德康醫療 (DXCM) 2017 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

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

    歡迎參加 DexCom 2017 年第三季財報發布電話會議。我是 Adrian,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'll now turn the call over to Matt Dolan, Vice President, Corporate Development. Matt Dolan, you may begin.

    現在我將把電話會議交給企業發展副總裁 Matt Dolan。Matt Dolan,您可以開始了。

  • Matt Dolan

    Matt Dolan

  • Thank you, Adrian, and welcome to DexCom's Third Quarter 2017 Earnings Call. With us today are Kevin Sayer, DexCom's President and CEO; Steve Pacelli, our Executive Vice President of Strategy and Corporate Development; and Quentin Blackford, our Executive Vice President and Chief Financial Officer. We will begin with our prepared remarks and then open the call up for your questions. (Operator Instructions) I will begin with our safe harbor statement and then pass the call over to Kevin.

    謝謝你,Adrian,也歡迎各位參加 DexCom 2017 年第三季財報電話會議。今天與我們一同出席的有 DexCom 總裁暨執行長 Kevin Sayer;策略與企業發展執行副總裁 Steve Pacelli;以及執行副總裁暨財務長 Quentin Blackford。我們將先進行事先準備的發言,接著開放各位提問。(接線員指示)我將先宣讀安全港聲明,然後把電話會議交給 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 hereof 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 such forward-looking statements after the date of this presentation or to conform these forward-looking statements to actual results.

    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。本簡報中所有前瞻性陳述均以本日為準,係基於 DexCom 目前可得資訊作出,並受各種風險與不確定性影響,實際結果可能與前瞻性陳述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產生重大差異的因素,已詳載於 DexCom 的 Form 10-K 年報、Form 10-Q 季報及向美國證券交易委員會提交的其他文件中。除法律要求外,我們不承擔在本簡報日期後更新此等前瞻性陳述,或使其與實際結果一致的任何義務。

  • Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP net loss and 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.

    此外,在本次電話會議中,我們將討論若干未依 GAAP 編製的財務衡量指標,包括我們的非 GAAP 淨損失與以現金為基礎的營運結果。此額外資訊之呈現不應被孤立看待,亦不應作為依 GAAP 編製之結果的替代,或被視為優於依 GAAP 編製之結果。

  • With that, I'll turn it over to Kevin.

    接下來,我把電話會議交給 Kevin。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you, everyone, for joining us today. I will begin the call with an overview and then hand it over to the team for their comments on our financial results. I would like to start by publicly welcoming Quentin to our executive management team. He's already been a big contributor to DexCom, and we're looking forward to the next leg of our journey together.

    謝謝各位今天加入我們。我將先就整體情況做概述,接著把電話會議交給團隊,請他們評論我們的財務結果。我想先公開歡迎 Quentin 加入我們的高階管理團隊。他已經為 DexCom 做出很大貢獻,我們也期待與他一同邁向下一段旅程。

  • DexCom continues to shine with revenues up 24% through the first 3 quarters of the year. We remain significantly underpenetrated in the intensive diabetes marketplace, and the number of covered lives that we have access to has doubled since last year.

    DexCom 持續表現亮眼,今年前三季營收成長 24%。在重度糖尿病市場中,我們的滲透率仍明顯偏低,而我們可觸及的受保人數自去年以來已翻倍。

  • From an overall business perspective, our financial picture has never been better. Gross margins are within our targets. Our expenses are scaling as anticipated. The business is generating cash, and we continue to make key investments for our future. Our U.S. business continues to see adoption across the intensive population, where approximately 2/3 of our new patient additions are on multiple daily injections. We continue to believe that CGM should be the first-line device in the management of diabetes regardless of a patient's insulin delivery preference. Internationally, DexCom adoption accelerated again with several markets driving overall growth of greater than 80%. Our strategy outside the U.S. is working even in the face of increased competition. We remain disciplined in driving our value proposition through the clinical benefits of real-time CGM particularly as we see improving reimbursement in these markets.

    從整體業務角度來看,我們的財務狀況從未如此良好。毛利率落在我們的目標範圍內;費用如預期般隨規模擴張;業務正在產生現金流,我們也持續為未來進行關鍵投資。我們在美國的業務持續在重度族群中被採用,其中約 2/3 的新增病患使用每日多次注射(MDI)。我們仍相信,無論病患偏好何種胰島素輸送方式,連續血糖監測(CGM)都應是糖尿病管理的一線裝置。在國際市場方面,DexCom 的採用再次加速,多個市場帶動整體成長超過 80%。即使面臨更激烈的競爭,我們在美國以外的策略仍然奏效。我們在推動價值主張上保持紀律,透過即時 CGM 的臨床效益來驅動,特別是在我們看到這些市場的給付情況持續改善之際。

  • In the U.S., the team has been working aggressively to fulfill the significant demand we have seen from the Medicare population. As we told you on our last call, early in the third quarter, the billing codes for CGM became effective and we are now servicing and submitting claims for our Medicare patients. I'm pleased to tell you that these early submissions have gone well. In Q3, between our direct and distributor efforts, we estimate that we shipped to more than 4,000 Medicare customers and continue to have a strong Medicare pipeline, totaling close to 20,000 patients. This Medicare roll-out is an unprecedented opportunity for DexCom but it's also been a significant drag on our commercial organization. Patients have simply been waiting too long. To our Medicare patients, please trust me. We have heard you loud and clear, and for this reason, our first priority for the rest of the year is to get the product to you.

    在美國,團隊一直積極努力,以滿足我們在 Medicare 族群中看到的龐大需求。正如我們在上次電話會議所提到的,第三季初 CGM 的計費代碼已生效,我們目前正為 Medicare 病患提供服務並提交理賠申請。我很高興地告訴各位,這些早期提交進展順利。在第三季,透過我們的直營與經銷商努力,我們估計已向超過 4,000 名 Medicare 客戶出貨,且仍有強勁的 Medicare 潛在客戶管線,總計接近 20,000 名病患。這次 Medicare 的推廣對 DexCom 而言是前所未有的機會,但也對我們的商業組織造成了相當大的拖累。病患等待的時間實在太久了。對我們的 Medicare 病患而言,請相信我:我們已清楚聽到你們的聲音,因此,我們今年剩餘時間的首要任務,就是把產品交到你們手上。

  • Finally, we submitted our G6 PMA with the FDA, as committed to, at the end of the third quarter. Since then, we've had several interactions with the agency. In addition to the once-per-day calibration system we submitted, we believe we have a regulatory pathway to launch a no-calibration, real-time system sometime before the end of 2018. I will dig into this on our product pipeline plans shortly.

    最後,我們如承諾在第三季末向 FDA 提交了 G6 的 PMA。此後,我們已與主管機關進行了多次互動。除了我們所提交的每日一次校準系統之外,我們相信在 2018 年底之前的某個時間點,我們有一條法規途徑可推出免校準的即時系統。我稍後將在產品管線規劃中進一步說明。

  • With that, I will turn the call over to Steve for a review of our financials. Steve?

    接下來,我把電話會議交給 Steve,請他回顧我們的財務狀況。Steve?

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Thanks, Kevin. DexCom reported record revenue of $185 million for the third quarter of 2017 compared to $149 million for the same quarter in 2016, a $36 million or 24% increase. Sequentially, revenue was up 8%.

    謝謝你,Kevin。DexCom 2017 年第三季營收創下新高,達 1.85 億美元,較 2016 年同期的 1.49 億美元增加 3,600 萬美元,增幅 24%。以季比來看,營收成長 8%。

  • As Kevin mentioned, we began processing our Medicare-eligible patients in the third quarter. The revenue contribution remained relatively small, but considering the monthly subscription model established by CMS as compared to our commercial business, where we generate higher upfront revenues, we expect contribution from this population to steadily increase over the next several quarters. Of note, our early metrics are positive. Both approvals and reorders have been strong. While we were still early in our Medicare ramp, we see significant demand from the field and are optimistic about our commercial team's ability to execute from here.

    如 Kevin 所提到,我們在第三季開始處理符合 Medicare 資格的病患。其營收貢獻仍相對較小,但考量到 CMS 所建立的按月訂閱模式,相較於我們的商業業務(通常可產生較高的前期收入),我們預期該族群的貢獻將在未來幾季穩步提升。值得注意的是,我們的早期指標表現正面,核准與再訂購都很強勁。雖然我們仍處於 Medicare 擴張的早期階段,但我們看到來自前線的顯著需求,並對商業團隊接下來的執行能力感到樂觀。

  • Our third quarter gross profit was $127 million, generating a gross margin of 69% compared to a gross margin of 68% for the same quarter in the prior year. We remain comfortable with our full year gross margin outlook. As you saw in our press release, our product mix was within our normal historical range at approximately 70% sensors and 30% hardware. Average sensor pricing, again, came in just under $70 due to the strength of our international business, where we have a larger percentage of revenue running through our distributors at a lower ASP.

    第三季毛利為 1.27 億美元,毛利率 69%,相較於去年同期毛利率 68% 有所提升。我們對全年毛利率展望仍感到安心。如同你們在新聞稿中所見,我們的產品組合落在正常的歷史區間,約為 70% 感測器與 30% 硬體。感測器平均售價(ASP)再次略低於 70 美元,主要因國際業務表現強勁,而在國際市場中,我們有較高比例的營收透過經銷商銷售,ASP 較低。

  • Operating expenses totaled $128 million for Q3 compared to $120 million in Q3 of 2016, reflecting an increase of 7% year-over-year and down 3% sequentially. Overall, operating expenses were well-controlled relative to our top line growth, and we continue to invest in our key initiatives, including DTC marketing campaigns, OUS expansion and product innovation.

    第三季營業費用合計 1.28 億美元,較 2016 年第三季的 1.20 億美元增加,年增 7%,季減 3%。整體而言,營業費用相對於營收成長受到良好控制,我們也持續投資於關鍵計畫,包括 DTC(直接面向消費者)行銷活動、OUS(美國以外)擴張與產品創新。

  • Our GAAP net loss was $2 million or $0.02 per share. Excluding a noncash tax benefit related to our convertible notes, non-GAAP net loss was $3.1 million or $0.04 per share. Absent approximately $30 million in noncash charges, primarily share-based compensation and noncash interest expense and excluding the tax benefit mentioned above, our non-GAAP cash-based net income was $27 million.

    GAAP 淨損失為 200 萬美元,或每股 0.02 美元。若排除與可轉換公司債相關的非現金稅務利益,非 GAAP 淨損失為 310 萬美元,或每股 0.04 美元。若不計約 3,000 萬美元的非現金費用(主要為股份基礎給付與非現金利息費用),並排除上述稅務利益,我們的非 GAAP 以現金為基礎的淨利為 2,700 萬美元。

  • We ended the third quarter with $526 million in cash and marketable securities on our balance sheet compared to $124 million at the end of 2016. Our increased cash balance was driven by cash flow from operations and our convertible debt offering earlier this year, offset by higher CapEx primarily associated with our manufacturing infrastructure build-out.

    第三季末,我們資產負債表上的現金及有價證券為 5.26 億美元,較 2016 年底的 1.24 億美元增加。我們現金餘額的提升主要來自營運現金流,以及今年稍早的可轉換債券發行;但部分被較高的資本支出所抵銷,該資本支出主要與我們製造基礎設施的建置相關。

  • With respect to the balance of 2017, we have narrowed our expectations and now expect global revenue in 2017 to come in at the lower end of our guidance range. This would be consistent with our mid-teens sequential growth last year from Q3 and Q4. As we've discussed, the timing of our Medicare ramp in Q4 creates variability in the revenue contribution from this patient base. Finally, the amount of competitive noise in our marketplace and the uncertainty surrounding several of our partners warrants a bit of conservatism.

    就 2017 年剩餘期間而言,我們已縮小預期範圍,並預期 2017 年全球營收將落在我們指引區間的低端。這與去年第三季到第四季的季增率落在十幾個百分點中段相一致。如我們所討論的,第四季 Medicare 擴張的時點,將使該病患族群的營收貢獻存在變動性。最後,市場中的競爭雜音程度,以及我們若干合作夥伴相關的不確定性,使我們需要保持一定程度的保守。

  • With that, I would like to turn the call over to Quentin for some additional commentary. Quentin?

    接下來,我想把電話會議交給 Quentin,請他補充一些評論。Quentin?

  • Quentin S. Blackford - CFO

    Quentin S. Blackford - CFO

  • Thank you, Steve. Having been on the CFO seat for 2 months to the day and having witnessed several market-changing dynamics, I can say that I have never been more excited about the opportunities ahead of us here at DexCom. Our CGM technology has applicability far beyond my original assumptions and has tremendous upside to our current penetration levels. Beyond the commercial opportunities of the DexCom technology, one of the aspects that attract me to DexCom was my belief that there were numerous opportunities to identify and drive efficiencies in our cost structure. Those beliefs are now convictions as I've had the opportunity to get into the details and better understand the existing cost structure.

    謝謝你,Steve。我在財務長職位上到今天正好滿兩個月,並見證了多項改變市場的動態,我可以說,我從未像現在這樣對 DexCom 未來的機會感到興奮。我們的 CGM 技術適用範圍遠超出我原先的假設,且相對於我們目前的滲透水準,仍有巨大的上行空間。除了 DexCom 技術的商業機會之外,吸引我加入 DexCom 的其中一個面向,是我相信在我們的成本結構中,有許多機會可以辨識並推動效率提升。隨著我有機會深入細節並更了解現有成本結構,這些信念如今已成為確信。

  • For example, we're in the very early stages of standing up our manufacturing facility in Mesa, Arizona, which weighs on operating margins today and will continue through 2018 but then become a meaningful lever for us well into the future. A large component of our product cost today is manufacturing overhead. As a result, a good portion of our product cost will remain relatively fixed as we scale into the future and the benefits of incremental volume through the plant will drive meaningful cost reductions. Further, the ability to automate a large part of our processes will lead to further efficiencies, translating to cost improvements and enabling meaningful scale at a lower cost.

    例如,我們正處於在亞利桑那州梅薩建立製造設施的非常早期階段,這在目前對營業利益率造成壓力,並將持續到 2018 年,但之後將在未來很長一段時間內成為我們重要的槓桿。我們目前產品成本中的一大部分是製造間接費用。因此,隨著我們在未來擴張規模,我們相當一部分的產品成本將保持相對固定,而透過工廠增加的增量產量所帶來的效益,將推動顯著的成本降低。此外,自動化我們流程中的很大一部分的能力將帶來進一步的效率提升,轉化為成本改善,並使我們能以更低成本實現有意義的規模化。

  • From an operating expense perspective, we have multiple levers within our G&A spend profile, where we have hundreds of basis points of improvement which can be accomplished with automation and scalability initiatives that we'll begin to implement gradually. Further, similar opportunities exist within our sales and marketing profile, where we can become more efficient without impacting our customer experience.

    從營業費用的角度來看,在我們的 G&A(一般及行政)支出結構中有多個槓桿可用;透過自動化與可擴展性計畫,我們可實現數百個基點的改善,而我們將開始逐步推動落實。此外,在我們的銷售與行銷支出結構中也存在類似機會,我們可以在不影響客戶體驗的情況下提升效率。

  • The multitude of opportunities to address in our cost structure become a meaningful enabler of our ability to continue to out-innovate our competitors and aggressively capture new customers in these rapidly evolving markets. As we continue to introduce a more disciplined approach to capital deployment across the company, you'll hear more from us with respect to our plans to deliver an improved profit profile with meaningful free cash flow generation over time. Kevin?

    在我們成本結構中可著手的眾多機會,將成為我們持續在創新上超越競爭對手、並在這些快速演變的市場中積極獲取新客戶能力的重要推動力。隨著我們持續在全公司導入更具紀律的資本配置方法,未來你們將聽到我們更多關於計畫的內容,即如何隨時間推進,透過有意義的自由現金流產生來交付更佳的獲利結構。Kevin?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you, Quentin. Well, as you all know, the diabetes industry is never boring. I will discuss our current market dynamics momentarily, but I would like to begin by affirming our long-term positioning.

    謝謝你,Quentin。嗯,正如各位所知,糖尿病產業從來不無聊。我稍後會討論我們目前的市場動態,但我想先重申我們的長期定位。

  • In our core intensive diabetes markets around the world, CGM remains less than 10% penetrated. We remain committed to best-in-class performance, increased patient convenience, enhanced connectivity, data analytics and lower-cost platforms. Beyond our intensive strategy, our product initiatives will drive a number of business model innovations for the nonintensive population that, we believe, will fundamentally shift how we serve these patients.

    在全球我們核心的重度(intensive)糖尿病市場中,CGM 的滲透率仍低於 10%。我們仍致力於同級最佳的效能、提升病患便利性、強化連結性、資料分析以及更低成本的平台。除了我們的重度策略之外,我們的產品計畫也將為非重度族群帶來多項商業模式創新;我們相信,這將從根本上改變我們服務這些病患的方式。

  • In our U.S. business, the commercial pipeline is as strong as it's ever been even with the Medicare challenges of the past 9 months. We are making strides working through our Medicare backlog, and Steve gave you those metrics. Given the progress we saw in the quarter, we are doing everything we can to get this backlog taken cared of by the end of the year.

    在我們的美國業務方面,即使過去 9 個月面臨 Medicare 的挑戰,我們的商業管線仍一如既往地強勁。我們在處理 Medicare 積壓案件方面正取得進展,Steve 也向各位提供了相關指標。鑑於我們在本季看到的進展,我們正盡一切努力在年底前把這些積壓案件處理完成。

  • To add a little more color on our international markets, of course, Germany has been very strong. But our growth has been broad-based. Our commercial investments are paying off with revenue roughly doubling in nearly all of our direct geographies. It's also worth noting that with our receiver optional configuration, more international patients are choosing to go direct to their phones and not purchasing a receiver. By driving down the upfront cost of CGM, we are seeing a very nice uptick in demand.

    再補充一些我們國際市場的細節,當然,德國表現非常強勁。但我們的成長是廣泛分布的。我們的商業投資正在見效,在幾乎所有我們直接經營的地區,營收大約都翻倍成長。也值得注意的是,透過我們「接收器可選」的配置,更多國際病患選擇直接使用手機,而不購買接收器。透過降低 CGM 的前期成本,我們看到需求出現非常不錯的上升。

  • Later in the third quarter, the FDA approved Abbott's FreeStyle Libre Flash Glucose Monitoring System. We always believe the FDA would approve the system. And while we understand why it has been labeled as CGM, it is not real-time CGM. The benefits of real-time CGM are clear. Reliable accuracy, actionable alerts and alarms, and connectivity will all drive clinical outcomes in the intensive world and will deliver value in all applicable markets.

    在第三季稍晚,FDA 核准了 Abbott 的 FreeStyle Libre Flash Glucose Monitoring System。我們一直相信 FDA 會核准該系統。雖然我們理解它為何被標示為 CGM,但它並非即時(real-time)CGM。即時 CGM 的效益是明確的:可靠的準確度、可採取行動的提醒與警報,以及連結性,將在重度領域推動臨床結果,並在所有適用市場中創造價值。

  • Overall, there is a very positive conclusion here for DexCom. We believe the pathway is clearly paved for sensors to replace finger-sticks, and we're going to take this opportunity to move faster. Please remember we have been competing against Libre outside the U.S. for 3 years, and our growth there has accelerated for the fifth consecutive quarter.

    整體而言,對 DexCom 來說這裡有一個非常正面的結論。我們相信,感測器取代指尖採血的道路已清楚鋪就,而我們將把握這個機會加速前進。請記得,我們在美國以外與 Libre 競爭已 3 年,而我們在那裡的成長已連續第五個季度加速。

  • Our focus on driving reimbursement based on a differentiated value proposition for real-time, continuous glucose monitoring is resonating with payers around the world. Many international payers have recognized that flash-based systems are not equivalent to real-time CGM and have created different reimbursement categories for each. Early signs in the U.S. suggest that payers feel the same way. We also know that many of our new international patients have transitioned from Libre to DexCom because of these important differences. Ultimately, this is a very, very large and very underpenetrated market.

    我們專注於以「即時、連續血糖監測」的差異化價值主張來推動給付(reimbursement),這一點正與全球各地的支付方產生共鳴。許多國際支付方已認知到 flash 型系統不等同於即時 CGM,並為兩者建立了不同的給付類別。美國的早期跡象顯示,支付方也有相同看法。我們也知道,許多新的國際病患因為這些重要差異,已從 Libre 轉換到 DexCom。最終而言,這是一個非常、非常龐大且滲透率極低的市場。

  • Last month, J&J Animas announced it is finally exiting the pump business in the U.S. J&J announced this change in direction back in January. And Animas' contribution to our new patient additions has been minimal for some time. At this point, although this decision will ultimately be a drag on our patient base, we view it as manageable.

    上個月,J&J Animas 宣布其終於將退出美國的胰島素幫浦業務。J&J 早在今年 1 月就宣布了這項方向轉變。而 Animas 對我們新增病患數的貢獻已在一段時間內相當有限。在此時點,雖然這項決定最終將對我們的病患基礎造成拖累,我們認為其影響仍在可控範圍內。

  • Now for a pipeline update. Turning to our product pipeline, we submitted our G6 PMA to the FDA at the end of the third quarter. Based on our review of the data, the G6 platform takes real-time CGM sensor performance to the next level especially in terms of its improvements in stability and consistency over an extended period of time. It also carries important ease-of-use enhancements, including a new applicator and smaller form factor. We know patients will be excited by the reliability and convenience of this system. As I mentioned in my opening remarks, since our filing, we have been in regular communication with the FDA. And while it is early, we believe we have a path to bring the first real-time, no-calibration sensor to market before the end of 2018. We will continue discussions with the FDA to bring this important advancement to the diabetes community.

    接下來更新一下研發管線。談到我們的產品管線,我們在第三季末向 FDA 提交了 G6 的 PMA。根據我們對資料的審視,G6 平台將即時 CGM 感測器的效能提升到新的層級,特別是在更長時間範圍內的穩定性與一致性方面的改善。它也帶來重要的易用性提升,包括新的安裝器(applicator)以及更小的外形尺寸。我們知道病患會對這套系統的可靠性與便利性感到興奮。如同我在開場致詞中提到的,自我們送件以來,我們一直與 FDA 保持定期溝通。雖然目前仍早,但我們相信在 2018 年底前,我們有一條路徑可將第一款「免校準」的即時感測器推向市場。我們將持續與 FDA 討論,把這項重要進展帶給糖尿病社群。

  • On the app and wearables front, the number of DexCom customers using their mobile phones is rising steadily with the availability of both iOS and Android systems. Patients want to share their data with loved ones, and DexCom's connectivity provides that very important capability. We are also leveraging our connectivity to provide patients' CGM data on alternative displays, like the Apple Watch and Android wear devices. We also recently announced our efforts with Fitbit to provide a display on their new smartwatch. Our open API platform went live during Q3 and received a great response.

    在 App 與穿戴裝置方面,隨著 iOS 與 Android 系統皆可使用,使用手機的 DexCom 客戶數正穩定上升。病患希望與親友分享其資料,而 DexCom 的連結性提供了這項非常重要的能力。我們也正運用連結性,將病患的 CGM 資料提供在替代顯示裝置上,例如 Apple Watch 與 Android 穿戴裝置。我們最近也宣布與 Fitbit 的合作努力,將在其新智慧手錶上提供顯示。我們的開放 API 平台在第三季上線,並獲得非常好的回應。

  • Within our insulin delivery partners, development of DexCom integrated systems are making progress. Insulet has shown tremendous dedication to our partnership, and our teams are working hard to bring our connected systems to market. Once launched, we see a number of differentiating features in our combined systems, including an attractive form factor and opportunities for smartphone connectivity. In the meantime, we have embarked on a few commercial activities together, and we'll continue to work with Insulet to deliver attractive options for our shared patients.

    在我們的胰島素輸送合作夥伴方面,DexCom 整合式系統的開發正在推進。Insulet 對我們的合作展現了極大的投入,我們的團隊正努力將連網系統推向市場。一旦上市,我們在整合系統中看到多項差異化特點,包括具吸引力的外形尺寸,以及智慧型手機連結性的機會。與此同時,我們已共同展開一些商業活動,並將持續與 Insulet 合作,為我們共同的病患提供具吸引力的選擇。

  • Tandem recently launched its G5 sensor-augmented pump, representing the first insulin pump system that carries a non-adjunctive sensor claim. And because Tandem's pump offering is field upgradable, patients won't be locked into a legacy technology and will be able to use enhancements as soon as they're available.

    Tandem 最近推出其搭載 G5 感測器的幫浦,這代表第一套具備「非輔助(non-adjunctive)」感測器宣稱的胰島素幫浦系統。而且由於 Tandem 的幫浦產品可在現場升級,病患不會被鎖定在舊有技術上,並能在改良功能一推出時就立即使用。

  • Shifting to our nonintensive strategy. We are making good progress with our pilot programs, and we'll expand our efforts in 2018. We look to complete development of our first-generation CGM system with Verily in the first half of next year. The timing of its commercial launch will be dependent upon the outcome and timing of our no-calibration regulatory strategy. The DexCom and Verily R&D teams are also beginning to accelerate efforts on the smaller, less expensive second-generation system. Our early experience continues to show the value of real-time, connected CGM outside of the insulin intensive diabetes population. Real-time data is intuitive and allows patients and caregivers to quickly optimize drug therapies and behavior.

    接著談我們的非重度(nonintensive)策略。我們的試點計畫進展良好,並將在 2018 年擴大投入。我們預期在明年上半年完成與 Verily 合作的第一代 CGM 系統開發。其商業上市時點將取決於我們免校準法規策略的結果與時程。DexCom 與 Verily 的研發團隊也開始加速推進更小型、成本更低的第二代系統。我們的早期經驗持續顯示,即時、連網的 CGM 在胰島素非重度糖尿病族群之外同樣具有價值。即時資料直觀,能讓病患與照護者快速優化藥物治療與行為。

  • In conclusion, the DexCom team continues to deliver in 2017, and we have a number of positive catalysts as we look forward to next year. Medicare will become a key contributor. Our OUS momentum should remain very, very strong. Product innovation in 2018 promises to be the most remarkable year in DexCom's history, and we have tremendous opportunities to continue to improve our financial results going forward.

    總結來說,DexCom 團隊在 2017 年持續交出成果,展望明年我們也有多項正面催化因素。Medicare 將成為關鍵貢獻來源。我們的 OUS(美國以外)動能應會維持非常、非常強勁。2018 年的產品創新有望成為 DexCom 歷史上最卓越的一年,而我們也有巨大的機會在未來持續改善財務表現。

  • With that, I'd now like to open up the call to Q&A, but before Q&A, I'm going to turn it back over to Matt to go over the ground rules again. Thanks, everyone. Matt?

    接下來,我想開放進入問答環節;但在問答之前,我會把時間交回給 Matt,請他再次說明基本規則。謝謝大家。Matt?

  • Matt Dolan

    Matt Dolan

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

    謝謝你,Kevin。(操作員指示)Adrian,請提供問答說明。

  • Operator

    Operator

  • (Operator Instructions) And our first question comes from David Lewis from Morgan Stanley.

    (操作員指示)我們的第一個問題來自 Morgan Stanley 的 David Lewis。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • Could we start, Kevin, talking about the U.S. market in this quarter? I think you talked about in our conference, given the Medicare push, there were some distraction amongst some of the U.S. sales force, Kevin. So just the trends you're seeing in the U.S. marketplace this quarter and how you expect it to trend into the balance of the year. And I had a quick follow-up.

    Kevin,我們可以先談談本季美國市場嗎?我記得你在我們的會議上提到,鑑於推動 Medicare 的因素,美國部分銷售團隊出現了一些分心的情況,Kevin。所以想請你談談你在本季美國市場看到的趨勢,以及你預期在今年剩餘時間會如何發展。另外我有一個簡短的追問。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Sure, thanks. With respect to the U.S. market, the noise that you talked about from the Medicare push has been very real. Each of us has been out in the field over the past -- literally in the past month and ridden around in it. And frequently, we walk into a physician's office with our sales rep and get handed a list, "Here is my Medicare patients. When you take care of them, we'll give you some more." And so it has been a bit of a difficult issue for our field team. But now that we've learned how to process these things and we've got -- we think we're over the initial hurdles, we can start getting these patients out the door. Our U.S. commercial pipeline is still very robust and very large. Our digital marketing program continues to generate a large number of leads, and we're getting a good number of leads from the field as well. It's just a matter of execution right now and we need to push through this. But Medicare has had a big impact on us. There's no question.

    當然,謝謝。就美國市場而言,你提到由 Medicare 推動所帶來的雜音確實非常明顯。我們每個人在過去——真的就在過去一個月——都到第一線跑過、親身感受過。很多時候,我們和業務代表一起走進醫師診所,對方就遞給我們一份清單:「這些是我的 Medicare 病人。你們把他們處理好,我再給你們更多。」因此,這對我們的外勤團隊來說一直是個有點棘手的問題。但現在我們已經學會如何處理這些狀況,而且我們也——我們認為已經跨過了最初的障礙,就可以開始把這些病人順利推進流程。我們在美國的商業端管線仍然非常強勁、規模也很大。我們的數位行銷計畫持續產生大量潛在客戶,我們也從外勤端獲得相當多的線索。現在就是執行面的問題,我們需要把它推過去。但 Medicare 對我們的影響很大,這點毫無疑問。

  • David Ryan Lewis - MD

    David Ryan Lewis - MD

  • Okay. I think, Kevin, just -- you talked to some of this in your prepared remarks, and I appreciate that. But it sounds like your strategy going forward is going to continue to -- as it relates to competition, price to value and not compete on price. So I just want to have you kind of walk through that. And have you thought about the pharmacy benefit channel? And is it more important now for the company to start approaching payers more proactively to start talking about these differences between real-time CGM and CGM? And I'll jump back in queue.

    好的。我想,Kevin,只是——你在事先準備的發言裡已經談到一部分,我也很感謝。不過聽起來你們接下來的策略會繼續——就競爭而言,會以「價值對應價格」(price to value)為主,而不是打價格戰。所以我想請你再帶大家走一遍這個邏輯。你們有沒有考慮過藥局給付通路(pharmacy benefit channel)?而且現在公司是否更重要的是要更主動地接觸付款方(payers),開始溝通即時 CGM(real-time CGM)與 CGM 之間的差異?我會回到隊列後面。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Thank you. A couple of thoughts here. First of all, with respect to pricing, as we've been competitive in Europe with Libre for a -- for quite some time, we've been able to maintain a higher price level with them because of the additional features of our product. Because of the actionable alerts, the alarms, the continuous data, the connectivity, the ability to share data, all the things that really make our system unique have a great benefit to our intensively managed patients. And we will continue to emphasize those features as we go forward. With respect to the distribution channel, we push hard on the pharmacy benefit channel for quite some time. And of all our initiatives, this has very much been an uphill battle. We'll win one. We'll lose one. Medicare is in the DME channel. So that's where we're focusing a lot of our distribution efforts right now. With respect to the long term and with respect to cost and pricing everything, please understand we've had cost-reduction initiatives in place for a long, long time, and those things are going to start hitting. Quentin talked about increased volumes, reducing overhead. Longer sensor wear -- or longer sensor labeling certainly reduces our cost per day. We have electronics configurations on the horizon. It will come very quickly with orders of magnitude cheaper than the ones that we make now. We've had cost reduction plans in place for a long time. And as you look out 3, 4 years, then we have our Verily disposable products coming, which really have aggressive cost targets and we hit them. We can compete that way as well. For today, for our intensive world, we're going to stick to value and we're going to go about it that way. Over time, we're prepared to whatever direction the market takes us.

    謝謝。這裡有幾點想法。首先,關於定價,我們在歐洲與 Libre 競爭已經——已經有相當長一段時間了,我們之所以能維持較高的價格水準,是因為我們產品具備額外的功能。可採取行動的警示(actionable alerts)、警報、連續數據、連線能力、資料分享能力,以及所有真正讓我們系統獨特的要素,對於我們密集管理(intensively managed)的病患都有很大的效益。我們未來也會持續強調這些功能。至於配銷通路,我們在藥局給付通路上強力推動已經很久了。但在我們所有的倡議中,這一直是非常艱難的逆風戰;我們會贏一個、也會輸一個。Medicare 在 DME 通路,所以我們目前把很多配銷資源聚焦在那裡。就長期而言,關於成本與定價等各方面,請理解我們已經推動降本計畫很長、很長時間了,而這些效益將開始顯現。Quentin 提到的量增、降低間接費用;延長感測器配戴——或更長的感測器標示(labeling)當然會降低我們的每日成本。我們也有即將推出的電子元件配置,會很快到來,成本將比我們現在製造的低上好幾個數量級。我們的降本計畫已經部署很久了。當你往後看 3、4 年,我們還會有 Verily 的一次性(disposable)產品推出,其成本目標非常積極,而且我們能達成。我們也可以用那種方式競爭。但就今天、就我們的密集管理市場而言,我們會堅持以價值為核心,並以此方式推進。隨著時間推移,我們也已準備好因應市場帶我們走向的任何方向。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • David, I think one other comment on pricing that should not be lost on people has to deal with a real-world -- like what we view as a real-world per day cost for the product, right, because while, on its label, where a 7-day label at around $70, the sensors are $10 a day. People get nervous when they hear Abbott talking -- you hear Abbott talking $4 or $5 a day. But in reality, if patients wearing a sensor for 12 days of 14 days, our per-day price on a sensor -- in reality, the revenue per patient is how we really look at it. The revenue per patient per day is a lot closer to where Abbott is in Europe and, frankly, where we think Abbott is going to come in, in the U.S. So that's an important thing that analysts and investors, frankly, shouldn't be lost on.

    David,我想關於定價還有一點不應該被大家忽略:那就是我們所認為的「真實世界」每日成本(real-world per day cost),對吧?因為雖然在標示上,7 天標示大約是 70 美元,感測器看起來是每天 10 美元。當大家聽到 Abbott 談——你聽到 Abbott 談每天 4 或 5 美元時,會感到緊張。但實際上,如果病患一個感測器戴 14 天中的 12 天,我們感測器的每日價格——實際上,我們看的是每位病患的收入。每位病患每日的收入其實更接近 Abbott 在歐洲的水準,而且坦白說,也更接近我們認為 Abbott 在美國最終會落在的水準。所以這是一個重要的點,分析師與投資人坦白說不應該忽略。

  • Operator

    Operator

  • And our next question comes from Jeff Johnson from Baird.

    下一個問題來自 Baird 的 Jeff Johnson。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • Kevin, you mentioned in your prepared remarks that you're seeing some early signs that payers are seeing a difference between real-time CGM and, obviously, the Libre product. I was wondering if you could flesh that out a little bit and maybe talk about what you're hearing from U.S. commercial payers between your product and Libre over time as well.

    Kevin,你在事先準備的發言中提到,你們看到一些早期跡象顯示付款方開始看出即時 CGM(real-time CGM)與顯然是 Libre 產品之間的差異。我想請你再多補充一點,並談談你們從美國商業保險付款方那裡,長期以來聽到的你們產品與 Libre 之間的比較。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, this is Steve. I'll take that one. A couple of things, somewhat anecdotal at this point, but there was a call hosted by one of your competitors a few -- maybe a few weeks ago that had a couple of payers, and that was kind of the general theme. "This is not CGM. It shouldn't be priced as the same category." We've seen it in Europe. I mean, Germany is a great example where we certainly receive a premium price on an annualized basis versus the Libre. We're starting to hear the same thing just anecdotally from physicians and from physicians who, frankly, have influence over the payers. So we have to wait and see how it plays out. I think Abbott's path to reimbursement is going to take some time. This is not a -- it's not something that they're just going to flip the switch and have reimbursement overnight. So we'll see how it plays out, but initial indication is there's certainly differentiation among the premium-priced product that we offer.

    是的,我是 Steve,我來回答。幾點說明:目前還有點偏軼事性(anecdotal),但幾——可能幾週前,有一場由你們某個競爭對手主辦的電話會議,邀了幾個付款方,整體主軸大概就是:「這不是 CGM,不應該用同一個類別來定價。」我們在歐洲也看到了。德國就是很好的例子,我們按年化基礎來看,確實能相對於 Libre 取得溢價。我們也開始從醫師那裡聽到類似的說法,而且坦白說,這些醫師對付款方是有影響力的。所以我們得再觀察後續如何發展。我認為 Abbott 取得給付的路徑還需要一些時間。這不是——不是他們只要一按開關就能一夜之間拿到給付的事情。所以我們會看它怎麼走,但初步跡象顯示,我們所提供的高價位(premium-priced)產品確實存在差異化。

  • Jeffrey D. Johnson - Senior Research Analyst

    Jeffrey D. Johnson - Senior Research Analyst

  • All right. That's helpful, Steve. And I know we've gone out and talked to plenty of endocrinologists and diabetologists. And I would love to hear what maybe you're hearing in the field. If Abbott would get pharmacy access, obviously, that makes it much easier for the docs to prescribe a Libre over a DexCom system. Just what would your strategy be if there's a big move to pharmacy for Libre versus your products staying largely in the DME channel at this point?

    好的,這很有幫助,Steve。我也知道我們出去和很多內分泌科醫師與糖尿病專科醫師聊過。我也很想聽聽你們在第一線可能聽到什麼。如果 Abbott 能取得藥局通路(pharmacy access),顯然會讓醫師開立 Libre 比開立 DexCom 系統容易得多。若 Libre 大幅轉向藥局通路、而你們的產品目前仍主要留在 DME 通路,你們的策略會是什麼?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, quite honestly, it would be nice if somebody else would go somewhere first instead of us. We've been first everywhere here. So if, in fact, there is a big push to pharmacy and we can get acceptable reimbursement rates there, we'd be happy to follow. With respect to DME in general, like I said, Medicare has put our product in the DME category. And several payers have told us, as we push for pharmacy benefit, that CGM is a DME product regardless of how we want to put it in pharmacy. So it's been an uphill fight for us. If they get pharmacy coverage with payers, certainly, we will take the opportunity to follow if that simplifies distribution and we can generate the type of gross profits that are acceptable to us. In the meantime, we can still sell DME. And while distribution channel does make it easier for people to get our product, ultimately, for people who have this condition, the most important thing is the product that they use and the features that it offers and the benefits it provides. And we believe we went out that way.

    嗯,老實說,如果能有別人先走一步而不是我們,會很好。我們在很多地方都是第一個。所以如果確實有很大的推力轉向藥局通路,而我們也能在那裡取得可接受的給付費率,我們很樂意跟進。至於一般的 DME,如我所說,Medicare 已把我們的產品歸在 DME 類別。而且當我們推動藥局給付時,有幾個付款方告訴我們,不管我們想怎麼把它放進藥局,CGM 都是 DME 產品。所以對我們來說一直是逆風戰。如果他們能在付款方那裡取得藥局給付,當然,如果那能簡化配銷、並且我們能產生我們可接受的毛利水準,我們會把握機會跟進。與此同時,我們仍然可以在 DME 銷售。而且雖然配銷通路確實會讓人更容易取得我們的產品,但最終,對於有這個疾病的人來說,最重要的是他們使用的產品、它提供的功能,以及它帶來的效益。我們相信我們會以這種方式勝出。

  • Operator

    Operator

  • And our next question comes from Mike Weinstein from JPMorgan.

    下一個問題來自 JPMorgan 的 Mike Weinstein。

  • Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

    Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

  • Can you hear me? I apologize.

    你們聽得到我嗎?不好意思。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes, we can hear you, Mike.

    是的,Mike,我們聽得到。

  • Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

    Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

  • Sorry. I'm still at PCT on my cell phone. So I apologize. So let me just circle back on the updated guidance for the year. So this quarter, obviously, OUS business had a great quarter. U.S. business grew 16%. Your guidance for the year seems to imply that you've been -- the U.S. business grows at a similar rate in the fourth quarter. Am I reading that correctly? Basically, I think the U.S. business grows at about that 16% rate in the fourth quarter.

    抱歉。我還在 PCT,用手機通話,所以不好意思。那我回到今年更新後的財測指引。這一季,顯然 OUS(美國以外)業務表現很強;美國業務成長 16%。你們對全年指引看起來意味著——美國業務在第四季會以類似的速度成長。我這樣解讀對嗎?基本上,我認為美國業務在第四季大約也是 16% 的成長率。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes, that's fair.

    是的,這樣說合理。

  • Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

    Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

  • Okay. And then I want to make sure I understand, Kevin, your thoughts and plans for Verily. Well, let me step back. So I want to understand your thoughts and plans for G6 and no-calibration. It sounded like you were saying by the end of the year, next year, that you would need to get an initial approval for one calibration and like a supplement on that to no-calibration. So, a, do I understand that correctly? And then, b, the timing of Verily gen 1 is unclear at this point because it may be influenced by what happens with G6.

    好的。接著我想確認我是否理解,Kevin,你對 Verily 的想法與計畫。嗯,我先退一步。我想了解你對 G6 與免校準(no-calibration)的想法與計畫。聽起來你在說,到今年底、明年,你們需要先取得「一次校準」(one calibration)的初始核准,然後再以補充申請(supplement)把它推進到免校準。所以,a,我理解得對嗎?然後,b,Verily 第一代(gen 1)的時程目前不明朗,因為它可能會受到 G6 進展的影響。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • That piece is correct, Mike. The way we look at this -- and understand we just completed the largest CGM study that the FDA has ever seen. We have matched pairs, almost 30,000 matched pairs in the study to YSI. There's all sorts of data here. And people have seen what our no-calibration G6 data looks like at numerous seminars over the past several months. As we looked at the results for that trial and we looked at that data, we felt the product is accurate enough to go no-calibration now. And we've had open discussions with the FDA about how we would do that. Now the PMA is on file, and we discussed 3 or 4 alternatives with the FDA with respect to how we do that. And one of them is the one you outlined to whereby we get the one calibration a day product approved and then file a supplement on top of that. We're discussing a couple of other alternatives with them as well, and I really don't want to give the whole playbook here because it's all very tentative. Our first priority is to get the product to our patients with no-calibration that serves the current patient base and can meet the cost profile that they're looking for. That's our G6 system as it is now with the reusable transmitter. Once we get through that filing, then the first Verily product becomes a priority. That product has disposable transmitter and will be thrown away. We have decisions to make, for example, about 14-day life versus 10 days and things of that nature that we'll make as we go through these processes. The second-generation Verily product will come after that, and we're accelerating work on that product rapidly because that is our product with the most aggressive cost targets and really with the size and usability that we think our patients want ultimately. And that is a very, very -- it's going very well. It has a very aggressive time frame, and we need to work on that, too. So we've got several things lined up in the pipeline, but they're all dependent upon decisions we'll make over the next 6 months. But I can tell you by the time we're out of the first quarter, we'll know exactly what's happening. We wouldn't say we were comfortable with the no-calibration G6 sensor if we weren't. We're very comfortable we have...

    那部分是正確的,Mike。我們看待這件事的方式是——也請理解,我們剛完成了 FDA 迄今看過最大規模的 CGM 研究。我們在研究中與 YSI 做了配對,將近 30,000 組配對數據。這裡有各式各樣的資料。而且在過去幾個月的多場研討會上,大家也都看過我們免校準 G6 的數據表現。當我們檢視那項試驗的結果並查看那些數據時,我們認為產品的準確度已足以現在就做到免校準。我們也已就如何實現這點與 FDA 進行了公開討論。現在 PMA 已經送件,我們也就如何推進與 FDA 討論了 3 或 4 種替代方案。其中一種就是你所描述的:先讓每日一次校準的產品獲批,然後再在其上提交補充申請。我們也正在與他們討論其他幾種替代方案;我真的不想在這裡把整套劇本都講出來,因為一切都還很初步。我們的首要任務,是把免校準的產品交到病患手上:既能服務現有病患基礎,也能符合他們所期待的成本結構。那就是我們目前的 G6 系統,搭配可重複使用的發射器。等我們完成那個申報之後,第一個 Verily 產品就會成為優先事項。那個產品採用一次性發射器,用完就丟。我們也需要做一些決策,例如 14 天壽命 versus 10 天,以及諸如此類的事項,我們會在推進這些流程時逐步決定。第二代 Verily 產品會在那之後推出;我們正在快速加速該產品的工作,因為那是我們成本目標最具進取性的產品,而且在尺寸與易用性方面,我們認為最終是病患真正想要的。那個項目非常、非常——進展得非常順利。它的時程非常積極,我們也需要同步推進。因此我們在管線中排了好幾件事,但都取決於我們在未來 6 個月內要做的決策。不過我可以告訴你,等到第一季結束時,我們會非常清楚到底會發生什麼。如果我們對免校準的 G6 感測器沒有把握,我們不會說我們很有信心。我們非常有信心我們已經……

  • Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

    Michael Neil Weinstein - Senior Medical Technology Analyst and Head of Healthcare Group

  • And maybe just one more. I don't know if I could sneak it in. You didn't give a full update on reimbursement in Germany. So can you do that in terms of where you are as well as any progress with other geographies?

    另外也許再問一個。我不知道能不能插問一下。你沒有完整更新德國的給付(reimbursement)狀況。所以你能否就你們目前的進度,以及其他地區是否也有進展,做個更新?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes. We have reimbursement now, I think, from 43% of the payers have direct contract relationships. So 43% of the payers now and are about to knock off another one of the big ones, which I think puts us up over...

    可以。我們現在的給付,我想是有 43% 的保險支付方已與我們建立直接合約關係。所以目前有 43% 的支付方,而且我們也即將再拿下一家大型支付方,我想那會讓我們提升到超過……

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Over 50%.

    超過 50%。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes, we have over 50%, and the other ones approved it on a one -- on a use-by-use basis. We're not having any trouble getting people to pay for product in Germany. It's going very well.

    是的,我們已經超過 50%,其他的也以個案——以逐案使用(use-by-use)的方式核准。我們在德國讓人們為產品付費這件事上沒有遇到任何困難,進展非常順利。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes, it's actually covered lives. And that's what we committed to, by the end of the year, was to have north of 50%. That's covered lives under commercial contract.

    是的,這其實是以涵蓋人數(covered lives)來看。而這也是我們承諾的:到年底要達到超過 50%。那是指在商業合約下的涵蓋人數。

  • Operator

    Operator

  • And our next question comes from Jayson Bedford from 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 to clarify, would you launch G6 with a no -- with a one-cal system? Or are you waiting for the no-cal?

    我想確認一下,你們會以免——以每日一次校準的系統來推出 G6 嗎?還是你們會等到免校準?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • That remains to be seen, Jayson. We'll see what happens as we head down the path.

    這點還有待觀察,Jayson。我們會看在推進的過程中會發生什麼。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • Okay. And then...

    好的。然後……

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • We -- let me just add a little bit to that. We need a new product in the U.S. The G5 is wonderful with its connectivity. We've added Android. We've added things around it, but the fact is our guys need something new to sell. We're going to launch something new next year. And if the fastest path to get something new is that, we'll pursue it. We would prefer to go to no-calibration directly, but we will do whatever is most efficacious and whatever we can work through with the FDA.

    我們——我再補充一點。我們在美國需要一個新產品。G5 的連線功能很棒。我們加入了 Android,也在周邊加了很多東西,但事實是,我們的業務團隊需要一些新的東西可以賣。我們明年會推出某個新產品。如果取得新產品的最快路徑是那樣,我們就會去做。我們更希望能直接走向免校準,但我們會做最有效率的做法,以及任何我們能與 FDA 一起推進並完成的做法。

  • Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst

  • Okay, Kevin. And then my question, I guess, in terms of Medicare, it seems like you're progressing well here. At what point do you get more aggressive with the advertising?

    好的,Kevin。那我想問的是,就 Medicare 而言,看起來你們進展得不錯。你們會在什麼時點開始更積極地投放廣告?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • We've just started trickling it out a little bit. We've not gotten too aggressive yet, but we have started a little bit out there. It's a very good question. One of the nice things about Medicare is we don't have the seasonality deductibles that we have in our other commercial business in the U.S. I think we'll start pushing harder in the fourth quarter and very much early on in the year next year.

    我們才剛開始一點點地釋出,還沒有太積極,但確實已經開始在外面做一些了。這是個很好的問題。Medicare 的一個好處是,我們不像在美國其他商業保險業務那樣,會受到自付額(deductibles)季節性影響。我想我們會在第四季開始更用力推,並且在明年年初非常積極。

  • Operator

    Operator

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

    下一個問題來自 Canaccord 的 Kyle Rose。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • Can you hear me all right?

    你們聽得到我嗎?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes.

    聽得到。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • Great. So I appreciate the additional color at the beginning of the call as far as the patient demographics. It sounded like 2/3 of the underlying patient base in the commercial sector are MDI. I just wondered if you could give us a little more color as far as how you think about the rest of the mix. Maybe break down as far as adults versus peds and then potentially what type of exposure you may have to Animas, say, pumps in particular.

    很好。謝謝你們在電話會議一開始補充了更多關於病患人口結構的資訊。聽起來在商業保險領域的既有病患基礎中,有 2/3 是 MDI。我想請你們再多補充一些你們如何看待其餘組合的想法。也許可以拆分一下成人 versus 兒科(peds),以及你們可能對 Animas——例如特別是其幫浦——有多少曝險?

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes. I mean, we've never given a real breakdown on a quarterly basis of adults versus pediatric adds. What we've said in the past -- and it holds true, is that peds have been trending nicely. Out of the gate, peds were obviously a huge contributor when we got that approval a couple of years ago. But I would tell you today peds are roughly tracking, and they typically track about the estimates of whatever we think the peds represent in the U.S. As far as Animas -- so peds is an important aspect of Animas, the Animas shutdown, a couple of things. Kevin mentioned in his prepared remarks that new patient contribution from Animas has been basically 0 for a pretty long period of time. So this isn't going to impact new patient additions. From a shutdown perspective for existing Animas patients, they -- Animas does do quite well. It's well known Animas does well in the pediatric segment. And so to the extent Medtronic has access to those patients, they wouldn't have access in theory, shouldn't have access to the pediatric patients because they're not labeled -- the 670 is not labeled for pediatric use. I would also add on the Animas front, look, people have chosen Animas pump for a reason. They chose an Animas pump with DexCom connectivity because of superior sensor, right. I mean, to the extent Medtronic is able to fix their sensor manufacturing challenges and actually supply sensors at some point in the future, patients have opted for a far superior sensor with the DexCom technology. So when we say it's manageable, that's what we're thinking. I mean, Insulet's running an aggressive program to target those patients. Tandem is running a program as well. So this isn't something that we're going to lose a whole bunch of patients overnight to the extent we could have some at risk, but we think it's manageable.

    是的。我們其實從未按季度提供成人與兒科新增用戶的明確拆分。我們過去說過——而且現在仍然成立——兒科的趨勢表現不錯。一開始,在我們幾年前拿到核准時,兒科顯然是很大的貢獻來源。但我可以告訴你,今天兒科大致上是跟著走的,而且通常會與我們對兒科在美國所占比重的估計相當一致。至於 Animas——所以兒科是 Animas、Animas 關停事件中的一個重要面向,有幾點。Kevin 在事先準備的發言中提到,來自 Animas 的新病患貢獻在相當長一段時間裡基本上是 0。所以這不會影響新增病患數。從既有 Animas 病患的關停角度來看,他們——Animas 的表現其實相當不錯。眾所周知,Animas 在兒科族群做得很好。因此在 Medtronic 能接觸到那些病患的程度上,理論上他們不應該能接觸到兒科病患,因為他們沒有標示——670 並未標示可用於兒科。我也要補充,在 Animas 這一塊,大家選擇 Animas 幫浦是有原因的。他們選擇具備 DexCom 連線的 Animas 幫浦,是因為感測器更優秀,對吧。也就是說,即便 Medtronic 未來某個時間點能解決其感測器製造上的挑戰並實際供應感測器,病患之所以選擇的是 DexCom 技術,是因為那是明顯更優秀的感測器。所以當我們說這是可控的,我們的思考就是這些。Insulet 正在運行一個積極的計畫來鎖定那些病患,Tandem 也在運行一個計畫。因此這不是那種我們會在一夜之間流失一大堆病患的事情;即便我們可能有一些面臨風險的病患,我們仍認為是可控的。

  • Kyle William Rose - Senior Analyst

    Kyle William Rose - Senior Analyst

  • Great. I really appreciate that additional color. And then just, obviously, I think the approval with Libre and the label had got -- you caught a lot of people by surprise. I just wanted to see if you could step back and give us a little color on. And how do you think the FDA is just evaluating the risk benefit of CGM in these -- in flash products, overall, from a high level? And it sounds like you guys have moved around or at least evaluating the pipeline, but just high-level thoughts as far as how you guys think about the future regulatory pathways for some of these products?

    很好,非常感謝你補充這些細節。然後再問一下,顯然 Libre 的核准以及其標示——讓很多人感到意外。我想請你們退一步,從高層次談談:你們認為 FDA 在這些——在 flash 產品中——整體上是如何評估 CGM 的風險效益?另外聽起來你們已經調整或至少正在評估產品管線,但就高層次而言,你們如何看待未來這些產品可能的監管(regulatory)途徑?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, I think, the regulatory pathways, I can tell you, we're going to be more aggressive. If I can take one learning away from the whole experience and labeling there, I think we're going to push ourselves to do better and to move faster. We need to. And we went through 1.5-year time frame working on that non-adjunctive claim because that was the first they'd ever done and the first they had ever seen. And it's great we got it, but it literally slowed us down for about 1.5 years to work through all that data and with that processing and the panel meeting and all of that stuff. I think moving forward, we can go much more aggressively. I think the statement I made earlier in the call is very applicable. After the shock and surprise, we sat back and said, "You know what, we really can replace finger-sticks. Finger-sticks can go away now. We can make devices that can replace them across the board. And we'll work with the agency to make those devices. What we are focused on and what we'd encourage the committee to focus on, we need to make sure these devices are good. We need to make sure these devices are safe and these devices meet patient needs. We can't have devices where you get into some of the fiascos we've gotten into with finger-sticks, for example, where you have accuracy across the board products out there. And we need to make sure that the devices do what they claim they're going to do and provide the patient the benefit that they need. But I think it's a new day for us, and I think we'll make everybody happy with the pipeline we have coming.

    嗯,我認為在監管途徑方面,我可以告訴你,我們會更積極。如果我能從整個經驗以及那邊的標示中帶走一個學習,我想我們會推動自己做得更好、動得更快。我們必須如此。我們花了1.5年的時間在那個非輔助(non-adjunctive)宣稱上,因為那是他們第一次做、也是他們第一次看到。拿到當然很好,但它確實讓我們為了處理所有那些資料、以及相關流程、專家小組會議和所有那些事情而慢了大約1.5年。我認為往後我們可以更具侵略性地推進。我覺得我在電話會議前面所說的那段話非常適用。在震驚與意外之後,我們坐下來說:「你知道嗎,我們真的可以取代指尖採血。指尖採血現在可以消失了。我們可以製造能全面取代它們的裝置。我們也會與主管機關合作來做出那些裝置。」我們專注的、也鼓勵委員會專注的,是我們必須確保這些裝置是好的。我們必須確保這些裝置是安全的,且能滿足病患需求。我們不能讓裝置落入像我們在指尖採血上遇到的一些亂象,例如市面上到處都有準確度參差不齊的產品。我們需要確保這些裝置能做到它們所宣稱要做到的事,並為病患提供他們所需要的效益。但我認為對我們而言這是新的一天,我想我們會用我們即將推出的產品管線讓大家都滿意。

  • Operator

    Operator

  • And our next question comes from Doug Schenkel from Cowen and Company.

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

  • Doug Schenkel - MD & Senior Research Analyst

    Doug Schenkel - MD & Senior Research Analyst

  • Two questions. First on CMS, you said you expect to clear the remainder of backlog by the end of the year. Could you give us some more details on how the billing process is working today? And are you ready to really open this up? Or are you still working through just some of the ramp and inefficiencies there? But then the second question is on FDA. Based on everything we've talked about in terms of the evolving environment, what's the outlook for you removing the current requirement in the U.S. to sell a receiver to all new patients?

    兩個問題。第一個關於 CMS,你們說預期在年底前清掉剩餘的積壓案件。能否再多提供一些目前帳單/請款流程如何運作的細節?你們是否已經準備好真正把它全面開放?還是仍在處理一些爬坡期與效率不彰的問題?第二個問題關於 FDA。基於我們談到的整個環境演變,你們對於在美國取消目前「所有新病患都必須購買接收器(receiver)」這項要求的展望如何?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • With respect to the receiver requirement, that really is going to require additional filing for us. And the thing that we're concerned about or contemplating there as we do that, we don't want to mess up our Medicare label, which requires for a receiver to have DME coverage. So we have to balance those 2 things, and we will do that. With respect to CMS and the Medicare patient backlog, we have made some progress. There are 20,000 patients, we said, in the pipeline. I also said we're hopeful we get through the whole backlog. Again, we need to meet the demands of our commercial patients, and the pipeline addition to servicing those. So it's going to be a balancing act, but we need to take care of these people. And with respect to our billing experiences so far, we've been paid quite regularly on claims. The reorder history for those actually eligible for reorders has been solid. It's been very good, but it is still very different than our regular patients. I mean, I had a 5-email exchange with a Medicare patient last year because the birthdate that he gave his doctor is not the birthdate in his Medicare record, and he can't believe that we were so stupid that we couldn't get that processed. And finally, we figured it out, and this was somebody that was acquainted with a dear friend of mine from that past. So I got involved and I had a look into the life of our inside sales people, and I wanted to walk over there and thank him on -- apologize for what they're going through. But this is what's happening and this is how it works, and we just need to learn what the rules are and play by them. We hope to get through that whole pipeline and get them shipped. But as the guy said earlier, again, on a Medicare patient, that first billing is only $500 versus our commercial patients that are $1,500 on average with 2, 3 boxes of sensors, 2 transmitters and receiver. So we don't get the same amount of revenue, but it is probably more paperwork. So it's a balance. We need to take care of these patients and honor our commitments here, and we will do so as best as we can. But that's kind of how it plays out, and that's a big factor we look at Q4 going forward.

    關於接收器的要求,這確實需要我們再做額外的申報。而我們在做這件事時所擔心或考量的是,我們不想影響我們的 Medicare 標示,因為那個標示要求必須有接收器才能取得 DME 給付。所以我們必須在這兩件事之間取得平衡,我們也會這麼做。至於 CMS 與 Medicare 病患的積壓案件,我們已經取得一些進展。我們說過管線裡有 20,000 名病患。我也說過我們希望能把整個積壓清完。再次強調,我們也需要滿足商業保險病患的需求,以及在服務他們的同時新增的管線量。所以這會是一個平衡動作,但我們必須照顧這些人。就目前的請款經驗而言,我們的理賠款項其實相當規律地收到。對於那些確實符合再次訂購資格的人,他們的再訂購紀錄很穩健,表現非常好,但它仍然和我們一般病患非常不同。我的意思是,我去年和一位 Medicare 病患來回寄了 5 封 email,因為他提供給醫師的生日日期並不是他在 Medicare 紀錄上的生日日期,而他無法相信我們竟然「笨到」無法把它處理好。最後我們終於弄清楚了,而這位病患又剛好認識我過去的一位摯友,所以我介入了,並且稍微看了一下我們內勤銷售人員的日常,我真想走過去跟他說聲——為他們正在經歷的事情道歉。但這就是現況、這就是運作方式,我們只需要學會規則並遵守它。我們希望能把整個管線都處理完並把產品出貨給他們。但如同先前那位所說,再次強調,對 Medicare 病患而言,第一次請款只有 500 美元,相較之下我們的商業保險病患平均是 1,500 美元,通常包含 2、3 盒感測器、2 個發射器以及接收器。所以我們拿到的營收不一樣,但文件作業可能更多。因此這是一個平衡。我們需要照顧這些病患並履行我們在這裡的承諾,我們也會盡我們所能做到。但大致上就是這樣的情況,而這也是我們展望未來 Q4 時會考量的一個重要因素。

  • Operator

    Operator

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

    下一個問題來自 Leerink Partners 的 Danielle Antalffy。

  • Danielle Joy Antalffy - MD, Medical Supplies and Devices

    Danielle Joy Antalffy - MD, Medical Supplies and Devices

  • I was wondering if you could talk a little bit about what changes in the manufacturing process for a no-calibration G6. And depending upon what that change is, do you expect the same level of yield with a no-calibration product as you're getting with the current product?

    我想請你談談無需校正(no-calibration)的 G6 在製造流程上會有哪些改變。並且取決於改變的內容,你是否預期無需校正產品能達到與目前產品相同水準的良率?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • I'm not going to go into all those details right now. Our manufacturing processes are pretty solid as it is. This does not require a major change or I wouldn't be telling you we'd pursue this as aggressively as we are. We're very comfortable with the procedures we have in place that we can get there. So more to come later.

    我現在不打算深入所有那些細節。我們的製造流程本來就相當穩健。這不需要重大改變,否則我也不會告訴你我們會如此積極地推進。我們對現有的作業程序很有信心,能夠達成目標。之後會再提供更多資訊。

  • Danielle Joy Antalffy - MD, Medical Supplies and Devices

    Danielle Joy Antalffy - MD, Medical Supplies and Devices

  • Okay, that's fine. And then just curious. When you look at Europe and where you're competing directly head-to-head with Libre in the European markets, where there is currently CGM coverage, what are you seeing from a competitive perspective? Is Libre really more of a market expander? Or do you feel like you're competing really directly head-to-head with them? I guess, I'm just trying to get a sense of what you expect here in the U.S., where CGM is well covered. So they don't have the benefit from a cash pay -- a largely cash pay market that they've had in Europe because you look at their installed base and they have hundreds of thousands of patients. Obviously, your installed base is much less than that. Maybe give us some color on why that's the case?

    好的,沒問題。接著我只是好奇:當你看歐洲、以及你們在歐洲市場與 Libre 直接正面競爭的地方——而且目前那裡已有 CGM 給付——從競爭角度你們看到了什麼?Libre 真的比較像是在擴大市場嗎?還是你覺得你們其實是在非常直接地正面交鋒?我想了解的是你們對美國的預期,因為美國的 CGM 給付相當完善。所以他們不像在歐洲那樣,能受惠於現金自費——以自費為主的市場;因為你看他們的裝機基礎(installed base),有數十萬名病患。顯然你們的裝機基礎遠少於此。能否提供一些背景,說明為什麼會是這樣?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, in those markets where we go head-to-head, again, we're up over 80% year-over-year. And I can go through a couple of the geographies. In Australia, for example, where there is government-approved reimbursement, we have over 70% market share in CGM for what the government is paying for. And we're classified as CGM there, compete with them directly. In the U.K., Abbott announced the Libre approvement there, but we're reimbursed under a completely different system in the U.K. We're more than double in the U.K. what we were a year ago. Canada, our business -- we've gone direct in Canada. Our business, again, has more than doubled in Canada. And I think it's more -- it's almost 2 different audience than what we've done. The products are appealing to different people. In the Nordics, where it's a tender process and everything is paid for kind of from the overall general budget, one of the things that's been very successful is our campaign to eliminate the receiver from the original purchase. By taking that large amount of money on upfront, patients could look at that and say, "Okay, I can get into the CGM technology easier than I could before." And we're getting a lot of new patients in the Nordics who are former Libre users. And that market, while it hasn't doubled like the others, since it was our biggest market before, we're still experiencing accelerated growth there from where we were a year ago. Italy is the same thing. Our Italian distributor is doing very well, reimbursement for CGM that excludes flash glucose monitoring. It's come through in a couple of geographies, and we've been very successful in those areas. So it's been a real good year over in Europe. And I just want to remind you all, 2 years ago, we had 3 employees there. And this is a big move for us. And it's been very successful so far. And our team has worked really, really hard to get where we need to be. But we're appealing to a different group of people, I guess, what I would say. And we're going about as fast as we can, to be honest with you.

    嗯,在那些我們正面交鋒的市場,我們的年增率再次超過 80%。我可以舉幾個地區來說明。以澳洲為例,那裡有政府核准的給付,我們在政府支付範圍內的 CGM 市占率超過 70%。我們在那裡被歸類為 CGM,並與他們直接競爭。在英國,Abbott 宣布 Libre 在那裡獲准,但我們在英國是走一個完全不同的給付體系。我們在英國的規模比一年前增加了不只一倍。加拿大方面,我們——我們在加拿大改為直營。我們在加拿大的業務同樣也增加了不只一倍。我認為更重要的是——這幾乎是兩種不同的受眾。我們的產品對不同的人有吸引力。在北歐,那裡是招標制度,所有費用大致由整體一般預算支付;其中一個非常成功的作法是我們推動在首次購買時取消接收器。把那筆可觀的前期費用拿掉後,病患會覺得:「好,我更容易導入 CGM 技術了。」我們在北歐獲得了很多新病患,他們以前是 Libre 使用者。那個市場雖然不像其他市場那樣翻倍——因為它原本就是我們最大的市場——但相較一年前,我們仍然在那裡看到加速成長。義大利也是同樣情況。我們的義大利經銷商表現非常好;排除 flash 血糖監測的 CGM 給付已在幾個地區落地,我們在那些地區非常成功。所以歐洲今年表現非常好。我也想提醒各位,兩年前我們在那裡只有 3 名員工。這對我們而言是很大的推進,而且到目前為止非常成功。我們的團隊非常、非常努力,才走到我們需要的位置。但我想我們吸引的是不同的一群人。老實說,我們也正以我們所能的最快速度在推進。

  • Operator

    Operator

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

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

  • Malgorzata Maria Kaczor - Research Analyst

    Malgorzata Maria Kaczor - Research Analyst

  • First question from me is given the success that you've seen out of Libre, given their simpler form factor, why wouldn't you launch similar product on the market? Is it specific market indicators that you're looking for that would make you want to launch that? And if you were to do it, how long would it take?

    我第一個問題是,鑑於你們看到 Libre 以更簡單的外形設計取得成功,為什麼你們不在市場上推出類似的產品?你們是在觀察哪些特定的市場指標,會讓你們想要推出那樣的產品?如果你們要做,會需要多長時間?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • You know what, we certainly could take our technology down a level if we wanted to. For now, we need to finish what we started. A no-calibration G6 system with the performance [accurate] that we have, combined with the sharing and connectivity and the ability to get your data where you want to, we think it's a product that best serves our current patient base and those that we call on now. As far as future product offerings, again, take a look at what we talked about with our Verily systems, low-cost disposable transmitters. They certainly will be very, very competitive, in fact, have features far beyond what Libre offers by a long ways. And those will be the products that we had looked to compete with, against that, versus our current system. We think this ultimately bifurcates into 2 different paths, and we're very prepared and very ready to go down that path.

    你知道嗎,如果我們想的話,確實可以把我們的技術往下做一個層級。就目前而言,我們需要先完成我們已經開始做的事。一個免校準的 G6 系統,具備我們目前的(性能)[精準]表現,再加上分享、連線,以及把你的數據帶到你想要的地方的能力,我們認為這是最能服務我們目前病患基礎以及我們現在所接觸客群的產品。至於未來的產品供應,再次請看看我們談到的 Verily 系統:低成本的一次性發射器。它們當然會非常、非常有競爭力,事實上,功能遠遠超過 Libre,差距很大。而那些才是我們用來與其競爭的產品,相對於我們目前的系統。我們認為這最終會分岔成兩條不同的路徑,而我們已經非常準備好、也非常有能力走上那條路。

  • Malgorzata Maria Kaczor - Research Analyst

    Malgorzata Maria Kaczor - Research Analyst

  • Okay. And then in terms of your hiring plans, now that you're up against the 2 big players in the marketplace, I know you've known that they're going to come [on blind] for a while, but has this changed structurally, what you think you need from a market presence perspective? And will this have any impact on your advertising budget as we look out over the next year or 2?

    好的。接著談到你們的招募計畫,現在你們要面對市場上的兩大玩家,我知道你們早就知道他們會來([on blind])一段時間了,但這是否在結構上改變了你們對市場能見度/市場存在感所需的看法?另外,當我們展望未來 1 到 2 年,這會對你們的廣告預算造成任何影響嗎?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • I think we'll -- if anything -- and we're in the middle of the planning process right now. So I'm probably speaking a little out of turn. I think we'll stay very aggressive on the marketing and advertising campaign. Particularly, our digital efforts will continue to be there. As far as field expansion, I think we'll give that some more thought. They're going through their field plan right now and developing all their models. And we'll evaluate the payback from field presence versus marketing dollars, and that's an exercise that actually Quentin gets to lead us through because he's been through this several times before, and it's really good to have a new set of eyes, question the return we get on the different investments we make. So we're evaluating that now. We'll give you more guidance after the first of the year.

    我想我們——如果有什麼變化的話——而且我們現在正處於規劃流程的中間,所以我可能有點說得太早。我想我們會在行銷與廣告活動上維持非常積極的態度。特別是,我們的數位行銷投入會持續進行。至於外勤團隊的擴張,我想我們會再多想一想。他們目前正在做外勤規劃並建立各種模型。我們會評估外勤佈局相對於行銷費用的投資回收,而這個工作其實會由 Quentin 帶著我們走過,因為他以前做過好幾次;有一雙新的眼睛來質疑我們在不同投資上的回報,真的很有幫助。所以我們正在評估中。過了年初之後,我們會給你們更多指引。

  • Quentin S. Blackford - CFO

    Quentin S. Blackford - CFO

  • But Margaret, the one thing I would add to that is when you look at the cost structure here, there's plenty of opportunity for us to be more efficient and thoughtful with respect to how we deploy our capital, which means as we get more efficient in some of these areas, we redirect it into these things that really move the needle and it doesn't become a net reduction to the overall investment or an increase in the investments that we have to make. They balance each other out but much better directed or well directed.

    不過 Margaret,我想補充的一點是,當你看這裡的成本結構時,我們在如何部署資本方面,有很多機會可以做得更有效率、更周全。這表示當我們在其中一些領域變得更有效率時,我們就能把資源重新導向到那些真正能帶來顯著影響的事情上,而不會變成整體投資的淨減少,或是我們必須增加的投資。它們彼此會互相平衡,但方向會更精準、也更到位。

  • Operator

    Operator

  • And our next question comes from Matt O'Brien from Piper Jaffray.

    我們的下一個問題來自 Piper Jaffray 的 Matt O'Brien。

  • Jonathan Preston McKim - Research Analyst

    Jonathan Preston McKim - Research Analyst

  • This is JP on for Matt. I wanted to ask a question about just kind of when you're going through the (inaudible) Medicare process and how important from that side of the field. Was it that you guys had these alerts and the alarms given the much higher incidence of hypo unawareness? Just trying to really gauge your thoughts on Libre's access there eventually?

    我是 JP,代替 Matt 提問。我想問一個問題,關於你們在走(聽不清)Medicare 流程時,以及從外勤端來看這件事的重要性。你們之所以能做到,是因為你們有這些警示與警報嗎?考量到低血糖無感(hypo unawareness)的發生率高得多。只是想更好地了解你們對 Libre 未來在那邊取得給付/可近性(access)的看法?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, we certainly believe that hypo unawareness is one of the key factors in the Medicare patients using -- to use a continuous glucose monitoring. We provide actionable alerts and alarms. I might even add the G6 system has a predictive low glucose alert that will predict when you're going -- well, in addition to the heart alert that has performed very well on our studies and been extremely accurate. We think patients will migrate to that and they will want it, but only time will tell. But that will certainly be what we push, and that will certainly be our message.

    我們確實相信,低血糖無感是 Medicare 病患使用——使用連續血糖監測(CGM)的關鍵因素之一。我們提供可採取行動的警示與警報。我甚至可以補充,G6 系統有一個預測性低血糖警示,能預測你何時會——此外還有在我們研究中表現非常好、而且極其精準的心臟警示(heart alert)。我們認為病患會轉向這些功能並且會想要它,但最終還是要時間來證明。不過那肯定會是我們主打的重點,也肯定會是我們的訊息主軸。

  • Jonathan Preston McKim - Research Analyst

    Jonathan Preston McKim - Research Analyst

  • Got it. And then I'm not sure what was the [exact facts] that pushed you to the lower end of the guidance? There was a handful of things, but was it more one thing or the other? Was it Medicare? Was it competitor noise?

    了解。接著我不太確定,是哪些[確切事實]讓你們把指引(guidance)下修到區間的低端?有好幾個因素,但主要是某一個因素比較大,還是各因素都有?是 Medicare?還是競爭對手的雜音?

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes. I mean, as we kind of mentioned in the prepared remarks, with the competitive noise out there, some uncertainty around a couple of our commercial integrated pump partners, combined with some of the distraction and, even frankly, the near-term revenue contribution, the upfront revenue contribution from Medicare warrant some being conservative at this point.

    是的。我的意思是,正如我們在事先準備的發言中提到的,外部的競爭雜音、我們幾個商業整合式胰島素幫浦合作夥伴周邊的一些不確定性,再加上一些分心因素,以及坦白說,Medicare 在短期營收貢獻、前期營收貢獻方面的情況,都使得我們在這個時間點採取較保守的態度是合理的。

  • Operator

    Operator

  • And our next question comes from Raj Denhoy from Jefferies.

    我們的下一個問題來自 Jefferies 的 Raj Denhoy。

  • Rajbir Singh Denhoy - MD, Equity Research and Senior Equity Research Analyst

    Rajbir Singh Denhoy - MD, Equity Research and Senior Equity Research Analyst

  • I wondered if I could just maybe ask one question. When you came into this year, you talked about adding, I think, 70,000 patients. Obviously, there's been a lot of changes with Medicare and the competitive landscape. And so, one, are you still comfortable with that level of new patient additions this year? And then when you think about 2018, again, with all the puts and takes with competition mostly, how do you think about that patient number? Are you expecting a higher rate of attrition in your customer base? Do you still expect to add a fair amount of patients next year? Any thoughts on that complexion will be really helpful, I think.

    我想我是否可以只問一個問題。你們在今年年初進來時,談到要新增大約 70,000 名病患。我想,顯然 Medicare 和競爭格局都發生了很多變化。所以第一,你們今年仍然對新增病患達到那個水準感到有把握嗎?第二,當你們思考 2018 年時,同樣地,在競爭等各種利弊拉扯之下,你們如何看待那個病患數字?你們是否預期客戶基礎會有更高的流失率?你們是否仍預期明年會新增相當數量的病患?任何對這種組成/樣貌(complexion)的想法,我想都會很有幫助。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • We're looking into the crystal ball, as you speak, and I don't have all the answers. With respect to the 70,000 net new patient adds, certainly, with the growth we've experienced in Europe and adding Medicare patients, we're comfortable that we're going to add that many new patients. The flip side of that argument is, for example, the Medicare patients are all coming back-weighted in the fourth quarter. So they're not going to contribute that much to the revenue. Hence, you'll have a new patient number that grows faster than our revenue numbers do in general. The second thing to consider is even with all the new patient adds outside of Germany, where reimbursement is very, very strong, in most of our European entities, (inaudible) through distributors and our pricing is a bit lower. So the revenue per patient from those new patient adds hasn't been as high, and that kind of reconciles the revenue number versus the new patient adds. But we've done well on new patients this year. With respect to attrition and retention, we'll give a little more color on that as we come out the first half the year with our remarks and guidance for next year. The one thing I would tell you that we've learned as we've studied and looked at this, as we go deeper into these markets and we attract more patients, it's a little bit different than the old days when the people who bought our device or people who really depended on it for life. Now we get customers who call up, say, "Hey, I hear this thing talks to the phone, sounds cool. Can I get one?" And then the thought of using that CGM all the time is a little bit different value proposition than what they're used to. So what we're saying with some of our new patients is a different utilization pattern. They might use it for 2 months and take a month off. We're seeing more variability, and we're learning to live with that. We're great with that. We think it's fine. We want all those people, but we don't want to overshoot. So we're giving more guidance on that at the end of the year.

    我們正在如你所說地看水晶球,但我沒有所有答案。就 70,000 名淨新增病患而言,考量到我們在歐洲經歷的成長,以及新增 Medicare 病患,我們有信心能新增那麼多新病患。這個論點的另一面是,例如 Medicare 病患的加入都偏向在第四季後段才回流/進來,所以他們對營收的貢獻不會那麼大。因此,你會看到新病患數字的成長速度,通常會比我們的營收數字更快。第二個要考慮的是,即便在德國以外新增了很多病患——德國的給付非常、非常強——在我們多數歐洲營運單位,(聽不清)是透過經銷商,而我們的定價也稍微低一些。所以,這些新增病患帶來的單一病患營收並沒有那麼高,這也就某種程度上解釋了營收數字與新增病患數之間的差異。但今年我們在新病患方面做得不錯。至於流失與留存,我們會在明年上半年發布談話與明年指引時,提供更多細節。我想告訴你的一點是,當我們研究並深入觀察後學到的是:隨著我們更深入這些市場並吸引更多病患,情況和過去有點不同。以前購買我們裝置的人,往往是非常依賴它、甚至攸關生命的人。現在我們會遇到一些客戶打電話來說:「嘿,我聽說這個東西可以連到手機,聽起來很酷。我可以拿一個嗎?」然後,『一直使用 CGM』這件事的價值主張,對他們來說就和他們習慣的不太一樣。所以我們在一些新病患身上看到的是不同的使用型態。他們可能用 2 個月,然後停用 1 個月。我們看到更多變異性,也正在學著與之共存。我們對此很可以,我們覺得沒問題。我們希望擁有所有這些人,但我們也不想高估。因此,我們會在年底提供更多相關指引。

  • Rajbir Singh Denhoy - MD, Equity Research and Senior Equity Research Analyst

    Rajbir Singh Denhoy - MD, Equity Research and Senior Equity Research Analyst

  • So that's helpful. Maybe just a -- sort of a follow-up there. But I guess, one of the concerns on the headlines is when Libre hit and obviously, the label that they received, was it -- somehow, it was going to pull away a lot of your patients, right? And certainly, we haven't seen that in Europe or other places. But do you expect that is going to happen? And when you look out into '18, do you expect you're still going to add a fair number of patients on a net basis next year?

    這很有幫助。也許再追問一下——算是延伸問題。但我想,新聞標題上的一個擔憂是,當 Libre 推出、而且很明顯他們拿到的標示(label)之後,它是否——在某種程度上會把你們很多病患拉走,對吧?而且我們確實還沒在歐洲或其他地方看到那種情況。但你們預期那會發生嗎?以及當你們展望 2018 年時,你們是否仍預期明年在淨值基礎上會新增相當數量的病患?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Oh, we absolutely do expect we'll have a fair amount of net new patients next year. There is no question. Our market is still underpenetrated. We still have a lot of reimbursement in a lot of places. If you go internationally, we're getting patients. We still have Medicare patients to add next year. That market has just began. We absolutely think we'll add net new patients. We do not see our patience running away to go use the other product. If you'd recall, last year, on this earnings call, we were answering the same question. They were all going to go away for 670G, and it doesn't appear that they have. So we will stick to it and we'll push our folks. We expect to continue to add new patients and grow the business. And remember, as I said on those remarks, more innovation next year than any year in our history. We haven't had anything new to push in the United States for quite a while other than connectivity, but that applicator looks the same way it did in 2006. It works lovely but it's kind of scary. And if you read the blogs and the patient's comments, "Man, I got my new DexCom, but I don't know if I want to push that plunger." That problem is gone when we launched G6. It's pushing a button. And the ease of use of this product and the lower profile, the consistency of the sensor, this is going to give our guys a fabulous story to tell in the field, and they need one. We owe them one, and we're going to give it to them.

    喔,我們絕對預期明年會有相當數量的淨新增病患。毫無疑問。我們的市場仍然滲透不足。我們在很多地方仍有大量的給付(reimbursement)空間。如果你看國際市場,我們也在獲得病患。我們明年還有 Medicare 病患可以新增。那個市場才剛開始。我們絕對認為會增加淨新增病患。我們不認為我們的病患會跑去使用另一個產品。如果你還記得,去年在這通財報電話會議上,我們也在回答同樣的問題。大家都說他們會因為 670G 而全部離開,但看起來並沒有發生。所以我們會堅持下去,並推動我們的團隊。我們預期會持續新增病患並成長業務。也請記得,正如我在那些談話中所說,明年的創新將比我們歷史上任何一年都多。我們在美國已經有一段時間沒有什麼新東西可以推了,除了連線功能之外,但那個施打器看起來跟 2006 年時一樣。它運作得很棒,但有點嚇人。而且如果你去看部落格和病患的留言,會看到「天啊,我拿到新的 DexCom 了,但我不知道我是否想按下那個推桿。」當我們推出 G6 時,這個問題就消失了。只要按一個按鈕。這個產品的易用性、更低的外型高度、感測器的一致性,將讓我們的業務同仁在第一線有一個很棒的故事可以講,而他們需要這個。我們欠他們一個,我們會給他們。

  • Operator

    Operator

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

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

  • Joanne Karen Wuensch - MD & Research Analyst

    Joanne Karen Wuensch - MD & Research Analyst

  • I just want to make sure I have my head around the timing of G6. You're talking about several different pathways, but then you're also talking about it being at the end of next year. Is there a pathway by which it might be earlier in the year?

    我只是想確認我對 G6 時程的理解。你提到幾種不同的途徑,但你也說會在明年年底。是否有某種途徑可能在年初更早推出?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Joanne, there's a bunch of pathways that we're looking at. As I said, we've been given clear direction and clear guidance in our meetings with the FDA that we think we can get G6 and no-calibration that we would launch before the end of the year. Our last decision on that product will be greatly dependent upon our further discussions with the agency. If it appears we have a path we can get to you sooner by going straight to no-calibrations and sooner pick a date before the 1st of September or something like that, we might go direct there. We also have the option if we wanted to stick with the one calibration a day and go with that when we can. We have a lot of balls up in the air with the agency on G6, and they're all good. And it's all good because of the reliability and accuracy and performance of that system. We just wanted to let everybody know that we will have a no-calibration system out relatively soon, and it's what patients want. And we will meet that need with real-time CGM.

    Joanne,我們正在評估很多途徑。正如我所說,我們在與 FDA 的會議中得到了明確方向與清楚指引,我們認為可以在年底前推出 G6 與免校正(no-calibration)。我們對該產品的最後決策將高度取決於我們與主管機關進一步的討論。如果看起來我們可以透過直接走免校正的路徑更快把產品帶給你們,並且能在 9 月 1 日之前或類似時間點選定日期,我們可能就會直接走那條路。我們也有另一個選項:如果我們想維持每天一次校正(one calibration a day),也可以在可行時先以那個版本推出。就 G6 而言,我們與主管機關同時在進行很多事項,而這些都是正面的。而之所以都是正面的,是因為該系統的可靠性、準確性與效能。我們只是想讓大家知道,我們會在相對不久的將來推出免校正系統,而那正是病患想要的。我們將以即時 CGM 來滿足這個需求。

  • Joanne Karen Wuensch - MD & Research Analyst

    Joanne Karen Wuensch - MD & Research Analyst

  • I think that's incredibly clear right now. Just as a follow-up or as my second question, I would anticipate that Libre is going to undergo a fair amount of direct-to-consumer campaigning. Do you have a similar expectation? And if so, how do you plan on countering it or not countering that type of approach?

    我覺得目前已經非常清楚了。作為追問或我的第二個問題,我預期 Libre 會進行相當多的直接面向消費者(direct-to-consumer)的宣傳活動。你們也有類似的預期嗎?如果有,你們打算如何因應或不因應這種做法?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • You know what, we don't have Abbott's dollars to spend on television ads. So we will look and see how that goes. Our commercial guys and our direct-to-consumer campaigns have been really good for the amount of money that we spent. And we'll put in place actions to counteract that. Trust me, if I gave the guys all the money they ask for, we'd go head-to-head but we have a balance sheet and a P&L that balances well. Ultimately, if it creates more awareness for CGM and once people find out what they're not getting with Libre, it might be our best advertising campaign ever.

    你知道的,我們沒有 Abbott 那麼多預算可以花在電視廣告上。所以我們會觀察看看效果如何。我們的商業團隊以及我們的直接面向消費者行銷活動,以我們投入的金額來看,成效一直都很好。我們也會採取行動來對抗那種做法。相信我,如果我把他們要的錢都給他們,我們會正面對決,但我們有資產負債表和損益表(P&L)需要維持良好平衡。最終,如果這能提高大家對 CGM 的認知,而一旦人們發現使用 Libre 得不到哪些東西,這可能會成為我們史上最好的廣告活動。

  • Quentin S. Blackford - CFO

    Quentin S. Blackford - CFO

  • Joanne, I think Germany is a fantastic example of that, right, where awareness has been created. And ultimately, patients find their way to the best technology in the marketplace. And Germany has shown that time after time.

    Joanne,我認為德國就是一個很棒的例子,對吧?那裡已經建立起認知。最終,病患會找到市場上最好的技術。德國一次又一次地證明了這點。

  • Operator

    Operator

  • And our next question comes from Matt Taylor from Barclays.

    下一個問題來自 Barclays 的 Matt Taylor。

  • Matthew Charles Taylor - Director

    Matthew Charles Taylor - Director

  • I guess, I was hoping you could clarify 2 earlier points when you're talking about some of the dynamics outside the U.S. Firstly, could you help us put a finer point on the reimbursement differentials that you're seeing between your technology given the additional features and flash monitors? And then you referenced a couple of times on call that you're converting patients from Libre. Could you help quantify how many patients are converting?

    我想我希望你能釐清先前提到的兩點,當你談到美國以外的一些動態時。第一,你能否更精確地說明你們看到的給付差異(reimbursement differentials):在你們的技術因為具備額外功能,與 flash 監測器相比,差異到底如何?第二,你在電話會議中提到幾次你們正在把病患從 Libre 轉換過來。你能否協助量化有多少病患正在轉換?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • I really can't quantify that number. We don't have that sitting in a statistical bin somewhere. We certainly hear the stories as we go out in the field in our foreign offices. And so we do know that it happens. I don't have that number handy. As far as reimbursement differences, that varies widely, geography to geography. In some places, it's 25%, 30%. In other places, it’s significantly higher. And so it really depends upon the reimbursement agency that we're dealing with.

    我真的無法量化那個數字。我們沒有把它放在某個統計分類裡。當我們到海外辦公室、在第一線走訪時,確實會聽到這些故事。所以我們知道確實有發生。但我手邊沒有那個數字。至於給付差異,會因地區而有很大不同。有些地方是 25%、30%;其他地方則顯著更高。所以這真的取決於我們所面對的給付機構。

  • Matthew Charles Taylor - Director

    Matthew Charles Taylor - Director

  • Okay. And then I just wanted to clarify something in the U.S. with your strategy. This is the first quarter, I guess, that we haven't seen a large amount of growth in the Medicare pipeline. I'm assuming you're taking a foot off the gas a little bit there because it's just taking some time to get through the backlog. Is that right? And do you kind of step back on the gas next year once you've gotten through the people that are waiting?

    好的。接著我想釐清你們在美國的策略。我想這是第一個季度,我們沒有看到 Medicare 管線(pipeline)有很大幅度的成長。我猜想你們是在那邊稍微放慢腳步,因為需要一些時間消化積壓量(backlog)。是這樣嗎?而且等你們把等待的人處理完之後,明年會再加速嗎?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Actually, we never put our foot on the gas. The pipeline that we created has come simply because of the approval and people looking at our web page. We'll put our foot on the gas later this quarter and certainly early in 2018.

    其實我們從來沒有踩油門。那個我們建立起來的管線,純粹是因為核准之後,人們去看我們的網頁而自然形成的。我們會在本季稍晚踩油門,當然也會在 2018 年初。

  • Operator

    Operator

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

    下一個問題來自 Wedbush 的 Tao Levy。

  • Tao Leopold Levy - MD of Equity Research

    Tao Leopold Levy - MD of Equity Research

  • So first, maybe -- since you didn't call it out, I assume it's probably not much of an impact, but anything probably related to the hurricanes and ability to get product to your customers?

    首先,也許——因為你沒有特別提到,我猜影響可能不大——但颶風是否對你們有任何影響,例如把產品送到客戶手上的能力?

  • Quentin S. Blackford - CFO

    Quentin S. Blackford - CFO

  • Yes, that's not something that I don't believe had a material impact on the quarter. Certainly, it had somewhat of an impact, and the revenue number would have been higher. But it's hard to quantify exactly what that is. I will tell you those are 2 regions in the U.S. that happened to be stronger regions for us. But the exact number, we're not going to put out there.

    是的,我不認為那對本季有重大影響。當然有一些影響,營收數字本來會更高。但很難精確量化是多少。我可以告訴你,那是美國兩個剛好對我們而言較強的區域。但確切數字我們不會對外公布。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • I would also add that our field sales force and, frankly, even our third-party distributors, our DME distributors really went above and beyond to help get patients product when they needed it. So kudos to them.

    我也要補充,我們的外勤銷售團隊,以及坦白說甚至我們的第三方經銷商、我們的 DME 經銷商,確實都超乎本分地協助病患在需要時取得產品。所以要給他們肯定。

  • Tao Leopold Levy - MD of Equity Research

    Tao Leopold Levy - MD of Equity Research

  • Okay. And then just so I can understand, the G6 products that might be coming out next year, I mean, is there a major difference between a no-calibration and a one time a day calibration just from a product standpoint? I mean, can it just be a calibration optional? And the data that you had shown previously, wasn't that just all on the same system whether you calibrate it once or no times?

    好的。接著為了讓我理解,明年可能推出的 G6 產品,我是說,從產品角度來看,免校正與一天一次校正之間有重大差異嗎?我的意思是,它能不能做成校正可選(calibration optional)?而且你們之前展示的數據,不是都在同一套系統上嗎,不管你校正一次或完全不校正?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Tao, that's exactly right. It was the G6 sensor. It's the same configuration mechanically, and the membranes and stuff on the sensor are the same. What changes is the software. And that's what we have to work through. It's how we configure that software for that product. And again, we have several options. We'll clarify that at year-end.

    Tao,你說得完全正確。那是 G6 感測器。機械結構配置相同,感測器上的薄膜等也都相同。改變的是軟體。而那就是我們必須處理的部分:我們要如何為該產品配置那套軟體。再說一次,我們有幾個選項。我們會在年底釐清。

  • Operator

    Operator

  • And our next question comes from Suraj Kalia from Northland Securities.

    下一個問題來自 Northland Securities 的 Suraj Kalia。

  • Suraj Kalia - MD & Senior Research Analyst

    Suraj Kalia - MD & Senior Research Analyst

  • So Kevin, all of us seem to be asking the same question in different ways, and let me try a different approach. It almost seems like cost versus accuracy is the new battlefront that's going to open up. So my first question is, is $10 per day a fixed threshold that you all look at when developing new sensors? I guess, where I'm trying to head out is for the newer products coming online, how much would you all be willing to sacrifice on the $10 per day bogey without sacrificing accuracy? And the sub-part of my question is -- I appreciate the commentary you all made versus Libre, but let's say Suraj comes in and XYZ comes in, and they both need sensors. When you all go head-to-head with Libre, how do those statistics stand up in some of these countries? I understand Germany and others, the reimbursement has propped up things recently and I can appreciate that. But I'm just trying to understand, in Europe, when you all go head-to-head for the same patients coming in, what is your success rate?

    Kevin,我們大家似乎都在用不同方式問同一個問題,讓我換個角度試試看。看起來成本對精準度(cost versus accuracy)幾乎要成為新的戰場。我的第一個問題是:你們在開發新感測器時,是否把每天 10 美元視為一個固定門檻?我想問的是,對於即將上線的新產品,在不犧牲精準度的前提下,你們願意在「每天 10 美元」這個目標(bogey)上讓步多少?我問題的第二部分是——我很感謝你們對 Libre 的評論,但假設 Suraj 來了、XYZ 也來了,他們都需要感測器。當你們與 Libre 正面競爭時,在一些國家這些數據表現如何?我理解德國和其他地方,近期給付在某種程度上支撐了市場,我也能理解。但我想了解的是,在歐洲,當你們為同一批新進病患正面競爭時,你們的成功率是多少?

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • So I'll take the first one. As I mentioned in an answer -- in response to a prior question, we're not getting close to $10 a day today for our sensors. So trying to compare a $10 a day sensor to a $5 a day Libre, which is pretty typical in Europe, isn't a fair comparison when you consider that patients are wearing our sensors off-label and wearing them for an extended period of time. In terms of going head-to-head with Libre, as we mentioned, anecdotally, we're seeing patients who -- when we get reimbursement, who have access to our technology, we are seeing them switch. We don't have great data on how many of them, but a full-featured CGM, when patients have access to it, is definitely a preference particularly for an intensively managed type 1 or intensively managed type 2 patient. So we compete quite favorably. We'll continue to push the message of our performance accuracy, connectivity and really try to maintain a premium price point. But trying to evaluate the $10 a day -- or $10 of revenue per day per patient isn't the real world today. So I wouldn't try to do that going forward.

    那我先回答第一個。如同我在先前問題的回覆中提到的,我們的感測器目前並沒有接近每天 10 美元的水準。因此,若拿每天 10 美元的感測器去和每天 5 美元的 Libre(在歐洲相當常見)做比較,並不公平,因為病患是以適應症外(off-label)的方式配戴我們的感測器,而且配戴時間會延長。至於與 Libre 正面競爭,如我們所提到的,從一些軼聞觀察來看,當我們取得給付、病患能夠使用我們的技術時,我們確實看到他們轉換過來。我們沒有很好的數據能說明有多少人,但具備完整功能的 CGM,在病患能取得的情況下,絕對是偏好,特別是對於密集管理的第 1 型或密集管理的第 2 型病患。因此我們的競爭力相當不錯。我們會持續強調我們的效能準確度、連線能力,並努力維持較高的定價水位。不過,試圖用「每天 10 美元」——或每位病患每天 10 美元的營收——來評估,並不符合當今的真實世界情況。所以我不會建議未來用這種方式來推估。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • And I'd just add on Steve's comments. Again, a lot of times, it's what a patient is looking for and it depends on the geography. But if a patient is looking to avoid low -- hypoglycemia at night, there's only one product they're going to pick. And if they're looking to manage a child, whereby you can see the child's information from afar, there's really only one product that you can pick. Our feature set is much more robust. So it's not just a cost versus accuracy. It's a cost versus features and what a patient wants and what are the needs of that patient. As far as the future, please understand, again -- and I need to emphasize this. We haven't been just sitting here thinking we're not going to take cost out of the system [or renew]. And we will be competitive on the cost front regardless of where it heads. For us, the most important thing in considering pricing is what does that do to access because having a race to the bottom really doesn't do much for us at all to the extent that we can really expand access and get more people access to the system. We've always been open for different pricing structures with payers, with people that we talk to. It's just -- that's kind of how the business works, but we're prepared for wherever the market goes.

    我再補充 Steve 的評論。很多時候,關鍵在於病患想要的是什麼,而且也取決於地理區域。但如果病患想避免夜間低血糖(hypoglycemia),他們只會選一種產品。如果他們要管理小孩,並且希望能在遠端看到孩子的資訊,基本上也只有一種產品可選。我們的功能組合更為強大。所以這不只是成本對準確度,而是成本對功能、以及病患想要什麼、病患的需求是什麼。至於未來,請理解——我需要再次強調——我們並不是坐在這裡什麼都不做、覺得不需要把系統成本降下來(或更新)。無論市場走向如何,我們在成本面都會具備競爭力。對我們而言,定價時最重要的是:這對可近性(access)有什麼影響,因為一味比誰更便宜的「向下競賽」對我們幾乎沒有幫助;我們更希望能真正擴大可近性,讓更多人能使用這套系統。我們一向對不同的定價結構保持開放,無論是對付款方(payers)或我們接觸的對象。這就是這個產業的運作方式,但無論市場怎麼走,我們都已做好準備。

  • Operator

    Operator

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

    下一個問題來自 Stephens 的 Chris Cooley。

  • Christopher Cook Cooley - MD

    Christopher Cook Cooley - MD

  • Can you hear me now? Sorry about that.

    你們現在聽得到我嗎?抱歉剛剛那樣。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • You're okay.

    沒問題。

  • Christopher Cook Cooley - MD

    Christopher Cook Cooley - MD

  • Okay. I had it on mute. Just 2 quick ones from me at this point I just wanted to clarify. In prior discussions, you had explored the realm of possibility of maybe having a fixed shutoff and I fully appreciate what Steve conveyed now twice in terms of your real cost per use per day really tracking close to about that $6 level, which is an attractive premium or (inaudible) attractive price point for all the end benefit and features that you get. But is that off the table at this point? Or just how do we think about -- maybe you fixed end of use on the sensor? And then secondly, just my last follow-up, you may have mentioned this in the prepared remarks, but did you give us an update on smart pen development with CGM, with 2/3 of your new patients starts now coming for that [FDI] population? Do you think that would be even more attractive on a go-forward basis?

    好的。我剛剛把它設成靜音了。此刻我有兩個很快的小問題想釐清。先前的討論中,你們曾探討過是否可能採用固定關閉(fixed shutoff)。我完全理解 Steve 現在已經兩次傳達的重點:你們實際的每次使用、每天成本其實大約接近 6 美元,考量到最終帶來的效益與功能,這是一個很有吸引力的溢價(premium)或(聽不清)很有吸引力的價格點。但這個選項現在已經不考慮了嗎?或者我們該如何看待——也許在感測器使用期結束時採固定終止?第二個也是最後一個追問,你們可能在事先準備的講稿裡提過,但你們是否能更新一下智慧筆(smart pen)與 CGM 的開發、以及 flash 整合的進度?目前你們 2/3 的新病患起始(new patient starts)來自那個 [FDI] 族群。你們認為未來這會更具吸引力嗎?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Good questions, Chris. With respect to the sensor shutoff situation, we're evaluating that as we speak and as we talked on the upcoming product pipeline. Certainly, our Verily products are designed to last 14 days, and electronics isn't going to work anymore after that. The battery will be dead. We have to look at our other product platforms and make the right decisions. At some point in time, we know the accuracy of those systems isn't good anymore, and it's actually in the patient's best interest for them to be done. So we'll look at that and consult with the FDA, like our future-generation products. And we're open to both alternatives, and we haven't made any final decision.

    好問題,Chris。關於感測器關閉(shutoff)的議題,我們正在評估中,正如我們在即將推出的產品管線中所談到的。當然,我們的 Verily 產品設計為可使用 14 天,之後電子元件就不會再運作,電池會沒電。我們必須檢視其他產品平台並做出正確決策。在某個時間點,我們知道那些系統的準確度已不再理想,實際上讓病患停止使用才符合病患的最佳利益。因此我們會就此進行評估,並像未來世代產品一樣與 FDA 諮詢。我們對兩種替代方案都保持開放,目前尚未做出任何最終決定。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Okay. And with respect to the smart pen development, flash integration, we've got a number of irons in the fire. Not really in a position to give update on this call but hope to be able to provide some additional color before the end of this year or early part of next year.

    好的。至於智慧筆的開發、flash 整合,我們同時在推進好幾個方向。目前在這通電話上不太適合提供更新,但希望能在今年底前或明年初提供更多細節與說明。

  • Operator

    Operator

  • And next question comes from Steven Lichtman from Oppenheimer.

    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

  • I was wondering if you guys have an early read on adoption among type 2 patients among the Medicare population since the beginning of the roll-out. And can you update us on how you see the potential for expansion into the intensive insulin type 2 patient population commercially as well?

    我想請問,自從開始推廣以來,你們是否已經對 Medicare 族群中的第 2 型病患採用情況有初步觀察?另外,你們能否更新一下,你們如何看待在商業市場(commercial)也擴展到密集胰島素治療的第 2 型病患族群的潛力?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Go ahead, Steve.

    Steve,你先說。

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

    Steven R. Pacelli - EVP of Strategy & Corporate Development

  • Yes. I was going to say I anticipated this question and checked with our commercial team. And quite frankly, we've not done a great job with the initial bolus of patients at capturing type 1 versus type 2. But our guess is that the vast majority at this point are type 1.

    好的。我本來就預期會有這個問題,所以我跟我們的商業團隊確認了一下。坦白說,我們在第一波病患中,並沒有把第 1 型與第 2 型的分類掌握得很好。但我們的推測是,目前絕大多數是第 1 型。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Yes. We haven't pushed that yet. I think word of mouth and getting the product out there is going to be key to reaching those patients over time. We certainly have clinical data with our DIaMonD study that shows with intensive insulin using type 2 patients, that CGM definitely provides a benefit. We just -- again, we just need to get our pipeline serviced, and then we'll turn on the faucet and go after those guys.

    是的。我們還沒有在那方面用力推。我認為口碑以及把產品推到市場上,會是隨時間觸及那些病患的關鍵。我們確實有 DIaMonD 研究的臨床數據顯示,對於使用密集胰島素治療的第 2 型病患,CGM 的確能帶來效益。我們只是——再次強調——需要先把我們的供應鏈/產能(pipeline)服務到位,然後我們就會打開水龍頭,去爭取那些病患。

  • Steven M. Lichtman - MD and Senior Analyst

    Steven M. Lichtman - MD and Senior Analyst

  • Got it. And then, Kevin, you mentioned during Q&A, we have -- you guys have some electronic enhancements on the horizon that can significantly reduce cost. It sounded like that was outside of the Verily product pathway? Is that right? And can you flesh out that opportunity a little bit more?

    了解。接著,Kevin,你在問答中提到,你們在電子元件方面有一些即將到來的強化,能顯著降低成本。聽起來那是在 Verily 產品路徑之外?是這樣嗎?你能否把那個機會再多說一點?

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • It is actually stuff that has been designed by our people in-house. But we did launch a new receiver this quarter. And while the actual cost profile on it -- to build it isn't any higher, we believe the warranty return rates on it are much less significant, and that will ultimately save us cost. We have a new transmitter coming in the G6 configuration that we (inaudible) we filed but coming not soon after -- not far after we launched. These electronics have been designed with us and one of our partners that cost, again, a lot less to manufacture and much more efficient automated manufacturing processes that we can push into that product as well. And literally, everything we do, we have 3 pillars. Every product that we make, we have to continue to have performance. You've got to take out cost, and you've got to increase patient convenience and compliance. Anything we start has to answer those 3 questions or we shut it down. So everything we're looking at answers all 3 of those.

    其實那是我們內部團隊自行設計的東西。不過我們本季確實推出了新的接收器(receiver)。雖然它的實際製造成本結構並沒有更高,但我們相信它的保固退貨率會顯著降低,最終將為我們節省成本。我們在 G6 配置中也有一款新的發射器(transmitter)即將推出,我們(聽不清)我們已經送件申報,但會在我們推出後不久——不會相隔太久——上市。這些電子元件是由我們與其中一個合作夥伴共同設計,製造成本同樣低很多,而且我們也能把更有效率的自動化製造流程導入該產品。基本上,我們做的每一件事都有三大支柱。每一個我們製造的產品,都必須持續具備效能;你必須降低成本;你必須提升病患便利性與依從性(compliance)。我們啟動任何專案都必須回答這三個問題,否則我們就會把它停掉。所以我們目前在看的每一件事,都同時符合這三點。

  • Operator

    Operator

  • And this concludes our question-and-answer session. I'll now turn the call back over to Kevin Sayer for final remarks.

    以上為問答環節。現在我把電話交回 Kevin Sayer 做最後結語。

  • Kevin R. Sayer - CEO, President and Director

    Kevin R. Sayer - CEO, President and Director

  • Well, I just want to make sure it's not lost on everybody. We had an amazing quarter, the biggest quarter in DexCom's history. You look at the cash we generated from operations, look at the management of our expenses, look at the gross profit line and gross margin lines hitting the targets that we've established. The company had a wonderful quarter, and everybody here should be congratulated. There really has never been a better time to be in our industry than we are now. And our confidence in our new pipeline to deliver the systems we know patient want has never been higher. We'll continue to innovate. We'll continue to drive our business. We'll continue to grow. We'll continue to take new approaches to attack this wonderful opportunity to serve patients who really need this technology across the board. Thanks, and have a great day.

    我只想確保大家不會忽略這一點:我們本季表現非常出色,是 DexCom 歷史上最大的一季。看看我們營運所產生的現金、看看我們對費用的管理、看看毛利與毛利率線達到我們所設定的目標。公司本季表現非常好,在座各位都值得被恭喜。就我們目前所處的狀況而言,從來沒有比現在更適合待在這個產業的時刻。而且我們對於新產品管線能交付我們知道病患想要的系統,信心也從未如此之高。我們會持續創新。我們會持續推動業務。我們會持續成長。我們會持續採取新方法,去把握這個絕佳機會,全面服務那些真正需要這項技術的病患。謝謝,祝大家有美好的一天。

  • Operator

    Operator

  • Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating, and 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,現在可以掛線。