德康醫療 (DXCM) 2012 Q4 法說會逐字稿

Welcome to the DexCom Fourth Quarter and Full Year 2012 Earnings Conference Call. (Operator instructions). I would now like to turn the call over to Terry Gregg. You may begin.

歡迎參加 DexCom 2012 年第四季暨全年財報電話會議。（接線員指示）。現在我想把電話交給 Terry Gregg。您可以開始了。

Thank you operator, and thanks for joining us today for our Q4 and Full Year 2012 Conference Call. I'm going to ask Steve Pacelli to go through the safe harbor statement. Steve?

謝謝接線員，也感謝各位今天加入我們的 2012 年第四季暨全年電話會議。我將請 Steve Pacelli 宣讀安全港聲明。Steve？

Sure, 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.

好的，謝謝 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，且僅以本聲明日期為準。

These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements, is detailed under Risk Factors and elsewhere in our annual report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC.

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 年報、Form 10-Q 季報以及其他向 SEC 提交的報告之「風險因素」及其他章節中詳述。

We undertake no obligation to update publicly or revise these forward-looking statements for any reason. Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash operating loss. This non-GAAP information is provided to enhance your overall understanding of our current financial performance.

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。此外，我們將就現金營運虧損討論若干未依 GAAP 編製的財務資訊。提供此非 GAAP 資訊旨在增進您對我們目前財務表現的整體理解。

The presentation of this additional information should not be considered an isolation or as a substitute for results or superior results prepared in accordance with GAAP. Terry?

呈列這些額外資訊不應被視為單獨使用，亦不應作為依 GAAP 編製之結果的替代，或被視為更優越的結果。Terry？

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

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

Our agenda for today's call is fairly typical. I will provide a brief update on our G4 PLATINUM launch activities. Kevin will review our detailed fourth quarter 2012 financial results and provide our customary operations update, and then I will offer some concluding thoughts.

今天電話會議的議程相當典型。我將簡要更新我們 G4 PLATINUM 的上市推動進展。Kevin 將檢視 2012 年第四季的詳細財務結果並提供我們慣例的營運更新，接著我會做一些結語。

As we discussed during our third quarter 2012 earnings call, on October 5, 2012, we received approval from the Food and Drug Administration to begin commercially marketing our fourth generation CGM system, the DexCom G4 PLATINUM Continuous Glucose Monitoring system.

如同我們在 2012 年第三季財報電話會議中所討論的，2012 年 10 月 5 日，我們獲得美國食品藥物管理局核准，開始商業化行銷我們第四代 CGM 系統——DexCom G4 PLATINUM 連續血糖監測系統。

The US launch of G4 PLATINUM has generated a higher level of excitement among patients, partners and physicians, than any of our previous commercial launches. We began taking orders for G4 PLATINUM immediately upon approval and we completed our initial G4 PLATINUM shipments to patients before the end of October 2012. While our initial focus was on processing orders for new patients, we also successfully upgraded a fair number of existing SEVEN PLUS users to the G4 PLATINUM in Q4.

G4 PLATINUM 在美國上市所引發的興奮程度，超過我們以往任何一次商業上市，患者、合作夥伴與醫師皆反應熱烈。我們在核准後立即開始接受 G4 PLATINUM 訂單，並在 2012 年 10 月底前完成首批對患者的出貨。雖然我們初期重點放在處理新患者訂單，但我們也在第四季成功將相當數量的既有 SEVEN PLUS 使用者升級至 G4 PLATINUM。

Also during Q4, approximately 60% to 65% of PLATINUM starter kits shipped went to new patients, while the balance went to existing SEVEN PLUS patients including patients who took advantage of our $399 in-warranty upgrade promotion, patients who purchased the SEVEN PLUS in September 2012 who were entitled to a free upgrade, and SEVEN PLUS patients who were out of warranty and were processed through normal reimbursement channels.

同樣在第四季，出貨的 PLATINUM 入門套件約有 60% 至 65% 提供給新患者，其餘則提供給既有 SEVEN PLUS 患者，包括利用我們 399 美元保固內升級促銷方案的患者、於 2012 年 9 月購買 SEVEN PLUS 且享有免費升級資格的患者，以及已過保並透過一般給付/報銷流程處理的 SEVEN PLUS 患者。

To add some color to the new patients, I note that we had a 50% increase in kits shipped to new patients in Q4 2012, versus Q4 2011, and we sold more kits to new patients in the US alone in Q4 2012 than the total number of kits we sold in Q4 2011.

為了讓各位更了解新患者的情況，我補充說明：2012 年第四季出貨給新患者的套件數，較 2011 年第四季增加 50%；而且僅在美國市場，2012 年第四季賣給新患者的套件總數，就已超過我們在 2011 年第四季所售出的套件總量。

The commercial introduction of G4 PLATINUM continues to exceed our expectations. Our pipeline of new patient opportunities remains robust. Call volumes into customer service remain strong, and in spite of typical first-quarter seasonality, first quarter sales through late February have been solid.

G4 PLATINUM 的商業導入持續超出我們的預期。我們的新患者商機管線仍然強勁。客服來電量維持高檔，且儘管第一季通常具有季節性因素，截至 2 月下旬的第一季銷售表現依然穩健。

More than ever, we believe G4 PLATINUM sets a new standard for sensor performance. It is the most accurate and reliable continuous glucose sensor ever commercialized, and we believe this system will accelerate category adoption of CGM.

我們比以往任何時候都更相信，G4 PLATINUM 為感測器效能樹立了新標準。它是迄今商業化的最精準且最可靠的連續血糖感測器，我們相信此系統將加速 CGM 類別的採用。

Now, before I turn the call over to Kevin Sayer, I'm pleased to share that we have yet again delivered on a significant operational milestone at DexCom. Just this week, we received approval of an expanded indication for our CE mark to include pediatric patients and expect to update our product labeling and begin marketing to pediatric patients in Europe before the end of Q1.

在我把電話交給 Kevin Sayer 之前，我很高興分享 DexCom 再次達成一項重要的營運里程碑。就在本週，我們獲得 CE 標誌擴大適應症的核准，納入兒科患者，並預期在第一季末前更新產品標示，並在歐洲開始向兒科患者行銷。

Additionally, as promised, we have filed a PMA supplement with the Food and Drug Administration seeking a pediatric indication for the G4 PLATINUM here in the US.

此外，如同我們所承諾的，我們已向美國食品藥物管理局提交 PMA 補充申請，尋求在美國為 G4 PLATINUM 取得兒科適應症。

I would like to acknowledge the hard work of the people at DexCom, particularly our outstanding clinical and regulatory teams who have taken us one step closer to enabling DexCom to care for all people with diabetes. And with that, I would like to turn the call over to Kevin Sayer.

我想肯定 DexCom 團隊的辛勤付出，特別是我們傑出的臨床與法規團隊，讓我們更接近實現 DexCom 能照護所有糖尿病患者的目標。接下來，我想把電話交給 Kevin Sayer。

Thank you, Terry. I'll start with the financial updates. DexCom generated $31.7 million in product revenue for the fourth quarter of 2012, compared to $20.9 million for the same quarter in 2011, a $10.8 million or 52% increase. We note the product revenue for Q4 includes a $1.2 million reversal of a sales returns reserve we recorded in Q3 relating to our 30-day money back guarantee on DexCom hardware, or the so-called September patients.

謝謝你，Terry。我先從財務更新開始。DexCom 2012 年第四季產品營收為 3,170 萬美元，較 2011 年同期的 2,090 萬美元增加 1,080 萬美元，增幅 52%。我們指出，第四季的產品營收包含一筆 120 萬美元的銷售退貨準備回轉，該準備於第三季提列，與我們針對 DexCom 硬體提供的 30 天退款保證（亦即所謂的「9 月患者」）相關。

Sequentially, product revenue for Q4 of 2012 increased 50% from the prior quarter. As we stated in the G4 PLATINUM approval call we held in October 2012, we believe that many purchase decisions during Q3 were deferred as patients and healthcare providers anticipated the G4 PLATINUM introduction. While we believe this may have led to additional demand in Q4, as Terry mentioned in his remarks, we continue to see strong demand for G4 PLATINUM in the first quarter of 2013.

以季比季來看，2012 年第四季產品營收較前一季增加 50%。如同我們在 2012 年 10 月舉行的 G4 PLATINUM 核准電話會議中所述，我們認為第三季期間，因患者與醫療照護提供者預期 G4 PLATINUM 將推出，許多購買決策被延後。雖然我們相信這可能帶動第四季的額外需求，但如 Terry 在發言中提到的，我們在 2013 年第一季仍持續看到對 G4 PLATINUM 的強勁需求。

Total revenue for the fourth quarter of 2012 was $33.3 million, compared to $22.4 million during the same quarter in 2011. Our product gross profit totaled $17.2 million, generating a product gross margin of 54% for Q4 2012 compared to a product gross profit of $10.2 million and a product gross margin of 49% for the same quarter in the prior year.

2012 年第四季總營收為 3,330 萬美元，較 2011 年同期的 2,240 萬美元增加。我們的產品毛利合計 1,720 萬美元，使 2012 年第四季產品毛利率達 54%；相較之下，前一年同期產品毛利為 1,020 萬美元、產品毛利率為 49%。

Please note the product gross margin in Q4 2012 was affected by a number of factors related to our G4 PLATINUM launch, including the impact of our $399 in-warranty upgrade program, manufacturing scale-up activities for G4 PLATINUM, extremely high manufacturing and sales volumes, early-stage production yields, and the continued support of our SEVEN PLUS sensor manufacturing operations.

請注意，2012 年第四季的產品毛利率受到多項與 G4 PLATINUM 上市相關因素影響，包括 399 美元保固內升級方案的影響、G4 PLATINUM 的製造擴產活動、極高的製造與銷售量、初期生產良率，以及持續支援 SEVEN PLUS 感測器製造營運。

Some final thoughts on our product revenues and our gross profits during Q4. Our split between consumable and durable revenues was slightly more heavily weighted to durables in Q4 due to the G4 PLATINUM launch, with approximately 32% of our product revenues generated by sales of G4 PLATINUM hardware and approximately 68% generated by sales of both SEVEN PLUS and G4 PLATINUM sensors. [AFP] for sensors remained constant while the [ASP] for our hardware was negatively affected by our $399 in-warranty upgrade program.

最後補充一些關於第四季產品營收與毛利的看法。由於 G4 PLATINUM 上市，我們在第四季的耗材與耐用品營收結構略偏向耐用品：約 32% 的產品營收來自 G4 PLATINUM 硬體銷售，約 68% 來自 SEVEN PLUS 與 G4 PLATINUM 感測器的銷售。感測器的 [AFP] 維持不變，而我們硬體的 [ASP] 則因 399 美元保固內升級方案而受到負面影響。

Our international business continued to perform well in Q4, accounting for between 5% and 10% of our product revenues. However, the US launch of G4 PLATINUM somewhat overshadowed our consistent OUS growth.

我們的國際業務在第四季持續表現良好，約占我們產品營收的 5% 至 10%。然而，G4 PLATINUM 在美國的上市在某種程度上掩蓋了我們一貫穩定的美國以外（OUS）成長。

Research and Development expense totaled $8.7 million for Q4 of 2012, compared to $9.2 million in Q4 2011, and the decrease primarily resulting from lower clinical trial costs and lower G4 development expenses. Sequentially we are pleased to report that R&D expense was down 18% as a result of similar factors -- lower clinical trial costs, reduced Gen 4 development expenses, and reduced outside consulting services.

2012 年第四季研發費用合計 870 萬美元，較 2011 年第四季的 920 萬美元下降；下降主要來自臨床試驗成本降低以及 G4 開發費用降低。以季比季來看，我們也很高興報告研發費用下降 18%，原因同樣包括臨床試驗成本降低、第四代（Gen 4）開發費用減少，以及外部顧問服務減少。

As we move into 2013, we expect that R&D expense for the full year would be relatively flat versus 2012. Much will depend upon our timelines and opportunities with the FDA. With the pediatric PMA supplement on file, our R&D focus this year will be on the Animas and Tandem PMA filings and subsequent product approvals, mobile and cloud-based data platforms, continued system performance improvements, all of the elements of our Gen 5 CGM system and early-stage research on the Gen 6 sensor.

隨著我們邁入 2013 年，我們預期全年研發（R&D）費用相較於 2012 年將大致持平。實際情況在很大程度上將取決於我們與 FDA 的時程與機會。由於兒科 PMA 補充申請已提交在案，我們今年的研發重點將放在 Animas 與 Tandem 的 PMA 申請及後續產品核准、行動與雲端資料平台、持續的系統效能改善、我們第 5 代（Gen 5）CGM 系統的所有要素，以及第 6 代（Gen 6）感測器的早期階段研究。

Selling, General and Administrative expense totaled $17.2 million in Q4 2012, compared to $13.7 million during the same quarter of 2011. The increase primarily related to sales, marketing and information technology costs to support revenue growth.

2012 年第四季的銷售、一般及行政（SG&A）費用合計為 1,720 萬美元，較 2011 年同期的 1,370 萬美元增加。增加主要與支援營收成長所需的銷售、行銷及資訊科技成本有關。

A little more detail on the increase, of the $3.5 million increase in SG&A, $500,000 of it centered in non-cash, share-based compensation. The remaining increase was related to G4 PLATINUM launch costs. Increased variable sales costs related to our 50%-plus revenue growth, both sequentially and over 2011, and marketing information technology costs to support this revenue growth.

就增加部分再補充一些細節：SG&A 增加的 350 萬美元中，有 50 萬美元集中在非現金的股份基礎給付（share-based compensation）。其餘增加則與 G4 PLATINUM 上市（launch）成本有關。另有因我們營收成長超過 50%（無論是較前一季或較 2011 年）而增加的變動性銷售成本，以及為支援此營收成長所需的行銷與資訊科技成本。

As we look at Fiscal 2013, we do anticipate an increase in SG&A expense of up to 20% to support our growth. While G&A will increase moderately, we intend to invest in the sales and marketing side of our business. Earlier this month, we commenced a reorganization of our US field team. We have increased the number of US sales territories from 48 to 68, and we've consolidated what was previously a tiered model with multiple sales reps and field-based clinical support staff sharing larger territories, into a flat structure with a single sales rep solely responsible for a much smaller territory.

展望 2013 會計年度，我們確實預期 SG&A 費用將增加，增幅最高可達 20%，以支援我們的成長。雖然一般及行政（G&A）將溫和增加，但我們打算在業務的銷售與行銷端加大投資。本月稍早，我們啟動了美國外勤團隊的重整。我們已將美國銷售區域數量由 48 個增加至 68 個，並把先前的分層模式（多位業務代表與外勤臨床支援人員共同負責較大區域）整併為扁平化架構，由單一業務代表全權負責更小的區域。

Our clinical support team will no longer be field-based, but instead will be redeployed on phone lines and on computers as part of our DexCom Care Initiative, proactively reaching out to patients on predefined schedules to improve patient experience while also working to increase sensory utilization and patient retention.

我們的臨床支援團隊將不再採外勤配置，而是改為透過電話與電腦重新部署，作為我們 DexCom Care Initiative 的一部分，依預先設定的時程主動聯繫病患，以提升病患體驗，同時也致力於提高感測器使用率與病患留存。

As we have discussed on numerous occasions, most of our patients are trained using DexCom support resources including our online tools, in combination with support from their healthcare professionals and our technical support center. So, with smaller territories, we believe our sales reps will have the bandwidth to handle local training issues where necessary.

如同我們多次討論過的，我們多數病患的訓練是透過 DexCom 的支援資源（包括線上工具），並結合其醫療專業人員與我們技術支援中心的協助來完成。因此，在區域更小的情況下，我們相信業務代表將有足夠的量能在必要時處理在地訓練相關問題。

Upon completion of this reorganization, we will have expanded head count in our sales organization including non-field-based clinical support, by approximately 15%. We expect this reorganization to be completed by early Q2 2013.

完成此次重整後，我們的銷售組織（包含非外勤的臨床支援）人數將擴編約 15%。我們預期此重整將於 2013 年第二季初完成。

Our net loss for the fourth quarter 2012 totaled $8.5 million, including $6.3 million in non-cash expenses centered in share-based compensation, depreciation and amortization. Absent these non-cash charges, our net loss for Q4 2012 would have been $2.2 million.

2012 年第四季的淨損合計為 850 萬美元，其中包含 630 萬美元的非現金費用，主要為股份基礎給付、折舊與攤銷。若排除這些非現金費用，2012 年第四季的淨損將為 220 萬美元。

Compare this cash operating loss of $2.2 million to a cash operating loss of $9.8 million in the prior quarter and a cash operating loss of $7.2 million in Q4 2011. It's easy to understand our belief that we can in fact move our current business model to profitability with increased volumes. Our loss per share for the quarter was $0.12. With respect to our balance sheet, we ended the quarter with $48.7 million in cash and marketable securities, down $4.7 million from Q3. As we stated during our last call, we had significant working capital needs during Q4. As our receivables increased over $7 million from Q3, we had capital expenditures of another $1.4 million and we paid down our approximately $2 million in accruals in conjunction with year-end.

將這 220 萬美元的現金營運虧損與前一季 980 萬美元的現金營運虧損，以及 2011 年第四季 720 萬美元的現金營運虧損相比，就不難理解我們為何相信：隨著出貨量增加，我們確實能讓目前的商業模式轉為獲利。本季每股虧損為 0.12 美元。就資產負債表而言，本季末我們持有的現金及有價證券為 4,870 萬美元，較第三季減少 470 萬美元。如同我們在上次電話會議所述，第四季我們有顯著的營運資金需求。由於應收帳款較第三季增加逾 700 萬美元，我們另有 140 萬美元的資本支出，並在年終時配合結帳償付約 200 萬美元的應計項目。

Finally, as we disclosed on Form 8-K during our prepared remarks at the JPMorgan conference in January, our product revenue guidance for 2013 is $120 million to $130 million.

最後，如同我們在 1 月 JPMorgan 會議的事先準備發言中，於 Form 8-K 所揭露的，我們 2013 年的產品營收指引為 1.2 億至 1.3 億美元。

Now for a business update, turning to our product pipeline, as Terry stated earlier, we filed a PMA supplement with the Food and Drug Administration seeking a pediatric indication for the G4 PLATINUM, and we have received CE Mark approval for pediatric patients and expect to be in marketing to pediatric patients in Europe before the end of Q1.

接著提供業務更新，轉向我們的產品研發管線。如 Terry 先前所述，我們已向美國食品藥物管理局（FDA）提交 PMA 補充申請，尋求 G4 PLATINUM 的兒科適應症；同時我們已取得針對兒科病患的 CE Mark 核准，並預期在第一季末前於歐洲開始對兒科病患進行行銷。

We remain extremely excited about the prospect of a pediatric indication, as it not only significantly expands the number of endocrinologists we can call on in the US, we expect to be able to recommend our technology to patients as young as two years old which would be a first for CGM.

我們對取得兒科適應症的前景仍感到非常振奮，因為這不僅能大幅擴大我們在美國可拜訪的內分泌科醫師數量，我們也預期能將我們的技術推薦給年僅兩歲的病患，這將是連續血糖監測（CGM）領域的首例。

Our future generation products are very much geared towards this market segment. On the international front, we expect approval in Canada and India shortly, and we continue to explore opportunities in China, Japan and other Asian geographies. We continue with development of the Gen 5 system working on an improved applicator, combined with a mobile phone interface. We continue to have discussions with the FDA on this front and believe that DexCom is in a very strong position to become the first Class III Medical Device to communicate directly to a mobile platform.

我們的下一代產品在很大程度上是針對此市場區隔而設計。在國際方面，我們預期不久將取得加拿大與印度的核准，並持續探索中國、日本及其他亞洲地區的機會。我們持續開發第 5 代（Gen 5）系統，著手改良施用器（applicator），並結合手機介面。我們也持續就此與 FDA 討論，並相信 DexCom 具備非常有利的條件，成為第一個可直接與行動平台通訊的第三類（Class III）醫療器材。

Shifting to our integration partners, Animas continues to commercialize the Animas Vibe System in Europe, and in its recent earnings call Johnson & Johnson disclosed that in markets where Animas Vibe is commercial in Europe, they have seen 35% to 50% average sales growth compared to markets where the product has not let launched.

轉向我們的整合合作夥伴，Animas 持續在歐洲商業化 Animas Vibe 系統；而在其近期財報電話會議中，Johnson & Johnson 揭露，在歐洲已商業化 Animas Vibe 的市場，其平均銷售成長率較尚未上市的市場高出 35% 至 50%。

With regards to filing for US approval of the Animas Vibe, all development work and systems testing is complete and we are working diligently with Animas to finalize their PMA application to be submitted before the end of this quarter.

關於 Animas Vibe 在美國的核准申請，所有開發工作與系統測試均已完成，我們正與 Animas 積極合作，完成其 PMA 申請文件，並將於本季末前提交。

We are pleased to note that we reached an agreement with our newest partner, Tandem Diabetes Care, to accelerate our development efforts, and we will be incorporating the G4 PLATINUM into the Tandem system. We expect development to continue through 2013 and hope to be in a position to assist Tandem in filing a PMA with the Food and Drug Administration before the end of the year.

我們很高興指出，我們已與最新合作夥伴 Tandem Diabetes Care 達成協議，以加速我們的開發工作，並將把 G4 PLATINUM 整合至 Tandem 系統中。我們預期開發將持續至 2013 年，並希望在年底前能協助 Tandem 向美國食品藥物管理局（FDA）提交 PMA 申請。

Regarding our relationship with Insulet, as many of you are aware, Insulet announced during its presentation at the recent JPMorgan conference in San Francisco that it was seeking to partner with a to-be-named glucose sensor company in an effort to physically integrate a continuous sensor directly into the disposable pod, in addition to displaying CGM data on the insulin handheld device.

關於我們與 Insulet 的關係，如各位所知，Insulet 在近期於舊金山舉行的 JPMorgan 會議簡報中宣布，正尋求與一家尚未具名的葡萄糖感測器公司合作，目標是將連續感測器在實體上直接整合到一次性 pod 中，並在胰島素手持裝置上顯示 CGM 資料。

A couple of things have changed since we entered into our original agreement with Insulet. First, we have made significant progress in moving our CGM display directly to a phone. Both companies believe the display of CGM data on a patient's smartphone significantly reduces the market impact of displaying data on the pod handheld. This is different from a durable pump like Animas or Tandem products, where the device remains continuously tethered to the patient.

自我們與 Insulet 簽訂原始協議以來，有幾件事已經改變。第一，我們在將 CGM 顯示直接移轉到手機方面已取得重大進展。兩家公司都認為，在病患智慧型手機上顯示 CGM 資料，將大幅降低在 pod 手持裝置上顯示資料的市場影響。這與 Animas 或 Tandem 這類耐用型幫浦不同，因為該裝置會持續與病患連結。

Second, the physical integration that Insulet intends to pursue would present several problems for DexCom. An integration of this nature would require the transfer of much of our sensor intellectual property and know-how to Insulet so these combination devices could be manufactured. We would then have to determine how to share patients and the resulting revenues in the combination products. And finally, and perhaps most important, DexCom is working to develop a sensor that will last 10 to 14 days, so integrating our technology into three-to-four-day disposable doesn't make economic sense for us as it will cost us the same to manufacture a three-day sensor as a ten-day sensor.

第二，Insulet 擬採行的實體整合方式，對 DexCom 而言會帶來數個問題。此類整合將需要把我們大量的感測器智慧財產與專業技術（know-how）移轉給 Insulet，才能製造這些組合式裝置。接著我們還必須決定如何在組合產品中分配病患與由此產生的營收。最後且或許最重要的是，DexCom 正在開發可使用 10 至 14 天的感測器，因此把我們的技術整合到 3 至 4 天即丟棄的一次性產品中，對我們而言在經濟上並不合理，因為製造 3 天感測器的成本與 10 天感測器相同。

While we've not formally terminated our contract, the integration path chosen by Insulet effectively ends our relationship and we wish them well.

雖然我們尚未正式終止合約，但 Insulet 所選擇的整合路徑實質上結束了我們的合作關係，我們也祝福他們一切順利。

Turning to our development partnership with Roche, as we've discussed previously, Roche has spent the past several months evaluating the feasibility of incorporating G4 PLATINUM into their next-generation handheld diabetes management system. Roche recently concluded that the incremental expense associated with doing so could not be justified from a time-to-market perspective, particularly in light of our Gen 5 timelines.

轉向我們與 Roche 的開發合作夥伴關係，如同先前所討論，Roche 在過去數個月評估將 G4 PLATINUM 納入其下一代手持式糖尿病管理系統的可行性。Roche 近期得出結論，從上市時程（time-to-market）的角度來看，為此所需增加的費用無法合理化，特別是在我們第 5 代（Gen 5）時程的背景下。

Like Insulet, Roche also understands that as DexCom's hardware platform shifts directly to direct display on a smartphone, the value of integrating Gen 5 into a future Roche handheld device is much less meaningful as patients who will opt for CGM display on the phone.

如同 Insulet，Roche 也理解，隨著 DexCom 的硬體平台轉向直接在智慧型手機上顯示，將 Gen 5 整合到未來 Roche 手持裝置中的價值就小得多，因為患者會選擇在手機上顯示 CGM。

For these reasons, together with the fact that Roche and all other SMBG companies are looking at a very challenging diabetes marketplace with respect to pricing pressure and decreasing reimbursement, as a result of competitive bidding, Roche has made the decision not to move forward with Gen 5 integration at this time and will instead focus resources on their core business.

基於上述原因，再加上 Roche 及所有其他 SMBG 公司正面臨糖尿病市場在價格壓力與給付下降方面的嚴峻挑戰（競標採購所致），Roche 已決定目前不推進 Gen 5 的整合，而是將資源聚焦於其核心業務。

Our overall relationship with Roche remains very strong, as Roche is a very strong distribution partner in many of our international geographies, and we continue to explore future distribution collaborations with them.

我們與 Roche 的整體合作關係仍然非常穩固；Roche 在我們許多國際市場中是非常強的通路合作夥伴，我們也持續與其探索未來的通路合作機會。

Finally, on the Edwards front, we are very pleased to announce our second generation GlucoClear system has received CE Mark. While we don't expect significant sales this year, we expect 2013 to be a pivotal year as Edwards completes additional accuracy studies in Europe and obtains greater clarity on the pathway towards US approval. We remain enthusiastic about the significant breakout opportunity represented by this technology and look forward to supporting Edwards as they bring our best-in-class sensor technology to the critical care setting.

最後，在 Edwards 方面，我們非常高興宣布第二代 GlucoClear 系統已取得 CE 認證。雖然我們預期今年不會有顯著銷售，但我們預期 2013 年將是關鍵的一年，因為 Edwards 將在歐洲完成更多準確度研究，並對取得美國核准的途徑獲得更清晰的方向。我們仍對這項技術所代表的重大突破機會感到振奮，並期待在 Edwards 將我們同級最佳的感測器技術帶入重症照護場域時提供支持。

I would now like to turn the call back over to Terry for some concluding remarks.

現在我想把電話會議交回 Terry，請他做一些結語。

Thanks, Kevin. I'd like to start by highlighting our Q4 financial performance. Product revenue clearly exceeded our expectations in the quarter, but I am equally pleased by our operating performance.

謝謝你，Kevin。我想先強調我們第四季的財務表現。本季產品營收明顯超出我們的預期，但我對我們的營運表現同樣感到滿意。

As you know, our Board set a stretch goal for us to reach cash operating break-even during Q4 of 2012. We got within $2.2 million of that goal, in spite of a number of unanticipated expenses during 2012, such as costs related to our SweetSpot acquisition, costs related to advancing our mobile platform, and costs associated with an earlier-than-expected G4 PLATINUM product launch, none of which were contemplated in our original budget.

如各位所知，我們董事會為我們設定了在 2012 年第四季達到現金營運損益兩平的挑戰性目標。我們距離該目標僅差 220 萬美元，儘管 2012 年出現多項未預期費用，例如與 SweetSpot 收購相關的成本、推進行動平台的成本，以及 G4 PLATINUM 產品較預期更早上市所帶來的成本，而這些在我們原始預算中都未被納入。

Needless to say, I am excited by the long-term profitability profile we believe we can achieve here at DexCom.

不用說，我對我們相信在 DexCom 能夠達成的長期獲利能力輪廓感到非常振奮。

Now, in terms of our messaging for 2013, this is the year we put CGM first. We have long said that to effectively treat diabetes, you must know where you are going before you can figure out how to get there. We believe CGM is the first tool that should be used in any treatment approach.

接著，就我們 2013 年的訊息而言，今年是我們把 CGM 放在第一位的一年。我們長期以來一直說，要有效治療糖尿病，你必須先知道你要去哪裡，才能弄清楚如何到達。我們相信 CGM 應該是任何治療策略中首先使用的工具。

For newly-diagnosed patients, how does the doctor decide appropriate insulin dosage without understanding the patient's glucose profile? For all insulin-taking patients, the method of insulin delivery is not nearly as important as knowing when to dose and how much insulin to take. And for all people with diabetes, clinical data support the potential benefit of CGM for titration of insulin, oral medications, lifestyle changes such as changes to diet or exercise routine.

對於新診斷的患者，若不了解患者的葡萄糖曲線，醫師要如何決定適當的胰島素劑量？對所有使用胰島素的患者而言，胰島素的給藥方式遠不如知道何時給藥以及該打多少胰島素來得重要。而對所有糖尿病患者，臨床數據支持 CGM 在胰島素、口服藥物的劑量調整，以及生活型態改變（例如飲食或運動習慣調整）方面可能帶來的效益。

We believe CGM will become the first line of therapy for all insulin-taking patients, and one day for all diabetes patients.

我們相信 CGM 將成為所有使用胰島素患者的一線治療，並且有一天會擴及所有糖尿病患者。

Turning to our pipeline, we are obviously very excited about the prospects of bringing G4 PLATINUM to the pediatric community. Today, pediatric patients represent only about 10% to 15% of our install base, and with an estimated 300,000 to 400,000 people with Type 1 Diabetes in the US alone who are under the age of 18, we think this is an extremely important growth opportunity for the Company.

談到我們的產品管線，我們顯然對將 G4 PLATINUM 帶入兒科族群的前景感到非常興奮。目前兒科患者僅約占我們裝機基礎的 10% 到 15%；而僅在美國就估計有 30 萬到 40 萬名 18 歲以下的第一型糖尿病患者，我們認為這對公司而言是極其重要的成長機會。

In fact, as we studied the pediatric opportunity and the unique challenges faced by parents managing a child with Type 1 Diabetes, a new product concept was born. The DexCom Share System. So, the DexCom Share System will be a docking station for the G4 PLATINUM receiver, enabling the wireless transmission of glucose information such as the patient's trend graph and alert notifications from the G4 PLATINUM to designated recipients, allowing the recipient to view the patient's data on a smartphone.

事實上，當我們研究兒科機會以及家長在管理第一型糖尿病孩子時所面臨的獨特挑戰時，一個新的產品概念誕生了：DexCom Share 系統。因此，DexCom Share 系統將是 G4 PLATINUM 接收器的底座（docking station），可讓葡萄糖資訊（例如患者的趨勢圖與警示通知）從 G4 PLATINUM 以無線方式傳送給指定接收者，使接收者能在智慧型手機上查看患者資料。

For example, a parent can receive glucose information during the night time, while the child sleeps in another room. During the school day, while the parent is at work, or even for non-pediatric applications such as for a spouse while at work or when traveling. So, when I'm asked, what is DexCom Share, my response is straight forward. Share is not waking up at 3.00 am to take your finger stick from your child. The freedom to finally allow your child to sleep over at his or her friend's house, not worrying when your spouse is away on a business trip.

例如，孩子在另一個房間睡覺時，家長可以在夜間接收葡萄糖資訊；在上學日，家長在工作時也可以；甚至也適用於非兒科情境，例如配偶在上班或出差旅行時。因此，當有人問我 DexCom Share 是什麼，我的回答很直接：Share 就是不必在凌晨 3 點起床替孩子扎手指測血糖；是終於能讓孩子去朋友家過夜的自由；是不必在配偶出差時擔心。

The idea is simple. Connecting DexCom users to the people who care about them. We expect to file the DexCom Share System with the FDA in the third quarter of this year.

這個想法很簡單：把 DexCom 使用者與關心他們的人連結起來。我們預期在今年第三季向 FDA 提交 DexCom Share 系統的申請。

Now, I'd like to conclude with some market commentary regarding the G4 PLATINUM. While the general feedback from patients and healthcare providers has been nothing short of remarkable, we have seen three recurring points of praise. First, its accuracy. The sensor is 20% more accurate from [400] to 400 milligrams of detection, 30% more accurate in the 70 milligrams and below area of hypoglycemia detection. Second, it's range of connectivity. The SEVEN PLUS had somewhere between five and eight feet of connectivity. While the G4 PLATINUM is labeled for 20 feet, we're hearing it's closer to 50 feet, especially in line of sight.

現在，我想以一些關於 G4 PLATINUM 的市場評論作結。雖然患者與醫療照護提供者的整體回饋可說是非常驚艷，但我們看到三個反覆出現的稱讚點。第一是準確度：在 [400] 到 400 mg 的偵測範圍內，感測器準確度提升 20%；在 70 mg 及以下的低血糖偵測區間，準確度提升 30%。第二是連線距離：SEVEN PLUS 的連線距離大約在 5 到 8 英尺之間；而 G4 PLATINUM 標示為 20 英尺，但我們聽到的回饋更接近 50 英尺，尤其在視線可及（line of sight）的情況下。

So, if you think about a patient's mobility at home, the patient might be able to leave it on a nightstand, go down to the kitchen, come back up, and not lose any data packets. Third, is its size. Do you know it's about one-third the size of the old receiver, so the patient can slip it into a pocket, or put it into a purse.

因此，如果你想想患者在家中的活動性，患者可能把接收器放在床頭櫃上，走到樓下廚房再回到樓上，也不會遺失任何資料封包。第三是尺寸：你知道它大約只有舊接收器的三分之一大小，因此患者可以把它放進口袋，或放進手提包。

As I look back on my diabetes career, nearly 20 years ago I began my quest to develop a continuous glucose monitoring system, to meet the needs and expectations of all people with diabetes. Now four generations later, I truly believe we have delivered a product in the G4 PLATINUM with broad appeal and broad application that will continue to accelerate the growth of CGM as a category and DexCom as the market-leading [participate].

回顧我的糖尿病職涯，將近 20 年前我開始追求開發一套連續葡萄糖監測系統，以滿足所有糖尿病患者的需求與期待。如今歷經四代，我真心相信我們已透過 G4 PLATINUM 交付了一款具有廣泛吸引力與廣泛應用的產品，將持續加速 CGM 這一品類以及 DexCom 作為市場領先者的成長。

We will replace finger sticks. Not if, just when. Thank you, and we'll open it up for questions.

我們將取代指尖採血。不是會不會，而是何時。謝謝大家，接下來我們開放提問。

(Operator Instructions) Our first question comes from Ben Andrew from William Blair, please go ahead.

（接線員指示）我們的第一個問題來自 William Blair 的 Ben Andrew，請開始。

Good afternoon, gentlemen.

各位先生，下午好。

Hey, Ben.

嗨，Ben。

Hey, Ben.

嗨，Ben。

So Terry, two topics for me if you could, please. Talk a little bit more about the patient dynamics as you've gone through the launch, and how it's changing. You gave some statistics relative to the percent that were shipped on the new version and what-not, but can you give us a sense what the install base is, or any other metrics that we can use to kind of project forward from here?

Terry，我有兩個主題想請教。能否再多談一些你們在上市推進過程中看到的患者端動態，以及它如何在改變？你提供了一些關於新版本出貨占比等統計數據，但你能否讓我們了解一下裝機基礎（install base）是多少，或任何其他我們可以用來做後續推估的指標？

You know, we've never given direct install base. You guys all kind of make up your models, and quite frankly you're pretty good at that, so I don't think we'll help you out in that. That's what you get paid for, I think. I will say this -- the most interesting dynamic as you're preparing new models is the fact that we're seeing greater utilization of sensors in the G4 than we did with the SEVEN PLUS. And so, what does that mean? Are they using it more frequently? Possibly. Certainly I think there is a trust level with the accuracy of the technology, which is encouraging patients not to take as many holidays, possibly. But, we haven't, have all the metrics yet to analyze it as completely as we would like. But, that is one interesting thing that we're seeing post the launch and certainly moving into this first quarter.

你知道，我們從未直接公布裝機基礎。你們大家都會自己建立模型，坦白說你們做得相當不錯，所以我想我們就不幫你們做這件事了。我想那就是你們領薪水的原因。不過我會說——當你們在準備新模型時，最有趣的動態是：我們看到 G4 的感測器使用率比 SEVEN PLUS 更高。那代表什麼？他們使用得更頻繁嗎？有可能。我確實認為，對技術準確度的信任程度提高，正在鼓勵患者可能不要那麼常『放假』不用。但我們目前還沒有所有指標，能像我們希望的那樣完整分析。不過，這確實是我們在上市後、並且在進入第一季時所看到的一個有趣現象。

Okay, and is that, is it different in the newer patients than the patients who had been on Gen3 in that dynamic, or it's still too early to say?

好的，那在這個動態上，新患者與原本使用第三代（Gen3）的患者之間是否有差異，還是現在說還太早？

It's still too early to say. We haven't dialed down the metrics to that level yet, Ben.

現在下定論還太早。我們還沒有把指標細分到那個層級，Ben。

Okay, and then you talked about some changes in the field organization, and maybe give us a bit more detail there and what that will do through the P&L relative to kind of bringing more people on to, it appears like a commission basis, and hopefully driving more sales directly.

好的，接著你提到現場組織的一些變動，能否再多給我們一些細節，以及這會如何透過損益表（P&L）反映出來？尤其是看起來你們會以佣金制的方式引進更多人員，並希望能更直接地帶動銷售。

Yes, I'm going to have Kevin talk about that.

是的，我會請 Kevin 來談這部分。

Sure. You know Ben, as we look at our structure we just felt we needed more coverage, and we looked at, we had the field clinical sales team and as we look at how easy our product is to use, the fact that as I said earlier most of our patients train with our support materials, or online. We felt we could best deploy our resources in the field with feet on the street, so in essence we'll, as I said, we'll have 68 territories. We're also adding to the in-house team. We gave them a goal as to how much more they could spend. As I said, we won't spend more than 20% total on SG&A, but that will flow through the P&L. A little bit in the first quarter, more in the second and then you'll have the full throttle certainly for the entire third and fourth quarter, the variable expenses will go up obviously as they did this quarter, when we have a very successful quarter and sell a lot of product.

當然。Ben，你知道，當我們檢視我們的架構時，我們覺得需要更高的覆蓋率。我們看了現場臨床銷售團隊，也考量到我們的產品使用很容易；再加上如我先前所說，多數病患是透過我們的支援教材或線上完成訓練。我們認為最能在現場部署資源的方式，就是讓人員真正走上街頭、深入市場。所以本質上，如我所說，我們將會有 68 個銷售區域。我們也會擴編內勤團隊。我們給了他們一個目標，讓他們知道可以多花多少。如我所說，我們在銷售、一般及行政費用（SG&A）上的總支出不會超過 20%，但這會反映在損益表上。第一季會有一點，第二季會更多，第三、第四季則會全速運轉；而變動費用顯然會上升，就像本季一樣，當我們有非常成功的一季、賣出大量產品時。

Yes, I would only add to that, there's about somewhere between 800 and 1,000 pediatric endocrinologists that today we don't call on, and so part of this structure change and expansion was to give our sales reps the bandwidth to go call on that endocrinology group. The good news is that they tend to be centered in areas geographically that we can address it with the smaller territory without having to really expand more sales reps than moving from the 48 to the 68 territories.

是的，我只補充一點：目前大約有 800 到 1,000 位小兒內分泌科醫師我們還沒有拜訪到。因此，這次的架構調整與擴張，部分目的就是讓我們的業務代表有足夠的時間與量能去拜訪這個內分泌科族群。好消息是，他們多集中在我們可以用較小的銷售區域就能涵蓋的地理區域，因此我們不需要把業務人數擴張到超過從 48 個區域增加到 68 個區域所需的程度。

Okay, and then just briefly, extending on that point, when you—when you get the pediatric indication in the US and then bring on the Vibe, how should we think about the timing of those rollouts? Are those things that can step function quickly, or would they take some time to have an impact on patient adds? Thank you.

好的，接著簡短延伸一下：當你們在美國取得小兒適應症，然後再推出 Vibe 時，我們應該如何看待這些上市推廣的時程？這些是否能很快出現階梯式的成長，還是需要一些時間才會對新增病患數產生影響？謝謝。

Well Ben, we just launched a new product 20 days after it got approved, so when we get Pedes approval we'll roll it out pretty fast. When it comes to how it'll affect our numbers, we gave a range of $120 million to $130 million in revenue, and literally that range is, is kind of variable based upon Pedes approval. If we got no Pedes approval, that $120 [million] dollar number would be our target, or $125 million or something lower, and then Pedes takes us up into the higher end of that range.

Ben，我們在核准後 20 天就推出了新產品，所以當我們拿到小兒（Pedes）核准時，我們會很快推向市場。至於它會如何影響我們的數字，我們給出的營收區間是 1.2 億到 1.3 億美元，而這個區間其實就是會因小兒核准而有所變動。若沒有取得小兒核准，那 1.2 億美元會是我們的目標，或 1.25 億美元或更低一些；而小兒核准則會把我們推升到該區間的高端。

But new patients will jump on board pretty quickly with the Pedes approval. That will not be something we wait for. With Animas Vibe, that'll be a -- we think patients will find it pretty quickly. We know Animas will have very aggressive upgrade programs to get their patients to upgrade to stay on the Animas Vibe system. Some of those patients already use DexCom sensors, so we really haven't modeled a lot of that out and we don't have any of it in our 2013 numbers.

但在取得小兒核准後，新病患會很快加入。這不是我們會等待的事情。至於 Animas Vibe，我們認為病患也會很快注意到。我們知道 Animas 會有非常積極的升級方案，讓他們的病患升級以留在 Animas Vibe 系統上。其中一些病患已經在使用 DexCom 感測器，所以我們其實沒有把這部分做太多模型推估，而且在我們 2013 年的數字裡也沒有納入任何相關貢獻。

So, we'll give you more guidance on that, as the year goes on.

所以，隨著年度進展，我們會提供你更多指引。

Thank you.

謝謝。

Our next question comes from Bill Plovanic from Canaccord, please go ahead.

下一個問題來自 Canaccord 的 Bill Plovanic，請繼續。

Great, thanks, good evening. Can you hear me okay, gentlemen?

很好，謝謝，晚安。各位先生，你們聽得到我嗎？

We can, Bill.

聽得到，Bill。

Great. A couple of questions, first on gross margins. As you ramp up the manufacturing of this product, remind us, at this point what type of margins do you think you can hit on the disposables at scale and when is that at-scale time frame?

很好。幾個問題，先談毛利率。當你們擴大這個產品的製造時，提醒我們一下：以目前來看，你們認為耗材在達到規模化時可以做到什麼樣的毛利率？以及達到規模化的時間點大概是什麼時候？

Well, we've long maintained we can hit between 65% and 75% margins on these G4 disposables. That scale-up should really start to occur about the end of this year. The factors that will affect that, Bill, will be continuing to do our Gen 4 -- I mean excuse me, our SEVEN PLUS manufacturing line next door, so we still have to weigh those two things against each other. You know, I talked a bit about startup yields in my comments earlier for the fourth quarter. I can tell you the first quarter, our team is doing a spectacular job of getting yields much better than what we've targeted so kudos to those guys.

我們長期以來一直認為，這些 G4 耗材的毛利率可以達到 65% 到 75%。規模化的提升應該會在今年年底左右真正開始發生。會影響這點的因素，Bill，是我們仍會在隔壁持續運行第 4 代——我是說，不好意思，我們的 SEVEN PLUS 製造線，所以我們仍需在這兩者之間權衡。你知道，我先前在第四季的評論中談到一些啟動期良率。我可以告訴你，第一季我們的團隊表現非常出色，良率比我們的目標好很多，必須給他們肯定。

So, we think this process is much more robust than anything we've had for SEVEN PLUS, so that is something that will be a positive factor as well, so you know, we believe as we start hitting the end of this year we'll be getting close on our disposable margin targets. We certainly should be at the lower end of the 65% to 75% range anyway.

因此，我們認為這個製程比我們在 SEVEN PLUS 上用過的任何東西都更穩健，這也會是正面因素。所以我們相信，到了今年年底時，我們會接近耗材毛利率目標。至少我們應該能達到 65% 到 75% 區間的低端。

Okay, and you're still comfortable with that range to the higher end over time, now that you have a little experience?

好的，那麼現在有了一些經驗，你們仍然對這個區間、以及隨時間推進達到更高端的水準感到有信心嗎？

I'm more comfortable today than I've ever been, absolutely. I think Terry and Steve are, I say everybody else is, too. We're doing a very good job.

我今天比以往任何時候都更有信心，絕對是。我想 Terry 和 Steve 也是——我想其他人也是。我們做得非常好。

Okay, and then, congratulations. Then on R&D I think the one thing I didn't hear you talk about was the 10-day, and I was wondering if we could get some color on that?

好的，另外恭喜。接著談研發（R&D），我想有一件事我沒聽到你提到，就是 10 天（使用期），我想知道能否給我們一些說明？

You know what, our focus for next year will not be on the 10-day. Our filings for next year will be the things we talked about.

你知道嗎，我們明年的重點不會放在 10 天。我們明年的申報會是我們談到的那些事項。

This year.

今年。

I mean this year. I keep saying next year, because we're reporting on 2012. But our focus in 2013 will be on those items we reported, the Gen 5 sensor, getting these partnership products filed and out the door, a little work on our Gen 6 sensor, in addition to the Gen 5. Ten day is something that we kind of do off the main path. We'll work on our algorithms and our software and decide when we're going to drop that in, and Bill, we have not made a decision on that front yet.

我是說今年。我一直說明年，因為我們在報告 2012 年。但我們 2013 年的重點會放在我們所報告的那些項目：第 5 代感測器（Gen 5 sensor）、讓這些合作夥伴產品完成申報並推出上市、以及在第 5 代之外也會對第 6 代感測器（Gen 6 sensor）做一些工作。10 天是我們有點偏離主軸、在旁支進行的事情。我們會做演算法和軟體的工作，並決定何時把它導入；而且 Bill，我們在這方面還沒有做出決定。

Okay, and then since I'm on the R&D the last question, just it seems like with the guidance that you're providing at this roughly flat 2013 versus 2012, and even on the SG&A guidance of up 20% year-over-year, it seems like is you put together your 2013 budgets, you're extremely focused on driving this to cash flow break even or profitability. Is that a fair kind of statement?

好的，最後一個研發相關問題：看起來你們提供的指引顯示 2013 年相較 2012 年研發大致持平，而 SG&A 指引則是年增 20%。這讓人感覺你們在制定 2013 年預算時，非常專注於推動達到現金流損益兩平或獲利。這樣的說法公平嗎？

Hey, I would say that would be my new name. (laughter)

嘿，我會說那會是我的新名字。（笑聲）

That's a fair assessment.

這個判斷很公平。

That is a very fair assessment, Bill, and everybody is -- we're very focused on that.

這是非常公平的判斷，Bill，而且大家——我們都非常專注在這件事上。

Great, that's all I have. I'll jump back in. Thanks.

很好，我就這些。我先回到隊列裡。謝謝。

Our next question comes from Thom Gunderson from Piper Jaffray, please go ahead.

下一個問題來自 Piper Jaffray 的 Thom Gunderson，請繼續。

Hi, good afternoon. So, a couple things on regulatory. The supplement that you filed for pediatric, can you narrow that down a little bit for timing so we can model that in?

嗨，午安。關於法規（regulatory）有幾點。你們針對小兒提交的補充申請（supplement），能否把時程再縮小一點，讓我們可以把它納入模型？

Well, statutorily you know, it's a 180-day filing and that's -- we've got to stand by that not having a crystal ball. Obviously, you know, we're taking bets as we did with G4, as to when that will get approval, and of course Terry is always the most optimistic one, which means I'll probably lose another dinner bet, but that's okay. No, I think we should look at that 180-day and not know anything else. The only kind of factor that you might want to think about is the fact that they've already seen the adult data, so we're really just comparing the pediatric data to the adult data and submitting that.

嗯，依法定時程你知道，這是一個 180 天的申請審查期——在沒有水晶球的情況下，我們必須以此為準。當然，你知道，我們也像 G4 那時一樣在下注，猜它何時會獲准；而且 Terry 一向是最樂觀的那位，這表示我可能又會輸掉一頓晚餐的賭注，但沒關係。不是，我認為我們應該就看 180 天，而不要假設其他資訊。你可能想考慮的唯一因素是：他們已經看過成人資料，所以我們基本上只是把小兒資料與成人資料做比較並提交。

I know that they are anxious, and we're anxious to receive the file because their belief there, their being the FDA, belief is, that every child should be on a CGM device as part of the diabetes therapy model.

我知道他們很焦慮，而我們也急著收到檔案，因為他們——也就是 FDA——的信念是，每個孩子都應該在糖尿病治療模式中使用 CGM 裝置。

And what's the start time for that, Terry, for the 180 days?

那麼那個 180 天的起算時間是什麼時候，Terry？

Sometime in the first quarter.

第一季的某個時間點。

Yes, we --

是的，我們——

Okay.

好的。

As I said, we have filed the PMA application this quarter. It's already in, so the clock has started.

如我所說，我們本季已提交 PMA 申請。它已經送進去了，所以時鐘已經開始計時。

The clock has started.

時鐘已經開始計時了。

So I would say, sometime in the second, obviously the second half of the year.

所以我會說，大概在第二——顯然是在今年下半年。

Okay. And then, Kevin, when you were describing Animas, I got a little confused. Is that a supplement as well, and is it a supplement submitted by DexCom, or is it a new PMA submitted by J&J?

好的。然後，Kevin，你在描述 Animas 的時候我有點搞混。那也是補充申請（supplement）嗎？而且那是由 DexCom 提交的補充申請，還是由 J&J 提交的新 PMA？

I'll let Steve take care of that one.

我讓 Steve 來回答這題。

Yes, Thom, this has been a moving target, but now we have, we have some clarity out of the FDA and frankly it was extremely positive. So, you'll recall probably a year or so ago, we had this concept we were going to try to file a supplement on top of the PMA. We were guided during the Gen 4 review, the Gen 4 PLATINUM review, that we should wait until Gen 4 PLATINUM was approved before we filed the Animas Vibe.

是的，Thom，這一直是個不斷變動的目標，但現在我們從 FDA 那裡得到了一些明確訊息，而且坦白說非常正面。你可能還記得，大約一年前左右，我們有個想法是要在既有 PMA 之上嘗試提交一個補充申請。在 Gen 4 審查、也就是 Gen 4 PLATINUM 審查期間，我們被指導應該等到 Gen 4 PLATINUM 核准後，再提交 Animas Vibe。

What the FDA determined is that it would be a full PMA, but what they also determined is that Animas can file the Vibe system and actually rather than include all of the detailed information regarding G4 PLATINUM, they can actually just reference our PMA submission. So, it's really just a PMA filing that will be conducted by Animas referencing the G4 PLATINUM. Why that's a benefit to both of us, as you'll recall is, as the Vibe moves, Vibe moves the Animas pump platform from a 510(k) product to a PMA product, which means Animas becomes subject to, as we are on a daily basis, subject to all the change control procedures and requirements, and basically they become a PMA company that'd have to file every change they make with respect to their manufacturing operation and things like that.

FDA 的判定是，這會是一個完整的 PMA；但他們也判定 Animas 可以為 Vibe 系統提交申請，而且實際上不必納入所有關於 G4 PLATINUM 的詳細資訊，他們可以直接引用我們的 PMA 送件。因此，這其實就是由 Animas 進行的一個 PMA 申請，並引用 G4 PLATINUM。為什麼這對我們雙方都有利，你可能還記得，隨著 Vibe 推進，Vibe 會把 Animas 的幫浦平台從 510(k) 產品轉為 PMA 產品，這代表 Animas 會像我們每天一樣，必須遵循所有變更控制程序與要求；基本上他們會成為一家 PMA 公司，必須就其製造作業等事項所做的每一項變更進行申報。

By allowing Animas to file a PMA separate and distinct from ours and be able to reference ours, that enables them to control the regulatory process on their front with respect to ongoing manufacturing operations, with respect to the pump, so we don't have to be in the middle of that.

透過讓 Animas 提交一個與我們分開且不同的 PMA，並且能引用我們的資料，這使他們能在其端就幫浦相關的持續製造作業掌控法規流程，因此我們不必介入其中。

So, this is all kind of you know, new information to us within the last three to six months, but it's actually very positive from an operations perspective.

所以，這些在過去三到六個月內對我們來說算是新資訊，但從營運角度來看其實非常正面。

Got it, thanks for that. And then on Roche, I understand what you said in the prepared remarks but I didn't hear any reference to the in-office CGM that you have a partnership with. Is that still ongoing, or is that dissolving?

了解，謝謝你的說明。接著關於 Roche，我理解你在事先準備的發言中所說的，但我沒有聽到你提到你們合作的院內（in-office）CGM。那個合作還在進行嗎，還是正在解散？

It is, you know, I wouldn't read too much into the Roche announcement. I mean, Roche is a very strong partner for us, internationally. Roche has some direct distribution rights in some countries, and they work, frankly work with our distributors and our distribution network in other countries. They've been a very strong partner and will continue to be.

是的，你知道，我不會對 Roche 的公告做過度解讀。我的意思是，Roche 在國際市場上是我們非常強的合作夥伴。Roche 在某些國家擁有直接經銷權，並且坦白說，在其他國家也會與我們的經銷商與經銷網路合作。他們一直是非常強的夥伴，未來也會持續如此。

We've said before, on the SEVEN PLUS Professional Use system that Roche has carried in the bag has been less than successful. You know, that's -- we've been saying that for several quarters now, and I think that program is still ongoing, but look. As we look to wind down the SEVEN PLUS, naturally that program would look to wind down sometime this year, you know.

我們之前也說過，Roche 隨身攜帶的 SEVEN PLUS 專業用途系統成效不算成功。你知道——我們已經連續好幾季這麼說了。我認為那個計畫仍在進行，但你看，隨著我們準備逐步停止 SEVEN PLUS，自然那個計畫也會在今年某個時點逐步結束。

One of the other items on our R&D radar screen would be moving the Gen 4 PLATINUM to a professional use model, but it currently today is not labeled for multiple patient use, so that's something that we're looking at obtaining a labeled indication for. Not sure whether Roche would be the partner there or not, but we would evaluate that at the time we got an approval.

我們研發雷達上的另一個項目，是把 Gen 4 PLATINUM 推向專業用途模式，但目前它的標示並未涵蓋多病患使用，因此我們正在評估取得該標示適應症。不確定屆時 Roche 是否會是合作夥伴，但在我們取得核准時會再評估。

And then Kevin, I think you mentioned this in reference to a question from Bill, but does the $120 million to $130 million product revenue guidance that you gave out a month ago, it clearly assumes a pediatric approval moving different times through the year. Does it assume Vibe approved this year, or would that be upside?

然後 Kevin，我想你在回覆 Bill 的問題時有提到，但你們一個月前給出的 1.2 億到 1.3 億美元產品營收指引，顯然假設兒科核准會在一年中不同時間點發生。那個指引有假設 Vibe 今年會核准嗎？還是那會是額外上行空間？

It assumes no Vibe approval this year, there is no Animas numbers baked into that, and the pediatric impact is really something again Tom, that would push us to the upper end of the range or even outside the upper end of the range. Our numbers are built pretty solidly from the ground up.

那個指引假設今年不會有 Vibe 核准，裡面沒有納入任何 Animas 的數字；而兒科的影響，Tom，再次強調，會把我們推向區間上緣，甚至可能超出上緣。我們的數字是相當紮實地自下而上建立的。

Got it. That's it for me guys, thanks.

了解。我就這些了，各位謝謝。

Thanks.

謝謝。

Thanks.

謝謝。

Our next question comes from Chris Cooley from Stephens, please go ahead.

下一個問題來自 Stephens 的 Chris Cooley，請繼續。

Thank you, good evening, and congratulations on a great quarter. Was there, are there -- I should say, are there going to be charges that we should think about or any one-time items in the P&L associated with the change both with Insulet, and as well with Roche, in terms of the co-development agreements there that we should think of in addition to just you know, the timing out of those development efforts? I have one quick follow-up.

謝謝，晚安，並恭喜你們有個很棒的季度。想請問，針對與 Insulet 的變動，以及同樣針對與 Roche 的共同開發協議變動，在損益表上是否會有我們需要考量的費用，或任何一次性項目？除了你知道的，這些開發工作時程的結束之外。我還有一個簡短的追問。

No, there won't be any one-time charges with respect to that.

不，這方面不會有任何一次性費用。

There will be some changes with the development grant revenue.

開發補助收入會有一些變化。

Yes.

是的。

So, if you look at Edwards, we have effectively completed that development arrangement and recognize revenue through December. We won't have any going forward. Other than in Q1, of development grant revenue of about $1 million, going forward we expect development grant revenue of about $100,000 a quarter through 2014 as we stand here today.

所以，如果你看 Edwards，我們實際上已完成那項開發安排，並已認列到 12 月的收入。之後就不會再有了。除了第一季大約 100 萬美元的開發補助收入之外，依我們目前的狀況，往後我們預期到 2014 年每季約有 10 萬美元的開發補助收入。

Okay, super, and then just lastly when I think about product revenue guidance for the year, should we think about a normal split between consumables and hardware that we've seen historically? I'm just looking at what you put up in the fourth quarter and what seems to be intimated regarding the new patient starts here in the 1Q, and just trying to think about that a little bit while I think about both top line growth and margin. Just any additional color you could provide there would be great, thanks so much.

好的，很棒。最後，當我思考今年的產品營收指引時，耗材與硬體之間的拆分是否應該仍以我們歷史上看到的正常比例來看？我只是看你們第四季的表現，以及你們似乎暗示第一季新病患啟用的情況，想更理解一下，因為我在思考營收成長與毛利。若能提供一些額外說明會很有幫助，謝謝。

Sure, Chris. You know, we've stated in the past that our split is typically 25% to 30% on the durable, and the rest on the disposable side. We did 32% this quarter as we launched a new product, but in all reality if we didn't have the upgrade of the $399 upgrade program and also the $1.2 million that we recognized from the September patients, the ratios would have been in that, would've been within that range of 25% to 30%. So, we think things will remain relatively consistent on that front, 25% to 30% durables and the rest of it for the consumable products.

當然，Chris。你知道，我們過去曾表示，我們的拆分通常是耐久財約 25% 到 30%，其餘則在一次性耗材端。本季因為推出新產品，我們做到 32%；但實際上，如果沒有 399 美元的升級方案，以及我們從 9 月病患認列的 120 萬美元，那些比例本來會落在 25% 到 30% 的區間內。所以我們認為這方面會維持相對一致：耐久財 25% 到 30%，其餘為耗材產品。

Sounds great, that's all I have, thanks.

聽起來很棒，我就這些了，謝謝。

Thanks, Chris.

謝謝你，Chris。

Our next question comes from Danielle Antalffy from Leerink Swann, please go ahead.

下一個問題來自 Leerink Swann 的 Danielle Antalffy，請繼續。

Thanks, good afternoon guys, and congrats on a great quarter. I know you guys don't give quarterly guidance, but just trying to get a sense of first quarter is usually a down quarter sequentially, given deductibles resetting, etc., but was hoping you could give us some, some you know -- you have a lot of momentum it seems going into the first quarter. How do we think about the launch continuing to progress versus the trend of resetting deductibles, and how that might offset? If you could give any context around that, that would be really helpful.

謝謝，各位下午好，也恭喜你們有個很棒的季度。我知道你們不提供季度指引，但我想了解一下，第一季通常會因為自付額重置等因素而較前一季下滑；但希望你們能給我們一些——你知道——看起來你們在進入第一季時動能很強。那麼我們該如何看待產品上市持續推進，與自付額重置的趨勢，以及兩者可能如何互相抵銷？如果你們能提供一些背景脈絡，會非常有幫助。

Well certainly, I'll weigh in, then I'm going to ask Kevin to follow on, as I'll give you the 35,000 kind of foot level and he can get you to more specificity. Certainly, we are challenged with as you've already identified, the seasonality with deductibles and flexible spending accounts. That's not going to change. You know, we did it, $18 million in Q1 of 2012, so I -- you know, that was down, we had done $21 million in Q4, so we did $32 million in Q4. We're going to be down from that standpoint, and I can't -- I don't want to start -- if I gave you the what we think we're going to do this quarter, then every single quarter going forward we're going to have to do the same thing and we don't want to get into that.

當然，我先補充幾點，接著我會請 Kevin 延伸說明；我先從 35,000 英尺的高度概述，他可以再提供更具體的細節。確實，如同你已經指出的，我們面臨免賠額與彈性支出帳戶（FSA）所帶來的季節性挑戰。這點不會改變。你知道，我們在 2012 年第一季做了 1,800 萬美元，所以我——你知道，那是下降的；我們在第四季做了 2,100 萬美元，所以我們在第四季做了 3,200 萬美元。從這個角度看，我們會比那個水準低一些，而我不能——我不想開始——如果我告訴你我們認為本季會做多少，那麼之後每一季我們都得做同樣的事，而我們不想陷入那種狀況。

But, I would say that it is on the one end, the same type of softness that we see. The little bit of change that you know, I heard my comment saying we had a solid through the end of February, is just the Gen 4 I think in terms of word-of-mouth, by patient-to-patient communication which we've seen really I think more dramatically in the last three months than we have ever with the SEVEN PLUS, that there is that interest level. Kevin mentioned that the opportunities in the pipeline are as full as we've ever seen them in the history of the Company. I think -- now that doesn't mean that they absolutely translate into a new starter kit sale, but certainly the interest level is there, but again we haven't, as we look at the landscape of deductibles, they've gone up a bit, but it's still single digits this year as far as we can tell from that standpoint, so I think there are some of those headwinds.

不過，我會說，一方面，這是我們看到的同類型疲軟。你知道，我聽到我自己的評論說我們到二月底都很穩健，這一點的小變化，我認為主要是 Gen 4 在口碑方面——透過病患之間的病患對病患溝通——所帶動的；我想在過去三個月，我們看到的程度比 SEVEN PLUS 時期任何時候都更明顯，確實有那樣的興趣程度。Kevin 提到，管線中的機會是公司歷史上我們看過最滿的一次。我想——當然這不代表它們一定會轉化為新的入門套件銷售，但興趣確實存在。不過再說一次，當我們看免賠額的環境，它們確實上升了一點，但就我們目前能判斷的，今年仍是個位數的增幅，所以我認為仍有一些逆風。

But we're doing okay, and Kevin, you want to get to more granularity?

但我們表現還可以。Kevin，你要不要再講得更細一點？

No, Terry, you covered a number of the points, and one of the things different going into this quarter, let's just go back to Q4 revenues for a minute, because there are some things that won't reappear. We had the $1.2 million we carried over from Q3, but you can't extrapolate what Q1 is going to be like from that. We also had some pent-up demand, that I really can't quantify in Q3 of patients who did not buy, who waited to buy in Q4, but that makes things a little bit different, and we had the $399 upgrade program.

不用了，Terry，你已經涵蓋了不少重點。而本季有一點不同之處，我們先回到第四季營收談一下，因為有些事情不會再出現。我們有從第三季結轉過來的 120 萬美元，但你不能用那個去外推第一季會是什麼樣子。我們在第三季也有一些累積需求——我其實無法量化——有些病患當時沒有購買，而是等到第四季才買，這讓情況有點不同；另外我們還有 399 美元的升級方案。

So, we have a group of patients who are non-repeatable. That being said, as we've come out of most years I can tell you we have sold to most every patient we could ever find, or most quarters, and we came out of Q4 this year, that was not the case. We still had a very robust pipeline going into the year, and we're still getting a lot of phone calls. We are getting very favorable reaction not only from our patient customers, our distribution partners, our dealers, are ordering regularly and basically can't keep the thing on the shelf, [go through] stock.

所以，我們有一群病患是不可重複的。話雖如此，我可以告訴你，多數年份或多數季度，我們幾乎賣給了我們能找到的每一位病患；但今年從第四季出來時，情況並非如此。我們在年初仍有非常強勁的管線，而且我們仍接到很多電話。我們不僅從病患客戶那裡得到非常正面的反應，我們的通路夥伴、經銷商也都在規律下單，基本上貨架上都放不住，[需要補] 庫存。

So, while all the issues exist, with deductibles and copays and all these other things, it just appears that patients are a little more excited about this new product and might be able to deal with those issues and make an investment in their care earlier than they have in the past. So, you combine all the positives with all the things that are floating, and we're very excited about the quarter. But there's a bit of uncertainty, still.

所以，雖然免賠額、共付額以及其他所有這些問題都存在，但看起來病患對這個新產品更興奮，可能更能處理這些問題，並且比過去更早在照護上做出投資。因此，把所有正面因素與所有仍在發酵的事情加總起來，我們對本季非常興奮。但仍然有一些不確定性。

Got it, that's helpful. And then if I look at your product revenue guidance for 2013, the $120 million to $130 million, beyond Animas Vibe coming online this year, earlier pediatric indication, what are the other variables that could get you towards the higher end of that range? For example, you mentioned more frequent use of, or more sensors being used. Is that something that could continue, and if it does, is that something that gets you to the higher end, or is that more something that gets you within the middle? Any color on that? Thanks.

了解，這很有幫助。接著如果我看你們 2013 年產品營收指引 1.2 億到 1.3 億美元，除了 Animas Vibe 今年上線、以及更早的兒科適應症之外，還有哪些變數可能讓你們更接近區間上緣？例如，你們提到更頻繁使用、或使用更多感測器。這是否可能持續？如果持續，是把你們推到上緣，還是比較偏向落在中間？能否補充一些看法？謝謝。

You know, I -- Steve, Terry, anybody jump in if you think I'm too far out there. I think our utilization would move us up a bit into the range, probably doesn't get us to the very end, but I think it's very helpful. I think the other thing that you know, that is, if we can shave a point off the retention rate, or I mean, add a point to the retention rate, a point off the attrition rate, that's certainly very helpful. We know the Gen 4 does that, so far, from what we've seen. People really like this thing and appear to be using it very regularly.

你知道，我——Steve、Terry，或任何人，如果你們覺得我講得太超前請插話。我認為我們的使用率提升會讓我們在區間內往上移一些，可能還不到最上緣，但我覺得很有幫助。另一件事是，如果我們能把留存率提高 1 個百分點，或是把流失率降低 1 個百分點，那當然也非常有幫助。我們知道 Gen 4 到目前為止確實能做到這點，從我們看到的情況來看。大家真的很喜歡這個產品，而且看起來使用得非常規律。

Earlier pediatric approval helps more than anything else we could do right now, and we can't predict that, and certainly we don't have any Vibe numbers in what we've got. But those are really the levers we could pull. We're going to have more coverage with more sales reps and more territories, so we'll be calling on people we haven't called on in the past, or going more deeply into practices where we've had to be relatively shallow before.

更早取得兒科核准，比我們現在能做的任何其他事情都更有幫助，但我們無法預測，而且我們目前的數字也完全沒有把 Vibe 的量納入。不過，這些確實是我們可以拉動的槓桿。我們會有更多業務代表與更多區域的覆蓋，因此我們會拜訪過去沒拜訪過的人，或是在過去只能淺層覆蓋的診所裡更深入耕耘。

So, we might be able to go deeper and get, again get more from there, but bottom line is we've got a 40% target on our backs, that we put on our backs already. We're going to have to execute pretty well just to do that.

所以，我們或許能更深入，並且再次從那裡取得更多成果。但歸根結底，我們自己已經把 40% 的目標背在身上了。要做到那個目標，我們必須執行得相當好。

Right, okay, all right, thanks so much.

好，了解，謝謝你們。

The only other thing I would comment on is this peer-to-peer, which we're beginning to see early stages of that communication, which is then driving some sales, at outside of our normal call patterns, which we hope is kind of the vision of the future and what we've long predicted as a trajectory increase attribute of having more patient demand than physician prescribing. So, we'll see if that continues to play out in a robust way.

我唯一還想補充的是這種同儕對同儕（peer-to-peer）的溝通，我們開始在早期階段看到這種交流，進而在我們正常拜訪模式之外帶動一些銷售；我們希望這會是未來的願景，也符合我們長期以來所預測的趨勢：由更多病患需求驅動，而非醫師處方驅動的成長特性。所以，我們會看看它是否能以強勁的方式持續發展。

Perfect, thank you so much.

太好了，非常感謝。

You bet.

不客氣。

Our next question comes from Mimi Pham from ABR-HealthCo, please go ahead.

我們的下一個問題來自 ABR-HealthCo 的 Mimi Pham，請開始提問。

Hi, good afternoon. Can you clarify what percent of those 1,000 pediatric endocrinologists you would be able to access with your reorganized, reorganized sales force later this year?

嗨，下午好。你能否說明今年稍晚你們重整後的銷售團隊，能接觸到那 1,000 位兒科內分泌科醫師中的百分之多少？

That'd be 100%.

那會是 100%。

100% okay, and then regarding your guidance for 120 to 130 CGM sales, can you talk about how did you anticipate any hit from your growth due to the Medtronic NextGen CGM launch in the summer, if they get approval this summer, of Enlite? Have you taken that into guidance?

100%，好的。那關於你們 1.2 億到 1.3 億的 CGM 銷售指引，你能談談是否預期 Medtronic 在夏季推出 NextGen CGM（如果他們今年夏天讓 Enlite 獲批）會對你們的成長造成任何衝擊？你們有把這點納入指引嗎？

Well, I would say from a standpoint look, we address two different markets. They're really addressing the pump market, and that is something that as you know just based on their latest quarter announcement was declining, as a pump sale. They really never had a standalone product that was a competitive product, and I think even looking at the clinical results of Enlite versus G4, I would say most of the academic and clinical community have been disappointed in the performance of the Enlite.

我會說，從定位來看，我們面向的是兩個不同市場。他們主要在打胰島素幫浦市場，而如你所知，根據他們最新一季的公告，那個市場的幫浦銷售是在下滑。他們其實從來沒有一個具競爭力的獨立式產品；而且即便看 Enlite 相對於 G4 的臨床結果，我會說多數學術與臨床社群對 Enlite 的表現感到失望。

We've seen data, even in head-to-head competition by independent researchers, and it looks like it's approaching the same kind of accuracy as the SEVEN PLUS had achieved, but in terms of comparing that and contrast that to the current data we're getting from G4, in that contrast we're 70% more accurate overall between 40 and 400 milligrams of detection. We're really getting down below, close to that 10 MARD range, so I think that that's -- you know, from the user standpoint, accuracy really counts and they're really trying to sell it as part of an integrated system.

我們看過一些數據，甚至有獨立研究者做的正面對決比較，看起來它的準確度接近 SEVEN PLUS 達到的水準；但若把它與我們目前從 G4 得到的數據相比，在 40 到 400 毫克的偵測範圍內，我們整體準確度高出 70%。我們真的已經降到接近 10 的 MARD 範圍，所以我認為——你知道，從使用者角度，準確度非常重要，而他們主要是把它當作整合系統的一部分來銷售。

I think our pump partners will have to address that, both Animas and Tandem, and I would say this, and it gets back to -- so they've had the system approved in Europe for some time now and yet on the -- Kevin's comments, based on what they, what J&J presented in their first quarter call was, that they're -- in places where they've launched the Vibe, they're growing it anywhere from 35% to 50%. Their informal comments to us are that they're not very impressed with the Veo system. They don't find it as a competitive threat, and they're not seemingly having any problem replacing Medtronic pumps in that space.

我認為我們的幫浦合作夥伴——Animas 和 Tandem——必須去因應這點。我也想說，回到前面——他們的系統在歐洲已經核准一段時間了，但根據 Kevin 的評論，以及他們、也就是 J&J 在第一季法說中所呈現的內容，在已推出 Vibe 的地區，他們的成長約在 35% 到 50%。他們私下對我們的說法是，他們對 Veo 系統並不怎麼印象深刻，並不認為它是具競爭威脅的產品，而且看起來在那個市場空間裡，他們用自家產品取代 Medtronic 幫浦並沒有遇到什麼問題。

So, you know, is that going to translate the same in the US remains to be seen.

所以，你知道，這在美國是否會以同樣方式反映出來，還有待觀察。

Okay, but we should assume if they happen to do announce approval mid-summer, that necessarily doesn't change your guidance or expectations (multiple speakers)?

好的，但我們是否應該假設，如果他們剛好在仲夏宣布核准，那也不一定會改變你們的指引或預期（多位發言者）？

Oh, it doesn't change our guidance at all. I look at it, you know, again, I want to differentiate who we are versus the pump world. The pump world is a $2 billion market. Glucose monitoring is somewhere between $10 billion and $12 billion. We are in the glucose monitoring market. Our program this year for 2013 is CGM First, and what that means is, because if you look at the US pump market, maybe 28% penetrated. That means there's 60%-plus that are still using injections. We need to move the dynamic that when a patient walks in regardless of their insulin delivery mechanism, that the physician says, I need to know more about your glucose first, because that's really the goal.

不，這完全不會改變我們的指引。我看待這件事時，你知道，再次強調，我想區分我們與胰島素幫浦市場的不同。幫浦市場是20億美元的市場。葡萄糖監測大約在100億到120億美元之間。我們是在葡萄糖監測市場。今年我們2013年的計畫是「CGM優先（CGM First）」，其含義是，因為如果你看美國的幫浦市場，滲透率可能約28%。這表示仍有超過60%的人還在使用注射。我們需要改變這個動態：當病人走進診間時，不論其胰島素輸送機制為何，醫師都會說，我需要先更了解你的葡萄糖狀況，因為那才是真正的目標。

I mean, if you look at the pharmaceutical companies and all of the billions of dollars that they're spending on drugs, it's all about trying to figure out how to reduce glycemic variability. My god, we do that every day, and so I think we have got to get that point across to the prescribing population to say how important it truly is, about glucose. And that's really where we're focused, so I don't view the pending approval, that's if they can get approval, sometime later this year as being a competitive threat to us whatsoever.

我的意思是，如果你看看製藥公司以及他們在藥物上投入的數十億美元，一切都是為了試著找出如何降低血糖變異度。天啊，我們每天都在做這件事，所以我認為我們必須把這個重點傳達給開立處方的族群，讓他們知道葡萄糖到底有多重要。而這正是我們聚焦的方向，所以我不認為那個待核准的產品——如果他們能在今年稍晚取得核准——對我們構成任何競爭威脅。

That's helpful, and in terms of the international, the 5% to 10% of sales, is the majority of that associated with Vibe, or are you getting a ramp in the standalone Gen 4 sales?

這很有幫助。那在國際市場方面，銷售占比5%到10%，其中大多數是與Vibe相關，還是你們的獨立版Gen 4銷售正在爬坡？

Yes, we're getting good traction with the standalone, quite happily so, because that's a tough reimbursement market. And so, for the first time, as part of that contribution, we're routinely seeing patients willing to pay out of pocket which is something that is very unusual in a socialized medicine situation where they get all of their supplies for diabetes either from the clinic or certainly reimbursed by the government, but these, the value proposition is such that many of these patients are electing to pay out of pocket in order to maintain the product on an ongoing basis.

是的，我們在獨立版產品上取得了不錯的進展，坦白說我們很高興，因為那是一個報銷相當困難的市場。因此，作為那部分貢獻的一部分，我們首次例行性地看到病人願意自掏腰包，這在社會化醫療體系中非常不尋常；在那種體系下，他們的糖尿病用品不是由診所提供，就是由政府報銷。但這些產品的價值主張非常強，使得許多病人選擇自費，以便持續使用該產品。

Thanks, and then just last question regarding the Share System, you know, we've heard about there being a strong demand for something like that for a while, from parents. Is this a PMA supplement, or is it an easier FDA pass?

謝謝。最後一個問題關於Share系統，你知道，我們聽說家長對這類產品有強烈需求已經有一段時間了。這是PMA補充申請，還是比較容易通過FDA？

No, it's going to be a PMA supplement.

不，這會是一個PMA補充申請。

Okay, thank you so much.

好的，非常感謝。

Our next question comes from Steven Lichtman from Oppenheimer, please go ahead.

下一個問題來自Oppenheimer的Steven Lichtman，請繼續。

Thank you. Hi guys, just a couple of pipeline clarifications. In terms of Vibe in the United States, with the change in the structure of the filing, and it sounds like a -- I don't know if it was a full PMA, or a PMA supplement. If it is a full PMA, does that change your timing potential by end-of-year?

謝謝。各位好，我有幾個關於產品管線的釐清問題。就Vibe在美國而言，隨著申報架構的變更，聽起來像是——我不確定是完整PMA還是PMA補充申請。如果是完整PMA，這會改變你們年底前的時程可能性嗎？

No, because I mean, it's still, again -- statutorily it's 180 days. Look at our performance on the G4 PLATINUM, 177 days. If you look at the Vibe, the combination of the Vibe System, is effectively the G4 PLATINUM with their Base 20-20 pump with some modifications. So, you could argue that it's basically to approve products just talking to each other. So I don't think there's anything that gives us reason to believe that it's going to be an extended review cycle, even though it's classified as a full PMA.

不會，因為我的意思是，它仍然——再次強調——法定審查期是180天。看看我們在G4 PLATINUM上的表現，是177天。如果你看Vibe，Vibe系統的組合基本上就是G4 PLATINUM加上他們的Base 20-20幫浦並做了一些修改。所以你可以說，基本上就是核准兩個產品彼此溝通。因此我不認為有任何理由讓我們相信審查週期會被拉長，即使它被歸類為完整PMA。

Okay, all right, thank you, and then on -- as you do move to Gen 5 and recognizing you're already on 4.5, but as you move to 5, do you need to re-file with Animas and Tandem, or how will that work when that gets through?

好的，明白，謝謝。接著——當你們往Gen 5邁進，並且認知你們已經在4.5，但當你們走到5時，你們需要和Animas與Tandem重新申報嗎？或是那在通過時會如何運作？

Yes, I mean, they will ultimately, again they reference our PMA but they would need to file a subsequent filing with each sensor iteration that we achieve, that is right. So, there will always be a generation for some period of time, would be a generation behind us while their filing is pending.

是的，我的意思是，他們最終——再次強調——會引用我們的PMA，但他們需要針對我們達成的每一次感測器迭代提出後續申報，這是正確的。因此，在某段時間內，他們在申報審查期間，總會落後我們一個世代。

Okay. You haven't indicated, if I'm wrong, about Gen 5 filing potential right, in terms of timing?

好的。你們尚未提到——如果我沒聽錯——Gen 5申報的可能性，對吧？就時程而言？

We didn't give any timelines today, no.

我們今天沒有提供任何時程，沒有。

Okay. All right, thanks, guys.

好的。好，謝謝各位。

Thanks, Steve.

謝謝，Steve。

Our next question comes from Bill Plovanic from Cannacord, please go ahead.

下一個問題來自Cannacord的Bill Plovanic，請繼續。

Great, a couple of follow-up questions, here. Do you expect any upgrades in Q1 or Q2, or has that program been exhausted at this point?

很好，我這裡有幾個追問。你們預期在第一季或第二季還會有任何升級嗎？還是那個計畫到目前為止已經用盡了？

The $399 program, the in-warranty upgrade, is done. We ended that on January 31. Upgrades of patients out of warranty will occur all year long, and so there will be some, and it's always been part of our core business and will continue to be part of it. There are a lot of patients who would look at you know, they're sitting there in the fourth quarter looking at their insurance dollars, and say okay, I can pay $399 now or I can wait until the first quarter and my copay is going to be $275, I'm going to wait until the first quarter and go with the $275.

399美元的計畫，也就是保固內升級，已經結束了。我們在1月31日終止。保固外病人的升級會全年持續發生，所以會有一些，而且這一直是我們核心業務的一部分，也將持續如此。有很多病人會看著——你知道——他們在第四季坐在那裡看著自己的保險額度，然後說，好吧，我現在可以付399美元，或者我可以等到第一季，那時我的自付額會是275美元，我要等到第一季用275美元。

We gave the patients the option if they wanted to speed it up and they wanted to get on a Gen 4 system, we gave them the opportunity. A lot of them chose not to take it, they'll upgrade throughout the course of the year and take advantage of their copays or their deductibles and the other things.

我們給了病人選項，如果他們想加快速度、想用上Gen 4系統，我們就給他們這個機會。很多人選擇不採用，他們會在一年當中陸續升級，並利用他們的自付額或自負額（deductible）以及其他因素。

So, we will have upgrades all year, but our goal, our goal is very clear. We want everybody on Gen 4 by the end of this, before the end of this year.

所以，我們全年都會有升級，但我們的目標——我們的目標非常清楚。我們希望在今年結束前、在今年年底之前，讓所有人都用上Gen 4。

Okay, but so we will see some more of those in Q1 because it ended January 31?

好的，但所以我們會在第一季看到更多這類升級，因為它在1月31日才結束？

Yes, but they'll -- yes, but not many. Not much.

會的，但他們——會的，但不會很多。不多。

Okay. And then the development revenues were pretty big in this quarter. Was that Edwards, or was that, what was the extra amount that you received in Q4 and then the extra that you're picking up in Q1?

好的。然後本季的開發收入相當大。那是Edwards的嗎？或者說，你們在第四季收到的額外金額，以及你們在第一季會認列的額外金額，分別是什麼？

Jess, you want to take care of that?

Jess，你要回答這個嗎？

Yes, that's right, so we did receive additional funding from Edwards in Q4 just like we have in the prior quarters, outside of the development grant agreement. We expect that as we've stated before to really go away. In Q1 if we do have any we don't expect at this point to be overly significant, and I think you might have heard our comment before, but in Q1 as we sit here today, we expect about $1 million, $1.1 million, in development grant revenue, and then going forward through 2014 expect about $100,000 a quarter.

是的，沒錯，所以我們在第四季確實從Edwards收到額外資金，就像前幾季一樣，這是在開發補助協議之外。我們預期——如同先前所說——這部分會逐步消失。第一季如果還有，我們目前不預期會非常顯著。我想你可能之前也聽過我們的評論，但以今天的情況來看，我們預期第一季約有100萬到110萬美元的開發補助收入，之後一路到2014年，預期每季約10萬美元。

Okay, and then, on the accounts receivable, you did address it in your opening comments but a little more clarity on -- it was a pretty big jump sequentially and year-over-year, and I'm just curious if you could explain that a little.

好的。然後，關於應收帳款，你在開場評論中有提到，但我想更清楚一些——它在季對季以及年對年都大幅跳升，我只是好奇你能否再解釋一下。

Sure. We sold a lot of stuff in December. When we, you have a quarter that big, you know, as big as our $32 million quarter compared to $20 million last year, $21 million in Q3, we up -- the sales number $9 million and as is with particularly every quarter I've been at, at a diabetes company, December's the biggest month of the year. So, when you just look at straight timing, our receivables grew just based on a business activity and there was no other reason.

當然。我們在12月賣了很多產品。當你有那麼大的一季——你知道——像我們這季3200萬美元，相較去年2000萬美元、第三季2100萬美元，我們把銷售數字提高了900萬美元；而且就我在糖尿病公司待過的每一季而言，12月都是一年中最大的月份。所以，單就時間點來看，我們的應收帳款成長只是因為業務活動增加，沒有其他原因。

Most of those receivables are directly with payers, and we're billing and collecting that. First quarter should be a very good collection quarter, and Bill, we'd expect that to go down as we get into the first quarter and then manage it the same way throughout the other quarters of the year.

這些應收帳款大多直接來自付款方（payers），我們負責開立帳單並收款。第一季應該會是收款表現非常好的一季，而Bill，我們預期隨著進入第一季它會下降，之後在一年中其他季度也會以同樣方式管理。

So, there's nothing unusual there. It's just a lot of late in the year volume that we just, you just can't get paid on before the year's over.

所以，那裡沒有什麼不尋常的。只是年底有大量的出貨量，我們就是——你就是無法在年度結束前把款項收進來。

Okay, understood, and then historically I think your mix has been 70% non-pumpers, 30% pumpers. Is that mix changing now with G4, and -- or do you expect that to change outside of you know, obviously your partners as we look forward?

好的，了解。然後從歷史上看，我想你們的組合一直是 70% 非幫浦用戶、30% 幫浦用戶。隨著 G4 的推出，這個組合現在有在改變嗎？或者——你是否預期在未來（當然除了你們的合作夥伴之外）會有所改變？

Bill, that number's really been 60, and then it's all based, 60% pumpers, 40% MDI patients. Obviously, as the pumpers come on, we would expect some of that shift to happen, but I'm cautious because we've been pretty steady-stayed on that ratio for some time and as Kevin mentioned in one of his comments, with regards to once the Vibe is launched. If you look at the dynamics about, of that 60%, some 40%-plus are already on Animas, about 30% are on Medtronic, the rest on Insulet, we've got some on Roche and even some on the old Deltec pump.

Bill，那個數字其實一直是 60%，而且完全是以——60% 幫浦用戶、40% MDI（多次每日注射）患者為基礎。顯然，隨著幫浦用戶增加，我們預期會出現一些變化，但我會比較謹慎，因為我們在這個比例上已經維持相當一段時間的穩定；而且如 Kevin 在其中一則評論中提到的，關於 Vibe 一旦上市。如果你看那 60% 的動態，其中有 40% 以上已經在用 Animas，大約 30% 在用 Medtronic，其餘在用 Insulet；我們也有一些在用 Roche，甚至還有一些在用舊款的 Deltec 幫浦。

So, we've already got a pretty significant share of the Animas population, but going forward having them promoting the product, yeah, we would like to see an uptick there, as well. I [don't] know that the ratios are going to change all that much.

所以，我們在 Animas 用戶族群中已經有相當可觀的市占；但往後他們推廣這個產品，對，我們也希望那裡能看到一些提升。我不確定這些比例會改變很多。

And as we think of the Animas opportunity, how many pumpers do you think they have, or what -- yeah, how big is the pump market in your opinion, and what percent share do you think they have? Same question asked a different way.

那麼，當我們思考 Animas 的機會時，你認為他們大概有多少幫浦用戶？或者——對，你認為幫浦市場有多大？以及你覺得他們的市占大概是多少？同一個問題換個方式問。

Yes, well, I think in the US the pump market is probably somewhere around I don't know, 400,000 total. My guess is, yeah, again, I don't want to speak for Animas -- I've always said, gee, it looks to me like they've got about 18% to 20% share of that market.

是的，我想在美國幫浦市場大概在——我不知道——總量大概 40 萬左右。我的猜測是——對，再次強調我不想替 Animas 發言——我一直說，嗯，在我看來他們大概有 18% 到 20% 的市占。

The market, the challenge with the market is, it's not growing. It's actually, if anything, having a bit of a decline so if you're not growing, it's hard to predict where the share is shifting. We certainly know that you listen to Animas, if you listen to Insulet, they seem to be adding pumpers, so that means that they -- if the organic growth isn't growing, that means they've got to be cannibalizing from Medtronic.

市場的問題、挑戰在於，它沒有成長。實際上，如果有的話，還有一點下滑。所以如果市場不成長，就很難預測市占會如何移動。我們當然知道，如果你聽 Animas 的說法、如果你聽 Insulet 的說法，他們似乎都在增加幫浦用戶；所以如果自然成長沒有增加，那就表示他們必須是在從 Medtronic 那邊挖走用戶（互相侵蝕）。

If you listen to Tandem, their first, I don't know, three or four months they told us that about 50% of their patients that they put to the T-slim were Medtronic patients, 25% were brand new patients new to pump therapy, the remaining 25% came from cannibalization of Animas and Insulet, Roche and Smith. So, I think that's kind of the landscape that we look at it going forward.

如果你聽 Tandem 的說法，他們在最初——我不知道——三、四個月告訴我們，他們導入到 T-slim 的患者中，大約 50% 原本是 Medtronic 的患者，25% 是全新的患者、第一次使用幫浦治療，剩下的 25% 則是從 Animas 和 Insulet、Roche 以及 Smith 那邊轉換過來的。所以我想，這大概就是我們往後所看到的市場樣貌。

Okay, and then, as you think of the pediatric label, so you've submitted for that, would -- if you have approval on that, do you have to wait for that to submit the Animas, or would that approval for a Pede automatically roll on to the Animas? I'm just trying to figure this out from a timing standpoint. Are they going to have to basically hold up and wait until you get that Pede so that they can have the Pede label? Because I would assume that's important for them in the US.

好的。然後，談到兒科適應症標示，你們已經提交申請了；如果你們拿到核准——你們是否必須等到那個核准之後，Animas 才能提交？還是兒科（Pede）核准會自動延伸到 Animas？我只是想從時程角度釐清。它們是否基本上必須先暫停、等你們拿到兒科適應症，這樣他們才能有兒科標示？因為我猜這對他們在美國應該很重要。

Now you're right, remember, with the Animas Vibe, that the clinical trial requirement if you will, is more what we call a human factors trial, basically button-pushing. Animas will have to do a supplemental human factors trial with pediatric patients, and then file that and they will have to wait until we receive a -- our approval, so they can reference our approve. Again, it's all about referencing an approved product. So there will be, yeah, there will be a gap.

你說得對。請記得，對於 Animas Vibe 而言，臨床試驗的要求（如果你願意這麼說）更像是我們所稱的人因（human factors）試驗，基本上就是按鍵操作。Animas 必須用兒科患者做一個補充的人因試驗，然後提交申請；而且他們必須等到我們收到——我們的核准，這樣他們才能引用我們的核准。再次強調，這一切都在於引用一個已核准的產品。所以會有——對，會有一段落差。

There'll be a gap.

會有一段落差。

Now, that doesn't mean that holds up the initial Vibe. They will go forward with the initial Vibe filing, you know, as soon as possible now. They won't wait until we get a Pedes indication, they'll have to supplement their PMA submission with a Pedes submission at some point down the road.

不過，那不代表會延誤最初版 Vibe。他們會盡快推進最初的 Vibe 申請，你知道的，越快越好。他們不會等到我們拿到兒科適應症；他們必須在未來某個時間點，以兒科申請來補充他們的 PMA 申請。

Okay. Okay. And then just in my last question, that's why I waited, jump back in and wait until the end, but if I look at the Animas deal, the way it is now from a reimbursement standpoint, it's great that you have daily reimbursement, they have their reimbursement set up, but if you think about them selling the pumps and you now have some international experience, but in the US, are you going to -- are they going to get the reimbursement approval for the CGM, and -- or are you going to do it, and then how do you get the product to the patient? Has that all been worked out, at this point?

好的。好的。那我最後一個問題——這也是我為什麼等到最後才插話——但如果我看現在的 Animas 合作案，從給付（reimbursement）的角度來看，你們有每日給付很棒，他們也已經建立了他們的給付流程；但如果你想到他們在賣幫浦，而你們現在也有一些國際經驗，但在美國，你們會——他們會去取得 CGM 的給付核准嗎？還是你們會去做？然後你們要怎麼把產品交到病人手上？到目前為止，這些都已經談妥了嗎？

I would tell you it's a to-be-determined, Bill. There's a contract in place, but we're exploring you know, different ways that we might make it more seamless for the patient.

Bill，我會告訴你，這還有待決定（to-be-determined）。合約已經在那裡了，但我們正在探索——你知道——不同的方法，讓病人的流程更無縫。

So, what I would tell you is, table that question until probably the next conference call and we'll have some more clarity there.

所以我會建議你把這個問題先擱置到下一次電話會議，屆時我們會更清楚。

Okay great, thanks.

好的，很好，謝謝。

From the reimbursement standpoint, you know, the HCPCS codes are established, so, there is a mechanism if we got approval tomorrow, say, as an example, and even this wasn't worked out, it's really from a patient convenience standpoint, not from a reimbursement standpoint.

從給付的角度來看，你知道，HCPCS 代碼已經建立，所以有一套機制；舉例來說，如果我們明天就拿到核准，即便這些細節還沒完全談妥，這其實是從病人便利性的角度，而不是從給付角度。

Right. All right, well again congratulations on a great quarter, and thanks for taking my questions.

對。好吧，再次恭喜你們這一季表現很棒，也謝謝你們回答我的問題。

Thanks, Bill.

謝謝你，Bill。

Thanks, Bill.

謝謝你，Bill。

Thank you, at this time we have no further questions.

謝謝。目前我們沒有其他問題。

So, I'd like to wrap it up. Needless to say I'm very proud of our accomplishments. There are very few companies with that successful a track record as DexCom. So, I look back over my career here. In 2007 we had revenue of less than $5 million. In 2012, that revenue had grown to $93 million, and here we are forecasting revenue of $120 million to $130 million this year, and we believe that we can sustain that 35%-plus kind of growth over the next several years.

那我想做個總結。不用說，我對我們的成就感到非常自豪。像 DexCom 這樣擁有如此成功紀錄的公司並不多。所以我回顧我在這裡的職涯：2007 年我們的營收不到 500 萬美元；到 2012 年，營收成長到 9,300 萬美元；而今年我們預估營收將達到 1.2 億到 1.3 億美元，我們也相信未來幾年可以維持 35% 以上的成長。

We are the technology leader in the CGM space, and we continue actually to extend our lead over the competition. Patients are walking in to their physician's offices today and asking for the G4 PLATINUM. We are moving the category from a nice-to-have to a must-have. The DexCom team and I are extremely excited about 2013, and certainly beyond, as well. Thank you.

我們是 CGM 領域的技術領導者，而且我們實際上仍在持續擴大相對於競爭對手的領先優勢。病人今天走進醫師診間，會主動要求 G4 PLATINUM。我們正在把這個品類從「有了更好」推進到「非有不可」。DexCom 團隊和我對 2013 年、以及更長遠的未來都感到非常興奮。謝謝。

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

謝謝各位女士、先生，今天的會議到此結束。感謝各位參與。您現在可以掛線。