德康醫療 (DXCM) 2016 Q3 法說會逐字稿

Welcome to the DexCom third-quarter 2016 earnings release conference call. My name is Adrienne and I will be your operator for today's call.

歡迎收聽 DexCom 2016 年第三季財報發布電話會議。我是 Adrienne，將擔任今天會議的接線員。

(Operator Instructions)

（接線員指示）

Please note: this conference is being recorded.

請注意：本次電話會議將被錄音。

I will now turn the call over to Kevin Sayer, President and CEO. Kevin Sayer, you may begin.

我現在把電話交給總裁暨執行長 Kevin Sayer。Kevin Sayer，您可以開始。

Thank you very much and thanks, everyone, for listening to our third quarter conference call today. We'll start off by turning the line over to Steve Pacelli for our traditional Safe Harbor statement.

非常感謝，也謝謝各位今天收聽我們的第三季電話會議。我們將先把電話交給 Steve Pacelli，進行我們慣例的「安全港」聲明。

Thanks, Kevin.

謝謝你，Kevin。

Some of the statements we will make in today's call may constitute forward-looking statements. These statements reflect Management's intentions, beliefs and expectations about future events, strategies, competition, products, operating plans and performance. 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.

我們在今天電話會議中所做的部分陳述，可能構成前瞻性陳述。這些陳述反映管理層對未來事件、策略、競爭、產品、營運計畫與績效的意圖、信念與預期。本簡報中所包含的所有前瞻性陳述，均以本日為準，係基於 DexCom 目前可得之資訊作出，並受各種風險與不確定性影響，實際結果可能與前瞻性陳述中所預期者有重大差異。

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

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 年度報告、Form 10-Q 季度報告，以及向美國證券交易委員會提交的其他文件中。除法律另有規定外，我們不承擔在本簡報日期後更新任何此等前瞻性陳述，或使該等前瞻性陳述與實際結果一致之義務。

Additionally, during the call we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our 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. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measures can be found in today's press release, which is available on our website.

此外，在本次電話會議中，我們將就以現金為基礎的營運結果，討論若干未依 GAAP 編製的財務衡量指標。此等補充資訊之呈現不應被孤立看待，亦不應視為可替代或優於依 GAAP 編製之結果。非 GAAP 財務衡量指標與最直接可比之 GAAP 指標的調節表，可於今日新聞稿中查閱；新聞稿已發布於我們的網站。

Kevin.

Kevin。

Thank you, Steve. Joining me today are Jess Roper, our Chief Financial Officer; and Steve Pacelli, our Executive Vice President of Strategy and Corporate Development. Sticking with our usual format, Steve will review our third-quarter financial results and I will follow with our customary operations update and offer some concluding thoughts before opening the line for questions.

謝謝你，Steve。今天與我一同出席的還有：我們的財務長 Jess Roper，以及策略與企業發展執行副總裁 Steve Pacelli。依照我們一貫的流程，Steve 將先回顧第三季財務結果，接著我會進行例行的營運更新並提出一些結語，之後開放提問。

But before I turn the call over to Steve, I want to take a few minutes to discuss recent developments in the US competitive landscape. Approximately one month ago Medtronic announced it had received FDA approval of the 670G Hybrid Closed Loop System. Since that time there has been significant press surrounding this product, which has created considerable confusion in the marketplace. For example, we recently attended a diabetes charity event where it was declared from the podium that type I diabetes has now been cured because of the FDA approved artificial pancreas. Clearly this is not the case. Patients and caregivers are showing signs of skepticism and frustration due to the over-hype of the promise of this technology.

不過在把電話交給 Steve 之前，我想先花幾分鐘談談美國競爭態勢的近期發展。約一個月前，Medtronic 宣布其 670G 混合式閉環系統已獲 FDA 核准。自那之後，媒體對該產品有大量報導，造成市場相當程度的混淆。舉例來說，我們最近參加一場糖尿病慈善活動，主持人在台上宣稱因為 FDA 核准的人工胰臟，第一型糖尿病如今已被治癒。顯然事實並非如此。由於對這項技術承諾的過度炒作，患者與照護者已出現懷疑與挫折的跡象。

Our review of the currently available data suggests although this product may be an incremental step in automated insulin delivery, it appears to be an extremely complex system and its real-world performance remains to be seen. Earlier that same day, Abbott announced FDA approval of the Freestyle Libre Professional System. This system is not a direct competitor to our core commercial product portfolio in the US, as the data generated by this center is blinded to the patient and only made available to the clinician retrospectively.

我們對目前可得資料的檢視顯示，儘管該產品可能是自動化胰島素輸送的一個漸進式進展，但它似乎是一套極其複雜的系統，其在真實世界的表現仍有待觀察。同一天稍早，Abbott 宣布其 Freestyle Libre 專業系統獲得 FDA 核准。該系統在美國並非我們核心商業產品組合的直接競爭者，因為此中心所產生的資料對患者是盲測的，且僅在事後提供給臨床醫師。

Additionally, the first independent studies regarding Libre's performance as a consumer device are beginning to be published. One comparatively rated DexCom G5 where DexCom CGM outperformed on nearly every metric including improved time and range and reduced time in hypoglycemia. Just last week, at the ISPAD meeting in Spain a pediatric study was published showing that Libre accuracy is inconsistent and not reflective of previously published data. Put simply, this form of technology does not achieve the same result in diabetes management as CGM. And alerts and alarms and real-time communication are very critical in generating real clinical outcomes.

此外，關於 Libre 作為消費者裝置表現的首批獨立研究也開始發表。其中一項比較研究評估了 DexCom G5，結果顯示 DexCom 的 CGM 幾乎在所有指標上都表現更佳，包括在目標範圍內的時間增加，以及低血糖時間減少。就在上週，於西班牙舉行的 ISPAD 會議上發表了一項兒科研究，顯示 Libre 的準確度不一致，且與先前發表的資料不符。簡而言之，這種形式的技術在糖尿病管理上無法達到與 CGM 相同的效果。而警示、警報與即時通訊對於產生真正的臨床結果至關重要。

While we are always vigilant of these well resourced competitors, and we expect the noise around these offerings to only increase, we will continue to focus on the things that we do well. The superior performance and feature set of our current and future products, including industry-standard accuracy, reliable real-time alerts and alarms, and connectivity across multiple platforms, leave us well-positioned to remain the leader in CGM. I will now turn the call over to Steve.

雖然我們始終密切關注這些資源充足的競爭對手，且預期圍繞其產品的市場雜音只會增加，但我們將持續專注於我們擅長的事情。我們現有與未來產品的卓越效能與功能組合，包括業界標準的準確度、可靠的即時警示與警報，以及跨多平台的連線能力，使我們具備良好定位，得以持續保持 CGM 領導地位。現在我把電話交給 Steve。

Thanks, Kevin. DexCom reported revenue of $149 million for the third quarter of 2016 compared to $105 million for the same quarter in 2015, a $43 million or 41% increase. Sequentially, revenue for Q3 was up approximately 8% from the prior quarter.

謝謝你，Kevin。DexCom 2016 年第三季營收為 1.49 億美元，較 2015 年同期的 1.05 億美元增加 4,300 萬美元，增幅 41%。以季比季來看，第三季營收較上一季約成長 8%。

Our third-quarter gross profit was $101 million, generating a gross margin of 68% compared to a gross profit of $75 million and a gross margin 71% for the same quarter in the prior year. As we mentioned during our Q2 earnings call, our warranty costs remain higher than historical levels due primarily to the receiver recall. This has impacted gross margin by one to two points during Q3. However, as expected, warranty costs, as a percentage of sales, began to decline in Q3 and should normalize before the end of the year.

我們第三季毛利為 1.01 億美元，毛利率 68%；相較之下，去年同期毛利為 7,500 萬美元、毛利率 71%。如同我們在第二季財報電話會議中提到的，由於接收器召回，我們的保固成本仍高於歷史水準，主要即源於此。這使第三季毛利率受到 1 至 2 個百分點的影響。不過，如預期所示，保固成本占銷售額的比例在第三季已開始下降，並應在年底前回復正常。

Some final thoughts on our revenues and gross profits. Our mix between durable and consumable products was within our normal historical range in Q3 at approximately 30% durable and 70% consumable. The AFP for our hardware has remained stable and sensor pricing remains within an ASP range of $70 to $75 per sensor. Finally, our international business showed continued year-over-year growth, generating $18 million in revenue during the quarter, up 29% from last year. Although international sales were relatively flat sequentially, OUS revenues are up over 40% year-to-date.

關於營收與毛利的最後幾點說明。第三季耐用品與耗材的組合落在我們正常的歷史區間內，約為 30% 耐用品、70% 耗材。我們硬體的平均售價（AFP）維持穩定，感測器定價也仍在每個感測器 70 至 75 美元的平均售價（ASP）區間內。最後，我們的國際業務持續呈現年增成長，本季貢獻營收 1,800 萬美元，較去年增加 29%。雖然國際銷售在季比季方面相對持平，但年初至今的美國以外（OUS）營收已成長超過 40%。

Research and development expense totaled $44 million for Q3 of 2016, compared to $65 million in Q3 of 2015 with the decrease due primarily to the $36.5 million non-cash milestone payment to Verily in connection with our collaboration offset by increases consistent with those we have discussed throughout the year. Specific to our near-term pipeline, during the quarter we incurred significant expense associated with our G6 pivotal study, our continued efforts with the FDA to obtain a non-adjunctive claim for our system and several other recent FDA submissions. We also incurred significant expense related to our advance product pipeline, particularly expenses associated with our Verily partnership, future generation sensor technologies and the building out of our data platforms. Selling, general, and administrative expense totaled $76 million in Q3 of 2016 compared to $52 million during the same quarter in 2015 with the increase due primarily to year-over-year increases in headcount in our customer support organizations, as well as a ramp in our patient focused marketing expenses, higher IT costs, and investments in our OUS expansion efforts.

2016 年第三季研發費用合計 4,400 萬美元，較 2015 年第三季的 6,500 萬美元下降；下降主要係因與 Verily 合作相關的 3,650 萬美元非現金里程碑付款所致，但亦被我們全年持續討論的各項增加所部分抵銷。就近期產品管線而言，本季我們因 G6 關鍵性試驗、持續與 FDA 合作以取得本系統「非輔助（non-adjunctive）」適應症主張，以及其他數項近期 FDA 送件，而產生顯著費用。我們也在先進產品管線方面產生顯著費用，特別是與 Verily 夥伴關係、下一代感測器技術，以及資料平台建置相關的支出。銷售、一般及行政費用於 2016 年第三季合計 7,600 萬美元，較 2015 年同期的 5,200 萬美元增加；增加主要來自客戶支援組織人力的年增、以患者為導向的行銷費用提升、較高的 IT 成本，以及對 OUS 擴張的投資。

Our net loss for the third quarter of 2016 totaled $19 million which included $34 million in non-cash expenses centered primarily in non-cash share-based compensation expense across all functional areas of our business. Our net loss was wider than Street estimates and even our own internal expectations due to a number of factors including, one, building out customer ops and tech support infrastructure to address the customer service issues we experienced during the first part of the year. We believe that these groups are now staffed appropriately to support our anticipated growth and new product launches through 2017. Two, increased direct to consumer marketing in Q3 which we expect to further increase in Q4 as our metrics suggest strong conversion rates with our early programs. And finally, we added new senior talent during the first part of the year which led to incremental compensation expense and some severance expense during the quarter.

2016 年第三季淨損合計 1,900 萬美元，其中包含 3,400 萬美元非現金費用，主要為涵蓋公司各職能領域的非現金股份基礎給付費用。由於多項因素，我們的淨損較市場預估甚至較我們內部預期更大，包括：第一，為解決我們在年初所經歷的客戶服務問題，我們擴建了客戶營運與技術支援基礎設施。我們相信這些團隊目前的人力配置已足以支援我們預期的成長，以及至 2017 年的新產品上市。第二，第三季增加了面向消費者的直接行銷（direct-to-consumer marketing），且我們預期第四季將進一步增加，因為我們的指標顯示早期方案具有強勁的轉換率。最後，我們在年初新增了資深人才，導致額外的薪酬費用，並在本季產生部分資遣費用。

We also remind investors that our operating expenses this quarter included increased spend on the four strategic investments that we outlined at the beginning of the year. Mainly our Verily relationship, building out our data analytics capabilities, international expansion, and finally our new manufacturing facility in Arizona. We're now trending to the $40 million of incremental expense we outlined earlier this year. Absent non-cash charges, non-GAAP cash based net income was $15 million for Q3. Our GAAP loss per share for the quarter was $0.22. We ended the third quarter with $127 million in cash and marketable securities. And with respect to 2016 revenue guidance, we currently believe that we will fall within the mid- to upper-end of our range of $550 million to $575 million in revenue for the year. However, we don't expect to exceed the top end at this time. With that, I will turn the call back to Kevin for a business update.

我們也提醒投資人，本季營運費用包含年初所概述的四項策略性投資之增加支出，主要包括：與 Verily 的合作關係、建置資料分析能力、國際擴張，以及最後在亞利桑那州的新製造設施。我們目前的趨勢正朝向今年稍早所說明的 4,000 萬美元增量費用。若排除非現金費用，第三季以現金為基礎的非 GAAP 淨利為 1,500 萬美元。本季 GAAP 每股虧損為 0.22 美元。第三季期末我們持有現金及有價證券 1.27 億美元。至於 2016 年營收指引，我們目前認為全年營收將落在 5.50 億至 5.75 億美元區間的中段至上緣；然而，目前我們不預期會超過該區間上限。接下來我把電話交回 Kevin，進行業務更新。

Thank you, Steve. As many of you know, during the past few years, we have consistently increased our annual revenue guidance on the third-quarter call. We're obviously pleased with our continued growth during Q3 and adoption of DexCom CGM remains robust. More importantly, the majority of our new patient additions are now MDI patients, a long standing goal of our company. But there are some variables we're currently experiencing that we haven't seen in prior years. First, our hardware sales model has been significantly affected by the issues we've encountered with our receiver and the related product recall. Numerous patients have returned their receivers for new ones free of charge.

謝謝你，Steve。正如各位所知，在過去幾年中，我們一向在第三季電話會議上持續上調全年營收指引。我們對第三季持續成長感到非常滿意，而 DexCom CGM 的採用仍然強勁。更重要的是，我們新增病患中多數現在都是 MDI 病患，這一直是公司長期以來的目標。不過，我們目前正經歷一些過去幾年未曾出現的變數。首先，由於我們在接收器方面遇到的問題以及相關產品召回，我們的硬體銷售模式受到顯著影響。許多病患已將其接收器退回，以免費更換新的接收器。

Historically, these would have been revenue generating replacement receivers, particularly in the fourth quarter, as our patients' out-of-pocket expenses are much lower than at any other time of the year. I would like to note, however, that we have completed all of the compliance procedures related to this recall and have filed the appropriate documentation with the FDA to close out this action.

過去，這些通常會是可帶來營收的替換接收器，尤其是在第四季，因為在一年中的其他任何時候，我們病患的自付費用都沒有那麼低。不過我想指出，我們已完成與此次召回相關的所有合規程序，並已向 FDA 提交適當文件以結案。

Next, our international business grew 29% in Q3, a bit slower than the past several quarters, and our sequential increase from Q2 is relatively flat. In countries where CGM is not reimbursed, Libre has gained traction with its low cost approach. As we've consulted with healthcare providers and patients in these markets, we've found that these are cost-based decisions, not performance-based decisions. And virtually anyone we speak to would agree that our system offers so much more. This is exemplified by the recent reimbursement decision in Germany to not cover products like Libre. We remain optimistic about our long term international growth outlook particularly in the EU where we have made early progress on the reimbursement front in other geographies in addition to Germany.

接著，我們的國際業務在第三季成長 29%，較過去幾季稍慢，且相較第二季的序列增幅相對持平。在 CGM 未獲給付的國家，Libre 以其低成本策略取得進展。當我們與這些市場的醫療照護提供者與病患諮詢時，我們發現這些是基於成本的決策，而非基於效能的決策。而且幾乎我們接觸到的任何人都會同意，我們的系統能提供更多價值。這點可由德國近期的給付決策得到印證：不給付像 Libre 這類產品。我們對長期國際成長展望仍保持樂觀，特別是在歐盟地區；除德國外，我們也已在其他地區的給付推進上取得早期進展。

Our biggest growth opportunity internationally remains reimbursement for CGM. We knew that going into 2016 and that's why we made the decision to establish our international headquarters and to begin to ramp-up our internal sales and support staff. Germany represents a prime example of this strategy. We evaluated the opportunity and determined the best way to attack it was to bring our distributor team into DexCom. We expect to make additional international investment to obtain reimbursement and accelerate growth in reimbursed markets in future years.

我們在國際市場最大的成長機會仍是 CGM 的給付。我們在進入 2016 年時就已明白這點，因此決定設立國際總部，並開始擴編內部銷售與支援人員。德國正是此策略的典型例子。我們評估了機會後，認為最佳的切入方式是將我們的經銷商團隊納入 DexCom。我們預期未來幾年將進一步增加國際投資，以取得給付並在已給付市場加速成長。

Finally, as I mentioned in my opening remarks, there is a lot of confusion in the US marketplace today. The media blitz surrounding what is being called the new artificial pancreas has been deafening. Based on what they have been told, many patients currently perceive that they will no longer need to manage their diabetes if they purchase this product. Therefore, many patients are willing to delay purchase decision until the system becomes commercially available or they're being directed to purchase the current Medtronic offering with the promise of being first in line for the 670G.

最後，如同我在開場致詞中提到的，目前美國市場存在大量混淆。媒體對所謂「新型人工胰臟」的密集報導震耳欲聾。根據他們所接收到的訊息，許多病患目前認為，只要購買該產品就不再需要管理糖尿病。因此，許多病患願意延後購買決策，直到該系統正式商業化上市；或者他們被引導去購買目前 Medtronic 的產品，並被承諾可優先排隊取得 670G。

In the short term we intend to focus on the following: continue to reinforce our CGM first message, emphasize data from multiple recent clinical studies, demonstrating outstanding real-world outcomes with standalone CGM and focus on the connectivity and ease-of-use of our current and future systems. Over the long-term, we're developing CGM systems which are much more accurate and reliable than today's products and greatly reduce the daily burden of diabetes management. These systems will be cost-effective solutions for the management of type I and intensively treated type II patients globally. Our insulin delivery partners will have access to in this exquisite technology and we believe we will have very competitive product offerings in automated delivery market in the not-too-distant future.

短期內，我們打算聚焦於以下事項：持續強化我們「CGM 優先」的訊息；強調多項近期臨床研究的數據，顯示單獨使用 CGM 在真實世界中可帶來卓越結果；並聚焦於我們現有與未來系統的連線能力與易用性。長期而言，我們正在開發比現有產品更精準、更可靠的 CGM 系統，並大幅降低每日糖尿病管理負擔。這些系統將成為全球第一型與接受強化治療的第二型病患之具成本效益的管理方案。我們的胰島素輸注合作夥伴將可使用這項精湛技術，而我們相信在不久的將來，我們在自動化輸注市場將具備非常具競爭力的產品組合。

Now, I will move on to a pipeline update. We never believed that we would be alone in this marketplace. Accordingly we have strategically positioned our product pipeline to maintain our technological leadership position in CGM. Specifically, we continue to work with the FDA to finalize the parameters of a non-adjunctive claim for our G5 mobile system. For example, we are working through the additional training and education that will be required for a non-adjunctive sensor system.

接下來我將更新產品研發管線。我們從未認為自己會在這個市場中孤軍奮戰。因此，我們已策略性地布局產品管線，以維持我們在 CGM 的技術領導地位。具體而言，我們持續與 FDA 合作，以敲定 G5 mobile 系統「非輔助（non-adjunctive）」宣稱的相關參數。例如，我們正在處理非輔助感測器系統所需的額外訓練與教育。

We continue to work through the final size and scope of a post-market study. Finally, as we have stated previously, the FDA is working to establish standards for a non-adjunctive CGM, not just sensor accuracy standards but manufacturing and performance standards as well. We have submitted and will continue so submit data to support such standards but nothing has been finalized at this point. As a result, timing of this approval is more likely an early 2017 event. Importantly at this time we do not anticipate that these ongoing deliberations will impact our goal of obtaining Medicare coverage in 2018. We are actively engaged in discussions with both FDA and CMS regarding the non-adjunctive system. Let me emphasize this, this is a really big deal. When we go out into the field, Medicare coverage is the most common topic and the most urgent need presented by the caregivers we visit.

我們也持續推進上市後研究的最終規模與範圍。最後，如同我們先前所述，FDA 正在建立非輔助 CGM 的標準，不僅是感測器精準度標準，也包括製造與效能標準。我們已提交並將持續提交數據以支持這些標準，但目前尚未定案。因此，此項核准的時程更可能落在 2017 年初。重要的是，目前我們不預期這些持續中的討論會影響我們在 2018 年取得 Medicare 給付的目標。我們正積極與 FDA 與 CMS 就非輔助系統進行討論。我要強調，這是一件非常重大的事。當我們走訪第一線時，Medicare 給付是我們最常被提及、也是我們拜訪的照護者所提出最迫切的需求。

Turning to other pipeline developments. We continue to make progress on several enhancements to our G5 mobile platform. We recently received FDA approval for a new version of the IOS G5 mobile app and a new transmitter framework configuration which provides us with key features like mute override, improved Bluetooth connectivity and several other features to enhance the patient experience. We're pleased to report we have filed a PMA supplement seeking approval of our new insertion system and smaller transmitter. We've also filed PMA supplement seeking approval of a next generation receiver which incorporates a Kellar Touch Screen display. Finally, we have filed a PMA supplement for our G5 mobile app for Android. And depending on the timing of FDA review, we expect the US launch of our Android platform to occur in late 2016 or early 2017.

再談其他研發管線進展。我們持續在 G5 mobile 平台的多項強化上取得進展。我們近期已獲 FDA 核准新版 iOS 的 G5 mobile App，以及新的發射器框架配置，為我們帶來關鍵功能，例如靜音覆寫（mute override）、改善的藍牙連線能力，以及其他多項可提升病患體驗的功能。我們也很高興報告，我們已提交 PMA 補充申請，尋求核准我們新的插入系統與更小型的發射器。我們也已提交 PMA 補充申請，尋求核准下一代接收器，其整合 Kellar 觸控螢幕顯示器。最後，我們已為 Android 版的 G5 mobile App 提交 PMA 補充申請。視 FDA 審查時程而定，我們預期 Android 平台在美國的上市將落在 2016 年底或 2017 年初。

We already launched Android in several key markets internationally earlier this quarter. We continue to work on several other enhanced versions of our G5 mobile app to provide additional features and functionality including the incorporation of insulin data. Turning to future sensor technology, G6 is as important an advance in our technology as was the shift from 7 Plus to G4 Platinum in 2012. Gen6 is a complete change in our sensor platform. New algorithm, new sensor, many new features. Initially, it will provide the basis for reducing calibrations and we believe it will be the foundation of our no calibration technology both with our first Verily products and our Gen7 system. I am pleased to report that we have commenced our pivotal trial and to date 40% to 50% of patients have completed the study. The Gen6 pivotal is the largest pivotal study that we've ever executed, with pediatric and adult patients included in one combined study of approximately 300 subjects. We could not be more excited about the prospects for Gen6, in large part to due to extremely promising data sets captured during a number of pre-pivotal studies. Early Gen6 data will be presented next week at the Diabetes Technology Meeting in Bethesda. All we can tell you now is we are not going backwards with respect to accuracy and reduction in and/or elimination of calibrations.

本季稍早，我們已在國際上數個關鍵市場推出 Android。我們也持續開發 G5 mobile App 的其他強化版本，以提供更多功能與特性，包括整合胰島素數據。再談未來感測器技術，G6 對我們技術的推進重要性，不亞於 2012 年從 7 Plus 轉換至 G4 Platinum。Gen6 是我們感測器平台的全面變革：新演算法、新感測器、許多新功能。初期，它將作為降低校正次數的基礎，而我們相信它也將成為我們免校正技術的基石，涵蓋我們第一代 Verily 產品以及 Gen7 系統。我很高興報告，我們已啟動關鍵性試驗（pivotal trial），截至目前約有 40% 至 50% 的病患已完成研究。Gen6 的關鍵性試驗是我們迄今執行過最大規模的關鍵性研究，將兒科與成人病患納入同一項合併研究，受試者約 300 人。我們對 Gen6 的前景感到無比振奮，主要原因是多項前期（pre-pivotal）研究所取得的數據集極具前景。Gen6 的早期數據將於下週在 Bethesda 舉行的 Diabetes Technology Meeting 發表。我們目前能告訴各位的是：在精準度以及降低和／或消除校正方面，我們不會倒退。

We are working with several of our automated insulin delivery partners to incorporate Gen6 into their research and clinical studies to gather more valuable data on these systems. Gen6 will more than likely now be a 2018 launch and we will provide more color as we get further into the study and the filing. Turn to our partnership with Verily, our collaboration to develop simple low-cost disposable sensor systems is one of the most aggressive innovative development opportunities we have ever engaged in. Our initial joint product offering with Verily will be a no calibration CGM platform based on the Gen6 technology. We believe the products we develop in our Verily partnership will not only expand CGM use in type I, but will drive entry into the non-insulin using type II market. As we continue to do research into this type II market, it has become more and more evident that the approach to the treatment of type II diabetes has been historically very hit or miss. For example, roughly 40% to 50% of patients remain poorly controlled despite a proliferation of new drug classes over recent years. We believe the information our system provides to a type II patient exceeds anything they can learn from the tools that they use today.

我們正與數家自動化胰島素輸注合作夥伴合作，將 Gen6 納入其研究與臨床試驗，以蒐集更多關於這些系統的寶貴數據。Gen6 現在很可能會在 2018 年推出；隨著研究與申報進展，我們將提供更多細節。再談我們與 Verily 的合作：我們共同開發簡單、低成本、可拋棄式感測器系統的合作，是我們曾投入過最積極且最具創新性的研發機會之一。我們與 Verily 的首個聯合產品將是基於 Gen6 技術的免校正 CGM 平台。我們相信，透過與 Verily 的合作所開發的產品，不僅能擴大第一型糖尿病的 CGM 使用，也將推動我們進入未使用胰島素的第二型市場。隨著我們持續研究第二型市場，越來越明顯的是，歷史上第二型糖尿病的治療方式一直相當不穩定、成效時好時壞。舉例而言，儘管近年來新藥類別大量增加，約有 40% 至 50% 的病患仍控制不佳。我們相信，我們系統提供給第二型病患的資訊，超越他們目前所使用工具所能學到的任何內容。

CGM paired with knowledge based decision support delivers healthcare providers a window into glucose variability and enables patients to visually connect the cause and effect that diet, physical activity, and medication choices have on glucose, therefore driving sustainable behavioral changes. Put simply, CGM data advances the potential for treatment optimization and ultimately better clinical outcomes and lower long-term costs. We believe the first product developed in collaboration with Verily should be commercialized in the second half 2018 and we expect that the smaller bandage-like sensor could be available as early as 2020.

結合知識型決策支援的 CGM，讓醫療照護提供者得以掌握血糖波動的視窗，並使患者能以視覺方式連結飲食、身體活動與用藥選擇對血糖造成的因果影響，進而推動可持續的行為改變。簡而言之，CGM 數據提升了治療最佳化的可能性，最終帶來更佳的臨床結果並降低長期成本。我們相信與 Verily 合作開發的第一款產品應可於 2018 年下半年商業化，且更小、如繃帶般的感測器最早可於 2020 年問世。

The first feasibility studies of the bandage-like sensor is taking place this quarter. With respect to our insulin delivery partners, our G4 integrated pump offerings remain popular among patients. And all our partners are making progress on integrating more advancements in delivery systems that leverage our G5 and G6 technologies with pumps, smart pens, and other connected diabetes management platforms. Early studies on several of these platforms look promising and we anxiously await the outcomes.

這款如繃帶般感測器的首次可行性研究正在本季進行。就我們的胰島素輸送合作夥伴而言，我們的 G4 整合式幫浦產品仍深受患者歡迎。而我們所有合作夥伴都在推進整合更多輸送系統的先進功能，運用我們的 G5 與 G6 技術，結合幫浦、智慧胰島素筆以及其他連網的糖尿病管理平台。針對其中數個平台的早期研究看起來相當有前景，我們也迫切期待其結果。

In conclusion, we have long held that the largest market opportunity in insulin using patients for our product is in the MDI segment, representing more than 70% of patients in the US and more than 90% outside the US. With all the noise in the current marketplace, it appears people have lost sight of how compelling the data from our DIaMonD study actually is. In patients using CGM we saw a full 1% reduction in A1C, which is unheard of in almost any other diabetes study.

總結來說，我們長期以來一直認為，在使用胰島素的患者中，我們產品最大的市場機會在於 MDI（多次每日注射）族群：在美國占比超過 70%，在美國以外更超過 90%。在目前市場的各種雜音之下，似乎人們忽略了我們 DIaMonD 研究數據其實有多麼具說服力。在使用 CGM 的患者中，我們看到 A1C 足足下降 1%，這在幾乎任何其他糖尿病研究中都極為罕見。

Patients on DexCom also experienced decreased time in hypoglycemia and improved timing range, all of these outcomes achieved with a minimal amount of training and without a complicated and expensive insulin delivery system. The CGM first message will continue to resonate. We also remain extremely bullish on our future market opportunity to change the management of type II diabetes with our CGM platforms. The information we're gathering from patients is fascinating and confirms what we have long believed. To quote a type II patient who's also the father of one of our scientists, who has type II diabetes and has been using our product, diabetes has been a series of losing battles for 20 years. CGM has given me my first win.

使用 DexCom 的患者也經歷了低血糖時間減少以及目標範圍內時間改善；而這些成果是在僅需極少訓練、且不必依賴複雜且昂貴的胰島素輸送系統的情況下達成的。「CGM 優先」的訊息將持續引起共鳴。我們也依然對未來以 CGM 平台改變第二型糖尿病管理的市場機會極為看好。我們從患者身上蒐集到的資訊非常引人入勝，也印證了我們長久以來的信念。引用一位第二型糖尿病患者的話——他同時也是我們一位科學家的父親，患有第二型糖尿病並一直使用我們的產品——『糖尿病在 20 年來一直是一連串的敗仗。CGM 給了我第一次勝利。』

I would now like to open the call for questions and answers.

我現在想開放電話會議進入問答環節。

Thank you. We will now begin question and answer session.

謝謝。我們現在開始問答環節。

(Operator Instructions)

（接線員指示）

Mike Weinstein, JPMorgan.

JPMorgan 的 Mike Weinstein。

Thank you. Good afternoon, guys. Kevin, the first question is, it sounds like the approval of 670G and all the discussion around it has basically taken up all of the noise in the room and made things a little bit more difficult for the rest of the diabetes players. I don't know if you saw it but Tandem reported relatively soft results and guided down for the year. So it sounds like that is occupying all of the discussion right now in the space. Two questions. One, can you maybe just characterize the tone of business pre-and post that? Obviously, it is reflected in your guidance commentary for the fourth quarter. But any other color there would be great. And two, how you change that dynamic? How do you make it so that you're not spending the next six months trying to get people's attention when Medtronic seems to have dominated the discussion over the last month?

謝謝。各位下午好。Kevin，第一個問題是：聽起來 670G 的核准以及圍繞它的所有討論，基本上把房間裡的聲量都占滿了，讓其他糖尿病領域的業者處境更為艱難。我不確定你是否看到，Tandem 公布的結果相對疲弱，並下修了全年指引。所以看起來目前這個領域的討論幾乎都被它占據了。我有兩個問題。第一，你能否描述一下在那之前與之後的業務氛圍？顯然這已反映在你對第四季的指引評論中，但若能再提供一些補充說明會很有幫助。第二，你們要如何改變這種態勢？如何避免接下來六個月都在努力吸引大家注意力，而 Medtronic 似乎在過去一個月主導了整個討論？

Mike, not only getting their attention but talking about a product that is not commercially available yet, that patients can't see, and the perception being created that it truly is an artificial pancreas. Where we are taking this discussion, Mike, is back to the fact that CGM is the most important tool in intensively managing diabetes and the outcomes we've achieved in the DIaMonD study. There are several other studies coming out in the not-too-distant future that are similar to that, real-world studies, are great outcomes.

Mike，不只是吸引他們的注意力，還得談論一個尚未商業上市、患者也看不到的產品，而市場上卻正在形成一種認知：它真的就是人工胰臟。Mike，我們要把討論拉回到一個事實：CGM 是密集管理糖尿病最重要的工具，以及我們在 DIaMonD 研究中達成的成果。未來不久還會有幾項與此類似的研究發表，屬於真實世界研究，結果都非常出色。

Our problem -- the doctors have been very supportive, they are very much taking a wait-and-see attitude. We've done very well with clinics and getting our message across to them. It is just this confusion or cloud that is hanging above us all. We will focus on CGM first. Quite honestly, in the fourth quarter in particular, the investment in CGM if somebody has met their deductible is not tremendously large. We will offer programs to encourage new patients to sign up. You'll see those come out over the Internet over the next couple weeks. To see if we can get -- certainly get more patients on. I would tell you from a color perspective our reorder patterns still remain very strong.

我們的問題在於——醫師一直非常支持，但他們也採取「觀望」的態度。我們在診所端表現很好，也成功把訊息傳達給他們；只是目前有一種困惑或陰霾籠罩在我們所有人之上。我們會聚焦在「CGM 優先」。坦白說，特別是在第四季，如果某人已達到自付額（deductible），投資 CGM 的成本並不算特別高。我們會推出一些方案來鼓勵新患者加入。接下來幾週你會在網路上看到這些方案推出，看看能否——確實能讓更多患者開始使用。就補充說明而言，我可以告訴你，我們的再訂購（reorder）模式仍然非常強勁。

We are not seeing reorders fall out of the queue. We're not seeing new patients we get signed up fall out of the queue saying I want to go the other way, it is just conveying the overall noise. We went through, not as much noise with 530G but we did go through noise with 530G as well. The difference being that product's been out in Europe and we knew exactly what we were going after. There had been studies comparing our sensor to theirs and other things. We could adopt a technical and tactical approach. This time there isn't one because, again, the product is not out. We will continue to plug. We will continue to offer promotions. Our DTC campaign has been very effective as far as generating new leads. But it's -- that's just where we are today.

我們沒有看到再訂購從隊列中掉出來。我們也沒有看到新加入的患者從隊列中掉出來、說他想改用另一邊；問題只是整體雜音的傳遞。我們曾經歷過 530G 的雜音——雖然沒有現在這麼多，但也確實有。差別在於那款產品已在歐洲上市，我們很清楚我們要面對的是什麼；也有研究比較過我們的感測器與他們的，以及其他相關資訊。我們可以採取技術性與戰術性的方式來應對。這次卻沒有，因為同樣地，產品尚未上市。我們會持續努力。我們會持續提供促銷。我們的 DTC（直接面向消費者）活動在產生新線索方面非常有效。但——這就是我們目前的處境。

Ben Andrew, William Blair.

William Blair 的 Ben Andrew。

Good afternoon. Thanks for taking the questions. Kevin, you talked a little bit about international been flat sequentially, can you attribute some of that or what amount to the move to direct operations separate of maybe an impact from Libre? And then second, how should we think about the impact of you guys going direct and getting reimbursement and when that will begin to impact revenues at least in Germany?

下午好。謝謝讓我提問。Kevin，你提到國際市場按季持平，你能否將其中一部分歸因於轉為直營（direct operations），而非例如 Libre 的影響？另外第二個問題，我們應如何看待你們轉為直營並取得給付（reimbursement）的影響，以及至少在德國，這何時會開始反映在營收上？

There was no impact in Q3 with respect to reimbursement in Germany and if anything, what we did is we've significantly increased our operating expenses by adding the operating expenses of our distributor to our own expense line. We are seeing now, as reimbursement is starting to sporadically come in for some of the payers in Germany, that our opportunities of new patients have gone up quite significantly. I think there will be a bit of a bump in Q4 for 2016 for Germany. But it really is more of a 2017 event than it is late 2016. Probably more Q2 and beyond, again, as we have to get reimbursement and insurance contracts ironed out. We have the staff to go do that and we're calling on the people we need to meet with and talk to now. Our direct opportunity in the UK, as we said earlier we have gone direct in the UK. UK was very small for us. It's still not very big but the fact is our business has gone up at a nice rate since we hired a great team over there.

第三季在德國的給付方面沒有影響；若有的話，我們所做的是把經銷商的營運費用加到我們自己的費用項下，因而大幅提高了營運費用。現在，隨著德國部分付款方開始零星提供給付，我們的新患者機會顯著增加。我認為 2016 年第四季德國可能會有一些小幅上揚，但這更像是 2017 年的事件，而不是 2016 年末的事件。可能要到第二季及之後才會更明顯，因為我們必須把給付與保險合約等事項敲定。我們已具備人員去推動這些工作，並且正在拜訪、聯繫我們需要會面與洽談的對象。我們在英國的直營機會方面，如同先前所說，我們已在英國轉為直營。英國對我們而言原本規模很小，現在仍不算大，但事實是，自從我們在那裡聘請了一支很棒的團隊後，我們的業務以不錯的速度成長。

Again, we've hired people who can go drive reimbursement and there's a percentage of our patients who are getting covered in local geographies there. So I think, German reimbursement is going to help significantly. UK growing reimbursement might help a tad bit but it's not going to be a huge driving factor. As we look at other countries, we certainly have had meetings and discussions in France. We see reimbursement continuing to be talked about in Italy. Australia is now looking at reimbursement for CGM as well. We've got programs going on in Canada also. So there's a lot of opportunities and once we get reimbursement we think we can grow nicely in those markets. But with respect to cash payers, I will get back to what I said earlier, our product is very expensive and there's a reason it is, it's really good. It provides a lot. It is a large cash commitment for somebody. And when offered a much lower cash price upfront, most of them elected to try that. Over time, when we get reimbursement we can certainly work through that, because of the features that our product set offers.

同樣地，我們聘請了能推動給付的人員，且在當地不同地區已有一定比例的患者獲得給付。因此我認為德國給付將帶來顯著助益。英國給付成長可能會有一點點幫助，但不會是很大的驅動因素。至於其他國家，我們在法國確實已進行會議與討論；我們看到義大利也持續在討論給付；澳洲現在也在評估 CGM 的給付。我們在加拿大也有相關計畫在進行。所以機會很多，一旦取得給付，我們認為能在這些市場有不錯的成長。但就自費（cash payers）而言，我要回到我先前說的：我們的產品非常昂貴，且有其原因——它真的很好，提供了很多價值。對某些人而言，這是一筆很大的自費承諾。而當市場提供一個前期自費價格低得多的選項時，多數人會選擇先去嘗試那個。隨著時間推移，當我們取得給付後，憑藉我們產品組合所提供的功能，我們當然可以逐步解決這個問題。

So as we think about the transition while we wait for the other products to show up in the market, if they actually do with most likely 670G and then whatever label the Libre consumer might get next year, do we think about different growth rates before and after that happens? Is there a transition where people are holding back a bit and I come through with subpar revenue growth but after that gets out there and you can message you got the G5X that you would expect to see patient adds accelerate perhaps in the second half of 2017, is that a fair way to think of it?

因此，當我們思考在等待其他產品進入市場（如果它們真的會出現）的這段過渡期——最可能的是 670G，以及 Libre 消費者版本明年可能取得的任何標示（label）——我們是否應該用「發生前」與「發生後」的不同成長率來看待？是否存在一個過渡期，人們會稍微觀望，導致我看到較差的營收成長；但在那些產品推出後，你們可以傳達你們有 G5X 的訊息，因而預期患者新增數在 2017 年下半年可能加速？這樣理解是否合理？

I will let Steve start. I am going to look at Steve and let him start then I will add my two cents.

我先讓 Steve 開始。我會看著 Steve 讓他先講，然後我再補充兩句。

Obviously, Ben, we will give formal guidance for next year in January. It's something we are still evaluating. I would tell you we are starting to see new patient adds pick up again. I think it's too early to tell. I wouldn't even want to speculate on Abbott. The challenge we have with Medtronic, as Kevin mentioned, we went through this exact thing with 530G. It was supposed to put us out of business, but we had the benefit of having an actual product and independent investigators had the benefit of having an actual product to test it. We have scoured their safety statement. It appears that patients are being recommended to take at least four fingers sticks a day to keep the thing running. They also have to take finger sticks every time it drops out of automatic mode to keep it into automatic mode.

很明顯地，Ben，我們會在一月對明年提供正式指引。這是我們仍在評估的事情。我會告訴你，我們開始看到新增病患數又回升。我認為現在下結論還太早。我甚至不想對 Abbott 做任何揣測。我們在 Medtronic 這邊的挑戰，如 Kevin 提到的，我們在 530G 上經歷過一模一樣的事。當時說它會讓我們倒閉，但我們的優勢是我們有實際產品，而獨立研究者也有實際產品可以測試。我們仔細研讀了他們的安全聲明。看起來他們建議病患每天至少要做四次指尖採血才能讓系統運作。他們也必須在每次掉出自動模式時做指尖採血，才能讓它回到自動模式。

The alert -- the false alert rates seem pretty high, in fact potentially even worse than the 530G. And as we know in the 530G context, that's the one thing patients complain about most in the field is the false alarms they receive from that system. So we are fighting a ghost for the next 6 to 9 months and we won't really know what we're up against until we actually have a physical product to o test. I'm not sure how to speculate on the impact.

警示——誤警率似乎相當高，事實上可能甚至比 530G 更糟。而我們也知道在 530G 的情境下，病患在實際使用時抱怨最多的，就是該系統帶來的誤警報。所以接下來 6 到 9 個月我們是在跟一個「幽靈」作戰，直到我們真的拿到實體產品來測試之前，我們不會真正知道要面對的是什麼。我不確定該如何推測其影響。

I think we need to see what the fourth quarter brings and we need to see what our -- we also have a non-injunctive claim on the horizon and I believe that could be a very big deal for marketing and positioning DexCom against these other products before they are out there because when there is a sensor that is labeled, you can dose insulin off of this thing. I think that will be very compelling for physicians, caregivers and patients and present a very good story for us. And you've mentioned G5X. We have G5X coming which is the smaller transmitter and much easier insertion system, much more practical and easier experience for our patients. So we have a number of positives that we are not quite sure of the timing on that go into this entire discussion as well. I think you are going to have to -- we will be a little more concrete in January.

我認為我們需要看看第四季會帶來什麼，也需要看看我們——我們也有一項非禁令（non-injunctive）的主張即將到來，我相信那對行銷與定位 DexCom、在這些其他產品真正上市之前與之競爭，可能會是非常重大的因素。因為當有一個感測器的標示是「你可以用它來決定胰島素劑量」，我認為這對醫師、照護者與病患都會非常有吸引力，並為我們帶來很好的故事。你也提到 G5X。我們即將推出 G5X，也就是更小的發射器與更容易插入的系統，對病患而言更實用、體驗也更容易。所以在整個討論中，我們還有不少正面因素，只是時間點我們還不完全確定。我想你得——我們會在一月講得更具體一些。

Last question for me, is it then fair to assume hardware as a percent of revenues drops below 30 thus because of the warranty stuff you mentioned and perhaps the patient starts and replacement hardware for maybe the next one to three quarters? Thanks.

我最後一個問題：那麼是否可以合理假設，硬體占營收的比重會降到 30% 以下，原因是你提到的保固相關事項，以及可能在接下來一到三季的病患啟用與替換硬體？謝謝。

You know, Ben, what we said when we started the G5 transmitters is it was two for one. We expected our gross transmitter hardware dollars to go up and our gross margin percentage go down because we were supplying two transmitters for the price of one, and that has happened. What has affected us again is the lack of receiver revenues, but there has been an increase in transmitter revenues. We think ultimately the percentage will go down and we will be more sensor driven than transmitters.

你知道，Ben，我們在開始銷售 G5 發射器時說過，這是買一送一。我們預期發射器硬體的毛額美元會上升，而毛利率百分比會下降，因為我們用一個的價格提供兩個發射器，而這確實發生了。再次影響我們的是接收器收入的缺乏，但發射器收入確實增加了。我們認為最終這個占比會下降，我們會更由感測器而非發射器所驅動。

We are selling a lot of transmitters.

我們賣出很多發射器。

Yes, we are selling a lot of transmitters. I don't have percentages to give you to where that goes yet. We will provide more color in January.

是的，我們賣出很多發射器。我目前還沒有可以提供你占比的數字，還不知道會走到哪裡。我們會在一月提供更多說明。

Thank you.

謝謝。

Jayson Bedford, Raymond James & Associates, Inc.

Jayson Bedford，Raymond James & Associates, Inc.。

Good afternoon. Can you hear me okay?

午安。你聽得到我說話嗎？

Yes.

聽得到。

Okay. You kind of alluded to it, but have you seen any change in the attrition rate with the launch of G5?

好。你有稍微提到，但在 G5 上市後，你們有看到流失率（attrition rate）有任何變化嗎？

No.

沒有。

No. We have not. We think our patient retention metrics are still very good. I would tell you the thing that may have changed, and we are studying this, a little bit, and I cannot give you complete color because we study retention all the time. As we enter a broader market of patients, our early adopters were pretty intense on CGM. I need CGM or I am going to die basically was often the statement that we'd hear from patients.

沒有，我們沒有看到。我們認為病患留存的指標仍然非常好。我會告訴你，可能有變化的一點——我們正在做一些研究——我無法給你完整的細節，因為我們一直都在研究留存。當我們進入更廣泛的病患市場時，我們的早期採用者對 CGM 的需求非常強烈。病患常常會說：「我需要 CGM，不然我基本上會死。」

As we're entering a group of patients who are saying, I will give this a try, we see their use patterns may be different than our long-time use it every day all the time patients. We also see that just given the reimbursement world, the continued use of our sensor for more than seven days remains prolific. And so that is something we factor in to our revenue models and revenue analysis as well. I don't see a huge increase and we don't see a huge decrease. We think it's remained relatively consistent.

當我們進入一群病患，他們說「我願意試試看」，我們看到他們的使用型態可能與我們長期、每天一直使用的病患不同。我們也看到，考量到給付環境，感測器使用超過七天的情況仍然非常普遍。因此這也是我們納入營收模型與營收分析的因素。我沒有看到大幅增加，我們也沒有看到大幅下降。我們認為整體仍相對一致。

You mentioned some of the marketing initiatives you have, but just given some of the stiffer headwinds, any thoughts on adding to your sales team going forward?

你提到一些行銷計畫，但考量到更強的逆風，對於未來是否要擴增銷售團隊，有什麼想法嗎？

We are going through our 2016 planning efforts right now. More than likely, we will expand the team. We will announce how much and to what extent in early 2016 -- 2017. I'm sorry, early 2017.

我們正在進行 2016 年的規劃工作。很可能我們會擴編團隊。我們會在 2016 年初——2017 年，抱歉，是 2017 年初——宣布擴編多少以及到什麼程度。

Lastly, for me. On Germany, can you give clarity on the level of reimbursement or how ultimately price will shake out? Are the economics comparable to the US for DexCom?

最後一個問題，關於德國：你能否更清楚說明給付水準，或最終價格會如何落定？對 DexCom 而言，其經濟性是否可與美國相當？

Without giving you specifics, the preliminary numbers that I have seen look quite favorable even with respect to or in comparison to what we see here in the US. And that -- I would tell you I spoke to John Lister, he heads up our European operations, yesterday and he informed me we are currently in discussions with approximately 40% of the covered lives, if you want to look at it that way, in Germany and the pricing looks quite favorable.

在不提供具體細節的前提下，我看到的初步數字相當有利，即使是相對於、或與我們在美國看到的情況相比也是如此。我會告訴你，我昨天和負責歐洲營運的 John Lister 談過，他告訴我，我們目前正與德國約 40% 的受保人群（如果你想用這種方式來看）進行洽談，而定價看起來相當有利。

Thanks. I will let someone else jump in.

謝謝。我讓其他人接著問。

Kyle Rose, Canaccord Genuity.

Kyle Rose，Canaccord Genuity。

Great. Thank you very much. Can you hear me all right?

很好，非常感謝。你聽得到我嗎？

Yes.

聽得到。

Yes, we can.

是的，聽得到。

I just wanted to touch on the G5 and the potential dosing claim. Any color or -- you can add with your conversation with the FDA as far as potential either changes from a product perspective that they may be looking for, whether it may be a required number of calibrations a day or a sensor shutoff or something along those lines?

我想談一下 G5 以及潛在的「可用於劑量決策」（dosing claim）。就你們與 FDA 的溝通而言，能否提供一些資訊——例如他們可能從產品角度希望看到的變更，是否可能要求每天校正次數，或感測器關閉機制之類的？

Yes, nothing in particular. What the FDA is really focused on right now is what sort of standards do they want to set? What bar is going to be the bar for a dosing type sensor? Not just MARD, but we focused in on percent 20/20 and outliers, and things like that. The FDA is focused, we mentioned in the prepared remarks, the FDA is focused on manufacturing standards, manufacturing variability, things like that. There is a whole bunch going into this and very thoughtful, frankly, on the part of the FDA. It's just taking a little bit longer is all. We are not going to -- I don't expect that they'd come back and ask us to modify the product in any way.

是的，沒有特別的要求。FDA 目前真正關注的是他們想設定什麼樣的標準？對於可用於劑量決策的感測器，門檻要設在哪裡？不只是 MARD，我們也聚焦在 20/20 百分比、離群值等指標。FDA 也關注——我們在事先準備的講稿中提到——FDA 關注製造標準、製造變異性等。這裡面牽涉很多事情，坦白說 FDA 的思考非常周全。只是整體花的時間稍微久一點而已。我們不會——我不預期他們會回頭要求我們以任何方式修改產品。

I'd just add that's one of the reasons for the post-market study. After the post-market study if we see anything then we would go back and discuss with them but for today there's nothing significant.

我補充一下，這也是進行上市後研究（post-market study）的原因之一。上市後研究完成後，如果我們看到任何情況，我們會再回去與他們討論，但就目前而言沒有任何重大事項。

Okay. I appreciate the color there. Lastly, on the quarter, any comments, directionally on new patient additions and what that type of mix was there? I believe last quarter you talked about 60% of patients came from MDI? Any sort of color you can give us on, on this quarter? Once again, more of our patient adds came from MDI than did from the pump world. So we continue to make inroads there. With respect to numbers, just to get to $149 million in revenues we reported, the new patient number had to be significant. It certainly was within our target. Quite candidly, year-to-date, based on our internal targets, we are spot on at the end of Q3. New patient growth remains very robust for us.

好的，謝謝你提供的資訊。最後，關於本季：對於新增病患數的方向性趨勢，以及其組成（mix），有沒有什麼評論？我記得上季你提到 60% 的病患來自 MDI？這一季你能提供任何資訊嗎？再一次，我們新增的病患中，來自 MDI 的比來自幫浦族群的更多。所以我們持續在那裡取得進展。就數字而言，為了達到我們所報告的 1.49 億美元營收，新增病患數必須相當可觀，而且確實在我們的目標範圍內。坦白說，以年初至今來看，依照我們內部目標，我們在第三季末完全達標。新增病患成長對我們而言仍然非常強勁。

Great. Thank you very much for taking the questions.

很好。非常感謝回答問題。

Doug Schenkel, Cowen and Company.

Doug Schenkel，Cowen and Company。

Hi, this is Ron Bucker on for Doug. Thanks for taking my questions. Starting with sensor utilization. You mentioned that reorder rates haven't changed but then you also noted that the use patterns of the product may have changed given the broader patient base you now have. Can you clarify these comments and is average sensor utilization in Q3 into the first nine months of the year, maybe closer to the lower end of your historical range?

嗨，我是代替 Doug 的 Ron Bucker。謝謝讓我提問。先從感測器使用量談起。你提到再訂購率沒有改變，但你也指出，因為你們現在的病患基礎更廣，產品的使用型態可能已經改變。你能釐清這些說法嗎？以及第三季、乃至今年前九個月的平均感測器使用量，是否可能更接近你們歷史區間的低端？

I think sensor usage for the first nine months of the year is relatively consistent with what we've had before. What I was trying to do in making my comments was indicate that, again, patients continue to use [them long], particularly those where reimbursement is tough for them and they are not covered as well as others. And, again, some of the new patients. I don't think there has been a significant change in sensor utilization. As the whole population gets bigger, the portion or the raw numbers of people who use their sensors longer is going to go up and so it becomes more visible to us as we look at it. The same with the use patterns.

我認為今年前九個月的感測器使用情況，與我們過去看到的相對一致。我在評論時想表達的是，再次強調，病患仍然會[長時間]使用它們，特別是那些報銷對他們來說比較困難、保障不如其他人完善的病患。還有一些新病患也是如此。我不認為感測器使用率有出現顯著變化。隨著整體族群變大，使用感測器時間較長的人所占比例或絕對人數會上升，因此當我們觀察時就會更明顯。使用模式也是一樣。

We go through exercises -- I will get into a lot of the detail, but we go through exercises we pick samples of the new patients in the patient base and try and follow them all the way through and look at their purchasing patterns, look at their use histories and everything. And every time we do it we learn something different and something new. Those were really the two things that were pointed out from the last group and the last population that we studied, that we still see increased sensor use and maybe use patterns for some of these patients are not what they were before. That's okay. They are still patients. They still derive great benefit from it.

我們會做一些分析——我不會深入太多細節，但我們會做一些分析：從病患基礎中挑選新病患的樣本，嘗試一路追蹤到最後，查看他們的購買模式、使用歷史等等。每次做這件事，我們都會學到不同且新的東西。上一次那一組、以及我們研究的上一個族群，主要指出的就是兩點：我們仍然看到感測器使用增加，而且其中一些病患的使用模式可能已經不同於以前。這沒關係。他們仍然是病患，仍然能從中獲得很大的益處。

Okay. Thank you, that is helpful. You talked about the impact Libre had internationally. Can talk more about the features of your first-generation Verily product and how it stacks up versus Libre for type II patients or maybe type I patients in the near term who might desire a less comprehensive solution? Thank you.

好的，謝謝，這很有幫助。你談到 Libre 在國際市場的影響。能否再多談談你們第一代 Verily 產品的功能，以及相較於 Libre，對第二型糖尿病患者，或是短期內可能希望較不全面解決方案的第一型患者而言，它的競爭力如何？謝謝。

Certainly the first product -- let me couch this first by saying, we don't believe the first product that we launched in partnership with Verily is the end all product. We've said that on multiple occasions. Bu it will be --

當然，第一個產品——我先這樣說，我們不認為與 Verily 合作推出的第一個產品就是終極產品。我們已在多個場合說過。但它會——

It is a learning experience for us.

這對我們來說是一個學習經驗。

It will definitely be a smaller form factor than the Libre platform. In many ways similar attributes, no calibration, and up to 14 days. I think the performance characteristics, and you guys will be pleased when you see the data at DTM next week, it incorporates the core Gen6 sensor technology. So you will see some preliminary data on that next week and you'll understand the levels of performance that we will be able to achieve with that product, so I think that will be a real positive for us. In many respects, it's a smaller, better performing version of the Libre.

它的外形尺寸肯定會比 Libre 平台更小。在很多方面具備相似的屬性：不需要校準，且可使用長達 14 天。我認為其性能特徵——各位下週在 DTM 看到數據時會很滿意——它採用了核心的 Gen6 感測器技術。因此你們下週會看到一些初步數據，並了解我們用該產品能達到的性能水準，我認為這對我們會是很大的正面因素。在許多方面，它是 Libre 的更小、性能更好的版本。

And I would add one of the things that will dictate the software around that product and the features set is going to be our non-adjunctive label. As we head into a particularly intensively insulin managed markets, we are not going to give up our non-adjunctive label for anything. Once we get it, we are going to stay there. We believe our technology is more than robust enough, again, as Steve said, and as you will see next week, to maintain that label with reduced and with no calibrations over time.

我再補充一點：決定該產品軟體與功能組合的一個因素，將會是我們的「非輔助（non-adjunctive）」標示。當我們進入特別是胰島素密集管理的市場時，我們不會為了任何事情放棄非輔助標示。一旦取得，我們就會維持。我們相信我們的技術足夠強健——如 Steve 所說、也如你們下週將看到的——能在校準次數降低、甚至隨時間推進到不需校準的情況下，仍維持該標示。

I should add too, key differentiating factors, of course that it does have Bluetooth technology and it does have real-time alerts and alarms as part of the system.

我也要補充，關鍵的差異化因素當然是：它具備藍牙技術，並且系統包含即時提醒與警報。

Yes.

是的。

That's an important point not to overlook.

這是一個不容忽視的重要重點。

David Lewis, Morgan Stanley.

Morgan Stanley 的 David Lewis。

This is actually Jon Demchick in for David, thanks for taking my questions. I wanted to go back to the top line in guidance. You mentioned the number of times you see the sustainable growth rate of this business; 35% to 40% I think is what you've said historically. The guidance range, as we look into the fourth quarter I guess, implies just shy of that, even at the top end. Should we think of the fourth quarter more as fully baked in for these competitive pressures? And from that base we can start to recover back to more of a normalized rate? Or do you think there could potentially get larger impacts, sequentially, for a couple of quarters as the launches continue to competitively?

我是代替 David 的 Jon Demchick，謝謝讓我提問。我想回到指引中的營收（top line）。你提到你們認為這項業務可持續的成長率是 35% 到 40%，我想這是你們過去一貫的說法。從指引區間來看，進入第四季時，即使在區間上緣也略低於那個水準。我們是否應該把第四季視為已充分反映這些競爭壓力？並以此為基礎開始回到較正常的成長率？還是你認為隨著競品持續推出，可能會在接下來幾個季度出現更大的逐季影響？

The first part of the question, we don't have a crystal ball to tell you this confusion -- there was initially substantial confusion in the marketplace. We've now started the see some press to the contrary where they are trying to clear up the mistaken notion this is an -- actually an artificial pancreas coming. We don't have a perfect crystal ball to tell you what this is going to like going forward. We are being conservative, obviously, in our guidance.

關於問題的第一部分，我們沒有水晶球可以告訴你這種混亂——市場一開始確實有相當程度的混亂。現在我們開始看到一些相反的報導，試圖澄清一個錯誤觀念：以為這是——其實是——一個人工胰臟即將到來。我們沒有完美的水晶球能告訴你未來會是什麼樣子。我們在指引上顯然採取保守態度。

I want to, though, take a step back. We stated 35% to 40% sustainable growth something like or five years ago. As I looked four or five years out -- four or five years ago looking forward, we've successfully sustained and exceeded that level of growth. At some point, we have said, even on recent calls, the law of large numbers is such that on a percentage basis growth is not going to continue to exceed 40% to 50% like it has in the past. You guys are trying to read a whole lot more into this, I think, than (inaudible).

不過我想退一步看。我們大概在四、五年前說過 35% 到 40% 的可持續成長。以四、五年前往前看，我們已成功維持並且超過那個成長水準。到某個時間點，我們也說過——甚至在近期的電話會議上——基於「大數法則」，以百分比計的成長不可能一直像過去那樣超過 40% 到 50%。我認為各位試圖從這裡解讀出更多含義，可能超過了（聽不清）。

We need some time. The flip-side of that, and I will cover it a little more in my close, penetration in the type I market for CGM is still not above 20%. There is plenty of runway there. We are not penetrated in someone using type IIs, at all, reimbursement will come there. It will be a combination of when we can get our new technologies and products out and feature sets that can expand to broader populations combined with just market penetration in the current markets where we sit. We'll just see over time.

我們需要一些時間。另一方面——我在結語會再多談一點——在第一型市場中，CGM 的滲透率仍未超過 20%。那裡還有很大的成長空間。我們在第二型使用者方面幾乎尚未滲透，報銷也會逐步到位。這將是多種因素的組合：我們何時能推出新技術與新產品、以及能擴展到更廣泛族群的功能組合，再加上我們目前所在市場的滲透提升。我們會隨時間觀察。

Understood. Very helpful. Just a follow-up on gross margins, you mentioned last quarter they would jump back up to the upper 60s, they certainly did. It sounds like there is still elevated levels of warranty expense. So normalized for that, is that -- is it fair to say we get back in towards the 70% levels?

了解，很有幫助。再追問一下毛利率：你上季提到毛利率會回升到 60% 高段，確實做到了。聽起來保固費用仍處於較高水準。若把這部分正常化，是否可以說毛利率會回到接近 70% 的水準？

I think that's fair. You know our warranty expense was about 3.5% of revenue versus our historical averages of about 2%. So we have some opportunity there. The margins came up this quarter, kind of in combination of lower warranty costs as a percentage of revenues. We also had better yields, particularly on our Gen5 mobile transmitter and then, of course, we had higher sales volume.

我認為這樣說是合理的。你也知道，我們的保固費用約占營收 3.5%，而歷史平均大約是 2%。所以這裡還有改善空間。本季毛利率上升，部分原因是保固成本占營收比重下降。我們的良率也更好，特別是在 Gen5 行動發射器上；當然，我們的銷售量也更高。

Understood. Thank you.

了解，謝謝。

Joanne Wuensch, IMO Capital Markets.

IMO Capital Markets 的 Joanne Wuensch。

Good afternoon and thank you so much

下午好，非常感謝

for taking my questions. I really have two. We focus mostly on German reimbursement, can you give me a timeline of when we might get additional reimbursement? My second question has to do with non-adjunctive claim, is there anything qualitatively that you can provide regarding the conversation that you are having with the FDA?

讓我提問。我其實有兩個問題。我們主要關注德國的報銷，你能否提供我們可能獲得額外報銷的時間表？第二個問題與非輔助（non-adjunctive）主張有關：關於你們與 FDA 的對話，有沒有任何定性層面的資訊可以分享？

On the non-adjunctive claim, we are really not going to provide any more details than we have. We need to work through the requirements and standards and really have a clear position before we explain everything to everybody. Again, I will echo Steve's comments, the discussions have been very good and very focused and very regular. They have been paying significant attention to the process and we hope to get through it soon.

關於非輔助主張，我們真的不會提供比目前更多的細節。我們需要先把相關要求與標準走完流程，並在對外說明前確立清楚的立場。再次呼應 Steve 的評論，相關討論一直都非常良好、非常聚焦且非常定期。他們對流程投入了相當多的關注，我們希望能盡快完成。

With respect to the other geographies, we really don't have timelines. One of the things we're learning as we go to other geographies, a lot of these places are not national decisions, they are very local and it's state by state or region by region. We certainly have very good reimbursement in Sweden right now through the tender process. We have the German reimbursement decision that just came. There's reimbursement in Switzerland, Austria, and there's are some other regions, like I said, in the UK where we're get a little bit of reimbursement and a little bit is beginning to come forth in Italy but there's not been any national decisions. We'll just continue to work on region by region and we'll give you more color as time goes on

至於其他地區，我們確實沒有時間表。我們在拓展到其他地區時學到的一件事是，很多地方的決策不是全國性的，而是非常在地化，按州、按區域來決定。我們目前在瑞典透過標案流程已取得非常好的報銷。德國的報銷決定也剛出來。瑞士、奧地利也有報銷；另外還有一些地區——如我所說——在英國我們拿到一些報銷，而義大利也開始出現一些報銷，但尚未有全國性的決定。我們會持續逐區域推進，並隨時間提供更多說明

Okay. Thank you very much.

好的，非常感謝。

Tao Levy, Wedbush Securities.

Wedbush Securities 的 Tao Levy。

Hi. Can you hear me?

嗨，你聽得到我嗎？

Sure.

當然。

Perfect. Great. Just a couple quick questions. Am I right in estimating that there's maybe about a $3 million impact from receivers on the revenue line in the quarter? Is that ballpark?

太好了。幾個簡短問題。我估算本季接收器（receiver）對營收項目大概有約 300 萬美元的影響，這樣的量級對嗎？

We're not going to quantify it.

我們不打算量化它。

Okay. In terms of CMS, it doesn't sound like these are linear discussions where you are waiting for FDA approval of the non-adjunctive and then you'll go to CMS, it sounds like there is positive dialogue going on around ahead of that. Is that a fair --?

好的。就 CMS 而言，聽起來這些並不是那種線性的討論——也就是你們等到 FDA 核准非輔助（non-adjunctive）之後才去找 CMS——反而像是在那之前就已經有正向的對話在進行。這樣說公平嗎——？

That is a fair statement. In fact, it's communications together, CMS and FDA and our regulatory folks. So yes, there are certainly discussions ongoing. Obviously, we will still need the non- adjunctive labeling before we can really become active with CMS. I would say this is highly visible not just with FDA but within CMS as well. I do think our belief is that CMS is going to ask us to go directly for a national coverage decision as opposed to trying to go regionally like we had discussed previously. But still, from what we're hearing from our consultants and our internal folks, they don't think even if the non-adjunctive claim pushes into the early part of 2017, that will impact our path to Medicare by sometime in 2018.

這樣說很公平。事實上，這是共同溝通，CMS、FDA 以及我們的法規團隊一起。所以是的，確實有討論在進行中。當然，在我們真正能夠積極與 CMS 推進之前，我們仍然需要先取得非輔助（non-adjunctive）的標示。我會說，這件事不只在 FDA 那邊能見度很高，在 CMS 內部也是。我確實認為，我們的看法是 CMS 會要求我們直接申請全國性給付決定（national coverage decision），而不是像我們先前討論的那樣嘗試走區域性路徑。不過，從我們顧問以及內部同仁那邊聽到的情況來看，他們認為即使非輔助（non-adjunctive）主張延後到 2017 年初，也不會影響我們在 2018 年某個時間點取得 Medicare 的路徑。

Okay. Got you. And lastly, in terms of data that's going to come out next week, what specifically is it? Are these patients from pivotal trial? Or is this another study that you have going?

好的，了解。最後，關於下週要公布的數據，具體是什麼？這些病人是來自關鍵性試驗（pivotal trial）嗎？還是你們正在進行的另一項研究？

With all of our sensors, we run several pre-pivotal studies, the data that will be presented next week is from a relatively large pre-pivotal study using our [intensive] platform. That will be what is presented. It's not the pivotal data because we would not open it up until it's done, until we submit it.

針對我們所有的感測器，我們會進行數個關鍵性試驗前（pre-pivotal）的研究；下週要發表的數據來自一項規模相對較大的關鍵性試驗前研究，使用我們的 [intensive] 平台。將會呈現的就是這個。這不是關鍵性試驗（pivotal）的數據，因為在完成之前、在我們提交之前，我們不會把它打開。

That's what I figured, I just wasn't sure. Thank you.

我也是這麼想的，只是不太確定。謝謝。

Anthony Petrone, Jefferies and Company.

Anthony Petrone，Jefferies and Company。

Thanks and good afternoon. Maybe a little bit on CGM pricing broadly. You know you have 670G out there and then Libra and there's the potential for some other CGM clearances in 2017, if I'm not mistaken. How do you see pricing shaking out with all the increase technologies on the marketplace at this point? And then I have one follow-up.

謝謝，下午好。想先談一下整體 CGM 定價。你們知道現在有 670G，然後有 Libre，而且如果我沒記錯，2017 年還可能有其他 CGM 取得核准。以目前市場上技術不斷增加的情況，你們怎麼看定價會如何發展？然後我還有一個追問。

You know we have remained relatively consistent on the price front for quite some time. I think future prices will be accepted -- will be determined by the outcomes one can generate with the technologies. Another big factor on pricing is going to be the length and wear of the sensors. As we talked about, our Gen6 sensor is a 10-day product versus a 7-day product, which give us an opportunity to either increase price or increase value to the patient and payer and we'll probably end up with a combination of both with the Gen6 sensor. We prepare internally scenarios for every alternative.

你知道，我們在價格面上相當長一段時間都維持相對一致。我認為未來價格會被接受——會由技術所能帶來的結果（outcomes）來決定。另一個影響定價的重要因素，會是感測器的使用天數與配戴時間。正如我們談到的，我們的 Gen6 感測器是 10 天產品，相較於 7 天產品，這讓我們有機會提高價格，或是提高對病人與支付方的價值；而在 Gen6 感測器上，我們很可能會兩者兼具。我們內部會針對每一種替代方案準備情境。

We prepare for higher prices. We prepare for lower prices. We prepare for everything you can imagine. We have modeled several scenarios, we will adapt to where the market takes us. Being the leader, we want to take the market, obviously, to the right place. But these technologies have to be affordable to patients. They have to provide outcomes that are worth more than the cost of the CGM system and that's how we look at pricing in the future.

我們會為更高的價格做準備，也會為更低的價格做準備，會為你能想像的一切做準備。我們已經建模了好幾種情境，市場把我們帶到哪裡，我們就會調整。身為領導者，我們當然希望把市場帶到正確的方向。但這些技術必須讓病人負擔得起。它們必須提供的結果（outcomes）要值得、要高於 CGM 系統的成本，這就是我們看待未來定價的方式。

That is helpful. And maybe a follow-up on 670G. When you look at the dynamics between pumpers and MDI, it seems to me that the initial low hanging fruit would be pumpers, but how much of a broad push are you expecting from 670G? Do you think it's going to be broad-based in those two categories and therefore potentially more competition in the MDI segment of the marketplace? Thanks.

這很有幫助。再追問一下 670G。當你看打胰島素幫浦（pumpers）和 MDI（多次每日注射）之間的動態時，我覺得一開始最容易切入的會是幫浦族群，但你們預期 670G 會帶來多大範圍的推動？你覺得它會在這兩個類別都廣泛推進，因而可能在市場的 MDI 區隔帶來更多競爭嗎？謝謝。

You know, I think that's the big question, right?

你知道，我想這就是最大的問題，對吧？

When Terry and Kevin -- I am speaking for Kevin; he's sitting here. But when Terry and Kevin sold MiniMed 15 years ago, pump penetration was at about 20% in the US. Today it's about 30%. 15 years later, four commercial pump companies have been able to drive an additional 17 points of penetration. I mean, I personally don't believe that 670 is going to move the needle from 30% penetration to 40% or 50% penetration in any meaningful period of time. I think, particularly outside the US, MDI is going to remain the vast majority of patients' method for insulin delivery. And even in the US, I think patients -- as we continue to improve our technology, improve the form factor and shrink the form factor on the technology, add patients with the additional tools, additional decision support tools, with respect to their insulin on board, et cetera, I think that the product offering and from a pricing perspective the product offering of CGM and an intelligent insulin pen, for example, will be very compelling both from an outcomes perspective and from a cost perspective.

當 Terry 和 Kevin——我替 Kevin 說，他就坐在這裡——但當 Terry 和 Kevin 在 15 年前賣掉 MiniMed 時，美國的幫浦滲透率大約是 20%。今天大約是 30%。15 年後，四家商用幫浦公司也只把滲透率再推升了 17 個百分點。我的意思是，我個人不相信 670 會在任何有意義的時間內，把滲透率從 30% 推到 40% 或 50%。我認為，尤其在美國以外，MDI 仍會是絕大多數病人的胰島素給藥方式。即便在美國，我也認為病人——隨著我們持續改進技術、改進外形設計並縮小裝置體積，並透過更多工具、更多決策支援工具（例如關於體內胰島素量 insulin on board 等）來賦能病人——我認為從結果（outcomes）角度與成本角度來看，CGM 加上例如智慧胰島素筆（intelligent insulin pen）這樣的產品組合，在產品供給與定價面都會非常有吸引力。

That is helpful. Thank you.

這很有幫助。謝謝。

Well said.

說得很好。

Rebecca Wang, Leerink Partners.

Rebecca Wang，Leerink Partners。

Can you hear me okay?

你們聽得到我嗎？

We can.

聽得到。

This is Rebecca on behalf of Danielle, have you seen any impact on your patient adds from the time and the data that was released at the ADA this year?

我是 Rebecca，代表 Danielle 提問：今年 ADA 公布的時間點與數據，對你們新增病人數（patient adds）有看到任何影響嗎？

You know the DIaMonD study has not been officially published in a journal yet, so we remain relatively low-key about that data at this point in time. We know it's under review right now. We are going to be a little more aggressive with marketing as we think it is getting closer to publication. So we will really unleash a DIaMonD blitz over the month of November here and hopefully that will add -- help increase patient adds. Not a lot so far because we really haven't pushed it.

你知道，DIaMonD 研究目前還沒有在期刊上正式發表，所以在這個時間點我們對那份數據仍相對低調。我們知道它正在審查中。我們認為越接近發表，就會在行銷上更積極一些。所以我們會在 11 月這段期間真正啟動一波 DIaMonD 的密集推廣（blitz），希望那會帶來——幫助提升新增病人數。目前為止不多，因為我們其實還沒有大力推。

Yes. Can you provide more color on the timing of the rest of the DIaMonD data to be released? This year or?

是的。你能否更詳細說明其餘 DIaMonD 數據釋出的時間點？會在今年嗎？還是——？

There are a couple of other study arms. There's a type II patient study arm. There's also an arm of the study where some of the patients continue to use CGM for a longer period of time, another group of patients continue to use CGM, they go to an insulin pump in addition to CGM. I know the studies are winding down. I don't have timelines for you. They will be greatly affected by publication timelines as well. But the study is -- it will be wrapped up, the actual patient analysis will be wrapped up, by the end of the year. So the data will come after that.

還有幾個其他的研究分支。有一個是第二型糖尿病病人的研究分支。也有一個分支是部分病人會在更長一段時間內持續使用 CGM；另一組病人則是除了 CGM 之外，還會改用胰島素幫浦。我知道這些研究正在收尾。我沒有你要的時間表。它們也會很大程度受到發表時程的影響。不過研究本身——實際的病人分析——會在年底前完成。所以數據會在那之後出來。

Thank you.

謝謝。

Jeff Johnson, Robert Baird.

Jeff Johnson，Robert Baird。

Thank you and good afternoon, guys. Two quick questions, one on G6 it seems like the pivotal is moving very quickly there and FDA also seems to be moving fairly quickly on some of their approvals recently, just wondering how solid you feel on that 2018 commercial launch time? What are the options to maybe pull that forward or see that move up a little bit from a potential launch standing?

謝謝，下午好，各位。兩個快速問題：第一個關於 G6，看起來關鍵性試驗（pivotal）進展很快，而 FDA 最近在一些核准上似乎也推進得相當快；想請問你們對 2018 年商業上市（commercial launch）的時間點有多大把握？有沒有什麼選項可以把時程往前拉，或讓潛在上市時間再提前一些？

You know we have a sequence of launches next year, particularly with the new applicator and transmitter with the Gen5 system, that we need to get those manufacturing processes up and mature really quickly. That is really important to us. That is a bigger endeavor than anything we've undertaken for a long time. So it's probably better timed that G6 come out little after that because we fully intend to use the new transmitter and new applicator configuration and we would be much happier if we didn't have to start from scratch.

你知道，我們明年有一連串的上市計畫，特別是 Gen5 系統的新型施用器（applicator）和發射器（transmitter）；我們需要把那些製造流程很快地建置並成熟化。這對我們非常重要。那是一項比我們很長一段時間以來做過的任何事情都更大的工程。所以讓 G6 在那之後一點推出，時點可能更好，因為我們完全打算沿用新的發射器與新的施用器配置；如果不必從頭開始，我們會更開心。

If we could pull it in that would be wonderful if we were to pull it in but there is a lot of boxes to check. With respect to FDA timing and speeding things up, while I would agree they appear amenable to that, we have been discussing non-adjunctive claim for a very long time. And it's not through. So when you get into complex issues, it can become real tough. I think they will be very cooperative with Gen6. I think we can push it through quickly provided the data set is reflective of what you guys will see next week. I think it's a tremendous advance in sensor technology that we can get through. We have to remain diligent and keep going but there's a lot to get ready before it comes.

如果我們能把時程往前拉，那會很棒——但要把時程往前拉還有很多項目要確認。至於 FDA 的時程與加速審查，雖然我同意他們看起來願意配合，但我們針對非輔助（non-adjunctive）主張已經討論很久了，而且還沒結束。所以當你進入複雜議題時，就會變得很棘手。我認為他們會非常配合 Gen6。我認為只要數據集能反映你們下週會看到的內容，我們就能很快推進。我認為這是感測器技術的一大進步，我們可以把它順利推過去。我們必須保持謹慎並持續推進，但在它到來之前，還有很多事情要準備。

Understood. That's helpful. Steve, just want to go back and clarify something you said on Germany. It sounds like the reimbursement rates are coming in, you said pretty solid especially even relative to US rates. Just wondering, that's the sell in price or the price you're going to recognize for sensors and transmitters, and receivers, and things like that is on par? I don't put words in your mouth but relatively good relative to US?

了解。這很有幫助。Steve，我想回頭釐清一下你剛才談到德國時說的內容。聽起來報銷／給付費率正在出來，你說相當穩健，甚至相較於美國費率也很不錯。我只是想確認一下，那是指出貨／銷售端的價格，還是你們將要認列的感測器、發射器、接收器等產品的價格大致相當？我不想替你說話，但相對於美國來說算是相當不錯？

Yes. You can put words into my mouth. That's exactly right. None of this is finalized, we still don't expect to see an impact until really next year. But I would tell you so far so good.

是的。你可以替我說話。完全正確。這些都還沒定案，我們也仍然預期要到明年才會真正看到影響。但就目前而言，我會告訴你，進展不錯。

Okay, and do you have any idea the copay that patients are going to be -- are going to have on that system then in Germany, how that maybe stacks up, relative to self-pay for a Libre, or something like that?

好的，那你是否知道在德國，病患在那套系統上的自付額（copay）大概會是多少——也就是他們需要負擔的部分——以及相較於自費購買 Libre 之類產品，可能會是什麼樣的水準？

I don't but we can certainly -- maybe for the next call we'll have a little more detail here because we will have some contracts signed by that point.

我目前不知道，但我們當然可以——也許在下一次電話會議時，我們會有更多細節，因為到那時我們應該會簽下一些合約。

We will have a little more detail.

我們會有更多細節。

Yes. Understood. Thanks, guys.

是的。了解。謝謝各位。

Mike Weinstein, JPMorgan.

Mike Weinstein，摩根大通。

I think she probably put me back in from earlier, but let me ask you, relative to Europe since Germany was just discussed, do you have any greater visibility on the other countries coming through? And as you are aware, our checks on Germany have been pretty positive over the last several weeks, in terms of not only how reimbursement shaping up, but potential demand. Do you think that Germany could be bigger in 2017 than maybe you are assuming or the street's assuming?

我想她可能把我從先前又接回來了，不過我想問一下，既然剛剛談到德國，就歐洲其他國家而言，你們對於其他國家推進的情況是否有更高的能見度？而且如你所知，我們過去幾週對德國的調查結果相當正面，不僅是給付如何成形，還包括潛在需求。你是否認為德國在 2017 年可能會比你們或市場目前假設的還要大？

Yes, it certainly could be. Particularly as we mentioned, we're in discussions, I'd characterize discussions, with about 40% of the covered lives. As we continue to accelerate that, if we can truly contract with and grow something like 15-ish critical payers to get the vast majority of covered lives, Germany could be a much bigger contributor next year. Just giving an example in the UK we're actually seeing reimbursement. Most of our patients are seeing reimbursement these days, but it's a one off basis and they're having to apply individually. It's not something that is scalable. We really do need to reengage with NICE and push that issue to make it more formalized.

是的，確實有可能。尤其如我們提到的，我們正與大約 40% 的受保人群（covered lives）進行討論——我會把它形容為「討論」。隨著我們持續加速推進，如果我們真的能與大約 15 家左右的關鍵支付方簽約，涵蓋絕大多數受保人群，那麼德國明年可能會成為更大的貢獻來源。舉例來說，在英國我們其實已經看到給付；目前我們多數病患都能拿到給付，但那是以個案方式進行，必須由病患逐一申請。這不是可規模化的做法。我們確實需要重新與 NICE 接觸並推動這個議題，使其更正式化。

France the same thing. We are in discussions; there's not been any formal action taken in France. The signs are looking positive so that could be a contributor, potentially, as early as next year as well. So yes, I think you're thinking about it right, Mike, that Europe as a collective, if we knock off a couple more of these big countries it could be a big push for us next year.

法國也是同樣情況。我們正在討論中；法國目前尚未採取任何正式行動。跡象看起來正面，因此也可能成為貢獻來源，甚至可能最早在明年就會發生。所以是的，Mike，我認為你的思考方向是對的：歐洲整體而言，如果我們再拿下幾個這樣的大國，明年對我們可能會是一個很大的推力。

You know, obviously, there's something to learn from what's going on with Libre, right? Libre has taken off in Europe. There's this demand for diabetes technology in Europe that has not been satisfied. And so, when you think about the fact that there has been now a couple hundred thousand patients that potentially are on Libre or have tried Libre, better put, at this point, how do you tap into that once you get reimbursement in a country like Germany? What's the launch strategy look like? Because I have to think that with the Libre experience and the enthusiasm that product has seen, that how you think about going to market has to be different than maybe you were thinking a year or two ago.

你知道，顯然我們可以從 Libre 的情況學到一些東西，對吧？Libre 在歐洲成長很快。歐洲對糖尿病科技有一股尚未被滿足的需求。因此，當你想到目前可能已有數十萬名病患正在使用 Libre，或更準確地說，到目前為止已經嘗試過 Libre，那麼一旦你們在德國這樣的國家取得給付，你們要如何切入這些人群？上市策略會是什麼樣子？因為我認為，基於 Libre 的經驗以及該產品所引發的熱度，你們對於市場導入的思考必須不同於一兩年前的想法。

I think, Mike, we are very much evaluating product configurations. I'll give you one example. We have seen, [market] for the system without use of the receiver in Europe, now. If a patient wants to use the system, unlike in the US where we get a new patient we're required to sell them a receiver, we don't have to do that anymore. So we've put ourselves in a position where we can somewhat reduce the upfront costs for patients to get I to start. And as far as enthusiasm, we are enthusiastic. In fact, our German team is going through budget processes and their requests for sales hits is remarkable. They, obviously, are very optimistic about their ability to go sell, and poor Jess has to be the bad guy down at the end of the table, but we'll --- we're going to add significant feet on the street in Germany to go after that. I think one of the other lessons learned is people do want information.

Mike，我認為我們正在非常積極地評估產品配置。我舉一個例子：我們現在在歐洲已經看到，在不使用接收器的情況下使用該系統的[市場]。如果病患想使用系統，不像在美國，我們每新增一位病患就必須賣給他一台接收器，我們現在不必再這麼做。因此我們讓自己處於一個位置，可以在某種程度上降低病患開始使用時的前期成本。至於熱情，我們也很有熱情。事實上，我們的德國團隊正在走預算流程，他們對銷售人力的需求令人驚訝。他們顯然對自己去銷售的能力非常樂觀，而可憐的 Jess 在會議桌最後端得扮演壞人，但我們——我們將在德國大幅增加一線銷售人員去爭取那個市場。我認為另一個學到的教訓是，人們確實想要資訊。

And if their copay and out-of-pocket and their reimbursement covers this, by offering connectivity and the things that we offer from a feature set versus this product, we think they are going to really lead to fast growth. We will configure future products as we look at it. We are going to offer a no calibration sensor, over time. We are just going to offer one that's going to be accurate enough to meet our standards and to meet the non-adjunctive claim standards we believe will be set up by the FDA as well. There is a lot to learn here, and we will aggressively go after it.

而且如果他們的自付額、個人自掏腰包的費用，以及他們的給付能涵蓋這些成本，那麼透過我們所提供的連線能力與各項功能特色，相較於這個產品（指競品），我們認為將會真正帶來快速成長。隨著我們持續評估，我們也會配置未來產品。隨著時間推進，我們會推出免校正（no calibration）的感測器。我們只會提供一款在準確度上足以符合我們標準、也符合我們認為 FDA 將建立的非輔助性（non-adjunctive）宣稱標準的產品。這裡有很多可以學習的地方，而我們會積極進攻。

Understood. Thank you, guys.

了解。謝謝各位。

(Operator Instructions)

（接線員指示）

We have no further questions at this time.

目前沒有其他問題。

I will close with a couple concluding remarks. We want to thank everybody for being on our call today And everybody for their questions, they're very insightful. We continue to address what we believe is one of the most meaningful opportunities in all of healthcare. The treatment of diabetes, type I and type II, is one of the leading cost drivers in healthcare all over the world. We are going to continue to focus on what we do best, developing, manufacturing, distributing the world's leading CGM technology.

最後我做幾點結語。我們要感謝今天參與電話會議的每一位，也感謝大家的提問，都非常有洞見。我們持續在處理我們認為是整個醫療保健領域中最具意義的機會之一。糖尿病（第一型與第二型）的治療，是全球醫療保健成本的主要驅動因素之一。我們將持續專注於我們最擅長的事：研發、製造與銷售全球領先的 CGM 技術。

Our future platforms, sensor platforms, our new algorithms, Verily' s technology, advanced data analytics, we're going to be able to change the conversation of diabetes management over the next several years. Our growth opportunity, even in times like we have described today, is still huge. The type I market is very underpenetrated. There's a completely unpenetrated type II intensively managed insulin market. The global opportunities we've discussed with Germany, the UK, the other places we are seeing reimbursement come up, are huge, even in light of the increased competition that is coming. It's a great time to be here at DexCom. We will continue to deliver great products and great performance for our investors. Thank you.

我們未來的平台、感測器平台、我們的新演算法、Verily 的技術、先進的資料分析，將使我們能在未來幾年改變糖尿病管理的討論方式。即便在我們今天所描述的這種時期，我們的成長機會仍然非常巨大。第一型市場的滲透率仍然很低。第二型、採取密集胰島素管理的市場則完全尚未被滲透。我們談到的全球機會——包括德國、英國，以及其他我們看到給付逐步出現的地區——都非常龐大，即使考量到即將到來的競爭加劇也是如此。現在是加入 DexCom 的好時機。我們將持續為投資人交付優秀的產品與優異的表現。謝謝。

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

謝謝各位女士、先生。今天的會議到此結束。感謝各位參與。您現在可以掛線。