation are made as of the date thereof based on information currently available to DexCom and are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. 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, quarterly reports 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. Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our cash-based operating results. 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. Kevin?

    謝謝你,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、策略、競爭、產品、營運計畫與績效的意圖、信念與預期。本簡報中所包含的所有前瞻性陳述,均於其作成之日基於 DexCom 目前可得資訊而作出,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。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有重大差異的因素,已詳載於 DexCom 的 Form 10-K 年度報告、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。此外,在本次電話會議中,我們將就以現金為基礎的營運結果,討論若干未依 GAAP 編製的財務衡量指標。此額外資訊之呈現不應被單獨考量,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 R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you, Steve. Joining me today are Steve Pacelli, our Executive Vice President of Strategy and Corporate Development; and Kevin Sun, our Vice President of Finance and Interim CFO.

    謝謝你,Steve。今天與我一同出席的有:Steve Pacelli,我們的策略與企業發展執行副總裁;以及 Kevin Sun,我們的財務副總裁兼代理財務長。

  • Before Steve dives into a more detailed financial update, let me highlight a number of recent positive developments here at DexCom since our last call only 2 months ago. First, in terms of our sales performance, the quarter came in consistent with our expectations with revenue growing 22% over the first quarter in 2016. Our CGM-first message continues to resonate. Again, in Q1 of this year, new multiple daily injections or MDI patients drove our growth and represented the majority of our new U.S. patient additions estimated at just above 2/3 of our new patients for the quarter. Second, as we discussed in our last call, we received a nonadjunctive indication from the Food and Drug Administration near the end of 2016, making DexCom G5 Mobile the only CGM system approved for therapeutic decision-making. Shortly after FDA decision, Medicare issued a positive ruling for therapeutic CGM. And then late in Q1, we received additional coverage details from the regional MACs confirming that all people with diabetes on intensive insulin therapy will be covered under this ruling. This includes people with type 1 and type 2 diabetes. We have always believed that all intensively managed patients should have access to CGM regardless of age, and we hope to leverage the Medicare coverage criteria to our commercial relationships. So far, patient interest has been outstanding. We currently have over 10,000 prospective new Medicare patient opportunities in our pipeline, and this is before we have even started promoting Medicare availability. We commend CMS on this decision. And while we are still early in establishing the framework to serve these patients in a streamlined manner, we are excited to begin rolling this out to seniors who, we believe, will benefit tremendously from this technology. I will provide more on the timing later.

    在 Steve 進一步深入說明更詳細的財務更新之前,我先強調自上次電話會議(僅 2 個月前)以來,DexCom 近期出現的幾項正面進展。首先,就銷售表現而言,本季結果符合我們的預期,營收較 2016 年第一季成長 22%。我們「CGM 優先」的訊息持續引起共鳴。同樣地,在今年第一季,新增的每日多次注射(MDI)患者帶動了我們的成長,並占我們美國新增患者的大多數;估計本季新增患者中略高於 2/3 來自此類患者。第二,如同我們在上次電話會議中所提到的,我們在 2016 年底接近年末時,獲得美國食品藥物管理局(FDA)核准的「非輔助(nonadjunctive)」適應症,使 DexCom G5 Mobile 成為唯一獲准可用於治療決策的 CGM 系統。在 FDA 作出決定後不久,Medicare 也就治療性 CGM 作出正面裁定。而在第一季末,我們從各地區的 MAC 取得更多給付細節,確認所有採用強化胰島素治療的糖尿病患者都將在此裁定下獲得給付。這包括第 1 型與第 2 型糖尿病患者。我們一直相信,所有接受密集管理的患者不應因年齡而受限,都應能使用 CGM;我們也希望運用 Medicare 的給付標準,推動我們與商業保險夥伴的合作關係。截至目前,患者的興趣非常熱烈。目前在我們的管線中,已有超過 10,000 名潛在的新 Medicare 患者機會,而這還是在我們尚未開始宣傳 Medicare 可用性之前。我們對 CMS 的此項決定表示肯定。雖然我們仍處於建立架構、以更精簡方式服務這些患者的早期階段,但我們很期待開始向高齡族群推廣;我們相信他們將能從這項技術中獲得極大助益。我稍後會就時程提供更多說明。

  • And finally, we are beginning to see good initial uptick in Germany following our positive reimbursement decision there last year. Although we are still early in the adoption curve, Germany helped fuel 37% OUS growth in Q1.

    最後,在去年於德國取得正面給付決定後,我們開始看到德國市場出現良好的初步成長動能。雖然我們仍處於採用曲線的早期階段,但德國在第一季推動了我們美國以外(OUS)業務 37% 的成長。

  • With that, I will now turn the call over to Steve for a review of our financials, after which I will expand on these accomplishments and provide a general business update. Steve?

    接下來,我把電話交給 Steve,請他回顧我們的財務表現;之後我將進一步說明這些成果,並提供整體業務更新。Steve?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Thanks, Kevin. DexCom reported revenue of $142 million for the first quarter of 2017 compared to $116 million for the same quarter in 2016, a $26 million or 22% increase. Sequentially, revenue for Q1 was down approximately 17%. This reflects the seasonality we have experienced in the past several years as our U.S. patients faced resetting insurance deductibles at the beginning of the calendar year. In addition, because of the January CMS ruling, we are prohibited by law from balance billing our existing cash pay Medicare-eligible patients, which we estimate accounted for approximately $2 million to $3 million of loss sales during the quarter. As Kevin mentioned, there is a lot of excitement around the CMS ruling, and our sales channel is experiencing a significant amount of noise in the field, which has not yet translated into revenue.

    謝謝你,Kevin。DexCom 2017 年第一季營收為 1.42 億美元,較 2016 年同期的 1.16 億美元增加 2,600 萬美元,增幅 22%。若以季比來看,第一季營收約下降 17%。這反映了過去數年我們所經歷的季節性因素,因為美國患者在曆年年初面臨保險自付額(deductibles)重置。此外,由於 1 月的 CMS 裁定,我們依法不得再向既有的自費、且符合 Medicare 資格的患者進行差額收費(balance billing);我們估計這在本季造成約 200 萬至 300 萬美元的銷售流失。如 Kevin 所提到的,市場對 CMS 裁定非常振奮,而我們的銷售通路在前線出現大量雜訊,但尚未轉化為營收。

  • During Q1, we also saw a good uptick in our international business. This led to a slightly lower global sensor ASP due to a greater mix of distributor revenue outside of the U.S.

    在第一季期間,我們也看到國際業務出現良好的成長動能。由於美國以外的經銷商營收占比提高,導致全球感測器平均銷售單價(ASP)略為下降。

  • Finally, we saw a new weaker -- weaker new patient additions from our pump partners, which Kevin will touch on later. Our first quarter gross profit was $94 million, generating a gross margin of 66% compared to a gross profit of $75 million and a gross margin of 65% for the same quarter in the prior year. Our gross margin came in slightly below our anticipated range for the quarter due to a few factors. Obviously, gross margin was impacted by seasonally lower first quarter sales and slightly lower sensor ASPs. Our hardware sales mix continues to shift towards our G5 mobile transmitter, which has a shorter useful life and a lower ASP. And our warranty expense rate has stabilized, but continues to run above historical levels, exceeding 3% in Q1.

    最後,我們也看到來自胰島素幫浦合作夥伴的新患者導入較弱——新增患者數較為疲弱,Kevin 稍後會再談到。我們第一季毛利為 9,400 萬美元,毛利率 66%;相較之下,去年同期毛利為 7,500 萬美元、毛利率 65%。由於幾項因素,本季毛利率略低於我們原先預期的區間。顯然,毛利率受到第一季季節性較低的銷售量以及感測器 ASP 略降的影響。我們的硬體銷售組合持續轉向 G5 mobile 發射器,其可使用壽命較短且 ASP 較低。此外,我們的保固費用率已趨於穩定,但仍高於歷史水準,第一季超過 3%。

  • Some final thoughts on our revenues and our gross profit. Our mix between durable and consumable products was within our normal historical range in Q1 at approximately 30% durable and 70% consumable. The ASP for our hardware has remained stable, and average sensor pricing came in slightly below $70, again, due to geographic and distribution channel mix. Finally, our international business showed continued year-over-year growth, generating $26 million in revenue during the quarter, up 37% from last year and 24% sequentially. This represents 18% of our total revenue. Research and development expense totaled $48 million for Q1 of 2017 compared to $32 million in Q1 of 2016 and up approximately 10% sequentially. Our key R&D investments continued to make good progress. These include the G6 pivotal study and related submissions with the FDA as well as our advanced product pipeline, investments in our Verily partnership and a build-out of our data platform.

    最後補充幾點關於我們的營收與毛利。第一季耐用型與耗材型產品的組合落在我們正常的歷史區間內,約為 30% 耐用型、70% 耗材型。我們硬體的 ASP 維持穩定,而感測器平均定價略低於 70 美元,同樣是因地理區域與通路組合所致。最後,我們的國際業務持續呈現年增成長,本季營收為 2,600 萬美元,較去年成長 37%,季比成長 24%。這占我們總營收的 18%。2017 年第一季研發費用合計 4,800 萬美元,相較 2016 年第一季的 3,200 萬美元增加,且季比約成長 10%。我們的主要研發投資持續取得良好進展。其中包括 G6 關鍵性試驗(pivotal study)及其向 FDA 提交的相關申請,以及我們的先進產品管線、對 Verily 合作夥伴關係的投資,以及資料平台的建置擴充。

  • Selling, general and administrative expense totaled $86 million in Q1 of 2017 compared to $62 million during the same quarter in 2016, with the increase primarily due to year-over-year increases in headcount in our field sales and customer support organizations, including support for the initial phase of the Medicare launch as well as a ramp in our patient-focused marketing expenses, higher IT costs in our OUS expansion. Our GAAP net loss was $42 million in the first quarter of 2017, which included $35 million in noncash expenses consisting primarily of noncash share-based compensation expense across all functional areas of our business. Consistent with our prior comments, the sequential increase in our first quarter operating expenses included approximately $9 million in annual share-vesting payroll tax expenses and onetime charges associated with retirements, severance and restructuring. However, total operating expenses came in slightly below our recent commentary, primarily due to the timing associated with new hires as well as our direct-to-consumer marketing campaign. Our GAAP loss per share for the quarter was $0.49. Absent noncash charges, non-GAAP cash-based net loss was $7 million for the quarter. We ended the first quarter with $181 million in cash and marketable securities on our balance sheet versus $124 million at the end of 2016. During the quarter, we drew $75 million from our credit facilities to support our cash needs, primarily to fund expenditures associated with the build-out of our manufacturing facility in Mesa, Arizona.

    2017 年第一季的銷售、一般及行政費用合計為 8,600 萬美元,較 2016 年同季的 6,200 萬美元增加;此增幅主要來自我們現場銷售與客戶支援組織的人力編制年增(包括支援 Medicare 上線初期階段),以及以病患為導向的行銷費用提升、海外(OUS)擴張帶來較高的 IT 成本。我們 2017 年第一季的 GAAP 淨損為 4,200 萬美元,其中包含 3,500 萬美元的非現金費用,主要為涵蓋本公司各職能領域的非現金股份基礎給付(股權激勵)補償費用。如同我們先前的評論,第一季營運費用的季增包含約 900 萬美元的年度股權歸屬薪資稅費用,以及與退休、資遣與重整相關的一次性費用。然而,總營運費用略低於我們近期的說法,主要由於新進人員到職時點以及我們直面消費者(DTC)的行銷活動時程所致。本季 GAAP 每股虧損為 0.49 美元。若排除非現金費用,非 GAAP、以現金為基礎的淨損為 700 萬美元。第一季結束時,我們資產負債表上的現金及有價證券為 1.81 億美元,較 2016 年底的 1.24 億美元增加。本季我們自信用額度提取 7,500 萬美元以支應現金需求,主要用於資助在亞利桑那州梅薩(Mesa)建置製造廠的相關支出。

  • With respect to 2017 guidance, we continue to expect global revenue of $710 million to $740 million, reflecting growth of approximately 25% to 30%. We remain encouraged by our early progress with Medicare and are beginning to work through the practical implementation of the CMS ruling in the field. We are very confident that Medicare will be an important component of our future business, and Kevin will provide more on our outlook in a moment. For the full year, we now anticipate gross margin to be at the low end of our guidance range of 67% to 70%, due to continued ongoing warranty expenses as we transition to our new receiver. And we continue to anticipate OpEx will increase 20% to 25% versus 2016 on a GAAP basis.

    就 2017 年財測指引而言,我們仍預期全球營收為 7.10 億至 7.40 億美元,反映約 25% 至 30% 的成長。我們對 Medicare 的早期進展仍感到鼓舞,並開始在第一線推進 CMS 裁定的實務落地。我們非常有信心 Medicare 將成為未來業務的重要組成部分,Kevin 稍後會進一步說明我們的展望。就全年而言,由於在轉換至新接收器(receiver)的過程中仍持續發生保固費用,我們目前預期毛利率將落在 67% 至 70% 指引區間的低端。此外,我們仍預期在 GAAP 基礎下,營運費用(OpEx)將較 2016 年增加 20% 至 25%。

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

    接下來,我把電話交回給 Kevin,請他提供業務更新。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you, Steve. Life at DexCom continues to be very exciting. The company achieved multiple historical milestones in the past several months, and now it's time for us to execute on them. Following our nonadjunctive claim late last year and the CMS ruling in Q1, our pipeline is at an all-time high. We are proud that the DexCom G5 Mobile is the first and currently the only CGM system to be classified as therapeutic CGM. We continue to believe these accomplishments are a direct result of the strength of our CGM platform, both in clinical trials and in the real world.

    謝謝你,Steve。DexCom 的近況依然令人振奮。公司在過去幾個月達成多項歷史性里程碑,現在是我們落實執行的時候了。在去年底取得非輔助用藥(nonadjunctive)主張以及第一季 CMS 裁定之後,我們的產品/專案管線達到歷史新高。我們很自豪 DexCom G5 Mobile 是第一個、且目前唯一被歸類為治療性 CGM(therapeutic CGM)的連續血糖監測系統。我們持續相信,這些成就直接反映了我們 CGM 平台的實力,無論在臨床試驗或真實世界使用情境皆然。

  • In the U.S., our recently expanded sales force is ramping up and will be critical in supporting our preliminary launch into the Medicare market later this year. Our worldwide new patient additions met our internal projections. As I mentioned earlier, the estimated mix of our new MDI patients in the U.S. is now consistent with the underlying type 1 market. However, we have experienced softness in the growth of our new pump patient additions. As you are most likely aware, our 2 commercial pump partners have encountered difficulties in recent quarters driven by a variety of factors. However, we see several highly competitive DexCom-enabled insulin delivery systems, both on the near- and long-term horizons that will provide attractive options for the diabetes community.

    在美國,我們近期擴編的銷售團隊正逐步到位並加速發揮效能,對於支援我們今年稍晚在 Medicare 市場的初步上市將至關重要。我們全球新增病患數符合內部預期。如我先前提到的,我們在美國新增的 MDI 病患估計占比,現已與第一型糖尿病市場的基本結構一致。然而,我們在新增胰島素幫浦(pump)病患的成長方面出現疲弱。如各位多半所知,我們的兩家商業幫浦合作夥伴在近幾季因多項因素而遭遇困難。不過,我們看到多款具高度競爭力、可整合 DexCom 的胰島素輸送系統,無論在近期或長期都將陸續推出,為糖尿病社群提供具吸引力的選擇。

  • Outside the U.S., our year-over-year growth accelerated from fourth quarter levels buoyed by the broader reimbursement in Germany, efforts on our 2 other direct markets, the U.K. and Canada, and increased volumes throughout the European distribution channel.

    在美國以外市場,我們的年增成長率較第四季水準加速,主要受惠於德國更廣泛的給付(reimbursement)、我們在另外兩個直營市場(英國與加拿大)的推進,以及歐洲經銷通路整體出貨量提升。

  • Turning to Medicare. Nothing in this process has gone according to the standard plan. A CMS administrator's ruling is incredibly rare. And the timing of that ruling was completely unanticipated by us. Medicare certainly got this right for patients as this ruling should ultimately accelerate access to the eligible population. However, the joint article recently issued by the DME MAC is something that is typically issued simultaneously with or after a coverage decision has been published. So while the joint article provided guidance enabling patients to access this technology, the formal absence of a coverage decision makes it very challenging to process claims in an efficient manner and not to take significant regulatory and financial risk by shipping to these patients. Hence, the confusion and the delays. At this point, we are pulling every lever we have at our disposal and are speaking to Medicare regularly. It is also important to note that the change of administration and the stricter stance on new regulation can cause challenges. We hope to resolve this as soon as possible. Longer term, Medicare represents one of DexCom's biggest opportunities in the intensive market. We estimate that Medicare age type 1 population represents 20% of the overall type 1 market or as many as 300,000 patients in the U.S. We also estimate that type 2 Medicare age patients on intensive insulin therapy represent approximately 1/3 of the intensive type 2 population or approximately 500,000 patients in the U.S. Again, we have over 10,000 Medicare eligible patients in our pipeline, and we really haven't done any promotions yet. In the past year, we have certainly made dramatic progress on the reimbursement and access front. To put things in perspective, with positive coverage decisions from both Medicare and Germany's GBA, we estimate that we now have an incremental of 1.3 million covered lives to target with our technology. This roughly doubles the number of covered lives we had entering 2016. Globally, our goal remains to continue to drive CGM towards the standard of care for diabetes management, and we maintain our goal of achieving or exceeding an installed base of approximately 270,000 patients worldwide by the end of 2017.

    接著談 Medicare。這個流程沒有任何一件事是依照標準計畫進行的。CMS 管理員的裁定極為罕見。而該裁定的時點對我們而言完全出乎意料。就病患而言,Medicare 這次確實做對了,因為此裁定最終應可加速符合資格族群的取得管道。然而,DME MAC 近期發布的聯合文章,通常會在保障(coverage)決定公布時同步發布或於其後發布。因此,儘管該聯合文章提供了讓病患得以取得此技術的指引,但在正式缺乏保障決定的情況下,要以有效率的方式處理理賠(claims)非常困難,且若將產品出貨給這些病患,將承擔重大的法規與財務風險。因此才會出現混亂與延遲。目前我們正動用一切可用手段,並定期與 Medicare 溝通。同時也必須注意,政府換屆以及對新法規採取更嚴格立場,可能帶來挑戰。我們希望能儘快解決此事。從長期來看,Medicare 是 DexCom 在重度(intensive)市場中最大的機會之一。我們估計,Medicare 年齡層的第一型糖尿病人口約占整體第一型市場的 20%,或在美國多達 30 萬名病患。我們也估計,採用密集胰島素治療的第二型 Medicare 年齡層病患,約占重度第二型人口的三分之一,或在美國約 50 萬名病患。此外,我們的管線中已有超過 10,000 名符合 Medicare 資格的病患,而我們其實尚未進行任何促銷活動。在過去一年,我們在給付與可近性(access)方面確實取得顯著進展。為了讓各位更有概念,隨著 Medicare 與德國 GBA 皆做出正向保障決定,我們估計目前新增可由我們技術觸及的受保障人數(covered lives)達 130 萬。這大致使我們在 2016 年初所擁有的受保障人數翻倍。在全球範圍內,我們的目標仍是持續推動 CGM 成為糖尿病管理的標準照護(standard of care),並維持在 2017 年底前達成或超越全球約 270,000 名裝機用戶(installed base)的目標。

  • Now I'll provide you with an update on our pipeline -- our product pipeline. With respect to our product pipeline, we continue to have regular interactions with the FDA. We have received approval for our new more reliable touchscreen receiver, and we will begin transitioning new patients later this year. Our discussions on the submissions surrounding our new insertion system and corresponding transmitter are ongoing. As we mentioned on our last call, we are evaluating the implications of this filing on our commercial time lines. Considering the magnitude of launching a new applicator, coupled with our G5 platform, making -- G6 platform, making very good progress. We will assess the timing and a potential launch of the new insertion with that of G6 as we move through the year. On the app front, we hope to launch our Android platform in the U.S. by midyear. The majority of our G6 pivotal trial has concluded, and our goal remains to file the G6 PMA by the end of Q3 2017, which would allow us to launch this product in 2018, assuming a positive review by the FDA. We have very high expectations for G6 based on its impressive early data. Assuming this performance continues, we expect patients would quickly appreciate what G6 means for standards and CGM performance even with a reduction in the number of daily calibrations. In addition, G6 represents the basis of our future no-calibration technology.

    現在我將向各位更新我們的產品管線進展。就我們的產品管線而言,我們持續與 FDA 保持定期互動。我們的新款、更可靠的觸控螢幕接收器已獲核准,並將於今年稍晚開始讓新病患逐步轉換使用。我們就新型插入系統及其對應發射器相關申報的討論仍在進行中。如同我們在上次電話會議中提到的,我們正在評估此項申報對我們商業化時程的影響。考量推出新型施用器的規模,再加上我們的 G5 平台——我是說 G6 平台——正取得非常良好的進展。隨著今年推進,我們將評估新插入系統的時點以及其與 G6 的潛在上市時程。在 App 方面,我們希望於年中前在美國推出 Android 平台。我們的 G6 關鍵性試驗大部分已完成,我們的目標仍是在 2017 年第 3 季底前提交 G6 的 PMA,若 FDA 審查結果正面,將可讓我們在 2018 年推出此產品。基於其令人印象深刻的早期數據,我們對 G6 抱持非常高的期待。若此表現得以延續,我們預期病患將很快體會到,即使每日校正次數減少,G6 對標準與 CGM 表現所代表的意義。此外,G6 也代表我們未來免校正技術的基礎。

  • Turning to our Verily partnership, our collaboration continues to march towards a continuous real-time low-cost, no-calibration disposable sensor system, allowing us to target the nonintensive type 2 market. In addition to the progress we are making in product development, we are beginning to explore a variety of commercial channels to support our nonintensive strategy. As we have said in the past, the business models we consider in the nonintensive market will likely differ from what we have pursued in our intensive business to date. These include a shift to value-based programs and working in collaboration with payers, providers and employers to develop diabetes management solutions that leverage CGM and our data platform to facilitate both therapeutic and behavioral change. Considering the importance and cost associated with the broader type 2 patient population and health care management today, these efforts are driving significant interest in solutions for this important category. The noise in the type 2 diabetes market is only getting louder. New drugs, new programs, all with different outcomes. It seems like we have a new answer every week. It is our belief that none of these offer the diabetes community as much value as CGM. More specifically, there is a tremendous void in the information provided to these patients to manage their condition. The system's answer today is to take a pill, eat less and exercise more. Patients have heard this for years and yet those ineffective treatments cost the system a fortune. The opportunity lies with an approach that cannot only provide better outcomes, but alleviate expenses. For the first time, accurately viable and intuitive CGM data will provide payers, providers and patients with real-time feedback about timing and efficacy of medications and how eating, sleeping and exercise can impact their diabetes. One of our early learnings is the CGM accuracy matters in the nonintensive market every bit as much as it matters in our intensive market. Many of these patients are truly interacting with their diabetes for the first time. And they must have confidence in the data and information they receive. Our early pilot studies in the nonintensive type 2 space have demonstrated this with reductions in average glucose as well as improvements in A1c, time and range and glycemic variability over a relatively short period of time. Once patients begin using CGM, they quickly understand the repercussions of their decisions around both medication and behavior. These benefits will ultimately drive significant cost reductions in the care of these patients. From a product development perspective, for these initiatives, we believe our first Verily device should be commercialized by the end of 2018 and anticipate that the second-generation device will be available in the 2020, '21 time frame.

    接著談我們與 Verily 的合作夥伴關係。我們的合作持續朝向連續、即時、低成本、免校正的一次性拋棄式感測器系統邁進,使我們得以鎖定非密集治療的第二型糖尿病市場。除了產品開發的進展之外,我們也開始探索多元的商業通路,以支持我們的非密集策略。如同過去所說,我們在非密集市場考量的商業模式,可能會不同於我們迄今在密集業務所採取的模式。其中包括轉向以價值為基礎的方案,並與支付方、醫療提供者及雇主合作,開發運用 CGM 與我們資料平台的糖尿病管理解決方案,以促進治療與行為的改變。鑑於當今更廣泛的第二型病患族群及醫療照護管理所涉及的重要性與成本,這些努力正引發市場對此重要類別解決方案的高度興趣。第二型糖尿病市場的喧囂只會愈來愈大。新藥、新方案,各自帶來不同的結果。似乎每週都有新的答案。我們相信,這些方案沒有任何一個能像 CGM 一樣為糖尿病社群帶來同等價值。更具體而言,這些病患在管理病況時所獲得的資訊存在巨大的缺口。目前體系給出的答案是:吃藥、少吃、多運動。病患多年來一直聽到這些建議,但這些無效的治療卻讓體系付出龐大代價。機會在於採取一種不僅能帶來更佳結果、也能降低支出的做法。首次,準確、可行且直覺的 CGM 數據將為支付方、醫療提供者與病患提供即時回饋,了解用藥時點與療效,以及飲食、睡眠與運動如何影響其糖尿病狀況。我們早期的學習之一是:在非密集市場,CGM 的準確度與在密集市場同樣重要。許多這類病患其實是第一次真正與自己的糖尿病互動。他們必須對所接收的數據與資訊有信心。我們在非密集第二型領域的早期試點研究已證明這一點:在相對短的時間內,平均血糖下降,且 A1c、達標時間(time in range)與血糖變異度均有所改善。一旦病患開始使用 CGM,他們很快就能理解自己在用藥與行為決策上的後果。這些效益最終將推動照護這些病患的成本大幅下降。從產品開發角度來看,針對這些計畫,我們相信第一款 Verily 裝置應可在 2018 年底前商業化,並預期第二代裝置將於 2020、2021 年的時間範圍內推出。

  • Turning to our partnerships. We are making continued progress in our integrations of both G5 and G6 with advanced insulin delivery systems, including pumps, smart pens and other interconnected diabetes management platforms. We will highlight more specific progress as these integrated systems approach clinical trials and commercial launch.

    接著談我們的合作夥伴關係。我們在將 G5 與 G6 整合至先進胰島素輸送系統方面持續取得進展,包括幫浦、智慧筆以及其他互聯式糖尿病管理平台。隨著這些整合系統接近臨床試驗與商業上市,我們將分享更具體的進展。

  • To sum things up, DexCom continues to raise the bar in the CGM category. In the near term, we remain focused on driving awareness around therapeutic CGM and our recent positive reimbursement developments, both with Medicare and in Germany. In parallel, we continue to develop our nonintensive strategy and are excited by the early signs of significant potential, both in terms of product development and revolutionary new business models. Execution on our strategic pipeline will position us to maintain our position as a leader in CGM. The DexCom team continues to perform in a very high level. I want to take a moment to thank our employees for their continued efforts. With all of the major milestones the company has achieved in the first past few years, we now have the ability in the mission to bring this life-changing technology to a much greater number of patients. I'd now like to open the call up for Q&A.

    總結來說,DexCom 持續在 CGM 類別中提高標準。短期內,我們仍專注於提升治療型 CGM 的認知度,以及我們近期在給付方面的正面進展,包括 Medicare 與德國市場。同時,我們持續推進非密集策略,並對早期顯示出的巨大潛力感到振奮,無論是在產品開發或革命性的新商業模式方面。對我們策略性管線的有效執行,將使我們得以維持在 CGM 領域的領導地位。DexCom 團隊持續以非常高的水準表現。我想藉此機會感謝員工持續的努力。隨著公司在過去幾年達成多項重大里程碑,我們如今具備能力與使命,將這項改變人生的技術帶給更多病患。接下來我想開放電話會議進入問答。

  • Operator

    Operator

  • (Operator Instructions) And we have our first question. Our first question comes from Mike Weinstein of JP Morgan.

    (接線員指示) 我們收到第一個問題。第一個問題來自摩根大通(JP Morgan)的 Mike Weinstein。

  • Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

    Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

  • Let me just start with the U.S. sales performance. So it sounds like the inability to deal with some of your cash-pay customers cost $2 million to $3 million. If I -- even if I adjust for that, it would seem the U.S. business was down 21% sequentially. The last 2 years, U.S. business was down 15% sequentially. So can you give us some additional commentary on just the U.S. revenue performance and then from there, I'd like to follow up with the commentary you made about that backlog of 10,000 Medicare patients. Can you just explain what that backlog is and how you're coming up with that number?

    我先從美國銷售表現談起。聽起來,無法處理部分自費客戶讓你們少了 200 萬到 300 萬美元。即使我把這部分調整回來,美國業務看起來仍較前一季下滑 21%。而在過去兩年,美國業務較前一季下滑 15%。所以你能否就美國營收表現再補充一些說明?接著,我也想追問你提到的那 10,000 名 Medicare 病患的積壓訂單。你能否解釋那個積壓是什麼,以及你們如何得出這個數字?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, I'll start with the backlog because that's very concrete. Once the coverage decision was announced, we certainly have criteria when the patient phones in or goes to our website for creating what we believe is a patient opportunity or patient lead. And these are patients who have met criteria who shown enough interest and have enough of the criteria within our system to be qualified as patient leads. So again, there are more than 10,000 Medicare patients in our system outside of the traditional patients that we have as well coming in through the field or coming in through our website and through the digital market space. So these are again patients who have reached out to us and expressed interest and have enough information to qualify as someone who is truly interested in CGM. With respect to the U.S. business and our growth year-over-year, I think one thing that's very important to remember is we were in the middle of the G5 Mobile launch last year. We launched it late in the first quarter, could not meet everybody's need -- in the fourth quarter -- didn't meet all the needs in the fourth quarter and allowed our carryover into the first. So it is a tough U.S. comparison quarter-over-quarter. With respect to our patient ads, again pretty much like we had discussed before Mike, the majority of our growth came from MDI patients, and we see the MDI patient base growing very quickly. Where we were down a bit, where we've been in previous years on the new patient side, was on insulin pumpers, and we have fewer of those than we've had in the past. With respect to reorders and patient behaviors, the other thing Steve talked about and I can elaborate a bit on as well, it's back to seasonality in the first quarter and possibly changing nature in our patient base. We had good reorders. Our patients called in and that wasn't a problem, but the bigger issue is deductibles and co-pays and particularly as we get into the MDI markets, our insulin pump patients spend a lot more money on insulin supply -- insulin pump supplies and their pumps, meaning deductibles faster than this new market in this group of patients that we're seeing. So we know that there is some financial pressure on these people. We have not seen anything that would indicate increased attrition. We have not seen anything that would increase -- that they would indicate decreased utilization on the sensor. It's -- first quarter is a tough seasonal one, and those are really pretty much everything around the revenue numbers in the U.S.

    好,我先從積壓訂單(backlog)談起,因為那非常具體。一旦給付覆蓋的決定公布後,當病患來電或到我們網站時,我們確實有一套標準,用來建立我們認為的病患機會或病患線索(patient lead)。而這些病患是已符合標準、展現足夠興趣,並且在我們系統中具備足夠條件、可被認定為合格病患線索的人。所以再說一次,在我們系統中,除了我們既有的傳統病患之外,還有超過10,000名Medicare病患,另外也有透過外勤團隊、我們網站以及數位市場管道進來的。因此,這些同樣是主動聯繫我們、表達興趣,且具備足夠資訊、可被認定為確實對CGM有高度興趣的病患。就美國業務以及我們的年對年成長而言,我認為有一點非常重要需要記住:去年我們正處於G5 Mobile上市的中期。我們在第一季末才推出,無法滿足所有人的需求——在第四季——第四季也沒有滿足所有需求,因而把部分需求遞延到第一季。所以,美國的季度對季度比較是很艱難的。就我們的病患新增(patient adds)而言,基本上如同我們之前和Mike討論過的,我們的大部分成長來自MDI病患,而且我們看到MDI病患基礎成長非常快。我們略為下滑、相較於過去幾年在新病患端較弱的地方,是胰島素幫浦使用者(insulin pumpers),我們的這類病患比過去少。至於再訂購(reorders)與病患行為,Steve提到的另一點我也可以再補充一些:這又回到第一季的季節性,以及我們病患基礎可能正在改變的特性。我們的再訂購表現不錯。病患來電訂購並不是問題,但更大的問題是自付額(deductibles)與自付費(co-pays),尤其當我們進入MDI市場時,我們的胰島素幫浦病患在胰島素耗材——胰島素幫浦耗材以及幫浦本體——上的支出更高,意味著他們更快就會達到自付額門檻;而我們現在看到的這個新市場病患族群則不同。所以我們知道這些人確實承受一些財務壓力。我們沒有看到任何跡象顯示流失率(attrition)增加。我們也沒有看到任何跡象顯示——會顯示感測器使用量下降。第一季本來就是一個季節性較艱難的季度,而以上幾乎就是美國營收數字周邊的所有因素。

  • Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

    Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

  • Okay. So you -- just to cover a few things. So you reiterated your projections for the year on new patient starts and where your installed base would end up, which was -- is just going back to the fourth quarter fall was basically your patient adds are going to be -- are going to exceed your revenue growth in 2017. Is that your pipeline is at an all-time high? And you're reiterating your sales guidance for the year. So 2 questions. One, can you give us some sense on the second quarter, how you're -- what's your visibility is today? And how you're thinking about the second quarter versus the balance of the year since, obviously, there is some disconnect between how The Street is modeling you guys and how you are thinking about it? And then, second, can you just talk about how your expectations may have shifted to the positive on Germany and that may be offsetting a little bit of incremental U.S. weakness with your pump partners?

    好的。所以你——我只是想涵蓋幾件事。你重申了今年在新病患啟用(new patient starts)以及你們裝機基礎(installed base)最終會到哪裡的預測;也就是回到第四季時你們的說法,基本上你們的病患新增將會——將會在2017年超過你們的營收成長。也就是說,你們的管線(pipeline)處於歷史新高?而且你們也重申了今年的銷售指引(sales guidance)。所以有兩個問題。第一,你能否就第二季給我們一些概念,今天你們的能見度(visibility)如何?以及你們如何看待第二季相對於今年其餘期間,因為很明顯,市場(The Street)對你們的模型推估與你們自己的看法之間存在一些落差?第二,你能否談談你們對德國的預期是否已正向上修,而這是否可能在一定程度上抵消你們與幫浦合作夥伴相關的美國端增量疲弱?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, Germany has been very successful for us. We have -- while we've grown quite a bit in Germany, it's still only about 20% of our total international revenue. So it's not as big as it can be. We have contracts in place with less than 20% of the payers. We're sitting in front of 2 of the largest ones with contracts that should be executed shortly. That would give us up to 50% of contracted reimbursement with the payers we have been contracted with. We can process those claims and get paid, but it's very much one-off and requires a lot of documentation. So Germany will provide us some significant growth opportunities going forward. With respect to our estimates for the year in our pump patients, there are a number of factors that we look out as we weigh this. Again, we have our Medicare situation. We have a robust pipeline of potential new patients to serve without promoting it. We -- once we got this, we're excited. We think we can add a number of new patients there. We think on the patient number front, that would offset some softness on the pump side and possibly more than offset any softness on the pump side where the Medicare model is a little bit different is the revenue we derive from a new patient when we add them. And if I can give you an illustration, you all know if we go back in time or if you look at a new patient, the initial transmitters and a receiver and 3 sensors, the hardware is between $800 to $900 and 3 boxes of sensors just for the sake of being simple. Let's say, they're $300 a piece or $75. So you've got $900 and you've got somewhere between $1,500 and $2,000 to start up a new patient. On the Medicare side, as you've all read the CMS rulings, we're not going to get that big of an upfront payment. We will be getting -- us or our distributors will be getting rental payments on the receiver over a 13-month period and the average payment per month on the disposable component would be somewhere between $250 and $300. So a new patient in that first quarter gives -- will bring in somewhere between $750 to $900. So even if we grow the patient base significantly past the 270,000, if a number of them are Medicare patients, it won't have the immediate pop that we've experienced in our commercial business in the past. As we look it out -- as we look at the opportunities and the number of patients who continue to request CGM, the number of new non-Medicare patients in our pipeline, we're comfortable with our guidance for the year, in spite of all the other diabetes news that is out there, and we plan on achieving those goals. And second quarter typically, for us, has been up over first. We certainly expect that it will be much better than the first quarter, and we'll see how it goes from there.

    嗯,德國對我們來說非常成功。我們——雖然我們在德國成長不少,但它仍只占我們國際總營收的大約20%。所以它還沒有大到它可以達到的規模。我們目前與不到20%的付款方(payers)簽有合約。我們正與其中兩家最大的付款方洽談,合約應該很快就會簽署執行。那將使我們在已簽約的付款方中,合約給付覆蓋比例提高到最多50%。我們可以處理那些理賠(claims)並收款,但目前非常偏向個案處理(one-off),而且需要大量文件。因此,德國未來將為我們帶來一些顯著的成長機會。至於我們對今年幫浦病患的預估,我們在權衡時會考量多項因素。同樣地,我們有Medicare的情況。我們有一個非常強健的潛在新病患管線,即使不做推廣也有。我們——一旦拿到這個(覆蓋),我們很興奮。我們認為我們可以在那裡新增不少新病患。我們認為在病患數量方面,這將抵消幫浦端的一些疲弱,甚至可能不只抵消;而Medicare模式與幫浦端稍有不同之處在於:當我們新增一位新病患時,我們所取得的營收。我舉個例子,你們都知道,如果回到過去或看一位新病患,初始的發射器(transmitters)、接收器(receiver)以及3個感測器(sensors),硬體大約是800到900美元,再加上3盒感測器,為了簡化起見。假設每盒300美元或75美元。所以你有900美元,啟用一位新病患的起始金額大約在1,500到2,000美元之間。在Medicare端,正如你們讀過CMS的裁定,我們不會拿到那麼大的一筆前期款項。我們——我們或我們的經銷商——將在13個月期間就接收器收取租賃(rental)款項,而耗材部分的每月平均給付大約在250到300美元之間。因此,一位新病患在第一季帶來的收入大約會在750到900美元之間。所以即使我們的病患基礎顯著成長、超過270,000名,如果其中有相當一部分是Medicare病患,它也不會像過去商業保險(commercial)業務那樣,立刻帶來同等幅度的跳升(pop)。當我們展望——當我們看這些機會,以及持續要求CGM的病患數量、我們管線中新的非Medicare病患數量時,我們對今年的指引感到有信心;儘管外界還有各種糖尿病相關消息,我們也計畫達成那些目標。而第二季對我們而言,通常都會高於第一季。我們當然預期第二季會比第一季好很多,之後就再看進展如何。

  • Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

    Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

  • Yes. I mean, like one of the other...

    是的。我的意思是,就像其他人其中一位……

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Just a quick addition on U.S. about [QGs] specifically and those outside models. I mean, we certainly don't control those outside models, but what we said in our Q4 call, if you recall, as we expected to do somewhere between 18% and 20% of our annual revenues in the first quarter, and I think where we landed was right square in the middle of that. We've also typically historically said we expect to do 40% to 45% of our annual revenue in the first half of the year. And so, I think, we would be comfortable sticking with that as a historical guide.

    就美國部分再快速補充一下,特別是關於[QGs]以及那些外部模型。我的意思是,我們當然無法控制那些外部模型,但如果你們記得我們在第四季電話會議上說過的,我們預期第一季會貢獻我們全年營收的大約18%到20%,而我想我們最後的落點正好在那個區間的正中間。我們過去也一向表示,我們預期上半年會完成全年營收的40%到45%。因此,我想我們會願意繼續把這個當作歷史性的參考指標。

  • Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

    Michael N. Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group within Equity Research

  • Understood. And then last one (inaudible). I just want your comment on some kind of what you think the feedback has been so far in 670G in terms of how that scattering with the early clinicians and patients?

    了解。然後最後一個(聽不清)。我想請你評論一下,到目前為止在 670G 上,你認為早期臨床醫師與病患的回饋大概是怎樣?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, they've put on 500 people and my guess is they probably picked those 500 people specifically. So we've heard some relatively good feedback. We've also heard mixed reviews with respect to the complexity of the system. And going out of auto mode and everything, I don't think the book can be written on 670G till this is commercialized to a broad number of patients. I would tell you on the pump front, we do see as is evidenced by, I think, what we heard on Tandem's call that some doctors are waiting to see before they put a patient on a pump to see how 670G goes, and this will be more applicable to a patient. But in all reality, pumps again are 4-year warranty cycle. We believe that we can do very well with the pump patients that we have now. And as I said earlier, on our new patient adds on the pump side, we are slow. And that was really the most negative thing that we saw in the first quarter or so. We'll just keep going from there. But there is a lot of MDI patients who really can use CGM, and we will focus on those guys and other pump partners' patients as well.

    嗯,他們已經讓 500 個人上線了,我猜他們很可能是特別挑選了那 500 個人。所以我們聽到一些相對不錯的回饋。我們也聽到對於系統複雜度的褒貶不一。還有退出自動模式等等,我認為在 670G 尚未對更廣泛的病患群商業化之前,還無法對它下定論。但就幫浦端而言,我們確實看到——正如我想我們在 Tandem 的電話會議上聽到的——有些醫師在讓病患上幫浦之前會先觀望 670G 的表現,看看這是否更適用於某位病患。但實際上,幫浦仍然是 4 年保固週期。我們相信,對於我們目前既有的幫浦病患,我們可以做得很好。而且如我先前所說,在幫浦端新增病患方面,我們的速度偏慢。那確實是我們在第一季左右看到最負面的事情。我們會繼續往前推進。不過有很多 MDI(多次每日注射)病患其實很需要 CGM,我們會聚焦在這些人,以及其他幫浦合作夥伴的病患。

  • Operator

    Operator

  • We have our next question from Jayson Bedford of Raymond James.

    下一個問題來自 Raymond James 的 Jayson Bedford。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • Just a couple of quick ones. Kevin, I appreciate the explanation around Medicare, but what really needs to happen from here for Medicare patients to access the technology?

    我有幾個很快的問題。Kevin,我很感謝你對 Medicare 的說明,但接下來究竟需要發生什麼,Medicare 病患才能取得這項技術?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • The most important thing that can happen next is a coverage decision. And what a coverage decision does is it provides an explanation around the benefit criteria that have already been established. For example, in the documents that have been issued already, it says the patient needs to be taking 4 finger sticks a day, but we don't have any guidance as how to document that. What the local coverage decision will provide is documentation requirements to document 4 finger sticks a day, this is what you have to do. Same thing with the other criteria type 1 diabetes and the other things that are on that list. Also, with the local coverage decision, Jayson, while under the current pronouncements of Medicare, you can bill on a one-by-one basis on claims. We processed a few Medicare claims and our distributor has and they've all been pretty much denied and waiting a coverage decision. So we really need this coverage decision and then we can really open this up and get this process running smoothly. That is the next obstacle. And then again, I want to be very clear, CMS has been very progressive and helping us try and get this out. The things that they've done, the last guidance they gave towards the end of the first quarter. That was very much a positive step. We see it as a positive step by us to outline the criteria to specifically identify type 1 and type 2 diabetes patients using intensive therapy and that did keep the ball rolling. We need to get this local coverage decision, and we are going for local coverage decisions as soon as possible and then we can really get this thing going. That's the big holdup right now more than anything else.

    接下來最重要的是要有一個給付(coverage)決定。給付決定的作用,是針對已經建立的給付資格標準提供說明。例如,在已發布的文件中寫到病患需要每天做 4 次指尖採血,但我們沒有任何指引說明要如何佐證。地方給付決定(local coverage decision)會提供文件要求,說明要如何記錄每天 4 次指尖採血——你必須這樣做。其他標準也是一樣,例如第一型糖尿病,以及清單上的其他事項。另外,有了地方給付決定之後,Jayson,在目前 Medicare 的公告之下,你可以在申報(claims)時逐案請款。我們處理了少數 Medicare 申請案,我們的經銷商也處理了一些,但幾乎都被拒絕,並且在等待給付決定。所以我們真的需要這個給付決定,然後才能真正把它打開,讓流程順暢運作。這是下一個障礙。另外我想非常清楚地說,CMS 一直非常積極,協助我們把這件事推動出去。他們所做的事情,包括第一季末給出的最新指引。那是非常正面的進展。我們也視之為正面一步,因為它讓我們能夠界定標準,明確識別使用強化治療的第一型與第二型糖尿病病患,並讓進度持續推進。我們需要拿到這個地方給付決定,我們正盡快爭取地方給付決定,之後就能真正把這件事推動起來。這是目前最大的卡關點,勝過其他任何因素。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • And Kevin, are we going to see a series of local coverage decisions? Or is it one national that can be overlaid on the local?

    Kevin,那我們會看到一系列的地方給付決定嗎?還是會有一個全國性的決定,可以套用到地方層級?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • There is -- again it's more consolidated than that. It may be more than 1, but it probably would be 2 up to a maximum of 4. So a little bit (inaudible).

    會有——再說一次,它比那樣更集中一些。可能不只 1 個,但大概會是 2 個,最多到 4 個。所以有點(聽不清)。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • Okay. And when do you anticipate this to be put in place? Is midyear still a fair estimate?

    好的。那你預期什麼時候會到位?年中仍然是合理的估計嗎?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • There was a CMS webcast actually that happened earlier today, and they said it's -- basically said it's in process. And they wouldn't give specific timing, but it seem like it would be sooner rather than later. So we are hopeful before the summer.

    今天稍早其實有一場 CMS 的網路直播,他們表示——基本上說正在進行中。他們不願給出具體時間點,但看起來會是越快越好。所以我們希望能在夏天之前。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Certainly, before the end of this quarter is what we're hoping for.

    當然,我們希望在本季結束前。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • Okay. And last one on this topic. Is -- when the local coverage decision is in place, is that when you kick in a more aggressive marketing effort?

    好的。這個主題最後一個問題。當地方給付決定到位後,你們是否就會啟動更積極的行銷推廣?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • That is correct. Last thing we want to do is go add another 10,000 patients to the 10,000 patients we are not currently shipping and have them all frustrated. So yes, we will aggressively go after them as soon as we get that local coverage decision. We are more teed up. We're ready to go. This isn't something that will require a bunch of time. We'll get after it very quickly.

    沒錯。我們最不想做的,就是在目前我們還無法出貨、已有 10,000 名病患在等的情況下,再新增另外 10,000 名病患,讓大家都很挫折。所以是的,一旦拿到地方給付決定,我們就會積極去爭取他們。我們已經準備就緒。我們隨時可以出發。這不是需要花很多時間的事情。我們會非常快速地推進。

  • Operator

    Operator

  • And we have our next question from Doug Schenkel of Cowen & Company.

    下一個問題來自 Cowen & Company 的 Doug Schenkel。

  • Ryan Blicker - Associate

    Ryan Blicker - Associate

  • This is Ryan on for Doug. So you've talked historically about international ASPs being about 20% lower than the U.S. on average. Is this still the case in direct markets or should we assume it's closer to the U.S. indirect markets? And what are your expectations for sensor ASPs over the remainder of 2017?

    我是 Ryan,代 Doug 提問。你們過去曾提到,國際 ASP(平均銷售單價)平均比美國低約 20%。在直營市場仍然是這樣嗎?還是我們應該假設它更接近美國的間接市場?另外,你們對 2017 年剩餘期間的感測器 ASP 有什麼預期?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, so what we've said is the pricing in Germany is more reflective of our pricing -- our direct pricing in the U.S. But remember, Germany doesn't represent -- it represents an okay chunk, but it doesn't represent a huge chunk of our OUS business yet. So the vast majority of our OUS business is still through third-party distribution, which is at a lower ASP. As we look to go directly in other markets, I think you'll see some pricing improvement versus through distributions. But I'll tell you, giving example, in one of our reimbursed market, we actually elected to lower the price slightly to drive sale, to drive volume, and it's had a wonderful response, particularly against some of the competition that is priced lower. So we're still evaluating how we proceed OUS, but yes -- I mean, what you've seen today is certainly Germany being the only big direct market is still more reflective of our U.S. pricing.

    是的,我們的說法是德國的定價更能反映我們在美國的定價——也就是我們在美國的直營定價。但請記得,德國並不代表——它占比還可以,但目前還不是我們 OUS(美國以外)業務中非常大的一塊。因此,我們 OUS 業務的絕大多數仍透過第三方經銷,ASP 會比較低。當我們在其他市場轉為直營時,我認為你會看到相較於透過經銷的定價有所改善。但我也可以舉例,在我們某個已納入給付的市場,我們其實選擇把價格小幅下調,以帶動銷售、帶動量,而反應非常好,特別是在面對一些定價更低的競爭對手時。所以我們仍在評估 OUS 的推進方式,但沒錯——我的意思是,你今天看到的情況,確實是德國作為唯一主要的直營市場,其定價仍更接近我們的美國定價。

  • Ryan Blicker - Associate

    Ryan Blicker - Associate

  • Okay. So should we expect the -- where ASPs were this quarter or around that? We should expect it to be towards the lower end of your historical range for the remainder of 2017?

    好的。所以我們是否應該預期——本季的 ASP 水準或大致在那附近——在 2017 年剩餘期間會落在你們歷史區間的較低端?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes, this is Kevin. I think we get back up into the 70 range, probably not towards 75 as the U.S. volumes become a larger percentage of our business. And the U.S. international mix in Q1 of last year was also similar to this. In fact, the international business doesn't really suffer the seasonality that we suffer in the U.S. and many times Q1 has been our biggest quarter in the year internationally. Now we certainly wouldn't want that to be the way this year. But as U.S. business goes up and becomes a bigger percentage of the business, again you will see prices naturally move up because of again just distribution channel shift and geographic shift.

    是的,我是 Kevin。我認為我們會回到 70 美元左右的區間,可能不會到 75,因為隨著美國的出貨量成為我們業務中更大的占比。而去年第一季的美國/國際組合也與這次相近。事實上,國際業務並不像美國那樣受到季節性影響,而且很多時候第一季一直是我們國際業務全年最大的季度。當然我們不希望今年也是如此。但隨著美國業務上升並成為更大比例,你會看到價格自然上移,原因同樣是通路結構轉移與地理組合轉移。

  • Ryan Blicker - Associate

    Ryan Blicker - Associate

  • Okay. That's helpful. Moving back to Medicare. You said on the Q4 call that you believe within Medicare penetration of the type 1 patients could exceed the broader market rate over the next few years. What do you believe will happen within the intensively managed type 2 population?

    好的。這很有幫助。回到 Medicare。你在第四季電話會議上說,你相信在未來幾年,Medicare 內第 1 型患者的滲透率可能會超過整體市場的滲透率。你認為在高度密集管理的第 2 型族群中會發生什麼情況?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Specifically, to Medicare or more broadly speaking?

    是特指 Medicare,還是更廣泛地說?

  • Ryan Blicker - Associate

    Ryan Blicker - Associate

  • Specifically to Medicare, but both would be helpful.

    特指 Medicare,但兩者的看法都有幫助。

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, I mean, I will tell you, it's still a bit of an unknown as Kevin said in his prepared remarks. We hope to leverage the coverage criteria, the coverage language from Medicare into the commercial side of the business. I think it's a little bit of an unknown because our core commercial business is not -- it's not dominated by intensively managed type 2s due to a lack of coverage. So it will probably -- I'd tell you taking a little bit of wait-and-see approach, but the number of patients are much, much larger than the type 1. So I think it could be extremely additive over the next several years.

    是的,我的意思是,我會告訴你,正如 Kevin 在事先準備的發言中所說,這仍然有點未知。我們希望把 Medicare 的給付標準、給付條文的措辭,延伸運用到商業保險端的業務。我認為之所以有點未知,是因為我們的核心商業保險業務並不是——由於缺乏給付——並非以高度密集管理的第 2 型為主。所以可能——我會說我們會採取稍微觀望的做法,但患者人數遠遠大於第 1 型。因此我認為在未來幾年可能會帶來非常顯著的增量貢獻。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • And with respect to the type 1 market, again these are prevalent patient profile. These are patients many of whom who suffer from hypoglycemia unawareness, and this is a wonderful tool to help them and help give their families peace of mind. So we see a tremendous opportunity here. And if we didn't see a tremendous opportunity here, I can tell you it's emphasized because it would appear to me that most of the Medicare cash patients who we didn't ship, all send the e-mails regarding, in fact, that they don't have their product and they want it soon. So this is the group that has been very committed to the technology and done extremely well. So I think we have a wonderful opportunity here. The key for us will be executing, streamlining the reimbursement and shipment process as we have to bundle this with the strips and meters upfront and making sure the patients are properly trained and qualified, and we've staffed up for that. We've added more people on our tech support group and on our patient care team and in our processing team in anticipation of this. So we've done some things much better than we did a year ago. We put good plans in place to anticipate this, and we're just really excited to get started, but getting started is the keyword, we really need to go.

    至於第 1 型市場,再次強調,這些是既有(存量)的患者輪廓。其中許多患者有低血糖無感(hypoglycemia unawareness)的問題,而這是一個很棒的工具,可以幫助他們,也讓家人更安心。因此我們在這裡看到巨大的機會。而且如果我們沒有看到巨大的機會,我可以告訴你,之所以更被凸顯,是因為在我看來,多數我們未出貨的 Medicare 自費患者,都寄來電子郵件反映他們其實沒有拿到產品,而且希望盡快拿到。所以這個族群對這項技術非常投入,而且使用成效非常好。因此我認為我們在這裡有很棒的機會。對我們而言,關鍵在於執行:簡化給付核銷與出貨流程,因為我們必須在前端把試紙與血糖機一起打包,並確保患者接受適當訓練且符合資格;我們也已為此增聘人力。我們在技術支援團隊、患者照護團隊以及處理作業團隊都增加了人手,以因應這件事。所以我們做得比一年前好很多。我們制定了良好的計畫來預先因應,現在真的很興奮要開始,但「開始」是關鍵字——我們真的需要動起來。

  • Operator

    Operator

  • We have our next question from Jeff Johnson of Robert Baird.

    下一個問題來自 Robert Baird 的 Jeff Johnson。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • So let me ask, I guess, one other Medicare question. So I'm looking at the Noridian coverage decision from late March. The wording is pretty clear in there that you'll only get coverage if you are using the DexCom receiver, the display data. And in fact, I think in that document, the word "only" is capitalized and then it goes on to say that if a beneficiary uses a smartphone as the display device, the supply allowance will be noncovered by Medicare. So I guess my question is Liberty recently decided they're no longer going to process G5 orders, at least -- I'm not sure if that's temporary or not, but is there any connection between that and the display wording? Is there any risk that the payers take if it's found out that the patients are using their phone? Do patients take any risk? Do you guys have to change the share functionality on Medicare -- for Medicare patients. It just seems like a big issue tied to this word "only" and I'm just trying to figure out if there is anything there to be thinking about?

    那我再問一個 Medicare 的問題。我在看 Noridian 三月底的給付決定。裡面的措辭相當清楚:只有在你使用 DexCom 接收器來顯示資料時才會給付。事實上,我想在那份文件中,「only」這個字是大寫,接著又說如果受益人使用智慧型手機作為顯示裝置,耗材給付額度將不在 Medicare 給付範圍內。所以我的問題是,Liberty 最近決定他們不再處理 G5 訂單,至少——我不確定這是否是暫時性的——但這和顯示裝置的措辭有任何關聯嗎?如果被發現患者在使用手機,付款方會承擔任何風險嗎?患者會承擔任何風險嗎?你們是否必須針對 Medicare——針對 Medicare 患者——更改 SHARE 的分享功能?這看起來像是一個與「only」這個字高度相關的大問題,我只是想弄清楚是否有任何需要留意的地方?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Excuse me. This is Kevin. I'll take that. What is lost on many of this is we're about a year ahead of where we thought we'd be with respect to this Medicare stuff. And in order to get DME approval, we have to have a durable component of the system that would last a specific period of time that we would cover. And working with Medicare, again they worked very hard and they determined that durable component is the receiver. So we'll start with the rules that we have. As far as Liberty concluding, it still has absolutely nothing to do with their decision and with this and that is, by far and away, the least important gaining factor in doing this Liberty's decision and as we've looked at this and quite frankly spoke with other distribution channels, not knowing exactly what the coverage decision looks like and not knowing what you're going to have to have in your file to get paid when you have a Medicare license at risk and your business is very much Medicare-oriented is something of a risk that Liberty just wasn't ready to take at this point in time even though they could get paid on individual claims and go through the process and do a lot of work. So they stepped back and they're waiting -- and they want to wait for this local coverage decision as much as we do. Once this becomes clear, we will -- we'll determine how to best proceed. And I think it's important for everybody to understand, this hasn't been a onetime thing. This has been a process over several years, and while we may sit here today with that position on the receiver being the durable part and being kind of like the centerpiece and the most important component of the system, we have a number of options here. We can certainly work with CMS over time to see if we can move it to another category. We can also go back to what we did in the past with SHARE and have the receiver talk to the phone and we could -- certainly, we don't have that product in our portfolio right now, but since we were the first to make it way back when we know how to do that. So we have a number of options here. We just need to let this play out. We need to get this technology on patients. We need them to explain how it has changed their lives and how beneficial it is. And we need to be pleased with where we are and not get too crazy. I don't think that's over time going to be a factor.

    不好意思。我是 Kevin。我來回答。很多人忽略的是,就 Medicare 這件事而言,我們比原先預期大約提前了一年。而為了取得 DME 核准,我們必須讓系統中有一個可耐用的組件,能在特定期間內使用,並且是我們會涵蓋的。與 Medicare 合作時——他們也非常努力——他們認定那個耐用組件就是接收器。所以我們會先從現有規則開始。至於 Liberty 的結論,這完全與他們的決定以及這件事無關;而且就 Liberty 的決定而言,這在推動這件事的因素中,遠遠是最不重要的。當我們檢視這件事,坦白說也與其他通路談過,在還不清楚給付決定長什麼樣、也不清楚你必須在檔案中具備哪些資料才能請款的情況下,當你的 Medicare 執照面臨風險、而你的業務又高度以 Medicare 為導向時,這本身就是一種風險。Liberty 在此時點還沒準備好承擔這個風險,即使他們可以針對個別申請案拿到款項、走流程並做大量工作。所以他們先退一步,等待——他們想和我們一樣等待這份地方性給付決定(local coverage decision)。一旦變得清楚,我們就會——我們會決定如何以最佳方式推進。我也認為讓大家理解很重要:這不是一次性的事情。這是一個歷時數年的流程;雖然我們今天坐在這裡,接收器被定位為耐用部件,某種程度上像是系統的核心、最重要的組件,但我們其實有多種選項。我們當然可以隨時間與 CMS 合作,看看能否把它移到另一個分類。我們也可以回到過去 SHARE 的做法,讓接收器與手機通訊;我們當然——目前產品組合裡沒有那個產品,但因為我們當年是第一個做出來的,所以我們知道怎麼做。因此我們有很多選項。我們只需要讓事情發展下去。我們需要把這項技術用到患者身上。我們需要他們說明這如何改變了他們的生活、以及它有多麼有益。我們需要對目前的進展感到滿意,不要太過激動。我不認為長期來看這會成為一個因素。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • That's helpful. Can I ask one clarifying question, Kevin. Earlier you mentioned the supplies reimbursement monthly limit of $250 to $300. And just as I'm thinking about by Medicare model for you guys, I thought the number would come out at $238. Am I wrong on that and just wondering where your $250 to $300.

    這很有幫助。Kevin,我可以再問一個釐清問題嗎?你先前提到耗材每月給付上限是 250 到 300 美元。但我在思考你們的 Medicare 模式時,我以為數字會是 238 美元。是我搞錯了嗎?也想請問你的 250 到 300 是怎麼來的。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • .

    。

  • The receiver rental is the payment for the first 13 months. That's why I had that and then -- again, what we end up getting will depend on the distribution channel and our terms with distributors, and we'll have more color on that once we start going in future quarters.

    接收器租賃費是前 13 個月的付款。所以我才會那樣說;然後——同樣地,我們最後實際拿到的金額會取決於通路以及我們與經銷商的條款,等我們在未來幾季開始推進後,會提供更多細節。

  • Operator

    Operator

  • And our next question comes from Kyle Rose with Canaccord.

    我們的下一個問題來自 Canaccord 的 Kyle Rose。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • Yes, so just wanted to ask you more on the pump partnership side. Has the disruption in that side of the market changed? How you guys think about long-term opportunity of where our partnership should look, whether it be on pump partnerships versus smart pens versus connected Holters? Obviously, when you think about the type 2 opportunities, just trying to understand how you guys view some of the value of those longer-term partnerships?

    是的,我想再多問一些關於幫浦合作夥伴關係這一塊。那一端市場的干擾情況有改變嗎?你們如何看待長期機會、我們的合作夥伴關係應該聚焦在哪裡——不論是幫浦合作、智慧筆,或是連網 Holter(動態心電監測器)?顯然,當你們思考第二型糖尿病的機會時,我只是想了解你們如何看待這些較長期合作夥伴關係的一些價值?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • I'll take that one, Kyle. No, I don't think it changes our thinking on that at all. I think there is an extremely important segment of the market that we'll look to have to utilize the semi-automated or hybrid closed-loop systems, and we remain active with folks who you know with Insulet and some others -- and there's some others that you don't know. I think those are critically important to some subset of the market. We also think, as you mentioned smart pens, smart pen paired with a CGM, we think is an extraordinarily compelling product offering, particularly when you think about the power and computing power that we have on the phone and being able to really mimic using the algorithms that would be the similar algorithms that you have on the pump -- on the phone and actually really provide detailed dosing assistance and otherwise to the patients. But then if you really look out at the market, thinking about type 2s more broadly speaking, Kevin gave some color on our initial thoughts there, there is a much, much broader opportunity even in the noninsulin taking patient population in type 2s. And I think we're starting to see some really compelling preliminary data that will marry up with the appropriate products as we continue forward with our Verily relationship. So I don't think our product -- our partnership strategy has changed. In fact, I think our partners are becoming frankly more important, perhaps more diverse. We're not just going to focus on closed-loop or hybrid closed-loop systems. I think there is a broad spectrum of partnership product opportunities for us, but they're all going to be critically important over time.

    Kyle,我來回答這題。不,我不認為這會改變我們在這方面的想法。我認為市場上有一個極其重要的區隔,我們將需要運用半自動或混合式閉環系統;我們也持續與你所知道的 Insulet 以及其他一些夥伴保持合作——也還有一些你不知道的。我認為這些對於市場中的某一部分族群至關重要。另外,我們也認為,如你提到的智慧筆,智慧筆搭配 CGM(連續血糖監測),是一個極具吸引力的產品組合,特別是考量到手機端我們擁有的運算能力,能夠真正運用與幫浦上類似的演算法——在手機上進行模擬,並實際為病患提供更細緻的劑量建議與其他協助。但如果你把視野放到更大的市場,從更廣義的第二型糖尿病來看,Kevin 也分享了我們初步的一些想法;即使是在第二型中不使用胰島素的病患族群,也存在更大、更廣泛的機會。而且我認為,隨著我們與 Verily 的合作持續推進,我們開始看到一些非常有說服力的初步數據,未來將能與合適的產品相結合。所以我不認為我們的產品——我們的合作夥伴策略有改變。事實上,我認為我們的合作夥伴坦白說正變得更重要,或許也更多元。我們不會只聚焦在閉環或混合式閉環系統。我認為我們有廣泛的合作產品機會光譜,但隨著時間推移,它們都將至關重要。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • Great. I appreciate that. And then just a 2-part question and then I'll hop back in the queue. Just wanted to say -- just wanted to see, is it fair to think of the product cadence and I appreciate the color, but is the product cadence coming as G6? And then the Verily G1 and then the Verily G2. And I don't mean to imply that, that's not a very robust pipeline, but I'm just trying to understand, if we may see some incremental launches, whether that be different labeling, different types of use cases for those products along the way as we think about the '17 to '20 to '21 time period. And I just -- second question, is anything you guys want to highlight when we think about you're heading to ADA in June?

    很好。謝謝你的說明。接著是兩個問題,問完我就回到排隊序列。我想確認一下——我很感謝你提供的細節——是否可以把產品推出節奏理解為:先是 G6?然後是 Verily G1,再來是 Verily G2。我不是要暗示這不是一個很強的產品管線;我只是想了解,在我們思考 2017 到 2020、到 2021 這段期間時,是否可能沿途看到一些增量式的上市,例如不同的標示(labeling)、或這些產品不同類型的使用情境。另外第二個問題是:當我們想到你們六月要去參加 ADA(美國糖尿病學會年會)時,有沒有什麼你們想特別強調的?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Let me start with the product pipeline. On the product pipeline front, it's a real good question and a very good observation. We have been very successful over time. Once we get a technology platform established on the sensor side to turn that into enhanced performance and other different opportunities, and I think in today's hospital world and the expertise we're developing and the expertise, quite frankly, that's some of these important partners that Steve has talked about is, I think, you will see derivations of our core technologies. We tend to speak to our core technologies on these calls, but I can give you a simple example. We've certainly run feasibility studies on the Gen 6 sensor for 14 days, not only for purposes of the Verily first product that we're going to launch because there will be a G6 sensor, but also for possibly a 14-day version of G6, but all this is in feasibility phases. We are giving all these things thoughts and you will see iterations that will be different. I think the other place that we can iterate that will be very meaningful will be software. We believe once we have that accurate stable industry-standard sensor platform and algorithms that generate extremely accurate and well-performing numbers that we can then, in future worlds, come up with possibly different apps that might be approved for different labeling and might have different use cases for patients and back to what Steve talked about with our type 2 business models, our type 2 relationships. So now, there is a lot going on and there is a lot more going on here than just the -- when we talk about really the core basic things on these calls, there are many other projects and many other things we're considering along with those. And with respect to ADA, certainly, there will be talk about the second phase of the DIaMonD study, the type 2 DIaMonD data, and we have several technology papers. There will be posters. We have a couple of oral presentations. We don't have a new product coming this year. We would love to be able to knock on wood if we can launch Android at ADA that would be a wonderful event, but we're not there yet. So we'll -- it will certainly be a good show for us. It always is. And we'll have a great time here in San Diego.

    我先從產品管線談起。就產品管線而言,這是一個非常好的問題,也是一個很好的觀察。長期以來我們一直非常成功。一旦我們在感測器端建立起一個技術平台,就能把它轉化為更佳的效能與其他不同的機會;而我認為在今天的醫院環境中,我們正在建立的專業能力,以及坦白說 Steve 提到的一些重要合作夥伴所帶來的專業能力,將使你看到我們核心技術的衍生版本。我們在這些電話會議上通常只談核心技術,但我可以舉個簡單例子。我們確實已針對第六代(Gen 6)感測器做過 14 天使用期的可行性研究,不僅是為了我們將推出的 Verily 第一個產品(因為那會使用 G6 感測器),也可能是為了 G6 的 14 天版本,但這些都仍在可行性階段。我們正在思考所有這些事情,你也會看到不同的迭代版本。我認為另一個我們可以進行、且非常有意義的迭代領域會是軟體。我們相信,一旦我們擁有準確、穩定、符合產業標準的感測器平台,以及能產生極其準確且表現優異數值的演算法,那麼在未來,我們可能會推出不同的 App,這些 App 可能會以不同的標示(labeling)獲得核准,並對病患有不同的使用情境;也呼應 Steve 談到的第二型糖尿病商業模式與第二型合作關係。所以,目前有很多事情在進行中,實際上也遠不只我們在這些電話會議上談到的——當我們談核心基本事項時,還有許多其他專案與許多其他我們正在一併考量的事情。至於 ADA,當然會談到 DIaMonD 研究的第二階段、第二型糖尿病的 DIaMonD 數據,我們也有幾篇技術論文。會有海報展示。我們也有幾場口頭報告。我們今年沒有新產品要推出。如果我們能在 ADA 推出 Android 版本,那會是一件很棒的事——希望能敲敲木頭——但我們還沒到那一步。所以——這對我們來說肯定會是一場很好的展會。一向如此。而且我們會在聖地牙哥度過一段很愉快的時間。

  • Operator

    Operator

  • And our next question comes from Margaret Kaczor of William Blair.

    我們的下一個問題來自 William Blair 的 Margaret Kaczor。

  • Margaret Maria Kaczor - Research Analyst

    Margaret Maria Kaczor - Research Analyst

  • So the first question for me in terms of the final pieces for Medicare, once they're in place, how should we think about the ramp of these patients? Are you continuing to see that pipeline of patients grow even now as we go couple of months beyond the initial announcement? And I guess, more specifically, over what time frame should we look at those 10,000 patients to come online?

    我這邊第一個問題是,關於 Medicare(美國聯邦醫療保險)最後幾個環節,一旦都到位之後,我們應該如何看待這些病患的導入爬坡速度?在最初公告之後又過了幾個月,你們是否仍持續看到病患管線在成長?更具體地說,我們應該在多長的時間範圍內看到那 10,000 名病患上線?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, certainly, we want to get the 10,000 patients up and going as quickly as possible. I think the Medicare ramp, once this final coverage decision is in place, can go relatively quickly. As we qualify these patients and make sure they meet all the criteria and understand what documentation that we have to have. The impact of the patients though, as I described earlier, is a little different than our regular in-patients just based on the reimbursement model and the fact that we get a monthly rental rather that the big upfront payment. So our relationship with distributors are going to be a little bit different. Where the Medicare revenue really becomes material and significant is when we get, like, a 30,000 or 40,000-patient base and we're billing them all that monthly charge, and so you've got a regular monthly revenue stream, combined with monthly shipments that we think could be highly predictable. So like I said, our new Medicare patient upfront is probably about half of what a commercial patient is in our upfront revenues but as that [bolus] goes out over time, those patients become extremely valuable to us. So it's going to be a little bit different model, but it will be highly -- we're very excited about everything. I think it will be very additive to our business.

    當然,我們希望能盡快讓這 10,000 名病患啟用並運作起來。我認為一旦最終的給付涵蓋決定到位,Medicare 的導入爬坡可以相對快速。因為我們會去資格審核這些病患,確保他們符合所有條件,並了解我們必須具備哪些文件。不過,如我先前所述,這些病患帶來的影響,基於給付模式以及我們是按月收取租賃費、而不是一次性的大額預付款,會與我們一般的自費/商業保險病患略有不同。因此,我們與經銷商的合作關係也會有些不同。Medicare 營收真正變得具體且顯著,是當我們擁有例如 30,000 或 40,000 名病患的基礎,並對他們全部按月收取費用;如此你就會有穩定的月度營收流,再加上我們認為可高度預測的每月出貨。所以如我所說,我們新的 Medicare 病患在前期帶來的營收,大概只有商業保險病患前期營收的一半;但隨著那個[bolus]隨時間推移,這些病患對我們而言會變得極具價值。所以這會是一個有點不同的模式,但它將會高度——我們對一切都非常興奮。我認為這會對我們的業務帶來很大的增益。

  • Margaret Maria Kaczor - Research Analyst

    Margaret Maria Kaczor - Research Analyst

  • And are those pipeline of patients still growing beyond the 10,000 kind of the rate over the period of time?

    那麼在這段期間內,那些病患名單的管線是否仍以超過 10,000 的速度持續成長?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes. Well, we are still getting people calling in and wanting to join the pipeline. We get several -- we get many opportunities per day. But when they hear we can't -- or we can't ship to them, it's been a little bit difficult. I would say that we really need to turn on the faucet once we get the coverage decision marketed. And then we'll have a very good idea as to how robust these patients who have inquired is and how many will convert and how they'll use it. We really need to get going.

    是的。嗯,我們仍然有人打電話來,想要加入這個管線。我們每天都有好幾個——我們每天有很多機會。但當他們聽到我們無法——或我們無法出貨給他們時,就變得有點困難。我會說,一旦我們把給付決策推廣到市場,我們真的需要把水龍頭打開。然後我們就會很清楚,這些詢問的病患有多強勁,以及有多少會轉換、以及他們會如何使用。我們真的需要開始推動。

  • Margaret Maria Kaczor - Research Analyst

    Margaret Maria Kaczor - Research Analyst

  • Got it. And in terms of the second question, on the U.S. patient adds, is there anything that you guys can do in the near term to help maybe your existing pump partners improve those patient adds? And Steve, I don't know if you have the numbers or willing to share, but what percentage of your patient adds in the past have been through those pump partners last year versus what you guys saw this quarter?

    了解。那第二個問題,關於美國新增病患數,你們短期內是否能做些什麼,來協助你們現有的幫浦合作夥伴提升新增病患數?另外 Steve,我不知道你是否有數字或願意分享:過去你們新增病患中,有多少比例是透過那些幫浦合作夥伴(去年)帶來的,相較於你們這一季看到的情況?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Well, it's not -- I wouldn't say it's just pump partners. I mean, what we've said is, historically, this is 2 to 3 years ago, when we were a typical quarter, we would add roughly 50% pumpers, which included Animas, Tandem, not just integrated -- DexCom-integrated systems, but pumpers, broadly speaking. So the Animas, Tandem, Insulet and even Medtronic, and so with a couple of pump partners that we're seeing not adding -- just not adding new patients, generally speaking, we've seen a slowdown. So the point though is while it did have an impact, we've shifted the mix pretty dramatically over the last 12 months or so. So now in a typical quarter, we're adding 2/3 of our new patients are actually MDI patients. So while it's had an impact, it's not crippling the business. We just drew attention to it because it was a factor.

    嗯,這不——我不會說只是幫浦合作夥伴。我的意思是,我們說過,歷史上大概是 2 到 3 年前,在一個典型季度,我們新增的病患大約有 50% 是幫浦使用者,其中包括 Animas、Tandem,不只是整合——DexCom 整合系統,而是更廣義的幫浦使用者。所以包括 Animas、Tandem、Insulet,甚至 Medtronic;而由於我們看到有幾個幫浦合作夥伴——一般而言——就是沒有在新增新病患,我們確實看到成長放緩。不過重點是,雖然這確實有影響,但在過去大約 12 個月裡,我們已相當大幅度地調整了組合。所以現在在一個典型季度,我們新增病患中有 2/3 其實是 MDI 病患。因此雖然有影響,但並沒有讓業務陷入癱瘓。我們只是把它提出來,因為它是一個因素。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • It's a factor, yes.

    是的,這是一個因素。

  • Margaret Maria Kaczor - Research Analyst

    Margaret Maria Kaczor - Research Analyst

  • Got it. And then last one for me, maybe as we think about the G6 label, Kevin, what could DexCom offer for patients in exchange for that hard shutoff on the sensor? Whether it's 10 days, I think you mentioned 14 days that you're thinking about, what would make them excited about that prospect and effectively pay more per day per sensor than they do today?

    了解。那我最後一個問題,當我們思考 G6 標示(label)時,Kevin,DexCom 能為病患提供什麼,以交換感測器的硬性關閉(hard shutoff)?不論是 10 天——我想你提到你們在考慮 14 天——什麼會讓他們對這個前景感到興奮,並且實質上願意為每個感測器每天支付比現在更高的費用?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, the 10-day life per G6, the way G6 is configured, there is not a hard shutoff on G6. As we are filing it at this point in time and we will evaluate that hard shutoff feature going forward. We all read the blogs on our system and every time I get on the DexCom G5 user group, pretty much every night, somebody says "Hey, I just got my DexCom and I've worn my sensor for 2 weeks. How much longer is it going to last and what do I do to make it last longer?" And then you read -- the last couple of weeks, I read somebody said "Yes, I get 48 days for each of my sensors or 7 weeks per sensor and here's all the things that I do." So this is the feature we have built into our product. I mean, our product has been very reliable for more than 7 days. I think over time, the way our model works, particularly if you get out to 10 or 14 days, if we were to shut it off, it would be -- absolutely for quality purposes and to make sure that it's accurate, in particular, with our nonadjunctive claim. And the way we would look at that, Margaret, in all reality, while we're billing somewhere between $10 and $12 a day in the U.S. to the reimbursement entities. If we did shut the thing off hard, we would make sure we were fair with the patients because we always do and we would have a program to whereby patients -- we would hope patients will not be hurt economically. And that's something we will study and explore over time and give it lots of thought and consideration. So it will be a -- it will be an interesting evolution on our technology curve and we have a lot of things to think about and consider.

    嗯,G6 的 10 天使用壽命,就 G6 的配置方式而言,G6 並沒有硬性關閉。我們目前就是以這樣的方式在申報(filing),而未來我們會再評估這個硬性關閉功能。我們都會看我們系統的部落格,每次我上 DexCom G5 使用者社團,幾乎每天晚上都有人說:「嘿,我剛拿到我的 DexCom,我的感測器已經戴了 2 週了。還能撐多久?我要怎麼做才能讓它撐更久?」然後你會看到——過去幾週,我看到有人說:「對,我每個感測器可以用 48 天,或每個感測器 7 週,這裡是我做的所有事情。」所以這就是我們在產品中內建的特性。我的意思是,我們的產品在超過 7 天的情況下也一直非常可靠。我認為隨著時間推進,依照我們的模式運作方式,特別是如果延長到 10 或 14 天,如果我們要把它關閉,那將會——絕對是出於品質目的,並確保其準確性,尤其是在我們的非輔助(nonadjunctive)主張之下。而我們看待這件事的方式,Margaret,實際上,雖然我們在美國向給付方的計費大約是每天 10 到 12 美元。如果我們真的硬性關閉,我們會確保對病患是公平的,因為我們一向如此;我們也會有一個方案,使病患——我們希望病患在經濟上不會受到傷害。這是我們會隨時間研究與探索、並投入大量思考與審慎評估的事情。所以這將會——是我們技術曲線上一個有趣的演進,我們有很多事情需要思考與考量。

  • Operator

    Operator

  • And we have our next question. Our next question comes from Danielle Antalffy from Leerink Partners.

    接下來我們進入下一個問題。下一個問題來自 Leerink Partners 的 Danielle Antalffy。

  • Danielle Antalffy - Director, Medical Supplies and Devices

    Danielle Antalffy - Director, Medical Supplies and Devices

  • Just a question on the competitive landscape. I don't want to belabor this but Kevin, I'd want to hear your thoughts on another competitor expected to come to market at some point later this year, The Abbot Libre, and they've added a significant number of patients internationally. What I'm really looking for is maybe your view on how the U.S. market, the dynamics there are different than the international markets where you compete head-to-head with them and therefore, why the competitive landscape, when they do come to the U.S., might be different than what we see internationally?

    我想問一個關於競爭態勢的問題。我不想在這點上多做糾纏,但 Kevin,我想聽聽你對另一個預計在今年稍晚某個時間上市的競爭對手——Abbot Libre——的看法,他們在國際市場新增了相當多的病患。我真正想了解的是,你如何看待美國市場——那裡的動態與你們在國際市場與他們正面競爭的情況有何不同——因此當他們進入美國時,競爭態勢可能會與我們在國際市場看到的不同?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, one of the first things to note international us versus Libre is, when we've restarted our entire international team, consisted of 3 people. And so we really hadn't built much infrastructure over there and we didn't have any reimbursement and the decision for a patient was very simple: pay cash for Libre, which is much less expensive than a DexCom system. So adding cash patients with that little price point upfront led to some significant growth. As Steve alluded to earlier and I can validate again is we have received reimbursement in some of these European geographies, a reasonable number of our patients adds are Libre users who aren't getting what they want from Libre. In the U.S. markets, again, one of our biggest assets is our nonadjunctive claim that a patient can dose insulin off of the system. And we believe intensive -- people intensively manage their diabetes. That is going to be an important feature. And so we believe in the intensive market, we can do well. And the fact is, again, even in Europe, where we don't have any of the resources they've had, you just heard us talk about a 37% 1st quarter growth factor in Europe and I mean, U.S. markets for this quarter and our reimbursed markets we're doing very well. So in the U.S., I think there's a niche for this. I think there will be people who want it. I think in the intense world where we are now, we can maintain our share with our connectivity, our SHARE features, the Android app, the new technology we have coming and, really, more important than anything else, our accuracy and the performance of our system. This has been documented time and time and time again. Over time, as we look at that market, I assure you, as you look at the Verily products, we will have products to compete head-to-head with that in the not-too-distant future that we think will be extremely good.

    嗯,首先要注意的一點是,在國際市場我們相較於 Libre 的情況是:當我們重新啟動整個國際團隊時,團隊只有 3 個人。因此我們在那邊其實沒有建立太多基礎設施,也沒有任何給付,對病患而言決策非常簡單:自費購買 Libre,而它比 DexCom 系統便宜得多。所以以那樣較低的前期價格去增加自費病患,帶來了相當顯著的成長。如同 Steve 先前提到、我也可以再次證實的是:我們在一些歐洲地區已取得給付,在我們新增的病患中,有相當比例是 Libre 使用者,他們從 Libre 得不到他們想要的東西。在美國市場,同樣地,我們最大的資產之一是我們的非輔助(nonadjunctive)主張:病患可以依據系統來施打胰島素。而我們相信重度——也就是密集管理糖尿病的人。那將會是一個重要的特性。因此我們相信在密集市場中,我們能做得很好。而事實是,再次強調,即使在歐洲,在我們沒有他們所擁有的資源的情況下,你剛剛也聽到我們談到歐洲第一季 37% 的成長因素;而就本季的美國市場以及我們有給付的市場而言,我們表現得非常好。所以在美國,我認為這會有一個利基市場。我認為會有人想要它。我認為在我們目前所處的密集使用領域,我們可以憑藉連線能力、我們的 SHARE 功能、Android app、我們即將推出的新技術,以及更重要的——我們的準確度與系統效能——來維持市占。這已經一次又一次又一次地被證實。隨著時間推進,當我們觀察那個市場時,我向你保證,當你看到 Verily 的產品時,我們在不久的將來也會有產品能與之正面競爭,而且我們認為會非常出色。

  • Danielle Antalffy - Director, Medical Supplies and Devices

    Danielle Antalffy - Director, Medical Supplies and Devices

  • Okay, that's helpful. And I guess, another issue for Libre might be what reimbursement looks like for that system. But one more question, Kevin, I have on the long-term outlook here from an OpEx perspective. I'm not asking for guidance, but just trying to think directionally. I know you've talked about how the look of the business will have to change when you do have a type 2 product. And I'm just curious about how the run rate for OpEx might change? Can you continue to -- can you drive leverage as you sort of shift the infrastructure and build the infrastructure for the type 2 market? Or should we think about, just directionally speaking, over the next few years as you get ready for this, sort of negative leverage or, at best, flat?

    好的,這很有幫助。我想,對 Libre 來說,另一個問題可能是那個系統的給付/報銷會是什麼樣子。但我還有一個問題,Kevin,關於這裡從營運費用(OpEx)角度的長期展望。我不是在要求你們提供指引,只是想從方向性來思考。我知道你們談過,當你們有第二類產品(type 2 product)時,業務的樣貌將必須改變。我只是好奇,OpEx 的運行率(run rate)可能會如何變化?當你們在轉移基礎設施並為第二型市場建立基礎設施時,你們能否持續——能否推動槓桿效益?或者我們應該怎麼想:只是方向性地說,在接下來幾年、當你們為此做準備時,會是某種負槓桿,或充其量持平?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • I appreciate that. You're talking really more about the commercial and the SG&A aspect of those expenses. And we have -- it's become very clear to us that this will be a different type of business model for us. We can't have the one-on-one ordering that we have now on what patients through their DME benefits in the way that we do things. It's going to have to be different. And we are exploring new business models that can do that. As Steve talked about earlier, outcome-based -- excuse me, type programs that we can sell with employers, payers, communities and things of that nature. There's going to have to be leverage and it's going to have to be done differently than what we do today. And we think we can leverage that and be successful. And so we're taking as much time with the business model in this area as we are taking with the technology. And the development of business model is every bit as high tech and challenging and different as developing the technology as it's really been a wonderful effort so far. And you'll hear more probably more towards late this year or early next year as to what that's going to look like for us.

    我理解。你談的其實更多是這些費用中的商業端與銷售、一般及行政(SG&A)面向。而我們——我們已經非常清楚,這對我們而言將會是不同類型的商業模式。我們不能像現在這樣,透過病患的 DME 給付,以一對一的方式下單、用目前的做法來運作。它必須改變。我們也正在探索能做到這點的新商業模式。如 Steve 先前提到的,以結果為基礎的——抱歉,是某類型的方案,我們可以賣給雇主、支付方、社區等。必須要有槓桿效益,而且必須用不同於我們今天的方式來做。我們認為我們可以運用這些槓桿並取得成功。因此,我們在這個領域花在商業模式上的時間,和花在技術上的時間一樣多。而商業模式的開發同樣是高科技、具挑戰性且不同於以往,就像開發技術一樣——到目前為止真的是一項很棒的努力。你們可能會在今年稍晚或明年初聽到更多,了解它對我們而言會是什麼樣子。

  • Operator

    Operator

  • And we have our next question. Our next question comes from David Lewis from Morgan Stanley.

    我們接下來的問題。下一題來自 Morgan Stanley 的 David Lewis。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • A couple of follow-ups and some clarification. Kevin, just on this topic and maybe Steve, actually, I think you answered this question. But on the 2/3 MDI mix, if that mix holds at 2/3 where it sort of has been in the next several quarters, you're still comfortable with your guidance, I'm assuming, because that's where it's been in the last several quarters. You seem to have copped up a little bit. But is 2/3 MDI throughout the remainder of the year an issue or something you're comfortable with?

    有幾個追問以及一些釐清。Kevin,就這個主題,或許 Steve——其實我想你已經回答了這個問題。但關於 2/3 的 MDI 組合(mix),如果這個組合在接下來幾季仍維持在 2/3、也就是近幾季大致的水準,我假設你們仍對你們的指引感到有把握,因為過去幾季就是這樣。你看起來有點語塞。但今年剩下的時間 MDI 都維持 2/3 會是問題嗎?還是你們對此是有把握的?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • No, that's actually been a goal, right? I mean, historically, we were even -- with the endocrinology community people always -- this is the old days, but people used to characterize CGM as just an adjunct to a pump. So we set out a number of years ago with our CGM-first campaign to show the world that CGM is the most important tool in diabetes management. So if you're on MDI, you can effectively manage your diabetes without going to a pump with MDI and CGM. So now I think it's actually -- that's a huge positive for us.

    不,那其實一直是我們的目標,對吧?我的意思是,歷史上——在內分泌科社群裡,人們總是——這是以前的說法,但過去有人把 CGM 描述成只是幫浦的輔助配件。所以幾年前我們發起了「CGM 優先」的活動,向全世界證明 CGM 是糖尿病管理中最重要的工具。因此,如果你使用 MDI,你可以在 MDI 加上 CGM 的情況下有效管理糖尿病,而不必一定要使用幫浦。所以我認為這其實——對我們來說是非常大的正面因素。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • Okay. So I totally understand, Steve. I guess what I'm getting at is if that number would go to 80% in the back half of the year, do you have enough MDI momentum to offset the pump degradation?

    好的。所以我完全理解,Steve。我想問的是,如果今年下半年那個數字升到 80%,你們是否有足夠的 MDI 動能來抵消幫浦端的下滑?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Sure. There's lots more patients on MDI. Now if you remember, pumps are only about 30% penetrated in the U.S. and less than 10% penetrated outside the U.S. So there's tons more patients in the MDI group.

    當然。使用 MDI 的病患多得多。如果你記得,幫浦在美國的滲透率大約只有 30%,在美國以外甚至不到 10%。所以 MDI 族群裡有大量更多的病患。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • Okay. And then Kevin, just -- or for Steve, guidance for this year, I mean, no one's really specifically asking, but how should we think about the impact Medicare is having on guidance? So we still assume a very limited impact in your expectations for Medicare? Was there any channel load at all here in the second -- first quarter into your DME partners to speak of?

    好的。然後 Kevin——或者問 Steve,今年的指引,我的意思是,沒有人真的在特別問,但我們應該如何看待 Medicare 對指引的影響?所以在你們對 Medicare 的預期中,我們仍假設影響非常有限嗎?在這裡第二——第一季,你們對 DME 合作夥伴那邊是否有任何通路備貨(channel load)可言?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • No, there's no channel load for us. We monitor our distributors very carefully and no, there's no channel load there. With respect to the impact of Medicare, again -- and even the impact of new patients and patient growth and that's a very good question. In all reality, as you're looking at a $700-plus million business, the number of new patients you can add on your quarter dwarfs what new patients can contribute 3 years ago to a quarter. So the new patients are very important and Medicare will have an impact. But I don't think you can move the needle like 10% or 20% certainly over the back half of the year. It can move at a lower amount of that depending upon how many patients that we add. So we will give you more guidance and color on that as we add them and we probably have to be very clear with Medicare patient numbers on margins and breaking some of this out. So everybody understands the story. What really moves the needle is in the periods going forward as you get a large established base with recurring revenues and we continue to shift to that business and it is going to evolve more over time than the upfront payments we get from new patients now.

    沒有,我們沒有通路備貨。我們非常仔細地監控我們的經銷商,沒有,沒有通路備貨。至於 Medicare 的影響——以及新病患與病患成長的影響——這是個非常好的問題。實際上,當你在看一個超過 7 億美元的業務時,你每一季能新增的新病患數,遠遠超過 3 年前新病患對單一季度所能貢獻的量。所以新病患非常重要,而 Medicare 也會有影響。但我不認為它能在今年下半年把指標推動 10% 或 20% 這麼多。它可能會以較低的幅度推動,取決於我們新增多少病患。因此,隨著我們新增病患,我們會提供更多指引與說明(color),而且我們可能必須非常清楚地揭露 Medicare 病患數對毛利的影響,並把其中一些拆分出來。讓每個人都能理解這個故事。真正能推動指標的是未來的期間:當你有一個龐大的既有基礎、帶來經常性收入,而我們持續轉向那樣的業務時——它會隨時間演進得更明顯,而不是像現在新病患帶來的前期付款那樣。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • Okay. And then Kevin, just -- we get this question a lot from shareholders in the last couple of weeks and months. In light of this year with Medicare, Libre, 670G, is it likely we get a guidance update earlier in the year this year based on those parameters or do those parameters actually make it a lot less likely you provide an update for the year into your more traditional period?

    好的。然後 Kevin,我們在過去幾週、幾個月常常從股東那裡被問到這個問題。考量今年有 Medicare、Libre、670G,是否可能因為這些因素而在今年較早的時點就更新指引?還是說這些因素反而讓你們更不可能在較早時點更新,而會在你們較傳統的時間點才提供年度更新?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • No, I mean, we evaluate our guidance on a quarterly basis and at this point, we're not comfortable because we're not shipping to Medicare. We're not comfortable -- we do think Medicare is a huge opportunity, and we'll evaluate it at the end of Q2, which will -- that call's probably going to happen in a month after the end of the quarter. Just where we seat today, we don't feel comfortable (inaudible)

    不,我的意思是,我們每季都會評估我們的指引,而在此刻我們還不放心,因為我們還沒有對 Medicare 出貨。我們還不放心——我們確實認為 Medicare 是一個巨大的機會,我們會在第二季結束時評估;那通電話大概會在季度結束後一個月左右進行。就我們今天所處的位置而言,我們不覺得放心(聽不清)

  • Operator

    Operator

  • And our next question comes from Tao Levy of Wedbush.

    我們下一題來自 Wedbush 的 Tao Levy。

  • Tao Levy - MD, Equity Research

    Tao Levy - MD, Equity Research

  • Maybe some clarification questions. In terms of the percent of patients who are on G5 versus G4, is that number that you guys can provide?

    也許幾個釐清問題。就使用 G5 相對於 G4 的病患百分比而言,這個數字你們能提供嗎?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • No, we've not broken it out. But remember, the disposable sensor is the same. So with respect to 70% of our revenue, it doesn't matter whether they're on G4 or G5. The only difference it makes to us financially as we noted in our prepared remarks is that the COGS on the G5 transmitter are a little higher.

    不,我們沒有把它拆分揭露。但請記得,一次性(拋棄式)感測器是相同的。所以就我們約 70% 的營收而言,他們用的是 G4 還是 G5 並不重要。對我們財務上唯一的差異,如同我們在事先準備的講稿中提到的,是 G5 發射器的銷貨成本(COGS)稍微高一些。

  • Tao Levy - MD, Equity Research

    Tao Levy - MD, Equity Research

  • Right. And so that's -- I mean, that's a -- has a decent size impact on some of your hardware sales? If you separate the two, I mean, hardware sales growth was reasonable this quarter, up over 30%, and then kind of where you fell a little bit short, at least versus my model, was on the sensor side, and what you had said on the call was you get more international so that lowered the ASP a bit. And so my question is that $2 million to $3 million related to Medicare is -- was that all sensor-related? Or is any of that hardware? And also, what happens to that in the second quarter?

    對。所以那就是——我的意思是,那對你們部分硬體銷售有相當程度的影響?如果把兩者分開來看,我的意思是,本季硬體銷售成長還算合理,超過30%,而你們稍微不如預期的地方——至少相對於我的模型——是在感測器端;你們在電話會議上提到的是,國際占比提高使ASP(平均銷售單價)略有下降。所以我的問題是,與Medicare相關的那200萬到300萬美元——那全部都是感測器相關嗎?還是其中有任何一部分是硬體?另外,第二季那部分會怎麼處理?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Those are -- I mean, it's much more sensor-related. These would be existing patients, so not new patients. I suppose there could be, in that mix, some anticipated transmitters. The transmitter died during the quarter but that would be predominantly sensor revenue.

    那些——我的意思是,更多是感測器相關。這些會是既有病患,所以不是新病患。我想在那個組合裡可能會有一些預期的發射器(transmitter),例如發射器在本季期間故障,但主要會是感測器營收。

  • Tao Levy - MD, Equity Research

    Tao Levy - MD, Equity Research

  • Got you. And then -- and what happens in the second quarter with that $2 million to $3 million? Can you start charging for?

    了解。那麼——第二季那200萬到300萬美元會怎麼樣?你們可以開始收費嗎?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • So we haven't been able to ship for -- these are ex-cash pay patients. And now that we have Medicare coverage, we cannot ship to them and charge them cash. So once they -- once we have coverage -- again, so back to once we have the formal coverage in place, we can absolutely continue to service these patients. There won't be a makeup per se. It's revenue that they would have -- we'll start charging -- we'll start charging Medicare per sensors and shipping sensors to them, but there won't be a catch out.

    所以我們一直無法出貨——這些是原本以現金自費的病患。而現在我們有了Medicare給付後,我們就不能再出貨給他們並向他們收現金。所以一旦他們——一旦我們有了給付——再說一次,回到一旦正式的給付到位,我們絕對可以持續服務這些病患。不會有所謂的補回(makeup)。這是他們原本會——我們會開始向Medicare按感測器收費並出貨感測器給他們,但不會有一次性補收或追補。

  • Tao Levy - MD, Equity Research

    Tao Levy - MD, Equity Research

  • Got you. And then just lastly, from a sort of like a strategic perspective, I think -- the question around you, "Will you guys ever buy a pump company?" had come up in the past. I think the response was, "No not really," but if it did potentially have an impact on our sensor business, not having a competitive artificial pancreas or similar device, then you guys might consider it. Is this kind of what we're talking about here where your pump partners aren't as quick to launch artificial pancreas technology?

    了解。最後,從策略角度來看,我想——過去曾有人問過你們:「你們會不會買一家胰島素幫浦公司?」我記得回覆是:「不太會」,但如果它可能會影響我們的感測器業務,例如沒有具競爭力的人工胰臟或類似裝置,那你們可能會考慮。我們現在談的是這種情況嗎?也就是你們的幫浦合作夥伴推出人工胰臟技術的速度沒那麼快?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, I mean, I can cut you short. No, we're not looking to buy a pump company. I think we continue to evaluate our partnership relationships. You could see us become a little more involved with one or more of the partners if some of them seem to fall off, but at this point in time, we're going to continue with our partnership strategy, again, both on the pump side and on interconnected pens and other software platforms. So not interested in buying pump.

    是的,我的意思是,我可以先打斷你。不,我們不打算收購幫浦公司。我想我們會持續評估我們的合作夥伴關係。如果其中一些合作夥伴看起來進度落後,你可能會看到我們與一個或多個合作夥伴更深度地參與,但就目前而言,我們會繼續採取合作夥伴策略——同樣地,涵蓋幫浦端、互聯式注射筆(interconnected pens)以及其他軟體平台。所以對收購幫浦不感興趣。

  • Operator

    Operator

  • And our next question comes from Joanne Wuensch of BMO Capital Markets.

    下一個問題來自BMO Capital Markets的Joanne Wuensch。

  • Joanne Karen Wuensch - MD and Research Analyst

    Joanne Karen Wuensch - MD and Research Analyst

  • Out of the sales force hires, is there a way to qualify or quantify the people that you have coming on board? And how are they spending their time largely? And then the second question, which is somewhat related, you talked about 10,000 Medicare patients coming in before you really do an outreach program towards them, can you discuss what that outreach program might look like and the timing of when that might happen?

    關於銷售團隊的招募,有沒有辦法對你們新加入的人員做一些質化或量化的描述?他們大部分時間都在做什麼?第二個問題也有點相關,你們提到在真正對Medicare病患做外展(outreach)計畫之前,會先有10,000名Medicare病患進來;能否談談那個外展計畫可能會長什麼樣子,以及大概什麼時候會發生?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, the outreach program will start as soon as we get a coverage decision in earnest. It will be much more noisy. It will be a combination of digital platforms. We'll also -- we have some TV ads that we'll run and then other media programs, very similar to what we do with our DTC campaigns today. We have very focused web, all that type of stuff going into plan to help these patients. And so we're going to do that one announcement that will come. Sorry, what was your other question?

    嗯,外展計畫會在我們真正取得給付決定後就立刻開始。它會更高調、更有聲量。會是數位平台的組合。我們也會——我們有一些電視廣告會投放,還有其他媒體方案,跟我們目前做的DTC(直接面向消費者)活動非常類似。我們有非常聚焦的網站,以及所有這類內容,納入計畫來協助這些病患。所以我們會做那個即將發布的公告。抱歉,你的另一個問題是什麼?

  • Joanne Karen Wuensch - MD and Research Analyst

    Joanne Karen Wuensch - MD and Research Analyst

  • Your new sales force hires..

    你們新招募的銷售團隊人員……

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Sales reps, okay. So the new sales adds came on board late last year and early this year. The sales adds in the U.S. were determined literally by dividing current territories and reassigning people within those territories. I would tell you like any sales force reorganization, there are some bumps and some speed bumps along the way. We are extremely happy with the quality of the people that we brought on board and we had absolutely no shortage of people wanting these jobs who are very, very qualified. But it does take a while to get everybody up and running. And we did experience that in the first quarter as well in the U.S. I mean, [Dr. Jones], some said he just lost (inaudible) and a new one is coming in and relationships have to be redeveloped and redeployed. We believe our team is up and running and doing well and it does take a little while. I mean, we expanded 20% to 25% on the U.S. side. And so there's a lot of new people. They have all been trained. They have all been in for training. We've had our international sales meeting and then they should be ready to go and then certainly very productive in the second quarter. The way we analyze all our salespeople in the U.S. and our key criteria is new patient adds. And we evaluate everybody based on their new patient targets and are very thoughtful and deliberate as we set those up and get that done. And so we watch everybody.

    銷售代表,好的。所以新增的銷售人員是在去年底和今年初加入的。美國的新增銷售人力,是透過把現有區域切分並在這些區域內重新分派人員來決定的。我會說,就像任何銷售團隊重整一樣,過程中會有一些顛簸和小障礙。我們對新加入人員的素質非常滿意,而且想要這些工作的人完全不缺,且都非常、非常合格。但要讓每個人完全上手需要一些時間。我們在第一季於美國也確實經歷了這點。我的意思是,[Dr.Jones],有人說他剛失去(聽不清楚)而新的代表正在接手,關係需要重新建立並重新部署。我們相信我們的團隊已經上軌道、運作良好,但確實需要一點時間。我的意思是,我們在美國端擴編了20%到25%。所以有很多新人。他們都已受訓。他們都已參加訓練。我們也開過國際銷售會議,接下來他們應該就能準備就緒,並且在第二季確實會非常有生產力。我們分析美國所有銷售人員的方式,以及我們的關鍵指標,是新增病患數。我們依據每個人的新增病患目標來評估,並在設定這些目標與推動落實時非常審慎且有計畫。所以我們會觀察每一位。

  • Operator

    Operator

  • And we have our next question. Our next question comes from Steven Lichtman of Oppenheimer.

    我們接著進入下一個問題。下一個問題來自Oppenheimer的Steven Lichtman。

  • Steven M. Lichtman - MD and Senior Analyst

    Steven M. Lichtman - MD and Senior Analyst

  • So obviously, a nice uptake in Germany and that continues to build. Where are we in terms of CGM reimbursement in additional countries in Europe? I know you talked about France and U.K. in the past.

    很明顯,德國的採用率提升得很好,而且還在持續增長。在歐洲其他國家的CGM(連續血糖監測)給付方面,我們目前進展到哪裡?我知道你們過去談過法國和英國。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Why don't you go ahead, Steve?

    Steve,你要不要繼續?

  • Steven R. Pacelli - EVP of Strategy & Corporate Development

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, I mean, we're still working with the French authorities. I don't want to be more specific other than we're hopeful within the next 6 to 12 months, we hope to see some reimbursement in France. Similarly, in the U.K., we've submitted the appropriate paperwork and are having discussions with the National Health Service there. We're starting to see reimbursement but in a more limited fashion in some of the other countries in Europe, where they're looking to provide set fixed amount of money for reimbursement. We're trying to figure out how we would play in some of those markets. Australia is starting to reimburse. So we're seeing it's happening certainly as quickly as we would've hoped.

    是的,我的意思是,我們仍在與法國主管機關合作。我不想講得更具體,只能說我們希望在未來6到12個月內,能在法國看到一些給付。同樣地,在英國,我們已提交適當的文件,並正與那裡的國民保健署(National Health Service)進行討論。我們開始在歐洲其他一些國家看到給付,但形式較為有限,因為他們傾向提供固定金額作為給付。我們正在思考在其中一些市場要如何運作。澳洲也開始給付。所以我們看到這件事正在發生,只是速度當然沒有我們原本希望的那麼快。

  • Steven M. Lichtman - MD and Senior Analyst

    Steven M. Lichtman - MD and Senior Analyst

  • Okay, great. And then beyond the dosing claim, you also had positive data, obviously, come through over the past few quarters through DIaMonD. How do you think you can leverage the DIaMonD data sets with clinicians and with patients, particularly as they get published?

    好的,很棒。那麼,除了劑量(dosing)適應症聲稱之外,過去幾季你們也有正面的數據——很明顯——來自DIaMonD。你認為你們可以如何把DIaMonD資料集運用在臨床醫師與病患端,特別是在它們發表之後?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, I don't think that one's -- certainly, having a published paper to take into clinicians, particularly as I go back to the example Steve gave and when I first started with DexCom, going out in the field. Frequently, when I would go into physicians' office, the first thing they would say to me, "I'm not giving a patient CGM unless they're on a pump." They have to be on a pump first. And what the DIaMonD study clearly shows is that is not the case. Then you can drive significant benefit being an MDI patient and wearing DexCom CGM. And I would tell you as we have clinicians -- as we meet with clinicians and conduct symposiums and educational programs across the country, that attitude has changed. The CGM-first message is taking hold and that DIaMonD paper is really the first thing we've ever had to document those outcomes. We think you can also be helpful for us with payers over time as we look for lower-cost solutions in managing patients with type 1 diabetes and in terms of insulin-using type 2 patients and we will use it for that as we try and expand our markets and our coverage and go deeper. So it's a very good start and the other data would be very helpful as well.

    嗯,我不認為那是——當然,能有一篇已發表的論文帶去給臨床醫師,特別是回到 Steve 舉的例子,以及我剛加入 DexCom、開始到外勤跑市場的時候。我常常走進醫師診間,他們第一句就會對我說:「除非病人有用胰島素幫浦,否則我不會讓病人用 CGM。」他們得先上幫浦。而 DIaMonD 研究清楚顯示,情況並非如此。即使是 MDI 病人配戴 DexCom CGM,也能帶來顯著效益。我也可以告訴各位,隨著我們與臨床醫師會面、並在全國各地舉辦研討會與教育計畫,那種態度已經改變了。「先用 CGM」的訊息正在被接受,而那篇 DIaMonD 論文確實是我們第一次用來記錄這些結果的資料。我們也認為,隨著時間推進,當我們尋求以較低成本的解決方案來管理第一型糖尿病病人,以及使用胰島素的第二型糖尿病病人時,這也能在與支付方溝通上對我們有所幫助;我們會運用它,來擴大市場與給付覆蓋,並進一步深耕。所以這是一個非常好的開始,而其他數據也會同樣非常有幫助。

  • Operator

    Operator

  • And our next question comes from Chris Cooley of Stephens.

    下一個問題來自 Stephens 的 Chris Cooley。

  • Christopher Cook Cooley - MD

    Christopher Cook Cooley - MD

  • Just two for me. One, would you be willing to characterize the Medicare pipeline in terms of which channel they're primarily served in? Are they coming in primarily through the endo channel or are these patients that are being cared for by GP? Just trying to think a little bit about how frequently they visit their practitioner and then converting them over time, once the coverage decision comes into place. And then just as a quick follow-up from a model perspective, when the additional 2 payers come online, in Germany and Europe, over 50% of the covered lives there, should we think about incremental pressure to the global ASP on the sensor side or is that already kind of factored into your prior comments?

    我有兩個問題。第一,您是否願意就 Medicare 的導入管線做個描述,主要是透過哪個通路服務?他們主要是透過內分泌科(endo)通路進來,還是這些病人主要由一般科醫師(GP)照護?我想更了解他們多常回診,並在給付決策落地後,如何隨時間推進把他們轉換過來。另外,從模型角度快速追問:當德國與歐洲另外兩家支付方上線、覆蓋當地超過 50% 的受保人群時,我們是否應該預期感測器端的全球 ASP 會有額外下行壓力,還是這已經大致反映在您先前的評論中?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • As Steve said earlier, in Germany, our sensor reimbursement in Germany is very similar to what we get here in the U.S. So again, if these payers come on in Germany, chances are it would have a positive impact if Germany becomes a greater percentage of our international business. As I said earlier, it's probably around 20% of the total OUS business right now. So we'll just have to see how that goes. With respect to referrals and positions of our Medicare patients, we're getting leads from 2 sources, certainly online, and online referrals of patients coming through our website and enrolling, and those patients can have general practitioners and endocrinologists. With respect to referrals from the field, those are primarily coming from endocrinologists, which is where our field team spend most their time. And if you go into an endocrinologist's office, at least when I go in, as much as I want to talk about our pipeline, all the stuff that's coming in the future, the first question I get every time is, "When are you going to be able to take care of my Medicare patients?" So I think there is good pent-up demand amongst endocrinologists to help that senior population.

    如 Steve 先前所說,在德國,我們在德國的感測器給付水準與我們在美國拿到的非常相近。所以同樣地,如果這些支付方在德國上線,若德國在我們國際業務中的占比提高,這很可能會帶來正面影響。如我先前提到,目前它大概占我們 OUS(美國以外)業務總量的 20% 左右。所以我們就得看看後續發展如何。至於 Medicare 病人的轉介來源與就診端,我們的線索主要來自兩個來源:一是線上,病人透過我們網站進來並完成登錄;這些病人的主治醫師可能是一般科醫師或內分泌科醫師。至於來自外勤的轉介,主要來自內分泌科醫師,因為我們的外勤團隊大部分時間都在那個通路。而且你走進內分泌科診間——至少我每次去——不管我多想談我們的產品管線、未來要推出的各種東西,我每次收到的第一個問題都是:「你們什麼時候才能照顧我的 Medicare 病人?」所以我認為內分泌科醫師對於協助那個高齡族群有相當強的被壓抑需求。

  • Operator

    Operator

  • I am showing no further questions at this time.

    目前顯示沒有其他問題。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • All right. I'm go to wrap it up. I want to thank everybody for their participation on our call today and your continued support of DexCom. In preparation for today's call, we noted that my first earnings call with DexCom was exactly 6 years ago today. And we proudly reported $13.1 million in product revenue for the quarter, not 1 week's revenue for us going forward from now on. It's been a very fast and extremely rewarding 6 years driven by a tremendous amount of hard work and commitment from our team here. Think about the short list of industry first: CGM performance that finally met patient expectations, the first FDA-approved apps to allow patients to share data, the first system ever to communicate directly to a phone, the first device ever to be labeled to make therapeutic insulin dosing decisions, and finally, the first product to Medicare, at least in a few weeks or a few months, we hope. While this list is great and we're very proud of all that we've done, everybody here at DexCom would tell you that if you look out over the next 6 years, that list is going to be much longer and much more meaningful as we drive the message of CGM as a standard of care for glucose measurement across the board.

    好的。我來做個總結。感謝各位今天參與我們的電話會議,也感謝各位持續支持 DexCom。在準備今天的電話會議時,我們注意到,我第一次主持 DexCom 的財報電話會議,剛好就是 6 年前的今天。當時我們很自豪地報告該季度產品營收為 1,310 萬美元——而在未來,這甚至不會是我們一週的營收。這 6 年進展非常快速、也極其令人滿足,背後是我們團隊投入大量努力與承諾所推動的成果。想想那份「業界首創」的短清單:終於達到病人期待的 CGM 表現、第一個獲 FDA 核准可讓病人分享資料的 App、第一個能直接與手機通訊的系統、第一個被標示可用於治療性胰島素劑量決策的裝置,以及最後——我們希望——在幾週或幾個月內,成為第一個進入 Medicare 的產品。這份清單很棒,我們也為所做的一切感到非常自豪;但 DexCom 的每個人都會告訴你,如果把眼光放到未來 6 年,這份清單會更長、也更有意義,因為我們將推動「CGM 作為血糖量測的照護標準」這個訊息,全面落地。

  • I had an opportunity this past weekend to speak with an individual, whose family has been greatly affected by diabetes, in the recent JDRF gala here in San Diego. This person commented to me that while he is very generous and is supporting diabetes research, it's DexCom that saves his children every night and he told me to be very mindful of that as we go forward in what we do. We'll never forget that. As we launch our new product platforms, incorporate Verily's high technology and truly merge high tech and med tech, build out our new factory, communicate and connect to more and more devices and expand into new markets over the next several years, our commitment to patients will never change. We truly want to enable people to take control of their diabetes. Thank you.

    上週末在聖地牙哥這裡最近舉辦的 JDRF 慈善晚宴上,我有機會與一位人士交談;他的家庭深受糖尿病影響。他對我說,雖然他非常慷慨、也在支持糖尿病研究,但真正每晚拯救他孩子的是 DexCom;他也提醒我,隨著我們往前推進,務必要時刻記得這一點。我們永遠不會忘記。當我們推出新的產品平台、導入 Verily 的高科技並真正融合高科技與醫療科技、擴建新工廠、與越來越多裝置進行溝通與連結,並在未來幾年拓展到新市場時,我們對病人的承諾永遠不會改變。我們真心希望讓人們能掌控自己的糖尿病。謝謝。

  • Operator

    Operator

  • 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。今天的會議到此結束。感謝各位參與。您現在可以掛線。