德康醫療 (DXCM) 2014 Q4 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 fourth-quarter and full year 2014 earnings release conference call. My name is Leslie and I'll be your operator for today.

    歡迎參加 DexCom 2014 年第四季及全年財報發布電話會議。我是 Leslie,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 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 Kevin Sayer 先生。Sayer 先生,您可以開始了。

  • - CEO

    - CEO

  • Good afternoon, everyone. We'll start off with Steve Pacelli reading our Safe Harbor statement.

    各位下午好。我們先請 Steve Pacelli 宣讀我們的「安全港」聲明。

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Thanks, Kevin.

    謝謝你,Kevin。

  • Some 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. We undertake no obligation to update publicly or revise these forward-looking statements for any reason.

    我們在今天電話會議中所作的部分陳述,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,且僅截至本聲明日期有效。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之結果出現重大差異的因素清單,已在我們的 Form 10-K 年度報告、Form 10-Q 季度報告以及向美國證券交易委員會(SEC)提交的其他報告中的「風險因素」及其他章節詳述。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 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 or results superior to those results prepared in accordance with GAAP. Kevin?

    此外,我們將討論若干未依據 GAAP 編製、與我們現金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,亦不應作為依 GAAP 編製之結果的替代,或被視為優於依 GAAP 編製之結果。Kevin?

  • - CEO

    - CEO

  • 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. This being my first call as DexCom's CEO, I've decided to change the format slightly. Steve will start with a review of our detailed fourth-quarter 2014 financial results and some commentary on 2015. I will then provide our customary operations update and offer some concluding thoughts before opening the line for questions.

    謝謝你,Steve。今天與我一同出席的有我們的財務長 Jess Roper,以及策略與企業發展執行副總裁 Steve Pacelli。由於這是我以 DexCom 執行長身分主持的第一場電話會議,我決定稍微調整形式。Steve 將先回顧我們 2014 年第四季的詳細財務結果,並對 2015 年作一些評論。接著我會提供我們一貫的營運更新,並在開放提問前做一些結語。

  • But before I turn my call over to Steve, let's start big. At the JPMorgan healthcare conference in January, we announced Q4 and full year 2014 product revenue of approximately $84 million and $257 million respectively. What we did not disclose at JPMorgan, but I'm a pleased to announce today, is that for Q4 2014 we were profitable for the very first time on a GAAP basis. Yes, it's happened. We have earnings per share. I'm also very proud to announce that our G5 mobile PMA-supplement. All 15 volumes of it was filed earlier this week. What a great accomplishment for our team and obviously, we fulfilled several exciting milestones here at DexCom.

    但在我把電話交給 Steve 之前,先從大方向談起。今年 1 月在摩根大通醫療健康大會上,我們宣布 2014 年第四季及全年產品營收分別約為 8,400 萬美元與 2.57 億美元。我們在摩根大通大會上未揭露、但我很高興今天宣布的是:2014 年第四季我們首次在 GAAP 基礎上實現獲利。是的,真的發生了。我們有每股盈餘了。我也非常自豪地宣布,我們的 G5 行動(mobile)PMA 補充申請文件,本週稍早已完成提交,共 15 冊。這對我們團隊而言是非常了不起的成就,顯然我們在 DexCom 達成了數個令人振奮的里程碑。

  • I actually thought about with my new title, just ending the call right now and taking Q&A but I don't think we can do that. We have a lot more to talk about, so with that I'll turn it over to Steve.

    我其實想過,既然我有了新頭銜,乾脆現在就結束電話會議直接進入問答,但我想我們不能這麼做。我們還有很多要談,所以接下來我把時間交給 Steve。

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Thanks, Kevin. DexCom generated $84.3 million in product revenue for the fourth quarter of 2014, compared to $51.3 million for the same quarter in 2013, a $33 million or 64% increase. Sequentially, product revenue for Q4 of 2014 increased $16.4 million, up 24% from the prior quarter. Total revenue for the fourth quarter of 2014 was $84.3 million, compared to $51.7 million during the same quarter in 2013.

    謝謝你,Kevin。DexCom 2014 年第四季產品營收為 8,430 萬美元,相較 2013 年同季的 5,130 萬美元,增加 3,300 萬美元,增幅 64%。按季比較,2014 年第四季產品營收較前一季增加 1,640 萬美元,成長 24%。2014 年第四季總營收為 8,430 萬美元,相較 2013 年同季的 5,170 萬美元。

  • Our product gross profit totaled $59.4 million, generating a product gross margin of 70% for the fourth quarter of 2014. Compare that to a product gross profit of $34.1 million and a product gross margin of 66% for the same quarter in the prior year. Sequentially, product gross margin for Q4 increased 2 margin points from the prior quarter. Although we are now achieving our gross margin targets of 70% to 75% on our sensor disposables and approximately 50% to 60% on our hardware, going forward we'll continue to seek improved gross margins through increased volumes, continued manufacturing improvements, continued shift in the sales mix to more disposables revenue, and some cost savings in future product designs.

    我們的產品毛利合計為 5,940 萬美元,使 2014 年第四季產品毛利率達 70%。相較之下,前一年同季產品毛利為 3,410 萬美元,產品毛利率為 66%。按季比較,第四季產品毛利率較前一季提升 2 個百分點。雖然我們目前在感測器耗材已達成 70% 至 75% 的毛利率目標,硬體約為 50% 至 60%,但展望未來,我們將持續透過提高出貨量、持續製造改善、持續將銷售組合轉向更多耗材營收,以及在未來產品設計中導入部分成本節省,以追求更佳的毛利率。

  • However, in the first quarter of 2015, due to our typical seasonality together with the financial impact of the launch of our SHARE Receiver planned for March that we will discuss momentarily, we expect product gross margin to be down sequentially in Q1. We do expect margins to return to normal over the course of 2015. Some final thoughts on our product revenue and our gross profit. During Q4 we added more new patients and sold more sensors than in any our prior quarter. Just to add some perspective, our Q4 2014 product revenue of $84 million was just shy of our full-year 2012 product revenue of $93 million.

    然而,在 2015 年第一季,由於我們一貫的季節性因素,加上我們計畫於 3 月推出 SHARE 接收器(Receiver)所帶來的財務影響(我們稍後會討論),我們預期第一季產品毛利率將較前一季下滑。我們預期毛利率將在 2015 年期間逐步回復正常。關於產品營收與毛利的最後幾點想法:在第四季,我們新增的新病患數與售出的感測器數量均創下歷來單季新高。補充一點背景,我們 2014 年第四季 8,400 萬美元的產品營收,已接近我們 2012 年全年 9,300 萬美元的產品營收。

  • Our mix between durable and consumable products remained steady, approximately 30% durable and 70% consumable, a mix we expect to remain fairly constant going forward. ASP for sensors has stayed consistent at approximately $73 per sensor, and the ASP for our hardware continued at approximately $850 to $900 per starter kit. Finally, our international business exceeded our performance expectations in 2014 as it was up over 150% year-over-year and represented approximately 14% of product revenue in 2014.

    耐久財與耗材產品的組合維持穩定,約 30% 為耐久財、70% 為耗材;我們預期此組合未來將大致維持不變。感測器的平均售價(ASP)維持一致,約每個感測器 73 美元;我們硬體的 ASP 亦維持約每套入門組(starter kit)850 至 900 美元。最後,我們的國際業務在 2014 年超出我們的績效預期,年增超過 150%,並在 2014 年約占產品營收的 14%。

  • Research and development expense totaled $21.6 million for Q4 of 2014, compared to $12.6 million in Q4 of 2013, with the increase due primarily to additional payroll-related costs and expenses related to work on our near-term product pipeline and work on our advanced product pipeline. Sequentially, R&D expense was up $3.1 million with the increase primarily due to activities related to our G5 mobile filing, work on our next generation applicator system, software app development, and work on our advanced product pipeline. As we look to 2015 we expect that R&D expense for the full year will be up approximately 25% on a GAAP basis versus 2014, and less than 15% on a cash basis.

    2014 年第四季研發費用合計為 2,160 萬美元,相較 2013 年第四季的 1,260 萬美元;增加主要來自額外的人事相關成本,以及與我們近期產品管線與先進產品管線相關工作的費用。按季比較,研發費用增加 310 萬美元,主要因與 G5 行動版申報、下一代施用器(applicator)系統、軟體 App 開發,以及先進產品管線相關的活動所致。展望 2015 年,我們預期全年研發費用在 GAAP 基礎上將較 2014 年增加約 25%,在現金基礎上則增加不到 15%。

  • Some expenses, such as our overhead and share-based compensation expense will increase as a cost of doing business. Additional increases will depend upon our development progress and regulatory timelines with respect to continued system performance improvement, including completion of our Gen 5 system, work on our advanced sensor programs, work on our mobile and cloud-based data platforms, and a variety of clinical trial opportunities we expect to execute during 2015.

    部分費用(例如管理費用與以股份為基礎的薪酬費用)將隨著業務經營而增加。其他增加幅度將取決於我們在持續提升系統效能方面的研發進展與法規時程,包括完成第 5 代(Gen 5)系統、先進感測器計畫、行動與雲端資料平台,以及我們預期於 2015 年執行的各項臨床試驗機會。

  • Similar to prior years and consistent with our commitment to continued innovation, we will consider additional R&D spending opportunities if they will better position the business for the future. Selling, general and administrative expense totaled $36.2 million in Q4 of 2014, [compare that to] $23.8 million during the same quarter in 2013. The increase was primarily related to increased headcount in our sales organization, including both yield sales and internal sales support staff, increased sales commissions resulting from our robust product sales during the quarter, and increased marketing expenses.

    與往年類似,並符合我們對持續創新的承諾,若額外的研發支出機會能使公司在未來更具優勢,我們將予以考量。2014 年第四季銷售、一般及行政(SG&A)費用合計為 3,620 萬美元,[相較之下] 2013 年同季為 2,380 萬美元。增加主要與我們銷售組織人力擴編有關,包括外勤銷售與內部銷售支援人員;亦包括因本季產品銷售強勁而增加的銷售佣金,以及增加的行銷費用。

  • Just as reminder, we are growing our US sales team by 20% to 25%, with continued additional investment on the distribution channel team and our in-house support staff. Much of our 2015 sales expansion was completed by the end of FY14, and the remainder will be completed by the end of Q1 2015. We have also targeted several key international sales and marketing hires for 2015. It is also important to note that the year-over-year increase in SG&A expense includes $4.5 million of increased non-cash share-based compensation expense.

    提醒一下,我們正將美國銷售團隊擴編 20% 至 25%,並持續加碼投資於通路團隊與內部支援人員。我們 2015 年多數的銷售擴張已於 2014 財年底前完成,其餘將於 2015 年第一季底前完成。我們也已鎖定 2015 年數個關鍵的國際銷售與行銷招募職缺。同時也很重要的一點是,SG&A 費用的年增幅中包含 450 萬美元增加的非現金以股份為基礎的薪酬費用。

  • As we look to FY15, we anticipate an increase in SG&A expense of approximately 25% on a GAAP basis, and approximately 20% on a cash basis. The increase will be driven primarily by sales and marketing investments I discussed previously, as well as IT and related infrastructure investments to support our growth. The increase will also include expense related to an additional 90,000 square foot facility adjacent to our headquarters in San Diego that we leased in Q4 2014.

    展望 2015 財年,我們預期 SG&A 費用在 GAAP 基礎上將增加約 25%,在現金基礎上將增加約 20%。增加主要將由我先前提到的銷售與行銷投資所帶動,並包括為支持成長而進行的資訊科技(IT)及相關基礎設施投資。增加亦將包含與我們於 2014 年第四季租賃、位於聖地牙哥總部旁新增 90,000 平方英尺設施相關的費用。

  • Finally, the increase will include additional non-cash share-based compensation expense, largely resulting from our higher share price. Our net income for the fourth quarter of 2014 totaled $1.3 million and included $17.4 million in non-cash expense, centered in share-based compensation, depreciation, and amortization. Absent these non-cash charges, cash operating income was $19 million for Q4, and was $37 million for FY14.

    最後,增加亦將包含額外的非現金以股份為基礎的薪酬費用,主要源自我們較高的股價。我們 2014 年第四季淨利合計為 130 萬美元,其中包含 1,740 萬美元的非現金費用,主要為以股份為基礎的薪酬、折舊與攤銷。若排除這些非現金費用,第四季現金營運利益為 1,900 萬美元,2014 財年現金營運利益為 3,700 萬美元。

  • For Q4, that cash-based operating income number represents 23% of our sales. Our business model is achieving the success we have always envisioned. Obviously we're quite pleased with our cash operating results, and this compares quite favorably to our cash-based operating income for FY13 of only $5 million. Our earnings per share for the quarter were $0.02. With respect to our balance sheet, we ended the fourth quarter with $84 million in cash and marketable securities, up approximately $9 million sequentially.

    就第四季而言,該以現金為基礎的營業利益數字相當於我們銷售額的 23%。我們的商業模式正達成我們一直以來所設想的成功。顯然,我們對現金營運成果感到相當滿意,且與 FY13 僅 500 萬美元的以現金為基礎營業利益相比,表現更是相當亮眼。本季每股盈餘為 0.02 美元。就資產負債表而言,我們在第四季末持有 8,400 萬美元的現金及有價證券,較前一季約增加 900 萬美元。

  • I would like to (technical difficulties) of our financial results with some thoughts on Q1 and 2015. At JPMorgan we gave product revenue guidance for 2015 of between $340 million and $360 million, and we remain quite comfortable with that range. While we do not provide specific quarterly guidance, I remind investors that the first quarter is traditionally a seasonally slow quarter for our business as annual insurance deductibles reset and flexible spending accounts are largely unfunded. As a result, our patients typically purchase as much product as they can during the fourth quarter, and based on our reported Q4 sales you can see that 2014 was no exception. Add to that the fact that we have become much more efficient in our processing capabilities, we were quite successful during Q4 at filling virtually every order in the pipeline, taking care of those patients who could purchase at year end for little or no out-of-pocket expense.

    我想要(技術問題)在回顧我們的財務結果之後,補充一些對第一季與 2015 年的看法。在摩根大通(JPMorgan)會議上,我們提供 2015 年產品營收指引為 3.40 億至 3.60 億美元之間,我們仍對此區間相當有信心。雖然我們不提供特定季度指引,但我提醒投資人,第一季傳統上是我們業務的季節性淡季,因為年度保險自付額會重置,且彈性支出帳戶多半尚未到位。因此,我們的病患通常會在第四季盡可能多購買產品;從我們公布的第四季銷售可見,2014 年也不例外。再加上我們在處理能力上變得更有效率,我們在第四季成功地幾乎滿足了管線中的每一筆訂單,照顧到那些能在年底以極低或無自付費用購買的病患。

  • Of course, that means at the start of 2015 we need to rebuild our new patient pipeline, and we also experienced some delay in sensor and transmitter reorders by existing patients who loaded up in December. As we look to close out February, however, I'm pleased to report that our pipeline of new patient opportunities is larger than it has ever been. To add some final additional color I remind investors that in years past, including in 2014, approximately 40% to 45% of our product revenue was generated in the first half of the year, and 55% to 60% was generated in the second half, and we do not view 2015 any differently. Q1 has typically represented around 20% of our revenue for the year and in 2014 Q1 revenue represented only 18%.

    當然,這也意味著在 2015 年初我們需要重建新的病患管線;同時,部分既有病患因為 12 月大量備貨,導致感測器與發射器的再次訂購出現一些延遲。不過,當我們展望 2 月底結束之際,我很高興地報告,我們的新病患商機管線規模已創下歷來新高。再補充一些背景資訊:過去幾年(包括 2014 年),約有 40% 至 45% 的產品營收來自上半年,55% 至 60% 來自下半年,我們不認為 2015 年會有不同。第一季通常約占全年營收的 20%,而 2014 年第一季營收僅占 18%。

  • I'd also like to take this opportunity to give some color on the Q1 financial impact of our sooner-than-expected FDA approval of our SHARE Receiver, as this approval will affect both our product revenues and our gross profits for Q1. We announced that all US patients who purchased a G4 PLATINUM system from January 1 until the launch of the SHARE Receiver will receive a free upgrade to the SHARE Receiver. This program requires us to defer a portion of our G4 PLATINUM revenue until we ship the upgrade receiver. We also announced that we would ship a SHARE Receiver free of charge to any patient who previously purchased a SHARE Cradle. Additionally, we will be recording a charge to cost of sales for each of the upgrade receivers that we ship with no additional revenues.

    我也想藉此機會說明我們的 SHARE Receiver(接收器)比預期更早取得 FDA 核准,對第一季財務的影響;此核准將同時影響我們第一季的產品營收與毛利。我們宣布,所有自 1 月 1 日起至 SHARE Receiver 上市前購買 G4 PLATINUM 系統的美國病患,將可免費升級至 SHARE Receiver。此方案要求我們將部分 G4 PLATINUM 的營收遞延,直到我們出貨升級接收器為止。我們也宣布,將免費寄送一台 SHARE Receiver 給任何先前購買 SHARE Cradle(底座)的病患。此外,對於每一台我們出貨且不會帶來額外營收的升級接收器,我們將在銷貨成本中認列一筆費用。

  • Consistent with past practices we will offer a low cash cost -- low-cost cash upgrade to the SHARE Receiver for those patients who are still under warranty with their existing receiver. We set the cash upgrade price at $199. We expect to begin shipping the SHARE Receiver in early March, but to the extent we are unable to ship the full allotment of receiver upgrades before the end of Q1, we will be required to defer revenue until we ship in Q2. Finally, with respect to inventory and cost of goods sold, we expect to write down certain excess and obsolete inventory related to our G4 PLATINUM receivers as a result of this approval.

    依循過往作法,對於其既有接收器仍在保固期內的病患,我們將提供低現金成本——以低價現金升級至 SHARE Receiver。我們將現金升級價格訂為 199 美元。我們預期於 3 月初開始出貨 SHARE Receiver;但若我們無法在第一季結束前出貨全部配額的接收器升級,我們將必須將相關營收遞延至第二季,待出貨時再認列。最後,就存貨與銷貨成本而言,因應此次核准,我們預期將就與 G4 PLATINUM 接收器相關的部分過剩與呆滯存貨進行減記。

  • With that, I'd now like to turn the call back over to Kevin for a business update. Kevin?

    接下來,我想把電話會議交回給 Kevin,請他提供業務更新。Kevin?

  • - CEO

    - CEO

  • Thank you, Steve.

    謝謝你,Steve。

  • For our business update today I'd like to discuss several major initiatives for 2015. Let's start with innovation. On a worldwide basis, we launched a total of 5 new products in 2014, compared to a total of 3 worldwide product launches in the previous two years combined. We are currently planning at least five more launches in 2015, and depending upon execution and regulatory time frames, we can see that number go up to as many as 10 product launches in 2015.

    在今天的業務更新中,我想討論 2015 年的幾項重大計畫。我們先從創新談起。以全球範圍來看,我們在 2014 年共推出 5 項新產品,相較之下,前兩年合計僅有 3 次全球產品上市。我們目前規劃在 2015 年至少再推出 5 項產品;視執行狀況與法規時程而定,我們也可能在 2015 年將上市數量提高到多達 10 項。

  • Our nearest-term innovation is the DexCom SHARE Receiver. Work on a receiver of this nature commenced more than two years ago, when we received a research grant from the Juvenile Diabetes Research Foundation to develop better tools to support artificial pancreas research. We want to take the opportunity to recognize JDRF's support of this project. This is a great example of how industry and research collaborations can greatly benefit both parties.

    我們近期最重要的創新是 DexCom SHARE Receiver。此類接收器的研發在兩年多前就已開始,當時我們獲得青少年糖尿病研究基金會(Juvenile Diabetes Research Foundation, JDRF)的研究補助,用於開發更好的工具以支援人工胰臟研究。我們也想藉此機會肯定 JDRF 對此專案的支持。這是產業與研究合作能讓雙方大幅受益的絕佳例子。

  • The SHARE Receiver uses a secure wireless connection via Bluetooth low energy, or BLE, between a patient's receiver and an app on the patient's smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients or followers. Initially, the system will be compatible with the Apple iPhone, iPod Touch, or iPad. But we plan to launch apps on an Android platform later this year and on other devices like smart watches including the Apple Watch. I am also pleased to note that the SHARE Receiver will be compatible with the G5 mobile system.

    SHARE Receiver 透過藍牙低功耗(Bluetooth low energy, BLE)的安全無線連線,在病患的接收器與其智慧型手機上的 App 之間傳輸葡萄糖資訊,並可將資訊傳送至最多五位指定接收者或追蹤者的行動裝置 App。初期,該系統將相容於 Apple iPhone、iPod Touch 或 iPad。但我們計畫在今年稍晚推出 Android 平台的 App,並支援其他裝置,例如智慧手錶(包括 Apple Watch)。我也很高興指出,SHARE Receiver 將與 G5 行動系統相容。

  • As I stated in my opening remarks, we submitted our G5 mobile PMA-supplement to the FDA earlier this week. We believe that this system will truly make the cell phone the center of the diabetes universe for our patients. Some unique features of this system are -- the G5 mobile platform operates through a smart transmitter, meaning glucose values are computed on the transmitter, eliminating the need for a receiver. Glucose values will go directly from the transmitter to a patient's mobile device. Patients will still be able to use a Receiver if they wish because the G5 smart transmitter can communicate with two BLE-enabled devices simultaneously. Now patients will have a choice.

    如同我在開場致詞中所說,我們本週稍早已向 FDA 提交 G5 行動系統的 PMA 補充申請(PMA-supplement)。我們相信,這套系統將真正讓手機成為病患糖尿病世界的核心。此系統的一些獨特功能包括——G5 行動平台透過智慧型發射器運作,也就是在發射器上計算葡萄糖數值,因而不再需要接收器。葡萄糖數值將直接從發射器傳送到病患的行動裝置。若病患希望,仍可使用接收器,因為 G5 智慧型發射器可同時與兩個支援 BLE 的裝置通訊。現在病患將有選擇。

  • The communication protocol will enable our system to display on a number of different platforms. Glucose when you want it and where you want it. The user interface for the G5 mobile platform is completely different from the current patient experience and anything seen before in diabetes. It works very much like other apps in the mobile environment. We have conducted many, many hours of human factor studies to develop and refine our apps to best meet our patients' needs. Finally, the G5 mobile system will take full advantage of all of the FDA-approved data sharing capabilities of our SHARE platform. While it is impossible to predict FDA timing, we are cautiously optimistic that this product will be available before year-end. We also plan to introduce this platform in our major OUS markets, with timing to be discussed in the future.

    該通訊協定將使我們的系統能在多種不同平台上顯示:你想要的時間、你想要的地方,都能看到葡萄糖資訊。G5 行動平台的使用者介面與目前病患的使用體驗,以及糖尿病領域過去所見的任何介面都完全不同;它的運作方式非常像行動環境中的其他 App。我們已進行非常、非常多小時的人因研究,以開發並精進我們的 App,讓其最能符合病患需求。最後,G5 行動系統將充分運用我們 SHARE 平台所有已獲 FDA 核准的資料分享能力。雖然無法預測 FDA 的審查時程,但我們審慎樂觀地認為,該產品可在年底前上市。我們也計畫在主要海外(OUS)市場導入此平台,時程將於未來再行討論。

  • Shifting to our integration partnerships, I am pleased to report that Animas has initiated shipment of the Vibe in the US, and initial reports from the field suggest that patients are quite pleased with the user interface for CGM as displayed on the pump. Just yesterday, Tandem reported that they have completed an FDA site inspection associated with their t:slim G4 PMA filing, and are encouraged by the outcome. Tandem also reported that they are preparing for launch during the second half of 2015.

    接著談到我們的整合合作夥伴關係,我很高興報告 Animas 已在美國開始出貨 Vibe,且來自市場端的初步回饋顯示,病患對於在幫浦上顯示的 CGM 使用者介面相當滿意。就在昨天,Tandem 表示他們已完成與其 t:slim G4 PMA 申請相關的 FDA 現場稽核,並對結果感到鼓舞。Tandem 也表示,他們正為 2015 年下半年上市做準備。

  • We recently returned from the annual Advanced Technologies & Treatments for Diabetes meeting in Paris last week. I brought the cold with me. I would like to show some observations with you. With our recently launched 505 software, or G4 AP algorithm, DexCom has truly set a new standard for CGM accuracy and system performance. This represents a major hurdle for all of our competitors. We met with several groups utilizing G4 CGM and developing closed loop and partially closed loop artificial pancreas type systems. Significant progress has been made by many of these groups.

    我們上週剛從巴黎的年度「糖尿病先進技術與治療」(Advanced Technologies & Treatments for Diabetes)會議返國。我把感冒也帶回來了。我想與各位分享一些觀察。透過我們近期推出的 505 軟體(或稱 G4 AP 演算法),DexCom 確實為 CGM 的準確度與系統效能樹立了新的標準。這對我們所有競爭對手而言是一道重大門檻。我們也與數個使用 G4 CGM、並開發閉環與部分閉環人工胰臟類系統的團隊會面;許多團隊都已取得顯著進展。

  • But the pathway to commercialization for many of these projects remains unclear, and we will continually evaluate our own path to the artificial pancreas closely. With the world's most accurate and reliable CGM system, we intend to play in this arena. We left the meeting very confident that with execution of our planned product portfolio, we will remain the world's leader in continuous glucose monitoring. With our new insertion system, the G6 and other advanced sensor platforms, expanded connectivity with user-friendly apps, and the ability to perform advanced analytics, once CGM and other diabetes data is in the cloud we believe we are positioned to lead this industry for a very, very long time.

    但其中許多專案的商業化路徑仍不明朗,我們也將持續密切評估自身邁向人工胰臟的路徑。憑藉全球最準確且最可靠的 CGM 系統,我們打算在此領域扮演重要角色。我們離開會議時非常有信心:只要我們按計畫執行產品組合,我們將持續保持全球連續血糖監測的領導地位。透過我們新的插入系統、G6 及其他先進感測器平台、與更易用 App 的擴大連結能力,以及執行進階分析的能力——一旦 CGM 與其他糖尿病資料上雲,我們相信我們已具備在這個產業領先非常、非常長時間的定位。

  • In addition to innovation, access and awareness are major initiatives for 2015. We have made much progress to make it easier for patients to gain access to CGM. We have frequently discussed our plan to migrate CGM coverage to a pharmacy benefit. In 2014, we laid the foundation to make significant progress in 2015 and beyond by putting in place several key PBM wholesale and regional payer contracts. We are currently in discussion with several major payers, and plan to offer additional detail on these initiatives in future quarters. Increased access for our patients not only includes moving from DME benefit to pharmacy benefit, but it also includes obtaining broader coverage from those plans that choose to maintain CGM as a DME benefit.

    除了創新之外,提升可近性與提高認知度也是 2015 年的主要推動重點。我們已取得許多進展,使病患更容易取得 CGM。我們也經常討論將 CGM 給付轉移至藥局給付(pharmacy benefit)的計畫。2014 年,我們透過建立數項關鍵的 PBM 批發與區域性付款方合約,為 2015 年及往後的重大進展奠定基礎。我們目前正與數家主要付款方洽談,並計畫在未來幾季就這些計畫提供更多細節。提升病患的可近性不僅包括從 DME 給付轉為藥局給付,也包括在那些選擇維持 CGM 為 DME 給付的保險計畫中,爭取更廣泛的涵蓋。

  • We have succeeded in broadening coverage with several payers and in reducing documentation to streamline processing. But the most consistent question we get in the field with respect to access is very simple -- where are you with Medicare? We continue to pursue both traditional legislative pathways. Bills were introduced in the Congress last year, but with the elections and adjournment of Congress, no progress was made past introduction. We expect the bills to be reintroduced in early 2015.

    我們已成功在多家付款方中擴大涵蓋範圍,並減少所需文件以簡化處理流程。但在第一線就可近性而言,我們最常被問到的問題非常簡單——你們在 Medicare 的進展如何?我們仍持續推動兩條傳統的立法途徑。去年國會已提出法案,但因選舉與國會休會,未能在提出之後取得進一步進展。我們預期這些法案將於 2015 年初重新提出。

  • But we are not going to rely solely upon legislation. CMS was very clear with us that a product with a non-adjunctive claim will be required to obtain Medicare coverage. So we are planning the clinical study necessary to support this claim, in other words, to truly replace finger sticks for diabetes management decisions. We are actively engaged with the FDA and will update you on our progress in this area in future quarters.

    但我們不會只仰賴立法。CMS 非常明確地告訴我們,若要取得 Medicare 給付,產品必須具備「非輔助(non-adjunctive)」的宣稱。因此,我們正規劃支持此宣稱所需的臨床研究,換言之,真正能在糖尿病管理決策上取代指尖採血。我們正積極與 FDA 互動,並將在未來幾季向各位更新此領域的進展。

  • Finally, we recognize the need to expand our clinical study activity beyond simply supporting product approvals. Enrollment for our CGM first study, entitled the DiaMond Study, has commenced and will continue throughout the year. A large reimbursement study is underway in Sweden and we have a study plan for Germany later this year. We will continue to evaluate opportunities to conduct additional studies to demonstrate the effectiveness of CGM as the most important tool in diabetes management today. All of these initiatives will lead to increased awareness. While we are making progress, we still see awareness as a tremendous opportunity for future growth.

    最後,我們也認知到需要將臨床研究活動擴展到不僅僅是支持產品核准。我們的首個 CGM 研究(名為 DiaMond Study)已開始收案,並將持續整年。在瑞典,一項大型的給付研究正在進行中;我們也規劃於今年稍晚在德國展開研究。我們將持續評估進行更多研究的機會,以證明 CGM 作為當今糖尿病管理最重要工具的有效性。所有這些計畫都將提升認知度。雖然我們正在取得進展,但我們仍將認知度視為未來成長的巨大機會。

  • Just last week, we had an individual with type 1 diabetes in our office for an interview. The person is treated by a San Diego-based endocrinologist that we know very well. The person had not heard DexCom or CGM until they were introduced to our Company for potential employment and could not understand why a CGM recommendation had not been made for this person. Unfortunately, these types of conversations happen far too frequently.

    就在上週,我們辦公室有一位第一型糖尿病患者來面談。此人由我們非常熟悉的一位聖地牙哥內分泌科醫師治療。該名患者在被介紹到我們公司、作為潛在就業機會之前,從未聽過 DexCom 或 CGM,也無法理解為何從未有人建議他使用 CGM。不幸的是,這類對話發生得過於頻繁。

  • The expansion of our sales team should certainly help with awareness as more sales staff will allow more frequent contact with healthcare providers and patients. We have also expanded our DTC advertising programs. Our mobile platforms also provide us with a great opportunity to increase awareness. Just look at the tremendous amount of press that has been generated through discussion of our Apple mobile platforms. We will diligently look for opportunities to increase awareness and we will increase our investment as opportunities present themselves.

    擴編我們的銷售團隊確實有助於提升認知度,因為更多的銷售人員能讓我們更頻繁地與醫療照護提供者及病患接觸。我們也擴大了 DTC(直接面向消費者)廣告計畫。我們的行動平台同樣為提升認知度提供了極佳機會。看看圍繞我們 Apple 行動平台討論所帶來的大量媒體報導即可。我們將勤勉尋找提升認知度的機會,並在機會出現時增加投資。

  • Finally, I want to emphasize that all these efforts support the ultimate goal of scaling and simplifying our business activities. New products must be more cost-effective and more efficient than the products they replace. For example, our new insertion system has been designed with the goal of fully-automated assembly. Our Gen 6 manufacturing line eliminates many of the variables involved in the manufacturing of our current sensor. This is a key step in reducing and eventually, when proven safe, eliminating calibrations altogether.

    最後,我想強調,所有這些努力都支持一個最終目標:擴大規模並簡化我們的業務活動。新產品必須比其所取代的產品更具成本效益且更有效率。舉例來說,我們的新插入系統在設計時即以全自動化組裝為目標。我們的 Gen 6 製造產線消除了目前感測器製造中許多變因。這是降低校正需求、並最終在證明安全後完全取消校正的關鍵一步。

  • Improved access leads to a more efficient sales process, giving our sales team more and more time to spend with healthcare providers and patients, and not just collecting documents and being on the phone. The efforts of our sales process improvements were clearly demonstrated -- excuse me -- the success of our sales process improvements were clearly demonstrated with our incredible performance in Q4 2014. But we will continue to improve these processes. In conclusion, 2014 it was an amazing year all the way around.

    可近性的改善會帶來更有效率的銷售流程,讓我們的銷售團隊有更多時間與醫療照護提供者及病患互動,而不只是收集文件與打電話。我們在銷售流程改善上的努力已清楚展現——不好意思——我們銷售流程改善的成果,已在 2014 年第四季的亮眼表現中清楚呈現。但我們仍會持續改善這些流程。總結而言,2014 年各方面都是令人驚豔的一年。

  • We had over $100 million in revenue growth year-over-year, and we were able to drop $30 million -- more than $30 million of net to our cash-based operating results. We brought an FDA-approved CGM system to children all the way down to two years of age. Our G4 AP algorithm, or Software 505 as it is known commercially, has truly set a single-digit MARD accuracy standard for the entire industry and will become the foundation of our finger stick replacement claims. Finally, our first data-sharing platform was approved and launched to be the SHARE Cradle, even though we rendered it obsolete just three months later with our SHARE Receiver. We are moving fast, we moved fast in 2014, and we're going to move even faster in 2015.

    我們的營收年增超過 1 億美元,並且能在以現金為基礎的營運結果中增加 3,000 萬美元——超過 3,000 萬美元的淨額。我們將一套獲 FDA 核准的 CGM 系統帶給年齡低至兩歲的兒童。我們的 G4 AP 演算法(商業名稱為 Software 505)確立了全產業單位數 MARD 的準確度標準,並將成為我們「取代指尖採血」宣稱的基礎。最後,我們的第一個資料分享平台獲核准並以 SHARE Cradle 形式上市,儘管我們在三個月後就以 SHARE Receiver 讓它變得過時。我們正在快速前進,2014 年我們走得很快,而 2015 年我們會走得更快。

  • I'll now turn the call over to -- I'll open the call up for Q&A.

    我現在把電話交回——我將開放問答。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Ben Andrew, William Blair.

    Ben Andrew,William Blair。

  • - Analyst

    - Analyst

  • The first one for me, I guess, is as you look at the, as you said, stronger-than-ever pipeline for new patient flows, is the contribution there similar to what you saw maybe 6 or 12 months ago or has it shifted relatively heavily towards peds?

    我第一個問題是,當你們看待——如你所說——前所未有強勁的新病患導入管線時,這部分的貢獻是否與 6 或 12 個月前看到的情況相近,還是相對明顯地更偏向兒科?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Ben, we are not going to break out the distribution between adults and peds. What we said kind of earlier, or at launch what we said was that we -- the education effort required a pediatric [patient] and was slightly greater than we expected. Even the education of parents and patients with their parents was taking a little longer than expected. By Q2 we felt like that had kind of normalized and what we disclosed then is that we were tracking basically to what we thought was the ratio of adults to peds in the US, so roughly 25% of our new patient adds back in Q2.

    Ben,我們不會拆分成人與兒科的分布。我們先前提到,或在上市時提到的是——我們發現兒科(病患)所需的教育投入比我們預期略高。即使是對家長與病患(以及其家長)的教育,也比預期花更久時間。到第二季時,我們覺得這已大致正常化;而我們當時揭露的是,我們的追蹤結果基本上符合我們對美國成人與兒科比例的預期,因此第二季新增病患中約有 25% 來自兒科。

  • We said at the time that we were not going to break in out because frankly, internally a 5-year-old, a 15-year-old, or a 50-year-old, to us if they're on the system and using disposables, basically look and feel like the same patient. But I guess I'd summarize by saying just our peds adds are strong and we're quite pleased with where we are on the pediatric launch.

    我們當時也說過不會拆分,因為坦白說,在內部看來,5 歲、15 歲或 50 歲,只要他們使用系統並消耗耗材,基本上看起來與感受上都像同一類病患。但我想總結是:我們的兒科新增病患表現強勁,我們對兒科上市的進展非常滿意。

  • - Analyst

    - Analyst

  • Okay. And then do you expect the insertion device to be available with the G5 platform? Is that going to be in time?

    了解。那你們預期插入裝置會隨 G5 平台一起提供嗎?時間上來得及嗎?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Not initially. We're -- it's, again, we like to stop think about these things as we said before, we like to lump everything into generations but at the same time, as you saw when we launched the new algorithm, for example, with sort of in-between generations, if you will. We're probably going to -- we're not necessarily Gen 6 may not have been a new applicator, it could come before, it could come slightly after if the sensor is ready to go. I mean, there's a lot of moving parts here. But it definitely will not be with Gen 5 is, I guess, is the short answer.

    一開始不會。我們——再說一次——我們喜歡像之前所說的那樣,把各項改良歸類到不同世代,但同時,如你所見,例如我們推出新演算法時,也是在某種「介於世代之間」的時點推出。我們可能會——不一定要等到 Gen 6 才有新的施打器(applicator);它可能更早推出,也可能在感測器準備好後稍晚推出。這裡有很多變動因素。但我想簡短答案是:它肯定不會隨 Gen 5 一起推出。

  • - CEO

    - CEO

  • Not to start. I'd add to that, Ben, of all the things we're doing operationally, that is by far and away the most complex.

    一開始不會。我再補充一下,Ben,在我們所有的營運工作中,那項(插入裝置)無疑是最複雜的一項。

  • - Analyst

    - Analyst

  • Sure. It's got a lot of benefits as well, of course. But maybe talking about the pharmacy benefit, Kevin, I know this is important on a lot of different levels but what -- how much leverage can this create on a kind of standalone basis a year in, when you're fully implemented with pharmacy benefit? Because obviously you eliminate a lot of the back office functions, you'd eliminate a lot of the paperwork, et cetera, and how does that mix look several years in? Because you'd referred to some DMEs' functions sticking around over time with certain payers.

    當然,它也有很多好處。那談到藥局給付,Kevin,我知道這在很多層面都很重要,但——在你們完全導入藥局給付、實施滿一年後,單就這件事本身能帶來多大的槓桿效益?因為很明顯你們能減少許多後勤作業、減少大量紙本作業等等;那再往後幾年,這個組合會長什麼樣子?因為你提到,隨著時間推移,某些付款方仍會保留部分 DME 的功能。

  • - CEO

    - CEO

  • Our long-term goal is a 70/30 split --70% through the pharmacy, 30% through DME. It will take us a long time to get there. We, as I said in my remarks, we've got a lot of major discussions going on right now and I would tell you guys probably after the second quarter, we'll give you more of an update as to where we are. We really don't want to give anything away. But people are very interested and we're getting a lot of traction here.

    我們的長期目標是 70/30 的分配——70% 透過藥局、30% 透過 DME。要達到那裡需要很長時間。正如我在發言中提到的,我們目前正在進行許多重大討論;我會告訴各位,大概在第二季之後,我們會提供更多進度更新。我們真的不想透露太多。但大家非常有興趣,我們在這方面也獲得很大的推進力。

  • - Analyst

    - Analyst

  • Can you comment on organizational leverage in terms of -- through the P&L?

    你能評論一下在損益表(P&L)上,組織槓桿效益的情況嗎?

  • - CEO

    - CEO

  • Organizational leverage -- what this will enable us to do, Ben, more than anything is not add a bunch more bodies to process sales. I think we can keep our staff levels much broader as we go forward. The tricky part of this is if price erosion comes into play, how much price are you willing to give up versus the leverage you obtained operationally, and those are the types of equations that Jess and I look at all the time, and those types of trade-offs.

    組織槓桿——這最能讓我們做到的是,Ben,不必再增加一大堆人力來處理銷售。我認為隨著業務往前推進,我們可以讓人員編制維持在更可控的水準。這件事的棘手之處在於:若出現價格侵蝕,你願意讓出多少價格,來換取營運上的槓桿效益?這些就是 Jess 和我一直在看的方程式,以及這類取捨。

  • - Analyst

    - Analyst

  • Okay. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • William Plovanic, Canaccord.

    William Plovanic,Canaccord。

  • - Analyst

    - Analyst

  • So I'm trying to pick which questions to ask here, a lot to ask. Just clarity, I mean that was an amazing gross margin in the quarter. And as you think about it, are you pretty much kind of capped out until we move on to, I think it was the Gen 6 you said, on where we sit on the gross margin or do you -- can you continue to get operating overhead leverage?

    所以我正在想要在這裡挑哪些問題來問,能問的很多。先釐清一下,我是說這一季的毛利率真的非常驚人。那你們怎麼看,毛利率基本上是不是差不多已經到頂了,得等到你說的那個第六代(Gen 6)之後才會再往上?還是說——你們還能繼續透過營運費用的槓桿來提升?

  • - CEO

    - CEO

  • I think we can continue to get some overhead leverage as we continue to increase volumes. I mean, our volume increase last year was amazing. That was very helpful in getting G4 sensors through the margin level that we attained. I think over time we are going to have to have new platforms and new processes. But I mean, we never thought we'd be above 80% and we're clearly in the 70% to 75% range on our sensors now. So there will be some upside, Bill, I don't know how much more. I mean, we'll get it and we'll see how it goes.

    我認為隨著我們持續提高出貨量,我們還能繼續取得一些費用端的槓桿。我的意思是,我們去年出貨量的成長非常驚人,這對於讓 G4 感測器達到我們取得的毛利水準非常有幫助。我想長期來看,我們會需要新的平台和新的流程。但我的意思是,我們從沒想過會超過 80%,而我們現在的感測器毛利率很明顯是在 70% 到 75% 的區間。所以還會有一些上行空間,Bill,我不知道還能多多少。我的意思是,我們會努力爭取,然後看看進展如何。

  • - Analyst

    - Analyst

  • Okay, and then since I'm on the gross margin topic, just you mentioned that you're going to have a lot of one-time charges as you transition with of the old share. Just a ballpark number for us, what type of charge should we look for in Q1?

    好的,那既然我在問毛利率的話題,你剛提到在你們從舊的份額轉換過程中會有很多一次性費用。能不能給我們一個大概的數字,第一季(Q1)我們應該預期會有多大的費用?

  • - CEO

    - CEO

  • We -- honest to goodness, we don't have any idea as we sit here today. We've got a lot of work to do. Before we get there, there's a bunch of variables. For example, patients who want the new receiver have to fill out an application and say, I want my receiver upgraded, so we have to measure that response as to how many.

    我們——老實說,以我們今天坐在這裡的狀況,真的完全不知道。我們還有很多工作要做。在走到那一步之前,有一堆變數。舉例來說,想要新接收器的病患必須填寫申請,並表示「我想升級我的接收器」,所以我們得衡量那個回應率,也就是會有多少人這麼做。

  • We also have to see what's left in the distributor and the manufacturing pipeline with respect to potential G4 right-offs as to what's in the field, and it's all very early. I mean, we just got approval. Not too long ago this wasn't something we were planning on discussing today. A few weeks ago. So you are just going to have to give us some time.

    我們也必須看在經銷商端以及製造供應鏈中還剩下多少,涉及可能的 G4 沖銷,也就是現場端到底有多少庫存;而且現在都還很早。我是說,我們才剛拿到核准。不久之前這還不是我們打算今天要討論的事情,幾週前而已。所以你們得給我們一些時間。

  • - Analyst

    - Analyst

  • Okay. And then, we know -- so J&J, I believe, stocked a little into the fourth quarter. Just, can you help quantify that just so we understand, were they stocking $1 million, $10 million, $5 million? Just so we can understand what's normal throughput of versus maybe once time up-front from that partnership.

    好的。然後,我們知道——我相信 J&J 在第四季有做一些備貨。你能不能幫忙量化一下,讓我們理解:他們備了 100 萬美元、1,000 萬美元、500 萬美元?只是讓我們能了解什麼是正常的出貨量,什麼可能是那個合作夥伴關係一次性的前置拉貨。

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Bill, this is Steve. J&J doesn't stock anything. J&J does not serve as a distributor of sensors or transmitters in the US. So they sell the Vibe and then we support the patients with respect to transmitters and sensor disposables so there was no stocking by J&J. I don't know where you got that.

    Bill,我是 Steve。J&J 沒有備任何貨。J&J 在美國並不擔任感測器或發射器的經銷商。所以他們賣的是 Vibe,然後我們在發射器和感測器耗材方面支援病患,因此 J&J 沒有任何備貨。我不知道你是從哪裡聽來的。

  • - Analyst

    - Analyst

  • Good. And then, well, is there -- who is handling the back office reimbursement? So basically, are you handling the paperwork to get your stuff approved? CGM approved? And then you're just drop-shipping to them? Is that what is kind of keeping it separate yet it's a single device?

    很好。那麼,後台的報銷作業是誰在處理?也就是說,是你們在處理讓你們的產品獲得核准的文件嗎?CGM 的核准?然後你們再直接寄送給他們?這是不是讓它仍然保持分開、但又是一個單一裝置的原因?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • That's right. As it stands today, we treat the patients as our patients from a CGM perspective, so we're fulfilling all of their CGM needs, including tactical support on the CGM front. We're exploring some ways it to make it more seamless; as it sits today, that is the path.

    沒錯。以目前的狀況來看,從 CGM 的角度我們把病患視為我們的病患,因此我們滿足他們所有的 CGM 需求,包括在 CGM 端的實務支援。我們正在探索一些方式讓流程更無縫;但就目前而言,這就是現行的做法。

  • - Analyst

    - Analyst

  • Great. And then last question, just so we can put a stake in the sand, can you give us an idea of the number of patients you had at year-end 2014 US or --?

    很好。最後一個問題,為了讓我們能有個基準點,你們能不能給我們一個概念:2014 年底你們在美國的病患數大概是多少,或——?

  • - CEO

    - CEO

  • That is spectacular, Bill. I will reiterate what we said at JPMorgan. We certainly grew our new patient base more than 50% last year; it was a great year for us.

    這個問題很精彩,Bill。我會重申我們在 JPMorgan 會上說過的:我們去年新增病患基礎的成長確實超過 50%;對我們來說是非常棒的一年。

  • - Analyst

    - Analyst

  • All right. You can't blame me for trying. Congratulations.

    好吧。你不能怪我想試試看。恭喜。

  • - CEO

    - CEO

  • I can't blame you for trying. I love it. Wouldn't want it any other way.

    我不會怪你想試試看。我很喜歡。要是換成別的方式我反而不習慣。

  • Operator

    Operator

  • Mike Weinstein, JPMorgan.

    Mike Weinstein,JPMorgan。

  • - Analyst

    - Analyst

  • This is actually Robbie Marcus in for Mike. I just want to start, last night Tandem announced that they're going to start going for a low glucose suspend or a combo pump using the DexCom sensors, presumably the G5. Can you give us a little more clarity on that program, how that will impact the income statement and then how you'll handle the patients there?

    其實我是代替 Mike 的 Robbie Marcus。我想先問,昨晚 Tandem 宣布他們將開始推進低血糖暫停(low glucose suspend)或使用 DexCom 感測器的組合式幫浦,推測是 G5。你能不能就那個計畫多給我們一些釐清,它會如何影響損益表,然後你們會如何處理那邊的病患?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Yes, I mean this is really a Tandem program. I don't think we could comment on the specifics of the Tandem program other than to say that we're a partner with Tandem and we've been supporting them with our current sensor technologies. At this point we're not prepared to move forward with G5 with any partner because we're just, literally just filing it in the last week or so. So it's -- I would say it's largely a work in progress at this point. But it would not be a meaningful P&L impact to DexCom because it's really the partner, Tandem or any other potential artificial pancreas partner. The program is really being driven by the partner.

    是的,我的意思是,這其實是 Tandem 的計畫。我想我們無法評論 Tandem 計畫的細節,只能說我們是 Tandem 的合作夥伴,並且一直用我們目前的感測器技術支援他們。就目前而言,我們還沒有準備好和任何合作夥伴一起推進 G5,因為我們真的就是在上週左右才剛提交申請。所以——我會說目前大致上仍在進行中。但這對 DexCom 的損益(P&L)不會有重大的影響,因為主要是合作夥伴——Tandem 或任何其他潛在的人工胰臟合作夥伴——在推動這個計畫。這個計畫基本上是由合作夥伴主導。

  • - Analyst

    - Analyst

  • Okay. And then, at the ATTD conference, you or someone from DexCom presented information on the new Gen 6 sensor that a single calibration led to an 11.7% MARD in days 1 through 7; and 12.1% in days 1 through 10. Is that good enough to get patients to trade accuracy for the fewer calibrations? Or do need to come down further on that number?

    好的。然後在 ATTD 會議上,你或 DexCom 的某位同仁發表了新一代第六代(Gen 6)感測器的資訊:單次校正(single calibration)在第 1 到第 7 天的 MARD 為 11.7%;第 1 到第 10 天為 12.1%。這樣的表現是否足以讓病患為了更少的校正次數而在準確度上做取捨?還是那個數字還需要再降一些?

  • - CEO

    - CEO

  • You know, that is a wonderful question. There are three things involving making that decision -- length of time, calibrations, well, mainly the length of time, calibrations, and then just performance over time. And how the sensor works. We are working on a dosing claim with the FDA and that will be our next big technological advancement. We will probably focus on getting the dosing claim first and then continue making our sensors accurate enough to serve as a finger stick replacement.

    你知道,這是個很棒的問題。做出那個決策有三個面向——使用時間長度、校正次數,還有主要是使用時間長度、校正次數,以及隨時間的整體表現,以及感測器的運作方式。我們正在和 FDA 推進一個用藥(dosing)宣稱,那將是我們下一個重大的技術進展。我們可能會先專注於取得用藥宣稱,然後再持續把感測器的準確度提升到足以作為指尖採血(finger stick)的替代。

  • Making no-calibration sensors is pretty hard. You've got to manufacture within a very, very narrow range so they all perform exactly the same. And we actually had similar data with that system with no calibrations that we did not present at the show. So we're going to weigh that over time, the convenience versus the calibrations versus the accuracy versus the labeling that we look for. All those factors play in together. And honestly, as these guys will tell you, I'm pushing for more accuracy. I'm kind of a jerk when it comes to that. It's a big deal to me.

    要做出免校正(no-calibration)的感測器相當困難。你必須在非常、非常狹窄的範圍內製造,讓它們的表現完全一致。而且我們其實也有那套系統在免校正情況下的類似數據,只是沒有在會上發表。所以我們會隨時間權衡:便利性對比校正次數、對比準確度、對比我們想要的標示(labeling)。所有這些因素都會一起影響。老實說,正如這些人會告訴你的,我在推動更高的準確度;在這方面我有點龜毛。這對我來說很重要。

  • - Analyst

    - Analyst

  • All right, and then let me sneak in one last one. Abbott's FreeStyle Libre, obviously different from a CGM, but still doing really well in the initial launch in Europe with a significant amount of Type 1 patients as a percentage of the patients that are using it starting to adopt that product. Have you seen this impacting European new patients at all, and is this an area that DexCom would be willing to get into?

    好,然後讓我再偷塞最後一題。Abbott 的 FreeStyle Libre,顯然和 CGM 不同,但在歐洲初期上市表現仍然很好,使用者中第一型糖尿病患者占比相當高,開始採用那個產品。你們有看到這對歐洲新增病患有任何影響嗎?以及這是否是 DexCom 願意切入的領域?

  • - CEO

    - CEO

  • I'll go in and Steve will probably have some other comments. We've long said that Abbott is a very formidable competitor and in our view there has never changed. The system they've put out, again as you said, is not CGM. It is different; there is no alerts or alarms and you don't get the benefit that comes with CGM there. We could certainly move to that space if we thought that was what patients wanted, and make you go to a phone, for example, rather than to a handheld reader. But right now we're focused on intensive management and focused on what we do.

    我先說,Steve 可能也會補充一些看法。我們一直都說 Abbott 是非常強勁的競爭對手,而在我們看來這點從未改變。他們推出的系統,如你所說,並不是 CGM。它不一樣;沒有警示或警報,你也得不到 CGM 所帶來的那些好處。如果我們認為病患想要那樣的產品,我們當然可以進入那個領域,例如讓你用手機,而不是用手持讀取器。但目前我們專注在密集管理(intensive management),專注在我們所做的事情上。

  • We will watch it very closely. Obviously the form factor everybody loves, the reduced calibrations. But we've heard other things, I mean, we've heard, for example, that as I said earlier, manufacturing no-calibration sensors is very hard. We heard while within a certain lot of sensors, if one in the lot works, they all work. We also heard they have many lots that don't work and they're not even adding any new patients due to manufacturing difficulties. So it's early. There is a lot of looking at it as we miniaturize our technologies, as we reduce calibrations, as we go to our mobile platforms we'll be in the same space. Steve?

    我們會非常密切地觀察。很明顯大家都喜歡它的外型尺寸(form factor)以及較少的校正次數。但我們也聽到其他一些事情,我是說,例如我先前提到的,製造免校正感測器非常困難。我們也聽說在某一批(lot)感測器中,只要那一批裡有一個能用,那一批就都能用。我們也聽說他們有很多批次是不能用的,而且因為製造上的困難,他們甚至沒有新增任何新病患。所以現在還很早。我們在把技術微型化、降低校正次數、轉向行動平台的同時,也會持續評估;我們會在同一個競爭空間裡。Steve?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • I would just say I don't know that we have data to support, I think Abbott has done a great job of creating hype over in Europe. They have had a couple of recalls on the device, and my understanding is that they are in a pretty significant backorder, so while there may be some interest in the product I'm not sure we have data to support that they're having meaningful sales with respect to the product. And the other thing that I think, as we keep going back to, this is not a CGM. It doesn't provide the alerts and alarms; with the Abbott product you're going to miss any readings during the time you are asleep, and that's frankly a critically important time, particularly for intensively-managed insulin-using patients.

    我只能說,我不確定我們是否有數據可以支持;我認為 Abbott 在歐洲把市場熱度炒得很成功。他們的裝置曾有過幾次召回,而據我了解,他們目前有相當嚴重的缺貨待交(backorder),所以即便市場對該產品可能有一些興趣,我也不確定我們有數據能支持他們在該產品上有具實質意義的銷售。另一點我認為我們一直在強調的是,這不是 CGM。它不提供警示與警報;使用 Abbott 的產品時,你在睡覺期間會漏掉任何讀數,而坦白說,那段時間極其重要,特別是對於採取密集管理、使用胰島素的患者。

  • So we said before that we think this could be a very interesting product for the Type 2 market. We're keeping an eye on it, and certainly, to respond to the latter part of your question, if this is something that Abbott figures out an interesting angle into the Type 2 market and to figuring out the distribution model, the payment model, the education model, because remember, Type 2s are typically seen by primary care, by internal medicine, they're not typically seen by endocrinologists. Let someone else do some heavy lifting in developing a different category, but today we're going to stay focused on the insulin-using diabetes patients.

    所以我們之前說過,我們認為這對第二型市場可能是一個非常有趣的產品。我們會持續關注它;當然,回應你問題的後半段,如果這是 Abbott 能在第二型市場找到一個有趣切入角度,並且把通路模式、支付模式、教育模式都摸索清楚的事情——因為要記得,第二型患者通常是由家庭醫師、內科醫師看診,並不常由內分泌科醫師看診——那就讓別人先去做一些開創不同品類的重活;但就今天而言,我們會繼續專注在使用胰島素的糖尿病患者。

  • - Analyst

    - Analyst

  • All right. Great. Thanks a lot.

    好的。很棒。非常感謝。

  • Operator

    Operator

  • Brooks West, Piper Jaffray.

    Brooks West,Piper Jaffray。

  • - Analyst

    - Analyst

  • Kevin, congratulations on the GAAP profitability. I just wanted to start with, is that something on an annual basis that we should be thinking about DexCom achieving going forward?

    Kevin,恭喜達成 GAAP 口徑的獲利。我想先問,這是否是我們未來應該期待 DexCom 在年度基礎上持續達成的目標?

  • - CEO

    - CEO

  • You know, that's certainly one of our stretch goals for 2015. But Brooks, we had over $50 million in share-based compensation in 2014, and that number is not going down in 2015 as we have more grants come out with our stock price, so we'll look at it.

    你知道的,這確實是我們 2015 年的其中一個挑戰性目標(stretch goals)。但 Brooks,我們在 2014 年有超過 5,000 萬美元的股份基礎給付(share-based compensation),而隨著我們股價上升、發放更多授予(grants),這個數字在 2015 年不會下降,所以我們會再觀察。

  • We measure our results primarily on our cash-based performance and overtime, we know that stock-based compensation will come down as a percentage of everything and our financial statements will look more normal. So that's a stretch goal of ours, we're also going to not let that deter us from doing all the things that we want to do. If we can increase our cash-based operating income number; as I said, we grew $100 million in revenue and dropped over $30 million to the bottom line. That's a pretty good year and that's great execution of a plan.

    我們主要以現金基礎(cash-based)的表現來衡量成果;隨著時間推移,我們知道股票基礎給付占比會下降,財務報表看起來也會更正常。所以這是我們的挑戰性目標之一,但我們也不會讓它妨礙我們想做的所有事情。如果我們能提高以現金為基礎的營業利益數字;如我所說,我們營收成長 1 億美元,並且有超過 3,000 萬美元落到淨利(bottom line)。那是相當不錯的一年,也是對計畫的很好的執行。

  • - Analyst

    - Analyst

  • So I guess, let me push you on that a little, Kevin, if I could. If we use that metric, given the increased spend, obviously tied to still strong revenue growth, should we see that operating cash number increase significantly this year over last year?

    那我想,如果可以的話,Kevin,我再追問一下。若用那個指標來看,考量到支出增加、而且顯然仍伴隨強勁的營收成長,我們是否應該看到今年的營業現金數字相較去年顯著增加?

  • - CEO

    - CEO

  • We certainly hope so. That's our plan. We went from negative $30 million in 2012 -- negative $30 million-plus, to positive $5 million in 2013 to positive $37 million in 2014. There aren't that many businesses that show that kind of turn. Our business model is truly scalable, Brooks.

    我們當然希望如此。那是我們的計畫。我們從 2012 年的負 3,000 萬美元——負 3,000 萬美元以上,轉為 2013 年正 500 萬美元,再到 2014 年正 3,700 萬美元。能展現這種轉折的企業並不多。我們的商業模式確實具備可擴展性(scalable),Brooks。

  • Now, the key question for us is what investments to we make? Terry and I often discussed if we wanted to just turn this things into a cash money maker, there are ways to do it, but that doesn't position us for the next $0.5 billion in revenues. We've got to continue to invest, so we will. So it is a balance. It's a balance each and every day.

    現在,對我們而言關鍵問題是要做哪些投資?Terry 和我常常討論,如果我們只想把這件事變成一台現金印鈔機(cash money maker),有方法可以做到,但那無法讓我們為下一個 5 億美元的營收做好定位。我們必須持續投資,所以我們會投資。因此這是一種平衡——每天都在做平衡。

  • - Analyst

    - Analyst

  • Thanks, and let me ask you one product question then on the partnerships, the Vibe and the potential Tandem when that does launch. Do those systems support the G4 AP algorithm? I think the answer to that is no and if they don't, how do you see the kind of rapid adoption of the AP algorithm impacting those partnerships?

    謝謝。那我再問一個產品問題,關於合作夥伴:Vibe 以及 Tandem 未來推出時的可能合作。那些系統是否支援 G4 AP 演算法?我想答案是否定的;如果不支援,你怎麼看 AP 演算法的快速採用會如何影響這些合作關係?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Your correct in that the first question, which is no, neither the current iteration of the Vibe nor the Tandem product when it launches will accommodate the G4 AP algorithm. And quite frankly, we're cautiously optimistic that by the end of this year, we're going to be on the G5 platform so we'll also be on a mobile phone. I don't want to comment specifically on how the new algorithm will or will not impact the launch of those products.

    你第一個問題的答案是對的:不,無論是目前版本的 Vibe,或是 Tandem 產品在推出時,都不會支援 G4 AP 演算法。坦白說,我們謹慎樂觀地認為到今年年底,我們會在 G5 平台上,因此也會在手機端。我不想具體評論新演算法會或不會影響那些產品的上市。

  • I think, as we've said in past earnings calls and at conferences, I think from a revenue generation perspective, we're kind of treating the pump companies these days as more additive than transformative for our business. I think we've really -- we've not -- we've kind of downplayed them slightly and we're not really looking at those guys to be driving the top-line in any significant fashion, so I think -- I'm not sure we're that concerned about it to be honest.

    我想,正如我們在過去的法說會與會議上所說,從營收貢獻的角度來看,這些年我們把幫浦公司視為對我們業務「加分」多於「翻轉性」(transformative)。我認為我們確實——我們並沒有——我們有點淡化它們,我們並不真的指望那些公司以任何顯著方式推動營收成長,所以我想——老實說,我不確定我們有那麼擔心。

  • - Analyst

    - Analyst

  • Okay. Thanks so much.

    好的。非常感謝。

  • Operator

    Operator

  • Jayson Bedford, Raymond James.

    Jayson Bedford,Raymond James。

  • - Analyst

    - Analyst

  • You added more new patients than you ever have in the fourth quarter, and I realize that's becoming a bit of a trend but you also introduced the AP algorithm late last year. Obviously your current user base is thrilled with the upgrade, but you think that the new algorithm was a key driver, or the key driver of new patient growth in the fourth quarter?

    你們在第四季新增的新患者數創下歷史新高,我知道這正逐漸成為一個趨勢,但你們也在去年底推出了 AP 演算法。顯然現有用戶對升級很滿意,但你認為新演算法是第四季新患者成長的一個關鍵驅動因素,或是最關鍵的驅動因素嗎?

  • - CEO

    - CEO

  • This is Kevin. I think it helped but I don't think it was the key driver. Jayson, I think just as we increased awareness, that's what drove it. It certainly is an easy presentation to clinicians to say this is more accurate than what we had before. Most patients judge the accuracy of their system not from what's in the book but what they experience day to day. And that the algorithm -- one of its characteristics, it does move quicker with your glucose information so patients saw that and experienced that firsthand. So it helped, but I don't know that it was the primary driver, I think it's just increased awareness.

    我是 Kevin。我認為它有幫助,但我不認為它是最關鍵的驅動因素。Jayson,我認為是我們提升了市場認知度,這才是主要推動力。對臨床醫師來說,這確實很容易呈現:它比我們之前的更準確。大多數患者評估系統準確性,不是看手冊上寫什麼,而是看他們每天的實際體驗。而這個演算法——它的一個特性是,對你的葡萄糖資訊反應更快,所以患者親身看到並體驗到了。因此它有幫助,但我不確定它是主要驅動因素;我認為主要是認知度提升。

  • - Analyst

    - Analyst

  • Okay. And have you filed the algorithm for the peds indication?

    好的。那你們是否已經為兒科適應症提交該演算法的申請?

  • - CEO

    - CEO

  • We have filed the algorithm for the pediatric indication.

    我們已經為兒科適應症提交了該演算法的申請。

  • - Analyst

    - Analyst

  • Okay. And then just lastly for me and I'll jump off and let someone else ask. But international, I guess, by our math was just under $14 million in the quarter. I guess first, is that correct? And then second, you mentioned adding some key international hires. And I'm just wondering if you're adding more to an existing team or branching out into some new countries? Thanks.

    好的。最後一個問題,我問完就下線讓其他人提問。國際業務方面,我們按計算本季略低於 1,400 萬美元。第一,這是否正確?第二,你提到新增一些關鍵的國際聘用。我想了解你們是擴編既有團隊,還是要拓展到一些新國家?謝謝。

  • - CEO

    - CEO

  • Well, we're going to do both, Jayson. We branched out to approximately 10 countries last year. Our most significant new countries last year were in Canada it was last year and India near the end of the year, we are going there. We actually have an employee relationship in India that works with our distributor. We have all of four international employees as we sit here today. So as I look at key hires, they'll be to supplement what we have.

    嗯,我們兩者都會做,Jayson。我們去年拓展到大約 10 個國家。去年最重要的新市場是加拿大(是在去年)以及接近年底的印度,我們正在進入那裡。我們在印度其實有一位員工與我們的經銷商合作,屬於僱用關係。以目前來看,我們只有四位國際員工。所以當我談到關鍵聘用時,會是用來補強我們現有的配置。

  • In particular, health and economics expert to help drive reimbursement over there. On top of that a clinical research expert as we do more studies overseas. To prove the effectiveness and demonstrate the effectiveness of CGM we need somebody with more clinical experience than what we have now. So we've got a couple folks lined up in that area and that's where we'll start. Almost all of our revenue internationally goes through distributors. And so we monitor that distribution channel very closely and carefully.

    特別是聘請健康經濟學(health and economics)專家,協助推動當地的給付/報銷(reimbursement)。此外,還會有一位臨床研究專家,因為我們會在海外做更多研究。要證明 CGM 的有效性並展示其效果,我們需要一位比我們目前更有臨床經驗的人。所以我們在那個領域已經鎖定幾位人選,會從那裡開始。我們幾乎所有的國際營收都透過經銷商(distributors)進行。因此我們會非常密切且謹慎地監控該通路。

  • - Analyst

    - Analyst

  • Okay. Thank you.

    好的。謝謝你。

  • Operator

    Operator

  • Tao Levy, Wedbush.

    Tao Levy,Wedbush。

  • - Analyst

    - Analyst

  • So I was wondering if maybe you could talk a little about the, again, on the international business, I want to know if you've disclosed or talked in the past about the percentage of the OUS business that's -- [part] that is J&J-related or related to the Vibe.

    我想請你再談一下國際業務。我想知道你們過去是否有揭露或談過 OUS(美國以外)業務中,有多少比例是——[部分]——與 J&J 有關或與 Vibe 有關?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • No, we don't break that out. Frankly, J&J would never let us break that out.

    沒有,我們不會把那部分拆分揭露。坦白說,J&J 也不會讓我們拆分揭露。

  • - Analyst

    - Analyst

  • Okay. But is that a big part of the growth or is it mainly, I guess, non-J&J?

    了解。但那是成長的一大部分嗎?還是主要是非 J&J 的部分?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • It's certainly a part. But we're not going to give you a level of materiality, for example, but I mean it's a part, but our efforts through our network of distributors is obviously a very important part.

    那當然是一部分。但例如,我們不會告訴你其重要性(materiality)的程度;不過我的意思是,它是一部分,但我們透過經銷商網路所做的努力顯然也是非常重要的一部分。

  • - Analyst

    - Analyst

  • Okay. And on the Bluetooth, on the G5, will that enable sort of direct transmission of data from the blood glucose meter to the transmitter during calibration? Or is it just one way?

    好的。那關於藍牙、關於 G5,它是否能在校正(calibration)時,讓血糖機的數據直接傳到發射器?還是只是單向?

  • - CEO

    - CEO

  • The transmitter can have a two-way conversation. We have not written software to take a calibration from any specific meters yet.

    發射器可以進行雙向通訊。我們目前還沒有撰寫軟體,去從任何特定血糖機接收校正值。

  • - Analyst

    - Analyst

  • Is that --

    那是——

  • - CEO

    - CEO

  • We could. We could; I think as we look at our horizon we're more concerned about getting --

    我們可以。我們可以;我想當我們看我們的時間跨度時,我們更擔心的是要取得——

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • We'd rather get rid of calibration.

    我們寧可把校準拿掉。

  • - CEO

    - CEO

  • And we'd rather develop more apps through the Android platforms and the watches and stuff, so we can look at it.

    而且我們寧可透過 Android 平台以及手錶等等開發更多應用程式,這樣我們就能去看它。

  • - Analyst

    - Analyst

  • And just lastly, one of the benefits that Medtronic has is they've got both the pump and the CGM, and can work on things all under one roof, like threshold suspend and start to make some progress there, and it seems like they're at least moving a little bit faster than they have historically on developing new technologies in diabetes. And I was just trying to figure out whether at some point that is something that DexCom needs to start thinking about, just kind of putting everything under the same roof so you can move quickly and kind of go after artificial pancreas and those kinds of opportunities.

    最後再補充一點,Medtronic 的一個優勢是他們同時擁有幫浦和 CGM,能在同一個屋簷下做所有事情,例如閾值暫停(threshold suspend)並開始在那方面取得一些進展;而且看起來他們在糖尿病新技術的開發上,至少比過去歷史上快了一點。我只是想弄清楚,DexCom 是否在某個時間點也需要開始思考這件事——也就是把所有東西放在同一個屋簷下,這樣你就能快速推進,並且去追逐人工胰臟以及那類機會。

  • - CEO

    - CEO

  • That's a great question. As we sit here today and as we've sat here for the past several years, our message has been CGM first and making these CGM systems more and more accurate and reliable and better-suited work with an artificial pancreas and we're very comfortable with our product pipeline. The question then becomes is how do we play in the sensor augmented pump arena? Somebody said earlier Tandem announced a threshold suspend type device yesterday. We know J&J has ongoing efforts. There are a lot of efforts going on.

    這是個很好的問題。就我們今天坐在這裡、以及過去幾年一直以來,我們的訊息都是 CGM 優先,並讓這些 CGM 系統越來越精準、可靠,也更適合與人工胰臟搭配;我們對我們的產品管線非常有信心。接下來的問題就變成:我們要如何在感測器增強型幫浦(sensor augmented pump)的領域參與?剛才有人提到 Tandem 昨天宣布了一款類似閾值暫停的裝置。我們知道 J&J 也有持續的努力。有很多專案正在進行。

  • We won't sit and let somebody else control our fate forever. If nobody does this, we will get more involved if we see a project that is going very, very well. We haven't found anything that we wanted to commit to yet. We support all the artificial pancreas programs with sensors, we support our pump partners, but we're cognizant of this and we're cognizant of the fact that, you know, we need to play here. We've got the best sensor in the world. Our patients are going to want this, we're going to have to offer something to them.

    我們不會永遠坐著讓別人掌控我們的命運。如果沒有人做這件事,而我們看到某個專案進展得非常、非常好,我們就會更深入參與。我們目前還沒找到任何我們願意承諾投入的項目。我們用感測器支援所有人工胰臟計畫,也支援我們的幫浦合作夥伴,但我們很清楚這件事,也清楚我們需要在這裡參與。我們有全世界最好的感測器。病患會想要它,我們必須提供某些方案給他們。

  • - Analyst

    - Analyst

  • Okay. Great. Thank you.

    好的。太好了。謝謝。

  • Operator

    Operator

  • Shaun Rodriguez, Cowen and Company.

    Shaun Rodriguez,Cowen and Company。

  • - Analyst

    - Analyst

  • So first, another angle to one of the pharmacy channel questions. So given the growth here, is there a point over the next few years where you actually need to be pushing a significant portion of the business through this channel to just maintain the service and processing support you need to service patients? Or is there something you think you'll be able to stay ahead of with pretty good visibility in terms of internal resource requirements as you work through the process with the payers?

    首先,從藥局通路問題的另一個角度來問。鑑於這裡的成長,未來幾年是否會出現某個時間點,你們其實需要把相當大一部分業務推到這個通路,才能維持服務病患所需的服務與處理支援?還是說,當你們與付款方推進流程時,你們認為在內部資源需求方面能以相當好的能見度持續領先?

  • - CEO

    - CEO

  • We don't want to build the infrastructure to support our business the way it's designed today. We need to move through these channels. You can just fill building after building after building with employees in the DME environment, and quite honestly that's been one of Medtronic's great barriers to entry in the pump world and why all of our pump -- all the other pumps out there have a hard time making money. It's hard to replicate that structure unless you have a huge amount of revenues.

    我們不想用目前這種設計方式去建置支撐我們業務的基礎設施。我們需要透過這些通路轉移。你在 DME(耐用醫療設備)環境裡,真的可以一棟接一棟、一棟接一棟地蓋大樓塞滿員工;坦白說,那一直是 Medtronic 在幫浦領域的一個重大進入門檻,也解釋了為什麼我們的幫浦——市面上其他所有幫浦都很難賺錢。除非你有非常龐大的營收,否則很難複製那種結構。

  • We really have a mission to go this way; we need to make it more efficient. And think about how much easier it is for our patients right now, they call us, they fill out paperwork, they get letters from their doctors, et cetera. Glucose [flags] if we give them this at the pharmacy and drop some of the criteria, you go to your doctor and get a prescription, drop it off at Rite Aid and pick it up the next day when it shipped from Cardinal Health or McKesson or whoever to the drugstore.

    我們確實有一個使命要走這條路;我們需要讓它更有效率。想想看,對我們的病患而言現在有多麻煩:他們打電話給我們、填寫文件、從醫師那裡拿到信件等等。如果我們在藥局把這個給他們,並放寬一些條件,你去看醫生拿處方箋,拿到 Rite Aid 交件,隔天就能取貨——因為產品會由 Cardinal Health、McKesson 或其他供應商配送到藥局。

  • And when it comes to reordering, I don't know if you have any medications but I can tell you if I have 30 days worth of pills I start getting calls on day 27 every single month. So I think it just makes for a much more efficient, better patient order processing experience and the way we'll track that. We're going to give up some control which is very hard for me, but in all reality, when that data is all going to the cloud through your phone, we'll be able to track those patients and we'll know who is buying what and how often they use sensors and whether or they're up for reorder.

    至於再次訂購,我不知道你有沒有在吃任何藥,但我可以告訴你,如果我有 30 天份的藥丸,我每個月到第 27 天就會開始接到電話。所以我認為這會帶來更有效率、對病患更好的訂單處理體驗,以及我們追蹤的方式。我們會放棄一些控制權——這對我來說很難——但實際上,當那些資料都透過你的手機上雲端時,我們就能追蹤那些病患,知道誰買了什麼、多久用一次感測器,以及他們是否該再訂購。

  • And that data, and this data revolution that's coming is going to change our business processes, combined with pharmacy distribution. We see our Company in a far different place in three years.

    而這些資料,以及即將到來的這場資料革命,結合藥局配送,將會改變我們的業務流程。我們看到三年後公司會處在一個截然不同的位置。

  • - Analyst

    - Analyst

  • That's helpful. So jumping around a bit, but you previously talked about some specific reimbursement studies planned for Germany and Sweden, I believe. Any updates on these? And really the question is about the cadence of incremental OUS markets that you'll be opening up over the next, call it 12, 24 months.

    這很有幫助。那我跳著問一下,你們之前談到在德國和瑞典(我記得是這兩個國家)規劃了一些特定的給付研究。這些有任何更新嗎?更核心的問題是:未來大約 12、24 個月內,你們會逐步開放哪些海外(OUS)市場?節奏會是怎樣?

  • - CEO

    - CEO

  • You know, right now, we are opening up more smaller countries, we're in most of the large countries, certainly in Europe. Very little in Asia. Asia, we've got efforts going on in Japan right now, and we're kind of trying to decide what to take to China because we have to take an FDA-approved product over there but it takes some time to get approved and we don't want to get something approved but we don't build anymore. So there's a bunch of dominoes that have to fall in place for China approval.

    你知道的,目前我們正在開放更多較小的國家;在歐洲我們已經進入大多數主要國家。亞洲方面很少。亞洲我們現在在日本有一些努力在進行中,而我們也在思考要把什麼帶到中國,因為我們必須帶一個 FDA 核准的產品過去,但核准需要一些時間,而且我們不想把某個產品核准了、結果我們又不再生產它了。所以要取得中國核准,有一連串的骨牌必須先到位。

  • We've taken very much a shotgun approach in these countries because there hasn't been a lot of reimbursement. So the more countries, the more cash-paying patients, the more product we can sell. I think as we get reimbursement in hopefully in Germany, hopefully in Sweden, and other countries. Over the next 18 to 24 months you could see some significant pickup in sensor revenues overseas as this product is reimbursed, but it'll be a while. It's not going to happen overnight.

    我們在這些國家採取了很大程度的撒網式(shotgun)策略,因為給付並不多。所以國家越多、自費病患越多,我們就能賣出越多產品。我認為當我們在德國(希望如此)、在瑞典(希望如此)以及其他國家取得給付後,在接下來 18 到 24 個月,你可能會看到海外感測器營收有顯著提升,因為這個產品開始獲得給付,但還需要一段時間,不會一夕之間發生。

  • - Analyst

    - Analyst

  • All right, helpful, guys. Thanks very much. Congratulations.

    好,這很有幫助,各位。非常感謝。恭喜。

  • Operator

    Operator

  • Danielle Antalffy, Leerink Partners.

    Danielle Antalffy,Leerink Partners。

  • - Analyst

    - Analyst

  • Congrats on turning profitable and filing G5, big milestones in the quarter. Kevin, or Steve, I was hoping maybe to get some more color on the dosing claim. I think that's really exciting and just wondering how we should be thinking about what kind of trial that would require from a size perspective, and also end points. And just maybe if we can't get more color today, when we would be able to expect some more color from you guys on what that could look like.

    恭喜本季轉虧為盈並提交 G5 申請,都是很大的里程碑。Kevin 或 Steve,我希望能多了解一下「劑量(dosing)宣稱」。我覺得那真的很令人興奮,想請教我們應該如何思考這會需要什麼樣的試驗——例如樣本數規模,以及終點指標。另外,如果今天沒辦法提供更多細節,你們大概什麼時候能讓我們更清楚這可能會長什麼樣子?

  • - CEO

    - CEO

  • I think ultimately, Danielle, we'll have very -- a lot of visibility by the call in August for Q2. We have a number of meetings slated with the agency between now and the end of the second quarter to put this trial together. Suffice it to say it's not going to be a small one.

    我想最終,Danielle,我們在 8 月的第二季(Q2)電話會議時會有——會有很高的能見度。我們在現在到第二季末之間安排了多場與主管機關的會議來把這個試驗設計出來。簡單說,這不會是一個小型試驗。

  • - Analyst

    - Analyst

  • Right. Okay. That's good.

    好。了解。這很好。

  • - CEO

    - CEO

  • (Multiple speakers) test a whole bunch of things in a whole bunch of different patient population segments, et cetera. The guys are doing a great job working with the Agency on this; it's been a very interactive discussion. They want to help us, and so we meet regularly, we're going to get there.

    (多位講者)在很多不同的病患族群分段等等,測試一大堆不同的事情。團隊在與主管機關合作這件事上做得非常好;這一直是非常互動式的討論。他們想要幫助我們,所以我們定期會面,我們會達成的。

  • - Analyst

    - Analyst

  • Yes, I think that's awesome. And so, higher level, my next question is the G4, obviously there was a big step up in new patient adds. How do we think -- but now the base is much larger, of course. So as you guys continue to evolve the technology, how do we think about each short next evolution of technology? So starting with G5, and then G6, and maybe with the dosing claim, and then calibration, the increase in new patient adds. Do you see that just this steady 35% to 40%, which is what you've said historically? Could it be incremental to that? Just high-level, how do we think about that and what could ultimately drive the inflection point here?

    是的,我覺得那很棒。那麼更高層次地說,我下一個問題是:G4 顯然在新增病患數上有很大的跳升。但現在基礎也當然更大了。所以當你們持續演進技術時,我們該如何看待每一次短期的下一代技術演進?從 G5 開始,接著 G6,可能再加上劑量宣稱,然後是取消校準,對新增病患數的提升。你們是否認為會是穩定的 35% 到 40%(這也是你們過去一直說的)?會不會在此之上再有增量?高層次來看,我們該怎麼思考這件事?而最終什麼可能驅動這裡的拐點?

  • Because at the end of the day CGM is still just around 15% of T 1s and as this technology moves along, I mean, I feel like it could be much, much larger than that. And is there any sort of one obstacle you'd have to knock over to get it there?

    因為說到底,CGM 在第一型糖尿病(T1)中的滲透率仍然只有大約 15%;隨著技術持續進步,我覺得它可能會遠遠大於此。是否有任何一個你們必須克服的主要障礙,才能把它推到那個程度?

  • - EVP, Strategy & Corporate Development

    - EVP, Strategy & Corporate Development

  • Danielle, I'll take this one. I think you kind of hit it on the head. You said 35% to 40%. We've never said we were going to sustain 60%-plus growth. So let's start with, we need to sustain 40% growth for the foreseeable future. So our real mission internally is over the next several years, two to three or four years, to be able to continue that 35% to 40% growth rate. In order to do that we have to continue to iterate new and better products to increase the size of the addressable market.

    Danielle,這題我來回答。我想你說得很到位。你提到 35% 到 40%。我們從來沒有說過我們會維持 60% 以上的成長。所以先從這裡開始:在可預見的未來,我們需要維持 40% 的成長。因此,我們內部在未來幾年——兩到三年或四年——真正的使命,是能夠持續那個 35% 到 40% 的成長率。要做到這點,我們必須持續迭代推出更新、更好的產品,以擴大可觸及市場的規模。

  • The way I like to think about it is way back, in the STS 3-day days in 2006, the product didn't work particularly well and there were albeit very small handful of people who were willing to put up with a product that didn't work particularly well. Much better performance in the SEVEN and incremental improvement in the SEVEN PLUS. That drove the addressable market to a much larger size. Now, obviously with the G4 PLATINUM that has been a huge catalyst. I don't -- you used the term inflection point or not, been a huge catalyst for growth in terms of new patient adds.

    我喜歡用這樣的方式來思考:回到很久以前,在 2006 年 STS 三天佩戴的年代,產品其實並不是特別好用,但仍然有(雖然非常少數)的人願意忍受一個表現不太好的產品。到了 SEVEN,效能大幅提升;SEVEN PLUS 也有漸進式改良。這使得可服務市場擴大到更大的規模。現在,顯然 G4 PLATINUM 是一個巨大的催化劑。我不——你用了「拐點」這個詞與否——它確實是推動成長的巨大催化劑,特別是在新增病患數方面。

  • But to sustain, just to sustain this phenomenal growth that we're seeing, you need to get to Gen 5 with our mobile platform. You need to get to Gen 6 to reduce calibration and extend the duration. You need to get to call it Gen 7, 8, 9, eliminate calibration, miniaturization, new applicator. All of the things that we keep talking about in our kind of near to midterm pipeline, I mean kind of near to midterm meaning three to five years. We need to do all of these things, in my opinion, just to sustain the growth that we're trying to achieve.

    但要維持——只是要維持我們目前看到的這種驚人的成長,你必須在我們的行動平台上做到第 5 代(Gen 5)。你需要做到第 6 代(Gen 6)以降低校正需求並延長使用天數。你需要做到所謂第 7、8、9 代:消除校正、微型化、新的貼附器。所有我們一直在談的、屬於近到中期產品線的事情——我所謂近到中期是指三到五年——依我看,我們必須把這些都做完,才能只是維持我們想要達成的成長。

  • So I don't think -- could there be upside to the number? Sure. But I think we're really targeting trying to do the things and iterate the technology in a way that we can assure ourselves that we can continue to grow at the rates we've been growing, or at the rates we've said that we're going to grow.

    所以我不認為——數字有沒有可能有上行空間?當然有。但我認為我們真正的目標,是把事情做好並以能夠反覆迭代技術的方式前進,讓我們能夠確信自己可以持續以我們一直以來的成長速度成長,或以我們所說將要達成的成長速度成長。

  • - Analyst

    - Analyst

  • All right. Thanks for that.

    好的。謝謝你的說明。

  • Operator

    Operator

  • Anthony Petrone, Jefferies.

    Jefferies 的 Anthony Petrone。

  • - Analyst

    - Analyst

  • Maybe a follow-up for Kevin on no-calibration and accuracy. And just thinking ahead as you attempt to do that from a manufacturing standpoint, I imagine it would be a little bit of a higher-cost manufacturing endeavor, so I guess the question is what is DexCom willing to give up in terms of margins in order to achieve reduced- or no-calibrations coupled with improved accuracy?

    也許給 Kevin 一個追問,關於免校正與準確度。往前看,當你們嘗試從製造角度做到這點時,我想這可能會是成本較高的製造工作;所以我的問題是,為了達成降低或免校正並同時提升準確度,DexCom 願意在毛利率方面讓出多少?

  • - CEO

    - CEO

  • You know, that's a great question and every time we make the sensor more accurate, we improve our margins. So, so far, as we've had manufacturing improvements they've been designed in mind that it would be more cost-effective and produce more accurate sensors and produce better yields. I think the key to the no-calibration sensor is to have an extremely repeatable manufacturing process. As I discussed earlier, the Gen 6 manufacturing line eliminates some of the steps that cause errors or yield loss in the G4 system. It is much more automated and much more advanced. There's more steps to automating this process.

    你知道,這是個很好的問題,而且每一次我們讓感測器更準確,我們的毛利率就會改善。所以到目前為止,隨著我們的製造改善,設計時就已考量要更具成本效益、能生產更準確的感測器,並帶來更好的良率。我認為免校正感測器的關鍵,是要有極度可重複的製造流程。如我先前提到的,Gen 6 的製造產線消除了 G4 系統中一些會造成誤差或良率損失的步驟。它自動化程度更高、也更先進。要把這個流程自動化,還有更多步驟要做。

  • So I don't think we'll have to give up much on the margin side, particularly as we go to extended wear, the math becomes quite simple. If we have a 10-day sensor and we can bill at the same per day rate as the seven-day sensor, we can pick up some more margin and even include a little extra cost in that sensor if that's what we have to do to get that label. I don't view it as a trade-off.

    所以我不認為我們需要在毛利率方面犧牲太多,尤其當我們走向延長佩戴時,計算就變得相當簡單。如果我們有一個 10 天感測器,並且能以與 7 天感測器相同的每日計費水準來收費,我們就能多拿到一些毛利,甚至可以在必要時把一些額外成本包含在那個感測器裡,以取得那個標示(label)。我不把它視為一種取捨。

  • - Analyst

    - Analyst

  • Okay, that's helpful. And maybe, just to switch gears to maybe coverage of endocrinologists, you're adding to the sales capability. Maybe just an update on how much room for expansion in the US particularly is there as it relates to adding new practices and then maybe an update on the average penetration of CGM into existing practices.

    好的,這很有幫助。那也許換個話題,談談內分泌科醫師的覆蓋,你們正在擴充銷售能力。能否更新一下在美國,特別是在新增診所方面,還有多少擴張空間?以及 CGM 在既有診所中的平均滲透率更新?

  • - CEO

    - CEO

  • That's a great question and as we've talked on this call several times with Terry when he was here, we have thousands, probably more than 8,000 physicians who prescribed one CGM system in 2014. We certainly have several champions and we consider champions -- a certain level of high prescribers, and that number has gone up but not as fast as we would like. We need to move everybody up further.

    這是個很好的問題。正如我們在這通電話中多次與 Terry(他當時還在)談到的,2014 年有數千名、可能超過 8,000 名醫師曾開立過一次 CGM 系統。我們當然有一些「擁護者」(champions),我們所謂的擁護者——是指達到某個高開立量水準的醫師;這個數字確實增加了,但沒有我們希望的那麼快。我們需要讓每個人都再往上提升。

  • Access drives a bit of that. If a patient can go to their doctor and get a prescription signed and go to the drug store and pick up a sensor, that will take physicians who had to spend inordinate amount of time doing paperwork for the one CGM they prescribed and get them more accustomed to prescribing CGM for their patients. So access is going to help with this, our product improvements are going to help with this. You know the data on the phone, the data in the cloud-based platforms. If we can show the physicians that -- hey look, you can sit down and pull up Steve's data on your computer without Steve plugging anything into his machine, that's pretty cool, and that will help.

    可近性(access)在其中扮演一部分角色。如果病患可以去看醫師、拿到簽好的處方,然後到藥局就能買到感測器,這會讓那些原本為了開立一套 CGM 而必須花大量時間處理文書作業的醫師,更習慣為病患開立 CGM。所以可近性會有幫助,我們的產品改良也會有幫助。你知道,手機上的資料、雲端平台上的資料。如果我們能向醫師展示——嘿,你可以坐下來,在你的電腦上直接拉出 Steve 的資料,而不需要 Steve 把任何東西插到他的機器上,這很酷,而且會有幫助。

  • So we are -- we call on every endo that we can. We're very, very, very specific as far as calling [endos] those who prescribe a lot of insulin and who have large practices, and we've worked our way down the food chain. We move further down those lists as we get bigger every year and there's still more room to grow. But at the end of the day, we still have too many onesies and twosies and we've got to get out to these other guys and get them to increase what they're prescribing.

    所以我們——我們會拜訪每一位我們能拜訪的內分泌科醫師。就拜訪對象而言我們非常、非常、非常精準,會鎖定那些開立大量胰島素、且診所規模大的(內分泌科)醫師,我們也一路往下拓展。我們每年規模變大,就會在名單上再往下延伸,仍然還有成長空間。但歸根結底,我們仍然有太多只開一套、兩套的情況(onesies and twosies),我們必須接觸到其他醫師,讓他們提高開立量。

  • - Analyst

    - Analyst

  • That's helpful and then just last for me, just a clarification on the SHARE ecosystem, is that an open architecture where eventually that data can be shared with competing offerings should they come down the road? Or is the data that's captured in SHARE only compatible with the DexCom CGM, therefore it cannot be accessed by competing companies?

    這很有幫助。那最後一個問題,關於 SHARE 生態系統的澄清:那是一個開放式架構嗎?也就是說,未來若有競品出現,資料最終也能與競爭產品共享?還是說,SHARE 所擷取的資料只相容於 DexCom 的 CGM,因此競爭公司無法存取?

  • - CEO

    - CEO

  • The data that is stored in the cloud from our SHARE platform is right now accessed only by DexCom devices. We have made a lot of progress over the past few months with respect to data and possibly sharing data with others. We have not signed any agreements with anybody to let them access that data in the cloud yet. We will consider it -- if it meets a patient need that we can't meet, and is something that patients want, we are open with respect to architecture as we've demonstrated with our relationships today. I will consider that over time but we're not going to run out and sign everybody up in the world to distract from what we're doing.

    目前從我們 SHARE 平台儲存在雲端的資料,只能由 DexCom 裝置存取。過去幾個月我們在資料方面、以及可能與他人分享資料方面,已取得很大進展。但我們尚未與任何人簽署協議,讓他們存取雲端中的資料。我們會考慮——如果它能滿足我們無法滿足的病患需求,而且是病患想要的,我們在架構上是開放的,正如我們目前的合作關係所展現的那樣。我會隨時間推進來考量,但我們不會為了分散我們正在做的事情,而跑去把全世界每個人都簽進來。

  • - Analyst

    - Analyst

  • Thanks again.

    再次感謝。

  • Operator

    Operator

  • At this time I show no further questions. I'll turn it back to you speakers for final remarks.

    此時我這邊顯示沒有其他提問。我將把時間交回給各位講者做最後結語。

  • - CEO

    - CEO

  • Thank you very much. In closing, I want to address one of the frequent questions that we hear as we meet with others on the outside. Now that you're in charge and Terry has graduated onto Executive Chairman, what's going to change? It's easiest to tell you what's not going to change, and that's our commitment to our patients. Our patient first strategy has put DexCom in a very enviable position. Even one of our competitors referred to our off-the-charts net promoter score at one of their presentations at ATTD. Our passion for patients is what drives this Company. That culture has been put in here by Terry and will never change.

    非常感謝。最後,我想回應一個我們在與外部人士會面時經常聽到的問題。現在你接任負責,而 Terry 已升任執行董事長,會有什麼改變?最簡單的方式是告訴你什麼不會改變——那就是我們對病患的承諾。我們的「病患優先」策略讓 DexCom 處在非常令人稱羨的位置。甚至我們的一位競爭對手在 ATTD 的一場簡報中提到我們「爆表」的淨推薦值(net promoter score)。對病患的熱情是驅動這家公司的力量。這種文化是 Terry 在這裡建立的,而且永遠不會改變。

  • I've been very fortunate for the past three years-plus with Terry in the CEO chair to become familiar with the intimate details of our Company, and help Terry build an excellent team here. What's different now is that our business is really undergoing major changes. You heard it in my prepared remarks earlier as we compared the number of product launches this year to our two previous years. We are much more complex; in addition to our growth, as I said previously, the business has got to be scalable. With this great team we've assembled, I'm very confident that we can execute our very ambitious plans and achieve our simple final goal -- we want to replace finger sticks. Thanks, everybody.

    過去三年多來,Terry 擔任 CEO 期間,我非常幸運能與他共事,因而熟悉公司各項細節,並協助 Terry 在這裡建立一支優秀的團隊。現在不同的是,我們的業務確實正在經歷重大變化。你們在我先前的準備講稿中也聽到了:我們比較了今年的產品上市數量與前兩年的差異。我們變得更複雜;除了成長之外,如我先前所說,這個業務必須具備可擴展性(scalable)。有了我們組建的這支優秀團隊,我非常有信心能執行我們非常雄心勃勃的計畫,並達成我們簡單的最終目標——我們想要取代指尖採血。謝謝各位。

  • 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。