德康醫療 (DXCM) 2011 Q2 法說會逐字稿

Welcome to the DexCom second quarter earnings release call. My name is Kim 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 a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Mr. Terry Gregg. Mr. Gregg, you may begin.

歡迎收聽 DexCom 第二季財報發布電話會議。我是 Kim，將擔任今天會議的接線員。目前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。現在我將把電話交給 Terry Gregg 先生。Gregg 先生，您可以開始了。

Thank you, Operator, and thank you all for joining us today. I am going to have Steve Pacelli kick it off with Safe Harbor statements. Steve?

謝謝，接線員，也謝謝各位今天加入我們。我將請 Steve Pacelli 先以安全港聲明開場。Steve？

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 here of. 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 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. 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，且僅以本日為準。這些前瞻性陳述涉及多項風險與不確定性。可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單，已在我們的 Form 10-K 年度報告、Form 10-Q 季度報告，以及其他向美國證券交易委員會（SEC）提交的報告中的「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。Terry？

Thanks, Steve. Joining me today are Kevin Sayer, our President; Steve Pacelli, Chief Operating Officer; and Jess Roper, our Chief Financial Officer. We plan to organize things a little differently for our prepared marks going forward. Kevin Sayer will provide you with a quarterly financial results and a brief operational update and I will conclude with a more macro update and some thoughts on our strategy going forward. This will be followed by the traditional question-and-answer period. I' d now like to turn the call over to Kevin Sayer. Kevin?

謝謝，Steve。今天與我一同出席的有：我們的總裁 Kevin Sayer；營運長 Steve Pacelli；以及財務長 Jess Roper。往後我們計畫以稍有不同的方式安排事先準備的發言。Kevin Sayer 將向各位提供季度財務結果與簡要的營運更新，而我將以較宏觀的更新與對未來策略的一些想法作結。之後將進入傳統的問答環節。現在我想把電話交給 Kevin Sayer。Kevin？

Thank you, Terry. I'll begin with our financial update. DexCom generated $15.2 million in product revenue for the second quarter of 2011, compared to $9.0 million for the same quarter in 2010, a 68% increase. During Q2, we shipped approximately 4,700 systems, representing a 33% increase compared to the same quarter in 2010. Sequentially, product revenue for Q2 of 2011 increased 16% from the prior quarter and both Starter Kit and Sensor revenues were up 19% on a sequential basis. Total revenue for the second quarter of 2011 was $21.4 million, compared to $11.8 million in the same quarter of 2010. Sequentially, total revenue was up 51% primarily due to increased product revenue and receipt of a $4.0 million development milestone payment from Animas Corporation related to CE Mark approval of the Vibe system.

謝謝你，Terry。我先從財務更新開始。DexCom 於 2011 年第二季的產品營收為 1,520 萬美元，相較於 2010 年同季的 900 萬美元，成長 68%。在第二季，我們出貨約 4,700 套系統，較 2010 年同季成長 33%。按季比較，2011 年第二季產品營收較前一季成長 16%，而入門套組（Starter Kit）與感測器（Sensor）營收按季皆成長 19%。2011 年第二季總營收為 2,140 萬美元，相較於 2010 年同季的 1,180 萬美元。按季比較，總營收成長 51%，主要由於產品營收增加，以及自 Animas Corporation 收到與 Vibe 系統 CE Mark 核准相關的 400 萬美元開發里程碑款。

Our product gross profit totaled $6.8 million with gross margin of 45% for Q2, compared to gross profit $2.7 million in gross margin of 30% for the same quarter in the prior year. Again, very strong trends. Sequentially, our gross profit increased $2 million resulting in additional 9 gross margin points over Q1. This improvement was primarily driven by increased production volumes and favorable manufacturing related variances.

我們第二季產品毛利合計 680 萬美元，毛利率為 45%；相較之下，去年同季毛利為 270 萬美元、毛利率為 30%。同樣地，趨勢非常強勁。按季比較，我們的毛利增加 200 萬美元，使毛利率較第一季再提升 9 個百分點。此改善主要由產量提升以及有利的製造相關差異所帶動。

Research and development expense totaled $7 million for Q2, compared to $5.4 million in Q2 of 2010, primarily a result of additional expenditures related to our future generation ambulatory products. Sequentially, R&D expense increased 12%, which is primarily due to higher consulting costs and share-based compensation, primarily related to increased development efforts on our future generation ambulatory products as well. Sales, general, and administrative expense totaled $12.2 million in Q2 of 2011, compared to $10.4 million during the same quarter in 2010. The increase was primarily due to additional selling, customer operations, and information technology costs to support our revenue growth. Sequentially, SG&A expense increased 14% with the increase primarily due to higher share-based compensation and additional seasonal marketing and trade show expenses.

第二季研發費用合計 700 萬美元，相較於 2010 年第二季的 540 萬美元，主要是因為與我們下一代可攜式（ambulatory）產品相關的額外支出。按季比較，研發費用增加 12%，主要由較高的顧問費用與股份基礎給付（share-based compensation）所致，亦主要與我們對下一代可攜式產品加大開發投入相關。2011 年第二季銷售、一般及行政費用（SG&A）合計 1,220 萬美元，相較於 2010 年同季的 1,040 萬美元。增加主要來自為支援營收成長而新增的銷售、客戶營運與資訊科技成本。按季比較，SG&A 增加 14%，主要由較高的股份基礎給付以及額外的季節性行銷與展會費用所致。

Our net loss for the quarter totaled $7.4 million and included $4.7 million in non cash expenses, centered primarily in share-based compensation. Our loss per share for the quarter was $0.11. We ended the quarter with $106 million in cash, restricted cash, and marketable securities, and had working capital of the $110 million. Finally, we remain committed to our guidance of estimated full year 2011 product revenue ranging for $67.5 million to $72.5 million. I reminded investors that over the past several years approximately 40% of our revenue has been generated during the first half of the year, with the remaining 60% generated during the second half of the year.

本季淨損合計 740 萬美元，其中包含 470 萬美元的非現金費用，主要集中在股份基礎給付。本季每股虧損為 0.11 美元。季末我們持有的現金、受限制現金及有價證券合計 1.06 億美元，營運資金為 1.10 億美元。最後，我們仍維持先前的 2011 全年指引：預估全年產品營收介於 6,750 萬至 7,250 萬美元。我也提醒投資人，過去幾年我們約有 40% 的營收來自上半年，其餘 60% 來自下半年。

Now I would like to provide an update on our Gen4 Sensor system. We are pleased to announce we have reached agreement with the FDA on our study design and the FDA has approved our IDE application within the initial 30 day calendar review cycle. As we had mentioned previously, the FDA now classifies studies involving continuous glucose monitoring devices as significant risks device studies, thus requiring both FDA and Institutional Review Board, IRB, approval prior to initiation of a clinical study. We are working diligently with our clinical trial sites to secure the necessary IRB approvals and expect to commence the Gen4 pivotal trial later this summer. We believe this timing puts us on track to complete the trial and file our submission for Gen4 before the end of the calendar year. However, we remind you that the Gen4 pivotal is much more complex than any trial we have executed previously and we will not rush the trial given this complexity. At an estimated cost of $1.2 million versus our prior pivotal trial cost of approximately $400,000. We intend to do this once and to do it right.

接下來我想就我們的 Gen4 感測器系統提供更新。我們很高興宣布，我們已與 FDA 就研究設計達成一致，且 FDA 已在最初 30 天的日曆審查週期內核准了我們的 IDE 申請。如同先前提到的，FDA 現將涉及連續血糖監測裝置的研究歸類為重大風險裝置研究，因此在啟動臨床研究前，需同時取得 FDA 與機構審查委員會（IRB）的核准。我們正與臨床試驗據點密切合作，以取得必要的 IRB 核准，並預期於今年夏末啟動 Gen4 關鍵性試驗（pivotal trial）。我們相信此時程可使我們如期在年底前完成試驗並在日曆年度結束前提交 Gen4 的申請。然而，我們也提醒各位，Gen4 的關鍵性試驗比我們以往執行的任何試驗都更為複雜，因此在此複雜性下我們不會倉促推進。其預估成本為 120 萬美元，相較於我們先前關鍵性試驗約 40 萬美元的成本。我們打算一次做到位，把事情做對。

With respect to our partnerships. Our combination products. First during Q2 Animas announced the receipt of CE Mark approval of the Vibe. We are pleased to report that Animas has launched this product in the UK and expects to launch it in up to 4 additional countries in Europe before the end of the year. As a reminder, Animas will act as a non-exclusive distributor of sensors and transmitters to patients who purchase the Vibe system outside the US.

關於我們的合作夥伴與組合產品。首先，在第二季 Animas 宣布其 Vibe 已取得 CE Mark 核准。我們很高興報告，Animas 已在英國推出該產品，並預期在年底前於歐洲最多再新增 4 個國家上市。提醒各位，對於在美國以外購買 Vibe 系統的病患，Animas 將作為感測器與發射器的非獨家經銷商。

Concerning the integrated system with Insulet, Senior Management from both Companies met last month of the ADA to further discuss the development and commercialization of an integrated product, which will abide our Gen4 sensor technology with Insulet's next-generation OmniPod system. And we continue to work towards filing a regulatory filing sometime in the first half of 2012. Finally, the development of our second-generation in-hospital glucose monitoring system, conducted in collaboration with Edwards Lifesciences, continues to move forward. A s Edwards announced in their Q2 earnings call, we are working to obtain CE Mark for this device by the end of this year. And expect that Edwards will begin European sales in 2012. In the US, we have met with the FDA to clarify the regulatory pathway and we plan to submit an IDE and begin a US clinical trial early in 2012. I'll now turn the call back over to Terry.

關於與 Insulet 的整合式系統，兩家公司高階管理團隊上月在 ADA 期間會面，進一步討論整合產品的開發與商業化；該產品將把我們的 Gen4 感測器技術與 Insulet 下一代 OmniPod 系統結合。我們也持續朝著在 2012 年上半年某個時間點提交監管申請的目標推進。最後，我們與 Edwards Lifesciences 合作開發的第二代院內血糖監測系統仍持續向前推進。正如 Edwards 在其第二季財報電話會議中所宣布，我們正努力在今年年底前為該裝置取得 CE Mark，並預期 Edwards 將於 2012 年開始在歐洲銷售。在美國方面，我們已與 FDA 會面以釐清監管途徑，並計畫提交 IDE 並於 2012 年初啟動美國臨床試驗。現在我把電話交回給 Terry。

Thanks, Kevin. Uncertainty regarding the global economy has increased over the past few months with debt ceilings talks weighing heavily on everyone's minds in recent weeks. The consumer confidence index quarterly average for Q2 2011 was down sequentially and unemployment rates have risen, and are now holding steady above 9%. Yet, in spite of the lingering macro economic downturn, we continue to show solid growth.

謝謝你，Kevin。過去幾個月全球經濟的不確定性升高，近幾週債務上限談判更是沉重地壓在每個人心頭。2011 年第二季消費者信心指數的季度平均值較前一季下滑，失業率也上升，且目前持續維持在 9% 以上。然而，儘管總體經濟低迷陰霾未散，我們仍持續展現穩健成長。

Although sequential growth in Starter Kits was not as robust as we might like, particularly in the OUS markets, we are pleased to see that sensor sales continue to outpace our internal projections, indicating that patients are recognizing the benefits of CGM therapy and that more and more patients are using the SEVEN PLUS more frequently. From the field, patients are still reporting sharp increases in their out-of-pocket expenses, and not just with deductibles, but also coinsurance obligations as employers ask their employees to share the burden of increasing healthcare costs. Nonetheless, our pipeline of new patients remains full. And DexCom is on track for a strong 2011 as the market leading performance of CGM technology continues to improve the lives of people with diabetes.

雖然入門套組（Starter Kits）的季比成長不如我們期望，尤其是在美國以外（OUS）市場，但我們很高興看到感測器銷售持續超越我們的內部預測，顯示病患正認知到 CGM 治療的效益，且越來越多病患更頻繁地使用 SEVEN PLUS。來自第一線的回饋顯示，病患仍在回報自付費用大幅增加，不僅是自付額（deductibles），也包括共同保險（coinsurance）義務，因雇主要求員工分擔不斷上升的醫療成本。儘管如此，我們的新病患管線仍然充足。DexCom 也正朝著 2011 年強勁表現邁進，因為作為市場領先者的 CGM 技術持續改善糖尿病患者的生活。

My personal focus for the balance of this year is to work with our field sales personnel to raise awareness among endocrinologists and diabitologists of the life-saving benefits of CGM. We need to move this from a nice-to-have category to a must-have for patients. As an example, I am tired of hearing anecdotes of patients who have died during the night from an episode of hypoglycemia that CGM could have detected and potentially saved a life. As I work in the field, I'm pleased by the number of healthcare providers I meet, physicians, nurse educators, support staff, who wear the DexCom SEVEN PLUS to better manage their disease.

我今年剩餘時間的個人重點，是與我們的外勤銷售人員合作，提高內分泌科醫師與糖尿病專科醫師（diabitologists）對 CGM 具備救命效益的認知。我們需要把它從「可有可無」的類別，推進到病患「必不可少」的需求。舉例來說，我已經厭倦聽到病患在夜間因低血糖發作而死亡的軼事；CGM 原本可以偵測到並可能挽救生命。當我在第一線工作時，我很高興看到我遇到的許多醫療照護提供者——醫師、護理衛教師、支援人員——會配戴 DexCom SEVEN PLUS，以更好地管理他們的疾病。

These are the healthcare providers who must drive this to a must-have. And as I survey the artificial pancreas research currently being conducted around globe, I am reminded that the DexCom SEVEN PLUS is the sensor of choice in virtually all of these important studies. These researchers who must also drive this to a must-have. Today, we remain keenly focused on the approximately 1.5 million people afflicted with Type I diabetes in the United States. As we believe this patient population represents the best near-term opportunity for the Company.

這些醫療照護提供者必須推動它成為「必不可少」。而當我檢視目前全球正在進行的人工胰臟研究時，我也想起 DexCom SEVEN PLUS 幾乎是所有這些重要研究中的首選感測器。這些研究人員也必須推動它成為「必不可少」。目前，我們仍高度聚焦於美國約 150 萬名第一型糖尿病患者，因為我們相信這個病患族群代表公司近期最佳機會。

However, just last month at the Annual Meeting of the American Diabetes Association here in San Diego, investigators presented results of a year-long independent, randomized clinical trial using the SEVEN PLUS CGM system in Type II patients demonstrating a significant decline in A1c in patients that use CGM, as compared to those who manage their diabetes with finger sticks alone. It is important to note that these were people with Type II Diabetes that were not insulin-dependent and did not use insulin at meal times. Most of the patients in both the control and study group treated their diabetes with oral medications, with some using basal insulin. It is also important to note that CGM was used intermittently for 12 weeks, 2 weeks on, 1 week off, for a total of 8 weeks of CGM. However, the 52-week results demonstrated the sustained benefits in A1c reduction shown during the initial 12 weeks of CGM use.

然而，就在上個月於聖地牙哥舉行的美國糖尿病協會（American Diabetes Association）年會上，研究人員發表了一項為期一年的獨立、隨機臨床試驗結果，該試驗在第二型糖尿病患者中使用 SEVEN PLUS CGM 系統，顯示使用 CGM 的患者其 A1c 顯著下降，相較之下，僅以指尖採血（finger sticks）管理糖尿病者則不然。需要特別指出的是，這些第二型糖尿病患者並非胰島素依賴型，且用餐時並不使用胰島素。對照組與研究組的大多數患者以口服藥物治療糖尿病，部分患者使用基礎胰島素（basal insulin）。同樣重要的是，CGM 以間歇方式使用 12 週：使用 2 週、停用 1 週，合計實際使用 CGM 8 週。然而，52 週結果顯示，A1c 降低的持續效益與最初 12 週 CGM 使用期間所呈現的效果一致。

We have long believed that CGM is more than simply a glucose monitoring tool, but, in fact, is an effective behavior modification tool across the spectrum of diabetes care. Of course, while data supporting the value proposition for CGM in Type II patients is exciting, as we said previously, we will not devote significant resources to target that market until the reimbursement landscape for that important patient population matures.

我們長期以來相信，CGM 不僅僅是血糖監測工具，事實上，它也是一種有效的行為改變工具，可涵蓋糖尿病照護的各個面向。當然，雖然支持 CGM 在第二型糖尿病患者之價值主張（value proposition）的數據令人振奮，但如同我們先前所說，在該重要病患族群的給付（reimbursement）環境成熟之前，我們不會投入大量資源去鎖定該市場。

Finally, some thoughts on the regulatory process. Although the regulatory environment remains challenging for all of us in the medical device, pharmaceutical, and biotech industries, I could not be more proud of our team and their ability to work collaboratively with the FDA to finalize the protocol of our upcoming Gen4 clinical trial, and to gain significant clarity in our ongoing efforts to bring a first-in-class critical care hospital sensor to the US market with our partner, Edwards Lifesciences. Through a series of meetings with the Food and Drug Administration, we were able to forge agreements on trial designs and end points that will result in new standards for the category, and will significantly raise the barriers-to-entry for others that compete or desire to compete in this space. I commend the Food and Drug Administration for their willingness to listen and engage in an earnest attempt to bring forth these advanced technologies in a timely manner. Thank you. And we will now entertain questions.

最後，談談法規審查流程。儘管醫療器材、製藥與生技產業的法規環境對我們所有人而言仍具挑戰，我仍為我們團隊感到無比自豪；他們能與 FDA 協同合作，完成即將進行的 Gen4 臨床試驗方案（protocol）的定案，並在我們與合作夥伴 Edwards Lifesciences 持續努力將同級首創（first-in-class）的重症照護醫院用感測器引進美國市場的過程中，取得更清晰且重大的方向。透過與美國食品藥物管理局（Food and Drug Administration）的一系列會議，我們得以就試驗設計與終點（end points）達成協議，這將為該類別建立新的標準，並大幅提高其他在此領域競爭或意圖競爭者的進入門檻。我也肯定美國食品藥物管理局願意傾聽並投入，真誠地嘗試及時推動這些先進技術問世。謝謝。接下來我們將開放提問。

Thank you. We will now begin the question-and-answer session. Bill Plovanic; Canaccord. Please go ahead.

謝謝。現在我們開始問答環節。Bill Plovanic；Canaccord。請開始。

Can you hear me? I just wanted to start off. I think that's really good news on the Gen4 trial. And a little more color if you could. Obviously, that will get going. But, if you look at the end point, how different are these from previous trials? And was there any discussion on the hard cut off of seven days on this sensor?

你聽得到我嗎？我想先開始提問。我認為 Gen4 試驗的消息真的很好。若你能再補充一些細節就更好了。顯然，試驗將會啟動。但如果你看終點指標，這些與先前試驗相比有多不同？另外，對於這個感測器在七天時「硬性截止」（hard cut off）的設定，有沒有任何討論？

The first point being the difference between the previous trials. The quantitative measurements are much more frequent in the course of looking at the data points. Historically, we do YSI measurements compared to both finger stick and to the CGM device at 1, 4, and 7 days.

第一點是與先前試驗的差異。在檢視資料點的過程中，量化測量的頻率高得多。過去我們會做 YSI 測量，並在第 1、4、7 天分別與指尖採血以及 CGM 裝置進行比較。

Although there was some in the original pivotal trials, there is some degree of flexibility when you take that sampling. In these pivotal trials it is very distinct when you must take the sampling and also looking at other parameters. So, that goes all the way out to a requirement to look at more data points at a 168 hours, which is 7x24 the 7-day approval.

雖然在原始的關鍵性（pivotal）試驗中也有一些規範，但在何時進行取樣仍有一定程度的彈性。在這些關鍵性試驗中，必須取樣的時間點以及其他參數的觀察都非常明確。因此，要求一路延伸到必須在 168 小時（也就是 7x24，對應 7 天核准）時檢視更多資料點。

The second question with respect to a hard shut off. No. We have not had any discussion with the agency regarding a hard shut off at the 7-day period. Certainly they have acknowledged that patients using the SEVEN PLUS will use it for the full 7 days and beyond. in terms of having an absolute hard shut off, we have not had any feedback from them at this point.

第二個問題關於硬性關閉（hard shut off）。沒有。我們尚未與主管機關就 7 天期間的硬性關閉進行任何討論。他們當然也已認知到，使用 SEVEN PLUS 的患者會使用滿 7 天甚至更久。至於是否要有絕對的硬性關閉，目前我們尚未收到他們任何回饋。

And then on the quick, easy questions. Just ASPs, any color there? Attrition rates, any color there?

接著是幾個快速、簡單的問題。ASP（平均銷售價格）方面，有沒有什麼補充？流失率（attrition rates）方面，有沒有什麼補充？

ASPs still running a little north of 800 on the Starter Kits, and somewhere a little south of $65 per sensor. So, the ASP on the censor has come up slightly. Additionally, as usual, no additional color on attrition, other than we continue to see patients using, as Terry mentioned in his remarks, sensors on a more frequent basis. So, it bodes well for sensor utilization going forward.

入門套組的 ASP 仍略高於 800，而每個感測器大約略低於 65 美元。因此，感測器的 ASP 略有上升。此外，一如往常，關於流失率沒有更多補充；除了我們持續看到患者使用感測器的頻率更高，正如 Terry 在談話中提到的。因此，這對未來感測器使用量而言是個好兆頭。

Did the attrition rates change from Q1 or Q4 last year? Have you seen any shift, more than numbers, just any color on any increase or decrease?

流失率相較去年第四季或今年第一季有變化嗎？你們有看到任何趨勢上的變動嗎？不一定是數字，只要任何增加或減少的方向性資訊即可。

No, as we mentioned we are pleased to see the continued utilization of sensors. I don't think we want to comment on up or down trends but we're happy with where we're seeing sensor use right now.

沒有，如同我們提到的，我們很高興看到感測器持續被使用。我想我們不希望評論上升或下降的趨勢，但我們對目前看到的感測器使用情況感到滿意。

The last question. In terms of the 4,700 new patients. Does that include any international stocking for J&J? Or is that a domestic number? How do we look at that number?

最後一個問題。關於 4,700 名新患者，這個數字是否包含任何為 J&J 進行的國際備貨？還是這是美國國內的數字？我們應該如何解讀這個數字？

Now, remember that the 4,700 is Starter Kits. J&J does have the right to distribute transmitters, but we wouldn't include those in that 4,700 number. So, those are all domestic or OUS individual patient kits that would be sold through our normal distribution network, not the J&J number.

現在，請記住這 4,700 指的是入門套件（Starter Kits）。J&J 確實有權利經銷發射器（transmitters），但我們不會把那些納入這 4,700 的數字中。所以，這些都是透過我們正常的經銷網路銷售的國內或 OUS（美國境外）個別病患套件，而不是 J&J 的數字。

Thank you.

謝謝。

Ben Andrew; William Blair.

Ben Andrew；William Blair。

Maybe a little bit of clarity around a couple of things. Kevin, maybe talk about the SG&A spending. It was a little above our targets. I know you gave a bit of color there, but maybe some more detail about back office versus selling organization increases there. And what other things you've learned in first few months of full time on the job that point toward additional needs for the Company in terms of investments?

想釐清幾件事。Kevin，能否談談 SG&A 的支出？它略高於我們的目標。我知道你已經提供了一些說明，但能否再多一些細節，關於後勤（back office）相較於銷售組織（selling organization）增加的部分？另外，你在全職上任的前幾個月還學到了哪些事情，顯示公司在投資方面還有額外需求？

With respect to the SG&A costs, we have ramped up our field sales force and our back office support staff pretty much on schedule to where we wanted to be by the end of the year. And we accelerated some of those hires here toward the end of the second quarter and in the third quarter.

就 SG&A 成本而言，我們已大致按計畫擴編前線銷售團隊與後勤支援人員，以達到我們希望在年底前達成的規模。我們在第二季末以及第三季加速了部分招募。

So, we did add some folks that would increase those expenses. I'm actually an increased expense because I wasn't in your number to begin with either. So, we've added some people and some infrastructure to get us to where we need. A lot of our costs on the SG&A side, there's quite a bit of non cash expense there. I will continue to watch and monitor that.

因此，我們確實新增了一些人員，這會推升相關費用。其實我本身也是一項增加的費用，因為一開始你們的數字裡也沒有包含我。所以，我們新增了一些人員與基礎建設，讓我們能達到所需的狀態。SG&A 端的成本中，有相當一部分是非現金費用（non cash expense）。我會持續觀察並監控。

As far as my observations, it's been a great time to start, particularly with the ADA in my first month, to see where our Company is positioned in the industry. I would say after being here as long as I've been, the opportunity is greater than I would've seen as a Board Member sitting in the board meetings and listening to the team.

至於我的觀察，這是一個很好的加入時點，尤其我第一個月就遇到 ADA，能看到我們公司在產業中的定位。我想說，在這裡待了一段時間之後，我看到的機會比我以前以董事身分坐在董事會、聽團隊報告時所感受到的還要大。

I think the potential here is vast. And the other thing that I really see is we have some very iterative steps from a product development side to get to where we need to get to on that end point. For us it's a question of time and money and execution to get there. And that's what I lay awake at night thinking about.

我認為這裡的潛力非常龐大。另一件我真正看到的是，從產品開發的角度，我們需要透過一些非常循序漸進（iterative）的步驟，才能走到我們需要達到的終點。對我們而言，這是時間、資金與執行力的問題，這也是我晚上躺著會思考的事。

What are the right steps and how do we get that product that really puts us, as Terry said, in the must-have category. Because that will come through a number of sales and marketing efforts combined with product development.

正確的步驟是什麼？以及我們如何打造出那個產品，真正讓我們如 Terry 所說，進入「必備（must-have）」的類別。因為那將會透過一系列銷售與行銷努力，結合產品開發而達成。

And I think the other thing, I'll go back to the what Terry said, the whole must-have conversation right now as I talk with people and go down the list of diabetes treatment options, CGM is too far down the list. We need to move it up. It needs to be right after you start taking insulin, we better put you on CGM. And that is going to be our marketing focus. And what we try and do and that's Terry's message as he goes out in the field.

我想另一點，我會回到 Terry 說的：目前在我與人交談、逐一討論糖尿病治療選項時，「必備」這個對話裡，CGM 排得太後面了。我們需要把它往前移。它應該是在你開始使用胰島素之後，緊接著就要讓你使用 CGM。這將會是我們的行銷重點，也是我們要努力去做的事；而這也是 Terry 在外勤拜訪時傳達的訊息。

That's helpful. I know you can't control the agency's review periods. But, what are the error bars around the execution of the clinical study in terms of months, if you had to characterize that for us?

這很有幫助。我知道你們無法控制主管機關的審查期間。但就臨床研究的執行而言，如果要用月份來描述，你能否為我們說明一下誤差範圍（error bars）大概會是多少？

As Kevin mentioned, Ben, this is Terry. Our goal is to complete the trials and get this filed by the end of the year. I think the complexity, to give you a flavor, when we are looking at the initial period, Day 1 as an example. We are really put in a situation where we've got to house those patients overnight to get all of the sampling that is required as part of the clinical trial.

如 Kevin 提到的，Ben，我是 Terry。我們的目標是在年底前完成試驗並提交申請。談到複雜度，給你一個概念：以初始期間、例如第 1 天（Day 1）來說，我們確實必須讓這些病患過夜，以取得臨床試驗所要求的所有採樣。

Therefore, we can't do all of the sites in parallel. We've got to stagger them. And in fact even doing 2 at a time you still have to stagger those because we're using every bit of our clinical research staff in order to ensure that all of the data points are captured when they are supposed to be captured, according to the protocol.

因此，我們無法讓所有試驗中心同時並行。我們必須錯開安排。事實上，即使一次做兩個中心，也仍然需要錯開，因為我們必須動用我們所有的臨床研究人員，確保依照試驗計畫書（protocol）在應該的時間點把所有資料點都收集到。

So, I wouldn't want to handicap it but those are the types of things that we are being extremely diligent about. We have planned this out with great detail. We've actually been at all the sites to ensure that their staff is trained to have all the capability and capacity that we are going to need to do all of these individual data point accumulations that are so critical in a trial of this nature. I hope that answers your question.

所以，我不想去預估它的上下限，但這些就是我們極度謹慎處理的事項。我們已非常細緻地規劃。我們其實也已到過所有試驗中心，確保他們的工作人員受過訓練，並具備我們進行這些個別資料點累積所需的能力與量能，而這在此類型試驗中至關重要。希望這回答了你的問題。

That's helpful. It doesn't do much good to do trial poorly, obviously. The final question for me, and I don't know if you're comfortable answering this. But any trends that you saw after the copay reset at the end of February month, even more recently suggestive of an economic impact, or a change in consumer attitudes?

這很有幫助。顯然，把試驗做不好也沒有太大意義。我最後一個問題，我不確定你是否方便回答：在二月底自付額（copay）重置之後，或更近期，你們是否看到任何趨勢，顯示經濟因素的影響，或消費者態度的改變？

I think for the first time, so here we are July, now August of 2011. In 2010, we had pretty much worked through the deductible challenges and we were a lot more robust about moving patients into the category. I think we've seen the shadow of the economic downturn now.

我想這是第一次——現在是 2011 年 7 月、8 月。2010 年時，我們大致已經處理完免賠額（deductible）的挑戰，並且在把病患移入該類別方面更為強勁。我認為我們現在看到了經濟衰退的陰影。

We've kind of worked through most of the deductible issues, but we are seeing this out-of-pocket expense. If you look at a patient having to typical 80/20 copay still $40, $60 a month depending upon their utilization, and that has been more in 2011 than we saw it in 2010.

我們大致已經解決了多數免賠額的問題，但我們看到的是這種自付費用（out-of-pocket expense）。如果你看一位病患典型的 80/20 自付比例（copay），每月仍可能要自付 40、60 美元，取決於他們的使用量，而這在 2011 年比我們在 2010 年看到的更明顯。

But, it looks like the patient add rates were right on target for us. So, there wasn't something at the end of the quarter that you found?

但是，看起來病患新增率（patient add rates）對我們而言仍完全符合目標。所以，你在季末並沒有發現什麼狀況嗎？

No. I think we are working through. In the second quarter we saw the tale, more detail from the first quarter with regards to deductibles working through that. It's an interesting dynamic on the 1 hand you have greater utilization of CGM by patients because they recognize the ease of use, the value of the information.

沒有。我想我們正在逐步消化。第二季我們看到的是第一季在免賠額方面的延續與更細節的影響，並持續在消化。這是一個有趣的動態：一方面，病患對 CGM 的使用量更高，因為他們認知到它的易用性與資訊價值。

It's not very obtrusive to them so it becomes part of their daily lives. So, certainly there using it more frequently, stopping a session, starting a new session. But at the same time, we are hearing that patients are concerned about that out-of-pocket expense because they are having to bare more of the burden from their employers. We do hear that but we're certainly not seeing it in terms of the number of sensors we're selling or patients added to it.

它對他們來說不太造成干擾，因此成為日常生活的一部分。所以，他們確實更頻繁使用：停止一段監測、再開始新的監測。但同時，我們也聽到病患擔心自付費用，因為他們必須承擔更多由雇主轉嫁的負擔。我們確實有聽到這些，但在我們銷售的感測器數量或新增病患數上，並沒有看到反映出來。

Okay. Thank you.

好的。謝謝。

Raj Denhoy; Jefferies.

Raj Denhoy；Jefferies。

Hi, this is Amy, in for Raj. Thanks for taking my question. I guess I would just like to talk a little bit more about the clinical trial design. Were there many changes that you've gone through since the pre-IDE submission with the FDA. It sounds like the actual time to run the trial now that hospitalizations and overnight stays is prolonging the duration of the clinical trial beyond your original expectations.

嗨，我是 Amy，代 Raj 提問。謝謝讓我提問。我想再多談一點臨床試驗設計。自從向 FDA 進行 pre-IDE 提交以來，你們是否經歷了很多變更？聽起來，由於需要在診所過夜研究，實際執行試驗的時間，正在把臨床試驗的期間拉長，超出你們原先的預期。

First of all, I want to be clear that we clarify that it is not a hospitalization. These are done in clinics and so, we've had to select clinics that have the capacity to do overnight studies. But that doesn't mean that these patients are in hospitals. These are still clinical research centers.

首先，我想澄清：這不是住院（hospitalization）。這些是在診所進行的，因此我們必須選擇具備進行過夜研究能力的診所。但這不代表這些病患是在醫院裡。這些仍然是臨床研究中心（clinical research centers）。

Thank you.

謝謝。

It's okay. Certainly, when we do IVBG work with the GlucoClear product with Edwards, we do in fact have those patients hospitalized. There is a different locale in which we conduct clinical efforts.

沒關係。當然，當我們與 Edwards 針對 GlucoClear 產品進行 IVBG 研究時，我們確實會讓那些病患住院。那是我們進行臨床工作的不同場域。

I would just characterize that the complexity from the pre-IDE to the final agreement was the result of multiple meetings with the agency, some of them face-to-face, in order to work out what their new standards and what they wanted to see. Certainly, it is much more extensive than what we originally applied for in the pre-IDE. But, it is something that our regulatory and clinical staff medical advisors felt that we could achieve and therefore we agreed with the agency that these were reasonable requests. But, it is much more extensive.

我會這樣描述：從 pre-IDE 到最終協議之所以複雜，是因為我們與主管機關進行了多次會議，其中一些是面對面會議，以釐清他們的新標準以及他們希望看到的內容。當然，這比我們最初在 pre-IDE 中申請的範圍要廣泛得多。但我們的法規與臨床人員及醫療顧問認為我們可以達成，因此我們也同意主管機關，這些都是合理的要求。不過，確實更為廣泛。

So, I look at it in the end as this is what the agency feels they need. And you have to understand from their perspective, all of these CGM products are eventually geared to an artificial pancreas. So, no matter what product is out there, even as a standalone, in the agency's mind, and quite frankly in our mind as well, we are gearing these products in iterative states to eventually, Number 1, dose insulin off interstitial fluid glucose, and Number 2, be a key part of an artificial pancreas.

所以，我最後的看法是：這就是主管機關認為他們需要的。你必須從他們的角度理解，所有這些 CGM 產品最終都會朝向人工胰臟。因此，不論市面上是什麼產品，即使是獨立產品，在主管機關的想法中——坦白說在我們的想法中也是——我們都是以迭代的狀態逐步推進這些產品，最終達成：第一，根據間質液葡萄糖來進行胰島素劑量給藥；第二，成為人工胰臟的關鍵組成部分。

So, agencies pushing the Company to achieve greater accuracy, greater robustness, we are adhering to that. And we've upped our side of the equation with that. As a result of that, they want to see more data. Which I think is very reasonable from that perspective.

因此，主管機關推動公司達到更高的準確度、更高的穩健性，我們也遵循這些要求。我們也在這方面提高了我們的投入。其結果是，他們希望看到更多數據。我認為從那個角度來看非常合理。

So, assuming that all of this is wrapped up hopefully submitted by the end of the year, given limited visibility with the regulatory, but hopefully gear for mid-2012 launch would be an ideal time frame give or take?

所以，假設這些都能在年底前完成並希望提交，鑑於對法規流程的能見度有限，但希望以 2012 年年中上市作為理想時程，前後些許浮動？

That would be an ideal time framing. We are currently operating under the assumption that we will file this as a PMA supplement.

那會是理想的時程安排。我們目前是在「將以 PMA 補充申請（PMA supplement）」提交的假設下運作。

That said, I just caution the audience that the FDA is under no obligation to accept it as a DMA supplement. They could in fact require us to fall within a PMA standard which would elongate the review period statutorily.

不過，我要提醒各位，FDA 並沒有義務接受它作為 DMA 補充申請（DMA supplement）。他們實際上可能要求我們依 PMA 標準辦理，這將在法定上拉長審查期間。

Also just a little bit, I don't know if you all much visibility in the rollout of the Vibe. But if you all have any sense of the initial rollout in the UK and what other countries are on tap for the next stage of launch?

另外，我也想稍微問一下，我不確定各位對 Vibe 的推廣進度是否有很多能見度。但各位是否了解在英國的初期推廣情況，以及下一階段上市還有哪些國家在規劃中？

It's only been launched in the UK to date, and I would tell you it's in very early stages of launch. I actually don't believe Animas has disclosed which country they plan to roll out and in which order.

截至目前只在英國上市，我會說它仍處於非常早期的上市階段。我其實不認為 Animas 已披露他們計畫在哪些國家推廣，以及推廣順序。

But there are up to 4 or 5 additional countries in Europe only the balance of this year that we would launch. We can update as Animas permits us to update where they launch. We can update that in future calls.

但在今年剩餘時間內，僅在歐洲就可能還會在另外 4 到 5 個國家上市。只要 Animas 允許我們更新他們在哪裡上市，我們就可以更新。我們也可以在未來的電話會議中再更新。

Thank you.

謝謝。

Chris Cooley; Stephens.

Chris Cooley；Stephens。

Terry, maybe you could comment a little bit about that new trial design. Is there anything inherent in the new design that from a competitive standpoint, when you think about your Gen4 technology versus potentially other CGM offerings, other sensors out there, that might be trying to come through the regulatory path in the United States into the commercial market? Maybe you could just update us on the Gen5 as well.

Terry，也許你可以稍微評論一下新的試驗設計。新的設計本身是否有任何特點，從競爭角度來看，當你把 Gen4 技術與其他可能的 CGM 方案、其他感測器（可能正試圖在美國走法規路徑進入商業市場）相比時？也請你順便更新一下 Gen5。

Certainly, from a Gen4 standpoint, remember this was originally built around the concept of scalability and manufacturability. And therein lies our desire to retain the PMA supplement status of this and get a 180-day review versus the 300-day review as a full PMA. Although no matter what this is going to be designated a panel track submission. I think the barriers to entry have grown.

當然。就 Gen4 而言，請記得它最初是圍繞「可擴展性」與「可製造性」的概念打造的。因此，我們希望保留其 PMA 補充申請的身分，並取得 180 天審查，而不是完整 PMA 的 300 天審查。雖然不管怎樣，這都會被指定為 panel track submission。我認為進入門檻已經提高了。

And 1 of the reasons we elected quite frankly to readily agree with a new level of accuracy, a new level of robustness, that the agency is requiring, because we felt the Gen4 could meet that standard. When we look at presentations of either products that are in the market today, or desire to be in the market tomorrow, many of them we believe will struggle to meet the regulatory standard that we can achieve. So, from that perspective, I do think that landscape is getting more difficult for others.

而我們之所以選擇——坦白說——很快同意主管機關要求的新準確度水準、新穩健性水準，其中一個原因是我們認為 Gen4 能達到該標準。當我們看目前已在市場上的產品，或希望明天進入市場的產品之展示時，我們相信其中許多將難以達到我們能達成的法規標準。因此，從這個角度，我確實認為對其他業者而言，整體環境正在變得更具挑戰。

Maybe just with this, not to put the proverbial cart before the horse, but Gen5, your thoughts there just in terms of when you move forward with that design?

也許再追問一下，不是要本末倒置，但就 Gen5 而言，你對於推進該設計的時點有什麼想法？

We're moving forward with the design. I will tell you that we are in feasibility trials with Gen5 and look to introduce that product in a timely fashion. If you look at the historical performance of the Company before Gen4, we had on average about 18 months of product cycle lifetime before we would iterate to the next design.

我們正在推進該設計。我可以告訴你，我們正在進行 Gen5 的可行性試驗，並希望及時推出該產品。如果你看公司在 Gen4 之前的歷史表現，我們平均大約每 18 個月就會進行一次產品週期迭代，進入下一個設計。

Gen4 because of a variety of reasons that you are all well familiar with, in terms of a greater regulatory science requirement, initiated by the Food and Drug Administration, we'll probably live with that generationally a bit longer than that 18 month period. Then look for Gen5 to replace that in some time frame.

Gen4 因為各位都很熟悉的各種原因——就 FDA 所啟動的更高法規科學要求而言——我們可能會在這一代產品上維持比 18 個月更長的時間。之後再尋求由 Gen5 在某個時間點取代它。

Given all the stacking of variables, I wouldn't want to predict when actually we would see that either filed or approved by the agency at this point. At this point, that we will continue to conduct the clinical trials as appropriate, and move that through the regulatory process in a timely fashion as we possibly can.

在變數層層堆疊的情況下，我目前不想預測我們何時會真正提交，或何時會獲主管機關核准。此時此刻，我們將持續按需要進行臨床試驗，並盡可能及時地推進法規流程。

John Putnam; Capstone Investments.

John Putnam；Capstone Investments。

You had a nice increase sequentially in gross margin. What do you see for the rest of the year?

你們的毛利率季比有不錯的提升。你們對今年剩餘時間的展望如何？

Our gross margins are very much dependent upon our manufacturing volumes. To cover the costs of our plants as we continue to increase sales providing prices remains consistent, we would hope to continue those upward trends. A lot of it depends on volume, and our efficiency, so right we're doing quite well and hope to continue.

我們的毛利率很大程度取決於製造量。隨著我們持續提升銷售、在價格維持一致的前提下，為了攤提並覆蓋工廠成本，我們希望能延續這些向上的趨勢。很多取決於產量與效率；所以目前我們表現相當不錯，也希望能持續下去。

Ben Haynor; Feltl and Company.

Ben Haynor；Feltl and Company。

I like the new marketing focus of putting the CGM higher up the list. Where do you guys see the current penetration levels of CGM's?

我喜歡你們把 CGM 放到更高優先順序的新行銷重點。你們認為目前 CGM 的滲透率水準如何？

We are still in that single digit penetration in the Type I market in the US. It is growing. But it's not growing as fast as I would like it to grow. And I think therein lies some of my personal frustration.

在美國第一型糖尿病市場，我們仍處於個位數的滲透率。它在成長，但成長速度沒有我希望的那麼快。我想這也是我個人挫折感的來源之一。

You know, this is my 17th year in diabetes. It's also my 17th year of chasing continuous glucose monitoring devices, both ambulatory and in the hospital sector, so I would like to see this whole thing. It's frustrating because I go to meetings around the world and you see CGM as labelled the standard of care. And then you look at those who practice diabetology, who have diabetes themselves all wearing CGM and wearing SEVEN PLUS as the most frequent CGM device.

你知道，我在糖尿病領域已經第 17 年了；我也追逐連續血糖監測裝置第 17 年，涵蓋門診與醫院端，所以我很希望看到整件事能更往前推。令人挫折的是，我到世界各地參加會議，你會看到 CGM 被標示為照護標準。然後你再看那些從事糖尿病學的人、或自己就有糖尿病的人，他們都在配戴 CGM，而且最常見的 CGM 裝置是配戴 SEVEN PLUS。

You get frustrated when you ask the question 'Well, if it's good enough for you, why isn't it good enough for your patients?' And a variety of comments come back. But it's really driving that message that they need to understand. This is simple. This is not a complex system, as some of the other systems have been.

當你問一句：「如果它對你來說夠好，為什麼對你的病人就不夠好？」你會感到挫折，因為會收到各式各樣的回應。但真正要推動的是讓他們理解這個訊息：這很簡單。這不是一個複雜的系統，不像其他一些系統那樣。

So, when Kevin says moving it up the totem pole, that's what we have to get out and remind practitioners and patients that this system is quite easy to use. And you can go from the basic understanding, all the way to what we call graduate school of understanding with pattern recognition. So, it is along that continuum of development and continuum of complexity that a patient can go from 1 extreme to the other. But, at least they get the basic protective nature at its most rudimentary part.

所以，當 Kevin 說要把它往優先序列上移，那就是我們必須走出去提醒臨床醫師與病人：這套系統非常容易使用。你可以從最基本的理解，一路進階到我們所說的「研究所等級」——透過模式辨識來理解。因此，病人可以沿著這個發展連續體與複雜度連續體，從一個極端走到另一個極端。但至少在最基礎的層面，他們能先獲得最基本的保護性效益。

Any updates on the Edwards renegotiation for GlucoClear?

Edwards 針對 GlucoClear 的重新談判有任何最新進展嗎？

It's still in progress. We're continuing forward both of us committed to the Gen2 development cycle. It's something that will happen. But probably this quarter, third quarter. But I would expect by the end of the year certainly we will have a new deal in place.

仍在進行中。我們雙方都持續推進，並承諾投入 Gen2 的開發週期。這件事一定會發生，但可能是在本季、第三季。不過我預期最晚在年底前，我們肯定會有一份新的協議到位。

1 last real quick 1. What type of accuracy rates do you think you are going to have to achieve to gain approval on that. Are you still seeing those single digit MARD's?

最後再快速問一個。你認為要達到什麼樣的準確率才能取得核准？你們仍然看到個位數的 MARD 嗎？

The interesting thing is in the hospital sector, I assume that you are referring to. As you know the Food and Drug Administration does not care for the ISO standard as it relates to point of care measurements in the hospital sector. I think we gained again face-to-face meetings along with Edwards regulatory people and operational people in meetings with the FDA, a greater understanding without actually pointing to a distinct point to point measurement of what they would expect to see.

有趣的是，在醫院端的領域——我想你指的是這個。如你所知，美國食品藥物管理局（FDA）在醫院端與即時照護（point of care）量測相關的部分，並不採用 ISO 標準。我認為我們再次透過與 Edwards 的法規與營運人員一起，與 FDA 進行面對面會議，對於他們期望看到的內容有了更深入的理解，雖然他們並未明確指向某個特定的逐點（point-to-point）量測指標。

Certainly we are now operating, as has been published in both protocol a and protocol b, in that mid single digit MARD versus a laboratory instrument we were statistically significantly better than point of care meters in those same 2 trials. I think that hasn't changed at all.

當然，我們目前的表現——如同在 protocol a 與 protocol b 中所發表的——相較於實驗室儀器，MARD 落在中個位數；在同樣那兩項試驗中，我們在統計上顯著優於即時照護血糖機。我認為這點完全沒有改變。

There has been no new standards established under the ISO standard so at this point I would give credit to the agency. They want to see the product. They recognize the benefit of the CGM in that sector of reduction of morbidity and mortality on the patient population. But until a new standard is set, we can't point to that standard yet.

在 ISO 標準之下並沒有建立任何新的標準，因此在此階段我會肯定主管機關。他們想看到產品；他們也認可 CGM 在該領域能降低病患族群的罹病率與死亡率的效益。但在新的標準訂出之前，我們還無法指向那個標準。

I know that they requested commentary from the ADA and other groups. Do you know whether they receive that back yet?

我知道他們曾向 ADA 和其他團體徵詢意見。你知道他們是否已經收到回覆了嗎？

They've received commentary back. I think there's still digesting it, because if you look at there are probably 3 or 4 different groups. In addition to ADA that they are seeking that information and including the laboratory people, so everybody is beginning to weigh in.

他們已經收到回覆。我想他們仍在消化，因為如果你看，可能有 3 到 4 個不同的團體。除了 ADA 之外，他們也在向其他單位徵詢資訊，包括實驗室端的人員，所以大家都開始提供意見。

And I do believe they will ultimately get to a known standard. I don't know if it's going to be this year, quite frankly, whether or not they will publish something that is the new ISO standard for close glucose measurement by point of care meter in the hospital sector. Until that time, we are moving forward with them and with their agreement as we create the next protocol and bring forth this technology.

而且我確實相信他們最終會形成一個明確的標準。坦白說，我不確定會不會在今年就發布，是否會公布某個新的 ISO 標準，用於醫院端以即時照護血糖機進行近端血糖量測。在那之前，我們會在他們的同意下持續推進，制定下一個試驗方案並推動這項技術。

Jonathan Bock; SunTrust.

Jonathan Bock；SunTrust。

Just 2 or 3 questions. The first 1, just on the US Animas SAP product if you could just offer some clarity there. Is the plan still do go ahead and file in and around 90 or 100 days after you go ahead and file the Gen4? Or due to the complexities in the trials does that get pushed out to the right a bit?

我有 2 到 3 個問題。第一個，關於美國的 Animas SAP 產品，能否請你再釐清一下？計畫是否仍是在你們提交 Gen4 之後約 90 到 100 天左右就提交？還是因為試驗的複雜性而會往後延？

As far as we understand from the agency that's still the plan process. That we'd get the Gen4 on file and then the 100 day time frame to go ahead and file the Animas pump.

就我們對主管機關的理解，流程仍是如此：先把 Gen4 送件，然後在 100 天的時間框架內再提交 Animas 幫浦的申請。

Steve, this 1 might be for you as well, or Jess. On the product gross margin of about 45%, that was solid. In the previous 2 quarters you had a lot of fluctuation as you build inventory then worked it back down.

Steve，這題也可能要請你或 Jess 回答。產品毛利率約 45%，表現不錯。前兩季你們在建立庫存、再把庫存降回來時，毛利率波動很大。

Do you think up 45% sort of represents a normalized level of inventory during the second quarter? As Terry mentioned, we go higher based on efficiency but we go higher off of that normalized 45% number.

你認為第二季的 45% 大致代表一個正常化的庫存水位嗎？如 Terry 所說，我們會因效率提升而更高，但會是在這個正常化的 45% 基礎之上再往上。

We did keep our inventory levels relatively constant. There's only about a $100,000 inventory fluctuation from the first to the second quarter here. So, by keeping inventory levels constant, we were able to eat at that overhead.

我們確實讓庫存水位維持相對穩定。從第一季到第二季，庫存波動只有大約 10 萬美元。因此，透過維持庫存水位不變，我們得以吸收那部分的間接費用。

As we increase manufacturing volumes and we continue to grow, we expect positive results to our margins. And we don't anticipate a huge inventory build up for some of the events like we had in the first quarter of this year, where we had to do some work over in a factory. We don't anticipate anything like that right now.

隨著我們提高製造量並持續成長，我們預期毛利率會有正向結果。我們也不預期會出現像今年第一季那樣的大幅庫存建立——當時我們必須在工廠端做一些作業。我們目前不預期會再發生類似情況。

I will caution you though, as we flip over to Gen4 in the beginning phases, there may be some startup costs that will have some effect on our margins when we launch that product. By right now, 45% seems like a good normal number for what we did this quarter with pricing remaining constant and volumes going up, we should continue to see that number get a little bit better.

不過我也要提醒你，當我們在初期切換到 Gen4 時，可能會有一些啟動成本，對我們在推出該產品時的毛利率造成影響。但就目前而言，45% 看起來是本季在價格維持不變、出貨量上升下的一個不錯的正常水準；我們應該會持續看到這個數字再稍微改善。

2 more quick ones. You mentioned, Terry, that the PMA or the PMA supplement, you are going in, you believe, as a supplement and you hope it's received that way. When you get clarity from the agency, in other words is that something where, if they go ahead and accept the filing you know it's an accepted supplement and then you fight that battle. When do they have to get back to you on some clarity there?

再兩個快速問題。Terry，你提到 PMA 或 PMA 補充申請，你們會以補充申請的方式送件，而且希望主管機關也會以此方式受理。你們何時能從主管機關得到明確答案？換句話說，如果他們接受送件，你就知道它是被接受的補充申請，然後再去面對後續的挑戰。那他們需要在多久之內回覆你們、給出明確性？

Again, under the regulatory statute, we will intend to file this is as a PMA supplement. Then they will get back to you within X number of days. And they will designated it as a PMA supplement or they will designate it as a PMA. We really won't know until that time.

同樣地，依照法規規定，我們會以 PMA 補充申請的形式送件。之後他們會在 X 天內回覆，並將其指定為 PMA 補充申請或指定為 PMA。我們在那之前其實無法確定。

It' s not something you can negotiate in advance until they've had an opportunity to look at all the data that you are submitting. I will say that as part of the ongoing discussions and the pre-pivotal and pre-IDE that we submitted to them, that we outlined in the matrix form what was different between SEVEN PLUS and the Gen4.

在他們有機會檢視你所提交的所有資料之前，這不是你能事先協商的事情。我會說，作為持續討論的一部分，以及我們提交給他們的 pre-pivotal 與 pre-IDE 文件中，我們以矩陣形式概述了 SEVEN PLUS 與 Gen4 之間的差異。

All the way from the manufacturing to the transmitter, to the receiver. And again at least at this point, they have acknowledged that it appears to be a PMA supplement based on the information that we have are already submitted to them. I just want to caution that I don't want to set expectations and then have to come back and say to you, well it's really a PMA and you're going to ask me, why didn't you know that. So, I'm trying to set the landscape up appropriately that we won't know until after we submit this PMA supplement.

從製造、發射器到接收器，全部都涵蓋。再者，至少就目前而言，他們已經承認，根據我們已提交給他們的資訊，看起來應該會是 PMA 補充申請。我只是想提醒，我不想先設定市場預期，然後又必須回頭跟你說，其實是 PMA，而你會問我為什麼一開始不知道。所以我想把情況說清楚：我們要等到提交這份 PMA 補充申請之後才會知道。

That's where helpful. Last one, Terry, you talked about the study that we saw at ADA this year on some of the early information on Type II. Are there any other studies that you know are going on that you believe could meaningful move the needle in terms of gathering support, or building clinical data for reimbursement for Type II? And if so, where is that in the pipeline. Is there anything in the works before ADA of next year?

這很有幫助。最後一題，Terry，你談到我們今年在 ADA 看到的那項研究，提供了一些關於第二型糖尿病早期資訊。你是否知道還有其他正在進行的研究，你認為可能在蒐集支持、或建立第二型糖尿病給付（reimbursement）所需的臨床資料方面，對結果產生實質影響？如果有的話，目前在管線中的位置如何？在明年 ADA 之前，有沒有任何正在推動的項目？

Great question. I would refer you to the clinicaltrials.gov site looking at CGM. The last look there were a little over 60 different trials ongoing or completed or enrolling. There were a number in that group that were involving Type II patients.

問得很好。我會建議你到 clinicaltrials.gov 網站查詢 CGM。上次我看時，有略多於 60 項不同的試驗正在進行、已完成或正在招募中。其中有不少涉及第二型糖尿病患者。

Without going through and analyzing each of those protocols to understand some were quite frankly sponsored by pharma companies, in which they are looking at oral agents but happen to be using CGM as part of their criteria for glycemic variability differences between treatment and control groups. But, I do think that there is this wealth of information that continues to build along a wide spectrum. It's certainly inclusive of the Type II population.

不逐一檢視並分析每個試驗方案來理解其內容的話——坦白說，其中一些是由藥廠贊助，他們在研究口服藥物，但剛好把 CGM 納入其評估標準的一部分，用於比較治療組與對照組之間的血糖變異差異——不過我確實認為，這些資訊在廣泛的範疇內持續累積，且當然也涵蓋第二型糖尿病族群。

Jan Wald; Morgan Keegan.

Jan Wald；Morgan Keegan。

This is actually Erica, in for Jan. I have 2 housekeeping questions to start off with. Could you help us understand what other revenues you saw beyond the Animas and your other line. The $2.4 million is a little more than we've seen lately, so we'd like to get some information there.

其實我是 Erica，代替 Jan。我先有兩個例行性問題。你能否協助我們了解，除了 Animas 以及你們的其他產品線之外，你們還看到哪些其他收入？2.4 百萬美元比我們最近看到的略高一些，所以我們想了解一下相關資訊。

Within the development grant and other revenue, it consisted of our amortization of our Edwards and Animas revenue that we amortize over time as we've discussed previously. It also included a $4 million milestone payment from Animas and then approximately $300,000 from Animas related to development dollars that we are entitled to receive upon CE Mark.

在開發補助與其他收入中，主要包含我們對 Edwards 與 Animas 收入的攤銷，正如我們先前討論過的，我們會隨時間攤銷。此外也包含來自 Animas 的 400 萬美元里程碑款，以及約 30 萬美元與 Animas 相關、我們在取得 CE Mark 後有權收取的開發款項。

And then there were some additional billings to Edwards related to our Gen2 in-hospital product that we agreed upon between the 2 parties. We had a very small miscellaneous other services revenue that we occasionally bill to other customers.

另外，還有一些針對 Edwards 的額外開立帳單，與我們的第二代（Gen2）院內產品相關，這是雙方同意的。我們也有非常少量、雜項的其他服務收入，偶爾會向其他客戶開立。

And then in the coming quarters you probably looked to not have the $4 million come back but the $300,000 from Animas, additional billings to Edwards, and a small other, probably we shouldn't expect the recurrent?

那麼在接下來幾季，你們大概不會再有那 400 萬美元，但會有來自 Animas 的 30 萬美元、對 Edwards 的額外開立，以及少量其他收入；所以我們大概不應期待會是經常性重複出現的？

That's correct. I wouldn't probably forecast more than that, say $1 million per quarter at this point.

沒錯。我目前大概不會預測超過這個水準，也就是說每季約 100 萬美元左右。

That's helpful. I'm just trying to understand where you're expecting to spend the money on the Gen4 trial. Would it be reasonable to expect that $1.2 million to be split pretty evenly between the third and fourth quarters?

這很有幫助。我只是想了解你們預期在 Gen4 試驗上會把錢花在哪裡。合理的預期是那 120 萬美元會在第三季與第四季之間相當平均地分攤嗎？

It will be split between the third and fourth quarters. Probably a heavier burden in the third and then the rest in the fourth. But, it will be pretty close.

會在第三季與第四季之間分攤。第三季的負擔可能會重一些，剩下的在第四季。但整體會很接近。

I'm not sure if you can let us know, but do you see any trends exiting the quarter versus towards the beginning or the average? Just in general, in useage, in use starts and reorders?

我不確定你是否方便透露，但你是否看到本季末相較於季初或平均水準有任何趨勢？就一般而言，在使用量、開始使用以及再訂購方面？

Starts, reorders, and usage.

開始使用、再訂購，以及使用量。

I think, historically, I don't know if it's a trend, but at the end of a quarter we see greater strength than at the front of a quarter. But, I have seen that in pharmaceutical companies. I've seen it in other device companies. I don't think it's anything unique to DexCom or CGM.

我認為，從歷史上看，我不確定這算不算趨勢，但在一個季度的末端，我們會看到比季度前段更強的表現。不過我在製藥公司也看過，在其他醫材公司也看過。我不覺得這是 DexCom 或 CGM 特有的現象。

I think that's the mentality of sales people when they look towards the end of a quarter and they see they are either close to their incentive compensation or that next level, they get aggressive. It drives internal people crazy. But that's just the landscape we all live with.

我想這是業務人員的心態：當他們看到季度快結束、自己離獎金或下一個獎金級距很接近時，就會變得更積極。這會把內部人員逼瘋。但這就是我們都得面對的現實。

That's helpful to know that that traditional cycle continues this time. I guess my last question is, are there any milestones or guideposts that you think you'll be able to see as you're working on your way to move CGM up to that need-to-have device. I know it's already stated as a standard of care, but is there anything else you see on the horizon that could help that method.

知道這次仍延續那種傳統週期很有幫助。我想我最後一個問題是：在你們努力把 CGM 推進成為「必備」裝置的過程中，你認為是否會有任何里程碑或指標可以觀察？我知道它已被表述為照護標準，但你是否看到未來還有什麼能促進這個方向的方法？

I wish I could answer in a positive fashion that I see a distinct criteria. What we do see from that standpoint is many of the payers adjusting their coverage decisions to allow a greater inclusion of patients, so they are reducing the number of documents as an example. Or there were removing age restrictions. And I think it's just this evolutionary growth.

我希望我能用更正面的方式回答，說我看到一個明確的判準。就這方面而言，我們確實看到許多保險支付方正在調整其給付決策，以納入更多病患，例如減少所需文件，或取消年齡限制。我認為這就是一種逐步演進的成長。

My goal is to try to accelerate that. The dilemma that I have right now is, I've seen this movie before. If you look at back in the early pump days, we watched this transition take several years. And today pumps represent about 30% penetration in the Type I market. And I think they are growing high single digit organically, but around that number. We are seeing the same kind of growth but it's happening quicker. So I'm getting anxious.

我的目標是試著加速這件事。我現在的兩難是：我以前看過這部電影。如果回顧早期胰島素幫浦的年代，我們看到這個轉變花了好幾年。如今幫浦在第一型糖尿病市場的滲透率約 30%。我認為它們有機成長大約是高個位數，差不多就是那個水準。我們看到類似的成長型態，但發生得更快，所以我開始焦慮。

I want to see this grow much faster because I know it has the capacity. And the benefits to the patients are unrefutable. There has never been a study presented or published that I am aware of on CGM and there are hundreds of studies either presented or published that aren't positive. So, there is no dispute.

我希望它成長得更快，因為我知道它有這個能力，而且對病患的益處無可辯駁。就我所知，從未有任何關於 CGM 的研究被提出或發表是負面的；相反地，有數百篇研究被提出或發表，結果都是正面的。所以沒有爭議。

W e never prove pump there any was more effective than MDI. We have proven that CGM therapy is more effective than SMBG time and time again. And yet we still struggle to push this forward with the healthcare professionals to acknowledge that every single 1 of their patients should be on CGM.

我們從未證明過幫浦一定比多次每日注射（MDI）更有效。我們已一再證明 CGM 治療比自我血糖監測（SMBG）更有效。然而，我們仍然很難推動醫療專業人員去承認：他們的每一位病患都應該使用 CGM。

I am sick and tired of getting comments from physicians when I ask them how many patients have you lost in the last year because of dead-in-bed syndrome. And they'll tell me more than 1, in some cases more than a handful, or a patient having a hypoglycemic event and running into a telephone pole killing themselves, and hopefully not others.

當我問醫師：你們去年因為「睡夢中猝死症候群（dead-in-bed syndrome）」失去多少病患？我已經厭倦聽到他們的回覆。他們會告訴我不只 1 位，有些情況甚至不只幾位；或者有病患發生低血糖事件，撞上電線桿而喪命，並且希望沒有傷及他人。

It's just criminal in my opinion that we haven't forced this along a faster adoption curve. So, now you've heard some of my soapbox for the remainder of the year.

依我看，我們沒有更快地推動採用曲線，簡直是犯罪。所以，接下來這一年你們就聽到我這些牢騷了。

Thank you. I hope those walls start to break down because it will be a big benefit. Thanks for answering my questions.

謝謝。我希望那些障礙開始瓦解，因為這會帶來很大的益處。謝謝你回答我的問題。

Stephen Lichtman; Oppenheimer.

Stephen Lichtman；Oppenheimer。

Steve?

Steve？

Why don't we wrap this up because Steve is not coming on. Thank you all. Operator, thank you. I have a closing comment. DexCom continues to grow our installed base as CG users, more healthcare professional and patients recognize the benefits of CGM.

我們就先做個結束吧，因為 Steve 不會上線。謝謝各位。也謝謝接線員。我有一段結語。隨著更多醫療專業人員與病患認知到 CGM 的益處，DexCom 持續擴大我們的已安裝基礎（installed base）與 CG 使用者。

Our sensor utilization also continues to grow as patients understand the value of continuous glucose measurements on their daily life activities. The SEVEN PLUS achieves our goals, performance, simplicity, and convenience. The number of publications and presentations on the benefits of CGM continue to add to the already robust compendium of positive outcomes associated with use of CGM. And that fact, contributes to the third-party payer system amending their coverage decision, as I just mentioned, to allow more patients to enjoy the benefits of CGM.

隨著病患了解連續血糖量測對其日常生活活動的價值，我們的感測器使用率也持續成長。SEVEN PLUS 達成了我們在效能、簡易性與便利性上的目標。關於 CGM 益處的出版與發表數量持續增加，為既有且相當扎實的正向成果彙編再添內容。而這一事實也促使第三方支付方體系修訂其給付決策，正如我剛才提到的，讓更多病患能享有 CGM 的益處。

In spite of all this positive momentum, I am very impatient on the update of CGM as a standard of care. And I leave you with, that CGM is a must-have. It is not a nice-to-have. And the faster we get this recognized by the professional societies and patients, the fewer people with diabetes will suffer the consequences of having diabetes. Thank you.

儘管有這些正向動能，我對 CGM 作為照護標準的更新進展仍非常沒有耐心。我最後想留給各位的是：CGM 是必備品，不是可有可無的選配。越快讓專業學會與病患認可這一點，糖尿病患者因糖尿病而承受後果的人就會越少。謝謝。

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect. [End of transcript]

謝謝各位女士、先生。今天的會議到此結束。感謝各位參與。您現在可以掛線。 [逐字稿結束]