德康醫療 (DXCM) 2011 Q1 法說會逐字稿

Welcome to the DexCom First Quarter Earnings Release Conference Call. My name is Christine and I will be your Operator for today's conference. 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 Terry Gregg, Chief Executive Officer. Mr. Gregg, you may begin.

歡迎參加 DexCom 第一季財報發布電話會議。我是 Christine，將擔任今天會議的接線員。目前所有與會者皆處於僅收聽模式。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執行長 Terry Gregg。Gregg 先生，您可以開始了。

Thank you, Christine, and thank you for joining us for the first quarter 2011 investor call. I'm going to ask Steve Pacelli, our Chief Operating Officer, to remind us all about our forward-looking statements. Steve?

謝謝你，Christine，也感謝各位參加我們 2011 年第一季投資人電話會議。我將請我們的營運長 Steve Pacelli 提醒大家關於前瞻性陳述的事項。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 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 10K, our quarterly reports on form 10Q, and our other reports as filed with the SEC. We undertake no obligation to update publicly or revise these forward-looking statements for any reason. Terry?

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出現重大差異的因素清單，已在我們的 Form 10-K 年報、Form 10-Q 季報以及其他向美國證券交易委員會（SEC）提交的報告中之「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. And joining me today in addition to Steve are Jess Roper, Chief Financial Officer, and Kevin Sayer, a DexCom Board Member. Jess will provide you with the first quarter financial results and then I will take you through a brief corporate update followed by the operational review. This in turn will be followed by a question and answer period. Jess?

謝謝你，Steve。今天與我一同出席的，除了 Steve 之外，還有財務長 Jess Roper，以及 DexCom 董事會成員 Kevin Sayer。Jess 將向各位提供第一季財務結果，接著我將進行簡要的公司近況更新，並隨後進行營運回顧。之後將進入問答時間。Jess？

Thank you, Terry. DexCom generated $13.1 million in product revenue for the first quarter of 2011 compared to $6.8 million for the same quarter in 2010, an increase of 94%. During Q1 we shipped over 4,000 systems representing a 56% increase compared to the same quarter in 2010. Sequentially, product revenue for Q1 of 2011 decreased by 3% from the prior quarter. Following a very strong fourth quarter, we experienced seasonality in Q1 similar to Q1 of last year and as is typical in the durable medical equipment business.

謝謝你，Terry。DexCom 於 2011 年第一季創造 1,310 萬美元的產品營收，較 2010 年同季的 680 萬美元增加 94%。第一季期間我們出貨超過 4,000 套系統，較 2010 年同季增加 56%。以季對季而言，2011 年第一季產品營收較前一季下降 3%。在非常強勁的第四季之後，我們在第一季出現季節性因素，與去年第一季相似，且這在耐用醫療設備產業中屬常見現象。

Total revenue for the first quarter of 2011 was $14.2 million compared to $9.5 million during the same quarter in 2010. Sequentially, quarter to quarter, total revenue was down 9%, primarily due to a $1 million development milestone earned and recognized during Q4 as part of our collaboration with Animas. Our product gross margin totaled $4.8 million or 36% for Q1 compared to $1.6 million or 24% in the same quarter of the prior year. Sequentially, our product margin declined $1.1 million. As discussed on our last conference call, we saw a small incremental improvement in our product margin during Q4 as we increased both hardware inventory levels in anticipation of Flextronics relocating their production line to China and sensor inventory levels to account for a shutdown of our internal sensor manufacturing lines for approximately 1.5 weeks during January 2011 in order to perform upgrades and maintenance.

2011 年第一季總營收為 1,420 萬美元，較 2010 年同季的 950 萬美元增加。以季對季而言，總營收下降 9%，主要原因是我們與 Animas 的合作案中，有一筆 100 萬美元的開發里程碑款於第四季取得並認列。第一季產品毛利為 480 萬美元（毛利率 36%），相較於前一年度同季的 160 萬美元（毛利率 24%）。以季對季而言，我們的產品毛利下降 110 萬美元。如同我們在上次電話會議中所討論的，第四季我們的產品毛利率出現小幅增量改善，原因是我們提高了硬體庫存水位，以因應 Flextronics 將其生產線遷移至中國；同時也提高了感測器庫存水位，以因應 2011 年 1 月我們內部感測器製造線為進行升級與維護而停線約 1.5 週。

We also noted that we anticipated a softening of our product margin in Q1 2011 as we expected to manufacture fewer units and also expected to manage down our inventory levels. During Q1, inventory declined by $1.7 million from the prior quarter. On a monthly basis, our product margin increased from 30% in January 2011 to 40% in March 2011. Barring unforeseen events, we expect our product margin to improve with increased product revenue beginning in Q2. Research and development expense totaled $6.3 million for Q1 compared to $4.7 million in Q1 of 2010. The increase in R&D cost was attributed to additional efforts associated with our next-generation ambulatory products. Sequentially, R&D expense decreased 9% which was primarily due to lower consulting costs.

我們也提到，預期 2011 年第一季產品毛利率將走弱，因為我們預計製造的單位數較少，且也預計將庫存水位下調。第一季庫存較前一季減少 170 萬美元。以月度來看，我們的產品毛利率由 2011 年 1 月的 30% 提升至 2011 年 3 月的 40%。若無不可預見事件，我們預期自第二季起，隨著產品營收增加，產品毛利率將改善。第一季研發費用為 630 萬美元，較 2010 年第一季的 470 萬美元增加。研發成本增加主要歸因於與我們下一代可攜式（ambulatory）產品相關的額外投入。以季對季而言，研發費用下降 9%，主要由於顧問費用較低。

Selling, general, and administrative expense totaled $10.7 million in Q1 2011 compared to $9.8 million during the same quarter in 2010. The increase was primarily due to additional selling, customer service, and information technology costs to support revenue growth. Sequentially, SG&A expense increased 7% with the increase primarily due to additional salary and share-based compensation costs as we added additional sales headcount.

2011 年第一季銷售、一般及行政費用（SG&A）為 1,070 萬美元，較 2010 年同季的 980 萬美元增加。增加主要由於為支援營收成長而增加的銷售、客戶服務與資訊科技成本。以季對季而言，SG&A 費用增加 7%，主要因我們增加銷售人力編制而帶來額外的薪資與股份基礎給付成本。

Our net loss for the quarter totaled $11.9 million and included $3.5 million in non-cash expenses centered primarily in share-based compensation. And the loss per share for the quarter was $0.19. We ended the quarter with $39 million in cash, restricted cash, and marketable securities and had working capital of $43 million.

本季淨損為 1,190 萬美元，其中包含 350 萬美元的非現金費用，主要為股份基礎給付。本季每股虧損為 0.19 美元。季末我們持有 3,900 萬美元的現金、受限制現金及有價證券，營運資金為 4,300 萬美元。

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

現在我把時間交還給我們的總裁兼執行長 Terry Gregg。

Thanks, Jess. Before I go through the operational review, I would like to update the investment community with exciting news regarding two new additions to our Board of Directors and a new member of our senior management team. It is no secret that we have a tremendous amount of work in front of us as we drive CGM and in particular DexCom's industry-leading technology in both the ambulatory and hospital settings to be recognized as the standard of care. Given DexCom's momentum and the projected growth of our category, we feel the time is right to enhance our Board with individuals that bring unique and diversified expertise to an already dynamic Board of Directors and to bolster our senior management ranks with an individual who has a proven track record in the industry.

謝謝你，Jess。在我進行營運回顧之前，我想向投資界更新一則令人振奮的消息：我們董事會新增兩位成員，且高階管理團隊也新增一位成員。眾所周知，為了推動連續血糖監測（CGM），尤其是讓 DexCom 業界領先的技術在門診與醫院場域都被認可為照護標準，我們面前仍有大量工作要做。鑑於 DexCom 的動能以及我們類別的預期成長，我們認為現在正是時機，透過引進具備獨特且多元專長的人士來強化本已充滿活力的董事會，同時也以一位在產業中具備可驗證實績的人士來充實我們的高階管理陣容。

Chip Doordan has spent the last 40 years in the hospital sector and is currently the Chief Executive Officer of Anne Arundel Health System in Annapolis, Maryland. Anne Arundel Health System is comprised of a 324 inpatient facility, a 40 bed inpatient substance abuse treatment center, the Edwards Outpatient Surgery Center, the AAMC, the DeCesaris Cancer Institute, and Anne Arundel Diagnostic Center, as well as three satellite facilities. All of this is staffed by more than 3,200 employees with an annual operating budget in excess of $500 million.

Chip Doordan 過去 40 年一直在醫院領域服務，目前擔任位於馬里蘭州安納波利斯（Annapolis）的 Anne Arundel Health System 執行長。Anne Arundel Health System 包含一所 324 床的住院機構、一所 40 床的住院藥物濫用治療中心、Edwards 門診手術中心、AAMC、DeCesaris 癌症研究所，以及 Anne Arundel 診斷中心，並另有三處衛星設施。整個體系由超過 3,200 名員工提供服務，年度營運預算超過 5 億美元。

As you are well aware, we believe the hospital setting is extremely important for the expansion of the role of continuous glucose monitoring for all patients, not just in the ICU environment but also for patients in the non-critical care areas of the hospital. Our partnership with Edwards Lifesciences provides us with access to the ICU with a sophisticated blood dwelling sensor. We are in feasibility testing with a new subcutaneous glucose sensor specifically designed to address the unmet needs of the step down ward and other areas of the hospital outside of the ICU. I am excited to welcome Chip with his extensive experience in managing and expanding Anne Arundel's hospital operations. This perspective will be an important part of our Board of Directors and the exciting future of DexCom.

各位都很清楚，我們認為醫院場域對於擴大連續血糖監測在所有病患中的角色極為重要，不僅是在加護病房（ICU）環境，也包括醫院內非重症照護區域的病患。我們與 Edwards Lifesciences 的合作，讓我們得以透過一款先進的血管內（blood dwelling）感測器進入 ICU。我們正在進行可行性測試，測試一款全新的皮下葡萄糖感測器，專為滿足降階病房（step down ward）及 ICU 以外其他院內區域的未被滿足需求而設計。我很高興歡迎 Chip 加入，他在管理並擴展 Anne Arundel 醫院營運方面擁有豐富經驗。這樣的觀點將成為我們董事會以及 DexCom 令人振奮未來的重要一環。

Also joining our Board is Barbara E. Kahn, the Patty and Jay H. Baker Professor, Professor of Marketing, and the Director of the Jay H. Baker Retailing Center at The Wharton School University of Pennsylvania. Barbara is an internationally recognized scholar on variety seeking, brand loyalty, and patient decision making whose research provides marketing managers with a better understanding of the consumer choice process. As mobile healthcare technologies converge with consumer devices and patients become more empowered and responsible for their own health, the role of patient choice becomes ever more important. And Barbara will be instrumental in advising DexCom as we bring advanced healthcare solutions to the marketplace.

同時加入我們董事會的還有 Barbara E. Kahn，她是賓夕法尼亞大學華頓商學院（The Wharton School, University of Pennsylvania）Patty and Jay H. Baker 講座教授、行銷學教授，並擔任 Jay H. Baker Retailing Center 主任。Barbara 是國際知名學者，研究領域涵蓋多樣性追求（variety seeking）、品牌忠誠度與病患決策，其研究可協助行銷管理者更深入理解消費者選擇流程。隨著行動醫療科技與消費性裝置加速融合，且病患在自身健康管理上更具自主性與責任感，病患選擇的角色變得愈發重要。Barbara 將在我們把先進醫療解決方案推向市場的過程中，為 DexCom 提供關鍵建議。

Finally, it is with great enthusiasm that I announce the appointment of Kevin Sayer to the position of President of DexCom effective June 1. As many of you remember, Kevin and I worked together from 1994 to 2002 as part of the team that grew MiniMed from $40 million in revenue to almost $400 million in revenue and resulted in the acquisition by Medtronic for $3.4 billion. I have relied on Kevin's counsel as a Board member here at DexCom the past couple of years as well as personal friend for more than 15 years. Kevin's position certainly enhances our bench strength and increases our bandwidth as CGM continues its adoption as a significant tool in diabetes care. Rest assured, I am in now way relinquishing my day to day operational control nor decision making. I am building the team that will allow DexCom to achieve product revenue of more than $67.5 million this year and continued strong growth in coming years. As I remind our staff, we anticipate continued growth within the CGM category and we must scale our operations and expand our capabilities to keep pace with the opportunities before us.

最後，我非常興奮地宣布，Kevin Sayer 將自 6 月 1 日起出任 DexCom 總裁。許多人還記得，1994 年至 2002 年間，Kevin 與我曾一起共事，作為團隊的一部分，將 MiniMed 的營收從 4,000 萬美元成長至接近 4 億美元，並促成其以 34 億美元被 Medtronic 收購。過去幾年，Kevin 以 DexCom 董事會成員身分提供我許多建議；同時他也是我超過 15 年的私人朋友。Kevin 的新職務無疑將強化我們的人才梯隊，並提升我們的承載能力（bandwidth），因為 CGM 正持續被採用為糖尿病照護的重要工具。請放心，我絕不會放棄我日常的營運控制或決策權。我正在打造一支團隊，使 DexCom 今年能達成超過 6,750 萬美元的產品營收，並在未來幾年持續強勁成長。正如我提醒同仁的，我們預期 CGM 類別將持續成長，而我們必須擴大營運規模並拓展能力，以跟上眼前的機會。

Today, we remain keenly focused on the type one market. Just two weeks ago, at the American Association of Clinical Endocrinologists' meeting here in San Diego, a key opinion leader in diabetology made reference publically about a late-breaking abstract to be presented at the American Diabetes Association annual meeting in June regarding a study in the type two population comparing CGM to traditional fingerstick measurements that will be in his words -- a game-changer for CGM. Just today, data from the first 12 weeks of this 52 week prospective randomized clinical study were peer review published in the Journal of Diabetes Science and Technology, demonstrating that the use of DexCom's CGM system significantly improved glycemic control in patients with type two diabetes not taking prandial insulin. We have long believed that CGM is more than continuous glucose monitoring and in fact is a strong behavior medication tool across the spectrum of diabetes tool.

今天，我們仍然高度專注於第一型市場。就在兩週前，在此地聖地牙哥舉行的美國臨床內分泌醫師協會（American Association of Clinical Endocrinologists）年會上，一位糖尿病學領域的關鍵意見領袖公開提到，將在六月的美國糖尿病協會（American Diabetes Association）年度會議上發表一篇最新重磅摘要，內容是針對第二型族群進行的研究，比較 CGM 與傳統指尖採血測量；用他的話說——這將是 CGM 的「遊戲規則改變者」。就在今天，這項為期 52 週的前瞻性隨機臨床研究之前 12 週數據，已通過同儕審查並發表於《Journal of Diabetes Science and Technology》，顯示在未使用餐時（prandial）胰島素的第二型糖尿病患者中，使用 DexCom 的 CGM 系統可顯著改善血糖控制。我們長期以來一直相信，CGM 不僅僅是連續血糖監測；事實上，它是一項強而有力的行為醫療工具，適用於糖尿病照護的各個面向。

I might add that this investigator initiated prospective randomized study utilize the DexCom SEVEN PLUS system exclusively. Expanding that thought, of the 12 to 15 artificial pancreas projects currently underway around the world, DexCom sensors are used in approximately two-thirds of the investigations. Of course while data supporting the value proposition for CGM in type two patients is exciting, as we've said previously, we will not devote significant resources to target that market until the reimbursement landscape for that important population matures.

我補充一下，這項由研究者發起的前瞻性隨機研究，完全採用 DexCom SEVEN PLUS 系統。進一步延伸來看，目前全球正在進行的 12 到 15 個人工胰臟專案中，約有三分之二的研究使用 DexCom 感測器。當然，支持 CGM 在第二型患者中價值主張的數據令人振奮；但如我們先前所說，在該重要族群的給付（reimbursement）環境成熟之前，我們不會投入大量資源去鎖定那個市場。

This is my 17th year in diabetes. I've never been more excited about the technologies that are being developed for patients. I consider my role in the industry as an elder statesman, philanthropist, and advantaged technologist that brings forth truly innovative products to the diabetes marketplace. In order to expand awareness of the benefits of CGM on a global basis, I need to focus my efforts more externally, particularly in the sales and marketing arenas. Adding Kevin to the team will certainly facilitate those efforts. Our business is multifaceted with the SEVEN PLUS performing as the best available CGM on the market and our next-generation sensor technology currently approved in the EU and under review by the FDA. Our partnerships with Animas and Insulet will bring forth sensor-integrated insulin pumps this year and next and our partnership with Edwards Lifesciences will introduce the next-generation critical care sensor technology to the marketplace next year as well.

這是我在糖尿病領域的第 17 年。我從未像現在這樣，對正在為患者開發的技術感到興奮。我將自己在產業中的角色視為資深領袖、慈善家，以及具優勢的技術推動者，將真正創新的產品帶入糖尿病市場。為了在全球範圍提升對 CGM 效益的認知，我需要把更多精力放在對外，特別是在銷售與行銷領域。Kevin 加入團隊，必然能促進這些努力。我們的業務多元：SEVEN PLUS 作為市場上最佳的 CGM 產品表現出色；而我們的下一代感測器技術目前已在歐盟獲准，並正由 FDA 審查中。我們與 Animas 及 Insulet 的合作，將在今年與明年推出感測器整合式胰島素幫浦；我們與 Edwards Lifesciences 的合作，也將在明年把下一代重症照護感測器技術導入市場。

Turning to the commercial update, as we guided during our Q4 call in March, we posted a relatively flat first quarter sequentially in terms of product revenue. As I reminded investors during that call, the first quarter is traditionally a seasonally slow quarter in the durable medical equipment business as annual insurance deductibles reset. And this year in particular patients are reporting sharp increases in their deductible amounts as employers ask their employees to share the burden of increased healthcare costs. Like the first quarter of 2010, we saw in January and much of February this year a short-term slowdown in patients' willingness to complete their purchases until such time as their deductibles were appropriately reduced. Nonetheless the deductible burden easing, our pipeline is full, and we remain committed to our guidance of estimated full year 2011 product revenue ranging from $67.5 million to $72.5 million.

轉到商業面更新，正如我們在三月的第四季電話會議中所指引的，就產品營收而言，我們第一季相較前一季呈現相對持平。我在那次會議中也提醒投資人，對於耐用醫療設備（durable medical equipment）產業而言，第一季傳統上是季節性較慢的一季，因為年度保險自付額（deductibles）會重置。尤其是今年，患者回報其自付額金額大幅增加，因雇主要求員工分擔上升的醫療成本負擔。與 2010 年第一季類似，我們在今年一月及二月大部分時間看到短期放緩，患者在自付額適當降低之前，完成購買的意願下降。儘管如此，隨著自付額負擔緩解，我們的銷售管線充實，我們仍致力於維持先前指引：2011 全年產品營收估計介於 6,750 萬美元至 7,250 萬美元。

Shifting to an update on clinical regulatory affairs, we have continued to maintain an open dialog with the agency on a pre-IDE basis and expect to reach agreement with the FDA on a study design to enable us to file a formal IDE and commence the required trial for gen four within approximately 60 to 90 days. We believe this timing will keep us on track to complete the trial and file an amendment to our fourth-generation TMA supplement during late summer provided however that should FDA's review of our IDE submission take longer than accepted, our submission timeframe would be adjusted accordingly. Regarding our combination products, we have had productive discussions with the FDA concerning the nature of the human factor study and associated technical information required by the FDA to support approval of the Animas VIBE system. Our application for CE Mark approval of the VIBE remains under review by the Animas notified body. We continue to expect that Animas will launch the combination product in Europe before the end of this quarter.

轉到臨床法規事務更新，我們持續在 pre-IDE 基礎上與主管機關保持開放對話，並預期在約 60 至 90 天內，就研究設計與 FDA 達成一致，使我們能提交正式 IDE 並啟動第四代（gen four）所需的試驗。我們相信此時程可使我們按計畫完成試驗，並在夏末提交第四代 TMA 補充申請的修正案；但前提是，若 FDA 對我們 IDE 送件的審查時間超出可接受範圍，我們的送件時程將相應調整。關於我們的組合產品（combination products），我們已就 FDA 為支持 Animas VIBE 系統核准所要求的人因（human factor）研究性質及相關技術資訊，與 FDA 進行了富有成效的討論。我們針對 VIBE 的 CE Mark 核准申請仍在 Animas 的公告機構（notified body）審查中。我們仍預期 Animas 將在本季結束前於歐洲推出該組合產品。

Concerning the integrated system with insulin, we are in the early stages of our development of an integrated system that combines our fourth-generation sensor with Insulet's next-generation Arrow system and we continue to anticipate that an FDA submission could occur sometime in the first half of 2012. Finally, we continue to work diligently towards the development of our second-generation hospital-based CGM system and plan to launch that system in Europe next year.

至於與胰島素整合的系統，我們正處於開發早期階段，致力於將我們的第四代感測器與 Insulet 的下一代 Arrow 系統結合；我們仍預期可在 2012 年上半年某個時間點向 FDA 提交申請。最後，我們也持續努力開發第二代院內（hospital-based）CGM 系統，並計畫於明年在歐洲推出該系統。

Needless to say, the regulatory environment remains difficult for all of us in the medical device industry. Yet, as we work collaboratively with the FDA to finalize the protocol for our upcoming clinical trial, we believe we will establish a new benchmark for the category, creating in effect a barrier to entry, not only for new entrants but for existing competitors in our market.

不必多說，對我們醫療器材產業的所有人而言，法規環境仍然艱難。然而，當我們與 FDA 協作以敲定即將進行的臨床試驗方案時，我們相信將為此類別建立新的標竿，實質上形成進入門檻，不僅對新進者如此，對我們市場中的既有競爭者亦然。

So, in conclusion, as we progress through the second quarter of 2011, the adoption of CGM continues to grow nicely as more and more patients and healthcare professional discover the benefits of continuous glucose monitoring. Although we continue to focus on the type one population, one cannot help but to take a peek at the future and envision the role of CGM in type two patients and even outside of diabetes care. Our plate is full with the SEVEN PLUS growing in the marketplace, our fourth-generation sensor technology winding its way through the FDA and the fifth generation in human feasibility studies in the step down work. Add to that the pending introduction in the EU of the J&J Animas VIBE, a sensor integrated continuous insulin infusion pump system, our progress with Edwards Lifesciences as the gen two glycolic product continues its development with an intended EU launch next year and our collaboration with Insulet to create the first tubeless insulin pump CGM combination product. Also expect it to be commercialized in 2012 along with the US introduction of the VIBE.

因此，總結而言，隨著我們進入 2011 年第二季，CGM 的採用持續穩健成長，因為越來越多患者與醫療專業人員發現連續血糖監測的益處。雖然我們仍聚焦於第一型族群，但人們不免會展望未來，想像 CGM 在第二型患者，甚至在糖尿病照護之外的角色。我們手上工作滿檔：SEVEN PLUS 在市場上持續成長；第四代感測器技術正逐步通過 FDA 流程；第五代則在人體可行性研究中進行降階（step down）工作。再加上 J&J Animas VIBE（感測器整合式連續胰島素輸注幫浦系統）即將在歐盟推出；我們與 Edwards Lifesciences 的進展，第二代重症照護產品持續開發，目標於明年在歐盟上市；以及我們與 Insulet 的合作，打造首款無管路（tubeless）胰島素幫浦與 CGM 的組合產品。也請期待該產品於 2012 年商業化，同時 VIBE 也將在美國導入。

From a leadership perspective, we have taken steps to build our bench strength both at the Board level as well as management level with Kevin Sayer joining us as President. Kevin and I have seen this movie before and our entire management team is excited that the opportunity to participate in making a newer and what we believe can be a much broader version. I'm excited to see the pieces being put in place that will allow DexCom to continue to grow and expand our mission.

從領導層角度來看，我們已採取措施強化人才梯隊（bench strength），不論在董事會層級或管理層級皆然，並由 Kevin Sayer 加入擔任總裁。Kevin 和我以前看過這部電影，而我們整個管理團隊都很興奮，能有機會參與打造一個更新、且我們相信可更廣泛的版本。我很期待看到各項拼圖逐步到位，使 DexCom 能持續成長並擴展我們的使命。

Personally, this is the perfect situation for me to lead this organization to profitability and beyond from both a revenue and technology perspective. I know that continuous glucose monitoring is one of the most impactful tools to allow people with diabetes to lead a more normal life. I am committed to seeing the technology established as the standard of care in glucose monitoring. At the same time I am privy to early results of a number of the artificial pancreas closed-loop projects we are participating in around the globe and I have never been more excited about the work that these fabulous researchers are conducting to further this technology and bring it to the market in a timely fashion. I want to be part of that accomplishment and have it as part of my legacy to diabetes.

就我個人而言，這是我從營收與技術兩個面向帶領組織走向獲利並更上一層樓的完美情境。我知道連續血糖監測是最具影響力的工具之一，能讓糖尿病患者過上更正常的生活。我致力於讓這項技術成為血糖監測的照護標準。同時，我也得以接觸我們在全球參與的多項人工胰臟閉環（closed-loop）專案的早期成果；我從未像現在這樣，對這些傑出研究人員為推進技術、並及時將其推向市場所做的工作感到興奮。我希望能成為這項成就的一部分，並將其作為我在糖尿病領域的傳承。

Thank you. Christine, we'll entertain questions now.

謝謝。Christine，我們現在開始回答問題。

Thank you. (Operator Instructions) The first question comes from Ben Andrew from William Blair and Company. Please, go ahead.

謝謝。（接線員指示）第一個問題來自 William Blair and Company 的 Ben Andrew。請開始。

Good afternoon, Terry, can you hear me?

下午好，Terry，你聽得到我嗎？

Hi, Ben.

嗨，Ben。

How are you? Kevin, welcome aboard. Good to work with you again. It's been awhile. I think you'll be a good addition to the team. Glad you were able to join the Company full-time.

你好嗎？Kevin，歡迎加入。很高興再次與你合作。已經有一段時間了。我想你會是團隊很好的補強。也很高興你能以全職身分加入公司。

I'm glad to be here.

我也很高興來到這裡。

So, maybe one quick question for you, Kevin, while we've got you. You've been on the Board now for some time. You've seen the Company develop. Maybe in your own words, why is now a particularly good time for you to join? What do you think your initial objectives will be as President?

那麼，趁你在這裡，Kevin，我可能先問你一個簡短問題。你在董事會已經待了一段時間，也看著公司發展。用你自己的話來說，為什麼現在是你加入的特別好時機？你認為你作為總裁的初期目標會是什麼？

As Terry said, we've seen this movie before. But in this case I'm thinking the sequel is going to be better. Coming up, there's a lot of things I can look at. Terry and my skills compliment each other very well as I've been involved in a number of -- a lot of things -- I think as we went towards rapid growth, profitability, and also from just a systems end and work perspective, there's a lot of things I can contribute there, particularly being here in the building and working with these people. With respect to the Company, it's just seeing the timing seemed perfect for me. I left my last employment as mentioned in the press release in December and this is the best opportunity I'm going to see. So, I'm happy to be here.

如 Terry 所說，我們以前看過這部電影。但這一次我認為續集會更好。接下來，有很多事情我可以著手。Terry 和我的技能彼此互補得很好；我曾參與許多——很多事情——我想當我們邁向快速成長與獲利時，無論是從系統端或工作流程的角度，都有很多我能貢獻的地方，尤其是能在這棟大樓裡，和這些人一起工作。就公司而言，我只是覺得時機對我來說非常完美。如新聞稿所提，我在十二月離開了上一份工作，而這是我所能看到的最佳機會。所以，我很高興能在這裡。

Great. Okay. And Terry, maybe turning to the quarter for a moment, talk about the change in deductibles that you're hearing about from customers and how the magnitude of that might've been different than last year's seasonality, seeing the flattish result was consistent largely with your guidance, maybe a touch worse. But maybe the other factors this year in terms of economic sensitivity or other patient drivers that led to a slightly weaker performance.

很好。好的。Terry，或許先談一下本季，請你談談你從客戶那邊聽到的自付額（deductibles）變化，以及其幅度相較於去年季節性可能有何不同。看到結果大致持平，基本上與你們的指引一致，可能稍微差一點。但也請談談今年在經濟敏感度或其他病患驅動因素方面，是否有導致表現略弱的其他因素。

It really was the extension from last year -- if you remember in January was very down. We had to pretty much go through half of February before we saw the uptick begin and then we came roaring back with March. I think we've seen the extension of that through the full month of February. We came roaring back again in March. We're happy to see that. And without giving guidance on a month by month basis, the pipeline was full, Ben. I think that's really as we look at things, the question you ask yourself when you see the flatness in January-February timeframe, is there a falloff of demand? The answer is absolutely not. Our pipeline has been full. We had orders ready to ship well beyond what the revenue number was. We just had to wait for patients to finally give us the go ahead because we have to collect the copay from that standpoint and relative to the deductible and just it's the economic -- I don't see at this point any lingering any more than we saw as we moved into the second quarter of 2010. So, again, as reaffirming our full year guidance, we're confident that we will meet that guidance number.

這其實就是去年情況的延續——如果你記得，一月非常疲弱。我們幾乎要到二月過了一半才開始看到回升，然後三月強勁反彈。我認為我們看到這種延續一路拉長到整個二月。我們在三月又再次強勁回升，我們很高興看到這點。在不逐月提供指引的前提下，Ben，我們的管線是滿的。我想當我們看事情時，你在一到二月這段時間看到持平，會問自己的問題是：需求是否下滑？答案絕對是否定的。我們的管線一直很滿。我們有準備出貨的訂單，遠高於營收數字所反映的水準。我們只是必須等病患最終給我們放行，因為從那個角度我們必須收取自付額（copay），並且與自付額門檻（deductible）相關；這就是經濟面的因素——就目前而言，我看不出有任何揮之不去的影響，超過我們在2010年進入第二季時所看到的程度。因此，再次重申我們全年指引，我們有信心能達成該指引數字。

Okay. Maybe one other question for me and I'll jump off. As you ramped up your efforts in the field this year, partially in response to regulatory delays on some of the combination products and maybe losing a little bit of the opportunity to have partners helping co promote, are you done doing that or are you in the selling process? And how should we think about the SG&A line, maybe a question for Jess, over the course of the year? Thanks.

好的。我這邊再問一個問題就下線。今年你們在前線加大投入，部分是因為某些組合產品的法規審查延遲，可能也少了一點由合作夥伴協助共同推廣（co-promote）的機會。你們這樣做已經完成了嗎，還是在銷售擴編的過程中？另外，全年SG&A費用線該怎麼看——也許這題給Jess——謝謝。

Let me first talk about the number of new sales people that we've put in. We've completed that increase in the number of sales people. So, we're done from that standpoint as far as we can see this year. I have to always say we look at that continuously. If there are particular unmet needs, if we get a payer as an example in a particular area that we are not serving adequately, we may adjust that accordingly. But the other side of that too and one of the questions you should be asking me -- how fast do those new sales reps measure up and get fully functional? We're still in that learning period. They've just -- many of them have gone through sales training in the formal sense of our sales training program within the last 60 days and so they're not fully -- in my opinion they're not fully functional. It usually takes anywhere from three to four maybe even five months. We have not recognized the increase there.

我先談我們新增的業務人員數量。我們已經完成這次業務人員的增聘。所以，就我們目前所見，今年在這方面算是告一段落。我必須一再強調，我們會持續檢視；如果有特定未被滿足的需求，例如某個地區出現我們服務不夠到位的付款方（payer），我們可能會相應調整。但另一方面，你也應該問我一個問題——這些新業務代表要多快才能達標並完全上手？我們仍在學習期。他們之中很多人在過去60天內才剛完成我們正式的銷售訓練計畫，因此他們還沒有完全——以我看來還沒有完全發揮戰力。通常需要三到四個月，甚至可能五個月。我們尚未反映那部分的增量。

Okay. Great. Thank you.

好的。非常好。謝謝你。

The next question comes from Bill Plovanic from Canaccord Genuity. Please, go ahead. Mr. Plovanic, please, go ahead. Your line is open.

下一個問題來自Canaccord Genuity的Bill Plovanic。請開始。Plovanic先生，請開始，您的線路已開通。

Sorry about that. It was on mute. Can you hear me?

抱歉，剛剛在靜音。你們聽得到我嗎？

Yes, Bill.

可以，Bill。

So, just as I look at this, the first question is just for Kevin is in some of your commentary that, Terry, you'll be focused on sales and marketing and external and basically, Kevin, you'll be focused on internal? Is that the way I should think about this going forward?

所以，我這樣看，第一個問題是問Kevin：在你們的一些說法裡，Terry會專注在銷售、行銷與對外事務，而基本上Kevin會專注在內部？我接下來應該這樣理解嗎？

Yes. That is how you should think about it, Bill.

是的，Bill，你應該這樣理解。

Okay. And then kind of on the back of that we saw gross margins drop and we talked about kind of the shutdown in January for the PDA and for also the disposable -- it's ramped back up to 40% as we exit Q1. What should we expect in Q2? Is it going to be a 40% to 43% number? Is it going to move up faster than that? How should we think about that?

好的。接著延伸一下，我們看到毛利率下滑，也談到一月PDA以及一次性耗材（disposable）的停工——到第一季末已回升到40%。第二季我們應該期待什麼？會是40%到43%嗎？還是會比那更快上升？我們該怎麼看？

I think if you look at Jess's comments that we should continue to see growth, we have never given forward-looking guidance on that, Bill. Now would not be the time to start that. But again we said as we ramp this is a very volume sensitive business, particularly on the disposable side. We today, we're not fully absorbed in our manufacturing operations. We expect that to continue to grow appropriately.

我想如果你看Jess的評論，我們應該會持續看到成長；我們從未提供毛利率的前瞻性指引，Bill，現在也不是開始這麼做的時候。但我們也說過，隨著我們爬坡，這是一個對量非常敏感的生意，特別是在一次性耗材端。以今天來看，我們的製造營運尚未完全吸收（fully absorbed）。我們預期這會持續適當成長。

What type of absorption -- what kind of gross margin can you get to on your current generation of product? And what revenue level do you kind of max out in your current gen, on the gen three.

以你們目前這一代產品，你們的吸收狀況——也就是毛利率——最高可以到多少？另外，在目前這一代（第三代，gen three）上，你們大概在什麼營收水準會達到上限？

We don't really max out from that standpoint. We have said -- and I think Steve's addressed it. I'll ask him to address it again, but just from a manufacturing capacity standpoint, this footprint with the gen three technology and a single ship, we can do a million sensors. At this point in time we believe -- and I think Steve -- I'll let actually Steve answer the margin question on a million sensors.

從那個角度來說，我們其實不太有所謂的上限。我們曾說過——我想Steve也談過——我會請他再談一次，但就製造產能而言，以第三代技術與單一班次（single shift）的這個廠區規模，我們可以做到一百萬個感測器。就目前而言，我們相信——我想Steve——我其實讓Steve來回答在一百萬個感測器規模下的毛利率問題。

Yes. So, Bill, somewhere between a million to 1.5 million sensors in the current configuration in the current footprint, we're north of 65% on the disposables. We'll probably be running 50% ish on the hardware. Yes. The hardware volumes are certainly not going to exceed that -- near that million unit number. And then we moved to gen four, again, same footprint due to the manufacturing changes. The scaling, some of the configurations that we manufacture in gen four, we move that 65% to north of 75% in that same kind of 1.5 million-ish sensor volume on the --

好的。Bill，在目前配置與現有廠區規模下，大約在一百萬到一百五十萬個感測器的區間，我們的一次性耗材毛利率會在65%以上。我們的硬體毛利率大概會在50%左右。是的，硬體出貨量當然不會超過——也不會接近那個一百萬台的數字。接著我們轉到第四代（gen four），同樣的廠區規模，因為製造變更帶來的擴產能力、以及我們在第四代製造的一些配置，我們可以在同樣約一百五十萬個感測器的量級下，把65%提升到75%以上——

Got you. Shifting gears once again, the study that you highlighted, that was talked about at the ACE meeting -- I guess we'll get to see this come out regarding the type two data, is this -- is that enough, that study, to drive the reimbursement? Or do you need multiple studies? What's your kind of thoughts at this time?

了解。再換個話題，你們提到的那項研究，在ACE會議上有討論——我想我們會看到關於第二型糖尿病（type two）的資料出來。這項研究本身是否足以推動給付（reimbursement）？還是需要多項研究？你們目前怎麼看？

I don't know to be honest with you. It's a 100 patient study. It's got a full year of analysis. It's randomized, independent, prospective. Certainly from an analytical standpoint and statistical standpoint it will more than stand on its own from that perspective. I just cannot tell you if it's going to be enough. I reflect back on the CGM trial that was sponsored by GDRF. It certainly had more patients in it -- over 300 patients. The analysis at six months was positive.

老實說我不知道。那是一項100位病患的研究，有完整一年的分析，是隨機、獨立、前瞻性的。從分析與統計的角度來看，它絕對足以自成一格。但我無法告訴你這是否就夠了。我回想由GDRF贊助的CGM試驗，病患數更多——超過300位。六個月的分析結果是正面的。

But even before that, you remember back it was finally released in September of 2008, we were getting positive coverage decisions before that. And so I don't know how the payer community will look at this. We haven't seen the final results. If you just look at the six month results, they're pretty compelling in reduction of A1c and some other components with regards to weight and blood pressure. I don't know if that's going to be sustainable at one year. Obviously when Dr. [Bodie] was making the comment from the podium about the game-changer, he may have had access to information that we don't. Therefore, I'm encouraged by his comments but I don't have the actual data, nor have I seen it. So, we just have to wait and see have the payer community reacts to that.

但甚至在那之前，你還記得它最後是在2008年9月才正式發布，而在那之前我們就已經拿到一些正面的給付覆蓋決策。因此我不知道付款方社群會如何看待這次。我們還沒看到最終結果。如果只看六個月結果，在A1c下降以及體重、血壓等其他面向上都相當有說服力。我不知道一年時是否能維持。顯然當[Bodie]醫師在台上提到「改變遊戲規則」時，他可能掌握了我們沒有的資訊。因此我對他的評論感到鼓舞，但我沒有實際數據，也還沒看過。所以我們只能等待，看看付款方社群會如何反應。

Okay. Then on the product update, this is the last question. You talked about the CE being under review, launch late Q2. That's coming shortly. And the US for the J&J product. I don't know if you talked about when you expect to submit on that one. I know Insulet you said you expect to submit in the first half of '12.

好的。那產品更新方面，這是最後一題。你提到CE正在審查中，第二季末推出，這很快就會到。那美國方面的J&J產品，我不確定你是否提到預計何時提交。我知道你說Insulet預計在2012年上半年提交。

Yes, Bill. There's no real update from the March call. What we said in March was that we expect to submit it in some period of time following the gen four. It'll -- theoretically we could submit it at the same time or the next day, quite frankly. But the FDA has asked us, without giving us definitive guidance on number of days or weeks, they've asked us to delay slightly from the time we file the gen four standalone to the time we file the Anima PMA supplement because remember it contains the gen four sensor, the Animas system is a gen four system. So, they want some period of time to review the gen four filing before they have another gen four filing sitting on top of them. We're guessing somewhere 90 to 100 days or so after our gen four filing which again we're holding consistent to our kind of late summer filing for that, the gen four standalone.

是的，Bill。相較於3月那通電話會議沒有實質更新。我們在3月說的是，我們預期會在第四代（gen four）之後的某個時間點提交。理論上，坦白說，我們可以同一天提交，或隔天就提交。但FDA要求我們——在未給出明確的天數或週數指引下——希望我們從提交第四代單機版（gen four standalone）到提交Anima的PMA補充申請（Anima PMA supplement）之間稍微延後一點，因為你要記得它包含第四代感測器，Animas系統本身就是第四代系統。所以他們希望先有一段時間審查第四代的申請，之後再讓另一個第四代申請疊加上來。我們猜測大概是在我們提交第四代之後約90到100天左右；而我們仍維持先前的說法，也就是第四代單機版大概在夏末左右提交。

Okay. Perfect. Thank you. I'll jump back into queue.

好的。完美。謝謝你。我會回到隊列裡。

The next question comes from Mimi Pham from Weeden and Company. Please, go ahead.

下一個問題來自 Weeden and Company 的 Mimi Pham。請開始。

Hi. Good afternoon. Just your quick comment about the 90 to 100 days for filing of the J&J integrated device, you don't need any additional data then? Or you don't do trials -- ?

嗨，午安。關於 J&J 整合式裝置申報需要 90 到 100 天這件事，您只要補充簡短說明：那麼就不需要任何額外資料了嗎？還是你們不做試驗——？

It will require what we call a human factors trial, Mimi. It should not require -- there was some discussion at certain points during the FDA's evaluation of establishing this class 2B category where it was looking like pump companies were going to have to run trials pumping insulin in patients or clinical trial subjects. It doesn't appear that that will be the requirement going forward. But we will have to do a small human factors trial which is a much less significant trial of course than we're running on the gen four stand alone.

Mimi，這會需要我們所稱的人因（human factors）試驗。應該不需要——在 FDA 評估、建立這個 2B 類別的某些階段，曾有一些討論，看起來幫浦公司可能必須在病患或臨床試驗受試者身上進行胰島素輸注試驗。看起來未來不會把那個當作要求。不過我們仍需做一個小型的人因試驗；當然，這比我們在第四代獨立式產品上進行的試驗要小得多、也沒那麼重大。

Which assuming you can get done and completed and compiled to the update within that 90 to 100 day?

也就是說，假設你們能在那 90 到 100 天內完成、結案並彙整更新內容？

It can be done in parallel. It can be done at the same -- there's nothing -- that kind of window of waiting is something we're doing at the request of the FDA. We will be prepared to file as soon as they will permit it.

可以並行進行。可以同時——沒有什麼——那段等待時間是我們依 FDA 的要求在做的。我們會準備好，只要他們允許，我們就會立刻送件申報。

And then regarding the pilot type two study, when the data comes out, do you have to wait for the data to be published before you approach the payers? Or do you think it will be published at the same time as the ADA late breaker?

另外關於第二型糖尿病的試點研究，當資料出來時，你們在接觸保險支付方之前，是否必須等到資料發表？還是你認為它會和 ADA 的 late breaker 同步發表？

I think it'll be published at the same time as the ADA late breaker. Typically those things, if you remember back to last year and the STAR 3 trial being a late breaking abstract and then published in the New England Journal of Medicine the same day that it was presented, I don't know the publication intent of the investigator. Certainly we hope that a prestigious journal such as the New England Journal of Medicine would consider this for publication. We think it's interesting enough and groundbreaking enough that it should warrant that type of publication, but I'm not the editor and chief of that prestigious magazine yet.

我認為會和 ADA 的 late breaker 同步發表。通常這類事情——如果你還記得去年 STAR 3 試驗是 late breaking abstract，並且在發表當天同日刊登於《新英格蘭醫學期刊》（New England Journal of Medicine），我不清楚研究者的發表意圖。我們當然希望像《新英格蘭醫學期刊》這樣的頂尖期刊會考慮刊登。我們認為它夠有趣、也夠具突破性，值得那種等級的發表，但我還不是那本權威期刊的總編輯。

I guess based on the last time you went through this on the type one side, can you just talk about your strategy for reimbursement? How many payer you will approach and how soon after this data is presented or published by the ADA could you see any type of decision for type two?

我想基於你們上次在第一型糖尿病那邊走過的流程，你能談談你們的給付策略嗎？你們會接觸多少家支付方？在 ADA 發表或刊登這些資料之後，多快可能看到第二型糖尿病方面任何形式的決定？

We have not formulated that strategy. Obviously if you look at a couple of payers that have any type of type two diabetes reimbursement although today the criteria for coverage is quite restrictive. I would make the assumption that those would be the first two payers we would want to approach and begin to explore and have that discussion. I think it's very early at this point to have any kind of stated strategy for that. We haven't seen the data yet, so I think we'd first have to see the data before we develop the strategy.

我們尚未制定那個策略。很明顯地，如果你看目前少數對第二型糖尿病有任何給付的支付方——雖然今天的給付條件相當嚴格——我會假設那兩家會是我們最先想接觸、開始探索並展開討論的對象。我認為現在要提出任何明確策略都還太早。我們還沒看到資料，所以我想我們得先看資料，再來制定策略。

Got it. And then last quarter you talked about potential partnerships to promote CGM without -- separate from your direct sales force. Can you provide an update on that?

了解。然後上季你們提到可能會有合作夥伴來推廣 CGM——不透過、或至少不完全依賴你們的直銷團隊。這方面有更新嗎？

The only thing I can tell you is we said by midyear we would have some kind of announcement.

我唯一能告訴你的是，我們說過在年中之前會有某種公告。

Midyear? Okay.

年中？好的。

I would say at this point we are -- to use the term, deep in the weeds, in discussion. I can't elaborate more than that. I think there's multiple different opportunities and we're deep in discussion with those opportunities.

我會說目前我們——用個說法——正在深入細節地討論中。我不能再多說。我認為有多個不同的機會，我們正就這些機會深入洽談。

Would it be fair to characterize it maybe we could see something on that front in ADA also?

那麼是否可以說，也許在 ADA 期間我們也可能在這方面看到一些進展？

I wouldn't want to speculate. The devil's always in the details in these deals. From us, negotiating and them negotiating and then at the final minute you get the attorneys involved. That can sometimes -- depending on the size of their organization, take longer than it would take for us to finalize an agreement. I don't want to speak to that or predict when that might be announced.

我不想臆測。這類交易的魔鬼總在細節裡。從我們這邊談、他們那邊談，然後到最後一刻律師介入。那有時候——取決於他們組織的規模——可能會比我們完成協議所需的時間更久。我不想對此發言或預測何時可能公告。

Okay. Thank you very much.

好的。非常感謝。

The next question comes from Amy Sullivan from Piper Jaffray. Please, go ahead.

下一個問題來自 Piper Jaffray 的 Amy Sullivan。請開始。

Hi, guys.

嗨，各位。

Hi, Amy.

嗨，Amy。

You guys gave us a lot of details there on all the different projects and stuff. So, I apologize if I missed this, but where are things at from a US perspective with the Edwards hospital product on the regulatory front?

你們剛剛提供了很多關於各種專案的細節。所以如果我漏聽了先說抱歉；但從美國的角度來看，Edwards 的醫院產品在法規／監管進度上目前到哪一步了？

Where in -- I would classify this as a state of limbo from the standpoint of what the FDA is looking for. They have -- and it's not related to the product itself. If we characterize their concern, they being the agency, their first issue is they do not like the standards when it comes to glucose monitoring. The ISO standard. And so they have to come up with something that is acceptable. Obviously the institute of medicine will weight in. International standards organization will weight in. They've asked for advice from ACE. They've asked for advice from ADA, from IDE, and everybody that can weigh in, it's more related to establishing what would be an acceptable point to point accuracy standard. Until that data is established, we can't actually do a follow-on clinical trial because we don't have an end point to shoot for in terms of accuracy.

目前——我會把這形容為一種僵持狀態，因為 FDA 到底在尋找什麼還不明確。他們——而且這與產品本身無關。如果要描述他們（也就是主管機關）的疑慮，第一個問題是他們不喜歡血糖監測的標準，也就是 ISO 標準。因此他們必須提出一個可接受的方案。很明顯地，醫學研究院（Institute of Medicine）會提出意見；國際標準組織（International Standards Organization）也會提出意見。他們也向 ACE 徵詢建議；向 ADA、IDE，以及所有能提供意見的單位徵詢。這更多是關於建立一個可接受的點對點（point-to-point）準確度標準。在那個標準確立之前，我們其實無法進行後續的臨床試驗，因為我們沒有一個在準確度上可作為目標的終點（end point）。

That said, they are very open and have asked us to again collaborative way to sit down with them and discuss what other attributes of the product that we could bring forth. Their big concern is direct dosing off of the value and as you know and even all the way back to November of last year when Dr. [Gutierrez] got up and commented that point of care meters are not indicated for therapy adjustment, particularly in the hospital sector and yet they are used by most facilities, most hospital facilities. I think this is a much larger issue than just continuous glucose monitoring in the ICU. I think there are some basic standards that have to be established. But that said, I think the agency embraces the role of CGM and the reduction of potential morbidity and mortality in that sector and want to find a solution that they can live with and that's the level of dialog that we're engaged with them along with Edwards' regulatory personnel.

話雖如此，他們非常開放，並且再次要求我們以合作的方式與他們坐下來，討論我們還能提出產品的哪些其他屬性。他們最大的擔憂是直接依據數值來調整給藥（direct dosing off of the value）。如你所知，甚至回到去年 11 月，當 [Gutierrez] 醫師上台評論時也提到，床邊血糖機（point of care meters）並未核准用於治療調整，尤其是在醫院領域，但大多數機構、絕大多數醫院仍在使用。我認為這是一個比 ICU 連續血糖監測更大的議題。我認為必須先建立一些基本標準。不過即便如此，我認為主管機關也認同 CGM 的角色，以及在該領域降低潛在發病率與死亡率的價值，並希望找到一個他們能接受的解決方案；這就是我們與他們、以及 Edwards 的法規人員正在進行對話的層級。

Okay. That's helpful. And then secondly with the SEVEN PLUS system out there now for, what? Almost two years? I'm curious what you guys are seeing as far as trends or patterns on the actual durable components of the system? How long are patients using the system and has there been any sort of pushback or anything from payers as they go to reorder a new system?

好的，這很有幫助。第二個問題：SEVEN PLUS 系統現在上市大概——什麼？快兩年了？我想了解你們在系統的耐用組件方面看到哪些趨勢或模式？病患使用系統的時間有多長？當他們要重新訂購新系統時，支付方那邊有沒有任何反彈或其他狀況？

There's certainly been no pushback from payers whatsoever from that standpoint and as far as the durability of the disposable, I think that's what you're referring to in terms of use patterns. We continued to see the number of patients using it more frequently grow as they realized that the utilization on a continuous basis provides them with much greater benefit than using it periodically. So, that has, as we've said each quarter, that continues to grow. The only other thing I would add is we would continue to grab share from the standpoint as more patients become dissatisfied with competitive products, we certainly capture what I consider to be more than our fair share of that competitive landscape and we're happy to do that.

從那個角度來看，支付方完全沒有任何反彈。至於一次性耗材（disposable）的耐用性——我想你指的是使用模式——我們持續看到更頻繁使用的病患人數在成長，因為他們逐漸意識到，持續性使用所帶來的效益遠大於間歇性使用。所以，正如我們每一季所說，這個趨勢持續成長。我另外想補充的是，隨著更多病患對競品不滿，我們也持續在市占上取得份額；在我看來，我們在競爭版圖中拿到的份額超過我們應得的比例，而我們也樂見其成。

Are you seeing patients that have been using the system now for over a year? Is it around that year timeframe that they're getting a new transmitter?

你們是否看到有病患已經使用這套系統超過一年？大概是在一年左右的時間點，他們會更換新的發射器嗎？

The transmitter -- we carry a one year product warranty on both the transmitter and the receiver. But as you know the transmitter would be the gating item because the transmitter has a fully contained battery. But the transmitter will typically last somewhere between 12 to 18 months and so we're not seeing any issues with our ability to process -- it's kind of across the board. It's either a new transmitter or potentially a whole new kit for the patient processing through their insurance.

發射器——我們對發射器與接收器都提供一年產品保固。但如你所知，發射器會是關鍵項目，因為發射器內建的是完全封裝的電池。不過發射器通常可使用約 12 到 18 個月，所以我們在處理方面沒有看到任何問題——大致上各種情況都有：要嘛是更換新的發射器，要嘛是病患透過保險申請可能更換整套套件。

Okay. That's it for me. Thanks.

好的。我就這些。謝謝。

The next question comes from Raj Denhoy from Jefferies and Company. Please, go ahead.

下一個問題來自 Jefferies and Company 的 Raj Denhoy。請開始。

Hi. Good afternoon.

嗨，午安。

Hi, Raj.

嗨，Raj。

I wonder if I could ask about the timing of the IDE for the next-generation sensor here in the US. If I look back on the fourth quarter, I think you mentioned it was going to be 60 to 90 days to submit then and that was early March. If I'm not mistaken I think you're still saying 60 to 90 days. I'm curious if there's been a slip there or any discussion with the FDA that's taking a little longer?

我想請問美國這邊下一代感測器 IDE 的時程。如果我回頭看第四季，我記得你們提到大約 60 到 90 天內會提交，當時是三月初。如果我沒記錯，我想你們現在仍然說是 60 到 90 天。我好奇是否有延後，或是與 FDA 的討論花了更久一些？

What we said in March, we said we would be in a position -- we would file the IDE and be in a position 60 to 90 days thereafter to launch the clinical trial. And so, no, at this point we're not slipping. The one caveat we added and what we're hearing sort of anecdotally in the industry is that IDE they're typically a 30 day filing. Statutorily the FDA will respond to you in 30 days. But we're hearing that the IDEs are not going through as rapidly as that and that sometimes the FDA is coming back with comments and things that could result in multiple iterations of the IDE. I will tell you that we've spent a considerable amount of time working with the agency on a pre-IDE basis which is -- that's what we've been doing for the last couple months. To really nail down precisely what the FDA would like to see in our clinical trial that we're going to conduct. So, we're hopeful that we get the IDE through in a timely fashion. But that's the only caveat that we added to our comments today. We didn't slip the timing at all, just added the caveat that if the IDE doesn't go through in a timely fashion that could push the trial.

我們在三月所說的是，我們會處於一個位置——我們會遞交 IDE，並在其後 60 到 90 天內具備啟動臨床試驗的條件。所以，不，現階段我們沒有延遲。我們今天補充的唯一但書，以及我們在產業裡聽到的一些軼聞是：IDE 通常是 30 天的申請案。依法 FDA 會在 30 天內回覆你。但我們聽到 IDE 的審查並沒有那麼快，有時 FDA 會回來提出意見等，可能導致 IDE 需要多次往返修訂。我可以告訴你，我們花了相當多時間在 pre-IDE 的基礎上與主管機關合作——這就是我們過去幾個月一直在做的事——以便精準釐清 FDA 希望在我們將要進行的臨床試驗中看到什麼。因此，我們希望 IDE 能及時通過。但這就是我們今天評論中唯一新增的但書。我們完全沒有調整時程，只是補充如果 IDE 未能及時通過，可能會推遲試驗。

Okay. Very helpful. The comments on the Edwards trial and your relationship with them, I'm curious what effect it has on the grant revenues. I think you'd mentioned before that you'd give an update at some point but as you guys continue to work what that's going to look like. Have you updated when we could start to see some of those?

好的。非常有幫助。關於 Edwards 試驗以及你們與他們的關係，我想知道這對補助金收入（grant revenues）有什麼影響。我記得你之前提過會在某個時間點更新，但隨著你們持續合作，這會呈現什麼樣子。你們有更新我們何時可以開始看到其中一些收入嗎？

The milestones outside of the gen one FDA which is the one that we need to renegotiate and Edwards is quite open and interested to renegotiate that as we identify gen two and even a subsequent generation beyond the gen two so the other milestones remain the same and that's gen two approval, OUS gen two approval, US, and the Japanese approval at some point in time. So, those do get extended out into 2012 and probably the Japanese approval in 2013 even potentially longer than that depending on the Japanese regulatory process.

除了第一代（gen one）FDA 的里程碑之外——那個是我們需要重新談判的，而 Edwards 對重新談判相當開放且有興趣——當我們確認第二代（gen two），甚至在 gen two 之後的後續世代時，其他里程碑都維持不變，也就是 gen two 核准、OUS 的 gen two 核准、US，以及某個時間點的日本核准。因此，這些確實會延後到 2012 年，而日本核准可能在 2013 年，甚至可能更久，取決於日本的法規流程。

But that's the only what I would say as delay in terms of receiving those milestone payments. We're currently highly engaged with them. They just, as you may know, there was a period of time in which their leadership of the glucose monitoring, they recruited a new individual from a very successful Edwards individual to now head up that program. He came in from Israel around the first of the year and I can say that energetically how we are engaged on the technical front, I have never seen the teams works as closely as they are today. So, I think it's moving quite nicely. But again we do have to renegotiate that contract.

但就我會說的延遲而言，僅限於收到那些里程碑款項的時間。我們目前與他們高度投入合作。你可能知道，曾有一段時間他們在葡萄糖監測方面的領導層——他們從 Edwards 內部延攬了一位非常成功的人士來領導該計畫。他在年初左右從以色列加入。我可以說，就技術面而言我們合作的投入程度，我從未見過團隊像今天這樣緊密合作。所以我認為進展相當順利。但同樣地，我們確實需要重新談判那份合約。

Just so I'm clear, there was no kind of nearer-term milestones that are maybe getting pushed out. These were all based upon approvals and kind of later milestones?

我只是想確認清楚，並沒有什麼較近期的里程碑可能被往後推。這些全部都是以核准為基礎、屬於較後期的里程碑，對嗎？

Yes. The milestones are the ones that we had published previously.

是的。里程碑就是我們先前已公布過的那些。

Fair enough, just a couple other ones as well, pending approval of the combined J&J product in Europe, what are your expectations for that product early on, particularly given some of the reimbursement challenges for CGM in international markets? Are you expecting much in the near-term from that product?

了解。另外還有幾個問題：在歐洲 J&J 組合產品待核准的情況下，你們對該產品初期的期待是什麼？特別是考量到 CGM 在國際市場的一些給付（reimbursement）挑戰。你們預期該產品在近期會有很多貢獻嗎？

No. I would not put much in terms of revenue as it relates to DexCom. That's a market introduction. I think it allows the Animas as well as DexCom, but it allows a competitive -- a highly competitive product to be introduced. No. Medtronic diabetes has had their way with a technology of the combination of their two systems. I think this allows DexCom a hunting license not only on the new two pump therapy patients but as well to go after some of that install base of Medtronic's. But it is a limited, what I would consider to be a limited interruption, therefore limited revenue potential for DexCom.

不。我不會把太多收入期待放在與 DexCom 相關的部分。那是一個市場導入。我認為它讓 Animas 以及 DexCom——但它讓一個具高度競爭力的產品得以推出。不，Medtronic diabetes 一直以來在他們兩套系統的整合技術上占盡優勢。我認為這讓 DexCom 不僅能在新的胰島素幫浦治療患者上取得「狩獵執照」，也能去爭取 Medtronic 既有裝機基礎（install base）的一部分。但這是有限的——我會認為是有限的干擾，因此對 DexCom 的收入潛力也有限。

Okay. And sorry, just one last one. You know I appreciate the comments as well on kind of the changing reimbursement landscape, the insurance landscape for patients. That's changing some of the adoption, the rate of adoption of the technology. But have you seen any change in the time the patients are wearing sensors, if the deductibles are increasing or even the copays are increasing, are patients stretching out the time they're keeping sensors on?

好的。抱歉，最後一個問題。你提到給付環境、保險環境對患者正在改變，這也改變了技術採用的情況與採用速度。但你們有沒有看到患者配戴感測器的時間有任何變化？如果自付額（deductibles）增加，甚至共付額（copays）增加，患者是否會拉長感測器的使用時間？

No. They always do that. I mean that's just kind of the -- if you want to have an ah-ha moment as a Company, when we move to reimbursement originally we were certainly under the impression that once reimbursement was in place, patients would be less motivated to, quote, extend the life of the sensor beyond its labeled indication. That said, even patients that have zero deductible, they are 100% covered, oftentimes extend the use of it well beyond its indicated label indication and part of it is convenience, they don't have to change out the sensor but I think even more importantly is the fact that when they get to a certain point and it's still running strong, from that perspective they just say -- why would I want to change it at this point? I trust it. And I'm going to wear it until it actually begins to fail. Of course that's going to vary with each individual patient. But we're -- if anything we see patients using sensors and exchanging them more frequently in terms of the exchange where historically I think we also believe that a patient would wear it and take more holidays from wearing it. I think you see less of that today and that may stop one session and initiate the next session pretty quickly.

沒有。他們一直都會那樣做。我的意思是，這有點像——如果你想要公司出現一個「啊哈」時刻，當我們最初轉向給付時，我們確實以為一旦有了給付，患者就不會那麼有動機去——引用一下——把感測器的使用壽命延長到超過其標示適應症（labeled indication）。但話雖如此，即便是零自付額、100% 給付的患者，也常常把使用時間延長到遠超過其標示適應症；其中一部分是便利性，他們不必更換感測器，但我認為更重要的是，當他們用到某個時間點而它仍然運作良好時，從那個角度他們就會說——我為什麼要在這個時候換掉？我信任它。我會一直戴到它真的開始失效為止。當然這會因每位患者而異。但我們——如果有任何趨勢的話——看到患者在使用感測器並更頻繁地更換它們；過去我們也曾認為患者會戴一段時間，然後在配戴上會有更多「休假」（holidays）。我認為現在這種情況變少了，他們可能結束一個 session 後，很快就開始下一個 session。

So, in a sense despite the economic challenges that may be emerging because of the insurance landscape changing, you're not seeing any change in the way patients are using the technology?

所以某種程度上，儘管保險環境變化可能帶來的經濟挑戰正在浮現，你們並沒有看到患者使用這項技術的方式有任何改變？

No. Once they're onboard and if you really look at it from the economic proposition, if they've met their deductible and patients with diabetes meet that fairly quickly in the first quarter of the year with all their diabetes supplies, not just sensors, there's less of an impact from an economic standpoint. The real impact on the insurance change and the increase in deductible is in starter kits. Not really on the sensor side of the business.

沒有。一旦他們開始使用，而且如果你真的從經濟命題來看，若他們已達到自付額門檻，而糖尿病患者通常在一年第一季就會因為所有糖尿病用品——不只是感測器——很快達到那個門檻，那麼從經濟角度的影響就比較小。保險變更與自付額提高的真正影響是在入門套組（starter kits），而不是在感測器這一端的業務。

Okay. Fair enough. Thank you.

好的。了解。謝謝。

The next question comes from Richard Lau from Wedbush. Please, go ahead.

下一個問題來自 Wedbush 的 Richard Lau。請繼續。

Hey, guys. Thanks for taking my question. A lot of them have been answered already. Can you maybe give us an update on the gen five development and maybe sort of performance you're seeing in the step down order or anything like that?

嗨，各位。謝謝讓我提問。很多問題已經被回答了。你們能否更新一下第五代（gen five）的開發進度，以及你們在 step down 病房的試驗中看到的表現或類似情況？

We're awfully excited about it is the easiest way to describe the results. It's not a huge number of patients. But it's more than a handful and we're able to subject those patients to a variety of the normal occurring drugs and stress factors that a patient undergoes in a step down ward. So, they're post-surgical. They've moved into still a monitored situation. They're still receiving analgesics and other concomitant medication and yet we're seeing an excellent single digit MARD type of results from a broad range of -- and these are in both patients with diabetes as well as non-diabetes patients. So, we're very encouraged as is the facilities that we're doing the work in. So, very excited about it.

用最簡單的方式形容，我們對此非常興奮。患者數量不是很大，但也不只是少數幾位；而且我們能讓這些患者在 step down 病房中經歷各種一般會出現的藥物與壓力因素。也就是說，他們是術後患者，已轉入仍受監測的環境；他們仍在接受止痛藥（analgesics）以及其他併用藥物（concomitant medication），但我們仍看到非常優異的結果——MARD 在個位數（single digit）——而且涵蓋很廣的範圍；這些結果同時出現在糖尿病患者與非糖尿病患者身上。因此我們非常受到鼓舞，進行研究的機構也同樣如此。所以我們非常興奮。

That's great. That's all for me. Thanks, guys.

太好了。我這邊就這些。謝謝各位。

The next question comes from Jonathan Block from SunTrust. Please, go ahead.

下一個問題來自 SunTrust 的 Jonathan Block。請繼續。

Thanks. Good afternoon. Most have been answered. But maybe just two or three quick ones. The first, and I apologize if I missed this -- Jess, did you give the sensor revenue numbers in terms of a percentage basis, what that was up either year over year or Q over Q?

謝謝。下午好。大多數問題都已被回答。不過我再快速問兩三個。第一個，如果我漏聽了先說抱歉——Jess，你有提供感測器收入的數字嗎？以百分比來看，年增或季增是多少？

We did not on this call.

我們在這通電話中沒有提供。

Is that a change you're going to make going forward?

這是你們未來要做的改變嗎？

To be honest with you we haven't really given that a lot of thought.

老實說，我們還沒有真的仔細想過這件事。

Okay. Alright. Just to shift, do R&D, a little bit lower than what we were looking for the R&D expense? I think you mentioned annualizing about $20 million for the year. Has that changed? Or is this going to be a little bit more backend weighted as you finalize some of these projects?

好的。好。再換個話題，研發（R&D）費用比我們預期的稍低一些？我想你提到全年年化大約 2,000 萬美元。這有改變嗎？還是說隨著你們完成其中一些專案，費用會比較偏向下半年（backend weighted）？

That holds true in terms of what we expect out of Q4 run rate of about $7 million a quarter. It was a little bit lower this quarter. It does fluctuate. It can fluctuate dramatically just depending on the number of trials we're running, the timing of those trials. In this quarter in particular, we had lower consulting dollars. I would expect something similar to what we announced previously which is about $7 million per quarter.

就我們對第四季（Q4）每季約700萬美元的執行率（run rate）預期而言，確實如此。本季略低一些。它確實會波動，而且會因為我們正在進行的試驗數量以及這些試驗的時點而出現大幅波動。尤其在本季，我們的顧問服務收入較低。我預期會與我們先前公告的水準相近，也就是每季約700萬美元。

Got it. Last two, Terry, maybe for you. The first one, just a clarification -- I remember you mentioned on some of the trials that will be published that DexCom was the exclusive. I'm sorry, were you guys the exclusive in the upcoming type two trial or was it a different one?

了解。最後兩個問題，Terry，可能想請教你。第一個是釐清一下——我記得你提到有些即將發表的試驗中，DexCom 是獨家使用者。不好意思，你們在即將進行的第二型糖尿病試驗中是獨家嗎？還是另一個試驗？

No. That's the one we were exclusive on. That was, by the way, just to frame the landscape, in an investigator initiated trial, they buy the product. This was not something that DexCom sponsored in any way. This particular principle investigator made the decision to conduct this trial and we were -- quite frankly we were not even apprised of his intent to do this until well after the trial was started. It is independent and randomized. But we were the exclusive CGM device used in that trial.

是的，就是那個我們是獨家的。順帶一提，為了讓大家了解背景，在研究者發起的試驗（investigator initiated trial）中，他們會購買產品。這並不是 DexCom 以任何方式贊助的。這位主要研究者（principal investigator）決定進行這項試驗，坦白說，直到試驗開始很久之後，我們才得知他有這個意圖。該試驗是獨立且隨機分派的。但在那項試驗中，使用的 CGM 裝置是我們獨家提供。

Okay. Great. And last one, anything on the competitive landscape, Terry? I know probably the other CGM guys are a ways away but maybe you can comment on what you're hearing from Medtronic and their light sensor OUS?

好的。很好。最後一個問題，Terry，關於競爭態勢有什麼看法嗎？我知道其他 CGM 業者可能還要一段時間，但也許你可以談談你從 Medtronic 那邊聽到的消息，以及他們在美國以外（OUS）的光學感測器？

Yes. Really I haven't heard much. Unfortunately in the European sector they are not obligated to publish data. We really don't know what the performance of that sensor is. If you look in the FDA requirements, we have to fulfill a certain format where you -- it has to be prospective. You have to demonstrate the range between 40 and 400 and they've got nomenclature that we have to follow so it's pretty easy to compare a Medtronic sensor to an Abbott sensor to a DexCom sensor. In this scenario we can't find anything in any of the published data other than what they've presented in an R&D format which is always somewhat questionable as together it was prospective or retrospective data and how they analyzed the data. So, until we either actually get it in our hands and do our own testing or we see a head to head competitive study done by an investigator or they get approval in the US, we're -- it's always subject to interpretation of how they've analyzed their data.

是的。其實我沒有聽到太多。不幸的是，在歐洲市場他們沒有義務公布數據。我們真的不知道那個感測器的表現如何。若看 FDA 的要求，我們必須符合特定格式——必須是前瞻性（prospective）的；必須證明量測範圍涵蓋 40 到 400；而且他們有我們必須遵循的命名規範（nomenclature），因此很容易把 Medtronic 的感測器、Abbott 的感測器與 DexCom 的感測器做比較。但在這種情況下，我們在任何已發表的資料中都找不到相關資訊，除了他們以研發（R&D）形式呈現的內容；而那種資料通常多少令人存疑，因為不清楚是前瞻性還是回溯性（retrospective）數據，以及他們如何分析數據。所以，除非我們實際拿到產品並自行測試，或看到由研究者進行的正面對決（head-to-head）競爭性研究，或他們在美國獲得核准，否則——這一切都取決於他們如何分析其數據，仍然有很大的解讀空間。

Understood. Thanks, guys. Very helpful.

了解。謝謝各位。非常有幫助。

The last question comes from Vivian Wohl from Kaufman Funds. Please, go ahead.

今天最後一個問題來自 Kaufman Funds 的 Vivian Wohl。請開始。

Hi, guys. So, since I'm last I'm not going to ask you to go through all 80 -- let me turn off my cell phone that's ringing. I won't ask you to go through all 80 plus studies that are listed on ClinicalTrials.gov for continuous glucose monitoring. But I am curious in Europe what the reimbursement environment looks like there for continuous glucose sensing? Do you have any color on the major markets in Europe that you'll be addressing?

嗨，各位。既然我是最後一位，我就不會請你們逐一說明在 ClinicalTrials.gov 上列出的 80 多項連續血糖監測研究——我先把正在響的手機關掉。我不會請你們把那 80 多項研究都講一遍。不過我很好奇，在歐洲，連續血糖感測（CGM）的給付／報銷（reimbursement）環境看起來如何？你們能否分享一下你們將要切入的歐洲主要市場的概況？

The only color I could ascribe to it would be grey from a standpoint of there are some local funds that do in fact reimburse for CGM. They're limited. So, from that standpoint I would characterize the CGM reimbursement landscape in Europe as probably what we were in 2007 and 2008. There's some reimbursement but it's limited. I think that's going to continue. I will say there's a lot of studies ongoing with the express intent to create portfolios in which to submit dossiers for reimbursement. We have some pending as well but I think at this point it's still a ways away.

我能給的「顏色」大概只能說是灰色：因為確實有一些地方性基金會對 CGM 進行給付，但範圍有限。因此，就這點而言，我會把歐洲的 CGM 給付態勢形容為大概相當於我們在 2007、2008 年的狀況：有一些給付，但很有限。我認為這種情況還會持續。我也要說，目前有很多研究正在進行，其明確目的就是建立資料組合，以便提交給付申請的檔案（dossiers）。我們也有一些正在等待中，但我認為就目前而言，距離全面到位仍還有一段路。

And Medtronic hasn't really paved the way there yet?

那 Medtronic 還沒有真正替那邊鋪路嗎？

No. Medtronic I think has seen the light and certainly are spending more of their effort on the area of glucose sensing because they recognize like I think all of your recognize that at some point as the VIBE comes into the marketplace, it's going to take market share as the both OUS and particularly in the US market and as well as the Insulet product here in the US next year. So, they've got to in order to kind of sustain their share or certainly revenue, they're going to have to make up the capitalization of their systems with -- I would assume with sensor revenue.

沒有。Medtronic 我想已經看清楚趨勢，並且確實把更多精力投入到血糖感測領域，因為他們認知到——就像我想你們各位也都認知到的——當 VIBE 進入市場後，無論是在美國以外（OUS）市場，尤其是在美國市場，都會搶走市占；此外，明年在美國還會有 Insulet 的產品。因此，他們為了維持其市占或至少維持營收，就必須透過——我推測是透過感測器營收——來補足其系統的資本化／變現（capitalization）。

So, they're going to have to get through that regulatory process much like all -- from the other competitive landscape, we monitor everything that we can to get all the scientific research meetings. We don't see anything that is alarming to us. Bayer demonstrated their sensor technology in London. The iSense technology. I think we all came away from that thinking they were further along in the development of that and they were the ones that quite frankly really I had been more worried about and now I'm less worried about.

所以，他們必須像其他人一樣走完那個法規審查流程。就其他競爭態勢而言，我們會監控所有能監控的資訊，參加各種科學研究會議。我們沒有看到任何讓我們感到警覺的事情。Bayer 在倫敦展示了他們的感測器技術，也就是 iSense 技術。我想我們看完後都覺得他們在那項技術的開發上沒有我們原先以為的那麼超前；而坦白說，他們才是我之前更擔心的對象，現在我反而沒那麼擔心了。

I don't see any disruptive technology out there that's anytime soon and I think with the FDA having the kinds of requirements and what we see as an opportunity to increase the standard with some of our technology that it's going to become even more difficult as a barrier to entry for existing competitors or even more importantly I think for anybody that wants to come up the ranks. The other comment I make is it's going to be really expensive. Three years ago, two years ago, PMA product was probably $150 million to get to commercialization, you can pretty much double that these days. So, I think that these privately financed companies are going to have to find deep pockets to support them through that -- the length and cost of a PMA process.

我看不到任何短期內會出現的顛覆性技術。而且我認為，隨著 FDA 提出這類要求，以及我們看到可透過部分技術提升標準的機會，對既有競爭者而言，甚至更重要的是對任何想要後進切入的公司而言，進入門檻只會變得更高。另一點是，成本會非常昂貴。三年前、兩年前，一個 PMA 產品要走到商業化可能需要約1.5億美元；如今基本上可以翻倍。我認為這些由私人資金支持的公司，必須找到資金非常雄厚的支持者，才能撐過——PMA 流程的時間與成本。

Thanks very much.

非常感謝。

That was the last question for today. Please go ahead with any final remarks.

以上是今天最後一個問題。請進行任何最後的結語。

Thank you. I just want to say DexCom is truly a remarkable Company blessed with talented people and we continue to add to that strength. As I look at our portfolio of products in the R&D pipeline, I'm proud to say that we own a leadership position in the CGM technology and that leadership position continues to grow. We are well positioned to address unmet needs on the most important fronts in both glucose monitoring and insulin delivery. Thank you.

謝謝。我只想說，DexCom 真的是一家非凡的公司，擁有才華洋溢的人才，我們也持續強化這項優勢。當我看著我們研發（R&D）產品線中的產品組合時，我很自豪地說，我們在 CGM 技術上擁有領導地位，而且這個領導地位仍在持續擴大。我們已做好充分準備，能在血糖監測與胰島素輸送這兩個最重要的面向上，滿足尚未被滿足的需求。謝謝。

Thank you for participating in the DexCom first quarter earnings release conference call. This concludes the conference for today. You may all disconnect at this time.

感謝您參與 DexCom 第一季財報發布電話會議。今天的會議到此結束。各位現在可以掛線。