德康醫療 (DXCM) 2013 Q3 法說會逐字稿

Welcome to the DexCom third quarter 2013 earnings release conference call. My name is Adrian, and I'll be you operator for today's call.

歡迎參加 DexCom 2013 年第三季財報發布電話會議。我是 Adrian，將擔任今天會議的接線員。

(Operator Instructions)

（接線員指示）

Please note, this conference is being recorded. I'll now turn the call over to Terry Gregg, CEO. Terry Gregg, you may begin.

請注意，本次電話會議將被錄音。現在我將把電話交給執行長 Terry Gregg。Terry Gregg，您可以開始。

Thank you, and welcome to our third quarter 2013 earnings call. We'll kick it off with Steve Pacellli, and reading our Safe Harbor statement. Steve?

謝謝，歡迎參加我們 2013 年第三季財報電話會議。我們將先由 Steve Pacellli 宣讀我們的安全港聲明。Steve？

Thanks, Terry. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans and performance and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K, our quarterly reports on Form 10-Q, and our other report as filed with the SEC. We undertake no obligation to update publicly or revise these forward-looking statements for any reason.

謝謝你，Terry。我們在今天電話會議中所做的部分陳述，可能構成前瞻性陳述。這些陳述反映管理層對未來事件、營運計畫與績效的預期，且僅截至本日有效。這些前瞻性陳述涉及若干風險與不確定性。可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單，已在我們向美國證券交易委員會（SEC）提交的 Form 10-K 年報、Form 10-Q 季報及其他報告中的「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 loss. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP.

此外，我們將討論若干未依 GAAP 編製的財務資訊，涉及我們的現金營運虧損。提供此非 GAAP 資訊旨在增進您對我們目前財務表現的整體理解。此額外資訊之呈現不應被孤立看待，亦不應作為依 GAAP 編製之結果的替代，或被視為優於依 GAAP 編製之結果。

Terry?

Terry？

Thanks, Steve. Joining me today are Kevin Sayer, our President and Chief Operating Officer, Jess Roper, our Chief Financial Officer, and you just heard from Steve Pacelli, our Executive Vice President of Strategy and Corporate Development.

謝謝你，Steve。今天與我一同出席的有：我們的總裁兼營運長 Kevin Sayer、財務長 Jess Roper，以及您剛剛聽到的策略與企業發展執行副總裁 Steve Pacelli。

I assume by now most of you have seen our earning press release. Our financial results speak for themselves. During the third quarter, we achieved record sales, record margins, and we were cash flow positive.

我想此刻各位多數已看過我們的財報新聞稿。我們的財務結果不言自明。第三季我們創下銷售新高、毛利率新高，且現金流轉為正。

Before I turn the call over to Kevin to review our financial results in greater detail and provide a brief operations update, I would like to update the investment community with some exciting news regarding a new addition to our Board of Directors. It is no secret that we have a tremendous amount of work in front of us, as our system evolves into display on a smartphone, paired with robust data management tools.

在我把電話交給 Kevin 更詳細檢視財務結果並提供簡要營運更新之前，我想向投資界更新一則令人振奮的消息：我們董事會新增一位董事。眾所周知，隨著我們的系統演進為可在智慧型手機上顯示，並搭配強大的資料管理工具，我們面前仍有大量工作要做。

To that end, we are pleased to announce the addition of Steve Altman, Vice Chairman of Qualcomm, and long-time diabetes advocate to our Board. Steve brings unique and diversified expertise to an already dynamic Board of Directors. Steve has served on Qualcomm's Executive Committee for nearly 15 years, providing direction and guidance on key initiatives across all areas of the business, as well as on overall Qualcomm vision and strategy.

為此，我們很高興宣布 Qualcomm 副董事長、長期糖尿病倡議者 Steve Altman 加入我們董事會。Steve 為本已充滿活力的董事會帶來獨特且多元的專業。Steve 在近 15 年來一直擔任 Qualcomm 執行委員會成員，為公司各業務領域的關鍵倡議，以及 Qualcomm 整體願景與策略提供方向與指導。

He joined Qualcomm in 1989, and his leadership roles have included General Counsel, President of Qualcomm Technology Licensing, President of Qualcomm, and most recently as Vice Chairman of Qualcomm. Throughout his 24-year tenure, Steve's contributions helped enable the successful growth, evolution, and expansion of Qualcomm into a world-leading mobile technology innovator, and we are pleased to welcome him to the Board.

他於 1989 年加入 Qualcomm，曾擔任的領導職務包括總法律顧問、Qualcomm Technology Licensing 總裁、Qualcomm 總裁，最近則擔任 Qualcomm 副董事長。在其 24 年任期中，Steve 的貢獻協助促成 Qualcomm 成功成長、演進與擴張，成為全球領先的行動技術創新者；我們很高興歡迎他加入董事會。

I would now like to turn the call over to Kevin.

現在我想把電話交給 Kevin。

Thank you, Terry. I'll start with the financial update.

謝謝你，Terry。我將先從財務更新開始。

DexCom generated $42.5 million in product revenue for the third quarter of 2013 compared to $21.1 million for the same quarter in 2012, a $21.4 million or 101% increase. We remind investors that in the third quarter of 2012, we reserved $1.2 million for sales returns relating to our 30-day money-back guarantee on SEVEN PLUS hardware in anticipation of the G4 PLATINUM launch. Absent that increase in returns reserve, our year-over-year product revenue growth would have been 91%.

DexCom 2013 年第三季產品營收為 4,250 萬美元，較 2012 年同期的 2,110 萬美元增加 2,140 萬美元，增幅 101%。我們提醒投資人，2012 年第三季我們就 SEVEN PLUS 硬體的 30 天退款保證，因預期 G4 PLATINUM 上市而提列 120 萬美元的銷售退貨準備。若不計該退貨準備的增加，我們的產品營收年增率將為 91%。

We also remind investors that we believe third-quarter 2012 product revenues were somewhat suppressed, because purchase decisions during Q3 2012 were deferred, as patients and health care providers anticipated the G4 PLATINUM introduction.

我們也提醒投資人，我們認為 2012 年第三季的產品營收在某種程度上受到壓抑，因為在 Q3 2012 期間，病患與醫療照護提供者預期 G4 PLATINUM 推出而延後了購買決策。

Sequentially, product revenue for Q3 of 2013 increased 20% from the prior quarter. And we note that if you back out the impact of approximately $1.3 million in higher than expected Q2 2013 revenue, attribute it to Animas royalties, and GlucoClear sensor sales, our sequential improvement in product revenue would have been 24%. Total revenue for the third quarter of 2013 was $42.9 million, compared to $23.1 million during the same quarter in 2012.

以季比季來看，2013 年第三季產品營收較前一季成長 20%。我們也指出，若扣除 2013 年第二季約 130 萬美元高於預期的營收影響（歸因於 Animas 權利金及 GlucoClear 感測器銷售），則我們產品營收的季增幅將為 24%。2013 年第三季總營收為 4,290 萬美元，較 2012 年同期的 2,310 萬美元增加。

Our product gross profit totaled $27.7 million, generating a product gross margin of 65% for the third quarter, compared to product gross profit of $7.7 million and a product gross margin of 36% for the same quarter in the prior year. As a reminder, our product gross margin was artificially low in Q3 2012, based on a number of one-time charges and reserves we took in connection with our transition from the SEVEN PLUS to the G4 Platinum.

我們的產品毛利合計 2,770 萬美元，使第三季產品毛利率達 65%；相較之下，去年同期產品毛利為 770 萬美元、產品毛利率為 36%。提醒各位，2012 年第三季的產品毛利率因我們從 SEVEN PLUS 轉換至 G4 Platinum 的過程中提列若干一次性費用與準備而被人為拉低。

Sequentially, product gross margin for Q3 of 2013 increased 4 margin points from the prior quarter, primarily the result of increased sensor volumes combined with continued improved operational performance.

以季比季來看，2013 年第三季產品毛利率較前一季提高 4 個百分點，主要是感測器出貨量增加，並結合持續改善的營運表現所致。

Some final thoughts on our products revenues and our gross products during Q3. During Q3, we added more new patients and sold more sensors than in any prior quarter. Consumable and durable revenues both increased significantly from Q2 2013; although, sensor sales grew at a much faster rate than durable sales.

關於第三季的產品營收與產品毛利，最後補充幾點。第三季我們新增的病患數與售出的感測器數均高於以往任何一季。消耗品與耐用品營收皆較 2013 年第二季顯著增加；不過，感測器銷售成長速度遠快於耐用品銷售。

We continue to see increased patient retention, combined with increased sensor utilization with the G4 PLATINUM system compared to the SEVEN PLUS, resulting in a very favorable impact upon gross margins and gross profits for the quarter. With respect to the split between consumable and durable revenues, our mix has naturally shifted more towards consumable products, and is now closer to 25% durable and 75% consumable. ASP for sensors has stayed consistent, at approximately $70 per sensor, and the ASP for our hardware continued at approximately $850 per starter kit.

我們持續看到病患留存率提升，且相較於 SEVEN PLUS，G4 PLATINUM 系統的感測器使用率更高，對本季毛利率與毛利帶來非常有利的影響。就消耗品與耐用品營收的拆分而言，我們的組合自然更偏向消耗品，目前約為 25% 耐用品、75% 消耗品。感測器的平均售價（ASP）維持一致，約每個感測器 70 美元；硬體的平均售價亦持續約為每套入門組 850 美元。

Our international business performance continued to exceed our expectations in Q3, as well, as it was up approximately 100% year-over-year and continues to represent close to 10% of product revenue.

我們的國際業務在第三季的表現也持續超出預期，年增約 100%，且仍約占產品營收的 10%。

Research and development expense totaled $11.8 million for Q3 of 2013, compared to $10.3 million in Q3 of 2012, with the increase due primarily to additional payroll-related cost and expenses related to work on our near-term product pipeline. Sequentially, R&D expense was up 6%, with the increase due primarily to non-cash charges related to our SweetSpot acquisition and share-based compensation.

2013 年第三季研發費用合計 1,180 萬美元，較 2012 年第三季的 1,030 萬美元增加；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相關工作的費用。以季比季來看，研發費用增加 6%，主要因 SweetSpot 併購相關的非現金費用及股份基礎給付所致。

Selling, general, and administrative expense totaled $21.6 million in Q3 of 2013, compared to $15.4 million during the same quarter in 2012. The increase was primarily related to selling and information technology expenses necessary to support growth. The increase also included $900,000 of additional non-cash, share-based compensation.

2013 年第三季銷售、一般及行政費用合計 2,160 萬美元，較 2012 年同期的 1,540 萬美元增加。增加主要與支持成長所需的銷售與資訊科技費用相關。增加金額亦包含 90 萬美元額外的非現金股份基礎給付。

Our net loss for the third quarter of 2013 totaled $6 million, and included $9.5 million in non-cash expenses centered in share-based compensation, depreciation, and amortization. Absent these non-cash charges, our net income would have been $3.5 million for Q3 2013. Compare this to an adjusted cash base net loss of $9.7 million for the same quarter last year.

2013 年第三季淨損合計 600 萬美元，其中包含 950 萬美元的非現金費用，主要為股份基礎給付、折舊與攤銷。若不計這些非現金費用，2013 年第三季淨利將為 350 萬美元。相較之下，去年同期調整後以現金為基礎的淨損為 970 萬美元。

We would also like to point out that year-to-date, our cash operating loss is $1.5 million, compared to a cash operating loss of $27 million for the first three quarters of last year. Another way to look at our year-to-date performance, our product revenues have increased by $44.6 million or 73%, resulting in a gross profit increase of $37.6 million, that's more than double. The gross margin percentage on these additional revenue is actually in excess of 80%.

我們也想指出，截至目前為止（年初至今），我們的現金營運虧損為 150 萬美元，相較去年前三季的現金營運虧損 2,700 萬美元大幅改善。換個角度看我們年初至今的表現：產品營收增加 4,460 萬美元（增幅 73%），帶動毛利增加 3,760 萬美元，超過一倍。這些新增營收的毛利率百分比實際上超過 80%。

Even with our robust investment in sales expansion and our continued investment in our R&D pipeline, more than $25 million of these gross profits have fallen to our bottom line and into the bank. Our loss per share for the quarter was $0.08.

即使我們大力投資於銷售擴張並持續投資研發管線，這些毛利中仍有超過 2,500 萬美元落入損益表最終盈餘並進入銀行。本季每股虧損為 0.08 美元。

With respect to our balance sheet, we ended the third quarter with $47.6 million in cash and marketable securities, an increase of $1.2 million from the end of Q2 2013; and we note that our cash and marketable securities balance at the end of Q3 is roughly where we started the year.

就我們的資產負債表而言，我們在第三季末持有4,760萬美元的現金及有價證券，較2013年第二季末增加120萬美元；同時我們也注意到，第三季末的現金及有價證券餘額大致與年初水準相當。

With our cash on hand at the end of Q3, our debt availability of $28 million, and most importantly, our operating performance improvement through three quarters of 2013, we remain very comfortable with our commitment not to raise additional equity funds in the near term.

憑藉第三季末的手頭現金、2,800萬美元的可用債務額度，以及最重要的是2013年前三季營運表現的改善，我們對於短期內不再額外募集股權資金的承諾仍然非常有信心。

I would like to close the discussion of our financial results with some thoughts on Q4. While we are not formally adjusting our full-year guidance at the this time, we're confident that we will exceed the top end of our current range of $140 million in product revenue. That being said, as we look to the balance of the year, there are a number of factors, some positive and some negative, that will impact Q4 revenue growth.

在結束對我們財務結果的討論之前，我想就第四季分享一些看法。雖然我們目前尚未正式調整全年財測指引，但我們有信心產品營收將超越目前區間上緣的1.40億美元。不過，展望今年剩餘期間，仍有多項正反因素將影響第四季營收成長。

Obviously, you are all aware that in September, Medtronic received approval of its 530-G insulin pump with threshold suspend, and is currently commercializing the system. While it remains to be seen whether this product will have a meaningful clinical impact over time, we expect Medtronic to aggressively market this device over the next several quarters as the first artificial pancreas. More to come on that from Terry.

顯然，各位都知道美敦力（Medtronic）於9月取得其具備「低閾值暫停（threshold suspend）」功能的530-G胰島素幫浦核准，並正進行商業化。雖然此產品是否能隨時間帶來具意義的臨床影響仍有待觀察，但我們預期美敦力將在未來數季積極行銷此裝置，作為第一個人工胰臟。Terry稍後會再補充。

This could impact the rate at which we are able to add new patients to our installed base, as clinicians and patients take time to evaluate this product. It's also important to remember that we sold an extraordinary amount of hardware during Q4 2012 in connection with the launch of G4 PLATINUM. So for our year-over-year comparison in Q4 2013, we will be comparing against a quarter in which we launched our first new product in three years.

這可能會影響我們將新病患納入既有裝機基礎（installed base）的速度，因為臨床醫師與病患需要時間評估此產品。同時也要記得，我們在2012年第四季配合G4 PLATINUM上市，硬體銷售量異常地高。因此在2013年第四季的年對年比較中，我們將對比一個在三年來首次推出新產品的季度。

We exceeded in Q3 what most analysts expected us to do in Q4. However, I remind investors that we've never suggested that we would continue to grow at 65% year-over-year as we did in Q2, and certainly not the 100% that we experienced this quarter. So for Q4 2013, given the comparison to our first quarter, our G4 PLATINUM sales in Q4 2012, we expect our product revenue growth to begin to normalize at closer to 40% year-over-year as we've guided previously, and we do not expect to exceed 50% year-over-year growth in Q4 2013.

我們在第三季的表現超出多數分析師原先預期我們在第四季才能達成的水準。然而，我也提醒投資人，我們從未表示會像第二季那樣維持年增65%的成長，更不可能維持本季所達到的100%。因此，就2013年第四季而言，考量與去年第四季（G4 PLATINUM於2012年第四季的銷售）之比較基期，我們預期產品營收成長將開始回歸常態，接近我們先前指引的年增約40%，且我們不預期2013年第四季的年增幅會超過50%。

With respect to operating expenses in the fourth quarter, we expect to increase our spending in a couple of very important commercial areas. As many of you know, last year and early this year, we added approximately 20 sales territories to our US sales force. And before the end of this year, we plan to add an additional 20 territories, bringing our total US field set sales force to approximately 90 reps.

就第四季的營運費用而言，我們預期將在幾個非常重要的商業領域增加支出。如各位所知，去年及今年年初，我們在美國銷售團隊新增約20個銷售區域；並且在今年年底前，我們計畫再新增20個區域，使美國前線銷售團隊總規模達到約90名業務代表。

We're also commencing a number of clinical studies designed to demonstrate both the clinical and economical benefits of CGM as a front line therapy to support our position that CGM is the most important and cost-effective tool in the intensive management of insulin-dependent diabetes.

我們也將啟動多項臨床研究，旨在證明CGM作為第一線治療在臨床與經濟層面的效益，以支持我們的立場：在胰島素依賴型糖尿病的密集管理中，CGM是最重要且最具成本效益的工具。

Finally, we note that our historical cash usage has always been high in Q4, as accounts receivable increased due to late Q4 sales and we pay out a number of accrued liabilities before year end. Adding to factors this year, inventories may increase in Q4 depending upon the timing of the approvals of our three pending FDA filings.

最後，我們也指出，歷史上我們在第四季的現金使用量一向偏高，原因在於第四季末銷售帶動應收帳款增加，以及我們會在年底前支付多項應計負債。此外，今年還有一項因素：存貨可能在第四季增加，取決於我們三項待審FDA申請核准的時間點。

Now on to the business update. Turning to our regulatory activities, I'm very pleased to report that during Q3, we filed a PMA supplement with the FDA seeking an expanded indication for G4 PLATINUM for professional use. Professional CGM enables clinicians to gain better insight into their patient's glycemic profiles. Devices are owned by the health care professional, and can be used either in blinded mode for simple collection and retrospective review of glucose data by the clinician, or in unblinded mode which allows the patient to experience the full benefits of real-time CGM while still providing the doctor with an opportunity to review glucose data retrospectively with the patient.

接下來是業務更新。就法規相關進展而言，我很高興報告，我們在第三季向FDA提交了一份PMA補充申請，尋求擴大G4 PLATINUM於專業用途（professional use）的適應症。專業CGM可讓臨床醫師更深入了解病患的血糖曲線。設備由醫療專業人員持有，可在盲測模式下用於簡單蒐集並由臨床醫師回溯檢視葡萄糖資料；或在非盲測模式下，讓病患體驗即時CGM的完整效益，同時仍提供醫師與病患回溯檢視葡萄糖資料的機會。

Clinicians can use the insights gained from a professional CGM session to adjust therapy and to educate and motivate patients to modify their behavior after viewing the effects of specific foods, exercise, stress, and medications have on their glucose levels.

臨床醫師可運用一次專業CGM監測所獲得的洞見來調整治療，並在病患看到特定食物、運動、壓力與藥物對其血糖水準的影響後，進一步教育並激勵病患改變行為。

With respect to our pediatric indication, we continue to have regular open dialogue with the FDA concerning our US pediatric submission. Our discussions continue to center on appropriate labeling of the products, specifically for children, and we remain optimistic that we will receive approval prior to year end.

就兒科適應症而言，我們持續就美國兒科申請案與FDA保持定期且開放的對話。我們的討論仍聚焦於產品的適當標示（labeling），特別是針對兒童的標示；我們仍樂觀預期可在年底前取得核准。

Finally, with respect to our share filing, we have received written feedback from the FDA, and we are currently preparing our responses to the questions posed to us. These questions required some simple clarification and a bit more testing of the system, and we expect that our responses will be submitted to the FDA within a couple of weeks.

最後，就我們的share申請案而言，我們已收到FDA的書面回饋，目前正準備回覆其提出的問題。這些問題需要一些簡單的釐清，以及對系統進行更多測試；我們預期將在數週內把回覆提交給FDA。

Turning to our future CGM product offerings, we remain focused on replacing finger sticks as our primary long-term objective, and we continue to work on both Gen5 and Gen6 in an effort to achieve this goal. We continue to believe that simplicity, patient convenience, and expanded connectivity, paired with our superior sensor technology will enable us to maintain our leadership position in the CGM market.

談到我們未來的CGM產品供應，我們仍以取代指尖採血（finger sticks）作為主要的長期目標，並持續推進Gen5與Gen6以達成此目標。我們仍相信，簡易性、病患便利性與更廣泛的連結能力，搭配我們優異的感測器技術，將使我們得以維持在CGM市場的領導地位。

Shifting to our integration partnerships, Animus continues to work with the FDA on its PMA submissions, seeking approval of the Animus5 system in the US. Animus is currently completing additional verification and validation testing, and additional human factors testing requested by the FDA, and it expects to have all additional testing done and responses submitted to the FDA by the end of January.

在整合合作夥伴方面，Animus持續就其PMA申請與FDA合作，尋求Animus5系統在美國的核准。Animus目前正完成FDA要求的額外驗證與確認（verification and validation）測試，以及額外的人因（human factors）測試，並預期在1月底前完成所有額外測試並將回覆提交給FDA。

We continued to work diligently with Tandem Diabetes Care to incorporate the G4 PLATINUM into a next-generation version of Tandem's T-slim. Tandem's PMA application has not yet been filed with the FDA, and while the integrated system remains a top development and regulatory priority for them, as we're approaching year end, we do not anticipate Tandem will file this quarter.

我們也持續與Tandem Diabetes Care密切合作，將G4 PLATINUM整合至Tandem下一代版本的T-slim中。Tandem的PMA申請尚未向FDA遞交；雖然整合系統仍是其研發與法規上的最高優先事項之一，但隨著接近年底，我們不預期Tandem會在本季遞交申請。

Although Tandem management is currently highly engaged in their IPO process, we continue to work closely with the Tandem team to complete verification and validation testing, and submit a PMA application with the FDA as soon as possible.

儘管Tandem管理團隊目前高度投入其IPO流程，我們仍持續與Tandem團隊緊密合作，以完成驗證與確認測試，並儘快向FDA提交PMA申請。

I'd now like to turn the call over to Terry for some concluding remarks.

接下來我想把電話會議交給Terry，請他做一些結語。

Thanks, Kevin.

謝謝你，Kevin。

The third quarter was a record breaking quarter for DexCom, as we continued to execute on all aspects of our business, be it commercial, clinical, regulatory, or with our R&D efforts. Further evidence that our business model is scalable, and is evolving in the way we've always said it would.

第三季對DexCom而言是破紀錄的一季，我們持續在業務各面向落實執行，無論是商業、臨床、法規，或研發投入。這也進一步證明我們的商業模式具備可擴展性，並正以我們一直以來所說的方式持續演進。

There's been a lot of buzz in the diabetes community of late with Medtronic's announcement in September of approval of the 530-G. I'd like to briefly share my thoughts on this approval and its impact on DexCom.

近來糖尿病社群對於美敦力在9月宣布530-G獲准一事議論紛紛。我想簡要分享我對此核准以及其對DexCom影響的看法。

While a system that suspends insulin when a low glucose threshold is breached, it's considered a first step to achieve a closed-loop or bionic pancreas, I do not believe the 530-G adequately achieves that first step due to its poor sensor accuracy and reliability. In fact, in my opinion, the pursuit of an artificial pancreas has unfortunately been dealt a substantial blow with the introduction of this product. The diabetes community is already complaining that after seven years and hundreds of millions of dollars spent, is this the best industry could come up with? I share their frustration. Patients deserve better.

雖然當血糖低於門檻時會暫停胰島素輸注的系統，被視為邁向閉環或仿生胰臟的第一步，但我不認為530-G能充分達成這第一步，原因在於其感測器準確度與可靠性不佳。事實上，以我之見，這項產品的推出不幸地對人工胰臟的追求造成了相當大的打擊。糖尿病社群已在抱怨：花了七年、投入數億美元後，這就是業界能拿出的最佳成果嗎？我也同感挫折。病患值得更好的產品。

Sensor accuracy is what matters. In multiple independent studies, our G4 PLATINUM sensor is anywhere from 40% to 70% more accurate than the new Medtronic sensor. At this point, most investors are aware of the work done out of Boston University and presented at the ADA Scientific Session Meeting last Summer, where Dr. Steven Russell shared comparative data from patients simultaneously wearing the G4 PLATINUM and Medtronics Enlite, and reported an MARD of 10.8% for the G4 PLATINUM and 17.9% for the Enlite.

感測器準確度才是關鍵。在多項獨立研究中，我們的G4 PLATINUM感測器準確度比美敦力的新感測器高出約40%到70%。截至目前，多數投資人都已了解波士頓大學所進行並於去年夏天ADA科學年會上發表的研究工作；當時Steven Russell醫師分享了病患同時配戴G4 PLATINUM與美敦力Enlite的比較數據，並報告G4 PLATINUM的MARD為10.8%，Enlite為17.9%。

And just last week, at the Diabetes Technology Meeting in San Francisco, Dr. Gary [Stile] presented comparative sensor data as part of a study examining the use of CGM in critically ill infants, reporting an MARD for the Enlite of 17.8% and an extremely high 81% early failure rate. By comparison, Dr. Stile reported an MARD of only 11.7% for the G4 PLATINUM with no early failures. We expect additional studies with similar results will follow.

就在上週，在舊金山舉行的糖尿病科技會議上，Gary [Stile] 醫師在一項研究中發表了比較感測器數據，該研究檢視 CGM 在重症嬰兒中的使用情況；他報告 Enlite 的 MARD 為 17.8%，且早期失敗率極高，達 81%。相較之下，Stile 醫師報告 G4 PLATINUM 的 MARD 僅 11.7%，且沒有早期失敗。我們預期後續將會有更多研究出現類似結果。

Medtronics cites several different accuracy metrics in their labeling. But unfortunately, it seems that no independent investigator can reproduce the Medtronic data, and we believe the sensor's poor performance will be obvious to patients who try the device.

美敦力在其標示中引用了數種不同的準確度指標。但不幸的是，似乎沒有任何獨立研究者能重現美敦力的數據；我們相信，嘗試使用該裝置的病患將會明顯感受到該感測器表現不佳。

Furthermore, while Medtronic's data raises a number of questions, we believe that to achieve any reasonable level of accuracy with this particular product, patients will need to take up to four finger sticks calibrations per day. We know from our own market research that reducing or eliminating calibrations is extremely important to patients.

此外，雖然美敦力的數據引發了許多疑問，但我們認為，若要讓這項特定產品達到任何合理的準確度水準，病患每天可能需要進行最多四次指尖採血校正。我們從自身的市場研究得知，減少或取消校正對病患而言極其重要。

We've also heard initial reports from patients that a considerable number of 530-G alerts are false, which is in line with one of the Enlite data tables where Medtronic discloses that more than 50% of the Enlite's alerts at 70-milligrams per deciliter within a 15-minute window are false. As we learned with several of our prior products, repeated, inaccurate, or false alarms undermines a patient's trust and faith in a CGM system, and are a key factor in patients electing to quit using CGM. ¶ We are very prepared with our messaging in the field, particularly around the benefits of CGM first. But we are also cognizant of the fact that the Medtronic marketing machine is out in full force. As a result, we do expect some impact to our new patient additions over the next several quarters, as clinicians and health care providers evaluate this new product.

我們也聽到病患的初步回報，指出相當多的 530-G 警示為誤報；這與 Enlite 的其中一個數據表一致，美敦力在該表中揭露：在 15 分鐘視窗內、以每分升 70 毫克為門檻的 Enlite 警示中，超過 50% 為誤報。正如我們在先前數款產品中所學到的，反覆、不準確或誤報的警報會削弱病患對 CGM 系統的信任與信心，並且是病患選擇停止使用 CGM 的關鍵因素之一。¶ 我們已在第一線的訊息傳達上做好充分準備，特別是圍繞 CGM 的核心效益。但我們也清楚，美敦力的行銷機器正全力運轉。因此，我們確實預期在接下來幾個季度，隨著臨床醫師與醫療照護提供者評估這項新產品，我們新增病患數可能會受到一些影響。

Diabetes is a burden. It's a burden for the patient 24/7, 365. There are no holidays, there are no vacations. It is a life sentence. And it as challenging as it is for patients, loved ones, friends, and colleagues are all impacted by diabetes. Our mission remains steadfast. Replace finger sticks. And in the process, eliminate one of the most cumbersome and painful requirements of managing diabetes successfully.

糖尿病是一種負擔。對病患而言，這是 24/7、365 天的負擔。沒有假期，沒有休假。這是一種終身的判決。而且不僅病患面臨挑戰，親人、朋友與同事也都會受到糖尿病的影響。我們的使命依然堅定不移：取代指尖採血。並在此過程中，消除成功管理糖尿病時最繁瑣且最痛苦的要求之一。

For DexCom, the future is about simplicity, patient convenience, and connectivity. Our goal is to continually miniaturize the footprint on the body to make the patient experience as minimally invasive as possible. Our goal is to enable the patient to interact with their glucose data directly on a smartphone, which will not only add to the overall patient experience, but will enable parents to receive their glucose information during the nighttime, during the school day from the child while the parent is at work, or allow a spouse to monitor a loved one while at work or when traveling.

對 DexCom 而言，未來關乎簡化、病患便利性與連結性。我們的目標是持續縮小在身體上的裝置占用面積，使病患體驗盡可能微創。我們的目標是讓病患能直接在智慧型手機上與其葡萄糖數據互動；這不僅能提升整體病患體驗，也能讓父母在夜間、在上學日孩子在學校而父母在工作時接收孩子的葡萄糖資訊，或讓配偶在工作或旅行時監測所愛之人的狀況。

As I routinely tell our employees, stay the course. With their substantially larger field presence, we expect our competition will attempt to create confusion in the marketplace with regards to sensor performance. But we are committed to compete toe to toe in marketing the superiority of our system. In the end, by presenting performance data that is truthful and accurate, we will continue to win the hearts, minds, and loyalty of patients and health care providers.

我經常告訴我們的員工：堅持既定方向。由於競爭對手在第一線的佈局規模大得多，我們預期他們會試圖在市場上就感測器表現製造混淆。但我們承諾將在行銷上正面競爭，推廣我們系統的優越性。最終，透過呈現真實且準確的效能數據，我們將持續贏得病患與醫療照護提供者的認同、信任與忠誠。

Thank you, and we will open it up for Q&A.

謝謝，接下來我們開放問答。

(Operator Instructions)

（接線員指示）

Thom Gunderson from Piper Jaffray.

Piper Jaffray 的 Thom Gunderson。

Hi, everybody. So, I'll be quick, Terry and crew, Kevin. Where do I want to go with this? Terry, on the Vibe and the PMA that J&J is doing, has there been any correlation -- any changes in how you think that product is going to be launched, given the reorg in the diabetes business at J&J?

各位好。我會簡短一點，Terry 和團隊、Kevin。我想問的是：Terry，關於 Vibe 以及 J&J 正在進行的 PMA，鑑於 J&J 在糖尿病事業的重組，你們對該產品的上市方式是否有任何關聯——或任何看法上的改變？

Thom, I'm actually going to ask Steve -- since Steve heads up our steering committee relationship with Animas, and he would be better suited to answer that.

Thom，我其實要請 Steve 來回答——因為 Steve 負責我們與 Animas 的指導委員會合作關係，他更適合回答這個問題。

Look, the Vibe remains a critical priority. They still talk about the Vibe, not just at the diabetes franchise level, but we hear mention of the Vibe all the way up the corporate chain.

你看，Vibe 仍然是關鍵優先事項。他們仍在談 Vibe，不僅是在糖尿病事業群層級，我們也聽到一路到公司高層都提到 Vibe。

I think that the real challenge right now for the diabetes franchise is the diabetes franchise is being dragged down, frankly, by their finger stick business. So, there's a lot of moving parts in that organization.

我認為目前糖尿病事業群真正的挑戰是，坦白說，他們的糖尿病事業群正被其指尖採血業務拖累。所以那個組織裡有很多變動因素。

But I think, first and foremost, the priority is get the Vibe out. We are working -- although it's largely being driven by J&J, we are working on a more advanced system.

但我認為，首要之務是先把 Vibe 推出。我們正在合作——雖然主要由 J&J 主導——我們也在開發一個更先進的系統。

Without disclosing too many details, there's been some limited data published, but it's certainly a more advanced product than the 530G. I can't give you any specific timelines on that product because it's really a J&J product, and they've asked us not to disclose those yet. J&J -- I think, frankly, that the launch of the 530G has reinvigorated particularly the Animas side of the diabetes franchise.

在不透露太多細節的前提下，已經有一些有限的數據發表，但它確實比 530G 更先進。關於該產品我無法提供任何具體時程，因為那主要是 J&J 的產品，而他們要求我們暫時不要揭露。J&J——我認為，坦白說，530G 的上市已重新激勵了糖尿病事業群，特別是 Animas 這一端。

Thanks. And then, Kevin, you guys held back so long on adding reps, and all of a sudden you're on quite a ramp here. Can you help me understand or clarify -- of those 20 that you plan on adding before the end of the year -- 20 additional -- are those commission-generating sales guys' territories calling on unique customers?

謝謝。接著，Kevin，你們在增聘業務代表這件事上拖了很久，但突然之間就大幅加速擴編。你能否幫我理解或釐清——你們計畫在年底前新增的那 20 位（額外 20 位）——他們是能產生佣金的銷售人員，且各自負責不同的區域、拜訪不同的客戶嗎？

That's exactly what they are, Thom. We've gone through a very detailed process of analyzing our demographics and where our current sales are coming from, where physicians and patients are located based on the insulin DSI reports and everything. And we've, again, divided the country back up and added 20 more reps. So, that's exactly what they are: more commission-based salespeople.

完全正是如此，Thom。我們經過非常細緻的流程，分析我們的人口統計與目前銷售來源、根據胰島素 DSI 報告等資料判斷醫師與病患的分布位置。然後我們再次把全國區域重新劃分，並新增 20 位代表。所以他們就是：更多以佣金為主的銷售人員。

Got it. And then last, really quick question. You repeated that pediatric FDA clearance by the end of the year. Are you prepared for an early 2014 launch of pediatric?

了解。最後一個很快的問題。你們再次提到兒科 FDA 核准會在年底前取得。你們是否已準備好在 2014 年初推出兒科版本？

Yes, we will be. Absolutely.

是的，我們會。絕對會。

(multiple speakers) We're prepared for the day that we get the approval.

（多位講者）我們已準備好在取得核准的那一天就開始。

It only took us three weeks to launch Gen4 PLATINUM last time. We will get the thing out as absolutely quickly as possible.

上次我們推出 Gen4 PLATINUM 只花了三週。我們會以最快的速度把產品推出去。

Okay. Thanks, guys.

好的。謝謝各位。

Bill Plovanic from Canaccord.

Canaccord 的 Bill Plovanic。

Great, thanks, good evening. Congratulations, gentlemen.

很好，謝謝，晚安。恭喜各位先生。

Thank you, Bill.

謝謝你，Bill。

Wow. So, as we parse through the numbers here, it wasn't lost on me, and I just want to get clarification. If it's the 75/25 mix, your durable revenues' growth is accelerating, and your utilization went up significantly. Are my numbers that off, or is that what we're actually seeing?

哇。所以，當我們在這裡拆解數字時，我注意到一點，想請你們澄清。如果是 75/25 的組合，你們耐用品收入的成長正在加速，而且使用量顯著上升。是我的數字差太多，還是我們實際上看到的就是這樣？

I'm not looking at your numbers, but what we're seeing is our durable revenues went up, and our sensor revenues went up faster. So, utilization and retention are doing very well for us right now.

我沒有看你的數字，但我們看到的是：我們的耐用品收入上升了，而我們的感測器收入上升得更快。所以目前對我們而言，使用量與留存表現都非常好。

Are there any metrics you can share with us -- maybe -- even just sequentially? Is your utilization going -- improving X amount of sensors a quarter or a percentage, or is there -- just anything you can share to help quantify so we can understand? Because in my model, it looks like the utilization metrics are going up something like a 30% improvement on a quarter-on-quarter basis. And it seems a little high. But I'm just trying to get some clarification on drivers.

你們是否能分享任何指標——也許——即使只是按季？你們的使用量是否在上升——每季多用 X 個感測器或提升某個百分比？或是——任何你們能分享的資訊來幫助量化、讓我們理解？因為在我的模型裡，看起來使用量指標按季提升大約 30%。這似乎有點高。但我只是想釐清驅動因素。

I'm not sure that you're that high, Bill. I think -- again, we have imperfect data. We share data with a lot of independent distributors. And while they give us tracings, we're still consolidating as best we can.

我不確定你是否真的高到那樣，Bill。我想——再說一次，我們的數據並不完美。我們與許多獨立經銷商共享數據。雖然他們會提供我們一些追蹤資料，但我們仍在盡可能地彙整。

What we reviewed earlier this week -- we sat down and went through all the data that we could come up with. We see patients using more sensors.

我們本週稍早回顧了——我們坐下來把能取得的所有數據都過了一遍。我們看到病患正在使用更多感測器。

One category that really struck me and Terry is there appeared to be a much higher number of patients, for example, who are purchasing enough sensors to wear a new sensor every seven days. And if patients are wearing a new sensor every seven days, then you can do the economics for that model. That's a very, very strong piece of evidence for us.

有一個類別特別讓我和 Terry 印象深刻：例如，似乎有更高比例的病患購買了足夠的感測器，以便每七天更換一個新感測器。而如果病患每七天更換一個新感測器，那你就可以為那個模型做經濟性計算。這對我們而言是非常、非常有力的證據。

And as we have stratified our user base from those who use very few sensors to those who don't even -- who buy the first kit and then don't buy anything else -- what our goal all along was is to move everybody up the food chain to get everybody utilizing more sensors. And that's what's happening. Everybody is moving up a notch and purchasing more.

而且，隨著我們把使用者基礎分層，從使用感測器很少的人，到那些甚至——買了第一套套件之後就不再買任何其他東西的人——我們一路以來的目標，就是把每個人都往上推，讓大家使用更多感測器。而這正正在發生。每個人都在往上提升一個層級，並購買更多。

So, this product is being utilized very regularly by the patients who have it. And even our distributors have confirmed for us, because these guys -- they live to sell diabetes supplies. They are call centers: they track every call they make, every purchase made.

所以，擁有這項產品的病患，使用頻率非常高。甚至我們的經銷商也向我們確認了這一點，因為這些人——他們靠銷售糖尿病用品維生。他們是呼叫中心：他們會追蹤每一通電話、每一筆購買。

Our distributors have come back to us and told us that the retention rate on this product is fabulous. So, we're not just coming up with that with our own numbers. We're coming up that with our large distributors have verified that fact, as well.

我們的經銷商回來告訴我們，這項產品的留存率非常出色。所以，這不只是我們用自己的數據得出的結論；我們的大型經銷商也驗證了這個事實。

Okay. And then, again, more in the weeds, but as I look at the past couple quarters, you've benefited from upgrades of patients. I think last quarter you mentioned maybe a third of the patients were upgrades. As you look at this quarter, is there any metric around that you're willing to share?

好的。然後再深入一點，當我看過去幾個季度，你們受惠於病患升級。我記得上季你們提到可能有三分之一的病患是升級而來。那看這一季，有沒有任何相關指標你們願意分享？

Yes, I can tell you upgrades are down. We added more new patients in this quarter than any quarter we've ever had. We've swapped out almost all of the SEVEN PLUS patient base at this point in time that is active.

有，我可以告訴你，升級比例下降了。我們這一季新增的新病患數量，是我們歷來任何一季都沒有過的。我們目前幾乎已經把仍在使用的 SEVEN PLUS 病患基礎都替換掉了。

So, upgrades, as a percentage, came down this quarter versus going up. This was a quarter of new-patient growth more than upgrades.

所以，升級占比在本季是下降而不是上升。這一季是新病患成長多於升級的一季。

Okay. And then my last question, and I'll jump back into queue. You generated cash in the quarter. You lose money only because you have big D&A and stock comp.

好的。然後我最後一個問題，問完我就回到隊列。你們本季產生了現金流。你們之所以虧損，只是因為有很大的折舊與攤銷（D&A）以及股票薪酬。

As you think about the Business going forward, is the strategy to drive revenues and just keep it cash-flow neutral because revenues is what you're valued on at the end of the day? Or do you expect that you'd actually drive bigger positive cash flow in earnings? What is the focus of management at this point?

當你們思考未來的業務策略時，是要推動營收、並讓現金流大致持平，因為說到底市場對你們的估值看的是營收？還是你們預期會推動更大的正向現金流與獲利？管理層此刻的重點是什麼？

Bill, I'll take a crack at it. I'm sure Terry can add. We've been through this exercise before. And we want to grow that top line as fast as we can. That will require significant investment on both the commercial side of the Business and in our product pipeline.

Bill，我先試著回答。我相信 Terry 也可以補充。我們以前做過這個取捨。我們希望盡可能快地把營收（top line）做大。這將需要在商業端以及產品研發管線上進行相當可觀的投資。

That being said, we've been at this for a long time. It's time to make some money. So, we will manage our top-line growth and work to manage our bottom line, as well, and try and keep a balance. And ultimately, over the next few years, we'd expect our bottom line to grow faster than the top line.

話雖如此，我們做這件事很久了。是時候賺點錢了。所以，我們會在管理營收成長的同時，也努力管理獲利（bottom line），並嘗試保持平衡。最終，在未來幾年，我們預期獲利成長會快於營收成長。

But we will never ignore the reinvestment back into the Business. We need to garner as much market share as we possibly can over the next two- to three-year period, and get as many people on CGM as we can support within our system. So, it will be a balancing act, but we aren't going to ignore the bottom line. Once we get here, I don't think there's a lot of turning back.

但我們永遠不會忽視對業務的再投資。我們需要在未來兩到三年內，盡可能取得更多市占，並在我們系統可支援的範圍內，讓更多人使用 CGM。所以這會是一種平衡，但我們不會忽略獲利。一旦走到這一步，我不認為還有太多回頭路。

No, you can't go back. And obviously, on the cash flow, we've made comments about the full-year 2014, and our Board has always maintained that that's the direction that we should go. And then look at GAAP positive in 2015 and beyond.

不，你回不去了。而且很明顯，在現金流方面，我們已經對 2014 全年做過評論，而我們董事會一直認為那就是我們應該前進的方向。然後在 2015 年及之後，朝 GAAP 轉正看齊。

So, it is always going to be an incremental goal to continue to make this Business more profitable. But echoing Kevin's comments, not at the expense of having a robust R&D pipeline. Not at the expense of achieving our goal of replacing finger sticks, which -- I look on the horizon and see how close we think we are with some of the technology that we're currently developing, and it would be a shame. I think it would be -- it's our moral obligation to pursue this for people with diabetes.

所以，持續讓這門業務更有獲利能力，永遠會是一個循序漸進的目標。但呼應 Kevin 的話，不會以犧牲強健的研發管線為代價；也不會以犧牲我們「取代指尖採血」的目標為代價——我看向前方，看到我們正在開發的一些技術距離實現有多近，如果因此放慢腳步，那會很可惜。我認為那會——我們有道德義務為糖尿病患者追求這件事。

Great. Thank you, and congratulations on an unbelievable quarter.

很好。謝謝你，也恭喜你們交出一個令人難以置信的季度。

Thanks.

謝謝。

Ben Andrew from William Blair.

William Blair 的 Ben Andrew。

Not sure how to follow that praise or sequence, but I'll do my best, guys. Terry, if you think about the productivity in the sales force, did you add anybody in the third quarter in terms of staffing? Or was this just a significant improvement in productivity by the reps? And so, as you extrapolate forward with the 20 adds, can we -- again, that multiplier effect, in terms of that you're either getting patients on at this point with this new product?

不確定要怎麼接在剛才那段稱讚或順序之後，但我會盡力，各位。Terry，談到銷售團隊的生產力，你們在第三季有人員編制上新增嗎？還是這只是業務代表生產力的大幅提升？因此，當你往前推估新增的 20 人時，我們能否——再談談那種乘數效應，也就是你們在這個時間點用這個新產品把病患導入的效果？

Ben, it's a combination of things. So, number one, in answer to your question, no, we didn't hire the additions in the third quarter that shows this difference.

Ben，這是多種因素的組合。第一，回答你的問題：沒有，我們第三季並沒有增聘人員來造成這個差異。

But I would like to contrast that by -- we hired better reps in terms of our attractiveness to the people that we hire. And the next 20 -- I'm sure we are not lacking opportunities to hire some of the best, particularly as you get some contraction in the diabetes world as a result of economic impact. We get to kind of pick the -- who we choose, and I think that's an influence.

但我想對比說明的是——我們招募到更好的業務代表，因為我們對求職者的吸引力提升了。而接下來的 20 人——我很確定我們不缺機會去聘到最優秀的人才，特別是當糖尿病產業因經濟影響而出現一些收縮時。我們某種程度上可以挑選——我們想要的人，我認為這也有影響。

What that translates into is that they are more active, more successful more quickly. So, you don't have that long traditional four- to six-month learning curve that new reps, particularly those that are coming from outside of the CGM business, tend to take in order to get them up to speed.

這代表他們更積極，也能更快取得成功。因此，你不會看到那種傳統需要四到六個月的學習曲線；新進業務，尤其是從 CGM 業務以外領域轉進來的人，通常需要那麼久才能上手。

I think the second thing, and my field visits contrast that the same docs that I called on a year ago that I called back on today in ride-alongs -- just their attitude toward CGM first has driven -- so, in many cases, the product is selling itself. And the reps are certainly out promoting it. That's one of the reasons that Kevin and the team have made the decision to expand the sales force again, because we are not completely serving the entire diabetes population that we should. And now there's enough awareness about the G4 PLATINUM that now is the time to drive that message to a larger group of physicians and prescribers.

我認為第二點，從我到前線拜訪的觀察也形成對比：同樣那些我一年前拜訪過的醫師，我今天在隨行拜訪（ride-alongs）時再去拜訪——他們對 CGM 的態度首先就帶動了——所以在很多情況下，產品幾乎是自己在賣。當然業務也在外面推廣。這也是 Kevin 和團隊決定再次擴編銷售團隊的原因之一，因為我們還沒有完全服務到我們應該覆蓋的整個糖尿病族群。而且現在市場對 G4 PLATINUM 的認知已經足夠，是時候把這個訊息推向更大一群醫師與開立處方者。

Okay. That's helpful, thank you, Terry.

好的。這很有幫助，謝謝你，Terry。

And then, as you think about, Kevin, maybe the hardware components in the quarter. You obviously gave us some insights into the mix of new patients and upgrades. If you're pretty much done with SEVEN PLUS, where do you think the steady state, if there is one, will be in terms of hardware for new patients and equipment upgrades for existing patients after SEVEN PLUS? So, new transmitters, new handhelds, things like that?

然後，Kevin，談到本季硬體組件。你顯然已經給了我們一些關於新病患與升級的組合洞見。如果你們幾乎已經完成 SEVEN PLUS 的替換，那麼在 SEVEN PLUS 之後，你認為硬體在穩態（如果存在的話）會是什麼樣子：對新病患的硬體，以及對既有病患的設備升級？例如新的發射器、新的手持接收器之類？

And that's a very complex question with the G4 PLATINUM, and I can give you one variable. When we launched the G4 system, one of the things that we did is we warranteed the transmitter for six months, building in an estimated shelf life, and then selling it possibly to a distributor where there would be another month of shelf life, and then to a patient. So, we've given a six-month guarantee. The transmitters we shipped last October, by and large, are still working.

這在 G4 PLATINUM 上是個非常複雜的問題，我可以給你一個變數。當我們推出 G4 系統時，我們做的一件事是把發射器保固期設為六個月，並把預估的保存期限納入考量，然後可能賣給經銷商——那裡又會消耗一個月的保存期限——再到病患手上。所以我們提供六個月保固。我們去年十月出貨的發射器，大多數到現在仍在運作。

And so, we haven't been able to predict when the transmitter sales are going to come back in. We were thinking originally we'd get two transmitters a year. Our product works too well. Good for the patient, and a little tough for us to model. I think over time, Ben, on the hardware cycle, it probably won't be every year with the receiver maybe a SEVEN PLUS, because I think this hardware will become more reliable.

因此，我們一直無法預測發射器銷售何時會回流。我們原本以為一年會用到兩個發射器。我們的產品太耐用了。對病患是好事，但對我們建模有點難。我想長期來看，Ben，就硬體更換週期而言，接收器可能不會像 SEVEN PLUS 那樣每年更換一次，因為我認為這些硬體會變得更可靠。

On the flip side of that, we've got a lot of hardware innovation coming, like the share system, that we will launch, again, as soon it's approved. That's more hardware sales. I don't know what that does to receiver and to transmitter revenues, but it could have a very positive impact.

另一方面，我們也有很多硬體創新即將推出，例如 share 系統，我們會在核准後儘快上市。那會帶來更多硬體銷售。我不確定那對接收器與發射器營收會造成什麼影響，但可能會有非常正面的效果。

And as we look out over time with another transmitter when we talk to a phone, or additional improvements that we have, our hardware cycle may become a little more traditional based on multiple product launches versus waiting three years for a new system. So, for now, our percentage -- we were 30% last quarter durable, creeping down closer towards 25% this quarter with huge sensor sale increases. We'll just kind of play it by ear.

而且，隨著時間推進，當我們談到下一代能與手機通訊的發射器，或我們還有其他改良，我們的硬體週期可能會因為多次產品上市而變得更傳統，而不是等三年才推出一套新系統。所以目前，我們的占比——上季耐用品約 30%，本季在感測器銷售大幅增加下，逐步下降到接近 25%。我們就先視情況調整。

Okay. So, the new-patient revenue -- it's over 50% of the handheld revenues, or is 75% within that?

好的。所以，新病患營收——它占手持式產品營收的50%以上，還是其中有75%是在那裡面？

We've never broke it out, but it's high. It's higher than it's been in other quarters.

我們從來沒有把它拆分出來揭露過，但占比很高。而且比其他季度都更高。

Okay, great. And then the last question, and this is another one for Terry I guess. Why would somebody take off a good sensor at seven days? And you said you were surprised by that. Is it patient comfort or is it just a routine they get into? Thanks.

好的，很好。那最後一個問題，我想這也是問Terry的。為什麼有人會在第七天把一個狀況良好的感測器拆掉？你說你對此感到驚訝。是病患舒適度的問題，還是只是他們養成的例行習慣？謝謝。

No, you know what I suspect it is -- I think it's new patients coming into the system that are different than the patients that originally were the earlier adopters and high-technology people. They actually read the label, the instructions, and use it according to the indicated use. I think they're just following the instructions appropriately. And they haven't gone to the -- because we do actually -- at the end of a session, we give them advanced notice that the session is ending.

不，我猜是這樣——我認為是有新的病患進入系統，他們跟最早那批採用者、那些高科技族群不太一樣。他們真的會去看標籤、看說明，並依照核准適應用途來使用。我覺得他們只是很恰當地遵循指示。而且他們還沒有去——因為我們其實——在一次使用期結束時，我們會提前通知他們這次使用期要結束了。

It's this other group, earlier adopters, that figured out ways to trick the system to allow longer use. So, I think this is a population that is behaving appropriately according to indications for use.

反而是另一群早期採用者，想出各種方法去「騙」系統以延長使用時間。所以我認為這是一個依照核准使用適應症而行為得當的人群。

Good. Thank you.

很好。謝謝你。

Kim Gailun from JPMorgan.

接下來是來自JPMorgan的Kim Gailun。

Thanks for taking the question. And congrats on the quarter. This is a nice one for me coming on board for my first quarter. So, nice work there.

謝謝讓我提問，也恭喜本季表現。對我來說，這是我加入後的第一個季度，這一季很不錯，所以做得很好。

I guess the first question is for Kevin. Just looking at your comments for your full-year outlook, and no formal change, but certainly exceeding the top end of the $140 million on production revenue. I think that you also said, in the fourth quarter, you'll look to normalize toward the 40% growth in product revenues, and not exceed 50%.

我想第一個問題問Kevin。看你對全年展望的評論，雖然沒有正式調整，但生產營收顯然已超過1.40億美元的上緣。我想你也提到，第四季你們會希望回到產品營收約40%的成長常態，而不是超過50%。

Are you essentially saying then, for the fourth quarter, just based on those growth rates, $44 million to $48 million? And then for the full year, on product revenues, that gives you $150 million to $153 million?

所以你基本上是在說，第四季依照那些成長率，產品營收會在4,400萬到4,800萬美元？那全年產品營收就會是1.50億到1.53億美元？

We created a frame that you can paint any way you would like, yes.

我們提供了一個框架，你想怎麼畫都可以，是的。

Okay, but those numbers -- I heard those numbers correctly?

好的，但那些數字——我有聽對那些數字嗎？

Yes, you heard the 40% and not exceeding 50%. That's correct.

是的，你聽到的40%，以及不超過50%，沒錯。

Okay. Fantastic. And how do you think that that plays out as we go into 2014? I know, broadly, you've said the 40% to 50% is the right number for 2014. How do you think about Medtronic's impact next year, as we move through the year?

好的，太棒了。那你們認為進入2014年後會如何發展？我知道你們大致上說過，2014年40%到50%是合理的數字。你們怎麼看明年Medtronic的影響，隨著一年推進會怎麼變化？

It's a little early to tell, Kim, but we've been committed to 35% to 40% growth for next year for a long time here, and we knew this product was coming. So, it's not like we're completely caught unaware.

Kim，現在判斷還有點早，但我們很長一段時間以來就承諾明年成長35%到40%，而且我們也知道這個產品會推出。所以並不是我們完全措手不及。

Driving our growth next year, obviously, a ped's indication is going to be very helpful. We believe our share system, combined with a ped's indication, gives parents an opportunity to monitor their children all night long, and even when they go to school when they take it with them.

推動我們明年成長的因素，顯然兒科適應症會非常有幫助。我們相信，我們的Share系統結合兒科適應症，能讓父母整晚監測孩子，甚至孩子去學校、把裝置帶著走時也能監測。

It will also be, based on our market research, used very extensively with spouses and other loved ones. That will help drive revenue. And combine that with possibly a J&J launch -- we have a lot of things in our favor that are good, good growth drivers for next year. Bottom line: As we look to start next year with this patient base buying a lot more sensors, we've got a pretty good start.

另外，根據我們的市場研究，它也會被配偶與其他親友非常廣泛地使用，這會帶動營收。再加上可能的J&J上市——我們有很多有利因素，都是明年良好的成長驅動。總結來說：明年一開始，這個病患基礎會購買更多感測器，我們的起跑點相當不錯。

Yes. Okay. And then, just a followup on the gross margin, which was obviously also very strong in the quarter. Was there anything one-time in there, or is that the level -- with the mix of business that you're seeing, is that the level we should expect to grow off of going forward?

是的，好的。接著就毛利率再追問一下，本季毛利率顯然也非常強勁。裡面有沒有任何一次性的因素？還是以你們目前看到的業務組合來看，這就是我們未來應該預期、並在此基礎上成長的水準？

There were no one-time events in there that had a material effect on margins. We have little one-time things every quarter.

裡面沒有任何對毛利率造成重大影響的一次性事件。我們每一季都會有一些小的一次性項目。

We've often said our margin target for our sensors was in the 70% to 75% range. And as you guys do the math and figure out hardware versus sensor sales, it's not too hard to deduce that we've got there. So, again, we've achieved what we said we were going to do from a margin perspective, and we look to go forward from here.

我們也常說，感測器的毛利率目標是在70%到75%的區間。各位如果做一下數學、把硬體與感測器銷售拆開來看，不難推導出我們已經達到那個水準。所以，再次強調，我們在毛利率面已達成我們說要做到的事，接下來會以此為基礎往前走。

Okay. Great. Thanks, guys.

好的，很棒。謝謝各位。

Mimi Pham from ABR.

接下來是來自ABR的Mimi Pham。

Good afternoon. I appreciate, Terry, your honest thoughts on Enlite. They talked about launching sometime in the end of October. Have you actually seen them in your account base yet?

午安。我很感謝你，Terry，對Enlite提出坦率的看法。他們提到會在10月底左右推出。你們在你們的客戶基礎中實際上已經看到它了嗎？

Yes, we've actually got reports. And in fact, I have screen shots that have been sent to me from patients showing the highly inaccurate Enlite sensor, and a direct screen shot with our own meter and our sensor, and it's alarming. And I don't mean that as a tongue-in-cheek pun. But the reports of excessive alarms is remarkable.

是的，我們其實已經收到回報。事實上，我收到病患傳給我的螢幕截圖，顯示Enlite感測器非常不準，並且有我們自家血糖機與我們感測器的對照截圖，這很令人震驚。我不是在玩雙關語。但關於警報過多的回報非常驚人。

Yes, we've seen them out there. And I think that's -- my comments are attributed to that type of information. The blogs are already populated with -- this thing isn't working the way that Medtronic is hyping it. And I think that's the disservice to the artificial pancreas consortium that tries to get this out and pursue this.

是的，我們已經在市場上看到它。我想——我的評論就是基於這類資訊。部落格上已經充斥著——這東西並沒有像Medtronic吹捧的那樣運作。我認為這對人工胰臟聯盟（artificial pancreas consortium）是一種傷害，因為大家正努力推動並追求把它做出來。

I think it's -- like I said, I think we've taken -- for those of us that are active in the AP world, and clearly we're in 17 projects around the world, I think this overhyping by Medtronic is gong to blow back in them, number one. And I think, number two, it's going to cause the AP projects and patient advocacy groups to take a second look at where we've come. We've spent all this money. The patient advocacy groups like JDRF and others -- I think there's a question in everybody's mind as to -- this is the best we can do? This is certainly dismal, in my opinion.

我認為——就像我說的，對於我們這些在AP領域積極投入的人而言，而且我們很清楚在全球有17個專案，我覺得Medtronic這種過度炒作，第一會反噬到他們自己。第二，我認為這會讓AP專案與病患倡議團體重新檢視我們目前的進展。我們花了這麼多錢。像JDRF等病患倡議團體——我想每個人心裡都會有個疑問：這就是我們能做到的最好程度嗎？以我個人看法，這確實相當糟糕。

And for patients looking for pump CGM integration, how much can you say about the pending Vibe in the US now? I'm assuming -- (multiple speakers)

那對於尋求幫浦與CGM整合的病患，你能談談目前在美國待核准的Vibe嗎？我猜——（多位講者）

I'd have to look at the -- use the international experience as a proxy. So, the Veo system, which is the 530G and European launch, and it's been there for about three years now, has not grown particularly. The Vibe has taken share in every country that they are in.

我得用國際市場的經驗作為參考。所以，Veo系統，也就是530G在歐洲的上市，已經在那邊大約三年了，成長並不特別明顯。Vibe在其進入的每個國家都拿到了市占。

I think the physicians recognize the lack of utility of that, quote, low glucose suspend over their low threshold. Here, that when you're only suspending for an average of 11 minutes and overnight, and you're -- that suspension represents probably less than a couple of units of insulin, that you're really not doing much.

我認為醫師已經意識到，所謂的「低血糖暫停」（low glucose suspend）在低閾值設定下其實效用不大。因為你平均只暫停11分鐘，而且是在夜間；而那段暫停所代表的胰島素量可能不到幾個單位，其實並沒有做太多事情。

So, I don't think they would necessarily harm a patient, but all it's going to do is just drive them crazy with alarms. They wake up, do a confirmatory finger stick, recognize that the Enlite sensor is wrong. And so, I think the more that happens, the more frustrated and the more alarm secession that patients engage in. And that's all going to come back to the blogs and to the health care providers.

所以我不認為它一定會傷害病患，但它只會讓他們被警報搞到抓狂。他們醒來後做一次指尖採血確認，發現Enlite感測器是錯的。因此，我認為這種情況發生得越多，病患就越挫折，也越會進行警報關閉（alarm secession）。而這些都會回到部落格與醫療照護提供者那裡。

Got it. And then -- (multiple speakers)

了解。然後——（多位講者）

I think the Vibe well launch launch tier will take share.

我認為Vibe一旦順利上市，將會取得市占。

And should we be updating our models for Vibe to reflect more of a mid-2014 launch next year?

那我們是否應該更新模型，把Vibe反映為明年更偏向2014年年中上市？

As Steve -- I thought Steve had a great answer that this is driven by J&J. And although we're helping them every step of the way, it's really their filing. And until that actually goes in and they've responded appropriately, it would be inappropriate for us to comment on timing.

就像Steve——我覺得Steve回答得很好，這是由J&J所主導。雖然我們一路都在協助他們，但申報文件畢竟是他們的。除非他們真的送件並且也適當回覆了相關問題，否則我們不適合評論時程。

Got it. And then just last -- a comment about the sales productivity increasing. Have you reached the max sales productivity, or is there still a lot more upside?

了解。最後——關於銷售生產力提升的評論。你們是否已經達到銷售生產力的上限，還是仍有很大的上行空間？

There's a lot more upside. If you look at data that says where we're at, as a penetration in a category, we clearly -- most everybody thinks we've got more than 50% share in the US. And I don't know whether that's true or not true.

還有很大的上行空間。如果你看一些數據，從我們在這個類別的滲透率來看，我們很明顯——幾乎所有人都認為我們在美國的市占已經超過50%。但我不知道那到底是真的還是不是真的。

But as a category approaching 10% -- if you look at pumps, they're not quite at 30%. So, I would say hard target has to be north of pumps. So, we've got a lot of runway yet in front of us to achieve much greater goals.

但作為一個接近 10% 的類別——如果你看幫浦，它們還不到 30%。所以，我會說硬性目標必須高於幫浦。因此，我們前方仍有很長的跑道，可以去達成更高的目標。

Thank you.

謝謝。

Tao Levy from Wedbush.

Wedbush 的 Tao Levy。

Good afternoon. So, just to be clear then, so in the current quarter, in the third quarter, you really didn't have much in terms of incremental six-month transmitter type revenues?

下午好。那麼，為了確認清楚，在本季、也就是第三季，你們在增量的六個月發射器（transmitter）類型營收方面，其實沒有太多？

Not much.

不多。

No.

沒有。

We had some, but not a lot.

有一些，但不多。

And do you think that -- that has to start hitting here in the fourth quarter, right?

了解。那你認為——這應該會在第四季開始反映出來，對吧？

It started picking up a little bit in September. And it's gone a little faster here in October and November. It still has the -- the floodgates haven't opened yet.

9 月開始有些微回升。而在 10 月和 11 月這裡又快了一點。只是——閘門還沒有完全打開。

Got you. Okay. And have you closed down the old sensor manufacturing the SEVEN?

了解。好。那你們已經關閉舊款感測器 SEVEN 的製造了嗎？

Yes, we have. We don't manufacture SEVEN PLUS sensors anymore. We've got a safety stock of inventory built, primarily to service our professional-use patients until the G4 PLATINUM professional-use system is approved, and occasional one-off shipments to our patients. We're in the middle of implementing some very aggressive upgrade programs for the remainder of the SEVEN PLUS patients to get them switched over. And those will be going out shortly. We'll push pretty hard over the next six weeks.

是的，我們已經關了。我們不再製造 SEVEN PLUS 感測器了。我們建立了一些安全庫存，主要是為了在 G4 PLATINUM 專業使用系統獲准之前，服務我們的專業使用患者，以及偶爾對我們患者的一次性出貨。我們正在推行一些非常積極的升級計畫，讓剩餘的 SEVEN PLUS 患者轉換過來。這些很快就會開始出貨。我們會在接下來六週內大力推進。

Thank you. So, in the Q3 gross-margin number, that still includes some of the old manufacturing? (multiple speakers)

謝謝。所以在第三季的毛利率數字裡，仍然包含一些舊製造的影響？（多位發言者）

Yes. It absolutely does.

是的，絕對包含。

Okay. So, then that gets better, from what we've seen?

好。所以接下來會改善，依我們看到的情況？

Should.

應該會。

Should. Right. And then just lastly, I didn't hear anything on GlucoClear, and if there's any updates there. Thanks.

應該會。對。最後一個，我沒有聽到 GlucoClear 的消息，有沒有任何更新？謝謝。

I can go ahead. You know what? They're marketing it commercially on a limited basis in Europe. And they appear, as we hear comments in their calls and such, to be very bullish on the product. And we didn't have much on the revenue side there. So, it all appears to be going well.

我可以回答。你知道嗎？他們在歐洲以有限的方式進行商業化行銷。從我們在他們電話會議等聽到的評論來看，他們似乎對這個產品非常看好。而我們在那邊的營收面並沒有太多。所以，看起來一切進展順利。

And feedback -- clinical feedback -- that's all trending in the right direction?

那回饋——臨床回饋——都朝著正確方向發展？

Yes.

是的。

As far as we can tell. We have to -- Mike Mussallem certainly has that as a key growth driver in his comments. And I know they've committed a lot of resources to launch the product in the European sector in a very limited way. And their goal is, not only from the accuracy and that which is exquisite, we're down laboratory reference accuracy with the sensor technology.

就我們所能判斷，是的。我們必須——Mike Mussallem 在他的評論中，確實把它視為關鍵成長動能。我也知道他們投入了大量資源，以非常有限的方式在歐洲市場推出這個產品。他們的目標不僅在於精準度——而且精準度非常出色——我們的感測器技術已達到與實驗室參考值一致的精準度。

But there's this other factor that they believe is important, and that is changing behavior in the ICU to allow it to be more functional by the nursing staff and the ICU staff. I think that's what they're trying to look at behavior modifications for the intents of us and the anesthesiologist and the staffing and how they use it in an effective way, because it is quite a change for the behavior in that environment.

但他們認為還有另一個重要因素，那就是改變 ICU 的行為模式，讓護理人員與 ICU 團隊能更有效地運作。我想他們正在觀察行為改變，從我們以及麻醉科醫師與人力配置的角度，看看如何以有效方式使用它，因為在那樣的環境中，這確實是很大的行為改變。

Okay, great. Thank you very much.

好，太好了。非常感謝。

Danielle Antalffy from Leerink Swann.

Leerink Swann 的 Danielle Antalffy。

Thanks so much. Good afternoon, guys, and congrats on another great quarter. I just wanted to touch on the full-year guidance a little bit. Appreciating the numbers that you gave, but could you talk a little bit about -- in more detail, about the variables driving the fact that you're not raising guidance when the numbers you provided would imply a $10 million beat on the top line for the product revenue.

非常感謝。各位下午好，恭喜又有一個很棒的季度。我想稍微談一下全年指引。感謝你們提供的數字，但你們能否更詳細談談——有哪些變數驅動你們在所提供的數字看起來意味著產品營收上線可超出 1,000 萬美元的情況下，仍不調升指引？

So, I guess, what's keeping you from just going out and raising the guidance? Is it just conservatism against the Medtronic launch? Now we're already six weeks in, I guess. So, could you give a little bit more color about your thinking there?

所以，我想問的是，究竟是什麼讓你們沒有直接上調指引？只是因為對 Medtronic 上市的保守看法嗎？我們現在大概已經過了六週了。所以，你們能否多提供一些你們思考上的脈絡？

This isn't conservatism against the Medtronic launch. This is just a look at our Business and where we are and what we'd anticipate for the fourth quarter.

這不是因為對 Medtronic 上市的保守。這只是檢視我們的業務、我們目前的位置，以及我們對第四季的預期。

We typically, in the past, have never upgraded our year-end guidance in the fourth quarter, and we're going to stick with that policy. Because if we do upgrade it specifically, then we end up changing that year-end guidance. And we don't feel the need to do that.

過去我們通常在第四季從不上調全年指引，我們會維持這個政策。因為如果我們特別去上調，就等於改變了年終指引，而我們覺得沒有必要這麼做。

We feel we've given you enough of a frame, and enough information to figure out where we think our numbers will be. And that's where we are.

我們覺得已經給了你們足夠的框架與資訊，讓你們可以推算我們認為數字會落在哪裡。而我們就是在那個位置。

And the other impact, and I'll just be very transparent that if we gave you the Q4, you're going to look for it in Q1 2014, and that's not what we want to do. We don't want to give quarterly guidance.

另外一個影響，我也很透明地說，如果我們給你們第四季的數字，你們就會在 2014 年第一季也期待同樣的做法，而那不是我們想要的。我們不想提供季度指引。

Okay. Got it. Thank you.

好，了解。謝謝。

And then, as far as the Medtronic launch does go, a good number of your sensor wearers are Medtronic pump users. What are you seeing -- and I actually am not sure if you've disclosed that number, or if you could give us that number -- but what are you seeing of those patients? Are you still managing to hold on to those patients, or are you seeing some of those patients switch over to Medtronic? Because Medtronic sometimes automatically upgrades patients, I know. So, I'm not sure how that's playing out.

另外，關於 Medtronic 的上市，你們有相當多的感測器使用者也是 Medtronic 幫浦使用者。你們看到——而且我其實不確定你們是否揭露過這個數字，或你們是否能提供——你們看到這些患者的情況如何？你們是否仍能留住這些患者，還是看到其中一些患者轉去 Medtronic？因為我知道 Medtronic 有時會自動替患者升級。所以我不確定實際情況如何發展。

Well, I will tell you we haven't -- it's been too early in their launch to really have a good optics on what it's going to turn out to be. That's why, in Kevin's comments, two to three quarters -- you can't -- from a billing standpoint, there are some issues to the individual component parts, transmitters and so forth that our patients have already been reimbursed for. So, Medtronic can't bill for some of those things.

我可以告訴你，現在還太早，Medtronic 的上市時間還不夠長，我們很難清楚看出最後會是什麼結果。這也是為什麼 Kevin 的評論提到要兩到三個季度——你不能——從請款（billing）的角度來看，涉及到一些個別零組件，像是發射器等等，我們的患者有些已經獲得過這些項目的給付。因此，Medtronic 不能對其中一些項目再請款。

So, I think it's a very complicated scenario. And I would expect that, even in those that have upgraded and get to do their own comparative analysis between the G4 PLATINUM and the Enlite sensor -- I worry less about the attrition of those based on a few inputs that we've received. As I mentioned, I get screen shots from patients making their own comparison. And I think we'll see more and more of that. So, I'm not as concerned, I believe, as maybe some others are. (multiple speakers)

所以我認為這是非常複雜的情境。而我預期，即便是那些已經升級、並能在 G4 PLATINUM 與 Enlite 感測器之間做自己的比較分析的人——基於我們收到的一些回饋，我對這些人的流失反而沒那麼擔心。如我提到的，我會收到患者傳來的螢幕截圖，讓他們自己做比較。我想我們會看到越來越多這樣的情況。所以我沒有那麼擔心，我認為可能不像其他人那麼擔心。（多位發言者）

Okay. Thanks. Okay. Thanks so much.

好，謝謝。好，真的非常感謝。

Korosh Saba from Stephens Incorporated.

Stephens Incorporated 的 Korosh Saba。

Hello, guys. Congrats on the triple-digit quarter. Really nice to see.

各位好。恭喜這個三位數成長的季度。很高興看到。

Just going back to the J&J and Tandem -- the integrated launches -- can you guys just speak around some color of how you guys see those two partners supporting the launch? Whether they'll be going after new patients versus converting their existing patient base, and just some color would be helpful. Thanks.

回到 J&J 和 Tandem——整合式上市——你們能否談談你們如何看這兩個合作夥伴支援上市？他們會去爭取新患者，還是轉換他們既有的患者基礎？提供一些脈絡會很有幫助。謝謝。

Yes, this is Steve. I can't speak with specifics for Tandem because we haven't, frankly -- I haven't talked to the Tandem business folks as to their specific launch plans. But absolutely with Animas and with the Vibe product, their expectation is to go straight after the Medtronic installed base. Look, it's no secret that the vast majority of pump patients in the US wear a Medtronic pump. They probably have 65%-plus market share.

是的，我是 Steve。關於 Tandem 我無法談太多細節，因為坦白說——我還沒有和 Tandem 的業務團隊談過他們具體的上市計畫。但對 Animas 以及 Vibe 產品而言，他們的預期是直接鎖定 Medtronic 的既有裝機基礎。你看，這不是秘密，美國絕大多數的幫浦患者使用的是 Medtronic 幫浦。他們的市占可能超過 65%。

So, every year, the number of pumps sold in the US -- there's probably -- I would venture to guess there's more pumps sold to existing patients than there are new patients to pump therapy. So, the lowest of the low-hanging fruit is a patient who has already chosen to wear a pump, but is just within -- just outside of their upgrade cycle. So, absolutely, that will be the Animas primary target. My guess is that Tandem will probably do the same.

所以每年在美國售出的幫浦數量——我猜，賣給既有患者的幫浦可能比賣給新進入幫浦治療的患者還多。因此，最容易摘取的果實，就是已經選擇使用幫浦、但剛好在——或剛過——他們的升級週期邊緣的患者。所以，毫無疑問，這會是 Animas 的主要目標。我猜 Tandem 也可能會採取同樣做法。

We have heard, and this is publicly shared from Tandem, that they have done an excellent job in adding the patients they've added to date in converting Medtronic patients. So, I would assume that Tandem would probably take the same approach.

我們也聽說——而且這是 Tandem 公開分享過的——他們在目前新增患者方面做得非常好，其中相當一部分是轉換 Medtronic 患者。所以我會假設 Tandem 很可能也會採取同樣的策略。

That's helpful. And then, just on pediatrics -- can you guys just provide some color around how you see that coming on board, and how quickly throughout next year you see that coming?

這很有幫助。然後，關於兒科——你們能否提供一些脈絡，談談你們如何看它開始導入，以及明年你們預期它會以多快的速度推進？

Well, again, we continue to have discussions with the FDA. The discussions center on labeling a product specifically for pediatric patients. And they are requiring specific pediatric patient labeling, and a specific pediatric patient product offering. We're discussing those features with the agency, and coming to where they want us to be.

嗯，再次強調，我們仍持續與 FDA 進行討論。討論的重點在於針對兒科病患對產品進行特定標示。他們要求有明確的兒科病患標示，以及一個專門面向兒科病患的產品方案。我們正在與主管機關討論這些特性，並逐步達到他們希望我們達到的狀態。

As far how that comes on board, again, I'll go back to our past history. We announced G4 PLATINUM, I believe, on October 7 or 8 last year, and were shipping October 20. We expect the same from our team here, again.

至於何時能到位，我再回到我們過去的經驗。我們去年 10 月 7 日或 8 日（我記得是這個時間）宣布了 G4 PLATINUM，並在 10 月 20 日開始出貨。我們也期待我們這邊的團隊這次同樣能做到。

And then, once it comes on board, we can directly market to the pediatric endocrinologists. And we believe over time that segment of our patient base will grow from the 8% to 10% that it is now to be more reflective of the general diabetes population in the 20% to 30% range. So, it's a wonderful growth opportunity for us. And with our -- the accuracy of our product with the connectivity and convenience and communication features we're about to offer, we think it's a wonderful area for us to go.

接著，一旦到位，我們就能直接向兒科內分泌科醫師進行行銷。我們相信，隨著時間推進，這一段病患基礎將從目前的 8% 到 10% 成長，變得更貼近整體糖尿病人口的 20% 到 30% 區間。因此，這對我們而言是很棒的成長機會。再加上我們產品的準確度，以及我們即將提供的連線、便利性與溝通功能，我們認為這是一個非常值得切入的領域。

Great. And then just last one from me. In terms of the share product, have you guys given, or could you guys provide some color around how you expect to price that, whether it be a monthly, quarterly, or how you guys are looking at that?

很好。那我最後一個問題：就 share 產品而言，你們是否已經決定，或能否提供一些方向，說明你們預期會如何定價？例如按月、按季，或你們目前的思考方式？

To start with, we've got some pricing models built. I'd rather not disclose that now. I need to let my marketing team figure their way through it.

一開始，我們已建立了一些定價模型。不過我現在寧可不揭露。我需要讓我的行銷團隊把這件事再梳理清楚。

I can tell you our goal on this product is not to launch a product that people look at and go -- oh, I can't afford that. We want people to buy this and use it and buy more sensors. So, it will be very economically feasible for the patients.

我可以告訴你的是，我們對這個產品的目標不是推出一個讓人看了就覺得——喔，我負擔不起的產品。我們希望大家能買得起、用得起，並且購買更多感測器。所以，對病患而言，它會是非常具有經濟可行性的。

It will add something to our bottom line. But ultimately, our goal here is to sell more sensors. And that's what we're shooting for.

它會對我們的獲利有所貢獻。但最終，我們在這裡的目標是賣出更多感測器。這就是我們努力的方向。

Great, thanks. And congrats again.

很好，謝謝。也再次恭喜。

Jayson Bedford from Raymond James.

接下來是來自 Raymond James 的 Jayson Bedford。

Good afternoon. Thanks for squeezing me in; I'll be quick here. You mentioned increased retention as one of the factors in the growth here. Is there any way to quantify the improvement in retention? Meaning: Is it 5%, 10% higher than what you were seeing with the SEVEN PLUS?

下午好。謝謝讓我插進來；我會很快。你提到留存率提升是這次成長的因素之一。有沒有辦法量化留存率改善的幅度？也就是說：相較於 SEVEN PLUS，你們看到的是高出 5%、10%，還是多少？

We've never given a retention or attrition percentage in detail to anybody. It's a lot better; I'll just leave it at that. It's a very significant improvement over what we saw before.

我們從未向任何人詳細提供留存或流失的百分比。只能說好很多；我就先講到這裡。相較於我們之前看到的情況，這是非常顯著的改善。

Okay. Internationally, I think you've talked in the past about adding 10 new countries. I realize it's a small piece of the pie right now, but are you seeing any contribution from these new countries, or is the growth you're seeing from countries you're already selling into?

了解。國際市場方面，我記得你們過去談過要新增 10 個國家。我知道目前占比還小，但你們是否已看到這些新國家帶來任何貢獻？還是你們看到的成長主要來自既有銷售國家？

Most of the growth this year has been in our core countries. As the new countries come on board, they start a little slow. But we are making progress in adding those 10 new countries.

今年大部分的成長都來自我們的核心國家。新國家一旦加入，起步通常會比較慢。但我們在新增那 10 個國家方面確實正在取得進展。

By the end of the year, we're confident we'll be approved in pretty much all 10 of the ones we look to add. And then, we'd expect those to account for a decent piece of our international revenues next year. So, we'll finish that up.

到今年年底，我們有信心在我們計畫新增的那 10 個國家中，幾乎全部都能取得核准。接著我們預期，明年它們將在我們的國際營收中占到相當不錯的一部分。所以我們會把這件事收尾完成。

Every country is important, and every one of these adds is important to us. That's how we'll build that business over time. So, our team is doing exactly what we've asked of them.

每一個國家都很重要，而每一次新增對我們也都很重要。這就是我們隨時間建立這門業務的方式。因此，我們的團隊正在完全按照我們的要求在執行。

Okay. And then just lastly on gross margin, I may have misheard it, but did you say that gross margin on the G4 PLATINUM sensor was 70% to 75% in the quarter?

好的。最後關於毛利率，我可能聽錯了，但你是否說本季 G4 PLATINUM 感測器的毛利率是 70% 到 75%？

I said that has always been our target. And then one can deduce, looking at 65% over our margins with the hardware and sensor mix, that we're there. We're within that target range.

我說的是，那一直是我們的目標。然後你可以從我們整體 65% 的毛利率、以及硬體與感測器的組合占比來推論，我們已經達到那個水準——我們就在那個目標區間之內。

Fair enough. Thank you.

了解。謝謝。

Jan Wald from Benchmark.

接下來是來自 Benchmark 的 Jan Wald。

Congratulations on the quarter. It was exceptional.

恭喜這一季，表現非常出色。

I just have a couple of quick questions. Most of the questions that I had were answered.

我只有幾個簡短問題。我原本的大多數問題都已經被回答了。

But one is -- just to make sure on the share submission, the questions you're getting are benign, right? There's nothing that's untoward or getting in the way of a smooth answer and response?

其中一個是——想確認一下 share 的送件（submission），你們收到的問題都算是溫和的、沒有惡意的，對吧？沒有什麼不尋常或會妨礙順利回覆與應對的狀況？

We don't see anything as major, but we also never see anything from the agency as benign either. So, we're giving them due diligence. They didn't ask us anything we can't answer. How's that?

我們沒有看到任何重大問題，但我們也從不把主管機關的任何問題視為「無關緊要」。所以我們會做足盡職調查。他們沒有問我們任何無法回答的問題。這樣說可以嗎？

That's a good answer. I guess another question I had is -- are there any updates on the clinical studies you have ongoing or planned? They seem to be important to your marketing strategy, and I was wondering where they are?

這回答得很好。我另外一個問題是——你們正在進行或規劃中的臨床研究，有沒有任何更新？這些研究看起來對你們的行銷策略很重要，我想了解目前進度如何？

We're going to give more color on that next year, once these things get rolling. I think we're in a phase -- in the fourth quarter, we're running some pilot studies. We're doing a lot of trial design and consultation.

等到明年這些事情開始推進後，我們會提供更多細節。我想我們目前處在一個階段——在第四季，我們正在做一些試點研究（pilot studies）。我們也在做大量的試驗設計與諮詢。

I think next year, as we go forward, you'll hear a lot more on these studies. But right now, it's a little early to tell you anything.

我想明年往前走時，你會聽到更多關於這些研究的消息。但現在要告訴你任何內容都還有點早。

Okay. And just in terms of your sales force, you have 90 reps now. You added 20. How do we see the sales -- (multiple speakers)

好的。再來就你們的銷售團隊而言，你們現在有 90 位業務代表。你們新增了 20 位。那我們怎麼看銷售——（多位講者同時發言）

Not yet. We will have -- when we get --

還沒有。我們會——等我們——

But when you add the 20, you'll have 90.

但當你新增那 20 位之後，你們就會有 90 位。

Correct.

沒錯。

Okay, sorry.

好的，不好意思。

That's okay.

沒關係。

How do you see the sales force growing, let's say, over the next couple of years? Are you there and ready with the leverage, or a lot more territories and a lot more leverage opportunities even if you add?

你怎麼看銷售團隊在未來幾年的成長？例如接下來一兩年，你們是否已經到位、可以靠槓桿效應放大？還是即使再增員，仍有很多新區域與更多槓桿機會？

Well, as pointed out earlier, these guys were pretty leveraged this quarter, as we didn't add any bodies that are up 24% when comparing to the quarter before. I think we're getting more leverage out of this group all the time, particularly as we continue, again, to sell more sensors.

嗯，如同先前提到的，這一季這些人其實已經被高度槓桿化，因為我們沒有增加任何人手，但相較前一季仍成長了 24%。我認為我們一直都能從這個團隊身上取得更多槓桿效益，特別是當我們持續賣出更多感測器時。

But I also don't see us stopping our expansion either. There will be -- at some point in time, we'll get to the right mix, and more than likely be done. But the time is not now. It's certainly not next year. And we probably don't see it being through 2016. We think we can continue to grow.

但我也不認為我們會停止擴張。在某個時間點，我們會達到合適的組合，並且很可能就會告一段落。但現在不是那個時候，明年當然也不是。我們大概也不認為會在 2016 年之前就停止。我們認為我們可以持續成長。

And internationally, we use distributors everywhere. We've got a pretty small, effective international staff right now. There's investments to be made in that area, as well.

而在國際市場，我們各地都使用經銷商。我們目前的國際團隊規模很小但很有效率。那個領域也同樣需要投資。

So, if we're thinking about the sales force additions over time, we should just consider that what you're doing now is what we should see over the next year to two years?

所以，如果我們在思考銷售團隊隨時間的增員，我們是否可以把你們現在的做法視為未來一到兩年會持續看到的節奏？

As we look at our spending, and it's a good question. We've spent a whole bunch of years before 2010 investing a whole bunch in trying to get product developed and product right. And what we're doing right now, to a large extent, even though we continue to spend on the product front, it's now time for the commercial side of our Business to catch up. Not only are you going to see continued investments in the sales force as we grow it, but in all candor, we've got to become a marketing company, too.

就我們的支出來看，這是個好問題。2010 年之前，我們花了很多年投入大量資金，努力把產品開發出來並把產品做到位。而我們現在做的事情，在很大程度上，即使我們仍持續在產品端投入，現在也到了我們商業端必須追上的時候。不只是你會看到我們隨著成長持續投資銷售團隊，坦白說，我們也必須成為一家行銷公司。

And so, we'll be not only investing in sales, but you asked about the clinical studies. We've never run a clinical study other than for product approvals. We've got to do things that support the value and, again, support our fundamental belief that CGM is the most important technology in diabetes. And it's the most important thing for anybody with insulin-dependent diabetes to manage their condition.

因此，我們不只會投資銷售；你也問到臨床研究。我們過去除了為了產品核准之外，從未做過臨床研究。我們必須做一些事情來支持其價值，並再次支持我們的核心信念：CGM 是糖尿病領域最重要的技術；對任何需要胰島素治療的糖尿病患者而言，它是管理病情最重要的工具。

And so, some of those studies that we're going to do -- it's different than what we've done before. We're going to invest in things like that, in addition to salespeople. So, as you look at where we grow our dollar spending-wise, we will more than likely grow dollars as much, if not more, on the commercial side than we will the others over the next few years while we get to an equilibrium. And then we'll see where we are after that.

所以，我們將要做的一些研究——會和我們過去做的不一樣。除了增聘業務人員之外，我們也會投資在這類事情上。因此，當你看我們未來幾年在資金投入上的成長方向時，在達到一個均衡之前，我們在商業端的投入金額很可能會與其他面向一樣多，甚至更多。之後我們再看看那時的狀況。

That goes back to a previous discussion, I think, where you were talking about growing the top line, but also recognizing now that you're going to have to return some earnings sooner than later, and probably by 2015. So, the spend rate -- I guess it's going to affect what you're going to be able to sell to the bottom line. How do you see that going in the next year to two years?

這讓我回想到先前的一段討論，我想當時你談到要拉升營收（top line），但同時也意識到你們現在必須在不久的將來、而且很可能在 2015 年之前就要更早地回饋部分獲利。因此，支出率——我想這會影響你們最終能夠落到淨利（bottom line）的部分。你怎麼看未來一到兩年的走勢？

I see that just being a balancing act, and we've got some great people here to manage it. Terry and I have been through this a few times before, as have many of the people on this team. Any project we take on, we look at the payback, we look at the return, and we sometimes learn to say no. And we do.

我認為這就是一個平衡的取捨，而我們這裡有一些很棒的人才來管理它。Terry 和我以前也經歷過幾次，團隊裡很多人也是如此。任何我們要做的專案，我們都會看回收期、看報酬，有時也學會說不。而我們確實會這麼做。

All right. Well, thank you very much. Again, congratulations on the quarter.

好的。非常感謝。再次恭喜本季表現。

You bet.

當然。

Raj Denhoy from Jefferies.

Jefferies 的 Raj Denhoy。

I was just curious about some of the trends you're seeing with the launch of the G4, things like higher sensor utilization, the lower attrition rates. And I'm curious how that compares back to the experience on the launch of the SEVEN PLUS? And in particular, is there a concern that some of those very robust trends may slow as patients get more experienced with the device or we move beyond the initial launch here?

我只是好奇你們在 G4 上市後看到的一些趨勢，例如更高的感測器使用率、較低的流失率。我也想知道這和 SEVEN PLUS 上市時的經驗相比如何？特別是，會不會擔心這些非常強勁的趨勢，隨著病患對裝置越來越熟悉或我們走過初期上市階段後而放緩？

I'll speak my piece. I think it's exactly the opposite. Sensor satisfaction and satisfaction with a product like this is determined very quickly. If patients find this product reliable and informative, and a tool to manage their lives -- if they're happy, they stay on.

我先說我的看法。我認為情況正好相反。對這類產品而言，感測器滿意度與產品滿意度很快就能決定。如果病患覺得這個產品可靠、資訊量足夠，而且是管理生活的工具——如果他們滿意，就會持續使用。

And so, early usage is probably the more important indicator versus long term with something like CGM or pumps or anything like that. And so, in this case, the early history of the Gen4 launch, where it has performed much better than SEVEN PLUS did in the beginning with retention and sensor utilization and those trends, is truly a positive trend for us. ¶ I don't know, Terry, if you have anything to add?

因此，對於像 CGM 或幫浦這類產品，早期使用情況可能比長期更重要的指標。就這個案例而言，Gen4 上市初期的表現，在留存率、感測器使用率以及這些趨勢上，都比 SEVEN PLUS 當初一開始好得多，這對我們確實是正向趨勢。¶ 我不知道，Terry，你有沒有要補充的？

I agree with Kevin. We're getting -- moving beyond the early adopters. So, it means we're also in CGM first with physicians and patients coming in naive to technology. And it's becoming a part of the fabric of their diabetes armamentarium, so they don't know any different.

我同意 Kevin 的看法。我們正在——逐步走出早期採用者階段。所以，這也代表我們在 CGM 上，首先接觸到的是對技術還很陌生的醫師與病患。而它正逐漸成為他們糖尿病治療工具箱的一部分，因此他們不會覺得有什麼不同。

And in that fact, if they've never been on a CGM, and the first one they go on in G4, they're extremely happy if they've been on SEVEN PLUS and have moved to G4, they're even happier because they have a benchmark for which to compare. If they've been on anybody else's sensor, then they're even happier to come to G4 because they have yet another wonderful experience.

在這種情況下，如果他們從未使用過 CGM，而第一個使用的就是 G4，他們會非常滿意；如果他們用過 SEVEN PLUS 並升級到 G4，他們會更滿意，因為有基準可以比較；如果他們用過其他廠商的感測器，那麼轉到 G4 會更滿意，因為又多了一次很棒的體驗。

And all of that goes to reduction of attrition and continued use on a more sensors-per-month basis that we're seeing. So, I don't see any headwinds associated with that, quite the contrary.

而這些都會帶來流失率下降，以及我們所看到的——以每月更多感測器用量為基礎的持續使用。因此，我看不到任何逆風，反而恰恰相反。

So, to just be clear, those trends you're seeing are being experienced in both the brand new patients, but in also the upgrade patients in terms of those metrics?

所以，為了確認清楚，你們看到的這些趨勢，在全新病患以及升級病患身上，這些指標都同樣出現嗎？

I don't think we have the detail available to answer that adequately, to say absolutely. And then the comments that we have from the metrics are, overall, we haven't dug down in to see which patients are using the sensors more frequently, naive patients are new to Gen4 versus SEVEN PLUS upgrades. We don't have that data.

我想我們沒有足夠細節可以充分回答、也無法斬釘截鐵地說是。就我們從整體指標得到的評論而言，我們還沒有深入去看哪些病患更頻繁使用感測器——是對 Gen4 完全陌生的新手病患，還是從 SEVEN PLUS 升級的病患。我們沒有那樣的資料。

Okay. Thank you.

好的。謝謝。

Steven Lichtman from Oppenheimer.

Oppenheimer 的 Steven Lichtman。

It's Rosemary in for Steve. Can you hear me okay? Thanks for squeezing me in.

我是 Rosemary 代替 Steve。你們聽得到我嗎？謝謝讓我插進來。

Just quickly on the tandem PMA filing -- can you elaborate on the type of validation testing that's being done, and generally how long you think this testing would take?

快速問一下 Tandem 的 PMA 申請——你能否更詳細說明正在進行的驗證測試類型，以及一般你認為這些測試需要多久？

No, I can't give any more specifics other than -- we've talked previously about -- applicable to Tandem and to Animus is, remember: they're moving from a 510(k) environment to a PMA environment. And the level of systems testing required of a PMA company versus a 510(k) is substantially greater. So, there's just a lot of work to do. And I think both Animus previously, and then this time around Tandem, probably underestimated the magnitude of the work that has to be done in order to complete an adequate PMA to submit to the FDA.

不，我無法提供更多細節，除了——我們之前談過——適用於 Tandem 以及 Animus 的情況是，請記得：他們正從 510(k) 的環境轉到 PMA 的環境。PMA 公司所需的系統測試層級，相較於 510(k) 要高出許多。所以，確實有大量工作要做。我認為 Animus 之前，以及這次的 Tandem，可能都低估了為了完成一份足以提交給 FDA 的合格 PMA 所必須完成的工作量。

So, I can't go into the specifics of the details of the testing. But let's just say they're very attuned to it. And we will help them in every way we can to get the filing done as soon as possible.

所以，我無法深入說明測試細節。但可以說，他們對此非常重視。我們也會盡一切所能協助他們，讓申請能盡快完成。

Okay. Fair enough. And Terry, can you talk a little more about the opportunity for G4 in professional use? How much more of an opportunity is G4 versus SEVEN PLUS in this professional-use market?

好的。可以理解。那 Terry，你能再多談談 G4 在專業用途（professional use）方面的機會嗎？相較於 SEVEN PLUS，G4 在這個專業使用市場的機會大多少？

Well, I think there's a tremendous opportunity for G4 in professional use. Physicians enjoy the opportunity to put patients on the sensor.

我認為 G4 在專業用途方面有非常巨大的機會。醫師很享受有機會讓病患配戴感測器。

We have the opportunity to do it either in a blinded or unblinded manner. We prefer unblinded. I think the majority of intelligent physicians today use the unblinded way as their preference, because that allows both the physician and the patient to experience the levels of glycemic variability and get a better understanding.

我們可以選擇以盲測或非盲測的方式進行。我們偏好非盲測。我認為如今多數有判斷力的醫師也偏好非盲測，因為那能讓醫師與病患都體驗到血糖波動的程度，並獲得更好的理解。

I always remind physicians who want to have such control, that they only see their patients, at best, four times a year. And so, the patient is left to be responsible for their own diabetes the 361 days a year that they don't see a physician. And so, it's better to have more information than less information with the help and education from the health care professional.

我總是提醒那些想要高度掌控的醫師，他們一年最多也就見病患四次。因此，在其餘 361 天沒有見到醫師的日子裡，病患必須自己對糖尿病負責。所以，在醫療專業人員的協助與教育下，資訊多一點總比少一點好。

But having that technology available to them will enable them to get more patients started who may, in fact, be hesitant to go on CGM. And this allows them to cross the threshold and realize how valuable the information is, and migrate then to their own personal system.

而讓他們能使用這項技術，將使他們能讓更多原本可能對使用 CGM 感到猶豫的病患開始嘗試。這能幫助他們跨過門檻，體會資訊的價值，然後再轉換到自己的個人系統。

All right. Thanks for the color.

好的。謝謝補充說明。

I will now turn the call back over to Terry Gregg.

我現在把電話會議交回給 Terry Gregg。

Thank you, and thanks for joining us. Obviously, this was, as I think one of you, maybe Bill Plovanic said -- wow. We agree, Bill -- wow.

謝謝，也謝謝各位加入。顯然，正如我想你們其中一位——也許是 Bill Plovanic 說的——哇。我們同意，Bill——哇。

So, we've done everything we've said we were going to do, and then some. This technology is the most exquisite, and the management team is the best that I have ever been associated with. And my last team was pretty good.

所以，我們做到了所有我們說要做的事，而且還更多。這項技術是最精湛的，而管理團隊也是我合作過最優秀的。我上一個團隊也相當不錯。

We know we're being chased by others who want to be the lead dog because if you're not the lead dog, the view never changes. While those who chase us shoot for G4 PLATINUM accuracy, for example, we've already set our sights and are deeply engaged in therapeutic accuracy, followed by reduced or factory-calibrated sensors. So, to the 350 million people with diabetes today, help is on the way, and it will have a DexCom label. Thank you.

我們知道有人在追趕我們，想當領頭羊，因為如果你不是領頭羊，看到的風景永遠不會改變。當追趕者以 G4 PLATINUM 的準確度為目標時，例如，我們已經把目標放在治療級準確度（therapeutic accuracy），接著是降低校正需求或工廠校正（factory-calibrated）的感測器。因此，對於今天全球 3.5 億名糖尿病患者而言，幫助正在路上，而且會貼著 DexCom 的標籤。謝謝。

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

謝謝各位女士先生。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。