德康醫療 (DXCM) 2010 Q3 法說會逐字稿

Welcome to the DexCom third quarter earnings release conference call. My name is Anthony and I will be your operator for today's call. (At this time, all participants are in a listen-only mode. Later we will conduct and question and answer session. Please note that this conference is being recorded. I would now like to turn the call over to Terry Gregg. Mr. Gregg, you may begin.

歡迎參加 DexCom 第三季財報發布電話會議。我叫 Anthony，將擔任今天會議的接線員。（此時，所有與會者皆為僅收聽模式。稍後我們將進行問答環節。請注意，本次會議將被錄音。現在我想把電話交給 Terry Gregg。Gregg 先生，您可以開始了。）

Thank you and thanks for joining us today for our third quarter earnings conference call. Joining me today is Steve Pacelli, our Chief Operating Officer, and Jess Roper, Chief Financial Officer. I'm going to have Steve lead it off by safe harbors.

謝謝，也感謝各位今天參加我們的第三季財報電話會議。今天與我一同出席的有我們的營運長 Steve Pacelli，以及財務長 Jess Roper。我會先請 Steve 進行前瞻性聲明的安全港說明。

Thanks, Terry.

謝謝你，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 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 the section "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有重大差異的因素清單，詳載於我們的 Form 10-K 年報、Form 10-Q 季報以及其他向美國證券交易委員會（SEC）提交之報告中的「Risk Factors」章節及其他處。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。

Terry?

Terry？

Thanks, Steve. Jess is going to start us off today with a financial review of the third quarter. Then I will follow with a commercial update. Then we'll spend some time talking about the clinical and regulatory environment, including the FDA, our standalone technologies and our partnerships, and then we can move to your questions. Jess?

謝謝，Steve。今天將由 Jess 先為我們進行第三季的財務回顧，接著我會提供商業面更新。之後我們會花一些時間談談臨床與法規環境，包括 FDA、我們的獨立式技術以及合作夥伴關係，然後我們就可以進入各位的提問。Jess？

Great. Thank you, Terry.

好的。謝謝你，Terry。

DexCom recorded product revenue of approximately $10.8 million for the third quarter of 2010, compared to $4.6 million for the same quarter in 2009, an increase of 133%. Sequentially, product revenue for Q3 increased by 19% from the prior quarter. During Q3, we sold over 3,900 systems and sequentially, sensor revenues were up 23% from the prior quarter.

DexCom 2010 年第三季產品營收約為 1,080 萬美元，較 2009 年同期的 460 萬美元成長 133%。以季對季來看，第三季產品營收較前一季成長 19%。第三季期間，我們售出超過 3,900 套系統；以季對季來看，感測器營收較前一季成長 23%。

Total revenue for the third quarter of 2010 was $11.7 million, compared to $7.3 million for the same quarter in 2009 and included $0.9 million in development grant and other revenue from our development and collaboration agreements with Edwards Lifesciences and Animas Corporation. Sequentially, development grant revenue declined from $2.7 million to $0.9 million as we reforecasted the timeframe for recognition of the balance of our development grant revenue from the end of 2010 to the end of 2011.

2010 年第三季總營收為 1,170 萬美元，較 2009 年同期的 730 萬美元增加，其中包含 90 萬美元的開發補助金及其他收入，來自我們與 Edwards Lifesciences 與 Animas Corporation 的開發與合作協議。以季對季來看，開發補助金收入由 270 萬美元降至 90 萬美元，原因是我們重新預測開發補助金收入餘額的認列時程，從原先預計於 2010 年底改為 2011 年底。

Our decision to reforecast the recognition of our development grant revenue was based on longer-than-expected development and regulatory review timelines under our development and collaboration agreements with Edwards and Animas. Terry will elaborate on this during his prepared remarks.

我們決定重新預測開發補助金收入的認列，係基於在與 Edwards 與 Animas 的開發與合作協議下，開發與法規審查時程較預期更長。Terry 將在其事先準備的發言中進一步說明。

We will recognize the same aggregate amount of development grant revenue, but going forward, the amount recognized per quarter will drop from approximately $2.6 million to $0.9 million and will now be recognized over a longer period of time, through the end of 2011. These quarterly amounts exclude any milestone-based payments that we may also earn. The impact of our change in recognition of our development grant revenue to our net loss in the third quarter was an increased loss of approximately $1.7 million.

我們將認列相同的開發補助金收入總額，但未來每季認列金額將由約 260 萬美元降至 90 萬美元，並將在更長期間內認列，延續至 2011 年底。這些每季金額不包含我們可能另外取得的任何里程碑式付款。第三季因變更開發補助金收入認列方式，對淨損的影響為損失約增加 170 萬美元。

Cost of sales, including both product and non-product, totaled $8.2 million for the quarter. Product cost of sales totaled $7.0 million for the Q3 of 2010, compared to $4.6 million for the same quarter in 2009. Sequentially, product cost of sales increased by $0.7 million from Q2 to Q3 of 2010 due to the increased number of starter kits and sensors sold during the quarter.

本季銷貨成本（包含產品與非產品）合計 820 萬美元。2010 年第三季產品銷貨成本為 700 萬美元，較 2009 年同期的 460 萬美元增加。以季對季來看，2010 年第二季至第三季產品銷貨成本增加 70 萬美元，係因本季售出的入門套件與感測器數量增加。

The corresponding improved gross margin totaling $3.8 million were 35% in the Q3, compared to $2.7 million or 30% in Q2 in the prior quarter, was mainly due to additional product revenue. During the third quarter we increased inventory, primarily hardware components, by $2.3 million in the prior quarter in anticipation of Flextronics, our contract manufacturer, relocating our production line and in anticipation of increased sales volumes.

相對應的毛利改善，第三季毛利合計 380 萬美元、毛利率為 35%，相較前一季第二季毛利 270 萬美元、毛利率 30%，主要係因產品營收增加。第三季我們增加存貨（主要為硬體零組件）230 萬美元，係為因應我們的委外製造商 Flextronics 搬遷生產線，以及預期銷售量增加。

Flextronics is in the process of relocating our production line from California to China. We expect the new production line to be validated and subsequently approved by the FDA in Q1 of 2011 and for production to start immediately thereafter. We also expect to add some additional hardware inventory in Q4 of this year in anticipation of the move and then to manage this inventory down beginning Q1 of 2011.

Flextronics 正在將我們的生產線自加州遷移至中國。我們預期新的生產線將於 2011 年第一季完成驗證並隨後取得 FDA 核准，之後立即開始生產。我們也預期在今年第四季為因應搬遷而增加部分硬體存貨，並自 2011 年第一季起開始降低該存貨水位。

In addition, we expect to increase our sensor inventories in Q4 to account for a shutdown of our internal sensor manufacturing lines for approximately two weeks, during Q1 of 2011, to perform upgrades and maintenance. This may lead to a small improvement in gross margins in Q4 due to an increase in manufacturing overhead absorption. Conversely, during Q1 of 2011 we anticipate a slight softening of our product margin as we manage our inventory levels down.

此外，我們預期在第四季增加感測器存貨，以因應 2011 年第一季我們內部感測器製造產線約兩週的停機，用於升級與維護。由於製造費用吸收增加，這可能使第四季毛利率小幅改善。相反地，在 2011 年第一季，隨著我們降低存貨水位，預期產品毛利率將略有走弱。

Development and other costs of sales totaled $1.2 million for the third quarter of 2010, compared to $1.8 million during the same quarter of 2009. The decline was primarily due to lower expenditures related to the development of our hospital-based system. Sequentially, development and other cost of sales increased slightly quarter-to-quarter.

2010 年第三季開發及其他銷貨成本合計 120 萬美元，較 2009 年同期的 180 萬美元下降。下降主要係因與我們院內（hospital-based）系統開發相關的支出較低。以季對季來看，開發及其他銷貨成本略有增加。

Research and development expense totaled $6.2 million for Q3, compared to $3.5 million in Q3 of 2009. The increase in R&D costs was attributed to additional efforts associated with our next generation ambulatory products. Sequentially, R&D costs increased by approximately $0.7 million from the prior quarter.

第三季研發費用合計 620 萬美元，較 2009 年第三季的 350 萬美元增加。研發成本增加主要歸因於我們下一代攜帶式（ambulatory）產品相關的額外投入。以季對季來看，研發成本較前一季約增加 70 萬美元。

Selling, general and administrative expense totaled $10.4 million in Q3 of 2010, compared to $8.9 million in the Q3 of 2009. The increase was primarily due to additional selling, customer service, and information technology costs to support revenue growth. Sequentially, SG&A remained flat over the prior quarter.

2010 年第三季銷售、一般及行政費用合計 1,040 萬美元，較 2009 年第三季的 890 萬美元增加。增加主要係因為支援營收成長而新增的銷售、客服與資訊科技成本。以季對季來看，SG&A 與前一季持平。

Our net loss for the quarter totaled $13.4 million, compared to $13.5 million doing the same quarter in 2009, and included $3.5 million non-cash charges. Sequentially, quarter-to-quarter, our net loss increased by $1.7 million, primarily due to recognizing a lower amount of development and grant revenue during the quarter as previously discussed.

本季淨損合計 1,340 萬美元，較 2009 年同期的 1,350 萬美元略為改善，其中包含 350 萬美元的非現金費用。以季對季來看，我們的淨損增加 170 萬美元，主要係因如前所述，本季認列的開發補助金收入金額較低。

During the quarter we converted out the remaining $4.0 million of our convertible debt, leaving a balance of $0 at quarter-end. The loss per share was $$0.23 and we ended the quarter with $32 million in cash, restricted cash, and marketable securities.

本季期間，我們將剩餘 400 萬美元的可轉換公司債全數轉換，使季末餘額為 0。每股虧損為 0.23 美元；季末我們持有 3,200 萬美元的現金、受限制現金及有價證券。

I would to now turn it back to our President and CEO, Terry Gregg.

現在我想把電話交回給我們的總裁暨執行長 Terry Gregg。

Thanks, Jess. Well, the third quarter of 2010 represented yet another quarter of sequential growth for DexCom. We were extremely pleased with our performance as we again exceeded analyst consensus estimates for Starter Kit sales and product revenue and we achieved a positive product gross margin of 35% for the quarter.

謝謝，Jess。2010 年第三季對 DexCom 而言，再次是連續成長的一季。我們對表現感到非常滿意，因為我們再次在入門套件銷售與產品營收方面超越分析師一致預期，並且本季達成 35% 的正向產品毛利率。

Highlighting some key metrics from the third quarter, total product revenue grew approximately 19% sequentially, from Q2 2010 to Q3 2010, and was up 133% compared to the third quarter of 2009. We sold approximately 3,900 Starter Kits for the SEVEN PLUS in third quarter, amounting to an 11% increase in Starter Kits compared to Q2 2010 and up 84% compared to the third quarter of 2009. And we posted an increase of approximately 23% in sensor revenues, quarter-to-quarter, as the stickiness among patients who go on the system continues to grow.

第三季的一些關鍵指標如下：總產品營收季對季約成長 19%，由 2010 年第二季提升至 2010 年第三季；相較 2009 年第三季則成長 133%。我們在第三季售出約 3,900 套 SEVEN PLUS 入門套件，較 2010 年第二季入門套件增加 11%，較 2009 年第三季增加 84%。同時，感測器營收季對季約增加 23%，因為使用本系統的病患黏著度持續提升。

We are pleased to report that the demand for our SEVEN PLUS remains strong heading into the fourth quarter and as we have discussed previously, the fourth quarter is historically a strong quarter for product sales in the durable medical equipment business.

我們很高興報告，進入第四季之際，我們的 SEVEN PLUS 需求仍然強勁；且如我們先前所討論，第四季在耐用醫療設備業務中，歷來是產品銷售表現強勁的一季。

Our pipeline of new patient referrals continues to expand and we expect a positive trends in sensor utilization we have witnessed thus far in 2010 to continue during the fourth quarter. We'll also continue to work diligently to deliver our message of convenience, performance, and simplicity to patients and caregivers alike. We continue to drive home our message, supported, of course, by published clinical outcomes data that "all sensors are not created equal".

我們的新病患轉介管線持續擴大，我們預期截至目前在 2010 年所觀察到的感測器使用率正向趨勢，將在第四季延續。我們也將持續努力，向病患與照護者傳達我們在便利性、效能與簡易性方面的訊息。我們也持續強化我們的主張，當然並有已發表的臨床結果數據支持：「並非所有感測器都一樣」。

With a substantially larger field presence, we expect our competition will continue to attempt to create confusion in the marketplace with regard to sensor performance. Nonetheless, with the best performing commercial sensor, we will stay the course and we will continue to win the hearts, minds and loyalty of patients and healthcare providers.

隨著我們在第一線的佈局大幅擴增，我們預期競爭對手將持續試圖在市場上就感測器效能製造混淆。儘管如此，憑藉表現最佳的商用感測器，我們將堅持既定方向，並持續贏得病患與醫療照護提供者的認同、信任與忠誠。

With only 26 direct field sales personnel, commercial reach is one of our greatest challenges. Yet we continue to make excellent progress in gaining share. Heading into 2011, we expect to add a modest number of additional sales and clinical personnel to our field ranks and we may explore one or more partnership arrangements involving the promotion of our standalone CGM systems in order to supplement our direct salesforce without significant additional expense.

我們僅有 26 名直屬第一線銷售人員，商業觸及範圍是我們最大的挑戰之一。然而，我們在提升市占方面仍持續取得優異進展。展望 2011 年，我們預期將在第一線團隊中適度增聘銷售與臨床人員；同時也可能探索一項或多項合作夥伴安排，推廣我們的獨立式 CGM 系統，以在不顯著增加額外費用的情況下補強直營銷售團隊。

Shifting now to an update on clinical and regulatory affairs. In early October this year we were subject to a follow-on site inspection by the Los Angeles District Office of the Food and Drug Administration. As you'll recall, several months ago we received a Warning Letter from the agency. We worked cooperatively with the FDA in response to the Warning Letter and we are pleased to report that we concluded this follow-on site inspection with no 483 observations. Additionally, we just this week we received written notification from the FDA that we had resolved to their satisfaction all outstanding issues cited in the Warning Letter.

接著更新臨床與法規事務進展。今年 10 月初，我們接受了美國食品藥物管理局（FDA）洛杉磯區辦公室的後續現場稽查。如各位所記得，數月前我們收到該機構的警告信（Warning Letter）。我們就警告信與 FDA 合作回應，並很高興報告，本次後續現場稽查結束時未收到任何 483 觀察事項。此外，就在本週，我們收到 FDA 的書面通知，確認警告信中所列的所有未結事項均已令其滿意地解決。

As you are all well aware, under the leadership of Dr. Margaret Hamburg, the FDA is undergoing sweeping changes to its review and approval policies and procedures and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products. The FDA has embraced a renewed focus on patient safety and risk avoidance.

各位都很清楚，在 Margaret Hamburg 醫師的領導下，FDA 正對其審查與核准政策及程序進行全面性變革，並將提升其對所有醫療器材所採用之法規科學水準列為優先事項，以更妥善地評估、衡量與審查產品。FDA 也重新聚焦於病患安全與風險避免。

Dr. Hamburg has emphasized publicly that it is the agency's responsibility to promote and protect public health into the 21st Century. As a result, the medical device industry is in the midst of a sudden and dramatic shift in the requirements for product approvals. This has created an atmosphere of unpredictability and uncertainty surrounding the submissions process and, in many instances, it is not altogether clear what the agency will require or expect of new submissions, particularly for companies seeking clearance under the 510(k) regime.

Hamburg 醫師已公開強調，該機構的責任是在 21 世紀促進並保護公共健康。因此，醫療器材產業正處於產品核准要求突然且劇烈變動之中。這使得送審流程充滿不可預測性與不確定性；在許多情況下，機構對新送件究竟會要求或期待什麼並不完全明確，尤其是尋求依 510(k) 制度取得核准的公司。

We are living in an era of heightened scrutiny where requests for additional information are becoming commonplace and consequently, approval times are extended. As we mentioned during our last earnings call, we filed a PMA supplement relating to our fourth generation ambulatory sensor during the second quarter and we have now received a formal written response from the FDA. To call the response comprehensive would be an understatement.

我們正處於審查更為嚴格的時代，要求補充資訊已成常態，因此核准時間也被拉長。如同我們在上次財報電話會議中提到的，我們在第二季就第四代可攜式感測器提交了 PMA 補充申請（PMA supplement），目前已收到 FDA 的正式書面回覆。若說該回覆內容相當全面，仍不足以形容。

Although the Gen4 filing has been classified as a PMA supplement by the agency, we have been requested to provide substantial additional information. For example, we're being asked to repeat certain systems tests that we conducted in support of our original PMA application back in 2004 and 2005. In many ways this feels like a full PMA review rather than a PMA supplement.

儘管該機構將 Gen4 送件歸類為 PMA 補充申請，我們仍被要求提供大量額外資訊。例如，FDA 要求我們重做部分系統測試，而這些測試我們早在 2004 與 2005 年為支持原始 PMA 申請時就已進行。從許多面向來看，這更像是完整的 PMA 審查，而非 PMA 補充申請。

Nonetheless, we are working collaboratively with the FDA as we formulate our response and I am extremely proud of our regulatory team and their continued ability to foster a cooperative relationship with the agency, even in this era of enhanced scrutiny and evolving regulations.

即便如此，我們仍在擬定回覆時與 FDA 協作；我也為我們的法規團隊感到非常自豪，他們即使在審查加嚴與法規持續演變的時代，仍能持續與該機構建立並維持合作關係。

In fact, we believe we have identified an opportunity to accelerate review of our next generation hardware platform as part of an amended Gen4 filing. Specifically, when we conducted the pivotal trial to support our Gen4 sensor filing, our next generation hardware platform, which includes a smaller receiver form factor with a color screen and a modified transmitter with more robust transmission frequency was still in the development stage.

事實上，我們相信已找出一個機會，可將下一代硬體平台的審查加速，並納入修訂後的 Gen4 送件中。具體而言，當我們進行關鍵性試驗（pivotal trial）以支持 Gen4 感測器送件時，我們的下一代硬體平台仍在開發階段；該平台包含更小型的接收器外型並配備彩色螢幕，以及一個經修改、具更強健傳輸頻率的發射器。

Due primarily to the manufacturer ability and scalability benefits provided by the Gen4 sensor, we elected to move forward with the trial and subsequent filing of the Gen4 sensor, paired with our legacy hardware platform. Now, as part of a comprehensive response to the FDA, we intend to include not only the additional information requested by the agency concerning the Gen4 sensor, we expect to include data to support approval of our next generation hardware platform. This would enable us to launch a more robust fourth generation system.

主要因 Gen4 感測器所帶來的製造能力與可擴充性效益，我們選擇推進試驗並進而提交 Gen4 感測器的申請，並與我們既有的硬體平台搭配。現在，作為對 FDA 的全面性回覆之一部分，我們不僅打算納入機構就 Gen4 感測器所要求的額外資訊，也預期將納入支持核准我們下一代硬體平台的數據。這將使我們能推出更強健的第四代系統。

To facilitate this, we expect to complete a small, additional clinical trial with the Gen4 sensor paired with our next generation receiver and transmitter and file an amendment to our Gen4 PMA supplement during the first half of next year. Although we cannot predict the ultimate decision or timing for a decision by the FDA, we believe this amended Gen4 submission will be incorporated into the current Gen4 180-day review cycle, give or take a few months.

為促成此事，我們預期將完成一項小型的額外臨床試驗，使用 Gen4 感測器並搭配我們的下一代接收器與發射器，並於明年上半年提交 Gen4 PMA 補充申請的修正案（amendment）。雖然我們無法預測 FDA 最終決定或作出決定的時間點，但我們相信此一修訂後的 Gen4 送件將被納入目前 Gen4 的 180 天審查週期中，前後可能相差數個月。

So, while our timeline for launching the Gen4 system will be slightly delayed, through an open and transparent dialog with the agency we believe we will be in a position to provide the additional information requested of us regarding the Gen4 sensor and at the same time, accelerate review of our next generation hardware platform, which would position us to launch yet another best in class CGM system during the second half of the year.

因此，雖然我們推出 Gen4 系統的時程將略為延後，但透過與機構進行公開且透明的對話，我們相信我們將能提供其所要求的 Gen4 感測器額外資訊；同時，也能加速下一代硬體平台的審查，使我們有機會在下半年推出另一套同級最佳（best in class）的 CGM 系統。

Shifting to our combination products, the regulatory uncertainty facing the insulin pump market is particularly daunting. Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear. This changing landscape will certainly impact approval timelines in the United States for our integrated systems with Animas and Insulet, as I suspect it will for Medtronic and the numerous small, privately-funded pump companies seeking to bring new pump products to market.

接著談到我們的組合產品（combination products），胰島素幫浦市場面臨的法規不確定性尤其令人卻步。如今胰島素幫浦公司很可能面臨其幫浦產品被納入第二類器材（class two）的新子類別監管，在該類別下核准標準仍在變動中，且對人體臨床數據的要求也不明確。這樣的變動格局，勢必會影響我們與 Animas 及 Insulet 的整合系統在美國的核准時程；我推測 Medtronic 以及眾多由私人資金支持、試圖將新幫浦產品推向市場的小型幫浦公司也將面臨同樣影響。

As you know, we filed a PMA supplement seeking approval of an integrated insulin pump continuous glucose monitoring system with Insulet Corporation earlier this year. We've now received a formal written response from the agency regarding our submission and much like the response to our Gen4 submission, the FDA has requested substantial additional information, including additional human clinical trial data concerning the safety of insulin delivery by the system.

如各位所知，我們今年稍早提交了 PMA 補充申請，尋求核准與 Insulet Corporation 的整合式胰島素幫浦連續血糖監測系統。我們目前已收到機構就該送件的正式書面回覆；與對我們 Gen4 送件的回覆相似，FDA 要求提供大量額外資訊，其中包括關於該系統胰島素輸注安全性的額外人體臨床試驗數據。

We are working with Insulet to formulate an appropriate response to the agency, but due to the time and expense associated with conducting an additional clinical trial, Insulet is evaluating whether it makes sense to move forward with the existing combination product that uses our SEVEN PLUS and the current OmniPod or whether it would be more beneficial for potential patients to incorporate our current or future generation CGM technology into Insulet's next generation OmniPod platform and conduct a more expansive trial as requested by FDA.

我們正與 Insulet 合作擬定對機構的適當回覆；但由於進行額外臨床試驗所需的時間與費用，Insulet 正在評估：是否應推進現有的組合產品（使用我們的 SEVEN PLUS 與現行 OmniPod），或對潛在病患而言，將我們現有或未來世代的 CGM 技術整合至 Insulet 的下一代 OmniPod 平台，並依 FDA 要求進行更大規模的試驗，是否更具效益。

We are also exploring the opportunity to submit an IDE relating to the existing combination product for research purposes, which would allow us use of the system in various artificial pancreas studies in the near-term.

我們也在探索提交一項與現有組合產品相關的 IDE（研究用器材豁免）之機會，以研究用途為目的，這將使我們能在短期內於各項人工胰臟研究中使用該系統。

With respect to our integrated system with Animas Corporation, we are pleased to report that we have concluded development and are nearing completion of final systems testing. However, in light of the uncertain clinical and regulatory landscape I just mentioned and based on our review of the additional information requested by FDA in response to our PMA supplement filing with our combination product with Insulet, we are seeking a pre-IDE meeting with the agency to determine the best clinical path to support approval of our combination product with Animas in the United States.

就我們與 Animas Corporation 的整合系統而言，我們很高興報告開發已完成，且最終系統測試也接近完成。然而，鑑於我剛提到的不確定臨床與法規環境，並基於我們對 FDA 就我們與 Insulet 的組合產品 PMA 補充申請所要求之額外資訊的檢視，我們正尋求與機構進行 pre-IDE 會議，以確定在美國支持我們與 Animas 組合產品核准的最佳臨床路徑。

While this path will not enable us to file a PMA supplement for the Animas system this calendar year, we believe that working, on a collaborative basis, with FDA prior to conducting a human clinical study is the most prudent course of action, from a timing perspective, and certainly the most cost-effective way to proceed. In addition, we remain committed to filing for CE Mark approval before the end of this year and expect to be in a position to launch the combination product in Europe during the first half of next year.

雖然此一路徑將使我們無法在本曆年內為 Animas 系統提交 PMA 補充申請，但我們相信，在進行人體臨床研究之前以合作方式與 FDA 先行溝通，從時程角度來看是最審慎的作法，也無疑是最具成本效益的推進方式。此外，我們仍致力於在今年底前提交 CE Mark 核准申請，並預期可在明年上半年於歐洲推出該組合產品。

We also mentioned during our last earnings call that we had submitted a 510(k) application for our first generation IV-based continuous glucose monitoring system developed in collaboration with Edwards Lifesciences. We have now received a formal written response from the agency regarding this submission and - no surprise - the FDA is asking for additional information.

我們也在上次的財報電話會議中提到，我們已就與 Edwards Lifesciences 合作開發的第一代、以靜脈（IV）為基礎的連續血糖監測系統提交了 510(k) 申請。我們現在已收到主管機關就此提交案的正式書面回覆，而且——毫不意外——FDA 正在要求提供更多資訊。

We are currently working with Edwards to determine the most appropriate response regarding the Gen1 system. However, we have made considerable progress in the development of our second generation system and we have agreed with Edwards, that should the agency require additional systems testing or additional human clinical data to support the Gen1 510(k) filing, our most prudent course would be to focus on completing Gen2 development and filing for CE Mark approval.

我們目前正與 Edwards 一起研議針對第一代系統最適當的回應方式。不過，我們在第二代系統的開發上已取得相當大的進展，並且已與 Edwards 達成共識：若主管機關要求額外的系統測試或額外的人體臨床資料以支持第一代 510(k) 申請，我們最審慎的作法將是專注完成第二代的開發，並申請 CE Mark 認證。

As Edwards' CEO Mark Mussallem mentioned during the Edwards earning call last week, this may enable us to launch the second generation product in Europe before the end of next year. We expect to work with the agency to ensure that our Gen2 clinical protocols, systems testing and ultimately our FDA filing for Gen2, meet the FDA's evolving requirements. If we shift from Gen1 and focus our efforts solely on Gen2, we would expect to work with Edwards to appropriately modify our contract to account for our milestone payments.

正如 Edwards 執行長 Mark Mussallem 上週在 Edwards 的財報電話會議中所提到的，這可能使我們能在明年年底前於歐洲推出第二代產品。我們預期將與主管機關合作，確保我們第二代的臨床試驗方案、系統測試，以及最終第二代的 FDA 申報，符合 FDA 不斷演進的要求。若我們從第一代轉向、並將資源完全聚焦於第二代，我們預期將與 Edwards 合理調整合約，以反映我們的里程碑付款安排。

Now I want to spend a few moments talking about advanced technology. Certainly driving the Gen4 system and our partnership products through the regulatory process to commercialization remains a primary focus of our clinical, regulatory and R&D teams. However, we cannot lose sight of the value of innovation to the development and growth of the CGM category and it is critical for us to maintain our technology advantage over competition.

接下來我想花幾分鐘談談先進技術。當然，推動第四代系統以及我們的合作夥伴產品通過法規審查並實現商業化，仍是我們臨床、法規與研發團隊的首要重點。然而，我們不能忽視創新對 CGM 類別發展與成長的價值；對我們而言，維持相較競爭對手的技術優勢至關重要。

We continue to make progress on our fifth generation sensor system, which we are developing not only as an advanced ambulatory sensor, but also as a subcutaneous sensor for use in the hospital outside of critical care. We continue to believe maintaining good glycemic control as patients transition from the ICU to other areas of the hospital is important in reducing morbidity and mortality, thus positively impacting the economics of caring for these patients.

我們在第五代感測器系統方面持續取得進展；我們開發它不僅作為更先進的院外（ambulatory）感測器，也作為可在醫院非重症照護環境使用的皮下感測器。我們仍然相信，當病患從加護病房（ICU）轉至院內其他區域時，維持良好的血糖控制對降低罹病率與死亡率很重要，進而對照護這些病患的經濟效益帶來正面影響。

So, in conclusion, DexCom is on track for a strong 2010 as the market-leading performance of our CGM technology continues to improve the lives of people with diabetes.

因此，總結而言，DexCom 正朝向 2010 年強勁表現的目標前進；我們作為市場領先者的 CGM 技術持續提升，並改善糖尿病患者的生活。

Just last month, we were pleased to learn that the American Association of Clinical Endocrinologists, or ACE, published consensus guidelines for CGM. This is the first-ever full consensus statement on CGM by ACE and is based on both the clinical experiences of ACE members and published clinical data. ACE recommends CGM for patients who are frequently hypoglycemic, who have A1c levels over their target, who experience large variability in their glycemic levels, who need to lower their A1c levels without increasing hypoglycemic events and/or who are pregnant or are planning to become pregnant.

就在上個月，我們很高興得知美國臨床內分泌醫師協會（American Association of Clinical Endocrinologists，ACE）發布了 CGM 的共識指引。這是 ACE 首次針對 CGM 發表完整的共識聲明，內容基於 ACE 會員的臨床經驗以及已發表的臨床數據。ACE 建議將 CGM 用於：經常發生低血糖的患者、A1c 高於目標值的患者、血糖波動幅度很大的患者、需要在不增加低血糖事件的情況下降低 A1c 的患者，以及／或已懷孕或計畫懷孕的患者。

In the ACE press release, it was noted that "CGM technology will likely become a key component of comprehensive diabetes management, particularly with Type 1 diabetes patients and that consistency of use is key, as studies have shown that the more consistently CGM is used the better the result for the patient". We are obviously pleased to see a consensus statement of this nature by the leading organization of endocrinologists in the United States.

在 ACE 的新聞稿中指出：「CGM 技術很可能成為全面性糖尿病管理的關鍵組成，特別是第一型糖尿病患者；而持續一致地使用是關鍵，因為研究顯示 CGM 使用越一致，患者的結果就越好。」我們顯然很高興看到美國內分泌科醫師領導組織發布此類共識聲明。

Certainly the regulatory environment in which we are operating is challenging. So much so that on October 12, 2010 a group of congressional lawmakers sent a letter to Dr. Hamburg asking here to delay the implementation of certain changes that the agency is considering for the 510(k) program. Lawmakers have raised concerns that their implementation could prevent companies from using important evidence in product applications, delay the introduction of innovative new therapies, and potentially upset the delicate balance that exists between providing information to the public and protecting intellectual property.

我們所處的法規環境確實充滿挑戰。挑戰之大，以至於在 2010 年 10 月 12 日，一群國會議員致函 Hamburg 醫師，要求她延後實施主管機關正在考慮的 510(k) 計畫若干變更。議員們提出疑慮，認為若予以實施，可能會阻止公司在產品申請中使用重要證據、延遲創新新療法的導入，並可能打破在向大眾提供資訊與保護智慧財產之間既有的微妙平衡。

I'm often asked about my greatest fears facing our industry. Honestly, it is the fear that the American medical device companies, long known as the leaders in medical innovation, will be forced to look to international markets to first launch new products where barriers to entry are less stringent. This could have a severe impact on the quality of care for patients in the U.S. and for our economy.

我經常被問到，面對我們產業時我最大的擔憂是什麼。坦白說，我擔心長期以來以醫療創新領導者著稱的美國醫療器材公司，將被迫轉向國際市場，先在進入門檻較不嚴格的地區推出新產品。這可能對美國病患的照護品質以及我們的經濟造成嚴重影響。

At the same time, I am reminded how fortunate we are to have a best in class, FDA-approved commercial product in the SEVEN PLUS that is making a difference in the lives of our patients each day. And that trajectory of our growth, both as a category and our Company, puts DexCom in a very enviable position despite the challenges of the current regulatory environment. We will continue to aggressively invest in our future, which we believe is very bright.

同時，我也再次體會到我們有多麼幸運：我們擁有同級最佳、已獲 FDA 核准的商業化產品 SEVEN PLUS，每天都在改變病患的生活。而我們的成長軌跡——無論是整個類別或公司本身——即使在目前法規環境的挑戰下，仍使 DexCom 處於令人稱羨的位置。我們將持續積極投資於我們的未來，而我們相信前景非常光明。

Thank you and we'll now entertain questions.

謝謝各位，接下來我們開始回答問題。

Thank you (Operator Instructions) Tom Gunderson, Piper Jaffray & Co.

謝謝（接線員指示）。Tom Gunderson，Piper Jaffray & Co.。

Hi. So that was a lot on the FDA, so let me see if I can dig in a little bit and just make sure that I caught it. If we look at Gen4, Terry, I'm sorry, you did a good job of going through a lot of this, but I'm not sure I caught it. If I take it to the bottom, are you going to do a sensor plus legacy hardware or are you just skipping over that and going to sensor plus the new hardware?

嗨。剛才談了很多 FDA 的部分，我想再深入一點，確認我有沒有聽懂。Terry，如果我們看第四代（Gen4），抱歉，你把很多內容講得很清楚，但我不確定我是否抓到重點。若我把問題簡化到最核心：你們會做「感測器＋既有硬體（legacy hardware）」的版本，還是會跳過那一步，直接做「感測器＋新硬體」？

We've already done the legacy with the Gen4 in the pivotal trial, but because they asked for additional not only sensor information, Tom, we've elected now to do the next trial as a brand new system in terms of the Gen4, which hasn't changed. That'll be add-on to the clinical data that they already have, plus the new hardware, the new transmitter, as well as global receiver.

我們在關鍵性試驗（pivotal trial）中已經用第四代做過既有硬體的版本；但因為 FDA 要求的不只是額外的感測器資訊，Tom，我們現在選擇在下一個試驗中以全新系統來進行，就第四代而言感測器本身並沒有改變。這將作為他們既有臨床資料的補充，再加上新硬體、新的發射器，以及全球版接收器。

And that's what will be launched first?

而那會是第一個推出的版本？

Correct. That will be launched first.

沒錯。那會先推出。

Okay and then I know this is painful, but I just have to make sure I understand it and that is on the Animas pump, which is approved, and your SEVEN PLUS, which is approved, they're asking for more data?

好。我知道這很痛苦，但我必須確認我理解正確：Animas 的幫浦已核准，你們的 SEVEN PLUS 也已核准，但他們仍在要求更多數據？

Yes. I think if you look at this whole area with regards to 510(k), back a few months ago they - "they" being FDA - issued new pump proposed guidance.

是的。我想如果你回頭看整個 510(k) 相關領域，幾個月前他們——「他們」指的是 FDA——發布了新的幫浦擬議指引。

Yes.

是。

That said, and the creation between Class 2a products and Class 2b products and pumps, insulin pumps, other pumps, LVPs, were also included in this proposed Class 2. The Class 2 now requires, under the guidance proposal and then I'll add the fact that they're actually using that and rejecting 510(k) applications from pump companies today, even though it's a guidance document, not officially sanctioned guidelines, that that requires clinical trial and the actual pumping of insulin. So we have to go through that yet with the Animas product.

該指引提到，並建立了 Class 2a 產品與 Class 2b 產品之間的區分；而幫浦、胰島素幫浦、其他幫浦、LVPs 也被納入這個擬議的 Class 2。依照該擬議指引，Class 2 現在要求進行臨床試驗，並且要實際進行胰島素輸注。我還要補充一點：即使這只是指引文件、並非正式核准的規範，他們目前也確實在採用，並拒絕幫浦公司今天提交的 510(k) 申請。因此，Animas 產品我們也必須走完這個流程。

Tom, just to clarify, actually. You're referring to the Insulet combination. Insulet, if you'll recall, is paired with the SEVEN PLUS. The Animas product, when complete and filed, will be paired with the Gen4 sensor.

Tom，我澄清一下。你其實是在指 Insulet 的組合。你如果記得，Insulet 是與 SEVEN PLUS 配對的。Animas 的產品在完成並提交申請後，將會與第四代感測器配對。

Thanks, Steve, yes.

謝謝你，Steve，是的。

So, still, I understand the rules as they've been put out there, but it seems like on the cusp for already approved might have might have gotten a by, but they didn't, so you've got to join the crowd.

所以，我仍然理解他們公布的規則，但看起來對於已經核准的產品，本來可能可以放行，但他們沒有放行，所以你們也得跟大家一起排隊。

No, I think, in this regulatory environment, no ones getting a by.

不，我認為在這種法規環境下，沒有人能被放行。

Yes. That's what it feels like. It applies to not only the development and the launch of new products, but as you pointed out in the beginning, it also applies to how we recognize the developmental revenues. Can you give us a sense of what you're looking at for new timing for Gen4, Edwards, Animas and Insulet in the U.S.?

是，感覺就是如此。這不僅影響新產品的開發與上市；正如你一開始指出的，它也影響我們如何認列開發收入。你能否讓我們了解一下，你們對於第四代、Edwards、Animas 以及 Insulet 在美國的新時程大概怎麼看？

Well, that's three different systems, four possibly, as we relate to it. I think in the case of -- let's start with Gen4. That's most near and dear to our hearts today.

嗯，這牽涉到三個不同的系統，可能是四個。我想就——先從第四代開始吧。那是我們目前最關心、也最重要的。

Yes.

是。

We will respond to the agency in the early part of next year. Can't give us an absolute data when we expect to have that filing. If, as I mentioned in my prepared remarks, we still fall under that 180-day review, the expectation would be late next year we could we introduce our product in the U.S. Again, I caution everyone. This is a moving target as it relates to the FDA and anything, I'm sitting here, is trying to look through a crystal ball that is quite cloudy.

我們將在明年年初回覆該機構。無法給出我們預期提交該申請的確切日期。如同我在事先準備的發言中提到的，如果我們仍落在那個 180 天的審查期內，預期我們可能在明年年底於美國推出我們的產品。再次提醒各位，這在 FDA 相關事項上是一個不斷變動的目標；我坐在這裡試圖透過一顆相當混濁的水晶球來預測。

I think, then, if you look at Animas as the next kind of combination, since it is using Gen4 we can't get that combo product approved certainly until the Gen4 is approved in the United States. But, as I mentioned, we have already filed the Gen4 with the agency. We've filed it with our notified body. I think getting it into the international sector in the first half of next year is something that is very doable. Unfortunately, then, it puts us in a position where the U.S. is a secondary market to the European sector for that combination product.

我想接下來如果你看 Animas 作為下一個組合，因為它使用 Gen4，我們當然不可能在 Gen4 於美國獲准之前就讓那個組合產品獲准。不過，如我所提到的，我們已經向該機構提交了 Gen4。我們也已向我們的公告機構提交。我認為在明年上半年把它推進到國際市場是非常可行的。不幸的是，這使我們在那個組合產品上處於美國成為相對於歐洲市場的次要市場的位置。

And the same situation is in the Edwards Lifesciences; in prepared remarks, say that if the agency is going to come back and force us to do more work on the Gen1 that was never intended to be a fully commercializable version. That was to gain awareness and understanding at the user level and to then come forth with a Gen2 product as a full, commercializable product. That is still the intent. I think, given what Mike said and the Edwards remarks and what I said earlier today, we would look to introduce that in the European sector late next year, towards the fourth quarter of next year.

Edwards Lifesciences 的情況也是一樣；在事先準備的發言中提到，如果該機構回頭要求我們在 Gen1 上做更多工作，而 Gen1 從來就不是要作為一個完全可商業化的版本。那是為了在使用者層面建立認知與理解，然後再推出 Gen2 作為完整、可商業化的產品。這仍然是我們的意圖。我想，基於 Mike 所說的、Edwards 的發言以及我今天稍早所說的，我們會考慮在明年年底於歐洲市場推出，接近明年第四季。

The Insulet situation is a bit more difficult to describe, only from the standpoint that Insulet's got to make some decisions as to what they want to do going forward, either to move forward with the SEVEN PLUS or, if they make the decision to go to Gen4 or even Gen5 for the future product, as they look at their own economic situation and just make that decision if they're going to combination that with our next generation system.

Insulet 的情況比較難描述，主要是因為 Insulet 必須就未來要怎麼做做出一些決定：要嘛繼續推進 SEVEN PLUS；要嘛如果他們決定未來產品要採用 Gen4 甚至 Gen5，則需考量他們自身的經濟狀況，並決定是否要把它與我們的下一代系統做組合。

I think those discussions are ongoing. No definitive answers have come of that. I'll just tell you my opinion is if I were driving the ship I'd be launching with the SEVEN PLUS, because I would certainly want to have some cannibalization going on of the existing pump combo by Medtronic. But I don't make that decision.

我認為這些討論仍在進行中，尚未有明確答案。我只能說我的看法是，如果由我掌舵，我會用 SEVEN PLUS 上市，因為我當然希望能對 Medtronic 現有的幫浦組合產品產生一些蠶食效應。但這不是我能做的決定。

Got it. I've got ten more, but I'll pass for now and get back in queue. Thanks, Terry.

了解。我還有十個問題，但我先暫停，回到隊列再問。謝謝你，Terry。

Bill Plovanic, Canaccord Genuity

Bill Plovanic，Canaccord Genuity

Great. Thank you. Can you hear me?

很好，謝謝。你聽得到我嗎？

Yes, Bill.

是的，Bill。

Great. Thanks. So, we'll start with kind of off the last question. Do you currently have an agreement with Insulet for the next generation, the Gen4 or that's the decision they have to make whether they would option that in?

很好，謝謝。那我們就從上一個問題延伸一下。你們目前是否已與 Insulet 就下一代（Gen4）達成協議，還是說這是他們必須決定是否要選擇納入的事項？

I'll let Steve answer.

我讓 Steve 來回答。

Yes. Well, the answer is no, not specifically. Our current contract does not provide for access to our future technology and certainly we're open to discussing that with them, via, as Terry mentioned, Gen4 or potentially even Gen5, depending on the development timelines there. I think the big question is whether we push forward hard and fast with the current developed product, which incorporates the Gen3 technology, versus looking at something that would require some additional development, time and expense and additional clinical work. So that's really a decision for the Insulet team at this point.

是的。嗯，答案是否，沒有特別針對下一代。我們目前的合約並未提供他們取得我們未來技術的權利；當然我們也願意與他們討論，如 Terry 所提到的 Gen4，或視開發時程而定，甚至可能是 Gen5。我認為最大的問題在於：我們是要快速且積極地推進目前已開發完成、採用 Gen3 技術的產品，還是要轉向需要額外開發、時間與費用，以及更多臨床工作的方案。所以目前這確實是 Insulet 團隊要做的決定。

Okay and then to gain clarity on the an -- I'm sorry, on the Edwards, you mentioned the EU second half '11 with the Gen2. Could we hypothesize then that the U.S. would be a late 2011 or probably even a 2012 as you just gain experience with the Gen2 in Europe?

好的，那再釐清一下關於——抱歉，關於 Edwards 的部分。你提到 Gen2 在歐盟於 2011 年下半年推出。那我們是否可以推測，美國會是在 2011 年底，或更可能是 2012 年，因為你們需要先在歐洲累積 Gen2 的使用經驗？

Well we're still, at this point, in discussion with the agency with regards to Gen1 and once we have a definitive answer from them as to what they're really looking for, the that will be the basis for what we do with Gen2 in the U.S.

嗯，我們目前仍在就 Gen1 與該機構討論；一旦我們從他們那裡得到明確答覆，了解他們真正想要的是什麼，那將成為我們在美國對 Gen2 採取行動的基礎。

But let's assume for discussion that they're going to ask us to do more systems testing and more additional clinical work on the Gen1. That doesn't make sense on a product that we only intended to have (technical difficulty) introduction just to gain experience with. So we would move much faster to Gen2. Therefore, under that scenario, Bill, Gen2 in the U.S. would be a 2012 and my guess, at this point, given what I know, following the Gen2 EU introduction. But again, it's a little bit -- I don't have good analytics on that yet, because we don't have all the information from the FDA yet.

但假設為了討論，他們會要求我們在 Gen1 上做更多系統測試以及更多額外的臨床工作。對於一個我們原本只打算（技術問題）做有限導入、只是為了累積經驗的產品而言，這沒有意義。因此我們會更快轉向 Gen2。所以在那種情境下，Bill，Gen2 在美國會是 2012 年；以我目前所知，我猜會是在 Gen2 於歐盟導入之後。但同樣地，這有點——我目前還沒有好的分析，因為我們還沒有從 FDA 得到所有資訊。

And then a tougher question, I guess. If you decide to just skip Gen1 and go right to Gen2, do you get a milestone payment from Edwards?

那再問一個比較棘手的問題。如果你們決定直接跳過 Gen1、改做 Gen2，你們仍會從 Edwards 收到里程碑款嗎？

I think I mentioned in the prepared remarks, yes there are. If you look back at the agreement, there's a $2.5 million Gen2 CE Mark and a $5.0 million Gen2 FDA approval and then a $2.0 million Gen2 Japan approval. So, I think the question is on the Gen1 FDA approval of $2.5 million plus some additional developmental dollars, that's what has to be reworked in the contract.

我想我在事先準備的發言中提過，是的，有里程碑款。回頭看協議，有 250 萬美元的 Gen2 CE 認證里程碑、500 萬美元的 Gen2 FDA 核准里程碑，另外還有 200 萬美元的 Gen2 日本核准里程碑。所以我想問題在於 Gen1 的 FDA 核准 250 萬美元加上一些額外的開發費用，這部分需要在合約中重新調整。

Okay and then just on the nature of the additional data. Obviously this all takes time, but is there anything in there that would be longer-term follow-up than what you've normally done in any of your studies?

好的，那關於額外資料的性質。顯然這些都需要時間，但其中是否有任何項目需要比你們以往研究更長期的追蹤？

No. No. I think some of the challenge -- you know in the world of glucose metering, there's a lot of debate that's going on with regards to the current ISO standard and so, as you know, there was first the PQQ enzyme issue and then there was a recommendation that the ISO standard be tightened. That has not beneficially done and so the agency has yet to give us any clear targets as to what their requirements are. Therein lies some of our problem. They don't know what they want yet and so therefore its kind of hard for us to plan accordingly, even to initiate additional bench top work or even additional clinical work. We don't know what the target is and I don't think they yet know what the target is. So its a little bit of a conundrum and very frustrating for the industry to try to target something that is yet to be defined.

沒有。沒有。我想部分挑戰在於——你知道，在血糖量測領域，對於現行 ISO 標準有很多正在進行的辯論。所以，如你所知，先是 PQQ 酵素的議題，接著又有人建議要收緊 ISO 標準。但這並沒有帶來正向的進展，因此該機構至今仍未給我們任何明確目標，說明他們的要求是什麼。這就是我們問題的一部分：他們還不知道自己想要什麼，因此我們也很難據此規劃，甚至難以啟動額外的台架測試或額外的臨床工作。我們不知道目標是什麼，而我也不認為他們目前知道目標是什麼。所以這有點兩難，也讓整個產業非常挫折，因為要去對準一個尚未被定義的目標。

Okay and then what type of ASPs did you see on your starter kits?

好的，那你們在入門套組（starter kits）上看到的 ASP 是多少？

We had ASPs of about $800 this last quarter.

我們上一季的 ASP 大約是 800 美元。

Really? So its going up?

真的嗎？所以它在上升？

Its gone up a little bit steadily, quarter-by-quarter.

它每一季都在穩定地小幅上升。

Thank you. Well, the good news is the base business continues to perform very well. Thank you very much.

謝謝。好消息是，基本業務持續表現得非常好。非常感謝。

Matt, William Blair & Company

Matt，William Blair & Company

Good afternoon. Its actually Matt in for Ben, kind of following up on Bill's question a little bit. If we could talk about that base business, I mean, the performance in the quarter and what's typically a seasonally soft quarter was very good. Can you talk about the patient follows in the quarter? Was it function of reimbursement? Is that sticky kind of improving a bit? Could you get better penetration of MDI patients? Can you just talk a little bit about the patient flows in the quarter?

午安。其實我是 Matt，代替 Ben 發問，算是延續 Bill 的問題一點。如果我們談談基本業務，這一季在通常屬於季節性偏淡的季度裡表現非常好。你能談談本季的病患流入（patient flows）嗎？這是報銷（reimbursement）的因素嗎？那種黏著度是否有些改善？你們是否能更深入滲透 MDI 病患？能否稍微談一下本季的病患流入？

Yes. No, it all boils down to more patients coming in, so that's the start of the cycle. Certainly our -- I won't call it the backlog, but the folks that are in line as they've come in, into our we call them opportunities, that flow has increased. Certainly both from pump patients as well as from MDI patients.

是的。不，歸根結底就是有更多病患進來，這是循環的起點。當然，我們——我不會稱之為積壓（backlog），但那些已經進來、排在隊列中的人，我們稱之為機會（opportunities），那個流量增加了。確實同時來自幫浦病患以及 MDI 病患。

I think we were still running in the last survey around 60% pumps, 40% MDI patients, which I think an increasing number of patients are using the product more consistently and that's the term we use, this term "stickiness" from this standpoint. But we're seeing more patients who use the product 24/7 rather than either not using the product 24/7 or even deciding not to use the product at all. And so I think that's all contributing to this growth.

我認為我們在上一份調查中仍大約是 60% 使用幫浦、40% 為 MDI 病患；我認為越來越多病患更一致地使用產品，而從這個角度我們用的術語是「黏著度（stickiness）」。但我們看到更多病患是 24/7 使用產品，而不是沒有 24/7 使用，甚至乾脆決定完全不使用。因此我認為這些都在促成這項成長。

I also think there's just greater awareness of CGM as a category, so we're beginning to get exposure beyond the traditional just endocrinology group treating Type 1 patients. We see referrals coming in from internal medicine, from family practice and general practitioners that are now much more aware of CGM as a category. Obviously having the ACE group come out with a positive recommendation is huge, because many of the folks who are non-endocrinology specialists but have large diabetes practices look to ACE for their recommendations of treatment therapy.

我也認為 CGM 作為一個品類的認知度就是更高了，所以我們開始獲得超越傳統僅限於治療第一型病患的內分泌科群體之外的曝光。我們看到轉介來源包括內科、家醫科與一般科醫師，他們現在對 CGM 這個品類的認識高出許多。顯然 ACE 團體給出正面建議非常重要，因為許多非內分泌專科、但擁有大量糖尿病門診的醫師，會參考 ACE 對治療療法的建議。

So I think its just a whole combination of our product is performing extremely well. We're producing the best sensors in the history of this Company in terms of accuracy, durability, and just a general robustness. Each quarter we tend to get better just as we increase in volume and move to more of a manufacturing controlled environment, less variability. And at the same time, we've got a growing awareness of CGM as an instrumental tool in reducing the amount of glycemic variability for these patients. So there's no one thing that is driving it. I think it's a combination.

所以我認為這就是多種因素的綜合：我們的產品表現非常好。我們正在生產本公司歷史上最好的感測器，就準確度、耐用性以及整體強韌性而言都是如此。每一季隨著產量提升、並轉向更受製造流程控管的環境、變異更小，我們往往都會變得更好。同時，大家對 CGM 作為降低這些病患血糖波動的重要工具的認知也在提升。所以並不是單一因素在驅動；我認為是組合效應。

Okay and then just flipping over to the production side of things and I caught a little bit of what Jess was saying, late. But the move to Flex, that's new news to me. Are you -- just walk us through that again a little bit in terms of I think you said you're going to ramp up inventory in Q4 in anticipation of that, move the manufacturing over there in Q4. Then it'll come online in Q1 and you'll start to work down that inventory beginning of next year. When do you think that you'll start to really see the benefits of Flex and then any sense of it longer-term, even on the Gen3 product, where the cost per system can go, in terms of manufacturing out of China?

好的，接著切換到生產端，我有點晚才聽到 Jess 剛才說的一部分。不過轉到 Flex，這對我來說是新消息。你能不能再帶我們走一遍？我想你說的是你們會在第四季為此先拉高庫存，並在第四季把製造移到那邊；然後第一季會上線，明年年初開始消化那批庫存。你認為什麼時候會真正開始看到 Flex 的效益？另外，長期來看，甚至在 Gen3 產品上，若在中國製造，每套系統的成本可能會走到什麼水準？

Well, I don't think that when we look at the opportunities from a reduction in COGS, that's really at the sensor level more so then at the hardware level. We do expect to see some reduction by moving to China, but when we talk about the great reductions that really Gen4 manufacturing, when we talk about COGS.

嗯，我不認為我們在檢視降低 COGS（銷貨成本）的機會時，重點會在硬體層級；主要是在感測器層級。我們確實預期移到中國會帶來一些降低，但當我們談到大幅降低時，那主要是 Gen4 製造所帶來的——也就是我們談 COGS 時的重點。

I think there is some 5.0% to 10% upside moving to China on the hardware side, but again, that's why we were stressing to move into Gen4. That's why we ran the pivotal trial with legacy hardware from that standpoint, because there were so many benefits on the manufacturing scalability of Gen4. So we're having to postpone that as a result of the agency delay, but the hardware is as I've stated.

我認為在硬體端移到中國大概有 5.0% 到 10% 的上行空間，但同樣地，這也是我們強調要轉進 Gen4 的原因。這也是為什麼我們在關鍵性試驗中使用既有硬體，因為從那個角度看，Gen4 在製造可擴充性上有很多好處。因此因主管機關延遲，我們不得不延後，但硬體部分如我所述。

Okay and then one last one and I apologize if it's a bit of a tough one. But just given the delay in integrated systems' gross margins are likely to be a bit softer than people have modeled and then additional spending on SG&A for new reps and then some more R&D spending. I mean, how do you feel about your cash position? Do you think you'll need to come back to the markets to raise more money or do you think you can get to profitability with the existing cash balances and other financing options?

好的，最後一題，如果有點尖銳先說抱歉。但考量到整合式系統的延遲，毛利率可能會比大家模型預估的更疲弱，另外還有為新業務代表增加的 SG&A 支出，以及更多的研發支出。我的意思是，你們對現金部位的看法如何？你們覺得需要再回到資本市場募資，還是你們可以用現有現金餘額與其他融資選項達到獲利？

Well, we still -- we exited the quarter at $32 million and still another $17 million due us from the milestone payments. $1.0 million we should get from Animas yet this year and $4.0 million in the first half from Animas as we hit that milestone in the first part of next year for OUS.

嗯，我們仍然——本季結束時有 3,200 萬美元，另外還有 1,700 萬美元的里程碑款項應收。Animas 今年內我們應該還會收到 100 萬美元，明年上半年在我們達成明年初 OUS 的那個里程碑時，還會再收到 Animas 的 400 萬美元。

We're always looking at it from that standpoint. Obviously we're sensitive to our cash needs. We discuss it with the board routinely and we keep an eye on the ball from that standpoint, but that's about the only way I can address is. I always remain anti-dilutive myself, but we have to do what's in the best interest of the Company.

我們一直都從這個角度在看。顯然我們對現金需求很敏感。我們會定期與董事會討論，也會持續緊盯這件事，但我大概只能這樣回應。我個人一向傾向避免稀釋，但我們必須做對公司最有利的事。

Okay, thank you.

好的，謝謝。

Richard Lau, Wedbush Securities Inc.

Richard Lau，Wedbush Securities Inc.

Hi guys, thanks for taking my questions. I think I'm all set on the FDA stuff, but I was wondering, you were talking about increased stickiness in the quarter. Can you comment at all on how long patients are now wearing the sensor per week or per month (inaudible - multiple speakers)?

嗨，各位，謝謝回答我的問題。我想 FDA 的部分我都了解了，但我想問的是，你們提到本季黏著度提升。你們能否談談病患現在每週或每月配戴感測器的時間有多長（聽不清楚－多位講者）？

Well, I mean, let's get to the -- they're supposed to wear it a week at a time.

嗯，我是說，先回到——他們本來就應該一次配戴一週。

Right.

對。

The indication for use. And that's all we promote and recommend. That said, obviously even by evidence of some of the questions that FDA is asking us on the Gen4 and their comments to us that, "DexCom, we know the patients traditionally wear your sensor for a longer period of time than the recommended use." As a result of that, they've asked us to do some additional testing relative to indwelling time in patients of a longer nature.

這是使用適應症（indication for use）。我們也只宣傳與建議這個。話雖如此，顯然從 FDA 對 Gen4 問我們的一些問題、以及他們對我們的評論也可看出來：他們說「DexCom，我們知道病患傳統上配戴你們的感測器時間會比建議使用時間更長。」因此，他們要求我們針對較長的體內留置時間（indwelling time）做一些額外測試。

So, I would say and I can only reflect on that if you look at people like Close Concerns that have indicated some in their surveys over 75% of the patients on DexCom tend to wear it routinely and vigorously and that's what we're continuing to see. Those types of reorder patterns, which would indicate the patients, when they go off or they cease wearing a sensor regardless of what the timeframe is, that they immediately put a new sensor on and activate it. So we're beginning to see that continue to creep up and I think that's positive. That's where we're seeing that stickiness.

所以我會說——我只能從這個角度反映：如果你看像 Close Concerns 這類機構在其調查中指出，超過 75% 的 DexCom 病患傾向於例行且積極地配戴，而我們也持續看到這種情況。這類補貨（reorder）模式顯示，病患一旦停用或停止配戴感測器——不論時間框架為何——他們會立刻換上新的感測器並啟用。因此我們開始看到這個比例持續上升，我認為這是正面的；這就是我們看到的黏著度。

Okay, great and then just can you guys comment at all about the Type 2 clinical trial that's going on? I believe there was a Walter Reed study that was scheduled to complete in September.

好的，很好。接著你們能否談談正在進行的第二型糖尿病臨床試驗？我記得有一項 Walter Reed 的研究原本排定在九月完成。

Yes. The only thing we know, now there's a meeting next week in Bethesda at the Diabetes Technology meeting.

是的。我們目前知道的唯一資訊是，下週在 Bethesda 會有一場 Diabetes Technology 會議。

Yes.

是。

I don't know if [Dr. Legursky] is going to be presenting. We know that the last patient should be enrolled this month, so I wouldn't expect anything. At best we would get interim data next week and I doubt it. I think given the nature -- and it's a 100-patient clinical trial for a year, Type 2 patients, half on SMBG, half on CGM. My suspicion is that he's going to want not to disclose information. He probably wants to present it at ADA here in San Diego in June and wants to not jeopardize having it in a major peer-reviewed journal. But that's kind of the status. That's the only status I know.

我不知道 [Dr. Legursky] 是否會發表。我們知道最後一位受試者應該會在本月完成入組，所以我不預期會有什麼消息。最好的情況是下週可能拿到期中數據，但我也懷疑。考量到試驗性質——這是一個為期一年的 100 位第二型病患臨床試驗，一半使用 SMBG，一半使用 CGM——我猜他會希望不要揭露資訊。他可能想在六月於聖地牙哥的 ADA 發表，並且不想影響在主要同儕審查期刊發表。但大致狀態就是這樣；這是我唯一知道的進度。

Okay, thanks and then one last question. I was kind of poking around on your website and I noticed for a little while now that you guys are making upgrades to the online store. Is there any sense of the timing of when the online store will be up and running?

好的，謝謝，最後一個問題。我剛剛在你們網站上稍微看了一下，我注意到你們有一段時間在升級線上商店。線上商店何時會上線營運，有沒有大概的時間點？

Yes. I mean, it is a project that we're currently undertaking. It's a 2011 project for sure. It'll be launched. I can't give us an exact time in 2011. It'll be launched first, Richard, with respect to reorders and then, so we're going to roll it out incrementally, for reorders first and then for new patients to the therapy.

有的。我的意思是，這是我們目前正在進行的專案，確定是 2011 年的專案。它會上線。我無法給出 2011 年的確切時間點。Richard，首先會先針對補貨（reorders）上線，然後我們會逐步推出：先做補貨，接著再提供給新病患開始使用這項治療。

Okay, thank you.

好的，謝謝。

Mimi Pham, Needham & Co.

Mimi Pham，Needham & Co.

Hi, good afternoon.

嗨，午安。

Hi Mimi.

嗨，Mimi。

Regarding the FDA requirement for clinical trial data for the integrated OmniPod and SEVEN PLUS, you're using both devices the same way, except for the screens, combined in one PDM. Can you just help us understand what their concern is and what they might get out of a clinical study?

關於 FDA 對整合式 OmniPod 與 SEVEN PLUS 的臨床試驗資料要求，你們使用這兩個裝置的方式其實相同，除了螢幕之外，並且整合在同一個 PDM 裡。你能否協助我們理解他們的疑慮是什麼，以及他們可能想從臨床研究中得到什麼？

Well, again, let's date back for a period of time and FDA's never had the opportunity, because of the 510(k) mechanism, to push these companies in this direction. That's the pump company, so we have to separate this. They want to insulin being pumped. It has very little to do with DexCom. It has almost everything to do with the pump side of the equation and then the integration.

嗯，再次強調，讓我們把時間往回推一段時間，FDA 因為 510(k) 機制，從來沒有機會把這些公司往這個方向推。那是幫浦公司，所以我們必須把這點區分開來。他們關注的是胰島素被幫浦輸注這件事。這跟 DexCom 幾乎沒有關係。幾乎全部都跟整個等式中的幫浦端以及後續的整合有關。

We've done all the human factors work that we needed to do, showing that patients could use the different screens. They could toggle between them effectively. They understand all of those applications. So now its, once these pump guidelines went into place, and Dr. Hamburg has stated publicly that the reason that they want to move pumps into this Class 2b is because over the last few years there have been over 50,000 reported MDRs for pump problems, both in insulin pumps reported by insulin groups as well as people like Baxter, CareFusion and Hospera and their large volume pumps in the hospital.

我們已經完成了所需的所有人因工程工作，證明病患可以使用不同的螢幕。他們可以有效地在螢幕間切換。他們理解所有這些應用。所以現在，一旦這些幫浦指引上路，而 Hamburg 博士也公開表示，他們之所以想把幫浦移到這個 2b 類別，是因為過去幾年針對幫浦問題通報的 MDR 超過 50,000 件，包含胰島素幫浦由胰島素相關團體通報的，以及像 Baxter、CareFusion、Hospera 這些公司在醫院使用的大量輸注幫浦。

So, we have to -- even though you have a 510(k) notified pump that's been on the market and you have a PMA approved CGM that's been on the market for a number of years, they now take this opportunity - "they" being the agency - to say, "Aha, now they want you to do this, which they should have been doing all along".

所以，我們必須——即使你有一個已通過 510(k) 通知、且已上市的幫浦，以及一個已通過 PMA 核准、且已上市多年的 CGM，他們現在就趁這個機會——「他們」指的是主管機關——說：「啊哈，現在他們要你做這個，而這其實是他們早就應該一直在做的。」

I can't really -- and remember, I've spent nine years in the pump world. I can't really fault the agency from that standpoint. And I've long said it amazed me that the pumps were 510(k) products that carry around anywhere from 180 to 300 units of insulin, which is a potential lethal amount of insulin. And so they were never quite required to do all the types of clinical evaluations that other more significant-risk devices were subject to.

我其實很難——而且記得，我在幫浦領域待了九年。從這個角度我也很難苛責主管機關。我一直都覺得很驚訝，幫浦竟然是 510(k) 產品，卻隨身攜帶大約 180 到 300 單位的胰島素，這是可能致命的胰島素量。因此，他們從未被真正要求做其他更高風險裝置所需的各類臨床評估。

So I think its just the agency flexing their muscle to say now we have this, we have a rationale. Remember, Dr. Hamburg. Publicly it is their, FDA's, responsibility to promote and protect humans in a clinical setting into the 21st Century and they're exercising their muscle.

所以我認為這只是主管機關在展現他們的權力，表示現在我們有這個，我們有理由。記得 Hamburg 博士。公開來說，這是他們——FDA——的責任，在 21 世紀的臨床環境中促進並保護人類，而他們正在行使這個權力。

And you used the word substantial. Did you guys get some sort of indication of patient trial size and follow-up timelines?

你用了「相當大」這個詞。你們是否得到任何關於受試者試驗規模以及追蹤時間表的指示？

No. I think if you're talking about the integrative product --.

沒有。我想如果你談的是整合式產品——。

For the integrative product, correct.

是的，整合式產品，沒錯。

No. I think its just that's part of the required -- we've got to go back to them. Insulet and DexCom make a decision as to the path forward, go back to them, secure their prior approval of the clinical trial protocol and then move forward from there. I can tell you I was at AdvaMed two weeks ago. Dr. Hamburg spoke there and made a recommendation to 1,700 attendees that whatever they're doing, they want to be part of the protocol development process.

沒有。我想那只是要求的一部分——我們得回去找他們。Insulet 和 DexCom 會就前進路徑做出決定，回去與他們溝通，先取得他們對臨床試驗方案的事前核准，然後再往前推進。我可以告訴你，我兩週前在 AdvaMed。Hamburg 博士在那裡演講，並向 1,700 位與會者建議，不管他們在做什麼，主管機關都希望參與試驗方案的制定流程。

So we can fight them or we can work in a collaborative fashion. We have, we DexCom, have elected to work with them in a collaborative fashion and present those in advance of protocols.

所以我們可以跟他們對抗，也可以用合作的方式。我們——DexCom——選擇以合作方式與他們合作，並在事前提交那些試驗方案。

Yes and I think that's reflected, Mimi, in our path forward with Animas. Rather than stay the course that we had charted in terms of the clinical trial that we were anticipating conducting before the end of this year and filing with Animas, we took a step back and we're going to work collaboratively with the FDA to get that clinical protocol blessed before we jump into a trial with Animas. So we think we can do it, out of the gate, do it the right way the first time.

是的，我想這也反映在我們與 Animas 的前進路徑上，Mimi。與其維持我們原先規劃的路線——也就是預期在今年底前進行臨床試驗並與 Animas 一起送件——我們退一步，將與 FDA 合作，在我們與 Animas 啟動試驗之前，先讓臨床方案獲得核可。所以我們認為我們可以一開始就把事情做對，第一次就用正確方式完成。

Got it and secondly, can you give us any ballpark figures on how many new centers or prescribing endos you sold SEVEN PLUS into, starter kits into the third quarter?

了解。第二個問題，你能否給我們一個大概的數字，第三季你們把 SEVEN PLUS（入門套件）賣進了多少新的中心或新的開立處方的內分泌科醫師？

No. We don't publish that information (inaudible - multiple speakers).

不行。我們不公布那項資訊（聽不清楚——多位講者）。

Would you characterize that there is enough under-penetrated areas out there to continue to expand the number of new centers and prescribing?

你會不會形容，市場上仍有足夠多尚未充分滲透的區域，可以持續擴大新的中心與開立處方的數量？

Clearly.

當然。

Okay and then just is there any current backlog in the back office or is that a totally done issue at this point?

好，那麼目前後台是否還有任何積壓，還是說到目前為止已經完全不是問題了？

It's a non-issue. I mean, we monitor the opportunities. There are basically mathematical models that we use. We know when an opportunity comes in. How fast we, depending upon the insurance, that that opportunity or that patient has, how fast we can get them through the system. Actually, its all home built. Its not something you can buy off the shelf. You have to build the software program with our utilization. So we've increased our sales numbers and throughput without increasing the back office folks, so its been quite effective and efficient.

這不是問題。我的意思是，我們會監控機會。我們基本上使用數學模型。我們知道當一個機會進來時，依據保險狀況——也就是那個機會或病患所擁有的保險——我們能多快把他們在系統中跑完流程。其實那套系統都是自建的，不是你能買現成的。你必須依照我們的使用情境來打造軟體程式。所以我們在不增加後台人員的情況下，提高了銷售量與處理量，因此相當有效率、也很有效。

And in another separate device sector, I guess they were talking about some pushback from insurers in late September and through October about them adding some requirements for devices and putting more resources behind the preapproval process. Did you see anything new over the last month or two on the payor side where they're trying to make it harder at all?

另外在另一個獨立的裝置領域，我想他們提到保險公司在 9 月下旬到 10 月期間有一些反彈，說他們對裝置新增了一些要求，並在事前核准流程投入更多資源。過去一兩個月在付款方那邊，你們有看到任何新的情況，讓他們試圖讓流程變得更困難嗎？

No. Actually, if anything we've seen a couple of the blues modify their criteria to make it easier and we think that's going to continue to move in that direction and then, on top of that, you have ACE coming out last month with a very strong statement. So I don't see any of that and then the data is irrefutable. No matter where you look, anything associated with CGM shows two things. Number one, you can reduce your A1c significantly without the increase in hypoglycemia and the second, the more you use it the better the results.

沒有。其實如果有的話，我們看到有幾家藍十字（Blue plans）修改了他們的標準，讓流程更容易，我們認為這個方向會持續。另外，上個月 ACE 發布了一份非常強而有力的聲明。所以我沒有看到那種情況，而且數據是無可辯駁的。不管你看哪裡，任何與 CGM 相關的結果都顯示兩件事：第一，你可以在不增加低血糖的情況下，顯著降低 A1c；第二，你用得越多，結果越好。

So the one thing we'd still like to see, obviously, is an economic analysis applied to that that shows the payor system and which we believe, wholeheartedly, that there will be a reduction in the payments for patients with diabetes in terms of the consequence from diabetes in terms of the morbidity, clinical complications as a result of better glycemic control.

所以我們仍然希望看到的一件事，當然，是把經濟分析套用到這些結果上，向付款方體系證明——而我們也完全相信——對糖尿病病患的支付將會下降，因為更好的血糖控制會降低糖尿病後果所帶來的疾病負擔、以及臨床併發症。

And then one other question, if I can ask. I think before you talked about your sales strategy. You were going to focus more time on MDI patients while your pump partners focused on the pump market. Now that that's pushed out, are you going to add more marketing dollars and resources towards the pump market through over the next year?

然後如果我可以再問一個問題。之前你談到你們的銷售策略：你們會把更多時間放在 MDI 病患，而你們的幫浦合作夥伴則專注在幫浦市場。現在這件事被往後推了，接下來一年你們會不會在幫浦市場投入更多行銷預算與資源？

No. I think our strategy is stay the course. I think our pump partners have an incentive, appropriate incentive that even without a combined system at this point for them, knowing that it is on the horizon, its just the horizon got a little bit further out. But they are highly motivated to get their pumps and so there's still today more than an informal effort, but we're still getting referrals from our pump partners and it that's still the strategy and course of direction that we'll choose to take.

不會。我認為我們的策略是維持既定路線。我想我們的幫浦合作夥伴有誘因——適當的誘因——即使目前他們還沒有一個整合系統，但知道它就在不遠的將來，只是那個時間點稍微往後移了一點。他們仍然非常有動力推動他們的幫浦，因此即使到今天，這已不只是非正式的努力，我們仍然從幫浦合作夥伴那裡獲得轉介，而這仍然是我們會選擇採取的策略與方向。

Okay, thank you so much.

好的，非常感謝。

Jonathan Block, SunTrust Robinson Humphrey

Jonathan Block，SunTrust Robinson Humphrey。

Thanks and good afternoon, guys. Maybe a first question, Jess. Just when I look at R&D it stepped up a little bit here in the third quarter. I'm just curious with some of your commentary, how we can look at that going forward. In other words, does it sort of flatten down from here, because I'm guessing, based on your commentary, the total spend is now likely to occur over a longer period of time?

謝謝，下午好，各位。也許第一個問題，Jess。當我看研發費用時，第三季這裡有小幅上升。我只是好奇，根據你的一些評論，我們該如何看待未來走勢。換句話說，它是否會從這裡開始趨於平緩，因為我猜，根據你的說法，總支出現在可能會分攤在更長的時間期間內發生？

Yes. This is Steve. I think that's right. I mean, look, if there's some additional spend that we'll incur during the first part of next year as we kind of look to enhance some of these clinical trials, we'll do an expanded Gen4 trial. We'll get to the trial with Animas, etc.

是的。我是 Steve。我想你說得對。我的意思是，你看，如果明年上半年我們會因為想要強化其中一些臨床試驗而產生一些額外支出，我們會做一個擴大的 Gen4 試驗。我們也會推進與 Animas 的試驗等等。

So, I would say and then mindful that we need, I hope Terry emphasized it sufficiently, we need to keep our eye on innovation and on the Gen5. So certainly the R&D dollars are not going to go down particularly in the first part of next year, but flat to slight uptick from where we are today I think is reasonable. And I think, as you get out into the 2012, 2013 timeframe is where you start to see that come down.

所以，我會說，同時也要留意我們需要——我希望 Terry 已經充分強調——我們必須把目光放在創新以及 Gen5 上。因此，研發支出在明年上半年當然不會下降；我認為，從目前水準持平到小幅增加是合理的。而我認為，到了 2012、2013 這個時間區間，你才會開始看到它下降。

Okay, great and then, Terry, sorry to circle back on this one, just a lot of moving parts with the FDA lately and I just want to make sure I've got it correctly. In the Gen4, now you're going to go ahead and file the new hardware platform with the Gen4, does that add any complexity to a filing where it's a lot of uncertainty with the FDA right now? In other words, you've gotten the questions from Gen4. If you sort of stay the course and you get that through, now that you're doing what looks like a combined filing, could they come back "Hey, you've got to make some change on the hardware side" and ultimately the whole thing gets kicked back to you in '11?

好的，很好。然後，Terry，抱歉再回到這個問題，最近 FDA 這邊變數很多，我只是想確認我理解正確。在 Gen4 方面，你們現在會把新的硬體平台和 Gen4 一起送件，這會不會讓申請變得更複雜？畢竟現在 FDA 的不確定性很高。換句話說，你們已經收到 Gen4 的問題清單；如果你們照原計畫把它推進並通過，現在看起來像是合併送件，他們會不會回頭說「嘿，你們硬體端也得做些改動」，最後整件事在 2011 年被退回給你們？

Well, I think if you look at the hardware, typically these would be relatively small PMA supplemental filings. From the hardware standpoint, if you look at what are you doing. I mean, the screen's the same. Its really the form factor is smaller. You've gone to a color screen versus an LED that we use now. So I don't see -- we've tried to keep it as much the same in terms of the screens and what the patient would see in order to avoid that potential problem.

嗯，我想如果你看硬體部分，通常這些會是相對較小的 PMA 補充申請（supplemental filings）。從硬體角度來看，你們做了什麼？我的意思是，螢幕是一樣的；主要是外形尺寸更小。你們從目前使用的 LED 改成彩色螢幕。所以我不認為——我們已經盡量在螢幕與病患看到的介面上保持一致，以避免那種潛在問題。

We will do a human factors evaluation, which is required regardless of we were combining it in a single file if we had to do. We would submit that anyhow. That's a standard requirement. The transmitter is, for all purposes, its an improved transmitter. We get greater range. There are just some nice attributes to it. But again, from the FDA standpoint, its no real change from what we're doing today. We're moving, on the transmitter, from 402 MHz to 2.4 GHz, but it's a standard transmission that they see all the time.

我們會做一個人因（human factors）評估，不管我們是否把它合併在單一檔案送件，這都是必須的。我們本來就會提交，那是標準要求。發射器方面，基本上它是一個改良版發射器，距離更遠，也有一些很好的特性。但同樣地，從 FDA 的角度看，這和我們今天在做的並沒有實質改變。我們在發射器上會從 402 MHz 轉到 2.4 GHz，但那是他們經常看到的標準傳輸。

o as long as we're able to do the basic fundamental testing, we know what that is and satisfy that, I don't believe that that makes it anymore complicated at all. Its really the Gen4 sensor has been the bulk of them asking for more information.

所以只要我們能完成基本的核心測試——我們知道那些是什麼——並且滿足要求，我不認為這會讓事情變得更複雜。真正讓他們要求更多資訊的主要是 Gen4 感測器。

Understood and maybe just one or two more. You mentioned building the inventory in Q4 as Flextronics takes you guys over, the production over to China, so first a little one just in terms of gross margins. So we think about it inflating Q4 in and around what, a 100 to 200 basis points that then subsequently comes out as you work down the inventory in the first half of '11?

了解。再問一兩個。你提到在第四季建立庫存，因為 Flextronics 會把你們的生產移轉到中國；先問個小問題，關於毛利率。就毛利來看，我們是否可以把它理解為第四季會被墊高大約 100 到 200 個基點，然後在 2011 年上半年隨著庫存消化而回吐？

Yes that's correct. When we're talking about margin, we're talking about building, in this case sensors as well as hardware, so when we shut down the line in January for those first two weeks, we'll build up some additional sensors. There's some overhead that we'll absorb in that and we do expect kind of in the range of one-to-three margin points that we may have higher in Q4 and then there'd be a little softening in Q1, as we don't need to build as many sensors.

是的，沒錯。當我們談到毛利時，我們指的是在這個情況下建立感測器以及硬體的庫存；因此當我們在一月前兩週停線時，我們會多做一些感測器。這裡面會吸收一些製造費用（overhead），我們預期第四季毛利可能會高出大約 1 到 3 個百分點，然後第一季會稍微走軟，因為我們不需要再生產那麼多感測器。

Okay, great and last one. And I hate to sound so conservative with the FDA, but what is -- from an inventory standpoint, I think you said you expect the FDA to sign off in China in Q1 '11. Where could you go, from an inventory standpoint, God forbid, that that timeline were to slip three or six months?

好的，很好，最後一個。我不想聽起來對 FDA 太保守，但從庫存角度來看——我想你說你們預期 FDA 會在 2011 年第一季對中國那邊簽核。如果萬一那個時程延後三個或六個月，從庫存角度你們能撐到什麼程度？

That's the whole purpose of building up this inventory. Without giving specifics, we have plenty of runway and that's really the exercise that we're undertaking here with some of the inventory. We started the hardware we started to build in the third quarter and we'll continue in the fourth.

這就是建立這些庫存的全部目的。不透露具體細節，我們有足夠的緩衝期（runway），這正是我們透過部分庫存所要做的演練。我們在第三季就開始建立硬體庫存，第四季會繼續。

And if you look, we added about roughly $2.3 million in inventory. Most of that in Q3 was hardware-related. We'll add -- I don't have the exact number, but another $1.0 million or $2.0 million probably in Q4, between a mix of hardware and sensors.

如果你看，我們大約增加了 230 萬美元的庫存。第三季其中大部分與硬體相關。第四季我們還會再增加——我沒有精確數字——大概再增加 100 萬到 200 萬美元，硬體與感測器混合。

Understood. Thanks for your time, guys.

了解。謝謝你們的時間，各位。

Yes.

是。

John Putnam, Capstone Investments

John Putnam，Capstone Investments

Yes, thanks very much. Terry, given the intensity of the discussion with the agency, can you -- do you have any feel, I guess, as to where this process is? Are we just in the beginning? Have you reached the middle? I'm sure you haven't reached the end.

是的，非常感謝。Terry，鑑於與主管機關討論的強度，你能不能——你是否大概感覺得到這個流程目前走到哪裡了？我們是才剛開始嗎？已經到中段了嗎？我確定還沒到尾聲。

Well, I've been doing this for 40 years and I will tell you this is the worst that I've ever seen it in 40 years of medical device experience and I think most CEOs would echo my comment. I don't think we're at the end. I think it'll be interesting to see, with the election, the way that it went yesterday, how much more pressure is brought to bear.

嗯，我做這行 40 年了，我可以告訴你，這是我 40 年醫療器材經驗中見過最糟的情況，我想大多數 CEO 都會附和我的看法。我不認為我們已經到尾聲。我想接下來會很有意思的是，隨著昨天選舉的結果，會有多少更大的壓力被施加出來。

We've already seen a dozen or so congresspeople respond in a very negative way. While I was in D.C. a couple weeks ago I went to Congressman Bilbray's office to meet with his Chief of Staff up on the Hill to talk about us as an employer in San Diego in a growing entity. And there were lots of industry people up on Capital Hill visiting their local congresspeople to express the same kind of concerns and sentiments.

我們已經看到大約十幾位國會議員以非常負面的方式回應。幾週前我在華府時，我去拜訪 Bilbray 眾議員的辦公室，在國會山莊與他的幕僚長會面，談我們作為聖地牙哥的雇主、且是一個成長中的實體。當時也有很多產業人士在國會山莊拜訪各自選區的國會議員，表達同樣的擔憂與情緒。

So time will tell. We saw this before. Not like this. We saw this during the Clinton administration with David Kessler. That was more of an enforcement-minded. This is more big government "we know what's best for you" and we saw how the voters responded to that kind of philosophy yesterday. So I just -- it's a timing issue. But if we're stuck with this no matter what, my guess is two-to-four years.

所以就讓時間來證明。我們以前也看過這種情況——但不是像現在這樣。我們在柯林頓政府、David Kessler 那時候見過，那比較偏向強化執法的思維；而這次更像是大政府式的「我們知道什麼對你最好」。而我們也看到選民昨天對這種理念的回應。所以我只是——這是時間問題。但如果不管怎樣我們都得面對這種狀況，我猜是兩到四年。

Understood. Did they respond at all to the Congressional Letter, the one you mentioned in October?

了解。他們對你在十月提到的那封國會聯名信有任何回應嗎？

I have not seen an public response. There was a meeting this week in Cleveland. I believe Dr. Hamburg spoke from that. We have an individual on our staff that was there. She did not comment on anything that Dr. Hamburg spoke of relative to that letter from the various congresspeople.

我沒有看到任何公開回應。本週在克里夫蘭有一場會議，我相信 Hamburg 醫師在那裡發言。我們有一位同仁在現場；她沒有提到 Hamburg 醫師就那封多位國會議員的信有任何相關評論。

Thanks and another issue. I just wondered where you were on pediatric approval?

謝謝。另一個議題，我想知道你們在兒科核准方面進度如何？

Well, its interesting, because we did, in fact, complete a pediatric trial with Gen4. The results were outstanding and now, but we finished that trial before we got the letter from the agency asking for more information on Gen4 in the adult population, so we've got to go back there. I'm not quite sure what we do with this pediatric pivotal trial information, if it will be sufficient or if they will require us to do another clinical trial. Don't know the answer.

嗯，這很有意思，因為我們確實已經用 Gen4 完成了一項兒科試驗，結果非常出色。但我們是在收到主管機關來函、要求我們就 Gen4 成人族群提供更多資訊之前就完成了那個試驗，所以我們得回頭處理。我不太確定我們要怎麼運用這些兒科關鍵性試驗（pivotal trial）資料；它是否足夠，或他們會要求我們再做一次臨床試驗。我不知道答案。

Wow. Okay. Thanks very much.

哇。好的。非常感謝。

Yes.

是。

Greg Chodaczek, Boenning & Scattergood Inc.

Greg Chodaczek，Boenning & Scattergood Inc.

Hi guys. I know its getting late, so I'll be quick with this. Terry, at the beginning of the year you were talking about high deductibles and co-pays pushing back the purchasing decisions of many of your potential customers. Do you see that waning a little bit as we get into the last half of the year?

嗨，各位。我知道時間有點晚了，所以我會很快。Terry，在年初你提到高自付額（deductibles）與自付額（co-pays）讓許多潛在客戶延後購買決策。你是否看到這種情況在今年下半年有稍微減弱？

Well, yes, we don't see any of that right now.

嗯，是的，我們目前沒有看到那種情況。

Okay.

好的。

I mean, in all the flexible spending accounts and so forth we're not seeing any of that. Obviously we've got Q1 looming in front of us and I would say again that, typically in the durable medical equipment business, Q1 is soft and we expect the January, even into February if it's a repeat of last year, January was very soft. Half of February was soft and then we starting roaring back in second half of February and March was an outstanding month. I'm predicting - and internally we're anticipating - that that's going to be a repeat of last year into the first quarter. But right now nothing that we're seeing, and just the opposite, are showing a strong fourth quarter as we expected.

我的意思是，在各種彈性支出帳戶（flexible spending accounts）等等方面，我們沒有看到那種情況。當然，第一季就在眼前；我再說一次，通常在耐用醫療設備（durable medical equipment）產業，第一季會比較疲弱，我們也預期一月會偏弱，甚至如果重演去年情況，二月也會延續到——去年一月非常疲弱，二月上半也很疲弱，然後我們在二月下半開始強勁反彈，三月是非常出色的一個月。我預測——而且我們內部也在預期——今年第一季會重演去年的情況。但就目前我們看到的，沒有任何那樣的跡象；反而相反，我們如預期看到第四季表現強勁。

All right. So that kind of fizzles out the last part of February and by March you're back to normal?

好。那麼二月最後那段時間就有點逐漸消退，到了三月你們就回到正常狀態了？

That's what happened in this year and so unless something changes in the healthcare environment that would alter that and its pretty predictable.

今年就是這樣發生的，所以除非醫療保健環境出現某些改變而影響到這點，否則它相當可預測。

Okay and with regards -- and maybe this is for Jess, with regards to the ASPs on the starter kits, why are those creeping up?

好的，另外關於——也許這題給 Jess——關於入門套組的 ASP，為什麼會慢慢往上走？

We've had the opportunities to amend our contract with some of the payors and then the new payors that we entered into, we're in a more favorable pricing than we were initially when we started this a couple of years ago.

我們有機會與部分付款方修訂合約，另外我們新簽進來的付款方，相較於兩年前剛開始時，我們拿到更有利的定價。

And do you see that trend continuing?

那你們覺得這個趨勢會持續嗎？

I, well --.

我，嗯——。

That's a great question.

這是個很好的問題。

Yes. That's a good question. I don't know if I would count on just continued pricing forever, but we got some good traction so far.

是的，這是個好問題。我不確定是否能指望價格永遠持續上升，但到目前為止我們確實取得了一些不錯的進展。

Greg, just some color. I don't know, you haven't been following the Company quite as long, but if you look back historically, back when we were a cash pay business, our (inaudible - multiple speakers) --.

Greg，補充一些背景。我不知道你追蹤這家公司有沒有那麼久，但如果你回頭看歷史，當我們還是現金自費的業務時，我們的（聽不清——多人同時說話）——。

Right.

對。

(Inaudible - multiple speakers) the chits were in the $400 or $500 range, crept up into the $600 range, so I think we've done an outstanding job. Our contracting team has done an outstanding job of moving that ASP to where it is today, creeping into that $800 range. I don't know how much more room there is to go, quite honestly. The goal is to, so long as we can maintain that positive ASP, I think we're pretty pleased with our pricing.

（聽不清——多人同時說話）當時那些單據大概在 400 或 500 美元的區間，後來慢慢爬升到 600 美元左右，所以我認為我們做得非常出色。我們的合約團隊在把 ASP 推升到今天的水準、逐步進入 800 美元區間這件事上做得非常出色。老實說，我不知道還有多少上升空間。我們的目標是——只要我們能維持正向的 ASP，我想我們對目前的定價就相當滿意。

Yes. I was a little shocked when you said $800. I was tapping out at about $800, but that was in the middle of next year, but we can adjust that slightly. And with regards to the insulin pumps -- Terry, this is more of a comment than a question. I think you're spot-on with regards to 510(k)s for insulin pumps. I think they're using your old device, the old 508 insulin pump for their predicate devices. I mean, and that's a long time ago, so I think that continues, so I wish you the best on that one. All right, guys, thank you, I appreciate it.

是的。你說到 800 美元時我有點震驚。我原本大概也把上限抓在 800 美元左右，但那是到明年年中，不過我們可以稍微調整一下。至於胰島素幫浦——Terry，這比較像評論不是問題。我認為你對胰島素幫浦的 510(k) 判斷非常到位。我想他們是用你們舊的裝置、舊的 508 胰島素幫浦作為其對照（predicate）裝置。我的意思是，那已經是很久以前的事了，所以我覺得這種情況會持續。那件事祝你順利。好，各位，謝謝，我很感激。

Thanks, Greg, take care.

謝謝你，Greg，保重。

Vivian Wohl, Federated Kaufmann Fund

Vivian Wohl，Federated Kaufmann Fund

Hi guys. There are a couple of questions on the FDA timelines. Are you still thinking that the Animas in combo with the Gen4 could get filed before or after the Gen4 is approved?

嗨，各位。關於 FDA 時程有幾個問題。你們是否仍然認為 Animas 與 Gen4 的組合，可能在 Gen4 核准之前或之後送件？

No it won't be filed before the Gen4 is approved.

不會在 Gen4 核准之前送件。

Okay, so in other words, they can process that in parallel?

好的，所以換句話說，他們可以並行處理？

Yes. Its in lockstep with the Gen4. That's our intent, that once that Gen4 gets filed, the Animas Gen4 combination will be filed very quickly thereafter.

是的。它會與 Gen4 同步推進。我們的意圖是，一旦 Gen4 送件，Animas Gen4 的組合產品會在非常短的時間內隨後送件。

And the same would be true, then, for the Insulet as well, whatever path they go down? They wouldn't need to wait for the Gen --?

那 Insulet 也是一樣嗎，不管他們走哪條路？他們不需要等 Gen——？

No. They would not need to wait for the Gen4 to have a formal PMA approval.

不需要。他們不必等到 Gen4 正式取得 PMA 核准。

Okay and then do you get a sense from Animas that they would be willing to commit to a full launch in Europe before the U.S. approval?

好的，那你是否從 Animas 那邊感覺到，他們願意在美國核准之前就承諾在歐洲全面上市？

Yes.

是的。

Okay.

好的。

I think they've just looked at the regulatory landscape for J&J, not just Animas, and this is what we're going to have to live with and we need to get that product out in the market wherever they're allowed to first. So we've jointly said we would go out into the European market first.

我想他們只是看了 J&J 的法規環境，不只是 Animas，而是整體而言，這就是我們必須面對的現實；我們需要在任何先被允許的市場把產品推出去。因此我們共同表示會先進入歐洲市場。

Okay, thank you.

好的，謝謝。

Bill Plovanic, Canaccord Genuity

Bill Plovanic，Canaccord Genuity

Great, thanks, just a couple points of clarity. One, the ASP on disposables and then two, I know you don't normally do this but you seem to be a bit [prognostic] about Q4. I was wondering if just directionally, in terms of new patient additions, you might give us some color. Is that going to be up 10%, up 20%, up 30%? That would be helpful, from Q3. Thanks.

很好，謝謝，想釐清幾點。第一是耗材的 ASP；第二，我知道你們通常不會這樣做，但你們似乎對第四季有點「預測性」的說法。我想知道如果就方向性而言，在新增病患數方面，你們能否提供一些顏色？相較第三季，是會成長 10%、20% 還是 30%？這會很有幫助。謝謝。

Well, I'll let Jess answer the ASP on the sensors.

好，我讓 Jess 來回答感測器的 ASP。

Sensors is hovering right around $60, just a little north of $60 per sensor.

感測器大約徘徊在 60 美元左右，每個感測器略高於 60 美元。

We've seen that stay pretty consistent over the last several quarters. Yes I do -- listen, I'm not going to give guidance percent-wise. We're having -- we're having, in other words, four days into November. We've got October behind us. We're happy with what we're seeing, both from patients we've already shipped and what's in the opportunity going forward.

過去幾個季度我們看到這個水準相當一致。是的，我確實——聽著，我不會用百分比給指引。我們現在——換句話說，11 月才過了四天。我們已經走完 10 月。我們對目前看到的情況感到滿意，無論是已出貨的病患端，或是未來機會管線中的狀況。

I've been out in the field recently. I'm happy with what I'm hearing out there from the prescribers and our salesforce and I would just say again, each quarter I say that we should do more than we did the last quarter. I'll say Q1's always the toughest, so that's soft, but certainly going into the fourth quarter we should see sequential growth from the third quarter. And I would be -- I'll probably get fired if we don't. So I am highly motivated.

我最近也到第一線跑了一些。我對處方醫師與我們業務團隊在外面回饋的情況感到滿意。我再說一次，每一季我都會說我們應該要比上一季做得更多。我會說第一季一向最艱難，所以那會比較疲弱，但進入第四季，我們肯定應該會比第三季呈現季增。我如果做不到可能會被開除，所以我動力十足。

Okay, thanks.

好的，謝謝。

That was our final question. Terry, did you have any closing remarks?

這是我們最後一個問題。Terry，你有任何結語嗎？

Just a couple. In summary, we have created a very special Company and we are being rewarded by the patients we serve and the healthcare providers we help. CGM continues to become more important in the therapy armamentarium to combat the complications of diabetes and excessive glycemic variability.

只有幾點。總結來說，我們打造了一家非常特別的公司，而我們正因為所服務的病患與所協助的醫療照護提供者而獲得回報。CGM 在治療工具組合中持續變得更重要，用以對抗糖尿病併發症以及過度的血糖波動。

DexCom is the continuous glucose sensor of choice by healthcare professionals. We are the technology leader and we expect to maintain our leadership position in the future with our Gen4, Gen5 and future technologies. We are the sensor of choice in more than a dozen artificial pancrease projects around the world and there is a reason we are the sensor of choice.

DexCom 是醫療專業人士首選的連續血糖感測器。我們是技術領導者，並預期在未來透過 Gen4、Gen5 以及後續技術持續維持領導地位。我們是在全球十多個人工胰臟專案中被選用的感測器，而我們之所以成為首選是有原因的。

Thank you.

謝謝。

Thank you, ladies and gentlemen. This concludes today's teleconference. Thank you for participating. You many 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。你們現在可以掛線。