德康醫療 (DXCM) 2016 Q1 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 first-quarter 2016 earnings release conference call. My name is Bianca and I will be your operator for today.

    歡迎參加 Dexcom 2016 年第一季財報發布電話會議。我是 Bianca,今天將擔任您的接線員。

  • (Operator Instructions)

    (接線員指示)

  • Please note that this conference is being recorded. I will now turn the call over to your host, Mr. Kevin Sayer. Mr. Sayer, you may begin.

    請注意,本次會議將被錄音。現在我將把電話交給主持人 Kevin Sayer 先生。Sayer 先生,您可以開始了。

  • - CEO & President

    - CEO & President

  • Thank you, Bianca, and welcome, everybody, to our first-quarter 2016 earnings call. I'd like to turn the time over to Steve Pacelli for our Safe Harbor statement.

    謝謝你,Bianca,也歡迎各位參加我們 2016 年第一季財報電話會議。我想把時間交給 Steve Pacelli,請他宣讀我們的安全港聲明。

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Great, thanks, Kevin. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs, expectations and strategies about future events, 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 that with deal future events are subject to various risks and uncertainties and actual results could differ materially from those anticipated in the forward-looking statements.

    好的,謝謝你,Kevin。我們今天電話會議中所做的部分陳述可能構成前瞻性陳述。這些陳述反映管理層對未來事件、營運計畫與績效的意圖、信念、預期與策略。本簡報所包含的所有前瞻性陳述均以本日為準,係基於 Dexcom 目前可得資訊所作;涉及未來事件者均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 quarterly report on Form 10-Q for the period ended March 31, 2016 as filed with the Securities and Exchange Commission, and our other reports filed with the SEC. Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this presentation or 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有重大差異的因素,已詳載於 Dexcom 向美國證券交易委員會(SEC)提交之截至 2016 年 3 月 31 日止期間的 Form 10-Q 季度報告,以及我們向 SEC 提交的其他報告中。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, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash-based operating results. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Kevin?

    此外,我們將討論若干未依 GAAP 編製、與我們以現金為基礎之營運結果相關的財務資訊。提供此等非 GAAP 資訊旨在增進您對我們目前財務表現的整體理解。此額外資訊之呈現不應被孤立看待,亦不應視為 GAAP 編製結果之替代,或優於 GAAP 編製結果。Kevin?

  • - CEO & President

    - CEO & President

  • 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 start with our detailed review of our 2016 first-quarter financial results, then I will follow with our customary operations update and offer some concluding thoughts before opening the line for questions. I'll now turn the call over to Steve.

    謝謝你,Steve。今天與我一同出席的有 Jess Roper,我們的財務長;以及 Steve Pacelli,我們的策略與企業發展執行副總裁。依照我們一貫的流程,Steve 會先詳細回顧 2016 年第一季財務結果,接著我會進行例行的營運更新並提出一些結語,然後開放提問。現在把電話交給 Steve。

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Thanks, Kevin. Dexcom reported revenue of $116 million for the first quarter of 2016 compared to $73 million for the same quarter in 2015, a $43 million or 60% increase. Sequentially, revenue for Q1 was down approximately 11% from the prior quarter, which was expected as the first quarter is traditionally a seasonally slow quarter for our business.

    謝謝,Kevin。Dexcom 2016 年第一季營收為 1.16 億美元,較 2015 年同季的 7,300 萬美元增加 4,300 萬美元,或成長 60%。就季比而言,第一季營收較前一季約下降 11%,此為預期之內,因第一季傳統上是我們業務的季節性淡季。

  • Our first quarter gross profit was $75 million, generating a gross margin of 65% compared to a gross profit of $47 million and a gross margin of 64% for the same quarter in the prior year. Our gross margin in Q1 was affected by several factors. Obviously, gross margin was negatively impacted due to lower sales volumes in Q1 as a result of seasonality.

    我們第一季毛利為 7,500 萬美元,毛利率 65%,相較於去年同季毛利 4,700 萬美元、毛利率 64%。第一季毛利率受到數項因素影響。顯然,由於季節性導致第一季銷售量較低,毛利率受到負面影響。

  • Compared to Q1 of last year, our gross margin on hardware was impacted by sales of the G5 Mobile transmitter which has a shorter useful life and, therefore, a lower ASP. And to a lesser extent, our gross margin was impacted by a lower yield on our G5 Mobile transmitter which is also expected with any new product launch. Finally, our gross margin was impacted by an increase in warranty expense.

    與去年第一季相比,我們硬體的毛利率受到 G5 Mobile 發射器銷售的影響,該產品使用壽命較短,因此 ASP 較低。此外(影響程度較小),我們的毛利率也受到 G5 Mobile 發射器良率較低的影響,這在任何新產品上市時亦屬預期之內。最後,我們的毛利率也受到保固費用增加的影響。

  • The impact of the increased warranty expense and scrap due to lower yield accounted for approximately 3 margin points in Q1 and absent these expenses our gross margin would've been approximately 68% for the quarter. Kevin will provide some additional clarity momentarily.

    保固費用增加以及因良率較低所造成的報廢,於第一季合計約影響 3 個毛利率百分點;若排除此等費用,本季毛利率約為 68%。Kevin 稍後會提供更進一步的說明。

  • For the full year, we expect our gross margin to return to our normalized operating range of 67% to 70%. However, depending on ongoing remediation efforts surrounding our receiver recall, margins could be negatively impacted in future periods during the year.

    就全年而言,我們預期毛利率將回到正常化的營運區間 67% 至 70%。然而,視我們針對接收器召回所進行的持續補救工作而定,毛利率在今年後續期間可能會受到負面影響。

  • Some final thoughts on our revenues and our gross profits, our mix between durable and consumable products shifted slightly in Q1 to approximately 28% durable and 72% consumable. Sensor pricing has remained constant with the ASP for sensors within a range of $70 to $75 per sensor and the ASP for our hardware has also remained stable. Finally, our international business continued to perform generating $19 million in revenue during the quarter.

    關於營收與毛利的最後幾點說明:第一季耐用品與耗材的組合略有變動,約為 28% 耐用品、72% 耗材。感測器定價維持不變,感測器 ASP 約落在每個 70 至 75 美元區間;我們硬體的 ASP 亦維持穩定。最後,我們的國際業務持續表現良好,本季貢獻營收 1,900 萬美元。

  • Research and development expense totaled $32 million for Q1 of 2016 compared to $20 million in Q1 of 2015, with the increase due primarily to additional payroll-related expenses and expenses related to work on our near-term product pipeline, particularly with respect to our next-generation insertion system and work in our advanced product pipeline including expenses associated with our Verily partnership.

    2016 年第一季研發費用合計 3,200 萬美元,較 2015 年第一季的 2,000 萬美元增加;增加主要來自額外的薪酬相關費用,以及我們近期產品線的研發支出,特別是下一代插入系統的相關工作,並包括我們先進產品線的研發支出,其中包含與 Verily 合作夥伴關係相關的費用。

  • Selling, general and administrative expense totaled $62 million in Q1 of 2016 compared to $39 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 marketing expenses in connection with our DTC awareness campaigns, investment in our OUS expansion efforts, and investment in our IT infrastructure.

    2016 年第一季銷售、一般及行政費用合計 6,200 萬美元,較 2015 年同季的 3,900 萬美元增加;增加主要來自我們客戶支援組織人力編制的年增,以及與我們 DTC(直接面向消費者)認知宣導活動相關的行銷費用提升、對 OUS(美國以外)擴張工作的投資,以及對 IT 基礎設施的投資。

  • With respect to our operating expenses, I want to remind investors of a few key points. As we said during our fourth quarter call, we did not anticipate that Q1 costs would go down sequentially, and our OpEx was up only approximately 5% from Q4 of 2015. Our non-cash expenses and taxes related to equity compensation included in our operating results were up $10 million year-over-year and $4 million sequentially, representing the bulk of our sequential OpEx increase.

    就營運費用而言,我想提醒投資人幾個重點。如同我們在第四季電話會議所說,我們並未預期第一季成本會較前一季下降,而我們的 OpEx(營運費用)僅較 2015 年第四季約增加 5%。我們營運結果中包含的與股權薪酬相關之非現金費用及稅負,年增 1,000 萬美元、季增 400 萬美元,構成我們 OpEx 季增的主要部分。

  • Our net loss for the first quarter of 2016 totaled $19 million, which included $28 million in non-cash expenses centered primarily in non-cash share-based compensation expense across all functional areas of our business. Absent these non-cash charges, cash-based net income was $9 million for Q1. Our loss per share for the quarter was $0.23.

    2016 年第一季淨損合計 1,900 萬美元,其中包含 2,800 萬美元的非現金費用,主要為公司各職能領域的非現金股份基礎給付薪酬費用。若排除此等非現金費用,第一季以現金為基礎的淨利為 900 萬美元。本季每股虧損為 0.23 美元。

  • With respect to our balance sheet, we ended the first quarter with $107 million in cash and marketable securities. Our Q1 revenue performance fell within our range of expectations, but consistent with past practices, we will stick with our current guidance of $540 million to $565 million in revenue for the year. However, also consistent with prior years, we will reevaluate our guidance during the Q2 earnings call and update as appropriate.

    就資產負債表而言,我們第一季末持有現金及有價證券 1.07 億美元。我們第一季營收表現落在預期區間內,但依照過往慣例,我們將維持目前對全年營收 5.40 億至 5.65 億美元的指引。不過,也同樣依照往年作法,我們將在第二季財報電話會議時重新評估指引,並視情況更新。

  • Before I turn the call back over to Kevin, let me add some color around our OpEx spend during Q1 and for the balance of 2016. As we mentioned during our last earnings call, we've indicated that we plan to spend up to $40 million this year on four key incremental strategic initiatives including our Verily partnership, expanded manufacturing capacity, international expansion, and investment in our advanced data platforms.

    在我把電話交回 Kevin 之前,補充一些關於第一季以及 2016 年其餘期間 OpEx 支出的說明。如同我們在上次財報電話會議提到的,我們表示今年計畫在四項關鍵的增量策略性計畫上投入最多 4,000 萬美元,包括與 Verily 的合作、擴充製造產能、國際擴張,以及投資於先進資料平台。

  • Our outlook for these investments remains unchanged, but expenses on these projects will be choppy on a quarterly basis. For example, Q1 expenses on these initiatives were less than $10 million with the biggest spend on Verily product development and our international expansion. With that, I'll turn the call back over to Kevin for a business update.

    我們對這些投資的展望維持不變,但這些專案的費用在季度間將呈現波動。例如,第一季在這些計畫上的費用低於 1,000 萬美元,其中最大支出為 Verily 產品開發以及我們的國際擴張。接下來我把電話交回 Kevin,請他進行業務更新。

  • - CEO & President

    - CEO & President

  • Thank you, Steve. So far in this reporting season, we have seen the big diabetes players report their performance and here's what they've said. J&J Diabetes down 15% operationally year-over-year in the US. Abbott US Diabetes down 32%, Roche diabetes down 49% in North America, and for Medtronic, we only have global numbers, but their diabetes only grew around 11% in its most recent quarter.

    謝謝你,Steve。到目前為止,在這一波財報季中,我們看到糖尿病領域的大型業者陸續公布表現,以下是他們的說法:J&J 糖尿病業務在美國以營運口徑年減 15%;Abbott 美國糖尿病業務年減 32%;Roche 糖尿病業務在北美年減 49%;至於 Medtronic,我們只有全球數據,但其糖尿病業務在最近一季僅成長約 11%。

  • We grew 60% in the first quarter of 2016 on top of 55% last year. Our new patient growth remains phenomenal, and our prospective patient pipeline remains robust. While our growth has enabled us to make significant investments for the future, we have experienced some growing pains in the past few months that I would like to address.

    我們在 2016 年第一季成長 60%,是在去年 55% 成長的基礎上再成長。我們的新病患成長依然非常亮眼,潛在病患的管線也仍然強勁。雖然我們的成長使我們得以為未來進行重大投資,但過去幾個月我們也經歷了一些成長陣痛,我想在此加以說明。

  • I'd like to start with some words regarding our recent FDA action and our plans to get through this. By way of background, we had noted an increased number of speaker failures in our MDR reporting over a number of months. Accordingly, together with the FDA, we determined that the appropriate course of action was to initiate a customer notification which was consistent with Class II recall procedures.

    我想先談談我們近期的 FDA 行動以及我們因應的計畫。背景說明:在數個月期間,我們在 MDR 申報中注意到喇叭故障的數量增加。因此,我們與 FDA 共同判定,適當的處置方式是啟動客戶通知,且該通知符合第二級(Class II)召回程序。

  • In compliance with the FDA's directives, Dexcom issued this notification letter on February 23, 2016. The letter was posted on our website and sent via certified mail to all US patients, either directly by Dexcom or by means of our distributors. Additionally, we implemented procedures to provide the same notification to Dexcom patients globally through our distributor network. For those of you who have not read the customer notification, it reminds patients of the importance of alerts and alarms and encourages them to test the audio functionality of their receiver regularly.

    為遵循 FDA 的指示,Dexcom 於 2016 年 2 月 23 日發布本通知函。該信函已張貼於我們的網站,並由 Dexcom 直接或透過我們的經銷商,以掛號回執郵件寄送給所有美國患者。此外,我們也建立流程,透過我們的經銷商網路向全球 Dexcom 患者提供相同通知。對於尚未閱讀客戶通知的各位,該通知提醒患者警示與警報的重要性,並鼓勵患者定期測試接收器的音訊功能。

  • The local FDA office inspected Dexcom in late March and determined that we had complied with our agreed-upon Class II recall procedures. The FDA continued to review this matter and subsequently determined that due to the extreme importance of alerts and alarms in CGM, this matter was more appropriately classified as a Class I recall. After this determination, and to increase awareness in the patient community, we issued a press release dated April 11, 2016, and the FDA posted the Class I recall notice on their website.

    當地 FDA 辦公室於 3 月下旬對 Dexcom 進行稽查,並認定我們已遵循先前同意的第二級(Class II)召回程序。FDA 持續審查此事,並隨後認定,由於在 CGM 中警示與警報極其重要,此事件更適合歸類為第一級(Class I)召回。在作出此認定後,為提高患者社群的認知,我們於 2016 年 4 月 11 日發布新聞稿,FDA 亦在其網站上公布第一級召回公告。

  • Given all of that information, there are two questions that we must address today. How is Dexcom going to fix this, and what does this mean to our business going forward? As for the fix, we are implementing several corrective actions. We have identified a new speaker for the current receiver that will be more robust. This replacement speaker and associated manufacturing change has already been filed with the FDA. As we've discussed on many of our previous earnings calls, we have a completely new receiver in our product pipeline and it will be filed with the FDA before the end of the second quarter. We believe this receiver will greatly improve the patient experience.

    綜合以上資訊,我們今天必須回答兩個問題:Dexcom 將如何修正此問題,以及這對我們未來的業務意味著什麼?就修正方案而言,我們正在採取數項矯正措施。我們已為現行接收器確認一款更耐用的新喇叭。此替換喇叭及相關製造變更已向 FDA 申報。如同我們在多次先前的財報電話會議中所討論,我們的產品管線中有一款全新的接收器,並將在第二季結束前向 FDA 申報。我們相信該接收器將大幅改善患者體驗。

  • Additionally, we are evaluating a software upgrade for the current receiver to systematically test its audio functionality on a regular basis. While the agency has not approved any of our proposed actions, the FDA is aware of them and we are confident that they will continue to work with us to implement features to improve patient safety.

    此外,我們正在評估為現行接收器進行軟體升級,以定期、系統性地測試其音訊功能。雖然主管機關尚未核准我們任何一項提案行動,但 FDA 已知悉這些措施,我們有信心他們將持續與我們合作,導入可提升患者安全的功能。

  • With respect to the business, Steve noted previously, that we have experienced an increase in warranty expense this quarter. Certainly, some portion of that increase relates to the recall situation. We have experienced a slight increase in the percentage of receivers returned due to speaker failure. Absolute numbers increase simply because of the size of the patient base, and the fact that we sent our patient notification letter also increased the number of returns. But our product returns across the board have increased this quarter.

    就業務面而言,Steve 先前提到,本季我們的保固費用有所增加。當然,其中一部分增幅與此次召回事件相關。由於喇叭故障而退回的接收器比例略有上升。絕對數量的增加,單純是因患者基數擴大所致,而我們寄發患者通知函也提高了退貨數量。但本季我們整體產品退貨率全面上升。

  • Some of the increase relates to the fact that the patients received the letter. Some relates to the fact that we are in the middle of our most complicated product launch ever. Some relates to the fact that we have not been able to address all patient concerns in a timely manner through our tech services group and we made the decision to ship replacement product quickly to take care of our customers. We should have anticipated better.

    部分增幅與患者收到信函有關;部分與我們正處於史上最複雜的產品上市過程有關;部分則與我們的技術服務團隊未能及時回應所有患者疑慮有關,因此我們決定快速出貨替換產品以照顧客戶。我們本應更好地預先規劃。

  • We currently have a very large number of receivers in stock as we built up inventory in anticipation of redeploying our manufacturing resources on the next generation receiver later this year. The timing of FDA's approval of our proposed corrections, combined with whatever additional actions we may implement, could have a financial impact in future periods. For example, we may be able to implement our proposed software upgrade for the receiver to include the systematic speaker test. While that may require some work, the cost would not be extensive if that is our corrective action.

    目前我們有大量接收器庫存,因為我們先前為了在今年稍晚將製造資源重新部署至下一代接收器而建立了庫存。FDA 核准我們所提矯正措施的時點,加上我們可能採取的任何額外行動,可能會對未來期間的財務造成影響。舉例而言,我們或許能為接收器導入所提軟體升級,以納入系統性的喇叭測試。雖然這可能需要一些工作,但若此為我們的矯正行動,其成本不會太高。

  • On the other hand, we may be required to implement the new speaker configuration going forward as soon as it is approved, which would require us to rework or scrap some or all of the current receiver inventory. We believe this example would be the worst case scenario. While it's impossible to predict the total impact of any corrective actions we might take, we currently estimate the potential write-off related to rework of all of our current receiver inventory to be approximately $5 million.

    另一方面,一旦新喇叭配置獲核准,我們可能被要求立即在後續產品中導入,這將使我們必須對現有接收器庫存的部分或全部進行返工或報廢。我們認為此例將是最壞情境。雖然無法預測我們可能採取之任何矯正行動的總影響,但我們目前估計,若需對所有現有接收器庫存進行返工,相關的潛在沖銷約為 500 萬美元。

  • For patients, it's business as usual. We continue to ship our current products and believe there is no safer way to manage the day-to-day treatment of diabetes than the world's most accurate connected continuous glucose monitor, and we continue to hear this over and over and over again.

    對患者而言,一切照常。我們持續出貨現行產品,並相信在日常糖尿病治療管理上,沒有比全球最精準、可連線的連續血糖監測器更安全的方法;而我們也一再、一再地聽到這樣的回饋。

  • I now want to take the opportunity to address our patient community. March of this year marked our 10th anniversary of commercialized CGM. We have come a very long way over the past several years and momentum is not slowing down, as you can see by our continued revenue growth. During the past 15 months, we have more than doubled the US patient base. It's one thing to double a patient base when you go from 2,500 to 5,000 patients. It's a completely different thing when you start talking about adding tens of thousands of new patients each and every quarter. When you combine the sheer number of new patients added to the Dexcom family, with the most complicated product launch in the history of our organization, then add the customer notification process to this, you can imagine things have been very hectic here.

    我現在想藉此機會向我們的患者社群說明。今年 3 月是我們 CGM 商業化的第 10 週年。過去幾年我們已走過很長一段路,而動能並未放緩,從我們持續的營收成長即可看出。在過去 15 個月中,我們在美國的患者基數已超過倍增。當你從 2,500 名增加到 5,000 名患者時,倍增患者基數是一回事;但當你開始談到每一季新增數以萬計的新患者時,那就是完全不同的情況。當你把加入 Dexcom 大家庭的大量新患者、我們組織史上最複雜的產品上市,再加上客戶通知流程結合在一起,你可以想像我們這裡一直非常忙碌。

  • We've learned many lessons over the past several months. While we felt that we planned the Gen 5 launch very well from a product and messaging perspective, we fell short from an infrastructure perspective. The G5 launch has been more complex on a number of fronts. For example, even though the pricing is the same, the process of purchasing two transmitters for six months of use versus one transmitter has taken an inordinate amount of customer service time causing patient delays and inconvenience. The same can be said for patients that were required to purchase the G5 receiver after buying a G4 receiver in a previous time period.

    過去幾個月我們學到了許多教訓。雖然我們認為從產品與訊息傳達的角度,Gen 5 上市規劃得很完善,但在基礎設施方面我們有所不足。G5 上市在多個面向都更為複雜。舉例來說,即使定價相同,購買可使用六個月的兩個發射器(transmitters)相較於購買一個發射器的流程,耗費了過多的客服時間,造成患者延遲與不便。對於先前已購買 G4 接收器、但又被要求再購買 G5 接收器的患者,也有同樣情況。

  • On top of that, we have learned that our technical support calls on the G5 system are approximately 40% longer than they are for G4. G5 technical support calls are also much more complex. For example, in addition to supporting our CGM system functionality, we spend a lot of time discussing things like Bluetooth pairing, Bluetooth range, what app are we supposed to download, how do we pair the app, how do we share data, and so forth. So now, we are providing medical device and consumer product support all at the same time to a much broader group of patients.

    除此之外,我們也了解到,針對 G5 系統的技術支援來電,平均通話時間約比 G4 長 40%。G5 的技術支援來電也更為複雜。舉例而言,除了支援我們的 CGM 系統功能外,我們還花大量時間討論例如藍牙配對、藍牙距離、應下載哪個 App、如何配對 App、如何分享資料等等。因此,我們現在同時提供醫療器材與消費性產品的支援,且面向更廣泛的患者族群。

  • Dexcom has been the highest rated CGM manufacturer in customer loyalty and satisfaction for seven years in a row and we will fix this. A couple of examples that will be implemented shortly, we have added and trained a number of people to work in customer service and believe that we will be right sized within a couple of weeks. We are also in the final stages of several IT efficiency projects including a new phone system that we will turn on over the next 30 days. These actions combined with several other things that we've already put in place will take us where we need to be. We apologize for slipping and we'll make this right for our Dexcom users.

    Dexcom 連續七年在客戶忠誠度與滿意度方面獲評為最高的 CGM 製造商,我們會把這件事修好。舉幾個即將實施的例子:我們已增聘並訓練多名客服人員,並相信在幾週內人力配置將達到適當規模。我們也正處於多項 IT 效率專案的最後階段,包括一套新的電話系統,將在未來 30 天內啟用。這些行動加上我們已經到位的其他措施,將使我們達到所需水準。對於我們的疏失,我們深感抱歉,並會為 Dexcom 使用者把事情做好。

  • Now I'm going to talk a bit about our G5 commercial launch. We continue to be very pleased with the feedback we've received on our G5 mobile system and the lives we're able to impact with our technology. Response in the diabetes community for mobile connectivity has been exceptional. This past quarter, we launched an app that enabled the Apple Watch. This enhancement has been very beneficial to a number of patients. We are still on track to launch the Android version of G5 mobile later this year and note that the Android follow application is already available. We are also planning to submit several additional enhanced versions of our G5 mobile app to provide additional features and functionality this year including a mute override on the alerts and the alarms and the possible incorporation of insulin data into the app.

    接下來我將談談我們的 G5 商業上市。我們持續對 G5 行動系統所收到的回饋,以及我們的技術能夠影響的生活感到非常滿意。糖尿病社群對行動連線的反應極為熱烈。本季我們推出了可支援 Apple Watch 的 App。此項強化對許多患者非常有幫助。我們仍按計畫在今年稍晚推出 G5 行動版的 Android 版本,並提醒各位 Android 的 follow 應用程式已可使用。我們也計畫在今年提交數個進一步強化的 G5 行動 App 版本,以提供更多功能與特性,包括對警示與警報的靜音覆寫(mute override),以及可能將胰島素資料納入 App。

  • I'd now like to speak about our non-injunctive claim. For several quarters now, we have discussed our efforts to obtain a non-injunctive or dosing claim for our CGM system. For purposes of background information, labeling for our current system requires that patients take a confirmatory finger stick to support the information provided by CGM prior to making a treatment decision. We have always believed that the information provided by CGM provides much better information for making an insulin dosing decision than a single finger stick, particularly when we look at the accuracy and performance of our system with our software 505 algorithm. We also want to remind investors that CMS is requiring this type of labeling for Medicare approval.

    我接著想談談我們的非輔助(non-injunctive)主張。過去數個季度,我們一直在討論為 CGM 系統取得非輔助或劑量(dosing)主張的努力。作為背景資訊,我們現行系統的標示要求患者在做出治療決策前,必須進行指尖採血確認,以支持 CGM 所提供的資訊。我們一直相信,CGM 所提供的資訊在做出胰島素劑量決策時,比單次指尖採血能提供更好的資訊,特別是當我們檢視搭載 505 軟體演算法之系統的準確度與表現時。我們也想提醒投資人,CMS 在核准 Medicare 時要求此類標示。

  • We began discussions with the FDA regarding this claim almost 18 months ago. Last fall, at the request of the FDA, we filed a PMA supplement seeking approval of non-injunctive labeling for the G5 system based upon the following: Clinical data obtained using our software 505 algorithm, thousands of simulations of CGM treatment scenarios, multiple human factor studies, revised labeling language, and ultimately, a new G5 app for non-injunctive claim. As a reminder, we received CE Mark for this labeling in August 2015.

    我們在將近 18 個月前便開始與 FDA 討論此主張。去年秋天,應 FDA 要求,我們提交了 PMA 補充申請,尋求核准 G5 系統的非輔助標示,依據包括:使用我們 505 軟體演算法取得的臨床資料、數千次 CGM 治療情境模擬、多項人因研究、修訂後的標示文字,以及最終用於非輔助主張的新版 G5 App。提醒各位,我們已於 2015 年 8 月取得此標示的 CE Mark。

  • Over the past several months, we have had multiple discussions with the FDA regarding this filing and we have continued to supply them with additional data. Earlier this quarter, the FDA notified us that this PMA supplement would be subject to an advisory panel review which has been scheduled for July 21, 2016 in Gaithersburg, Maryland. We are, obviously, preparing very thoroughly for this extremely important panel meeting. We are very pleased that the FDA has worked so closely with us during the PMA supplement review and we look forward for the opportunity to present our case. In the event that we receive a positive recommendation from the panel, and ultimately FDA approval, we anticipate a very significant post-market study will be required to support this labeling. The panel meeting could very well set the tone for all future CGM products.

    在過去幾個月中,我們已就此申請案與 FDA 進行多次討論,並持續向其提供額外資料。本季稍早,FDA 通知我們,這份 PMA 補充申請將接受諮詢委員會審查,會議已排定於 2016 年 7 月 21 日在馬里蘭州蓋瑟斯堡(Gaithersburg)舉行。顯然,我們正為這場極其重要的委員會會議做非常周全的準備。我們很高興 FDA 在 PMA 補充申請審查期間與我們密切合作,也期待有機會陳述我們的立場。若我們獲得委員會的正面建議,並最終取得 FDA 核准,我們預期將需要一項規模非常可觀的上市後研究來支持此標示內容。這場委員會會議很可能會為未來所有 CGM 產品定下基調。

  • Now I'd like to address things address things on our product pipeline front. We continue to make progress on our G6 sensor technology. Our IDE application is in the final stages of review and we expect to obtain approval in the coming weeks. We anticipate initiating our pivotal trial either late in Q2 or early in Q3 depending upon the timing of the IDE approval. In addition, we expect to work with our artificial pancreas partners to incorporate Gen 6 into their research and clinical studies as soon as possible, providing us with a very robust data set on the performance of this product.

    接下來我想談談我們產品研發管線方面的進展。我們在 G6 感測器技術上持續取得進展。我們的 IDE 申請已進入審查的最後階段,預期在未來幾週內取得核准。我們預計將於第二季末或第三季初啟動關鍵性試驗,視 IDE 核准時點而定。此外,我們也預期將與人工胰臟合作夥伴合作,盡快把第六代(Gen 6)納入其研究與臨床試驗,讓我們能取得一套非常扎實的產品效能資料集。

  • As a reminder, the G6 sensor will have a reduced calibration scheme, one per day after startup, driven with a completely new advanced algorithm platform. It will have the ability to block acetaminophen interference, a labeled indication of up to 10 days of sensor life, and a number of other features that will make the CGM experience better for our patients. Overall performance should be consistent with G5 Mobile on the 505 software, even with reduced calibration scheme and the extended wear. The G5 product will also leverage our new applicator and receiver technologies. We believe that by combining our best-in-class sensor accuracy with an enhanced patient experience, G5 will, again, raise the bar in the CGM marketplace.

    提醒各位,G6 感測器將採用降低校正的方案,在啟動後每天只需校正一次,並由全新的先進演算法平台驅動。它將具備阻擋乙醯胺酚(acetaminophen)干擾的能力、標示可達 10 天的感測器使用壽命,以及多項其他功能,讓患者的 CGM 使用體驗更佳。即使採用降低校正方案並延長配戴時間,其整體表現仍應與採用 505 軟體的 G5 Mobile 一致。G5 產品也將運用我們新的施打器(applicator)與接收器技術。我們相信,結合業界領先的感測器準確度與更佳的患者體驗,G5 將再次提高 CGM 市場的標準。

  • Looking ahead, our plans for advanced sensors continue to include a no calibration system. We know that we can run our G6 sensors with no calibrations. But what we don't know is the FDA regulatory path for this configuration, especially for intensively managed patients. We may well see the day when we have a more robust product for intensive insulin using patients that will continue to require some form of calibration and a lower cost diagnostic for non-insulin using patients that would require no calibration.

    展望未來,我們對先進感測器的規劃仍包括「免校正」系統。我們知道 G6 感測器可以在不校正的情況下運作。但我們不確定的是,這種配置的 FDA 法規審查路徑為何,特別是對於密集管理的患者。我們很可能會看到這樣的一天:對於需要密集胰島素治療的患者,我們提供更強健、仍需某種形式校正的產品;而對於未使用胰島素的患者,則提供成本較低、無需校正的診斷產品。

  • As some of you have noted, the clinical study for our new insertion system and transmitter has been posted on clinicaltrials.gov. We are in the middle of analyzing the study data. We will tell you that patients absolutely love the experience of this system. Our biggest variable with respect to the new applicator and transmitter system launch is scale. We have never built this system in quantity and all of our manufacturing procedures change when we launch it. We must be completely ready for this launch and with a three-month life on the transmitter, it will be much easier to cut patients over than it's been for us in the past. We are currently preparing our submission and will provide you with more color on timing next quarter.

    如各位部分人士所注意到的,我們新型插入系統與發射器的臨床研究已公布於 clinicaltrials.gov。我們目前正在分析研究資料。我們可以告訴各位,患者非常喜愛這套系統的使用體驗。就新施打器與發射器系統的上市而言,我們最大的變數是量產規模。我們從未大量生產過這套系統,一旦上市,我們所有製造流程都會改變。我們必須為這次上市做好萬全準備;而由於發射器壽命為三個月,將患者轉換到新系統會比過去容易得多。我們目前正在準備送件,並將在下季提供更多關於時程的細節。

  • With respect to our pump partners, Animas and Tandem continue to report positive results from their integrated pump offerings with G4 PLATINUM, and we believe all of our pump partners are making excellent progress on the development of more advanced integrated systems. We continue to make progress beyond our pump partnerships as we explore opportunities in connectivity with smart insulin pens, as well as other interconnected diabetes management plans.

    就我們的幫浦合作夥伴而言,Animas 與 Tandem 持續回報其與 G4 PLATINUM 整合式幫浦產品的正面成果;我們也相信所有幫浦合作夥伴在開發更先進的整合系統方面都取得了優異進展。除幫浦合作之外,我們也持續推進,探索與智慧胰島素筆的連線機會,以及其他互聯式糖尿病管理方案。

  • Finally, on the product pipeline front, our partnership with Verily is going extremely well. Verily has already completed a first-generation transmitter and is beginning to test its performance with both G5 and G6 sensors. Initial results have been very promising, and launch of our first combined product appears to be very much on schedule. Finally, our advanced sensor research program remains on track to deliver a sensor intended to work with the targeted bandage-sized disposable transmitter that we are co-developing with Verily.

    最後,在產品研發管線方面,我們與 Verily 的合作進展非常順利。Verily 已完成第一代發射器,並開始以 G5 與 G6 感測器測試其效能。初步結果相當令人鼓舞,我們第一款整合產品的上市看起來完全按計畫進行。此外,我們的先進感測器研究計畫也按軌道推進,目標是交付一款感測器,可搭配我們與 Verily 共同開發、鎖定的「繃帶大小」一次性發射器使用。

  • On the international expansion front, we are very close to opening our European headquarters in Scotland and we will begin to expand the European team on all fronts. Over the next several years, we expect to transition to a direct commercial presence in multiple European countries including the UK. We continue to believe that reimbursement could come in Germany, France, and the UK in the near future and we will be ready to capitalize on that opportunity.

    在國際擴張方面,我們已非常接近在蘇格蘭設立歐洲總部,並將開始在各方面擴編歐洲團隊。在未來幾年內,我們預期將在包括英國在內的多個歐洲國家,逐步轉型為直接的商業營運據點。我們仍相信德國、法國與英國在不久的將來可能取得給付(reimbursement),而我們也將準備好把握這個機會。

  • In conclusion, our results speak for themselves. With 60% sales growth in Q1, we believe Dexcom's competitive position is as strong as it's ever been, and as I look at the innovation in our pipeline, we are only scratching the surface of the opportunity ahead. We're all very proud of what we have accomplished so far and look forward to further changing the diabetes landscape.

    總結來說,我們的成果不言自明。第一季銷售成長 60%,我們相信 Dexcom 的競爭地位比以往任何時候都更強;而當我看到我們研發管線中的創新時,我們其實才剛開始觸及前方機會的表面。我們都為迄今所達成的成就感到非常自豪,並期待進一步改變糖尿病照護版圖。

  • I would like to take a moment to thank all of our hard working employees and our physician and patient community and shareholders for all of their continued support. I would now like to open the call up for Q&A.

    我想花點時間感謝所有辛勤工作的員工、醫師與患者社群,以及股東長期以來的支持。接下來我想開放電話會議進行問答。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • (Operator Instructions)

    (接線員指示)

  • Mike Weinstein from JPMorgan.

    摩根大通(JPMorgan)的 Mike Weinstein。

  • - Analyst

    - Analyst

  • Thank you. Kevin, there's a lot to cover here. So let me start first off by congratulations on, obviously, a very, very strong quarter and strong start to the year. I'm thinking just about the FDA advisory panel and, obviously, it creates another hurdle, which you guys, hopefully, will cross over.

    謝謝。Kevin,這裡有很多內容要談。所以我先開始,恭喜你們,顯然,本季表現非常、非常強勁,也為今年開了個好頭。我在想關於 FDA 諮詢委員會的事,顯然這又多了一道門檻,希望你們能跨過去。

  • It creates a little bit of uncertainty for investors here. But I think the positive side of it is the bar for anybody else getting a finger stick replacement claim just went up that much higher. I'd love just to get your additional thoughts on that and then a couple of other topics I wanted to cover?

    這讓投資人多了一點不確定性。但我認為正面的一面是:任何其他人想取得「取代指尖採血」的主張門檻都被拉得更高了。我很希望聽聽你對此的更多看法,另外還有幾個主題我也想請你談談?

  • - CEO & President

    - CEO & President

  • Mike, this is so important and such a paradigm shift in diabetes care to have that replacement claim. We're okay going to panel and we will just prepare and be the absolute best that we can. It's important that we learn exactly what we have to do because we do have to get this claim to get Medicare coverage and as I've gone out in the field and met with physicians, question number one every time I walk in an office is when are you going to get Medicare.

    Mike,這件事非常重要;能取得那個「取代」主張,對糖尿病照護而言是重大的典範轉移。我們可以接受上委員會審查,我們會準備到最好、做到我們能做到的極致。重要的是,我們要弄清楚我們究竟必須做什麼,因為我們確實需要取得這項主張才能獲得 Medicare 給付;而我到第一線拜訪醫師時,每次走進診所的第一個問題都是:你們什麼時候能拿到 Medicare。

  • So we need this labeling. We look forward to the opportunity and will take what comes. But we will be ready, rest assured. We will not lack for preparation here.

    所以我們需要這個標示。我們期待這個機會,也會接受結果。但請放心,我們會準備好。我們在準備上絕不會不足。

  • - Analyst

    - Analyst

  • Okay. Couple of other topics I was hoping you could touch on. One, is [Diamond trial.] Specifically, what data do you think we will see at ADA, now that there is a scheduled presentation?

    好的。我希望你能再談談另外幾個主題。第一個是 [Diamond trial.] 具體來說,既然已排定發表,你認為我們在 ADA 會看到哪些資料?

  • And, two, all the discussion around some of the challenges with the G5 launch and the learning curve on some of it. How has that impacted the timing for G6?

    第二個是,關於 G5 上市時的一些挑戰與學習曲線的討論很多。這對 G6 的時程造成了什麼影響?

  • - CEO & President

    - CEO & President

  • Let's start with -- we can start with that one. That really hasn't impacted our G6 timing. We have continued to work on our G6 IDE.

    我們先從——我們可以先從那個問題開始。這其實沒有影響我們的 G6 時程。我們仍持續推進 G6 的 IDE。

  • I can tell you the FDA is putting our IDE through a very rigorous process and standards are not getting easier, they are getting harder. And I think some of this is an anticipation of the non-injunctive claim, as they look at G6, they look at this, is this going to be a non-injunctive sensor and while we have multiple years of data on that G5 system with 505 software, we don't have multiple years of data on a new sensor. So that trial is going to be very, very robust. That would be the first one.

    我可以告訴你,FDA 正以非常嚴格的流程來審查我們的 IDE,而且標準不但沒有變得更容易,反而更嚴格。我認為其中一部分是因為他們預先考量「非輔助(non-adjunctive)主張」;他們在看 G6 時會思考:這會不會是一個非輔助感測器?雖然我們對採用 505 軟體的 G5 系統已有多年的資料,但對於一個新感測器,我們沒有多年的資料。因此那項試驗將會非常、非常扎實。這是第一點。

  • What were the other two? I'm sorry.

    另外兩個是什麼?不好意思。

  • - Analyst

    - Analyst

  • The question was, number one question was on diamond trial.

    問題是,第一個問題是關於 Diamond 試驗。

  • - CEO & President

    - CEO & President

  • Diamond, I will take that. We haven't seen the data yet. This is an independent study, certainly, and the results will be [repented]. We don't know.

    Diamond,我來回答。我們還沒看到資料。這是一項獨立研究,當然,結果將會被 [repented]。我們不知道。

  • Honestly, we do not know how the study's going to read yet. I believe the data will come in, certainly, a month or six weeks before the presentation. So they will come in soon.

    老實說,我們還不知道研究結果會怎麼呈現。我相信資料會在發表前一個月或六週左右出來,所以很快就會出來。

  • Certainly, our hope with the Diamond study was to show improved outcomes through the use of CGM in this patient population, and we anticipate there will be that, but we don't know what those outcomes are. This is a very independent group of diabetes thought leaders who are going to tell us what happened and what they saw.

    當然,我們對 Diamond 研究的期待,是希望能在這類患者族群中證明使用 CGM 可改善結果;我們預期會看到這點,但我們不知道具體結果是什麼。這是一個非常獨立的糖尿病意見領袖團隊,他們會告訴我們發生了什麼、以及他們看到了什麼。

  • - Analyst

    - Analyst

  • Okay. Last question, and I'll let someone else jump in. You didn't spend any time on this call talking about the attempt to develop the pharmacy channel. You made a lot of progress there, particularly in the back half of last year. Can you talk about where you are with that and would there be a point where you will start to talk about the percentage of your business that's going to the pharmacy?

    好的。最後一個問題,然後我就讓其他人接著問。你們在這通電話裡沒有花時間談到拓展藥局通路的嘗試。你們在那方面取得了很大進展,特別是在去年下半年。你能談談目前進度如何嗎?以及是否會有一個時間點,你們會開始談你們有多少比例的業務是透過藥局通路?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Yes, Mike, this is Steve. We're not going to disclose that today. But you're right, frankly, because there was so much information in this call, we didn't really have a specific update on pharmacy. We continue to say it's progressing, going a little slower than we probably anticipated out of the gate. We'll certainly update you as we see more progress. There's not a lot to talk about there today.

    是的,Mike,我是 Steve。我們今天不會披露那個數字。但你說得對,坦白說,因為這通電話資訊量很大,我們確實沒有針對藥局通路做特別更新。我們仍然認為它在推進中,只是進度可能比我們一開始預期的要慢一些。隨著我們看到更多進展,我們一定會更新你。目前今天在這方面沒有太多可談的。

  • - Analyst

    - Analyst

  • Okay. I will let some others jump in. Congrats again on the quarter, guys.

    好的。我就讓其他人接著問。再次恭喜這一季的表現,各位。

  • - CEO & President

    - CEO & President

  • Thanks, Mike.

    謝謝,Mike。

  • Operator

    Operator

  • Ben Andrew from William Blair.

    接下來是 William Blair 的 Ben Andrew。

  • - Analyst

    - Analyst

  • Good afternoon, guys. Kevin, at the panel, will it just be DexCom submission being discussed?

    各位下午好。Kevin,在那個專家小組(panel)上,討論的會只有 DexCom 的送件(submission)嗎?

  • - CEO & President

    - CEO & President

  • To our knowledge for our panel meeting, that is correct.

    就我們所知,就我們的小組會議而言,是的。

  • - Analyst

    - Analyst

  • Okay. Interesting. And then, as you think about the competitive dynamics coming out of that, let's say it does go positively, they approve it towards the of the year, how will your messaging change and how material do you think that is, as you talk to clinicians, as you talk to patients compared to the other products that are available? Or what might come out in 2017?

    好的。有意思。接著,當你們思考那之後的競爭態勢時,假設結果是正面的,他們在年底前後獲得核准,你們的訊息傳達會如何改變?你認為這在你們與臨床醫師、與病患溝通時,相較於目前可用的其他產品,會有多大的實質影響?或者 2017 年可能會出現什麼?

  • - CEO & President

    - CEO & President

  • Ben, that's really a fascinating question and it subject to debate all the time. Obviously, I can tell you one segment where this plays very well. There are still our physicians who are not overly familiar with CGM, who don't recommend it regularly because they say you still have to stick your finger anyway. With this claim, we will be able to go to that group and say, look, recommend this for your patients, they don't have to take finger sticks before they make a treatment decision.

    Ben,這真的是個很有意思的問題,而且一直都有不同看法。很明顯地,我可以告訴你有一個族群會非常受用。仍然有一些醫師對 CGM 並不熟悉,平常也不太會例行建議使用,因為他們會說反正你還是得扎手指。若有了這項宣稱(claim),我們就能去跟那群醫師說:你看,推薦給你的病患吧,他們在做治療決策前不必再做指尖採血。

  • This will be a very, very good outcome for us and we will be able to get deeper and into more physicians. With respect to the rest of the community, I think it certainly sets us to the standard above everybody else, which we are already at out there anyway. It will give us an advantage and we will continue to market and continue to push. I think will be helpful. There's certainly no downside here at all.

    這對我們會是非常、非常好的結果,也能讓我們更深入、接觸到更多醫師。至於其他社群,我認為這確實會把我們拉到高於所有人的標準之上——其實我們現在在市場上本來就已經是那樣了。它會帶來優勢,我們也會持續行銷、持續推進。我認為會有幫助。這裡面當然完全沒有任何壞處。

  • - Analyst

    - Analyst

  • Sure. Sure. The sequential decline in patient adds in the first quarter, seemed like it was smaller than previous quarters. Obviously, your second [print] after the G5 launch. How would you characterize the pipeline and the tone of business going through the quarter? Was it a typical Q1 progression? Or did it surprise you?

    了解。了解。第一季新增病患數的季比下滑,看起來比前幾季小。顯然這是 G5 上市後的第二個季度。你會如何描述本季的案源(pipeline)以及整體業務氛圍?這是典型的 Q1 走勢嗎?還是讓你意外?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • I think it was -- this is Steve -- I think it was a typical Q1 progression. Similar seasonality to prior years. I would say one thing we might be starting to see, it's a little early to tell, is maybe a reduction in seasonality over time as we move more of the business to the pharmacy channel because they are less sensitive. Now those are certainly not -- more attributable to sensor purchases as opposed to hardware purchases. But other than that, it was a very typical Q1 for us.

    我認為——我是 Steve——我認為這是典型的 Q1 走勢。與往年類似的季節性。我會說我們可能開始看到一件事,但現在判斷還太早:隨著我們把更多業務轉到藥局通路,季節性可能會隨時間降低,因為藥局通路對季節性較不敏感。當然,那更多是與感測器的購買相關,而不是硬體購買。除此之外,對我們來說這就是非常典型的 Q1。

  • - Analyst

    - Analyst

  • And then finally, maybe for Jess, how would you guess the sensor mix exiting the year? You, obviously, came down a couple points this quarter. Should we look for that to keep moving? How do you look at that? Thank you.

    最後一個問題,可能給 Jess:你猜今年年底感測器的組合占比會如何?你們這一季顯然下降了幾個百分點。我們應該預期它會繼續往那個方向走嗎?你怎麼看?謝謝。

  • - CFO

    - CFO

  • No, for the year, Ben, I would look it to probably normalize and be in the 70%/30% range. In prior years, we have had some fluctuation of consumables being in the 69% to 71%, 72% mix.

    不,Ben,就全年來看,我會預期它大概會回到正常水準,落在 70%/30% 的區間。過去幾年,我們的耗材占比曾在 69% 到 71%、72% 之間有些波動。

  • - Analyst

    - Analyst

  • Great. Thanks.

    很好。謝謝。

  • Operator

    Operator

  • Danielle Antalffy from Leerink Partners.

    接下來是 Leerink Partners 的 Danielle Antalffy。

  • - Analyst

    - Analyst

  • Good afternoon, guys. Thanks so much for taking the question. Just a question on some of the receiver issues. Did you see any change in patient attrition during this, or sensor days per patient?

    各位下午好。非常感謝讓我提問。我想問一下接收器(receiver)的一些問題。在這段期間,你們有看到病患流失率有任何變化嗎?或是每位病患的感測器使用天數(sensor days per patient)?

  • - CEO & President

    - CEO & President

  • Danielle, that's a very good question. Our internal checks would indicate we haven't seen any attrition, and one of our larger distributors was in last week and said they see retention at an all-time high. I would tell you in all candor, I have taken a couple of frustrated patient calls because of wait times.

    Danielle,這是個非常好的問題。我們內部檢查顯示沒有看到任何流失,而且我們一個較大的經銷商上週來訪時也說,他們看到的留存率創下歷史新高。坦白說,我確實接過幾通病患因等待時間而感到挫折的電話。

  • I do that from time to time and in no case has somebody called me and said I want to get rid of your product, I just want you to answer the phone and get on the line quicker and help me. We haven't seen that. But if we don't the fix the things we're working on we would, and that's why we're so committed to making these improvements and getting through these issues.

    我偶爾會這麼做,而在任何情況下,都沒有人打給我說他想丟掉你們的產品;他們只是希望你們能接電話、能更快接通並協助他。我們沒有看到(流失)。但如果我們不把正在處理的問題修好,就可能會發生,所以我們才會如此致力於做出這些改善並解決這些問題。

  • - Analyst

    - Analyst

  • Okay. Great. That's helpful. And then, second question for you on the adjunctive claim. Can you give some color and what exactly is FDA looking for here?

    好的。很好。這很有幫助。第二個問題是關於輔助性宣稱(adjunctive claim)。你能否提供一些背景,FDA 在這裡到底在看什麼?

  • You're already at an algorithm that is 9% MARD, our checks with regulatory folks, not that work for FDA, but imply that should be good enough. What more does FDA need to see? I'm happy to hear you guys are going to panel, but also feel like that's overkill, why can't we just get this approved without a panel. Would love to hear some color on what the FDA is looking for?

    你們的演算法已經達到 9% 的 MARD,我們與法規人士的查核(不是在 FDA 工作的人)顯示這應該已經足夠。FDA 還需要看到什麼?我很高興聽到你們要上 panel,但也覺得這有點小題大作,為什麼不能不經 panel 就直接核准?很想聽聽 FDA 具體在看什麼。

  • - CEO & President

    - CEO & President

  • Danielle, this is such a paradigm shift, I think they truly want to make sure we have the public panel and everybody can digest the information. As we've gone through this process, it's not only the MARD, it's overall patient safety. And as we talk about simulations, for example, we've built thousands, hundreds of thousands of use cases where if the CGM reads X and the finger stick reads Y and the finger stick is right but the CGM is wrong, what could happen or vice versa?

    Danielle,這是一個典範轉移(paradigm shift),我想他們真的希望確保有公開的 panel,讓大家都能消化這些資訊。在我們走這個流程的過程中,不只是 MARD,而是整體病患安全。舉例來說,談到模擬(simulations),我們建立了數千、數十萬種使用情境:如果 CGM 讀值是 X、指尖採血讀值是 Y,而指尖採血是對的但 CGM 是錯的,可能會發生什麼?或反過來呢?

  • What they wanted to see is how we protect patients. In all cases, in all reality, the best way to protect a patient is with the CGM. If they make a decision, even of the CGM, for whatever reason is off, and you know about our accuracy and reliability, the only way you know you've made a bad decision is with an alert and an alarm.

    他們想看到的是我們如何保護病患。就所有情況、就現實而言,保護病患的最佳方式是使用 CGM。即使病患做決策時 CGM 因某些原因有偏差——你也知道我們的準確度與可靠性——你唯一能知道自己做了錯誤決策的方法,就是透過警示與警報。

  • With our alerts and alarms and with our system, we believe it is much safer than the decisions patients make today with only finger sticks. But we've had to simulate and build those cases and make sure we have a very strong, strong actual data platform to build this on. But when you're going to make a change this big, I think what the FDA looked at, and said with all caution, we need to make sure we get this out in the public and we proceed down the proper path. The accuracy issue is fine.

    透過我們的警示與警報以及我們的系統,我們相信它比病患今天只靠指尖採血所做的決策安全得多。但我們必須去模擬並建立那些案例,並確保我們有非常、非常強的實際數據平台作為基礎。不過當你要做這麼大的改變時,我想 FDA 的看法是:出於謹慎,我們需要確保把這件事公開到公眾面前,並沿著正確的路徑推進。準確度的問題是沒問題的。

  • The other thing that we have to approve and support, and, again, our 505 software is the best ever file for this, is outliers. You really want to eliminate outlier sensors more than anything else, and our system does that, and we need to show that it does. All those things are being considered by them. Listen, we're going to comply.

    另外一件我們必須核准並支持的——而且再次強調,我們的 505 軟體是史上最好的送件檔案——是離群值(outliers)。你真正最想做的,是盡可能消除離群的感測器,而我們的系統做得到,我們也需要證明它做得到。這些都是他們正在考量的事情。總之,我們會配合。

  • - Analyst

    - Analyst

  • Great. Thank you so much.

    很好。非常謝謝。

  • Operator

    Operator

  • Jayson Bedford from Raymond James.

    接下來是 Raymond James 的 Jayson Bedford。

  • - Analyst

    - Analyst

  • This is Mike calling for Jason, can you hear me okay?

    我是 Mike,代 Jason 來電,你聽得到我嗎?

  • - CEO & President

    - CEO & President

  • Yes, Mike.

    聽得到,Mike。

  • - Analyst

    - Analyst

  • First, I wanted to ask you about the G5 upgrade cycle. Can you give us a sense what percent of your user base is either converted to G5 Mobile or is on the G5 Mobile, now?

    首先,我想問 G5 的升級週期。你能否讓我們了解一下,目前你們的使用者基礎中,有多少百分比已經轉換到 G5 Mobile,或現在正在使用 G5 Mobile?

  • - CEO & President

    - CEO & President

  • Yes. We decided not to break that out. What we've said before is still holding true. We've always offered a low cost cash upgrade to the next generation platform and, frankly, very few patients take us up on it.

    可以。我們決定不把那個拆分出來。我們之前說過的仍然成立。我們一直都有提供以低成本現金升級到下一代平台的方案,但坦白說,真正採用的病患非常少。

  • What we're seeing is a transition from G4 to G5 as people's warranties expire and they are eligible for a new system, they're just processing through insurance. Status quo, there. We're not aggressively pursuing an upgrade at this point, and you should just assume over the next 12 to18 months that the vast majority of patients will transition.

    我們看到的是,當人們的 G4 保固到期、符合取得新系統的資格時,就會從 G4 轉到 G5,並且只是透過保險流程在推進。這方面維持現狀。我們目前不會積極推動升級,你應該假設在接下來 12 到 18 個月內,絕大多數病患都會完成轉換。

  • - Analyst

    - Analyst

  • All right. That's helpful. (multiple speakers)

    好。這很有幫助。(多位講者)

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Just real quick, one point I do want to make, remember that from a center perspective, so 72% of our revenue in the quarter, the G4 and G5 sensor configuration is identical. You are really just talking about some hardware upgrade.

    我很快補充一點我想強調的:請記得,從感測器角度來看,本季我們 72% 的營收,G4 與 G5 的感測器配置是相同的。你們真正談的是一些硬體升級而已。

  • - Analyst

    - Analyst

  • Right. That makes sense. Okay. Anything new with the alternative paths to Medicare? We've been hearing a little bit about individual successes in the judicial front. Is there an option to maybe escalate that to a broader scale? And then, similarly, anything on the legislative front?

    對。這很合理。好。關於通往 Medicare 的替代途徑,有沒有什麼新進展?我們聽到一些在司法戰線上個別案件的成功。是否有可能把這些成果擴大到更廣泛的層面?另外,同樣地,在立法戰線上有什麼進展嗎?

  • - CEO & President

    - CEO & President

  • We're doing the best we can with those individual cases and on the judicial front. The legislative front is a little slow right now. We continue to work and try to get it through that channel, but we feel we've got to get the labeling, when all is said and done, to get there. That's where we are right now.

    在個別案件與司法戰線方面,我們已盡最大努力。立法戰線目前進度有點慢。我們持續努力並嘗試透過那個管道推進,但我們認為最終必須把標示(labeling)做到位,才能達成目標。這就是我們目前的狀況。

  • - Analyst

    - Analyst

  • Okay. Great. Thank you.

    好的。很棒。謝謝。

  • Operator

    Operator

  • Kyle Rose from Cannacord.

    來自 Cannacord 的 Kyle Rose。

  • - Analyst

    - Analyst

  • Great, thanks a lot. Congrats on a strong start to the year. I wanted to talk a little bit about the patient dynamics that you're seeing, and then also, when you think about the pipeline. Robust new patient growth over the last several years. You talked about the pipeline has never been stronger from a new patient perspective.

    很好,謝謝。恭喜今年開局強勁。我想談談你們看到的病患動態,還有你們如何看待產品管線。過去幾年新病患成長強勁。你們提到,從新病患的角度來看,管線從未如此強勁。

  • Can you talk a little bit about what do these patients look like? It feels like you've moved past the early adopters and you're now feeling some of the pain from a customer service standpoint of maybe a higher maintenance patient. Can you just talk about how do we think about the strength of that pipeline from an attrition standpoint, from the type of new patients that are coming on, and also how that could, potentially, affect utilization of the product, as well?

    你能談談這些病患的樣貌嗎?感覺你們已經走過早期採用者階段,現在從客服角度可能感受到一些壓力,因為病患可能更需要維護。你能談談我們該如何從流失率角度、從新加入病患的類型來看這條管線的強度,以及這可能也會如何影響產品使用量嗎?

  • - CEO & President

    - CEO & President

  • Sure. I'll take that and I think you're absolutely correct. We are moving past the early adopters, or those who would wear a product and absolutely put up with anything we had to offer because it was so much better than what they've had before. We have to take more care to service those patients.

    當然。我來回答,我覺得你的判斷完全正確。我們正在走過早期採用者階段,也就是那些願意使用產品、而且幾乎願意忍受我們提供的一切的人,因為它比他們以前用過的好太多了。現在我們必須更用心地服務這些病患。

  • I think from an attrition standpoint, I don't think we are going to lose them because, all in all, their experience has been remarkable. Again, I will go back to parents. We run into parents who say -- I ran into one the other day -- we were just able to go out on our first date and watch our child while we were at dinner. Send our kids off to college.

    我認為從流失率角度來看,我不覺得我們會失去他們,因為整體而言,他們的體驗非常出色。我再回到父母這個例子。我們遇到一些父母說——我前幾天就遇到一位——我們終於能第一次出去約會,吃晚餐時也能看著孩子的狀況。也能放心把孩子送去上大學。

  • This share feature in this connectivity is huge. The other thing that's been huge in our peds population is the ability to look at this on your phone. There are many, many 11-year-olds around the United States who need to thank DexCom for getting a cell phone two years earlier than their parents were going to let them have one.

    這個在連線功能中的分享(share)功能非常重要。另一個在我們兒科族群中很重要的,是能在手機上查看。美國各地有很多很多 11 歲的小孩,應該要感謝 DexCom,因為他們比父母原本打算允許的時間早了兩年拿到手機。

  • Kids are willing to look at their phone and to look at the insulin data there. The patient base is going to be every bit of sticky as what we've had before the quality of the pipeline is very, very good. And as many if you have heard around the country, CGM is becoming the standard of care for Type 1 diabetes. It is absolutely essential to be safe and to achieve the outcomes that patients need to achieve.

    孩子願意看手機,也願意在那裡查看胰島素資料。病患基礎會跟我們過去一樣非常黏著(sticky)。管線品質非常、非常好。而且如同許多人在全國各地所聽到的,CGM 正在成為第一型糖尿病的照護標準。它對於安全以及達成病患需要達成的療效結果是絕對必要的。

  • - Analyst

    - Analyst

  • Then, switching over to the CMS side, I understand that it's probably going to rest on the dosing claim. Assuming we get a positive panel and you do get approval before year-end, I'm just wondering, what are your expectations for positive coverage turning on at CMS? Is that a month, a couple of quarters afterwards?

    接著切換到 CMS 這邊,我理解這大概會取決於劑量(dosing)主張。假設我們得到正面的專家小組結果,且你們在年底前獲得核准,我想了解你們對 CMS 啟動正向給付(coverage)的預期是什麼?是一個月、還是之後幾個季度?

  • Just trying to understand, could this be a first half 2017 event, is more like a back half 2017 event? And then I'll hop back in the queue. Thank you.

    我想了解,這會是 2017 年上半年的事件,還是比較像 2017 年下半年的事件?我之後再回到提問隊列。謝謝。

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • It's somewhat to be determined. I will you tell you it's a multi-pronged strategy in the sense that we haven't made the decision to immediately go for a national coverage decision. The more likely event is that we will target the individual max first and try to obtain coverage on a regional basis, and that can happen much more rapidly. The national coverage decision process can take a year or more.

    這還有待確定。我可以告訴你,這是一個多管齊下的策略,因為我們尚未決定要立刻去爭取全國性給付決定(national coverage decision)。更可能的作法是,我們會先鎖定個別 MAC(Medicare Administrative Contractor,醫療保險行政承包商),嘗試以區域方式取得給付,而這可以更快發生。全國性給付決定流程可能需要一年或更久。

  • My expectation -- again -- these plans are not solidified at this point. But my expectation is that we would probably do this in parallel. But you would see us going after the max first, I don't want to guide you on specific timing because we just don't know yet.

    我的預期——再次強調——這些計畫目前尚未定案。但我的預期是我們可能會並行推進。不過你會看到我們先從 MAC 著手。我不想對具體時程給出指引,因為我們現在還不知道。

  • Operator

    Operator

  • James Franciscone from Morgan Stanley.

    來自 Morgan Stanley 的 James Franciscone。

  • - Analyst

    - Analyst

  • Hey, thanks for taking the question. I first wanted to touch on the impact of the recall to sales momentum exiting the first quarter. You talked quite a bit about the strain that managing the recall had put on your organization. We actually saw a very, very strong sales results in the first quarter.

    嗨,謝謝讓我提問。我首先想談談召回對第一季結束時銷售動能的影響。你們談了不少管理召回對組織造成的壓力。我們其實看到第一季銷售結果非常、非常強勁。

  • Is there any risk that that disruption or distraction to the organization in the first quarter will actually end up disrupting momentum into the second quarter? Or will we see a bit of a delayed impact with the recall in maintaining that sales momentum?

    第一季這種對組織的干擾或分心,是否有風險會在第二季反而打亂動能?或者我們會看到召回對維持銷售動能有一些延後的影響?

  • - CEO & President

    - CEO & President

  • We have not experienced that to date. We manage and watch it closely. That has not been our experience so far.

    到目前為止我們沒有遇到這種情況。我們有密切管理並持續監控。到目前為止並非我們的經驗。

  • - Analyst

    - Analyst

  • Okay. Understood. Second, just on gross margin. Would you be able to break out how much of the 3-point delta was scrapped versus warranty? As we look forward through the rest of the year, today, is there anything that we know about that we should be putting in our models, if it's going to be non-recurring in terms of those additional scrap or warranty expenses? Or are those still unknown risks at this point?

    好的,了解。第二個問題,關於毛利率。你能否拆分一下這 3 個百分點的差異中,有多少是報廢(scrap),多少是保固(warranty)?展望今年剩餘時間,就目前而言,有沒有任何我們已知、應該放進模型的項目——如果這些額外的報廢或保固費用屬於一次性(non-recurring)?還是說目前仍是未知風險?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Sure. The incremental cost we experienced this quarter was about 2 points due to warranty, extra warranty cost, and about 1 margin point due to scrap that Kevin mentioned before.

    當然。本季我們經歷的增量成本大約是 2 個百分點來自保固、額外保固成本,另外約 1 個毛利點來自 Kevin 先前提到的報廢。

  • - CEO & President

    - CEO & President

  • And as far as anything unknown in future quarters, we don't -- if we knew we would have accrued it. We don't know.

    至於未來季度是否還有任何未知項目,我們不知道——如果知道的話,我們就會提列(accrue)了。我們不知道。

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • We tried to outline the worst, what we believe today is the worst case scenario, it could be zero up to $5 million if we had to rework the entirety of our inventory.

    我們試著說明最糟情況,也就是以我們今天的判斷,最糟可能是 0 到 500 萬美元,若我們必須把全部庫存都重新加工(rework)。

  • - Analyst

    - Analyst

  • Okay. Understood.

    好的,了解。

  • - CEO & President

    - CEO & President

  • We haven't had any impact on the Company as a result of the recall. The impact we've had has been as a result of the G5 launch and that's not being ready for everything. We needed to be a little bit more ready and prepared from an infrastructure perspective. The recall on the patient notification did not impact our business or our sales, but it did impact our ability to serve our customers in the way we wanted to.

    召回本身並未對公司造成任何影響。我們受到的影響是來自 G5 上市,以及我們在各方面沒有完全準備就緒。我們在基礎設施層面需要更充分的準備與規劃。對病患的召回通知並未影響我們的業務或銷售,但確實影響了我們以理想方式服務客戶的能力。

  • - Analyst

    - Analyst

  • Understood. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Tao Levy from Wedbush.

    來自 Wedbush 的 Tao Levy。

  • - Analyst

    - Analyst

  • Hi, good afternoon. I was wondering, the rate of the events that you're seeing with the speakers, do you have a figure you'd like to share?

    嗨,午安。我想問一下,你們看到的喇叭相關事件發生率,有沒有什麼數字可以分享?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • No.

    沒有。

  • - CEO & President

    - CEO & President

  • (laughter) not that we are going disclose, no.

    (笑聲)我們不會揭露這個,沒有。

  • - Analyst

    - Analyst

  • Got you. One of the things that was surprising, when you look at -- when you read the blogs, and so forth, this is hardly mentioned. When it is mentioned, it's, so it will vibrate and you just put it next to your bed, you put the receiver next to the bed, it will vibrate and wake you up, if that's an issue, it's not -- again, it doesn't sound so alarming. Again, I might be wrong.

    了解。有件事讓人意外的是,當你看——讀部落格等等,幾乎沒有人提到這件事。就算提到,也會說它會震動,你把接收器放在床邊,它會震動把你叫醒;如果那是個問題的話——再說一次,聽起來也沒那麼嚇人。當然,我可能也錯了。

  • - CEO & President

    - CEO & President

  • We additionally dealt with in that manner, and notified patients to retest the speaker. Obviously, the FDA had a different opinion. I think what this tells you, again, is how important alerts and alarms are in the system, and we continue to emphasize that as we look at future product offerings and we need to make sure we meet people's alerts and alarms perspectives. Their expectations there, so it really relates more than anything else to the importance of the alerts and the alarms and that patients can hear them.

    我們也以那樣的方式處理,並通知病患重新測試喇叭。顯然 FDA 有不同看法。我想這再次告訴你,警示與警報在系統中有多重要;我們在展望未來產品供應時也持續強調這點,我們必須確保能符合人們對警示與警報的觀點與期待。因此,這更多是關於警示與警報的重要性,以及病患能夠聽到它們。

  • - Analyst

    - Analyst

  • In terms of impact on the sales force, does the sales force deal with this at all? Or are they completely separate so they can continue doing their thing?

    就對銷售團隊的影響而言,銷售團隊需要處理這件事嗎?還是他們完全分開,因此可以繼續做他們的工作?

  • - CEO & President

    - CEO & President

  • Oh, I'm sure they deal with it in phone calls they get from customers and dealing with it in discussing with the physicians. They don't have to deal with the actual execution of this at all, no.

    喔,我相信他們會在接到客戶電話時處理,也會在與醫師討論時處理。但他們完全不需要處理實際執行層面的工作,不需要。

  • - Analyst

    - Analyst

  • Got you. Lastly, you mentioned the incorporation of insulin data into the next generation app that will come out. Is that in collaboration with any specific pump manufacturer? Or is a not necessarily pump related? It could be from an injection?

    了解。最後,你提到下一代 app 會納入胰島素資料。這是與某個特定幫浦製造商合作嗎?還是不一定與幫浦相關?也可能來自注射?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • It could be from -- you are thinking about at the right way. It could be from an intelligent insulin pen that has either near field or Bluetooth connectivity to a phone. It could come from one of the existing or potential even future pump partners.

    可能來自——你的思路是對的。可能來自具智慧功能的胰島素筆,透過近場通訊(NFC)或藍牙與手機連線。也可能來自現有或甚至未來潛在的幫浦合作夥伴。

  • Our belief is, again, it's back to being able to aggregate the patient's data in a single place on the phone is going to be key to diabetes management going forward. And so we are making this available to patients and really evaluating any partner who is willing to come and participate here is a meaningful partner.

    我們的看法是——再次強調——未來糖尿病管理的關鍵,將是能在手機上把病患資料彙整到同一個地方。因此我們會把這能力提供給病患,並且真正去評估任何願意加入並參與的合作夥伴;只要願意參與,就是有意義的合作夥伴。

  • - Analyst

    - Analyst

  • Great, all right. Thanks a lot.

    太好了,好的。非常感謝。

  • Operator

    Operator

  • Jeff Johnson from Robert Baird.

    Robert Baird 的 Jeff Johnson。

  • - Analyst

    - Analyst

  • Thank you, guys, good afternoon. Kevin, on the panel, itself, July 21, if it meets then, could you paint in broad strokes for us, just kind of how you think the timeline could play out from there on when we might then see the dosing claim this year?

    謝謝各位,下午好。Kevin,關於 7 月 21 日的委員會會議本身,如果那天如期召開,你能否用較宏觀的方式為我們描繪一下,從那之後你認為時程可能會如何推進,以及我們今年何時可能看到劑量(dosing)標示主張?

  • - CEO & President

    - CEO & President

  • I really can't. I'm not going to anticipate what the panel is going to do.

    我真的無法。我不會去預測委員會會怎麼做。

  • - Analyst

    - Analyst

  • If it is a favorable decision, do you think approval and launch could come quickly? Are you prepared for that? Anything from a high level you can provide?

    如果是有利的決定,你認為核准與上市會很快嗎?你們準備好了嗎?有沒有任何你能從高層次提供的資訊?

  • - CEO & President

    - CEO & President

  • We certainly will have designed the app and the user guide and things of that nature. As far as launching immediately, we are going to have to go print things and get a new app filed and do a lot of stuff. It's not going to happen immediately, but we can prepare very rapidly for it after panel approval, but I can't give you a timeframe as to how quick after it's going to be.

    我們當然會把 App、使用者指南以及諸如此類的東西設計好。至於是否能立刻上市,我們還得去印製資料、提交新的 App 申請,並做很多事情。不會立刻發生,但在委員會核准後我們可以非常迅速地準備,不過我無法給你一個核准後多久能完成的時間表。

  • We try to be ready for launch every time we get an approval. We try and be as ready as we possibly can. We will behave in that manner. You saw with G5 we got approved and launched very shortly thereafter. Same in Europe.

    每次拿到核准時,我們都會努力做到隨時可以上市。我們會盡可能做好準備,並以這種方式行事。你們在 G5 上也看到,我們獲准後很快就上市了。歐洲也是一樣。

  • Our share receiver that we launched in 2015, we got approval on one week and we were shipping it two or three weeks later. That's our culture around here, is to be prepared, as prepared for approval as we possibly can.

    我們在 2015 年推出的 share receiver(分享接收器),我們某週拿到核准,兩到三週後就開始出貨。這就是我們這裡的文化:盡可能為核准做好準備。

  • This is a little bit different kind of nut because we are going to panel and that approval may be different than the typical approval we get from the agency. We will prepare every bit as much as we can, but we need to make sure we do it prudently. We don't want to do things twice. We want to do it once.

    這次有點不同,因為我們要上委員會,而那個核准可能不同於我們通常從主管機關拿到的典型核准。我們會盡一切可能做好準備,但也要確保審慎行事。我們不想做兩次,我們想一次就做到位。

  • - Analyst

    - Analyst

  • That makes sense, thank you. And then on the Diamond study, when we do get that data at ADA, as I keep thinking of this study, I think it could be very helpful in the long run, or even intermediate long term if we go into an era of bundling or something where healthcare costs are an even greater focus, and maybe it shows that CGM without pump is just as good or better than with pump. I get that. But how would you think about the near- to intermediate-term impact? Is it just if CGM shows better A1c control and what have you, it's just better data you can take out to the field to show patients, to show docs, things like that, is that really the near intermediate benefit we could see from Diamond?

    了解,謝謝。接著關於 Diamond 研究,當我們在 ADA 拿到那些數據時,我一直在想這項研究長期來看、甚至中長期在進入打包(bundling)或醫療成本更受關注的時代時,可能非常有幫助;也許它會顯示不搭配幫浦的 CGM 跟搭配幫浦一樣好甚至更好。我理解。但你會如何看待短期到中期的影響?是不是只要 CGM 顯示更好的 A1c 控制等,就只是更好的數據可以帶到前線,向病患、向醫師展示之類的,這就是我們從 Diamond 在短中期能看到的主要效益嗎?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • That's right, Jeff. We haven't seen the data yet. But, yes, this is going to be the preliminary portion of the Diamond study. So don't expect anything, the full-blown study results.

    沒錯,Jeff。我們還沒看到數據。不過,是的,這將是 Diamond 研究的初步部分。所以不要期待完整、全面的研究結果。

  • Yes, this is really to put to bed for once and for all that CGM versus traditional finger sticks, there is no question that CGM provides bigger benefit and we will be able to take that message -- one of the things we hear in the field there is not sufficient data to support the efficacy of CGM, and this should put that to bed for physicians, for payers, et cetera. Some of the other data that you were talking about would come at a later date.

    是的,這主要是要一勞永逸地釐清:CGM 相較於傳統指尖採血,毫無疑問 CGM 能帶來更大的效益。我們也能把這個訊息帶出去——我們在前線常聽到的一點是,支持 CGM 療效的數據還不夠,而這應該能讓醫師、支付方等不再有疑慮。你剛才提到的其他一些數據會在之後的時間點才會出來。

  • - Analyst

    - Analyst

  • Okay. Very helpful. Thanks, guys.

    好的。非常有幫助。謝謝各位。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Doug Schenkel from Cowen and Company.

    Cowen and Company 的 Doug Schenkel。

  • - Analyst

    - Analyst

  • This is Ryan Blicker on for Doug. Thanks for taking my questions. Another strong international quarter, growing faster year-over-year than the overall Company. Do you believe this is sustainable moving throughout the rest of the year? Do you think that international maybe reverts back a little bit closer to the corporate average?

    我是代替 Doug 的 Ryan Blicker。謝謝讓我提問。國際市場又是一個強勁的季度,年增率比公司整體還快。你們認為這在今年剩餘時間能否持續?還是你們覺得國際市場可能會回落一些,更接近公司平均?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Depends -- really depends (multiple speakers). If we get reimbursement, we mentioned that we were seeing positive signs in Germany, France and the UK. If we were to get all three of those, even one or two of them this year, that opens up a huge opportunity for patients that -- we are operating today in a cash pay world. If that happens, if two or three of them happen this year, or even into the first half of next year, I believe that will continue to accelerate European growth.

    要看——真的要看(多位講者)。如果我們拿到給付,我們提到在德國、法國和英國看到正面跡象。若這三個市場都拿到給付,即使今年只拿到其中一個或兩個,也會為病患帶來巨大的機會——我們目前是在自費市場運作。如果發生這種情況,如果今年其中兩個或三個成真,甚至延伸到明年上半年,我相信這將持續加速歐洲的成長。

  • - CEO & President

    - CEO & President

  • Yes, I would agree with Steve.

    是的,我同意 Steve 的看法。

  • - Analyst

    - Analyst

  • Okay. That's helpful. On the G5 transmitter, I know in the past you've talked about capacity constraints. Are you guys fully past that at this point?

    好的,很有幫助。關於 G5 發射器,我知道過去你們談過產能限制。你們現在已經完全度過那個階段了嗎?

  • - CEO & President

    - CEO & President

  • We are with the G5 transmitter, yes. But, again, getting through that, as Jess talked about earlier, we had some scrap and some yield issues as we've launched that product and built it out. We are through that, right now.

    就 G5 發射器而言,是的。不過,再次說明,正如 Jess 先前提到的,在我們推出並擴產那個產品時,曾有一些報廢與良率問題。我們現在已經解決了。

  • - Analyst

    - Analyst

  • Okay. And lastly, on Medicaid, you've talked about some impressive progress in public forums over the past several months. Can you give us an update on where that stands today and how you guys think about the total patient opportunity there?

    好的。最後,關於 Medicaid,你們在過去幾個月的公開場合談到一些令人印象深刻的進展。你能否更新一下目前的狀況,以及你們如何看待那裡的總體病患機會?

  • - EVP of Strategy & Corporate Development

    - EVP of Strategy & Corporate Development

  • Yes, I don't have great numbers for you on total patient opportunity, but we are pushing close to 25 states now with Medicaid coverage. We, obviously, know without specifically quantifying it, we know that in the Obamacare regime that the number of eligible patients for Medicaid in the various states has gone up pretty significantly. It is an important opportunity for us.

    是的,我沒有很好的數字可以提供你關於總體病患機會,但我們現在接近 25 個州已涵蓋 Medicaid 給付。當然,即使不做具體量化,我們也知道在歐巴馬健保(Obamacare)體制下,各州符合 Medicaid 資格的病患數量已相當顯著地增加。這對我們而言是重要的機會。

  • We'll continue, much like the private payers, we have to go state-by-state to negotiate and knock off coverage. So we're as focused on that as we are on the private payers and on Medicare.

    我們會持續推進;就像民間支付方一樣,我們必須逐州談判、逐州拿下給付。所以我們對這件事的專注程度不亞於對民間支付方與 Medicare 的專注。

  • - Analyst

    - Analyst

  • Okay. Thank you.

    好的,謝謝。

  • Operator

    Operator

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

    目前沒有進一步的問題。我想把電話交回給 Kevin Sayer 先生做結語。

  • - CEO & President

    - CEO & President

  • Thank you very much. It continues to be a very interesting time here at DexCom, particularly as we start to merge the world of medical devices and consumer devices, as I talked earlier about us supporting tech services phone calls related to consumer products. Another thing to note with respect to our speaker issue with the receiver, a lot of these receivers are very, very old and have been dropped multiple times.

    非常感謝。DexCom 目前仍處於非常有趣的時期,特別是當我們開始融合醫療器材與消費性裝置的世界;如我先前提到,我們正在支援與消費性產品相關的技術服務來電。另一點要注意的是,關於我們接收器的喇叭問題,很多接收器都非常、非常老舊,而且被摔過很多次。

  • So we're even dealing without a warranty product, as well. But we will get through that. But our G5 launch and everything going on here, even with our mistakes, everything has been going extremely well and as we look forward our product pipeline offers a feature set that is very much going to delight all of our current patients for years to come. But we're not going to stop there.

    所以我們也在處理一些已無保固的產品。不過我們會度過這個狀況。整體而言,我們的 G5 上市以及這裡正在進行的一切,即使有我們的失誤,一切仍進展得非常順利;展望未來,我們的產品管線所提供的功能組合,將在未來多年讓我們所有現有病患非常滿意。但我們不會就此止步。

  • We've been very up front with our discussions around future markets such as Type 2 diabetes, gestational diabetes in the hospital. As we begin to run small studies in those areas and talk with patients, the things we are hearing are remarkable.

    我們一直很坦率地討論未來市場,例如第二型糖尿病、妊娠糖尿病,以及住院場景。當我們開始在這些領域進行小型研究並與病患交流時,我們聽到的內容非常驚人。

  • Let me give you a couple of quotes I've heard. I didn't know what diabetes really was. I had no idea how to titrate my meds. I wasn't even sure that they worked.

    我分享幾句我聽過的原話:我以前根本不知道糖尿病到底是什麼。我完全不知道該如何調整我的用藥劑量。我甚至不確定那些藥是否有效。

  • No one's ever given me any feedback before and I just stick my finger once every day and thought I was okay. Who knew? Exercise makes a really big difference. And my favorite one, do you have any idea how many patients in this hospital have diabetes?

    以前從來沒有人給我任何回饋,我每天只扎手指一次,還以為自己沒問題。誰知道呢?運動真的會帶來很大的差異。還有我最喜歡的一句:你知道這家醫院裡有多少病患有糖尿病嗎?

  • Our diabetes opportunity is enormous. The healthcare community is realizing that improved outcomes cannot be achieved without better, realtime information. Our competitive environment consists of many large, aggressive well-funded entities on one side and many start-up technologies on the other, all focused on one thing, catching DexCom. Now it's not a time for us to slow down, but a time to increase our focus and execute on our amazing plans. Thank you.

    我們在糖尿病領域的機會非常龐大。醫療界正意識到,若沒有更好、即時的資訊,就無法達成更佳的治療結果。我們的競爭環境,一邊是許多大型、積極且資金雄厚的企業,另一邊是許多新創技術,所有人都聚焦在一件事:追趕 DexCom。現在不是我們放慢腳步的時候,而是要提高專注度、執行我們令人驚豔計畫的時候。謝謝。

  • Operator

    Operator

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

    謝謝各位女士、先生。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。