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Operator
Operator
Hello, and welcome to the DexCom third-quarter 2014 earnings release and conference call. My name is Joe and I will be your operator for today's call. (Operator Instructions). Please note that this conference is being recorded.
各位好,歡迎參加 DexCom 2014 年第三季財報發布與電話會議。我是 Joe,將擔任今天電話會議的接線員。(接線員指示)。請注意,本次會議將被錄音。
I will now turn the call over to the CEO of DexCom, Mr. Terry Gregg. Sir, you may begin.
現在我將把電話交給 DexCom 執行長 Terry Gregg 先生。先生,您可以開始了。
Terry Gregg - CEO
Terry Gregg - CEO
Thanks, Joe, and thanks, everyone, for joining DexCom today on our third-quarter 2014 investor conference call.
謝謝你,Joe,也謝謝各位今天參加 DexCom 2014 年第三季投資人電話會議。
I'm going to have Steve Pacelli read our Safe Harbor statement to kick things off.
我將請 Steve Pacelli 先宣讀我們的「安全港」聲明,作為開場。
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
Thanks, Terry. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans, and performance, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under risk factors, and elsewhere in our annual report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC.
謝謝你,Terry。我們在今天電話會議中所做的部分陳述,可能構成前瞻性陳述。這些陳述反映管理層對未來事件、營運計畫與績效的預期,且僅截至本日有效。這些前瞻性陳述涉及多項風險與不確定性。可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單,已於我們的 Form 10-K 年度報告、Form 10-Q 季度報告,以及其他向美國證券交易委員會(SEC)提交之報告中的「風險因素」及其他章節中詳述。
We undertake no obligation to update publicly or revise these forward-looking statements for any reason.
我們不承擔因任何原因公開更新或修訂這些前瞻性陳述的義務。
Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP, with respect to our cash operating performance. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. Presentation of this additional information should not be considered in isolation, or as a substitute, for results, or superior to results prepared in accordance with GAAP.
此外,我們將討論若干未依一般公認會計原則(GAAP)編製的財務資訊,涉及我們的現金營運表現。提供此非 GAAP 資訊旨在增進您對我們目前財務表現的整體理解。此額外資訊之呈現不應被孤立看待,亦不應作為依 GAAP 編製之結果的替代,或被視為優於依 GAAP 編製之結果。
Terry?
Terry?
Terry Gregg - CEO
Terry Gregg - CEO
Thanks, Steve. Joining me today are Kevin Sayer, our President and Chief Operating Officer; Jess Roper, our Chief Financial Officer; and you just heard from Steve Pacelli, our Executive Vice President of Strategy and Corporate Development.
謝謝你,Steve。今天與我一同出席的有:我們的總裁暨營運長 Kevin Sayer;財務長 Jess Roper;以及剛才各位聽到的策略與企業發展執行副總裁 Steve Pacelli。
So today's call will follow our traditional format. Kevin will review our third-quarter 2014 financial results and provide a business update. And I will then follow with some concluding thoughts. But before I turn the call over to Kevin, I'd like to comment briefly on our results for the quarter.
因此,今天的電話會議將依照我們一貫的流程進行。Kevin 將回顧我們 2014 年第三季的財務結果並提供業務更新。接著我會做一些結語。不過在把電話交給 Kevin 之前,我想先就本季的結果做簡短評論。
Our product revenue growth is unparalleled. We have grown over 60% annually for six consecutive quarters, and our average year-over-year quarterly revenue growth has been 65% since the launch of G4 PLATINUM. In Q3, our cash-based operating income increased by approximately 3 times over Q3 2013. Clearly, our business model is working as planned.
我們的產品營收成長無與倫比。我們已連續六個季度年增率超過 60%,自 G4 PLATINUM 推出以來,我們平均的年對年季度營收成長率為 65%。在第三季,我們以現金為基礎的營運收入較 2013 年第三季約增加 3 倍。顯然,我們的商業模式正如計畫般運作。
All the while, we are in the midst of three simultaneous product launches: first, a new, smaller version of our G4 PLATINUM transmitter; second, DexCom SHARE, our first step into mobile remote monitoring; and, third, our new G4AP algorithm, with an unprecedented 9% MARD. Things could not be better for us.
同時,我們正處於三項產品同步上市的階段:第一,我們 G4 PLATINUM 發射器的新款更小版本;第二,DexCom SHARE,我們跨入行動遠端監測的第一步;第三,我們新的 G4AP 演算法,具備前所未有的 9% MARD。對我們而言,一切再好不過。
With that, I will turn the call over to Kevin.
接下來,我把電話交給 Kevin。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Thank you, Terry. I'll start with the financial update. DexCom generated $67.9 million in product revenue for the third quarter of 2014 compared to $42.5 million for the same quarter in 2013, a $25.4 million or 60% increase. Sequentially, product revenue for Q3 of 2014 increased 17% from the prior quarter. Total revenue for the third quarter of 2014 was $69 million compared to $42.9 million during the same quarter in 2013.
謝謝你,Terry。我先從財務更新開始。DexCom 2014 年第三季產品營收為 6,790 萬美元,較 2013 年同期的 4,250 萬美元增加 2,540 萬美元,或成長 60%。按季比較,2014 年第三季產品營收較前一季成長 17%。2014 年第三季總營收為 6,900 萬美元,較 2013 年同期的 4,290 萬美元增加。
Our product gross profit totaled $46.1 million, generating a product gross margin of 68% for the third quarter of 2014, compared to product gross profit of $27.7 million and a product gross margin of 65% for the same quarter in the prior year. Sequentially, our product gross margin in Q3 2014 was flat. As we've said previously, our gross margin target for the G4 PLATINUM sensor is between 70% and 75%, and our gross margin target for G4 PLATINUM hardware is 50% or better.
我們的產品毛利合計為 4,610 萬美元,使 2014 年第三季產品毛利率達 68%,相較之下,前一年同期產品毛利為 2,770 萬美元、產品毛利率為 65%。按季比較,2014 年第三季的產品毛利率持平。如同我們先前所說,G4 PLATINUM 感測器的毛利率目標為 70% 至 75%,而 G4 PLATINUM 硬體的毛利率目標為 50% 或更高。
With a blended gross margin of 68%, we are achieving our targets. While we may see minor incremental gross margin gains in future quarters, we do not expect to see continued large improvements in gross margin until we introduce new products and achieve even greater sales volumes.
以 68% 的綜合毛利率來看,我們正在達成目標。雖然未來幾季我們可能會看到些微的毛利率增量提升,但在我們推出新產品並達到更高的銷售量之前,我們預期不會再看到毛利率持續出現大幅改善。
I would like to share some additional thoughts on our product revenue and our gross profits. During Q3 2014, our revenue mix between durable and consumable products was again approximately 30% durable and 70% consumable. ASP for sensors was flat for the third quarter, at approximately $72 per sensor. And the ASP for our hardware was approximately $850 per starter kit, with a little more than half of our hardware ASP attributable to the transmitter; while we continue to target ASPs in a range of $70 to $75 per sensor, and a range of $850 to $900 for a starter kit, going forward.
我想就我們的產品營收與毛利再補充一些看法。2014 年第三季,我們在耐久財與耗材產品之間的營收組合再次約為 30% 耐久財、70% 耗材。第三季感測器的平均售價(ASP)持平,約為每個感測器 72 美元。我們硬體的 ASP 約為每套入門套組 850 美元,其中略多於一半的硬體 ASP 來自發射器;同時,我們未來仍以每個感測器 70 至 75 美元、以及每套入門套組 850 至 900 美元的 ASP 區間為目標。
Finally, our international business continued to exceed our expectations in Q3, with international product revenues representing approximately 15% of product revenue during the quarter.
最後,我們的國際業務在第三季持續超出預期,國際產品營收約占本季產品營收的 15%。
On the expense side, research and development expense totaled $18.5 million for Q3 of 2014 compared to $11.8 million in Q3 of 2013, and $14.8 million in Q2 2014. Yes, we are making a significant investment in our future. As Terry mentioned in his opening remarks, we have seen exceptional growth since the launch of G4 PLATINUM. And we have clearly demonstrated that superior product performance has been key to driving this growth.
在費用方面,2014 年第三季研發費用合計為 1,850 萬美元,較 2013 年第三季的 1,180 萬美元增加,亦高於 2014 年第二季的 1,480 萬美元。是的,我們正在對未來進行重大投資。如 Terry 在開場致詞中提到,自 G4 PLATINUM 推出以來,我們看到卓越的成長。而我們也清楚證明,優異的產品表現是推動此成長的關鍵。
Yet, as we evaluate what we believe will be required in terms of improved sensor performance and advanced system features and functionality to meet the ever-increasing demands of our patients and clinicians, we must continue to invest in the near-term. In addition, we need to complete the clinical trial work necessary to demonstrate improved outcomes and lower cost to drive favorable payer policies.
然而,當我們評估為滿足病患與臨床醫師日益提高的需求,在感測器效能提升以及先進系統特性與功能方面我們認為所需的投入時,我們必須在短期內持續投資。此外,我們也需要完成必要的臨床試驗工作,以證明更佳的臨床結果與更低的成本,從而推動有利的支付方政策。
We will look to take advantage of near-term opportunities such as advanced integrated pump, CGM systems, simplification of sensor deployment, mobile and cloud-based data platforms; and additional system performance improvements such as improved accuracy, extended duration, and reduced calibration.
我們將把握短期機會,例如先進的整合式胰島素幫浦與連續血糖監測(CGM)系統、簡化感測器部署、行動與雲端資料平台;以及其他系統效能提升,例如更高的準確度、更長的使用期間與更少的校正需求。
Over time, we will focus on miniaturization and advanced decision-support tools, all with an eye on increasing patient convenience, improving outcomes, and lowering costs. We will not lose sight of our ultimate goal of replacing finger sticks entirely.
隨著時間推進,我們將聚焦於小型化與先進的決策支援工具,目標是提升病患便利性、改善臨床結果並降低成本。我們不會忽視最終目標:完全取代指尖採血。
Selling, general, and administrative expense totaled $33.7 million in Q3 of 2014 compared to $21.6 million during the same quarter in 2013, an increase of $12.1 million. The year-over-year increase in SG&A expense relates primarily to increased sales costs driven by our robust sales, increased marketing spending, and IT expenses for our commercial infrastructure as we scale of the business for continued revenue growth. SG&A expense also includes a $4.4 million increase in non-cash share-based compensation expense over the prior year.
2014 年第三季銷售、一般及行政(SG&A)費用合計為 3,370 萬美元,較 2013 年同期的 2,160 萬美元增加 1,210 萬美元。SG&A 費用的年對年增加,主要與我們強勁銷售帶動的銷售成本上升、行銷支出增加,以及隨著我們擴大業務以支持持續的營收成長而增加的商業基礎設施 IT 費用有關。SG&A 費用亦包含較前一年增加 440 萬美元的非現金股份基礎給付(share-based compensation)費用。
SG&A expense for the preceding quarter was $30.9 million. The sequential increase of $2.8 million includes $600,000 in incremental non-cash share-based compensation expense and commercial expenses to support our 17% sequential growth in product revenue. Our net loss for the third quarter of 2014 totaled $5.2 million, and included $15.2 million in non-cash expenses centered in share-based compensation, depreciation, and amortization. Absent these charges, our cash-based operating income would have been approximately $10.1 million for Q3 2014.
前一季的 SG&A 費用為 3,090 萬美元。按季增加的 280 萬美元,包括 60 萬美元的額外非現金股份基礎給付費用,以及為支持產品營收按季成長 17% 所需的商業費用。2014 年第三季淨損合計為 520 萬美元,其中包含 1,520 萬美元的非現金費用,主要為股份基礎給付、折舊與攤銷。若不計入這些費用,我們 2014 年第三季以現金為基礎的營運收入約為 1,010 萬美元。
Obviously, we are quite pleased with our cash-based operating results. This compares very favorably to a cash-based operating income for Q3 2013 of $3.5 million. Our basic loss per share for the quarter was $0.07.
顯然,我們對以現金為基礎的營運結果感到相當滿意。相較之下,2013 年第三季以現金為基礎的營運收入為 350 萬美元。本季基本每股虧損為 0.07 美元。
With respect to our balance sheet, we ended the third quarter with $74.9 million in cash and marketable securities, up almost $13.6 million sequentially. We remain quite comfortable with our cash position. Finally, consistent with past practices, we take this opportunity to update our full-year revenue guidance. We now expect product revenue for the full year to meet or exceed the top end of our range of $235 million.
就資產負債表而言,我們在第三季末的現金與有價證券為 7,490 萬美元,按季增加近 1,360 萬美元。我們對目前的現金部位仍感到相當安心。最後,依照過往慣例,我們也藉此機會更新全年營收指引。我們目前預期全年產品營收將達到或超過我們區間上緣的 2.35 億美元。
Now for our business update. Over the past few weeks, we have had a very exciting string of news related to our product portfolio. First, in mid-October, we were very pleased to announce the approval of DexCom SHARE, the first FDA-approved remote monitoring system developed to address the unique challenges faced by caregivers in assisting people with type 1 diabetes.
現在來更新我們的業務進展。過去幾週,我們的產品組合相關消息接連傳來,令人振奮。首先,在 10 月中旬,我們非常高興宣布 DexCom SHARE 獲得核准;這是第一個獲 FDA 核准的遠端監測系統,旨在因應照護者在協助第一型糖尿病患者時所面臨的獨特挑戰。
As a reminder, the DexCom SHARE system is a docking station for the G4 PLATINUM receiver, which enables wireless transmission of glucose information, such as a patient's trend graph, from the G4 PLATINUM to designated recipients, allowing the recipient to view the patient's data today on their iPhone or iPod Touch; and, in the future, on an Android platform as well.
提醒一下,DexCom SHARE 系統是一個供 G4 PLATINUM 接收器使用的底座,可讓葡萄糖資訊(例如患者的趨勢圖)從 G4 PLATINUM 以無線方式傳送給指定接收者,使接收者今天即可在其 iPhone 或 iPod Touch 上查看患者資料;未來也將可在 Android 平台上查看。
We view DexCom SHARE as the first of many steps in bringing CGM to mobile devices. We successfully launched DexCom SHARE within days of approval. And we couldn't be more excited about the early feedback we've received from patients using the system.
我們將 DexCom SHARE 視為把 CGM 帶到行動裝置上的眾多步驟中的第一步。我們在核准後數日內即成功推出 DexCom SHARE。而且,對於我們從使用該系統的患者那裡收到的早期回饋,我們感到無比振奮。
Just this morning, we were pleased to announce that FDA has approved a new algorithm for the G4 PLATINUM system that we dubbed the G4 Artificial Pancreas, or G4AP algorithm. The clinical data from this new algorithm was first presented at ADA in June in a late-breaking poster entitled, CGM is not the limiting factor in artificial pancreas systems. In this study, we demonstrated that our technology is approaching fingerstick accuracy, with an overall G4AP MARD versus YSI at an impressive 9.0%, compared to a fingerstick MARD of 5.6% versus YSI.
就在今天早上,我們很高興宣布 FDA 已核准 G4 PLATINUM 系統的一套新演算法,我們將其命名為 G4 Artificial Pancreas(人工胰臟),或稱 G4AP 演算法。這套新演算法的臨床數據於 6 月在 ADA 以最新突破海報首次發表,題為「CGM 並非人工胰臟系統的限制因素」。在該研究中,我們證明我們的技術正接近指尖採血的準確度:整體而言,G4AP 相較於 YSI 的 MARD 令人印象深刻地達到 9.0%,而指尖採血相較於 YSI 的 MARD 為 5.6%。
The new algorithm will be made available free of charge to existing adult patients using the G4 PLATINUM. They can simply go online and download the software to update their receiver. Additionally, we expect to file the PMA supplement for a pediatric indication for the G4AP algorithm this quarter. All new adult patients, going forward, will receive the software preloaded onto their DexCom receiver with new orders.
這套新演算法將免費提供給現有使用 G4 PLATINUM 的成人患者。他們只需上網下載軟體即可更新其接收器。此外,我們預期本季將就 G4AP 演算法的兒科適應症向 FDA 提交 PMA 補充申請。未來所有新的成人患者,在下新訂單時,其 DexCom 接收器將預先載入該軟體。
We believe this new algorithm represents an important next step on our path to obtaining an insulin-dosing claim and the potential for factory calibration, both of which support our ultimate goal of replacing fingersticks altogether.
我們相信,這套新演算法代表我們在取得「胰島素劑量給藥」主張以及潛在的出廠校準(factory calibration)之路上的重要下一步;兩者皆支持我們最終目標:完全取代指尖採血。
Shifting to our integration partnerships, Animas believes that the Vibe is nearing US FDA approval, and we are gearing up for a commercial launch of Vibe in the US which could come before the end of this year. On our last call, we shared that Tandem had submitted a PMA application to the FDA for the t:slim G4 Insulin Delivery System, which integrates the Tandem t:slim pump with our Gen 4 PLATINUM system. As Tandem reported this morning, they are extremely pleased with the level of interaction with the FDA since the filing, and they are confident in their ability to bring this device to market.
轉到我們的整合合作夥伴關係,Animas 認為 Vibe 已接近取得美國 FDA 核准,我們也正為 Vibe 在美國的商業上市做準備,可能在今年年底前推出。在上次電話會議中,我們分享 Tandem 已向 FDA 提交 t:slim G4 胰島素輸送系統的 PMA 申請,該系統整合 Tandem t:slim 幫浦與我們的第 4 代 PLATINUM 系統。正如 Tandem 今早所報告,自提交以來,他們對與 FDA 的互動程度非常滿意,並對將該裝置推向市場的能力充滿信心。
That being said, timing of product approval is at the discretion of the FDA, and Tandem continues to estimate a 12- to 18-month review cycle for the t:slim G4.
話雖如此,產品核准時程由 FDA 自行裁量,而 Tandem 仍估計 t:slim G4 的審查週期為 12 至 18 個月。
Finally, on the data integration and data management front, there seems to be a considerable amount of confusion in the marketplace as to where, and to what extent, DexCom is a participant. When it comes to retrospective display of our CGM data, we have announced an open architecture policy, whereby we will allow third-party software developers -- companies such as Tidepool, Diasend, and others -- to display retrospective data from our G4 PLATINUM system within their data aggregation platforms.
最後,在資料整合與資料管理方面,市場上對 DexCom 參與的範圍與程度似乎存在相當多的混淆。就我們 CGM 資料的回溯式(retrospective)顯示而言,我們已宣布開放式架構政策,允許第三方軟體開發商——例如 Tidepool、Diasend 等公司——在其資料彙整平台中顯示來自我們 G4 PLATINUM 系統的回溯資料。
When it comes to our mobile app platform, we have stated a desire to incorporate insulin onboard data and other potential relevant data into our mobile platform. To that end, we have entered into agreements with Insulet and Asante, and are considering others to integrate data from their insulin delivery systems into our Gen 5 mobile platform. This platform will enable us to aggregate glucose and other diabetes-related data from patients' devices, and display the integrated data on a smartphone. This will be DexCom-driven software development process, and we expect these apps to be PMA products.
就我們的行動 App 平台而言,我們已表達希望將「體內殘留胰島素」(insulin onboard)資料及其他可能相關資料納入行動平台。為此,我們已與 Insulet 與 Asante 簽訂協議,並正考慮其他合作方,以將其胰島素輸送系統的資料整合至我們的第 5 代(Gen 5)行動平台。該平台將使我們能彙整患者裝置中的葡萄糖及其他糖尿病相關資料,並在智慧型手機上顯示整合後的資料。這將是由 DexCom 主導的軟體開發流程,我們預期這些 App 將屬於 PMA 產品。
With respect to real-time display of DexCom's CGM data, we have thus far elected to maintain tight control, due in large part to the regulatory and quality systems requirements imposed upon CGM devices by the FDA. Obviously, our stand-alone products will provide patients with real-time information. To date, we have only granted rights to commercialize display of our real-time data to a select few insulin pump companies.
至於 DexCom 的 CGM 資料即時顯示(real-time display),迄今我們選擇維持嚴格控管,主要原因在於 FDA 對 CGM 裝置所施加的法規與品質系統要求。顯然,我們的獨立式產品將為患者提供即時資訊。截至目前,我們僅授予少數胰島素幫浦公司商業化顯示我們即時資料的權利。
Going forward, we will consider, on a case-by-case basis, whether we open up real-time data displayed for commercialization to other third parties, such as other insulin pump companies or groups working to develop an artificial pancreas utilizing our sensor technology where it makes commercial sense.
展望未來,我們將視個案情況考量,是否向其他第三方開放即時資料顯示的商業化,例如其他胰島素幫浦公司,或是利用我們感測器技術開發人工胰臟、且在商業上具合理性的團體。
Prior to doing so, however, we would want to assure ourselves that any such third party has a robust quality system and regulatory resources required by FDA to develop and maintain a Class III medical system.
然而,在這麼做之前,我們希望先確認任何此類第三方具備健全的品質系統,以及 FDA 要求用於開發與維護第三類(Class III)醫療系統所需的法規資源。
With that, I would now like to turn the call over to Terry for some concluding remarks.
接下來,我想把電話交給 Terry,請他做一些結語。
Terry Gregg - CEO
Terry Gregg - CEO
Thanks, Kevin. Well, our third-quarter performance did not entirely surprise us, as we continued to see momentum for the G4 PLATINUM build in the diabetes community. One needs only to read the diabetes blogs and chat room discussions to know what a tremendous difference we are making for patients, as well as their parents and loved ones, as they strive to improve control over their diabetes.
謝謝你,Kevin。嗯,我們第三季的表現並未讓我們完全意外,因為我們持續看到 G4 PLATINUM 在糖尿病社群中的動能增強。只要閱讀糖尿病部落格與聊天室的討論,就能知道我們為患者以及他們的父母與摯愛帶來多麼巨大的改變,幫助他們努力改善對糖尿病的控制。
We must continue to innovate, never resting on what we have accomplished; which, of course, today, is the industry-leading CGM technology. We will never be satisfied until we reach our goal of replacing fingersticks. And upon achieving that milestone, we will simply develop new goals to continue to drive DexCom to remain the dominant name in continuous glucose monitoring.
我們必須持續創新,絕不能停留在既有成就上;而我們今天的成就,當然就是業界領先的 CGM 技術。在達成以 CGM 取代指尖採血的目標之前,我們永遠不會滿足。而在達成該里程碑之後,我們也會設定新的目標,持續推動 DexCom 維持在連續血糖監測領域的主導地位。
We recently received approval for our SHARE system. And we believe this is the first step in the connectivity pipeline we are developing to ease the burden of trying to better control glucose levels safely. But even more important is that SHARE actively engages the patient and his or her support team, which are parents, spouses, and loved ones. For the first time with an FDA-approved device, you can be in the next room, the next state, or across the globe, and someone has your back, remotely. We are changing the paradigm of managing diabetes for the better.
我們最近取得 SHARE 系統的核准。我們相信,這是我們正在打造的連線能力管線中的第一步,可減輕在安全前提下更好控制血糖所帶來的負擔。但更重要的是,SHARE 能主動讓患者及其支援團隊參與其中,包括父母、配偶與親人。首次透過 FDA 核准的裝置,你可以在隔壁房間、隔壁州,甚至在地球另一端,而仍有人能在遠端為你提供支援。我們正在以更好的方式改變糖尿病管理的典範。
Kevin mentioned our recent approval of a new algorithm, the G4AP, that we will begin to distribute shortly. I can remember how happy and satisfied patients were with the improvement and accuracy from the 16% MARD of the SEVEN PLUS to the 13% MARD of the G4 PLATINUM. So I'm even more excited to get this new algorithm, with an MARD of 9%, into the hands of patients. We have learned the importance of accuracy in CGM. It translates into confidence and trust in the G4 system. It also translates into freedom for the patient to live a more normal life. And it moves DexCom a step closer to our goal of replacing fingersticks.
Kevin 提到我們近期核准的一套新演算法 G4AP,我們將在不久後開始配發。我記得,患者對於從 SEVEN PLUS 的 16% MARD 提升到 G4 PLATINUM 的 13% MARD 所帶來的改善與準確度,是多麼開心與滿意。因此,我更期待把這套 MARD 為 9% 的新演算法交到患者手中。我們已了解 CGM 準確度的重要性;它會轉化為對 G4 系統的信心與信任,也會轉化為患者能更自由地過更正常的生活,並讓 DexCom 更接近取代指尖採血的目標。
Our pipeline is very robust, and we expect to introduce a steady stream of product innovations on our sensor technology as we look at Gen 6 on the durables with an improved sensor deployment system, and especially on the connectivity side, as we introduce our Gen 5 system. We will continue to make the appropriate investments to achieve these goals.
我們的產品研發管線非常強勁;在感測器技術方面,我們預期將持續推出一系列產品創新,包括在耐用設備(durables)端展望第 6 代(Gen 6)並改良感測器部署系統;尤其在連線能力方面,隨著我們推出第 5 代(Gen 5)系統。我們將持續進行適當投資以達成這些目標。
As I have often commented, being in the CGM space is extremely difficult and expensive. Many have tried, and most have failed. And yet, we continue to prosper and drive adoption by providing superior technology in a patient-friendly format.
正如我常說的,投入 CGM 領域極其困難且成本高昂。許多人嘗試過,而大多數都失敗了。然而,我們仍持續成長並推動採用率,因為我們以對患者友善的形式提供更優異的技術。
Kevin touched on the reimbursement challenges facing the med tech world, as cost of care becomes front-and-center for the payer universe, and we believe we are well positioned to demonstrate improved outcomes while saving the system money.
Kevin 提到醫療科技產業面臨的給付(reimbursement)挑戰;隨著照護成本成為支付方世界的核心焦點,我們相信自己具備良好定位,能在節省體系成本的同時,證明可帶來更佳的臨床結果。
A single severe hypoglycemic event with a hospital admission can cost on average $17,000, and yet we can reduce or eliminate hypoglycemia events. And the compendium of positive outcome data associated with continuous glucose monitoring continues to grow. And one of our near-term goals is to harness that data to enable payers and healthcare providers to better manage treatment modalities, and, ultimately, further reduce cost of care.
一次嚴重低血糖事件若需住院,平均可能花費 17,000 美元;然而,我們能降低或消除低血糖事件。而與連續血糖監測相關的正向結果數據彙編也持續增加。我們其中一項近期目標,是善用這些數據,協助支付方與醫療照護提供者更好地管理治療方式,並最終進一步降低照護成本。
The world is waking up to the potential benefits of connectivity, with wearables for improved health. DexCom has been a pioneer in this area since our inception, so we are excited we have a partner with companies like Apple to accelerate our efforts. And you'll be hearing more about these collaborations in the future.
全世界正逐漸意識到連結性所帶來的潛在效益,包含透過穿戴式裝置改善健康。DexCom 自成立以來便是此領域的先驅,因此我們很高興能與 Apple 等公司成為合作夥伴,以加速我們的努力。未來你們也會聽到更多關於這些合作的消息。
With that, we will take questions.
接下來,我們將開始提問。
Operator
Operator
(Operator Instructions). Danielle Antalffy, Leerink Partners.
(接線生指示)。Danielle Antalffy,Leerink Partners。
Danielle Antalffy - Analyst
Danielle Antalffy - Analyst
Congrats on yet another great quarter. I was hoping you could comment. There was some talk in the quarter about a competitive launch in Europe. Obviously, I'm talking about Abbott's Libre, which, from what I understand, is not a true CGM. So I was hoping maybe you could talk a little bit about what that product is; and, more importantly, what you're seeing so far in Europe from an adoption -- potentially market expansion -- perspective. And also, any comments on pricing with that product.
恭喜你們又交出一個非常亮眼的季度。我想請你們評論一下。本季有一些討論提到歐洲出現競品上市。很明顯我指的是 Abbott 的 Libre,據我了解,它並不是真正的 CGM。因此我希望你們能談談那個產品到底是什麼;更重要的是,從採用情況——以及可能的市場擴張——的角度來看,你們目前在歐洲看到什麼趨勢。另外,也請評論一下該產品的定價。
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
Danielle, this is Steve. I'll take this one. I think you hit it on the head. Look, the Abbott Libre product is, first and foremost, it's not a CGM product. It does not have the capability of alerting a patient, for example, to nighttime hypoglycemia, which is a critical attribute to CGM. So it's not really fair to have an apples-to-apples comparison between DexCom's CGM and the Abbott Libre product.
Danielle,我是 Steve。我來回答這題。我想你說到重點了。你看,Abbott 的 Libre 產品,首先,它不是 CGM 產品。它不具備提醒病患(例如)夜間低血糖的能力,而這是 CGM 的關鍵特性。因此,拿 DexCom 的 CGM 與 Abbott Libre 做完全對等的比較,其實並不公平。
That being said, we long assumed that Abbott would come back into the market. They have been talking about this product for over a year now, so it certainly wasn't a surprise to us. We've been watching the blogs, frankly, but I think they are in the very early stages of their launch, so it there isn't a whole lot of detail or information out in the marketplace at this point.
話雖如此,我們早就預期 Abbott 會回到市場。他們談這個產品已經超過一年了,所以對我們而言並不意外。坦白說我們一直在看各種部落格資訊,但我認為他們仍處於上市初期階段,因此目前市場上並沒有太多細節或資訊。
Again, I've heard -- pricing, it appears to be priced favorably to a full-blown CGM. But again, your patients will be purchasing products that doesn't have the full protections of CGM in terms of alerts and threshold alerts and alarms. So I think at this point, we're going to take a wait-and-see approach; wait and see what, if and what, they develop as a category in the market in Europe. No idea. They've been very silent as to potential timelines for US commercialization, so we'll take a wait-and-see approach here.
再者,我聽到的——就定價而言,它看起來相較於完整的 CGM 定價更有利。但同樣地,病患購買的產品並不具備 CGM 在警示、閾值警示與警報方面的完整防護。因此我認為現階段我們會採取觀望策略;看看他們是否、以及如何在歐洲市場把這個產品發展成一個新的品類。我們也不清楚。他們對於美國商業化的可能時程一直非常低調,所以我們在這裡也會採取觀望。
And I think the net-net for us is, look, the configuration that Abbott has come to market with is certainly something that we could make it potentially -- make some tweaks to the Abbott product that would be very competitive to an Abbott Libre product, to the extent that they are able to develop some new category for the product. So I think, with that, we're going to take a bit of a wait-and-see approach.
而對我們來說,歸根結底是:你看,Abbott 目前推向市場的配置,確實是我們也可能做到的——我們可以對 Abbott 的產品做一些調整,使其在競爭上能與 Abbott Libre 相當,前提是他們真的能在市場上為該產品建立某種新的品類。因此,我想我們會先採取一點觀望的態度。
Danielle Antalffy - Analyst
Danielle Antalffy - Analyst
Okay, great. That's helpful. And then I was hoping you could give some more color on SHARE -- congrats on the approval -- how we should think about that contributing to revenue. Is that a subscription-based model? Or how does SHARE work? And how do we look at that going forward, from a revenue topline-driver perspective?
好的,很好。這很有幫助。接著我想請你們再多談一些 SHARE——也恭喜獲得核准——我們應該如何看待它對營收的貢獻?這是訂閱制模式嗎?或者 SHARE 的運作方式是什麼?從營收、尤其是帶動營收成長的角度來看,未來我們應該如何看待它?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Sure, Danielle. I'll take that one. The SHARE system is a -- it's an upfront charge of, I think, $299, and you get the cradle and your data to start off. It is not a subscription model at this point in time. Our patients buy the hardware, and that's what they get. With respect to driving our revenues, as I said on the prepared remarks, this is really the first step in our mobility platforms. And while we expect this to contribute some, it's not going to be a major revenue driver when we're already growing at 60%.
當然,Danielle。我來回答。SHARE 系統是——一次性前期收費,我記得是 299 美元,你會拿到基座(cradle)以及開始使用所需的資料。現階段它不是訂閱制模式。我們的病患購買硬體,得到的就是這些。至於帶動營收,如同我在事先準備的發言中提到的,這其實是我們行動化平台的第一步。雖然我們預期會有一些貢獻,但在我們已經以 60% 成長的情況下,它不會成為主要的營收驅動因素。
What we do see -- what we do anticipate is that this will be very helpful, and continue to grow the pediatric market. And the other benefit of SHARE, quite frankly, isn't on the top line; it's a pressure test for all the infrastructure we've been building for a long time to manage this data remotely. And we have learned a whole bunch in a very short period of time about our patients' behaviors and patterns, and their glucose readings. So, all in all, it's a great launch for us.
我們確實看到——我們預期這將非常有幫助,並持續推動兒科市場的成長。坦白說,SHARE 的另一個好處不在營收端;它是對我們長期建置、用於遠端管理這些資料的所有基礎設施的一次壓力測試。我們在很短的時間內就學到了很多,包含病患的行為與模式,以及他們的葡萄糖讀數。因此整體而言,這對我們是一個很成功的上市。
Danielle Antalffy - Analyst
Danielle Antalffy - Analyst
All right. Thanks so much, guys.
好的。非常感謝各位。
Operator
Operator
Ben Andrew, William Blair.
Ben Andrew,William Blair。
Ben Andrew - Analyst
Ben Andrew - Analyst
So, a few questions for me. If you think about the fact that FDA moved so quickly with the new algorithm -- obviously, the benefits it provides are material -- does it give you any information content, relative to what that could mean for the G5 approval? Or does that transmitter -- because it's really just that transmitter now that's changing, I believe, and the connectivity dynamic that would represent the G5.
我有幾個問題。若考量 FDA 對新演算法的審查推進得非常快——顯然它帶來的效益很重大——這是否能提供你們一些資訊含量,讓你們推估這對 G5 核准可能意味著什麼?或者說,因為我理解現在真正改變的其實只是那個發射器(transmitter),以及它所代表的連線方式變化,也就是 G5 的連結性動態。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
I think they're different. The algorithm is certainly science that the FDA is familiar with, with respect to DexCom, as we've been through several sensor launches, and even an algorithm change in the past with respect to the SEVEN system without changing hardware, and the data was very clear-cut. We're hopeful that we get a quick approval on the G5 system. But it is more than just a transmitter. It is displayed directly on the cell phone. It is human [factors] work on display on a cell phone. It's all the things we have to mitigate for loss of connectivity and things of that nature, Ben.
我認為兩者不同。就演算法而言,這當然是 FDA 熟悉的科學,因為 DexCom 已經歷過多次感測器上市,過去在 SEVEN 系統上也曾在不更換硬體的情況下做過演算法變更,而且數據非常明確。我們希望 G5 系統也能快速獲准。但它不只是發射器而已。它是直接顯示在手機上;涉及在手機顯示上的人因(human factors)工作;還包括我們必須針對連線中斷等情況進行風險緩解,以及諸如此類的所有事項,Ben。
So while we've met with the FDA on several occasions, and have a very good idea of what that file is going to look like, and we believe they have a very good idea what the file is going to look like, I don't think the two are related. We're hopeful, but we'll just have to wait and see.
因此,雖然我們已多次與 FDA 會面,對申報檔案會長什麼樣子有非常清楚的概念,而且我們相信他們也很清楚檔案會長什麼樣子,但我不認為兩者之間有關聯。我們抱持希望,但只能再觀察看看。
Ben Andrew - Analyst
Ben Andrew - Analyst
Okay. And then, Kevin, you talked about the R&D spending -- I think, Terry as well -- the allowing you to do some more things. And you mentioned device integration with advanced pumps or delivery systems, as well as advanced decision-making tools. Over what timeframe should we see you guys moving forward with that commercially? Is this two, three, four years? It seems like it will be an evolution, obviously, including the current portfolio. But does this allow you to accelerate some of that, and bring those things forward? Because those obviously may represent additional revenue opportunities as well.
了解。接著,Kevin,你談到研發支出——我想 Terry 也提到——這讓你們能做更多事情。你提到與先進幫浦或給藥系統的裝置整合,以及更進階的決策工具。從商業化角度來看,我們應該在什麼時間範圍內看到你們往前推進?是兩年、三年、四年?看起來這會是一個演進過程,顯然也會包含現有產品組合。但這是否能讓你們加速其中一些項目、把它們更早推向市場?因為那些顯然也可能代表額外的營收機會。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
You know, Ben, right now a lot of that is infrastructure building, and getting ready to develop those types of tools. I think it's two to three to four years out, where we really have good -- a really good live decision support tool. We haven't even been through an FDA path on something like that yet. But we do know that we have great data, and we will accumulate more to whereby we can develop those things.
你知道的,Ben,目前很多工作是在建置基礎設施,並為開發這類工具做準備。我認為大約兩到三到四年後,我們才會真正擁有一個很好的——真正成熟的即時決策支援工具。我們甚至還沒有走過這類產品的 FDA 審查路徑。但我們確實知道我們擁有很棒的數據,而且我們會累積更多數據,進而能開發這些東西。
And we're just making more investments. Terry and I have been around the diabetes industry for a very long time. And we've seen what happens when companies take their foot off the pedal as far as innovation. And we're not going to do that.
而我們也正在加大投資。Terry 和我在糖尿病產業待了很長時間。我們看過當公司在創新方面鬆開油門時會發生什麼事。而我們不會那樣做。
I don't know, Terry, if you have anything you want to add to that.
我不確定,Terry,你是否想補充什麼?
Terry Gregg - CEO
Terry Gregg - CEO
Sure. One of the things we did -- you know, we're the founding member, with Joslin translational group, as we look at taking data and not only using predictive analysis, but in a real-time sense to allow therapy changes on the fly that patients can do, ultimately, with obviously the consult of their physician. And all of this becomes -- the more you look at prediction software -- becomes very exciting to us that this disease called diabetes is one that would be particularly benefited by these types of programs.
當然。其中一件我們做的事——你知道,我們與 Joslin 的轉譯研究團隊(translational group)共同作為創始成員——是著眼於如何運用資料,不僅做預測分析,也在即時情境下,讓病患能夠即時調整治療方案,最終當然是在其醫師諮詢與指導下進行。當你越深入看預測軟體,這一切就越讓我們感到振奮:糖尿病這種疾病,特別能從這類程式中受益。
So we are moving as fast as we can. But, once again, it's DexCom breaking brand-new ground. And then we've got to go about it slowly. We can only move as fast as the Agency will allow us to move with this. Because we are -- in the end, we are not physicians, and there is a great degree of concern that we don't cross over that line.
因此我們正以最快速度推進。但再一次,這是 DexCom 在開創全新的領域,然後我們必須謹慎、循序漸進地進行。我們只能在主管機關允許的速度下前進。因為最終,我們不是醫師,而且外界非常擔心我們不要跨越那條界線。
Ben Andrew - Analyst
Ben Andrew - Analyst
Okay. And last thing for me -- Kevin, you were kind enough to give us the 30% of revenues coming from hardware. Can you give us a sense how that breaks down at all, in terms of replacement hardware versus new patients? Thank you.
好的。那我最後一個問題——Kevin,你很貼心地提供了我們營收中有 30% 來自硬體。你能否讓我們了解一下這部分的拆分情況,例如更換硬體與新病患之間的占比?謝謝。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
We get asked this question every quarter, and we're not going to add any more color to what we've had. We're having great new patient results. You can't grow as fast as we are without having that. So we'll leave it the way it is.
我們每一季都會被問到這個問題,而我們不會在既有說法上再補充更多細節。我們在新病患方面的成果非常好。若沒有這點,你不可能像我們現在這樣快速成長。所以我們就維持原先的說法。
Operator
Operator
Tom Gunderson, Piper Jaffray.
Tom Gunderson,Piper Jaffray。
Tom Gunderson - Analyst
Tom Gunderson - Analyst
So, my first question is around the pediatric indication. We all know a lot of parents that have been waiting for SHARE. But it begs the question of, oh, yes, that other approval that you had recently on pediatric expansion. Can you give us a little color on that; how you're doing, from a penetration of clinic standpoint? And also, is the split pretty much the same right now with pediatric and -- I'm sorry, with durable and consumable with pediatric? Or is it a little bit more on the starter kits? Any color there would be helpful.
所以,我的第一個問題是關於兒科適應症。我們都知道有很多家長一直在等 SHARE。但這也引出一個問題:喔,對了,你們最近在兒科擴適方面也拿到另一項核准。你能否就此提供一些補充說明;從診所滲透率的角度來看,你們目前進展如何?另外,就目前兒科而言,耐用品與耗材的拆分是否大致相同?還是說入門套組的比重稍微更高?若能提供一些顏色會很有幫助。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
You know, Tom, the pediatric launch has been very successful. We're a couple quarters into it. And as we said last quarter, a pediatric patient has the same usage and spending patterns as a regular patient, so we're not going to break that out, and continue to report on that every single quarter. But I can say it has certainly been a driver in our growth and been very successful so far. And you're right, a lot of parents are very happy with the SHARE launch.
你知道的,Tom,兒科上市推廣非常成功。我們已經推了幾個季度。正如我們上季所說,兒科病患的使用與支出模式與一般病患相同,所以我們不會把它拆出來,也不會每一季都持續單獨揭露。不過我可以說,這確實一直是我們成長的驅動因素,而且到目前為止非常成功。你說得對,很多家長對 SHARE 的推出非常滿意。
Tom Gunderson - Analyst
Tom Gunderson - Analyst
Okay. And then O-US coming in at roughly $10 million, it's starting to get significant here. Again, can you give a little more color there? Is it mostly Europe? Is it mostly out-of-pocket? Is it mostly starter kits, as people figure out that the accuracy is worth the investment? Thanks.
好的。接著,O-US 大約 1,000 萬美元,開始變得相當顯著了。能否再多給一些補充說明?主要是歐洲嗎?主要是自費嗎?主要是入門套組嗎——因為大家逐漸發現準確度值得投資?謝謝。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
It is really very much mostly Europe. We've done very well in Canada this year as we have launched there as well. We have some countries that have carried us -- Italy, Sweden, Germany, are three of the bigger ones; and the Netherlands. That there's four large ones in Europe where we've done very, very well. Reimbursement is improving. We see reimbursement in some countries in Europe.
確實非常、非常主要是歐洲。我們今年在加拿大也做得很好,因為我們也在那裡推出了。我們有一些國家帶動了我們——義大利、瑞典、德國是三個較大的;以及荷蘭。這四個歐洲大市場我們都做得非常、非常好。給付正在改善。我們在歐洲一些國家看到有給付。
We are also investing -- I talked about the study investment in my prepared remarks. We're investing in some very large studies over there to drive governmental reimbursement of CGM for patients. And so we're making investments over there to get full-on reimbursement for CGM. So a lot of it is out-of-pocket, and a lot of it is durable. It's a mix. It's not the same mix as the US, and it's not as predictable. We don't have as much color on those patients as we have over here, but the business is doing very, very well.
我們也在投資——我在事先準備的發言中談到研究投資。我們在那邊投資一些非常大型的研究,以推動政府對病患 CGM 的給付。因此我們正在那邊投入資源,以取得 CGM 的全面給付。所以其中很大一部分是自費,也有很大一部分是耐用品。這是一個混合。它和美國的組合不一樣,也沒那麼可預測。我們對那邊病患的掌握不如在這裡那麼多,但業務表現非常、非常好。
Tom Gunderson - Analyst
Tom Gunderson - Analyst
And just a quick follow-up, Kevin. Does Vibe contribute meaningfully to that $10 million, or is it still early?
再快速追問一下,Kevin。Vibe 對這 1,000 萬美元有顯著貢獻嗎,還是仍然算早期?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
No, it does. The Vibe is doing very well in Europe. Animas has done very well with that product over there.
有的。Vibe 在歐洲表現非常好。Animas 在那邊把這個產品做得很成功。
Tom Gunderson - Analyst
Tom Gunderson - Analyst
Got it. That's it for me. Thank you.
了解。我的問題就到這裡。謝謝。
Operator
Operator
Mike Weinstein, JPMorgan.
Mike Weinstein,JPMorgan。
Robbie Marcus - Analyst
Robbie Marcus - Analyst
This is actually Robbie Marcus in for Mike. Congrats on the great quarter. I was hoping maybe you could give us some more insight into trends, into where the patients are coming from. Is the pharmacy benefit helping out here? Are you taking share from Medtronic? Are these all new to CGM, adult versus pediatric? Any kind of insight into the trends would be really helpful.
我其實是代替 Mike 的 Robbie Marcus。恭喜這個很棒的季度。我想請你們多分享一些趨勢方面的洞見,病患來源主要來自哪裡?藥局給付(pharmacy benefit)在這裡是否有幫助?你們是否從 Medtronic 那邊拿到市占?這些病患是否都是 CGM 新用戶,成人對比兒科如何?任何關於趨勢的洞見都會很有幫助。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
All of the above, I mean, literally; pharmacy benefit has helped in some cases. We're certainly not losing market share based on all the independent data that we look at. We have very significant new patient growth. Combine that with the fact that we're not losing patients like we used to in the SEVEN PLUS days. Our retention rates are very good. Our utilization rates appear to be very strong, as people trust and rely on this sensor array. I can tell you I've had many, many patients say the worst two hours of my week, or two weeks if they were the (technical difficulty) is that warm-up time while they wait for the next sensor to start.
以上皆是,我是說真的;藥局給付在某些情況下確實有幫助。根據我們所看的所有獨立數據,我們當然沒有流失市占。我們的新病患成長非常顯著。再加上我們不像 SEVEN PLUS 時期那樣流失病患。我們的留存率非常好。我們的使用率看起來也非常強勁,因為大家信任並依賴這個感測器陣列。我可以告訴你,我聽過非常、非常多病患說:我一週最糟的兩個小時——或如果他們是(技術問題)則是兩週——就是在等待下一個感測器啟動的暖機時間。
So, every variable in there is working. And, again, I'll go back to our earlier statement -- to achieve growth like we have, they all have to hit. So every one of them is doing well.
所以,裡面的每一個變數都在發揮作用。而且我再回到我們先前的說法——要達到我們這樣的成長,這些因素都必須到位。所以每一項都表現得很好。
Robbie Marcus - Analyst
Robbie Marcus - Analyst
Okay, great. And then at the end of September, Medtronic revealed the Guardian mobile, their own stand-alone CGM. How are you looking at this as a competitor to G5? And any comments around your take on that product would be really helpful. Thank you.
好的,很棒。接著在九月底,Medtronic 發表了 Guardian mobile,他們自家的獨立式 CGM。你們如何看待它作為 G5 的競品?也請分享你們對該產品的看法,會很有幫助。謝謝。
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
Yes, Medtronic revealed a potential stand-alone system at a trade show earlier this year. We haven't seen or heard, frankly, anything else about it since that time. So, much like the Abbott Libre, we're going to take a wait-and-see approach. Not clear to us what sensor component would be included, whether it's the current Enlite sensor -- which we've all seen the performance of that sensor -- or some future sensor. So, again, it's somewhat unclear.
是的,Medtronic 今年稍早在一個展會上揭露了一個潛在的獨立式系統。坦白說,自那之後我們就沒有再看到或聽到任何更多消息。所以,和 Abbott Libre 一樣,我們會採取觀望態度。我們不清楚它會搭配哪一種感測器元件,是否是目前的 Enlite 感測器——我們都看過那個感測器的表現——或是某個未來的感測器。所以,仍然有些不明朗。
I think one of the comments that was made by Medtronic was that the first-generation Guardian remote, whatever they're calling it, would not have a remote monitoring feature. It would simply be displayed to the patient. So in that respect, it's somewhat different than what we're going to come to market with Gen 5. But outside of that, I don't think we know a whole lot about it.
我記得 Medtronic 有提到,第一代 Guardian 遠端(不管他們怎麼稱呼)不會有遠端監測功能,只會顯示給病患本人看。就這點而言,它和我們將以第 5 代(Gen 5)推出上市的產品有些不同。但除此之外,我不覺得我們對它了解很多。
Operator
Operator
William Plovanic, Canaccord Genuity.
William Plovanic,Canaccord Genuity。
William Plovanic - Analyst
William Plovanic - Analyst
So, a couple questions. Gen 5 -- what does that include today, and when do you expect to file that?
我有幾個問題。第 5 代(Gen 5)——目前包含哪些內容?你們預期何時會遞交申請?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
We expect to file that in the first quarter of 2015. The primary focus of Gen 5 is the transmitter will be able to speak directly with two separate devices via Bluetooth connectivity. So, it could speak to your phone and your receiver at the same time. It could speak to just your phone or just the receiver. And then that data will be shared through the applications on the phone to the cloud. And people have access to the SHARE system, which will be the exact same system that we've launched, pretty much with the SHARE that was launched this year.
我們預期在 2015 年第一季遞交申請。第 5 代的主要重點是:發射器將能透過藍牙連線同時與兩個不同裝置直接通訊。所以,它可以同時與你的手機和接收器通訊;也可以只與手機或只與接收器通訊。接著,這些資料會透過手機上的應用程式分享至雲端。人們可以使用 SHARE 系統,而這將會是我們已經推出的完全相同的系統,基本上就是今年推出的 SHARE。
So the focus of Gen 5, it would be a Gen 4 sensor, with respect to its performance characteristics. It will have the G4AP algorithm. It will have that level of accuracy. So we're not changing the system, or the system performance, for the Gen 5 platform. We are going to come with a user interface that's very much designed to be a mobile platform, for those who look at the data on the phone, that we think is just fabulous. So, that's with the Gen 5 system is going to be.
所以第 5 代的重點是:就效能特性而言,它會是第 4 代(Gen 4)感測器。它會有 G4AP 演算法,並具備那個等級的準確度。因此我們不會改變系統,或第 5 代平台的系統效能。我們會推出一個使用者介面,這個介面非常以行動平台為設計核心,適合那些在手機上查看資料的人,我們認為它非常棒。所以,第 5 代系統大致就是這樣。
William Plovanic - Analyst
William Plovanic - Analyst
Okay. And on that, is it going to address the calibration requirements, or the fingerstick replacement -- or that's a G6?
好的。那在這方面,它會處理校正需求,或取代指尖採血——還是那要到 G6?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
We will not change the calibration scheme for the Gen 5 system.
我們不會改變第 5 代系統的校正方案。
William Plovanic - Analyst
William Plovanic - Analyst
Okay. So it sounds like you're getting ready to lock that down and submit that.
好的。聽起來你們正準備把它定案並送件。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
We are working very hard to lock that down, yes.
是的,我們正在非常努力地把它定案。
William Plovanic - Analyst
William Plovanic - Analyst
Great, thank you. And then on the pediatric mix, as you think about the new patients coming in the door in the quarter, how much our peds and how much are adults, if you're looking at what was coming in, in the overall business?
很好,謝謝。接著關於兒科組合,當你們看本季進來的新病患時,如果看整體業務,新進病患中兒科占多少、成人占多少?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
You know what, peds are -- Bill, I'll go with what I said earlier. We've been out for a couple quarters with peds. Everybody is a patient, and they all have the same economic patterns, and we're just not going to report that every quarter. So it's going very well with peds. We're very happy. It's met all our expectations.
你知道的,兒科——Bill,我就沿用我先前說的。我們兒科已經推出幾個季度了。每個人都是病患,而且他們的經濟模式都一樣,我們就是不會每一季都報告那個拆分。所以兒科進展非常好。我們非常滿意。它符合我們所有的預期。
William Plovanic - Analyst
William Plovanic - Analyst
Great. And then my last question just is how long -- with the new G4AP algorithm - how long do you think that will take to get into your current installed base, number one? And then number two, I take it that will just be the algorithm going forward.
很好。那我最後一個問題是,採用新的 G4AP 演算法後——你認為要花多久時間才能導入你們目前的既有裝機基礎,第一點?第二點,我的理解是之後就會以這個演算法作為未來的標準。
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
Bill, this is Steve. For this purpose, for the purpose of your question, I went and asked the ops guys how we were doing. It was actually posted on our website earlier today. We have had several hundred users already download and install the upgraded software. So, it's going to go fast. We expect to start shipping the new algorithm with new purchases with new receivers next week, so we're going.
Bill,我是 Steve。就你這個問題的目的,我去問了營運團隊我們進展如何。其實今天稍早已經發布在我們網站上。我們已經有數百位使用者下載並安裝了升級後的軟體。所以推進會很快。我們預期下週開始,所有新購買、搭配新接收器出貨的產品都會搭載新的演算法,所以我們正在推進中。
William Plovanic - Analyst
William Plovanic - Analyst
And then are there any costs or anything that will be associated with that for you, that would be incremental material to call out, or not really?
那這件事對你們而言,會不會有任何相關成本,或需要特別點出的增量重大成本?還是其實不太會?
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
No.
不會。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Not material.
不重大。
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
Nothing material, no.
沒有任何重大的,沒有。
William Plovanic - Analyst
William Plovanic - Analyst
Okay, great. Congratulations on the phenomenal quarter.
好的,很棒。恭喜你們這個非凡的季度表現。
Operator
Operator
Raj Denhoy, Jefferies.
Raj Denhoy,Jefferies。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
Wondered if I could ask just one about the spending levels. And I appreciate that the necessity that you continue to spend on R&D and sales and marketing, to keep the growth as it is. But should we assume that the new $18.5 million R&D level, likewise with SG&A, is the new baseline we should assume going forward from here?
我想問一個關於支出水準的問題。我理解你們必須持續投入研發以及銷售與行銷,才能維持目前的成長。但我們是否應該假設新的 1,850 萬美元研發支出水準,以及同樣的 SG&A 水準,將會是未來的新的基準線?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Raj, that's a very good question. With respect to R&D, as we prepared, we sat and discussed that. And I started to hear about 3.5 years ago, R&D is a lot different than it was then. For example, now, whenever we do something new, we've got to run trials for adults and for peds. The cost of getting anything to market has now doubled, on the trials and execution side, once we get something developed. And we're spending money on the cloud infrastructure and a lot of things that we weren't working on before. Fortunately, we've had the acceleration of growth necessary on the top line to hit our performance objectives.
Raj,這是個非常好的問題。就研發而言,我們在準備時確實坐下來討論過。我大概在 3.5 年前就開始聽到,研發已經和當時很不一樣了。舉例來說,現在我們每做一個新東西,都必須同時進行成人與兒科的試驗。一旦我們把產品開發完成,從試驗與執行面把任何東西推向市場的成本,現在已經加倍了。而且我們也在雲端基礎設施等許多以前沒有做的事情上花錢。幸運的是,我們營收端的成長加速,足以達成我們的績效目標。
It is important, as we look going forward, that as we look going forward into next year that we look at baselines in Q3 and Q4 of this year. As everybody may remember, in Q1 of last year, everybody took our expenses way down for Q4 to lower numbers, and we ended up with much higher expenses than everybody thought. We typically don't give a lot of expense guidance. But I think you can look at this number and go from there. There's a lot of stuff going on here, and it's good.
展望未來很重要的是,當我們看向明年時,應該以今年第三季與第四季的基準來看。大家可能還記得,去年第一季時,大家把我們第四季的費用預估大幅下修到較低水準,但最後我們的費用遠高於大家的預期。我們通常不會提供太多費用指引。但我想你可以以這個數字作為參考往下推估。這裡有很多事情在進行,而且都是好事。
I don't know -- Steve, Jess -- you guys have anything else?
我不知道——Steve、Jess——你們還有要補充的嗎?
Terry Gregg - CEO
Terry Gregg - CEO
I'm going to weigh in a little bit. This is Terry. So, I spend a lot of my time thinking strategically for the Company, at this point. And what I'm always cognizant of is, as you look around the universe, the cost of care is something that is obviously on everybody's mind. We heard it as a keynote speech at the AdvaMed. Mike Mussallem talked about it during the Edwards. And so we need to spend some of those R&D dollars to ensure that we know, as a category, CGM saves the system money.
我補充一下。我是 Terry。此刻我花很多時間在公司的策略思考上。我一直很在意的是,放眼整個產業,照護成本顯然是所有人都在關注的事情。我們在 AdvaMed 的主題演講也聽到這點。Mike Mussallem 在 Edwards 的場合也談到。所以我們需要投入部分研發資金,確保我們能夠證明,作為一個品類,CGM 能為整個體系省錢。
And I have preached to whoever would listen that the first stage, as we look at ACA -- whether or not it gets changed because of administration change -- who knows? But I will tell you this, that in the future the healthcare providers will get some of their compensation based on outcomes.
而且我一直向願意聽的人宣導,當我們看 ACA 的第一階段——不管它是否會因政府更迭而改變——誰知道?但我可以告訴你的是,未來醫療服務提供者的部分報酬將會以結果(outcomes)為基礎。
And it won't be too long after that -- I can't tell you when my crystal ball says -- three years, four years -- that industry is going to be part of that game. That if you can't demonstrate you are taking dollars out of the cost of care with your products, your products are not going to be reimbursed.
而在那之後不會太久——我無法告訴你我的水晶球顯示的時間點——三年、四年——產業也會成為這個遊戲的一部分。也就是說,如果你無法證明你的產品能降低照護成本,你的產品就不會獲得給付。
And so, what we have to do is -- we know, and it's a lot of lip service, at this point -- everywhere we turn, I just gave you a $17,000 number for hospital admission. We're spending over $250 billion a year in the United States treating diabetes. And, unfortunately, it continues to grow at unparalleled rates that we have seen. So we've got to be cognizant of that. And some of that R&D spend is creating and demonstrating to the payer system that we are, in fact, saving them a lot of money, and we'll save them even more money in the future.
所以我們必須做的是——我們知道,而且目前很多都還只是口頭說說——不管走到哪裡,我剛才給了你一個住院 17,000 美元的數字。在美國,我們每年花超過 2,500 億美元治療糖尿病。而且不幸的是,它仍以我們所見前所未有的速度持續成長。所以我們必須意識到這點。而部分研發支出就是在建立並向支付方體系證明,我們確實在幫他們省下很多錢,而且未來還會省更多。
And as Kevin mentioned, everything we do from the standpoint of building is -- they hear it preached to them every day: Make it better. Make it less expensive. So at that level, as well. So these are investments for the future, with the return being things that are not as price-sensitive. We know we have to hit certain gross margins. And no matter what we do, regardless of what the price is, we've got to hit those gross margins. And so from that perspective, we need to make those investments today.
正如 Kevin 提到的,我們從製造建置的角度所做的一切——他們每天都被灌輸:做得更好、做得更便宜。所以在那個層面也是如此。這些都是對未來的投資,其回報是那些對價格不那麼敏感的事物。我們知道必須達到一定的毛利率。不管我們做什麼、無論價格是多少,我們都必須達到那些毛利率。因此從這個角度來看,我們今天就需要做這些投資。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
No, that's helpful. If I maybe just ask a couple follow-ups. You noted -- I think you mentioned that one of the things you were spending on is a new, smaller transmitter. Did I hear that correctly?
不,這很有幫助。我如果再追問幾個問題。你提到——我想你說你們其中一項支出是用在新的、更小的發射器上。我聽得沒錯吧?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Actually, we launched a new, smaller transmitter this quarter.
其實我們這一季已經推出了新的、更小的發射器。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
Okay.
好的。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
It's already out.
已經上市了。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
I guess I just wasn't appreciative of that. But maybe you can describe a bit about how much smaller that is, and what sort of receptivity you're seeing with that.
我想我之前沒有注意到。那你們能否稍微描述一下它小了多少,以及市場對它的接受度如何?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Well, the receptivity has been outstanding, because everybody likes things that are less obtrusive on their bodies when they have to wear our devices. So, people have liked it very much. Driving that, we had to make a transmitter that had all the features of the previous Gen 4 one, particularly the ability to transmit over an extended range; and also the ability to talk to our integrated pump partners. The transmitter does both of those things. And it does cost less to make, so it meets all of our objectives. As Terry stated, what we do -- make it better and make it cheaper. They achieved them both. The guys did a great job.
接受度非常好,因為當人們必須把我們的裝置戴在身上時,大家都喜歡更不顯眼的東西。所以大家非常喜歡。為了做到這點,我們必須做出一個具備先前第 4 代發射器所有功能的發射器,特別是能在更長距離範圍內傳輸;以及能與我們整合式幫浦合作夥伴通訊的能力。這個發射器兩者都做到了。而且製造成本也更低,所以符合我們所有目標。正如 Terry 所說,我們做的事——做得更好、做得更便宜。他們兩者都達成了。團隊做得很棒。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
Okay. And just one last one, sorry. I looked back, I think it's been almost exactly 2 years to when you got the Gen 4 approved. And as you noted, I think, in your remarks, you've grown consistently roughly 65% on average since then. And it invariably begs the question of how long you can sustain this. And it sounds like the Gen 5 is getting filed soon, and that should keep things going. But 65% is a pretty high bar to keep having to jump over, 60% even. Do you have any thoughts just around that?
好的。最後一個問題,不好意思。我回頭看了一下,距離你們拿到第 4 代核准,我想幾乎正好兩年。正如你在談話中提到的,自那之後你們平均大約每年持續成長約 65%。這不免讓人想問,你們能維持多久。聽起來第 5 代很快就會送件,應該能讓動能延續。但 65% 是個很高的門檻,即便 60% 也是。你對這點有什麼想法嗎?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
You know what, Raj? We've typically said that we believe our sustainable growth, and what we plan for is to grow at 40% every year. And that allows you to double every two years. And so we have been very fortunate to grow faster than that. But our plans have always been to grow at 40%, and have the infrastructure to support 60%. So we're doing both, and we'll keep pushing. But this pipeline that we're developing we firmly believe can drive the business the way it has.
你知道嗎,Raj?我們一向的說法是,我們相信可持續的成長、也是我們規劃的目標,是每年成長 40%。這樣你每兩年就能翻倍。所以我們很幸運能成長得更快。但我們的計畫一直都是以 40% 成長為目標,並建置能支撐 60% 成長的基礎設施。所以我們兩者都在做,也會持續推進。不過我們正在打造的這條產品管線,我們堅信能像過去一樣驅動業務成長。
But it takes every one of these innovations to keep it going. It took a peds approval. It's going to take a new algorithm. It's going to take going to the phone. It's going to take a SHARE system. It's going to take every one of these things to continue to drive that growth. We can't drive the growth just by continuing to market G4 as it sits. We've got to be better, and we will.
但要讓它持續下去,需要每一項創新。需要兒科核准;需要新的演算法;需要走向手機端;需要 SHARE 系統;需要每一項這些東西來持續推動成長。我們不能只靠持續行銷現有的 G4 來推動成長。我們必須更好,而且我們會做到。
Raj Denhoy - Analyst
Raj Denhoy - Analyst
That's great. Thank you.
太好了,謝謝。
Operator
Operator
Tao Levy, Wedbush Securities.
Tao Levy,Wedbush Securities。
Tao Levy - Analyst
Tao Levy - Analyst
The professional CGM -- did that have any impact in the quarter? Or how is the roll-out of that product? Is it allowing you to convert more patients to CGM? Any color there would be helpful.
專業型 CGM——這在本季有帶來任何影響嗎?或者那個產品的推廣進度如何?它是否讓你們能把更多病患轉換成 CGM 使用者?如果能提供一些補充說明會很有幫助。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
The roll-out has gone fine. As we said when we announced that approval a while ago, we don't expect this to be a huge, direct topline driver of our financials, and it has not been. They do convert some patients. I don't have the statistic off the top of my head. We know the percentage of people who wear our sensor on this professional use system. The percent who convert to purchasing one is very large. It's very consistent and very favorable, so it certainly helps us. But it really hasn't been a measurable driver in direct sales. And indirect sales, I don't have a number to share with you.
推行進展得很順利。正如我們在一段時間前宣布該項核准時所說,我們不預期這會成為我們財務上巨大、直接的營收(topline)驅動因素,而事實也確實如此。它確實會讓部分病患轉換。我一時沒有那個統計數字。我們知道在這套專業使用系統上配戴我們感測器的人之比例。而其中轉換為購買者的比例非常高;非常一致且非常有利,所以確實對我們有幫助。但它在直接銷售上,確實還不是一個可衡量的驅動因素。至於間接銷售,我沒有數字可以跟你分享。
Tao Levy - Analyst
Tao Levy - Analyst
Okay. And with the APM algorithm, is that applicable, also, to the integrated systems that will be coming out, the Animas Vibe and the Tandem?
好的。那關於 APM 演算法,它也適用於即將推出的整合式系統嗎,例如 Animas Vibe 和 Tandem?
Steve Pacelli - EVP of Strategy and Corporate Development
Steve Pacelli - EVP of Strategy and Corporate Development
This is Steve. Unfortunately, they will not have the ability. Neither the Animas Vibe or the Tandem t:slim pump have the ability to upgrade, as we do our G4 platform receivers, to upgrade to the new algorithm. So, those patients would have one or two options. They would have to wait until a next-generation, really a Gen 5 version of the pump. Or they would always had the opportunity to purchase -- and we've actually seen this happen in Europe -- where patients, even patients on the Animas Vibe, have elected to purchase a stand-alone DexCom receiver. Because they prefer to pull that out of their pocket, purse, backpack whatever, to check their glucose values, rather than pull their pump out.
我是 Steve。很遺憾,它們將不具備這個能力。Animas Vibe 和 Tandem t:slim 幫浦都無法像我們的 G4 平台接收器那樣,升級到新的演算法。因此,這些病患會有一到兩個選項:他們必須等到下一代——實際上是幫浦的第 5 代(Gen 5)版本;或者他們也一直都有機會另外購買——而且我們在歐洲確實看過這種情況——即使是使用 Animas Vibe 的病患,也選擇購買一台獨立的 DexCom 接收器。因為相較於把幫浦拿出來,他們更喜歡從口袋、手提包、背包等拿出接收器來查看葡萄糖數值。
So, the transmitter would be the same. So the patients who wish to use the new algorithm would be able to use it with the same transmitter, if they bought a separate receiver.
所以,發射器會是相同的。因此,想使用新演算法的病患,如果他們另外買一台獨立接收器,就能用同一個發射器來使用。
Tao Levy - Analyst
Tao Levy - Analyst
Okay, great. And then just lastly, Terry, you mentioned at the end here the collaboration with Apple. And I know with SHARE it's right now -- it only works on the Apple platform. Is that what you were referring to? Or is it potentially going to go beyond that, and you start thinking (multiple speakers).
好的,很棒。最後一點,Terry,你在結尾提到與 Apple 的合作。我知道 SHARE 目前——它只在 Apple 平台上運作。你指的是這個嗎?還是可能會超越這個,開始思考(多位講者)。
Terry Gregg - CEO
Terry Gregg - CEO
We'll go beyond that. As you know, you can buy the app on the iTunes store today for SHARE. So, that's the first stage. And as we have indicated, there is a trial being proposed now. It has been approved by Apple that we will utilize CGM (technical difficulty) on the G4 through -- first one being up at Stanford University at the hospital system; that will integrate into the Epic system using iOS 8 in their Healthkit. So, we view this as a long-term, opportunistic relationship.
我們會超越這個。你也知道,你今天就可以在 iTunes 商店購買 SHARE 的 app。那是第一階段。而且如我們所指出的,目前正提出一項試驗;Apple 已核准我們將在 G4 上透過 iOS 8 的 Healthkit 使用 CGM(技術問題)——第一個將在史丹佛大學的醫院系統啟動;並會整合進 Epic 系統。因此,我們將此視為一段長期、具機會性的合作關係。
Again, it got back to my part of my comment, too, is so we look at this wearable technology. That's really going to drive companies like Apple, Google, Samsung, whoever, into this digital health world that everybody looks at and says, wow, that's really something. That's a place we want to play to expand our own platforms from where they're at now. Because they see the aging of the population, and the opportunities to engage that population, and trying to empower them to take better care of themselves; and, again, reduce this healthcare burden that we spend a lot of time looking at.
再回到我剛才評論的一部分:我們看待這種穿戴式科技,這真的會驅動像 Apple、Google、Samsung 等公司,或任何人,進入這個大家都在看、並說「哇,這真的很了不起」的數位健康世界。這是他們想參與的領域,用以從目前的基礎上擴展自家平台。因為他們看到人口老化,以及與該族群互動的機會,並試圖賦能他們更好地照顧自己;同時再次降低我們花很多時間關注的醫療負擔。
And so, obviously, anything along those lines benefits what we intend to do. We have always considered CGM to be a consumer product. It has a requirement of a medical device, but the utility of it and its powers as a consumer tool -- because this is actionable for a patient that has to have many transactions in their daily life in order to better control their diabetes.
因此,顯然,任何這類發展都會有利於我們想做的事。我們一直把 CGM 視為消費性產品。它需要符合醫療器材的要求,但它的效用與作為消費者工具的力量——因為對病患而言這是可採取行動的工具;病患每天必須進行許多次操作與決策,才能更好地控制糖尿病。
So you'll continue to see these grow, as first you see the watch system develop. And that's only the beginning, because that's easy to do. We've demonstrated deploying our system with Pebble watch, as an example. And a lot of that stuff, from a technology standpoint, is off-the-shelf with the utilization of Bluetooth low energy. Now, getting this through the regulatory challenges is much different. Obviously, it's in the news with regards to tighter security; and other challenges, risk and risk mitigation, that Kevin mentioned during his presentation.
所以你會持續看到這些成長,首先你會看到手錶系統的發展。而那只是開始,因為那相對容易做到。我們已示範過把我們的系統部署到 Pebble 手錶上作為例子。從技術角度來看,很多東西都是現成可用的,透過使用低功耗藍牙(Bluetooth low energy)。但要通過法規監管的挑戰就完全不同了。顯然,新聞也在談更嚴格的安全性;以及其他挑戰、風險與風險緩解,Kevin 在他的簡報中也提到。
But you'll continue to see these grow. That's really what I was focused on in my comments.
但你會持續看到這些成長。這就是我在評論中真正聚焦的重點。
Tao Levy - Analyst
Tao Levy - Analyst
Okay, great. Thank you.
好的,很棒。謝謝。
Operator
Operator
Erica Layon, Benchmark.
Erica Layon,Benchmark。
Erica Layon - Analyst
Erica Layon - Analyst
I'm on for Jan Wald, because he had to hop. Looks like a great quarter, so congratulations there. As you are looking forward to the future, smaller and integrated systems, are you looking to move both sensor performance and quality of life together at the same pace? Or does one take precedence over the other, if you do have to make a compromise?
我代替 Jan Wald 上線,因為他得先離開。看起來這是一個很棒的季度,所以恭喜。當你們展望未來、更小型且整合式的系統時,你們是否希望感測器效能與生活品質能以相同速度一起提升?或者如果必須取捨,會有一方優先於另一方?
Terry Gregg - CEO
Terry Gregg - CEO
Well, I don't think you have to make a compromise. I think they are simultaneous. Right now, we focus -- look, sensor accuracy of 9% MARD, that is point-of-care kind of accuracy, particularly when you add in the variability associated with the human influence on accuracy. If you take a patient on SMBG, I assure you that it is not 5.6%. It is something far greater than that. And we've seen variability in fingerstick measurements upwards -- two measurements done on the same finger, within seconds of each other, to be wildly different.
嗯,我不認為你必須取捨。我認為它們是同步的。現在我們聚焦——你看,感測器準確度達到 9% MARD,這已是接近即時檢測(point-of-care)等級的準確度,尤其當你把人為因素對準確度的影響變異也納入時更是如此。如果你拿病患的 SMBG 來看,我向你保證它不是 5.6%;而是遠高於那個數字。我們也看過指尖採血的量測變異很大——同一根手指、相隔幾秒做兩次量測,結果可能差異非常大。
And so we actually, from an accuracy standpoint, are far better than fingerstick measurements. And we're certainly more consistent. So that is something that we will continue to drive to. We certainly believe that a 9% MARD, we are at that threshold in which we can dose insulin. We have to demonstrate that successfully to the Agency. But, clearly, we believe that accuracy is there.
因此,從準確度角度來看,我們其實比指尖採血量測好得多,而且一致性也更高。所以這是我們會持續推進的方向。我們確實相信在 9% MARD 這個水準,我們已達到可以進行胰島素劑量決策的門檻。我們必須向主管機關成功證明這一點。但很明顯,我們相信準確度已經到位。
Now you move to quality of life, and it goes hand-in-hand. And the patients have more confidence, more trust in the tools that they're using to better manage their diabetes, their quality of life has improved. They are less worried, day in and day out, of everything they do. A parent has less worry of sending a child over to an overnight because of the SHARE system. All of these things contribute to an improvement in the quality of life.
接著談到生活品質,它是相輔相成的。病患對他們用來更好管理糖尿病的工具更有信心、更信任,他們的生活品質就會提升。他們日復一日對自己所做的一切更不焦慮。因為有 SHARE 系統,家長在讓孩子去外宿過夜時也更不擔心。所有這些都促成生活品質的改善。
Erica Layon - Analyst
Erica Layon - Analyst
Okay. So it's just a matter of maybe one will step forward ahead of the other, but they're both moving forward together, just to (multiple speakers).
好的。所以這只是可能某一項會比另一項稍微走在前面,但兩者都會一起往前推進,只是(多位講者)。
Terry Gregg - CEO
Terry Gregg - CEO
They're both moving forward together. That's an accurate statement.
兩者都會一起往前推進。這個說法是正確的。
Erica Layon - Analyst
Erica Layon - Analyst
And what trials are you most excited about that are happening with your sensor? And when would you expect data on those trials?
那麼,關於你們感測器正在進行的試驗,你最期待哪些?你預期何時會有那些試驗的數據?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
You know, we're excited about a bunch of trials. The biggest trial that we started -- and it started this quarter -- is what we call our Diamond study internally, which is a study where we can truly bracket the benefit of CGM from a therapy perspective, from a cost perspective, where we can really do a study that shows how we drive CGM outcomes, in patients new to CGM; in particular, with MDI patients, and what happens and what changes in their lives.
你知道,我們對很多試驗都很興奮。我們啟動的最大型試驗——而且是在本季度開始——是我們內部稱為 Diamond 研究的試驗。這是一項研究,讓我們能從治療角度、成本角度真正界定 CGM 的效益;我們可以做一項研究,展示我們如何在初次使用 CGM 的病患身上推動 CGM 的結果(outcomes);特別是對 MDI 病患,以及他們的生活會發生什麼、會有哪些改變。
This is going to be a long-term study for us. The data probably won't be available for 18 to 24 months. But we're going to use 20 centers, and fund this study to really learn about those things that are important in our business, through a study of that nature. That's a study I'm very excited about. It's just going to not happen as fast as I'd like it.
這對我們而言會是一項長期研究。數據可能要 18 到 24 個月後才會出來。但我們會使用 20 個中心,並資助這項研究,透過這類型的研究來真正了解那些對我們業務重要的事情。這是我非常期待的一項研究,只是它不會像我希望的那麼快發生。
I don't know, Terry, if you have any other --.
我不知道,Terry,你是否還有其他——。
Terry Gregg - CEO
Terry Gregg - CEO
No, and you'll see interim results at some point during the course of the study. But it is really, in our opinion, a key study for the future. And certainly for the first time as a company, it's a study that is being conducted without the primary intent to get a product approved, from that perspective.
沒有,而且你會在研究進行期間的某個時間點看到期中結果。但就我們的看法,這確實是一項對未來至關重要的研究。而且可以說,這也是公司第一次進行一項研究,其主要目的並不是為了取得某個產品的核准,從那個角度來看是如此。
If you look at all the studies we're involved in, it's hard. We are in 20 different artificial pancreas programs -- not our studies. We participate; we provide some support. Those are exciting to see those progress along that intent to, again, reduce the challenges of managing glucose levels.
如果你看我們參與的所有研究,這很不容易。我們參與 20 個不同的人工胰臟計畫——不是我們自己的研究。我們參與其中並提供一些支援。看到它們朝著那個目標推進令人振奮,也就是再次降低管理葡萄糖水準的挑戰。
But I would agree with Kevin. And the Diamond study is, even though it's not a near-term study, is probably one that we're very focused on. And just given the magnitude of the study, with 20 centers at key sites throughout the US.
但我會同意 Kevin 的看法。而 Diamond 研究,即使它不是一項短期研究,可能也是我們非常關注的一項。並且考量到該研究的規模,在全美各地關鍵地點設有 20 個中心。
Erica Layon - Analyst
Erica Layon - Analyst
That sounds like a very powerful study, and sometimes you have to wait for the right science to happen. So, thanks for working on that one. That probably will help the growth even in those out years continue, hopefully outpacing your 40% goals. And you definitely gave us some good color towards, not quite guidance, but helping us look at the big picture here. There's one more that I was hoping that I could ask you.
聽起來這是一項非常有力的研究,而有時你必須等待正確的科學進展發生。所以,謝謝你們在這項研究上的努力。這大概會在未來幾年也持續幫助成長,希望能超越你們 40% 的目標。而你們也確實提供了一些很好的補充說明,雖然還不算是指引,但有助於我們從大局來看。我還有最後一個問題想請教你。
Right now, it's great that we're seeing that you're positive on a cash earning basis, even though we're not seeing reported positive earnings. Is that something you're putting much weight on? Or you're right now just trying to keep your foot on the gas, being responsible with your cash, but paying less attention to the reported earnings number because you think that there's more investment that needs to be made before that can be a main focus?
目前看到你們在現金獲利基礎上是正向的,儘管在報表上尚未呈現正的盈餘,這點很棒。你們是否很重視這個指標?還是說你們現在只是想持續加速前進、在現金運用上保持負責任,但對於報表上的盈餘數字相對不那麼在意,因為你們認為在把它當作主要焦點之前,還需要投入更多投資?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Erica, for a long time, Terry and I have philosophically operated under the principle of let's grow the top line fast, and let's grow the bottom line faster. And we're certainly doing that, as Terry said in his remarks, that the cash operating income was 3X what it was what it was the same quarter a year ago, when we had 60% growth on the top line.
Erica,長期以來,Terry 和我在理念上一直遵循一個原則:讓營收端(top line)快速成長,並讓獲利端(bottom line)成長得更快。我們確實正在這麼做。正如 Terry 在他的發言中所說,現金營運收入是去年同期的 3 倍,而當時我們的營收端年增率是 60%。
As we look at our business going forward, we think about three things: how much can we add to the top on a revenue basis, and then we get to an acceptable gross profit number? And we ask ourself two questions. How much do we need to spend to continue to push the agenda to keep growing the top line? And how much do we need to keep to meet our commitments to our shareholders? And we evaluate all three of those things at the same time, not just as a management team, but at the Board level and throughout the entire organization.
展望未來,我們思考三件事:在營收基礎上我們能增加多少,並且能達到一個可接受的毛利水準?接著我們會問自己兩個問題:為了持續推動策略、讓營收端繼續成長,我們需要花多少?以及為了履行對股東的承諾,我們需要保留多少?我們會同時評估這三件事,不僅是在管理團隊層級,也在董事會層級,並貫穿整個組織。
So, we look at all of them. And we will continue to evaluate our business that way.
所以,我們會把這些都納入考量。我們也會持續以這種方式評估我們的業務。
Terry Gregg - CEO
Terry Gregg - CEO
I have to laugh, because here we are -- thank you, FASB -- but we carry this non-cash-based equity that prevents us from being GAAP positive. So we've got -- when cash was king, and it still is -- and we like to add to it, rather than take away from it -- but we did, in order to attract the right talent in this Company, we were low on the salary side and we made it up on the equity side. So we gave our employees equity; and, lo and behold, our employees don't really want to sell the shares that they hold, because they look at the upside of what this Company can achieve from shareholder value improvement.
我得笑一下,因為我們現在——謝謝你,FASB——帳上有這種非現金的股權費用,使我們無法在 GAAP 下轉正。所以我們有——當現金為王時(現在仍然是)——而且我們喜歡增加現金,而不是消耗它——但為了吸引公司所需的合適人才,我們在薪資端給得較低,並在股權端補足。因此我們給員工股權;結果呢,我們的員工其實不太想賣掉他們持有的股票,因為他們看到公司在提升股東價值方面能達成的上行空間。
So, the end result of that is this probably $15 million-plus a quarter of share-based equity that we -- non-cash -- that we have to carry forward. So you just do the math, and say, if we want to get to 20% operating number, we've got to do a lot.
因此最終的結果是,我們每季大概有超過 1,500 萬美元的股份基礎股權費用——非現金——必須持續認列。所以你只要算一算就知道,如果我們想達到 20% 的營運水準,我們還得做很多。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
Just to cover the non-cash (multiple speakers).
只是為了涵蓋這個非現金的部分(多位發言者)。
Terry Gregg - CEO
Terry Gregg - CEO
The shares that people aren't selling. And you can't go out and tell your employees, hey, why don't you all go sell shares, in order to get this down? It's just a [sense routine] dynamic. And so yes, we do; we make statements relative to what we think we can do in 2015. But it's really driven, I think, growing top line, again, and by growing the bottom line faster.
人們不賣的那些股票。而你也不可能出去跟員工說,嘿,你們大家去賣股票,好讓這個數字降下來。這就是一種[sense routine]的動態。所以是的,我們會就我們認為 2015 年能做到什麼發表一些說法。但我認為真正的驅動因素,仍然是再次把營收端做大,並且讓獲利端成長得更快。
Erica Layon - Analyst
Erica Layon - Analyst
That's very helpful. And since you are so close to the number, I don't want us to focus too much on something that actually goes counter towards the goals for the Company. So, thank you so much on that. That was my last question. Thank you.
這非常有幫助。而且既然你們離那個數字很接近,我不希望我們過度聚焦在一件其實可能與公司目標背道而馳的事情上。所以非常感謝你的說明。那是我最後一個問題。謝謝。
Operator
Operator
(Operator Instructions). Jayson Bedford, Raymond James.
(接線員指示)。Raymond James 的 Jayson Bedford。
Jayson Bedford - Analyst
Jayson Bedford - Analyst
I wanted to ask about the marketing effort around the AP algorithm. Clearly, accuracy matters. It's proven to drive adoption. Your current user base will be ecstatic with the upgrade. But I'm just wondering if the software allows you to be more aggressive in going after new patients. And I guess the question really is, do you view it as a new driver of patient growth?
我想問一下圍繞 AP 演算法的行銷推廣。顯然,準確度很重要,也已被證明能推動採用率。你們現有的用戶群會對這次升級非常興奮。但我想知道,這套軟體是否讓你們在爭取新病患方面可以更積極一些。換句話說,你們是否把它視為帶動病患成長的新驅動因素?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
I think it will drive patient growth. When patients hear that we have an algorithm that was designed for the artificial pancreas, that's now been integrated into a commercial device that they can purchase, it will be very, very helpful. It definitely will be a driver. It was our goal to make our patients ecstatic, because that is how we build the business here.
我認為它會帶動病患成長。當病患聽到我們有一個為人工胰臟設計的演算法,現在已整合到他們可以購買的商用裝置中,這會非常、非常有幫助。它肯定會成為一個驅動因素。我們的目標就是讓病患非常興奮,因為這就是我們在這裡建立業務的方式。
Jayson Bedford - Analyst
Jayson Bedford - Analyst
Okay. When you think your sales team and infrastructure -- you've got a lot of new products here. Wondering your thoughts on increasing the team, as we look to 2015.
好的。當你們思考銷售團隊與基礎建設——你們這裡有很多新產品。我想了解你們對於在展望 2015 年時擴編團隊的想法。
Kevin Sayer - President and COO
Kevin Sayer - President and COO
We're in the middle of our planning process. Certainly, with 60%-plus year-over-year growth for the entire year, we have an opportunity to expand, to grow next year. And we'll give more guidance on that at the end of the year, after we get through our process.
我們正處於規劃流程的中段。當然,以全年 60% 以上的年增率來看,我們有機會在明年擴張、繼續成長。我們會在年底、完成流程之後,提供更多相關指引。
Jayson Bedford - Analyst
Jayson Bedford - Analyst
Okay. I guess last one. You mentioned the thinner transmitter has a lower cost of goods. But I'm wondering, were there startup costs that impacted gross margin this quarter associated with that?
好的。我想最後一個。你提到更薄的發射器有較低的銷貨成本。但我想知道,本季是否有與此相關的啟動成本影響了毛利率?
Kevin Sayer - President and COO
Kevin Sayer - President and COO
No, there were not.
沒有,沒有。
Jayson Bedford - Analyst
Jayson Bedford - Analyst
All right, thank you.
好,謝謝。
Operator
Operator
And at this time, I'm showing no further questions from the audience.
此時,我這邊顯示觀眾沒有進一步的提問。
I would now like to turn the call over to Mr. Terry Gregg for closing remarks.
我現在想把電話會議交給 Terry Gregg 先生作結語。
Terry Gregg - CEO
Terry Gregg - CEO
Thank you. Well, I hope everyone got a good picture of how excited we are about DexCom and the opportunities for our Company. I need you to understand, also, we are setting our sights that this will be a $1 billion revenue company -- not a $300 million, not a $500 million -- a $1 billion plus. And so our employees believe in our mission. We believe that they know the opportunity at DexCom is truly a unique one, and they want to participate in that. And they are clearly aligned with shareholder value.
謝謝。嗯,我希望大家都能清楚感受到我們對 DexCom 以及公司機會有多麼興奮。我也需要你們理解,我們的目標是把公司定位為一家年營收 10 億美元——不是 3 億美元,不是 5 億美元——而是 10 億美元以上的公司。因此,我們的員工相信我們的使命。我們相信他們知道 DexCom 的機會確實是獨一無二的,他們也希望參與其中。而且他們顯然與股東價值一致。
And so with that, I again will say thank you, and see you in 2015.
因此,就到這裡,我再次說聲謝謝,我們 2015 年見。
Operator
Operator
And thank you, ladies and gentlemen. This concludes today's conference. Thank you for your participation, and you may now disconnect.
也謝謝各位女士、先生。今天的會議到此結束。感謝各位的參與,您現在可以掛線。