使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Welcome to the DexCom 2013 first-quarter earnings conference call. My name is John, and I will be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Please note, the conference is being recorded. I will now turn the call over to Mr. Terry Gregg. Mr. Gregg, you may begin.
歡迎參加 DexCom 2013 年第一季財報電話會議。我叫 John,將擔任今天會議的接線員。目前所有與會者皆為僅收聽模式。稍後我們將進行問答環節。請注意,本次會議將被錄音。現在我將把電話交給 Terry Gregg 先生。Gregg 先生,您可以開始了。
- CEO
- CEO
Thank you, Operator, and thanks for joining us for this first-quarter 2013 conference call. I am going to ask Steve Pacelli to read our Safe Harbor Statement. Steve?
謝謝,接線員,也感謝各位參加我們 2013 年第一季的電話會議。我將請 Steve Pacelli 宣讀我們的「安全港聲明」。Steve?
- EVP of Strategy & Corporate Development
- EVP of Strategy & Corporate Development
Thanks, Terry.
謝謝你,Terry。
Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans, and performance, and speak only as of the [date provided]. 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 the section Risk Factors and elsewhere in our Annual Report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC. We undertake no obligation to update publicly or revise these forward-looking statements for any reason.
我們在今天電話會議中所做的部分陳述,可能構成前瞻性陳述。這些陳述反映管理層對未來事件、營運計畫與業績表現的預期,且僅截至所提供的[日期]為準。這些前瞻性陳述涉及多項風險與不確定性。可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單,已在我們的 Form 10-K 年度報告之「風險因素」章節及其他部分、Form 10-Q 季度報告,以及我們向美國證券交易委員會(SEC)提交的其他報告中詳述。我們不承擔因任何原因公開更新或修訂這些前瞻性陳述的義務。
Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash operating loss. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results, or superior to results, prepared in accordance with GAAP.
此外,我們將討論若干未依據 GAAP 編製的財務資訊,內容涉及我們的現金營運虧損。提供此等非 GAAP 資訊旨在增進各位對我們目前財務表現的整體理解。此額外資訊之呈現不應被孤立看待,亦不應作為依據 GAAP 編製之結果的替代,或被視為優於依據 GAAP 編製之結果。
Terry?
Terry?
- CEO
- CEO
Thank you, Steve. Joining me today are Kevin Sayer, our President and Chief Operating Officer; Jess Roper, our Chief Financial Officer; and Steve Pacelli, who you just heard from, our Executive Vice President of Strategy and Corporate Development.
謝謝你,Steve。今天與我一同出席的有:我們的總裁兼營運長 Kevin Sayer;財務長 Jess Roper;以及剛才各位聽到的 Steve Pacelli,我們的策略與企業發展執行副總裁。
As we just held our Q4 2012 earnings call in late February, today's call will be largely a financial update, with Kevin reviewing our first-quarter 2013 financial results, providing a brief operations update, I will then follow with some concluding thoughts. Kevin?
由於我們在 2 月下旬才剛舉行 2012 年第四季財報電話會議,今天的會議將主要是財務更新;Kevin 將回顧我們 2013 年第一季的財務結果並提供簡要的營運更新,接著我會做一些結語。Kevin?
- President & COO
- President & COO
Thank you, Terry. I will start with the financial update.
謝謝你,Terry。我先從財務更新開始。
DexCom generated $27.8 million in product revenue for the first quarter of 2013, compared to $18.6 million for the same quarter in 2012, a $9.2 million, or 49%, increase. Sequentially, product revenue for Q1 of 2013 decreased 12% from the prior quarter, which is consistent with the 11% decrease we experienced from Q4 of 2011 to Q1 of 2012. The seasonality is not unexpected, as annual insurance deductibles reset and flexible spending accounts are largely unfunded in Q1, requiring patients to spend more out-of-pocket dollars to obtain our products.
DexCom 於 2013 年第一季的產品營收為 2,780 萬美元,相較於 2012 年同季的 1,860 萬美元,增加 920 萬美元,或 49%。以季比而言,2013 年第一季產品營收較前一季下降 12%,與我們從 2011 年第四季到 2012 年第一季所經歷的 11% 降幅一致。此季節性並不意外,因為年度保險自付額在第一季重置,且彈性支出帳戶(FSA)在第一季多半尚未到位,導致病患為取得我們的產品需支付更多自付費用。
Total revenue for the first quarter of 2013 was $29.6 million, compared to $20.1 million during the same quarter in 2012. Our product gross profit totaled $15.4 million, generating a product gross margin of 55% for Q1 2013, compared to product gross profit of $9 million and a product gross margin of 49% for the same quarter in the prior year. As a reminder, product gross margin continues to be affected by a number of factors related to our G4 PLATINUM launch, including the impact of our $399 in-warranty upgrade program, which expired at the end of January; continued manufacturing scale-up activities for G4 PLATINUM; and the continued support of our SEVEN PLUS sensor manufacturing operations.
2013 年第一季總營收為 2,960 萬美元,相較於 2012 年同季的 2,010 萬美元。我們的產品毛利合計 1,540 萬美元,使 2013 年第一季產品毛利率達 55%,相較於前一年同季產品毛利 900 萬美元、產品毛利率 49%。提醒各位,產品毛利率仍持續受到多項與 G4 PLATINUM 上市相關因素影響,包括我們每台 399 美元的保固內升級方案(已於 1 月底到期)的影響;G4 PLATINUM 持續的製造擴產活動;以及對 SEVEN PLUS 感測器製造營運的持續支援。
Some final thoughts on our product revenues and our gross profits during Q1. Our split between consumable and durable revenues was, again, slightly more heavily weighted to durables in Q1, due primarily to existing patients upgrading to the G4 PLATINUM, with approximately 30% of our product revenue generated by sales of G4 PLATINUM hardware, and approximately 70% generated by sales of both, SEVEN PLUS and G4 PLATINUM sensors. ASP for sensors has increased slightly to a range of approximately $65 to $70 per sensor, and the ASP for our hardware continued at approximately $800 to $850 per starter kit.
關於第一季產品營收與毛利的最後幾點說明。我們在第一季的耗材與耐用品營收占比,再次略偏向耐用品,主要因既有病患升級至 G4 PLATINUM;約 30% 的產品營收來自 G4 PLATINUM 硬體銷售,約 70% 來自 SEVEN PLUS 與 G4 PLATINUM 感測器的銷售。感測器的平均銷售單價(ASP)小幅上升至每個感測器約 65 至 70 美元的區間,而我們硬體的 ASP 仍約為每套入門組 800 至 850 美元。
Our international business performance remained consistent in Q1, and continues to represent between 5% and 10% of product revenue, but remained somewhat overshadowed by our strong domestic growth. Research and development expense totaled $9.3 million for Q1 of 2013, which was flat compared to $9.4 million in Q1 of 2012. Sequentially, R&D expense was up 7%, as a result of increased spending on the development of our mobile platforms. We continue to expect that R&D expense for the full year will be relatively flat versus 2012. However, we will always consider adjusting our R&D spend to take advantage of near-term opportunities such as -- advanced integrated pump-CGM systems, mobile- and cloud-based data platforms, system performance improvements, all of the elements of our Gen5 system, and continued research on our G6 sensor platform.
我們的國際業務在第一季表現維持一致,且仍占產品營收約 5% 至 10%,但在我們強勁的美國本土成長之下仍略顯黯淡。2013 年第一季研發費用合計 930 萬美元,與 2012 年第一季的 940 萬美元相比持平。以季比而言,研發費用增加 7%,係因我們在行動平台開發上的支出增加。我們仍預期全年研發費用相較 2012 年將大致持平。然而,我們也會隨時考慮調整研發支出,以把握短期機會,例如——先進的整合式胰島素幫浦-CGM 系統、行動與雲端資料平台、系統效能改善、Gen5 系統的所有要素,以及對 G6 感測器平台的持續研究。
Selling, general and administrative expense totaled $18.1 million in Q1 of 2013, compared to $15.4 million during the same quarter in 2012. The increase primarily related to sales, administrative, and IT costs to support revenue growth. Of the $2.7 million increase, $400,000 of it is centered in non-cash share-based compensation. The remaining increase was primarily related to investments on the sales and marketing side of the business; in particular, the reorganization of our US field team and expanded headcount in our sales organization.
2013 年第一季銷售、一般及行政費用合計 1,810 萬美元,相較於 2012 年同季的 1,540 萬美元。增加主要與支援營收成長所需的銷售、行政與資訊科技(IT)成本相關。在增加的 270 萬美元中,有 40 萬美元屬於以股份為基礎之非現金薪酬。其餘增加主要與業務的銷售與行銷端投資相關;特別是我們美國外勤團隊的重整,以及銷售組織人力的擴編。
Our net loss for the first quarter of 2013 totaled $11.1 million and included $7.2 million in non-cash expenses centered in share-based compensation, depreciation, and amortization. Absent these non-cash charges, our operating loss for Q1 2013 would have been $3.7 million. Compare this cash operating loss of $3.7 million to a cash operating loss of $9.7 million in Q1 2012. We are pleased with our progress in driving the Company to profitability. Let me say it another way -- of the $9.2 million increase in sales from Q1 2012 to Q1 2013, $6 million dropped to the bottom line on a cash basis. Needless to say, we are excited about the long-term profitability profile we believe we can achieve here at DexCom. The business model is maturing as we planned. Our net loss per share for the quarter was $0.16. With respect to our balance sheet, we ended the first quarter with $45.3 million in cash and marketable securities (sic - see press release "$46.3 million"), down only $3.4 million from the end of 2012. Finally, we will reiterate our product revenue guidance for 2013 of $120 million to $130 million.
2013 年第一季淨損合計 1,110 萬美元,其中包含 720 萬美元的非現金費用,主要為以股份為基礎之薪酬、折舊與攤銷。若排除這些非現金費用,我們 2013 年第一季的營運虧損將為 370 萬美元。將此 370 萬美元的現金營運虧損與 2012 年第一季 970 萬美元的現金營運虧損相比。我們對推動公司邁向獲利所取得的進展感到滿意。換句話說——從 2012 年第一季到 2013 年第一季,銷售增加的 920 萬美元中,有 600 萬美元以現金基礎反映至最終損益。毋庸置疑,我們對 DexCom 長期可達成的獲利能力輪廓感到振奮。商業模式正如我們規劃般逐步成熟。本季每股淨損為 0.16 美元。就資產負債表而言,我們在第一季末持有的現金及有價證券為 4,530 萬美元(原文如此——見新聞稿「4,630 萬美元」),較 2012 年底僅減少 340 萬美元。最後,我們重申 2013 年產品營收指引為 1.2 億至 1.3 億美元。
Now, I will give you a business update. Turning to our business, we continue to be extremely pleased with the commercial launch of the G4 PLATINUM system. With its significantly improved accuracy, convenience and reliability, we believe that the G4 PLATINUM fulfills the potential of CGM as the first and most essential tool in the treatment of diabetes. Patient testimonials and blog postings regarding the performance of the system have been nothing short of remarkable. With G4 PLATINUM, we believe we have finally achieved the promise of CGM.
現在我將提供業務更新。就我們的業務而言,我們對 G4 PLATINUM 系統的商業上市持續感到非常滿意。憑藉其顯著提升的準確性、便利性與可靠性,我們相信 G4 PLATINUM 實現了 CGM 作為糖尿病治療中第一且最關鍵工具的潛力。病患對該系統表現的見證與部落格貼文可謂令人驚豔。透過 G4 PLATINUM,我們相信我們終於實現了 CGM 的承諾。
As we mentioned during our earnings call in late February, during the first quarter, we filed a PMA supplement with the Food and Drug Administration, seeking a pediatric indication for the G4 PLATINUM. We have also received CE Mark approval for pediatric patients and have begun marketing to pediatric patients in Europe. With respect to our US pediatric submission, similar to our previous filings, we continue to have a regular, open dialogue with FDA. We remain excited about the prospects of a pediatric indication, as it not only significantly expands the number of endocrinologists we can call on in the United States, we expect to be able to recommend our technology to patients as young as two years old, which will be a first for CGM. Many of our future-generation products, particularly our mobile- and cloud-based products, will be very applicable to this market segment. In particular, we continue to make considerable progress on the DexCom Share system, a remote monitoring system developed to address the unique challenges faced by caregivers in assisting people with Type 1 diabetes.
如同我們在二月底的財報電話會議中提到的,在第一季期間,我們已向美國食品藥物管理局(FDA)提交一份PMA補充申請,尋求G4 PLATINUM的兒科適應症。我們也已取得針對兒科患者的CE Mark核准,並已開始在歐洲向兒科患者進行行銷。就我們在美國的兒科申請而言,與我們先前的申報類似,我們持續與FDA保持定期且公開的對話。我們對兒科適應症的前景仍感到振奮,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患者,這將是連續血糖監測(CGM)領域的首例。我們許多下一代產品,特別是以行動與雲端為基礎的產品,將非常適用於此市場區隔。尤其是,我們在DexCom Share系統(為解決照護者在協助第一型糖尿病患者時所面臨的獨特挑戰而開發的遠端監測系統)方面持續取得相當可觀的進展。
As a reminder, the DexCom Share system is a docking station for the G4 PLATINUM receiver, enabling wireless transmission and 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. For example, a parent could receive their child's glucose information during the nighttime while they sleep in another room, or during the school day while the parent is at work. It will also have non-pediatric applications, such as for a spouse while at work or when traveling. We expect to file the DexCom Share system with the FDA in the third quarter this year.
提醒一下,DexCom Share系統是一個用於G4 PLATINUM接收器的底座,可讓G4 PLATINUM的血糖資訊(例如患者的趨勢圖與警示通知)以無線方式傳輸至指定接收者,使接收者能在智慧型手機上查看患者資料。例如,父母可以在夜間孩子睡在另一個房間時接收其血糖資訊,或在上學日父母上班時接收。它也可用於非兒科情境,例如配偶在上班或旅行時使用。我們預期將於今年第三季向FDA提交DexCom Share系統的申請。
On the International front, we are pleased to report that we have received approval from Health Canada to begin marketing the G4 system in Canada. Our initial approval is for adults only; however, we expect to file a supplement seeking pediatric approval later this quarter. Our distributor in Canada expects to commence a limited launch at the beginning of Q3, with a full launch commencing before the end of Q3.
在國際市場方面,我們很高興報告已獲加拿大衛生部(Health Canada)核准,得以開始在加拿大行銷G4系統。我們的初始核准僅適用於成人;然而,我們預期將於本季稍晚提交補充申請以尋求兒科核准。我們在加拿大的經銷商預期將於第三季初開始有限度上市,並在第三季結束前展開全面上市。
We also continue to explore opportunities in China, Japan, and other Asian geographies during the first quarter, and we had a number of productive meetings with potential business partners in both China and Japan. We are currently evaluating potential partners and better educating ourselves on the most prudent regulatory path into these countries. By the end of the year, we expect to be commercial in up to 30 countries worldwide, compared to approximately 20 at the end of 2012.
我們在第一季也持續探索中國、日本及其他亞洲地區的機會,並在中國與日本與潛在商業夥伴進行了多場富有成效的會議。我們目前正在評估潛在合作夥伴,並更深入了解進入這些國家最審慎的法規途徑。到今年年底,我們預期可在全球多達30個國家實現商業化,相較於2012年底約20個國家。
We continue development on the Gen5 system, working on an approved applicator, combined with a mobile phone interface. The FDA has been very cooperative with us regarding our efforts to develop a mobile CGM platform. The path is becoming more clear with each and every step we take. For example, the share product in this data platform represents a very well thought out and deliberate approach for our first connected product offering.
我們持續推進Gen5系統的開發,著手於一款已核准的施用器,並結合手機介面。FDA在我們開發行動CGM平台的努力上一直非常配合。隨著我們每一步的推進,路徑也愈發清晰。例如,在此資料平台中的Share產品,代表了我們針對首款連網產品所採取的周延且審慎的策略。
Shifting to our integration partnerships, we are pleased to report that Animas has filed the PMA with the FDA, seeking approval of the Animas Vibe system in the US. Animas continues to commercialize the Animas Vibe system in Europe and has reported strong success where the product has launched. We continue to work diligently with Tandem Diabetes Care to incorporate the G4 PLATINUM into a next-generation version of Tandem's t-slim, and we expect to be in a position to assist Tandem in filing a PMA with the Food and Drug Administration before the end of this year.
轉到我們的整合合作夥伴關係,我們很高興報告Animas已向FDA提交PMA,尋求Animas Vibe系統在美國的核准。Animas持續在歐洲商業化Animas Vibe系統,並回報該產品在已上市地區取得強勁成功。我們也持續與Tandem Diabetes Care密切合作,將G4 PLATINUM整合至Tandem之t-slim的下一代版本中,並預期在今年年底前能協助Tandem向美國食品藥物管理局提交PMA。
Finally, on the Edwards front, to quote Edwards CEO, Michael Mussallem -- we remain enthusiastic about the significant opportunity represented by our GlucoClear system, end quote. As we mentioned during our Q4 earnings call, we don't expect significant sales for GlucoClear this year. However, Edwards management expects 2013 to be a pivotal year, as Edwards completes additional studies in Europe and gains greater clarity on the path towards US approval. We remain enthusiastic about the significant 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,引用Edwards執行長Michael Mussallem的話——「我們仍對GlucoClear系統所代表的重大機會感到振奮」,引述完畢。如同我們在第四季財報電話會議中提到的,我們不預期GlucoClear在今年會有顯著銷售。然而,Edwards管理團隊預期2013年將是關鍵的一年,因為Edwards將在歐洲完成更多研究,並對通往美國核准的路徑取得更清晰的方向。我們仍對此技術所代表的重大機會感到振奮,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,持續提供支持。
I would now like to turn the call over to Terry for some concluding remarks. Terry?
接下來我想把電話交給Terry做一些結語。Terry?
- CEO
- CEO
Thanks, Kevin.
謝謝你,Kevin。
As I reflect upon the six months after our launch of the G4 PLATINUM, we have learned a number of important things. Accuracy is everything. The data demonstrates that the sensor is 20% more accurate in the 40-to-400 range, and 30% more accurate below 70 milligrams per deciliter, which is especially important to the detect hypoglycemia. While we believe accuracy is essential, we have also learned that the overall patient experience is what truly matters. We believe that our best-in-class accuracy and reliability empowers people to take control of their diabetes.
回顧G4 PLATINUM上市後的六個月,我們學到了幾件重要的事。準確度就是一切。數據顯示,該感測器在40到400的範圍內準確度提升20%,在低於每分升70毫克時準確度提升30%,這對偵測低血糖尤其重要。雖然我們相信準確度至關重要,但我們也了解到,整體患者體驗才是真正重要的。我們相信,我們同級最佳的準確度與可靠性,能賦能人們掌控自己的糖尿病。
G4 PLATINUM has set a new standard by which all future sensor technologies will be measured. In fact, just a few weeks ago, at a National Institutes of Health sponsored meeting on the development of an artificial pancreas, investigators from Boston University and Mass General Hospital reported the results of a 24-patient comparative study between Medtronic's Enlite Sensor, the Abbott Navigator Sensor, and the DexCom G4 PLATINUM.
G4 PLATINUM已建立一個新的標準,未來所有感測器技術都將以此作為衡量基準。事實上,就在幾週前,在一場由美國國家衛生研究院(NIH)贊助、關於人工胰臟開發的會議上,波士頓大學與麻省總醫院的研究人員報告了一項24名患者的比較研究結果,對比了美敦力(Medtronic)的Enlite感測器、雅培(Abbott)的Navigator感測器,以及DexCom G4 PLATINUM。
The researchers reported an MARD, or mean aptitude relative difference, of 17.9% for the Enlite, a 12.5% MARD for the Navigator, and a 10.8% MARD for the G4 PLATINUM -- a 10.8% MARD for G4. The researchers are currently completing a small outpatient study of an artificial pancreas system using the G4 PLATINUM and have received IDE approval for a larger follow-up study to be conducted at two New England diabetes camps this summer. But, we are certainly not stopping here. Prior to the G4 PLATINUM launch, we went several years without a new product introduction. That will not happen again. As Kevin highlighted, just this year we have filed for pediatric indication, we supported Animas in filing the Animas Vibe system, we have committed to filing the DexCom Share system in Q3, and assisting Tandem in filing a sensor-pump combination system before year end.
研究人員報告Enlite的MARD(mean absolute relative difference,平均絕對相對差異)為17.9%,Navigator的MARD為12.5%,而G4 PLATINUM的MARD為10.8%——也就是G4的MARD為10.8%。研究人員目前正在完成一項使用G4 PLATINUM之人工胰臟系統的小型門診研究,並已取得IDE核准,將於今年夏天在新英格蘭的兩個糖尿病夏令營進行更大規模的後續研究。不過,我們當然不會就此止步。在G4 PLATINUM上市之前,我們曾有好幾年沒有推出新產品。這種情況不會再發生。正如Kevin所強調的,僅在今年,我們已申請兒科適應症、支持Animas提交Animas Vibe系統申請、承諾在第三季提交DexCom Share系統,並在年底前協助Tandem提交感測器—幫浦組合系統的申請。
I am also pleased to report that we have completed development of a next-generation algorithm for the G4 PLATINUM to further improve our sensor performance and, we expect to file a PMA supplement for the new algorithm late this year or early next. So, we have the potential for up to five new product introductions in the next 12 to 18 months. All of these introductions are incremental steps towards our ultimate goal of replacing finger sticks.
我也很高興報告,我們已完成G4 PLATINUM的下一代演算法開發,以進一步提升感測器效能,並預期將於今年稍晚或明年初為新演算法提交PMA補充申請。因此,在未來12到18個月內,我們有機會推出多達五項新產品。所有這些推出都是朝向我們最終目標——取代指尖採血——所邁出的漸進步驟。
We entered 2013 with our principal message to the diabetes community of CGM first, targeted to both patients and professionals. Simply stated, CGM should be the first tool you use when treating diabetes. CGM is the best tool to determine a patient's glycemic variability and the best tool to understand the action of insulin and other anti-diabetes agents in improving glucose control, independent of how these agents are delivered. Our field team has been very effective in delivering that message. And while largely anecdotal, we believe a number of physicians are beginning to embrace the G4 PLATINUM as a front-line tool, in large part because of its convenience and simplicity, in addition to its exquisite accuracy.
我們在2013年進入市場時,向糖尿病社群傳達的核心訊息是「CGM優先」,同時面向患者與專業人士。簡而言之,在治療糖尿病時,CGM應該是你首先使用的工具。CGM是判斷患者血糖變異度的最佳工具,也是了解胰島素及其他抗糖尿病藥物在改善血糖控制方面作用機制的最佳工具,且不受這些藥物如何給藥的影響。我們的外勤團隊在傳遞這項訊息方面非常有效。雖然多屬軼事性觀察,我們相信不少醫師正開始將G4 PLATINUM視為第一線工具,主要原因在於其便利性與簡易性,再加上其極高的準確度。
Our second goal this year is to improve our outreach about the benefits of the G4 PLATINUM. A recent survey of approximately 300 patients indicated that for about 70% of the SEVEN PLUS respondents, their physician was the most influential driver in choosing CGM, where only 50% of the G4 PLATINUM respondents cited their physician as the driving factor. This supports our belief that we are experiencing an increase in patient-to-patient communication as a key factor in the uptick of CGM adoption.
我們今年的第二個目標,是加強我們對G4 PLATINUM效益的推廣。近期一項約300名患者的調查顯示,在SEVEN PLUS受訪者中,約70%表示其醫師是選擇CGM最具影響力的推動因素;但在G4 PLATINUM受訪者中,僅有50%將醫師視為主要驅動因素。這支持了我們的看法:患者之間的口碑交流正成為推動CGM採用率上升的關鍵因素之一。
Finally, a brief comment on Type 2 patients and CGM use. When I mentioned glycemic variability earlier, I was not restricting my comments to only Type 1 patients. Excessive glycemic variability occurs in both Type 1 and Type 2 patients. And lately, excessive glycemic variability is getting a lot of negative recognition in the literature, with reduction of glycemic variability cited as potentially more impactful than reduction of A1c to improve diabetes management.
最後,簡要談一下第二型糖尿病患者與 CGM 的使用。先前我提到血糖變異度時,並不是把我的評論侷限於第一型患者。過度的血糖變異度同時發生在第一型與第二型患者身上。而近來,文獻中對過度血糖變異度的負面關注愈來愈多,並指出降低血糖變異度可能比降低 A1c 更能改善糖尿病管理。
Several studies have linked excessive glycemic variability to adverse health outcomes, including diminished cognitive function, retinopathy, and increased cardiovascular disease. While we know that chronic elevated glucose levels contribute to the adverse clinical outcomes associated with diabetes, including both micro- and macro-vascular conditions, but acute daily glycemic variability is now being identified as causing oxidative stress, believed to be the underlying cause of these long-term complications.
多項研究已將過度血糖變異度與不良健康結果連結在一起,包括認知功能下降、視網膜病變,以及心血管疾病風險增加。我們知道,長期血糖偏高會導致與糖尿病相關的不良臨床結果,包括微血管與大血管疾病;但如今也逐漸確認,日常急性血糖波動會造成氧化壓力,而氧化壓力被認為是這些長期併發症的根本原因。
And, we are seeing an increase in the number of private payers covering insulin-using Type 2 patients. In just the last year, 12 payers of approximately 20-million covered lives have admitted their policies to provide coverage for Type 2 patients, and this is in addition to both CIGNA and Anthem, who have had policy in place. CGM is the only tool to determine the level of glycemic variability in order to take corrective action to improve glucose control. We believe our future is very bright.
此外,我們也看到承保使用胰島素之第二型患者的民間保險支付方數量正在增加。僅在過去一年,就有約 2,000 萬名承保人數所涵蓋的 12 家支付方調整其政策,提供第二型患者的給付;這還不包含早已制定相關政策的 CIGNA 與 Anthem。CGM 是唯一能用來判定血糖變異度程度、以便採取矯正措施改善血糖控制的工具。我們相信我們的未來非常光明。
Thank you, and we will now open it up for questions.
謝謝各位,接下來我們開放提問。
Operator
Operator
(Operator Instructions)
(接線員指示)
Thom Gunderson, Piper Jaffray.
Thom Gunderson,Piper Jaffray。
- Analyst
- Analyst
Just a quick clarification on the last part, Terry. I think you said 20-million covered lives for the 12 payers in T2 -- that's in addition to whatever covered lives you have for CIGNA or Aetna, or including?
Terry,針對最後一段我想快速釐清一下。我記得你說第二型(T2)那 12 家支付方合計約 2,000 萬名承保人數——這是另外加上你們在 CIGNA 或 Aetna 的承保人數,還是已經包含在內?
- CEO
- CEO
That is in addition to -- that is just in the last 12 months, Thom.
那是另外加上的——那只是過去 12 個月內的,Thom。
- Analyst
- Analyst
Got it.
了解。
- CEO
- CEO
So, you're seeing that improved, obviously, we knew that CIGNA, Anthem had established coverage, but this is new. This is primarily the responsibility of our managed care group, they have done an outstanding job of improving that policy coverage.
所以你們顯然看到改善;我們知道 CIGNA、Anthem 早就建立了給付,但這些是新的。這主要是我們的醫療保險管理團隊的功勞,他們在改善這些政策給付方面做得非常出色。
- Analyst
- Analyst
I know these are difficult, if not impossible, to count, but do you want to venture a guess as to what percentage of your sales is going to Type 2?
我知道這很難、甚至不可能精確統計,但你願不願意猜一下,你們的銷售有多少比例是賣給第二型?
- CEO
- CEO
It would, at this point still, in my opinion, be de minimus.
以目前來看,我認為仍然是微不足道(de minimis)。
- Analyst
- Analyst
Okay. Then maybe, one of you could talk about how the change in the sales field force is going? The reorg and the expanded headcount -- like clinical associates being shifted over to territory people? Give us a little more color on that if you could?
好。那也許你們其中一位可以談談銷售外勤團隊的變動進展如何?重整與擴編人數——例如臨床助理轉到區域業務人員——如果可以的話,請多提供一些細節?
- President & COO
- President & COO
Yes, Tom, this is Kevin. I will take that.
好的,Tom,我是 Kevin。我來回答。
We have -- with the exception of just a couple slots, we have filled the entire organization -- the additional 20 territories that we had outlined. Our sales reps, who have converted over, are all doing extremely well. The talent available to us, with our business and our product, has been outstanding. We have added some absolutely fabulous people who have hit the ground running. Most all of our territories are performing the way we expected them to. We are off to the races.
我們——除了少數幾個職缺外——已經把整個組織都補齊了,也就是我們先前提到新增的 20 個銷售區域。我們轉任過來的業務代表表現都非常好。以我們的業務與產品而言,可供我們延攬的人才非常優秀。我們加入了一些非常出色的人,他們一上任就立刻上手。幾乎所有區域的表現都符合我們的預期。我們已經全速前進。
With respect to the clinical aspect, our patient care team is what we had put together, in essence, to replace those clinical specialists in the field. We have expanded that from 4 to 12 people who work the phones continually and have a very structured program, with respect to contacting our new patients, and sometimes taking educational calls from those who have been patients for a longer period of time, versus our normal tech services group, which responds to product issues. And I can tel you, that group is fully staffed and doing very well, also. And, everything is clicking the way we wanted it to.
在臨床面向方面,我們的病患照護團隊基本上就是為了取代外勤的臨床專員而建立的。我們已將人數從 4 人擴增到 12 人,他們持續接聽電話,並有一套非常結構化的計畫,用於聯繫新病患;有時也會接聽使用較久的病患之教育性來電。這與我們一般的技術服務團隊不同,後者主要回應產品問題。我可以告訴你,那個團隊也已滿編且運作得非常好。而且一切都如我們所希望的那樣順利運轉。
- Analyst
- Analyst
Got it. And then, my last question and I'll let some others. ADA is a ways off in June, and yet we won't have one of these calls until after that. Are there any highlights or things we should look for at ADA that would be interesting to DexCom investors?
了解。那我最後一個問題,之後我就讓其他人提問。ADA 要到六月才舉行,還有一段時間,但我們下一次電話會議要等到那之後才會有。對 DexCom 投資人而言,在 ADA 上有沒有任何亮點或值得關注的事情?
- CEO
- CEO
It is an interesting question, Thom, and I would just say that I think the influence of the artificial pancreas group, certainly, will be on the podium talking about their experiences. As you know, in that environment, everything is kind of geared toward the artificial pancreas arena from the scientific community. So that, for us, will probably be the highlight, especially given that we are in 22 out of approximately 25 artificial pancreas programs around the world. So, that would be the highlight for us. Outside of that, I am not aware of anything, in particular, that you should be looking for.
這是個有意思的問題,Thom。我只能說,我認為人工胰臟團隊的影響力,肯定會在台上分享他們的經驗。如你所知,在那樣的環境裡,科學界的焦點幾乎都朝向人工胰臟領域。因此,對我們而言,那可能會是亮點,尤其是我們在全球約 25 個人工胰臟計畫中參與了 22 個。所以,這會是我們的重點。除此之外,我沒有特別知道你還需要關注什麼。
- Analyst
- Analyst
Got it. Thank you, guys.
了解。謝謝各位。
Operator
Operator
Ben Andrew, William Blair.
Ben Andrew,William Blair。
- Analyst
- Analyst
A few questions for me, please. First, Terry, talk a little bit about peds roll-out, and I think we are at 15% to 20% of your installed base in ASPs. What should that be, say, in one year from now?
我這邊有幾個問題。首先,Terry,請談談兒科(peds)推廣的進展。我想目前在你們的裝機基礎中,ASP(兒科內分泌專科醫師)大約占 15% 到 20%。那麼一年後大概應該到多少?
- CEO
- CEO
30%.
30%。
- Analyst
- Analyst
Okay, and what does it take to get there? Is it just getting in front of the endos and they already know the product, they just need detail? Is it -- take staffing? What sort of movements on the part of DexCom will that require?
好的,那要怎麼達到?只是去拜訪內分泌科醫師(endos),他們已經知道產品、只需要更詳細的資訊?還是需要增加人力?DexCom 需要做哪些動作才能達成?
- CEO
- CEO
First of all, to get an approval.
首先,要先取得核准。
And second, beyond that, just get in front of them. Luckily, that it is a rare situation in which there is a solo practitioner with a pediatric endocrinology practice. They're generally grouped with young adults and adults, or in, at least, close proximity. So, that won't require adding new bodies to our group, beyond what we have done in the reorg, so we are not going to be looking at substantial windshield time by the sales group. It is just the ability to go call on them, on a routine basis, and talk about the benefits of the G4 PLATINUM. Many of them know it already; but like anything, the more shots on goal, the more pucks go in, kind of attitude. So, this will be the first time that we have been able to call on that sector.
第二,除此之外,就是去拜訪他們。幸運的是,很少會出現只有單一執業者的兒科內分泌門診;他們通常會與青少年、年輕成人與成人的團隊一起,或至少地理位置很接近。因此,除了我們在重整中已做的擴編之外,不需要再額外增加人手;銷售團隊也不會需要大量的奔波時間。重點只是能夠例行性地拜訪他們,並談 G4 PLATINUM 的效益。很多人其實已經知道;但就像任何事情一樣,射門次數越多,進球就越多——大概就是這種心態。所以,這將是我們第一次能夠針對那個族群進行拜訪。
- Analyst
- Analyst
Okay. Terry, any information content yet, in the six months since the launch, about utilization trends or patient retention from G4, other than anecdotal commentary?
好的。Terry,自從上市六個月以來,除了軼聞式的評論之外,你們是否已有任何關於 G4 的使用趨勢或病患留存的資訊內容?
- CEO
- CEO
No, not really. I think we need at least one quarter or two to truly understand. We have stated earlier, and it has been truly anecdotal, the feeling it looks like they are using it -- they being patients -- using the product more frequently, and I cannot attribute directly, as that. More patients using it without taking a holiday -- we certainly -- reading the blog's is the best metric that we have right now. There is great utilization from that standpoint, greater confidence in the product, but beyond that, it is hard to come up with the qualitative or quantitative metrics on that, Ben.
沒有,還沒有。我認為我們至少需要一到兩個季度才能真正了解。我們之前提過,而且確實只是軼聞觀察,感覺看起來他們——也就是病患——更頻繁地使用產品;但我無法直接歸因。更多病患在使用時不再「放假」停用——我們目前最好的指標其實是看部落格。從那個角度看,使用度很高,對產品的信心也更強;但除此之外,要提出質化或量化的指標仍然很難,Ben。
- Analyst
- Analyst
Okay. Then finally, can you talk a little bit about the next-generation algorithm for the G4? What does that bring you, in order of magnitude, improvement of MARD, or other features? Thank you.
好的。最後,能否談談 G4 的下一代演算法?它能帶來什麼?例如 MARD 的改善幅度大概是多少,或其他功能?謝謝。
- CEO
- CEO
Yes, I can tell you that, overall, it is going to improve the MARD by about 2 points, from the 40-to-400 and day one through day seven. That's important because if you look at what the folks at Boston University and Mass General, they are at 10.8%.We certainly think we can get -- and what we published with the FDA was 13% MARD, so if we could get down into that overall range of around 11%, we would be sub-10% at some point during the week, because as you know, DexCom sensors get better over time. So, day four is better than day one and day seven is usually as good as day four, if not better. So, we are excited about that opportunity to improve the outcome of that.
可以。我可以告訴你,整體而言,它會把 MARD 改善大約 2 個百分點,涵蓋 40 到 400 的範圍,以及第 1 天到第 7 天。這很重要,因為如果你看波士頓大學與麻省總醫院那些團隊,他們是 10.8%。我們當然認為我們可以做到——而我們向 FDA 發表(published)的數據是 13% MARD,所以如果我們能把整體降到大約 11% 的區間,那麼在一週中的某些時點我們就會低於 10%,因為如你所知,DexCom 感測器會隨時間變得更好。因此,第 4 天比第 1 天更好,而第 7 天通常跟第 4 天一樣好、甚至更好。所以,我們對這個改善結果的機會感到很興奮。
- Analyst
- Analyst
Thank you.
謝謝。
Operator
Operator
Bill Plovanic, Canaccord.
Bill Plovanic,Canaccord。
- Analyst
- Analyst
Congratulations on a solid quarter. I would like to lever off Ben's question, there. As you look at G4, you have talked about new product launches, we talked about ped, when would we expect this new algorithm to come? I think I missed that in the prepared remarks.
恭喜你們交出一個穩健的季度。我想延伸一下 Ben 剛才的問題。談到 G4,你們提過新產品上市,我們也談到 ped,那麼這個新演算法預計什麼時候會推出?我想我在事先準備的發言裡漏聽了這一段。
- President & COO
- President & COO
We hope to file it, certainly, like fourth quarter or early 2014, and it would come sometime after that. And then, as Terry said earlier, that is really an accuracy enhancement for us. So, we don't have any real launch plans to share with you on that, but that will come out and be approved sometime next year.
我們希望能在第四季或 2014 年初提出申請,之後會在某個時間點推出。然後,如 Terry 先前所說,這對我們而言主要是精準度的提升。所以目前沒有具體的上市計畫可以跟各位分享,但它會在明年某個時候推出並獲得核准。
- Analyst
- Analyst
Is that what the study -- the 24-patient study that you referenced, Terry, is that what they used?
那這是否就是你提到的那個研究——Terry,你所引用的 24 位病患研究,他們用的就是這個嗎?
- CEO
- CEO
No, they're just using G4 PLATINUM. Originally, we developed part of this algorithm as part of an AP project. And then, like everything we do, we expanded that. If it is good enough for that project and we get comfortable with it, it is certainly something we want to incorporate for everybody. So, that is how it kind of evolved over time, and we got excited.
不是,他們只是使用 G4 PLATINUM。我們最初是在一個 AP 專案中開發了這個演算法的一部分。然後,就像我們做的所有事情一樣,我們把它擴展了。如果它對那個專案已經夠好、而且我們也對它感到放心,那當然就是我們希望納入、讓所有人都能使用的東西。所以它就是這樣隨著時間逐步演進,我們也因此感到很興奮。
- Analyst
- Analyst
Okay. And then, you have gone through the G4 upgrade. How many customers are left to upgrade, and did you have a lot of the $399s this quarter?
了解。接著,你們已經推動了 G4 升級。還有多少客戶尚未升級?另外,本季有很多 399 美元的升級方案嗎?
- President & COO
- President & COO
We had a good number -- it wasn't unexpectedly high or low. It was a piece of it. It had a little bit of a negative impact on margins, but not a whole lot. What we have seen, Bill, is quite a few have upgraded. What we have also seen is a lot of them are waiting until they're out of warranty because they want insurance to cover that purchase of the new system. While the $399 upgrade is appealing to a number of people, a lot of people who manage their diabetes dollars very closely, and they are waiting until where they can get the upgrade.
數量不少——但沒有特別高或特別低,符合預期。它占了一部分。對毛利率有一點負面影響,但不算太大。Bill,我們看到相當多的人已經升級。我們也看到很多人會等到保固期結束,因為他們希望由保險來支付新系統的購買。雖然 399 美元的升級對不少人很有吸引力,但也有很多非常精打細算管理糖尿病支出的人,會等到能透過保險取得升級的時點。
What we have also noticed with those customers on the SEVEN PLUS side is they are bleeding through every sensor they have in their closet and everything they have on their shelf, and their reorder numbers are actually lower than what we have experienced, historically, because they don't want up grade with any SEVEN PLUS sensor sitting on the shelf. So, what we are seeing is a rapid conversion in our sales numbers to Gen4 sensors, probably faster than we have converted on the hardware side, as people are using up the stock that they have.
我們也注意到,那些使用 SEVEN PLUS 的客戶正在把家裡衣櫃裡、架子上所有的感測器都用完,他們的再訂購數量其實比我們過去的歷史經驗還低,因為他們不想在架上還有任何 SEVEN PLUS 感測器的情況下就升級。所以我們看到的是:在銷售數據上,向 Gen4 感測器的轉換非常快速,可能比硬體端的轉換還要快,因為大家正在把手上的庫存用完。
- Analyst
- Analyst
Okay. And then, I have got a ton of questions, but I'll ask one more and let it slide. As you look at gross margins, do you still think the peak on the disposal is 70%, 75% by the end of this year? And then, where are the controller receiver, transmitter receiver margins today? And, where do you think those can go? That's my questions, thanks.
了解。然後我其實還有一堆問題,但我再問一個就先讓給其他人。就毛利率來看,你們仍然認為耗材的高點會在今年底達到 70% 到 75% 嗎?另外,控制器/接收器、發射器/接收器的毛利率目前大概是多少?你們覺得未來可以到哪裡?以上,謝謝。
- President & COO
- President & COO
We are never going to have fabulous electronics type margins on the transmitter and receiver. We don't build enough of them at this point in time. When we have had a lot of discussions with some of the cell phone manufacturers, and one of them told us they design a SKU, they build 55 million of them, and they shut down the line, they never build it again. We cannot quite do that and get those kinds of efficiencies. We are very convinced that we can get our Gen4 sensor margins up in the 70% to 75% range, and we can even go better than that as volumes permit us, over time. And, the hardware margins will be what they are. They are less than those. They will never get to 75%.
我們在發射器和接收器這類電子產品上,永遠不會有非常驚人的毛利率。因為以目前來說,我們的產量還不夠大。我們曾和一些手機製造商討論,其中一家告訴我們,他們設計一個 SKU,生產 5,500 萬台,然後就把產線關掉,再也不生產那個型號。我們無法做到那樣,因此也就無法取得那種效率。我們非常有信心,Gen4 感測器的毛利率可以提升到 70% 到 75% 的區間,隨著量能允許,長期甚至可以更高。而硬體毛利率就是它本來的樣子,會低於感測器,不可能到 75%。
- Analyst
- Analyst
Should we, as we think about them, always kind of float around maybe a 50% range?
所以我們在思考硬體毛利率時,是不是可以假設它大致會落在 50% 左右的區間?
- President & COO
- President & COO
Yes, that's fair.
是的,這樣說很合理。
- Analyst
- Analyst
Thank you.
謝謝。
Operator
Operator
Jayson Bedford, Raymond James.
Jayson Bedford,Raymond James。
- Analyst
- Analyst
Any way you could talk about growth in shipments to new patients in the quarter?
你們能否談談本季出貨給新病患的成長情況?
- President & COO
- President & COO
The new patient pattern is consistent with what we had during most of Q4. We do have upgrades -- we've always had upgrades, and they have always been a reasonable part of our sales. But, we have a lot of new patients coming on as well, we really don't have any numbers to share today. It's been very strong.
新病患的趨勢與我們在第四季大部分時間看到的情況一致。我們確實有升級——我們一直都有升級,而且升級一直是我們銷售中合理的一部分。但同時也有很多新病患加入;我們今天沒有具體數字可以分享,只能說表現非常強勁。
- Analyst
- Analyst
Right. And then, in terms of the sales force reorg, there, have the reps either been able to go deeper into existing counts, or are you finding the reps being able to open up new accounts? I guess, it is a way of asking the install base --?
了解。那在銷售團隊重整方面,業務代表是能更深入既有客戶,還是更能開拓新客戶?我想問的是裝機基礎——?
- President & COO
- President & COO
Yes, I'll take it first, and then Terry's been out in the field, also. What I have seen in the times I've had is our guys are going a lot deeper into a lot of accounts where they have been before because of the performance and the accepts of this product by the patients that a lot of our long-time physicians are seeing, is they prescribe Gen4, the reaction they're getting is -- oh my gosh, this thing is wonderful, and they are prescribing a lot more. We are getting broader coverage as well. My observation, again anecdotally, I don't have numbers sitting here, is we are going a lot deeper with our existing physician base.
是的,我先回答,然後 Terry 也一直在外勤。我看到的是,我們的同仁在許多既有帳戶中深入得多,因為病患對這個產品的表現與接受度,讓許多長期合作的醫師看在眼裡;他們開立 Gen4 後得到的回饋是——天啊,這東西太棒了——因此他們開立得更多。我們也獲得更廣的覆蓋。我的觀察同樣是軼聞性的,我手上沒有數字,但我們確實在既有醫師基礎上挖得更深。
Terry, you want to --?
Terry,你要補充嗎——?
- CEO
- CEO
Certainly, each year we target a particular message. As I indicated in my prepared remarks, CGM first is the message of 2013, and with [outreach] patient-to-patient communication. But within the CGM first, we are beginning to see traction. I mentioned it was anecdotal as we get information back from the field force. But certainly, they are spending much more time in each office than they historically have because the physicians are willing to give them more patients. Historically, it has always been much of a, unfortunately, a pump-centric type of environment in which they have had to operate, and we are moving the needle on that. We have not moved it dramatically, but we are moving the needle, so as a result of that, they are spending more time.
當然。每一年我們都會鎖定一個特定訊息。如我在事先準備的發言中提到,2013 年的訊息是「CGM 優先」,並搭配[外展]的病患對病患溝通。在「CGM 優先」這個主軸下,我們開始看到一些進展。我提到這是軼聞性的,因為我們是從外勤團隊回傳的資訊得知。但可以確定的是,他們在每一家診所停留的時間比以往更長,因為醫師願意提供更多病患。過去他們不得不在一個以幫浦為中心的環境中運作,老實說這很不利,而我們正在改變這個狀況。我們還沒有大幅改變,但確實正在推動,因此他們花的時間也更多。
And as Kevin said, that means that they're going deeper into each of those accounts. And again, in many of these accounts, there are multiple endocrinologists. It would be sufficient to say that not every single endocrinologist's in a particular group practice would necessarily be prescribing any technology, for that matter, let alone CGM, so they are broadening, even within a group practice of endocrinology, to call on more physicians. And of course, then, in relationships with our partners, often times, they call on a, in some cases high-insulin prescribing physicians who are not endocrinologists -- you could certainly think that there were diabetologists, but we are beginning to see scripts come from those as well. That's a little hard to make a judgment, how much is coming in from patient-to-patient, or how much is coming in from a referral from either a Tandem, or a Animas, or even, Roche partner.
而如 Kevin 所說,這代表他們在每個帳戶都挖得更深。再者,在許多帳戶中其實有多位內分泌科醫師。可以說,在同一個團體診所裡,未必每一位內分泌科醫師都會開立任何技術產品,更不用說 CGM,因此他們也在同一個內分泌科團體內擴大拜訪更多醫師。當然,透過我們與合作夥伴的關係,他們有時也會拜訪一些(在某些情況下)高胰島素處方量、但不是內分泌科的醫師——你當然可以把他們視為糖尿病專科醫師——我們也開始看到這些醫師開出的處方。不過要判斷其中有多少來自病患對病患的推動、或有多少來自 Tandem、Animas,甚至 Roche 夥伴的轉介,會比較困難。
- Analyst
- Analyst
That's helpful. Just last one for me, and I will jump back in queue. Just to clarify, the comment on utilization -- is it fair to assume that it's stable? It's not going down or up, at least, on the G4, it's largely stable from what you have seen?
這很有幫助。我最後一個問題,問完我就回到隊列。想確認一下你們對使用率的評論——是否可以合理假設它是穩定的?至少在 G4 上,你們看到的基本上是穩定,沒有下降或上升?
- CEO
- CEO
At the very least, it is stable.
至少可以說是穩定的。
- Analyst
- Analyst
Okay, thank you.
好,謝謝。
Operator
Operator
Mimi Pham, ABR-HealthCo.
Mimi Pham,ABR-HealthCo。
- Analyst
- Analyst
Just, I guess, a different way of asking the prior question. Last quarter, you said 60% to 65% of your starter-kit sales were to new patients. For this quarter, was it the same or higher?
我想用另一種方式問前面那個問題。上季你們說你們的入門套件銷售中,有 60% 到 65% 是賣給新病患。那這一季是相同還是更高?
- President & COO
- President & COO
You know what, I don't have that number with me -- patterns are pretty consistent. So, I would say, it is probably close to the same, but we don't have that number sitting here.
你知道嗎,我手邊沒有那個數字——但模式相當一致。所以我會說,可能跟之前差不多接近,但我們現在手上沒有那個數字。
- Analyst
- Analyst
And then, for reimbursement for Type 2 CGM, with Type 1s, you obviously had the help from the JDRF. Is there a society, or the AD, or any kind of other independent group that could help drive CGM reimbursement for Type 2s that your managed care group could get help from?
另外,關於第 2 型 CGM 的給付(reimbursement),在第 1 型方面你們顯然有 JDRF 的協助。那麼是否有某個學會、或 ADA、或任何其他獨立團體,可以協助推動第 2 型的 CGM 給付,讓你們的醫療管理團隊能獲得支援?
- CEO
- CEO
We look to the ADA, from that standpoint, because remember ADA is not only Type 1, in terms of their care, commitment, and cure mentality. In fact, they are, as a professional organization, all about the inclusive of both Type 1 and Type 2, where JDRF historically has been more towards the Type 1. And, a lot of that has come from that organization.
從這個角度我們會看 ADA,因為請記得,ADA 不只關注第 1 型——就其照護、投入與治癒(care, commitment, and cure)的理念而言。事實上,作為一個專業組織,他們強調同時涵蓋第 1 型與第 2 型;而 JDRF 歷來則更偏向第 1 型。很多推動其實都來自那個組織。
You have to understand -- here is an interesting dynamic, and I have stated this number before, but I will state it again. Every day in the United States, 10,000 Americans turn age 65. So, you can say -- well, 65 is the new 55, and what does that mean? Well, it means that we have got a lot more patients that are living longer, and therefore, developing Type 2 diabetes. As a result of that, that is something that ADA recognizes and has to embrace. It used to be that if you got to age 65 and you had Type 2 diabetes, or even Type 1, you're lucky. And then, you certainly would have all of the challenges. I don't think that is the situation, whatsoever, anymore. So, it is something that they recognize that there has got to be intervention, so they are helping drive that.
你必須了解——這裡有個有趣的動態。我以前提過這個數字,但我再說一次:在美國,每天有 10,000 名美國人滿 65 歲。所以你可以說——65 歲是新的 55 歲,那這代表什麼?代表我們有更多病人活得更久,因此會發展成第 2 型糖尿病。基於這點,ADA 也認知並必須接納這個現實。過去如果你活到 65 歲又有第 2 型糖尿病,甚至第 1 型,你算幸運;但你也一定會面臨各種挑戰。我認為現在完全不是那種情況了。所以他們認知必須介入,因此也在協助推動這件事。
I think, if you, now, look at some of the things I talked about glycemic variability, the amount of information that is being published in the literature about the role of excessive hyperglycemia, in particular, that is impacting and creating some of these economic costs that the payer system is looking to ways in which to reduce that. They have made all of the connect-the-dots assessments from that standpoint. So, I don't think we need a particular driver. I think, more than anything, we need more peer-review, independent-type studies, and those are ongoing, and they will be published over time, and we will be able to track them.
我想,如果你現在回頭看我談到的一些事情,例如血糖變異度(glycemic variability),以及文獻中大量發表的資訊——特別是關於過度高血糖(excessive hyperglycemia)的角色——這些正在影響並造成一些經濟成本,而付費方體系正在尋找降低這些成本的方法。他們從這個角度已經把所有線索都串起來了。所以我不認為我們需要某個特定的推手。我認為更重要的是需要更多同儕審查、獨立型態的研究;這些研究正在進行,會隨時間發表,我們也能持續追蹤。
- Analyst
- Analyst
If we see Vibe approved in September or October time-frame, would there be any reason they would delay that roll-out until next year? I just want to clarify if, with the filing now in, if a fourth-quarter approval could mean a fourth-quarter launch for Vibe?
如果我們在 9 月或 10 月左右看到 Vibe 獲批,是否有任何理由會把上市推遲到明年?我只是想釐清:既然現在已經送件,如果第四季獲批,是否就可能代表 Vibe 在第四季上市?
- President & COO
- President & COO
It could, Mimi, but again, this is a decision that needs to be made by Animas. And, just like we have commented in the past, where we would potentially choose not to launch a product in the fourth quarter with a fourth-quarter approval, the fourth quarter for Animas, or for any of pump companies, just like DexCom, is the biggest quarter. So, I would guess if that approval came late third quarter or very early fourth quarter, they would probably launch it. But, to be honest, if it comes in the middle or latter half of the fourth quarter, my guess is they would not want to pull their people out of the field and not want to disrupt their selling efforts in Q4, and would probably defer to Q1 to launch it.
有可能,Mimi,但再說一次,這是 Animas 必須做的決策。而且就像我們過去評論過的,我們可能會選擇在第四季獲批時不在第四季推出產品;對 Animas 或任何幫浦公司而言——就像 DexCom 一樣——第四季是最大的一季。所以我猜如果核准是在第三季末或第四季非常早期,他們大概會推出。但坦白說,如果是在第四季中段或後半段才核准,我猜他們不會想把人員從前線拉回來,也不想在 Q4 擾亂銷售動能,可能會延到 Q1 再推出。
Operator
Operator
Suraj Kalia, Northland Securities.
Suraj Kalia,Northland Securities。
- Analyst
- Analyst
Congrats on a nice quarter. Terry, let me just ask some macro-level questions. A lot of company-specific have been asked, hopefully, you can shed some light here. Where do you all see your current CGM share in the US?
恭喜這一季表現不錯。Terry,我想問幾個宏觀層面的問題。很多公司特定的問題都已經被問過了,希望你能在這裡提供一些看法。你們認為目前在美國的 CGM 市占率大概是多少?
- CEO
- CEO
I don't have an answer. Part of the problem here is we don't publish our numbers. The other company does not publish their numbers. If we look at independent surveys, if you look at dQ&A, as an example, from Close Concerns, has us almost 65% share in the US. I don't believe that for a second. I think, as the responders to the particular survey, yes we -- they're what we call, super users, and yes, we probably have that kind of share, but that is not the broader group. I think there is another bank that has published data based on a survey, and again, puts us a little over 50% share.
我沒有答案。部分原因是我們不公布我們的數字,另一家公司也不公布他們的數字。如果看獨立調查,例如 Close Concerns 的 dQ&A,說我們在美國的市占接近 65%。我一秒都不相信。我認為就那份特定調查的受訪者而言,是的——我們所謂的「重度使用者」(super users)——我們可能有那樣的占比,但那不是更廣泛的族群。我想還有另一家銀行根據調查發布過數據,同樣把我們放在略高於 50% 的市占。
Again, I really don't -- it is a tough question. Our people see that, and I always caution them, put your filters on because surveys are, like anything else, it depends upon the body of the responders. But, it is somewhere in that neck of the woods.
再說一次,我真的不——這是個很難的問題。我們的人會看到那些數字,而我總是提醒他們要加上濾鏡,因為調查就跟其他事情一樣,取決於受訪者的組成。但大概就在那個範圍附近。
- President & COO
- President & COO
This is Kevin. It is certainly between 40% and 60%. That's about as close as we can get it.
我是 Kevin。確實是在 40% 到 60% 之間。這大概是我們能給的最接近的答案。
- Analyst
- Analyst
Terry, the last one, I guess. I know this might be a little unfair question, but any thoughts on Medtronic's PreciSense -- you know the dual-sensing CGM that they were developing? Are you all hearing about it in the marketplace? Is it dead? Is a moribund? Is it still -- do you all see it on the competitive landscape? Any thoughts would be great.
Terry,最後一個問題。我知道這可能有點不公平,但你對 Medtronic 的 PreciSense——也就是他們在開發的雙感測 CGM——有什麼看法嗎?你們在市場上有聽到相關消息嗎?它死了嗎?是半死不活(moribund)嗎?還是仍然——你們在競爭版圖上還看得到它嗎?任何想法都很好。
- CEO
- CEO
I don't really know a lot about it. I certainly don't think it's dead. I think that they presented some data about their long-term intent with it to use that as part of a redundancy for an artificial pancreas. I don't know where it is at developmentally. Outside of that, they were at the NIH meeting as well, and so, we'll see -- but, don't know where they are at with that.
我對它其實不太了解。我當然不認為它已經死了。我想他們曾提出一些數據,談到他們長期的意圖,是把它作為人工胰臟冗餘(redundancy)的一部分。我不知道它在研發進度上到哪裡了。除此之外,他們也有參加 NIH 的會議,所以我們再看看——但我不知道他們目前做到哪一步。
- Analyst
- Analyst
Fair enough. Thanks for taking my questions, guys.
了解。謝謝各位回答我的問題。
Operator
Operator
Bill Plovanic, Canaccord.
Bill Plovanic,Canaccord。
- Analyst
- Analyst
A couple of follow ups here. One was on Thom's question earlier. Just on the distribution -- you have added 20. Where do you stand now in terms of your rep? And then, where do you plan to be by year end?
我有幾個追問。其中一個是延續 Thom 先前的問題。關於通路/佈局——你們新增了 20 個。那目前你們的業務代表配置到什麼程度?然後年底前計畫到什麼水準?
- President & COO
- President & COO
We are done adding for the year. When we had the first-quarter call, we said we were going to go from 48 to 68 territories, and 68 is where we are going to stop, through the end of the year, barring some incredible growth spurt. But, that is our plan we sit here right now. That's where we are today, and that's where we'll stand.
我們今年的增員已經結束了。在第一季電話會議時,我們說會從 48 個區域增加到 68 個區域,而 68 就是我們要停下來的地方,會維持到年底,除非出現某種驚人的成長爆發。但這就是我們現在坐在這裡的計畫。今天就是這個水位,之後也會維持如此。
- Analyst
- Analyst
Okay. Then, as you have been scaling up the manufacturing on the G4, are you able to make it? Are you running into any problems? Just, in general, how is that going?
好的。那麼,隨著你們在 G4 上擴大製造規模,你們做得出來嗎?有遇到任何問題嗎?整體來說,進展如何?
- President & COO
- President & COO
Bill, it is going fabulously. Our manufacturing team has just done an incredible job with this launch. You heard Terry laughing. My favorite email to send him every week is my yield report. These guys are doing a great job with sensor yields. It's been super.
Bill,進展非常棒。我們的製造團隊在這次上市上做得令人難以置信。你剛剛聽到 Terry 在笑。我每週最喜歡寄給他的 email,就是我的良率報告。這些人在感測器良率方面做得非常好。真的很棒。
- Analyst
- Analyst
Perfect. And then, on the 10-day label was something that got bantered about a while ago, I was just wondering if that is something that could still be out there with a 10-day label or shut off? Or, what do you think about that these days?
太好了。然後,關於 10 天標示(10-day label)這件事,之前討論過一陣子。我想問這是否仍有可能推出 10 天標示或關閉(shut off)機制?或者你們現在怎麼看?
- President & COO
- President & COO
It is still out there, and I can tell you in many of the studies that we do, particularly the ones we do internally, we are running them all now, 10 or 14 days, even if we just take the data and cut it off at 7. We're running them longer so we can get a sense of how the sensor will perform, from a physiology perspective within our patients, and when that cutoff point would be. I think, over time, and as we have discussed this as a team, with respect to shut off, the way we would plan on doing that would be -- have the algorithm shut the sensor off, based on the signal from the electrode on the sensor. When we can see that it is not up to standard, we would have it shut off that way versus having a fixed shut off at a point in time. That's what we think is the best ultimate long-term solution, and we will look at that, probably not as part -- certainly, not as part of the current Gen4 system, and not in the next algorithm that we'll file. We will take a look at it after that.
這仍然在考量中。我可以告訴你,在我們做的許多研究裡,特別是內部研究,我們現在都跑到 10 天或 14 天,即使最後只是把資料截到 7 天。我們把測試跑得更久,這樣才能從病人生理(physiology)的角度了解感測器的表現,以及切點會在哪裡。我認為,隨著時間推進,並且我們團隊也討論過關於 shut off 的做法,我們的規劃會是——讓演算法根據感測器電極的訊號來關閉感測器。當我們看到它不符合標準時,就用這種方式關閉,而不是在某個固定時間點做固定關閉。我們認為這是最佳、最終的長期解決方案;我們會再評估,但大概不會作為——當然不會作為目前 Gen4 系統的一部分,也不會放在我們下一個要送件的演算法裡。我們會在那之後再來看。
- Analyst
- Analyst
So, maybe in G5, is what you are saying?
所以,也許是在 G5,你的意思是這樣嗎?
- President & COO
- President & COO
G5 or G6, we'll see.
G5 或 G6,我們再看看。
- Analyst
- Analyst
That floats to the next question. Timeline on the G5?
這就帶到下一個問題了。G5 的時程如何?
- President & COO
- President & COO
The FDA has been working with us very diligently to define how we get a mobile platform and identifying all the risks and all the things we have to do to mitigate those risks, and this is very much an ongoing process. We have heard from the agency, at a number of fronts, that they're very comfortable with the device making a jump straight to a phone, without something in between or without a medical device, [rather] with all the mitigating factors. So, we are working with them to better understand it.
FDA 一直非常勤勉地與我們合作,來界定我們如何導入行動平台、辨識所有風險,以及我們必須做哪些事情來降低這些風險,而這非常是一個持續進行中的流程。我們已從主管機關在多個面向聽到,他們對於裝置直接跳到手機、而不是中間還要有其他東西或另一個醫療裝置,是非常放心的,前提是具備所有的風險緩解因素。因此,我們正與他們合作,以更深入理解這件事。
Bill, that is the beauty of the Share system, we are going to have a practice run that is not going to be lights out and all of our patients turning it on at exactly the same time, but we will have the server structure built, we will learn how to receive the data, we'll learn how to display the data back on the phone. The receiver is still the primary medical device, so with respect to their approval path, that is something that the FDA can comprehend and that we have made them comfortable with. So, we're excited for our first foray there, and we will see how it goes. With respect to the applicator and the other elements of Gen5, we have made the decision, we are going to keep manufacturing the same sensor when we go to the Gen5 platform. We do not need to change the sensor at all. And, with respect to the other hardware elements, we will pick the right time when we cut all those into manufacturing. While we don't have a timeline, as Terry said, we have got about five enhancements and different indications to launch over the next 12 to 18 months. That will keep us very busy. Gen5 will come after that.
Bill,這就是 Share 系統的美妙之處:我們會先有一次「演練」,不會是全面熄燈、所有病患在同一時間同時開啟;但我們會把伺服器架構建好,我們會學會如何接收資料,也會學會如何把資料顯示回手機上。接收器仍然是主要的醫療裝置,因此就其核准路徑而言,這是 FDA 能夠理解、也讓他們感到放心的做法。所以,我們對於第一次嘗試非常興奮,並會看看進展如何。至於 Gen5 的施用器與其他元件,我們已做出決定:當我們轉到 Gen5 平台時,會持續製造相同的感測器。我們完全不需要更改感測器。至於其他硬體元件,我們會在適當的時間點把那些導入量產。雖然我們沒有明確時程,但如 Terry 所說,未來 12 到 18 個月我們大約有五項強化與不同適應症要推出,這會讓我們非常忙。Gen5 會在那之後。
- Analyst
- Analyst
Definitely. Actually, one of my questions was to help me understand the benefit of the Share platform. So really, it's almost the baby step for your Gen5, in terms of getting to the mobile platform, eventually. Is that how we should think about it?
確實。其實,我其中一個問題是想幫助我理解 Share 平台的效益。所以實際上,它幾乎是你們邁向 Gen5 的「嬰兒步」,就最終走向行動平台而言。這樣理解對嗎?
- President & COO
- President & COO
Absolutely. From an operations and an internal perspective, yes. I can tell you, from a customer perspective, it is much more than that. I was discussing it with a physician this morning, and the physician's reaction was a huge wow. Kids are going to be able to take this to school and plug it in the back of the classroom, for example, and data can go to the parent all day long, and they can watch them. It can also go to the school nurse. This will be a big wow for our patients.
完全正確。從營運與內部角度來看,是的。但我可以告訴你,從客戶角度來看,它遠不止如此。我今天早上和一位醫師討論時,那位醫師的反應是「哇」非常震撼。孩子們將能把它帶到學校,例如插在教室後方,資料就能整天傳給家長,他們可以隨時查看。也可以傳給校護。這對我們的病患會是很大的驚喜。
For the traveling spouse who is on the road all the time who has Type 1 diabetes, the other spouse can watch the data at home and make sure nothing happens. The sense of comfort there is something that is going to be a big deal. And in our minds, as I walk around here and say all the time -- that is going to sell more sensors.
對於那種經常在外出差、患有第一型糖尿病的配偶,另一半可以在家裡查看資料,確保不會發生意外。那種安心感會是很重要的一件事。而在我們看來,我在這裡走來走去也常說——那會賣出更多感測器。
- Analyst
- Analyst
Yes, I don't know if I would want my wife to see my glucose levels when I traveled.
是啊,我不知道我出差時會不會想讓我太太看到我的血糖數值。
- President & COO
- President & COO
You can take the receiver out of the cradle, Bill (laughter).
你可以把接收器從底座上拿下來,Bill(笑聲)。
- Analyst
- Analyst
And then, lastly, does J&J's issues with the OneTouch Ultra have any impact on the SAP device? Because, if they -- I think they had a recall. I'm not exactly sure, but I think they have had challenges on the OneTouch, and if they've got something going on in the FDA, can they get a PMA approved?
最後一個問題,J&J 在 OneTouch Ultra 上的問題,會對 SAP 裝置有任何影響嗎?因為,如果他們——我想他們有召回。我不太確定,但我想他們在 OneTouch 上遇到一些挑戰;如果他們在 FDA 那邊有狀況,他們還能讓 PMA 獲得核准嗎?
- President & COO
- President & COO
It's different divisions. The Verio is at the LifeScan division. Animas is actually a separate operating company. So they have -- they operate somewhat together as a diabetes franchise, but they are two distinct companies. So, the warning letter on Verio went to LifeScan, not to Animas.
那是不同事業部。Verio 在 LifeScan 事業部。Animas 其實是另一家獨立營運公司。所以他們——作為糖尿病事業群在某種程度上一起運作,但它們是兩家不同的公司。因此,針對 Verio 的警告信是發給 LifeScan,而不是 Animas。
- Analyst
- Analyst
Okay, so the government, the FDA, doesn't look at J&J as one big company, they break them up into their operating companies?
了解,所以政府、FDA,不會把 J&J 當作一家大公司來看,而是把它拆成各個營運公司?
- President & COO
- President & COO
No, it is operating company -- at the operating company level.
對,是在營運公司——以營運公司層級來看。
- Analyst
- Analyst
Okay, thank you very much.
好的,非常感謝。
Operator
Operator
Danielle Antalffy, Leerink Swann.
Danielle Antalffy,Leerink Swann。
- Analyst
- Analyst
I was hoping you could -- so Kevin, you mentioned the split between hardware and sensor. I was wondering if you could give us any color on the split within the sensor revenue of SEVEN PLUS versus Gen4?
我希望你可以——Kevin,你提到硬體與感測器之間的拆分。我想請問你能否就感測器營收中 SEVEN PLUS 相對於 Gen4 的拆分比例,提供一些說明?
- President & COO
- President & COO
No, other than the Gen4 was substantially more.
沒有,除了 Gen4 明顯高很多之外。
- Analyst
- Analyst
Okay, that's helpful. And then, my second question is, if you speak to your competitor, Medtronic, they claim to be making progress with FDA on the Enlite sensor. I was just hoping to get a sense from you of what you're hearing in the marketplace in anticipation of the Enlite sensor, with the low-glucose suspend device. Because, the way they talk about it, they actually say they think it is negatively impacting your diabetes business now because patients are waiting for the device to be approved. So, if you have any sense of -- at least, what you are seeing in the marketplace on that front? Because, that would imply, obviously, that there's a whole list of patients waiting to go on this device. Just wondering if you had any comment there?
好的,這很有幫助。那第二個問題是,如果你去跟競爭對手 Medtronic 交流,他們宣稱在 Enlite 感測器方面與 FDA 的進展不錯。我只是想從你這邊了解一下,你在市場上聽到對 Enlite 感測器、搭配低血糖暫停(low-glucose suspend)裝置的預期是什麼。因為照他們的說法,他們甚至說他們認為這已經在負面影響你們目前的糖尿病業務,因為病患在等待該裝置獲得核准。所以,如果你對——至少你在市場端看到的情況有任何感覺?因為那顯然意味著有一長串病患在等著使用這個裝置。想請問你是否有任何評論?
- CEO
- CEO
Well I look at what is going on in Europe where the device is available, and certainly, Animas and Johnson & Johnson have made public comments that they're growing 30% to 50% in markets in Europe, where the Vibe has launched in direct head-to-head competition with the Veo System. So, they don't seem to be too worried about it. I think here in the US, when we talk to the folks, both J&J, and certainly, at Tandem, they seem to be cannibalizing the installed base. I'm not sure patients, quote, are waiting to go to this other system.
我會看歐洲那邊的情況,因為那個裝置在歐洲已經上市;而且 Animas 與 Johnson & Johnson 也公開評論過,在歐洲那些 Vibe 上市、與 Veo 系統正面競爭的市場,他們成長 30% 到 50%。所以他們看起來並不太擔心。我認為在美國這邊,當我們和各方交流時,不論是 J&J,或是 Tandem,他們似乎是在侵蝕既有裝機基礎。我不確定病患是否真的「在等待」轉去另一個系統。
The challenge is -- and here's part of our, and I will call it a conundrum for a lack of a better term. So last year, our Medical Director, David Price, got up and spoke and talked about all the ways you can manipulate data from a glucose-sensor standpoint and that we never do that, we always only do prospective analysis. Medtronic got up at that same meeting and said that the Enlite was about 13% MARD. We've tested the heck out of it. We couldn't get it to perform that way, and then Dr. Russell and [Dr. Damiano] presented results, and said they could not get it to perform that way, either. It was closer to 18% than 13%.Then, fast forward to ATTD, earlier this year, Medtronic gets up and says, the Enlite is, on a prospective basis, closer to 18%, which is consistent with where our experience with it is, and actually, out in the field experience.
挑戰在於——這也是我們的一部分,我姑且稱之為「兩難」(找不到更好的詞)。所以去年,我們的醫療總監 David Price 上台演講,談到從葡萄糖感測器角度有各種操弄資料的方法,而我們從不那樣做,我們永遠只做前瞻性分析。Medtronic 在同一場會議上表示 Enlite 的 MARD 約 13%。我們對它做了大量測試,無法讓它達到那樣的表現;接著 Russell 醫師與 [Damiano 醫師] 發表結果,也說他們同樣無法讓它達到那樣的表現,更接近 18% 而不是 13%。然後快轉到今年稍早的 ATTD,Medtronic 上台說 Enlite 以前瞻性基礎來看更接近 18%,這與我們對它的經驗一致,也與實際臨床使用的經驗一致。
Now, I think from an FDA standpoint, you've got an product that's pending before the FDA. They have seen our data, which is part of our strategy; and now, they're looking at something that can have an MARD for a sensor in order to shut off insulin delivery of somewhere close to 18%. It is a conundrum. It is a conundrum for the agency to say -- what are we going to do here? Now, most recently, you are hearing from Medtronic talk about Enlite 2, and other things predictive, so I don't know. I don't think the market reaction or that there is this huge pent-up demand. I know they are suffering, but I don't think it is related to waiting for the Veo System.
現在,我認為從 FDA 的角度,你有一個產品正在 FDA 審查中。他們已看過我們的數據,這也是我們策略的一部分;而現在,他們正在看一個感測器的 MARD 可能接近 18%,卻要用來關閉胰島素輸注。這就是兩難。對主管機關而言,這是兩難:我們到底要怎麼做?而最近,你又聽到 Medtronic 在談 Enlite 2,以及其他預測性功能,所以我也不確定。我不認為市場反應或存在這種巨大的被壓抑需求。我知道他們正承受壓力,但我不認為那與等待 Veo 系統有關。
- Analyst
- Analyst
Right. Okay, thank you so much. That's helpful.
對。好的,非常感謝。這很有幫助。
Operator
Operator
Robert Marcus, Leerink Swann.
Robert Marcus,Leerink Swann。
- Analyst
- Analyst
Thank you, my question has been answered.
謝謝,我的問題已經得到解答。
Operator
Operator
Greg Simpson, Wunderlich Securities.
Greg Simpson,Wunderlich Securities。
- Analyst
- Analyst
Let me add my congratulations on a great quarter. Terry, you kind of answered it in response to Bill's question -- I had two questions. My first one, you kind of answered. But, I was wondering with the new algorithm for the G4 -- how does that affect your pacing on the pipeline and the progression to the G5? I know they are different animals, but does it affect your thinking? In other words, do you do more on the G5, and maybe come out with a G5.5? Kind of like you did on G4 because of the FDA process?
讓我也恭喜你們這一季表現出色。Terry,你在回覆 Bill 的問題時其實已經有點回答了——我有兩個問題。第一個你算是回答了。不過,我想問的是,針對 G4 的新演算法——這會如何影響你們在產品研發管線上的節奏,以及推進到 G5 的進程?我知道它們是不同的東西,但這會影響你們的思考嗎?換句話說,你們會在 G5 上做得更多,甚至可能推出一個 G5.5 嗎?有點像你們當初因為 FDA 流程而在 G4 上做的那樣?
- President & COO
- President & COO
This is Kevin. I will take that. One of the things we have been, we believe, successful in is segmenting some of the improvements in our product and not linking everything together. One of the issues we had with Gen4 and launching it, as you just said, it became Gen4.5 because we took the membranes from the Gen5 system and moved them back when it took so long to file. We are going to do our improvements in smaller increments, and file them, and not necessarily interlink them. So, we will file the algorithm, and it certainly will run the Gen4, and may in fact be the algorithm we launch Gen5 with. Don't have the answer to that, yet. But, we can file the algorithm, and then we can launch it any time when we are ready. And, that's we look at it, and that's how we are going to treat this. And all of these things, we are trying not to link them all together, we want to do them in the order that best meets our business needs.
我是 Kevin。我來回答。我們一直以來、也相信自己做得成功的一件事,是把產品的一些改進做分段處理,而不是把所有東西都綁在一起。正如你剛才提到的,我們在 Gen4 推出時遇到的一個問題是,因為申報花了太久時間,我們把 Gen5 系統的膜片拿回來用,所以它最後變成了 Gen4.5。我們會以更小的增量來做改進並進行申報,而不一定把它們彼此連動。所以,我們會申報這個演算法;它當然會在 Gen4 上運行,而且事實上也可能就是我們在推出 Gen5 時所採用的演算法。這點我們現在還沒有答案。但我們可以先申報這個演算法,然後在我們準備好時隨時推出。這就是我們看待它的方式,也就是我們將如何處理這件事。我們也在努力不要把所有事情都綁在一起;我們希望依照最符合我們業務需求的順序來做。
So, it isn't tied with that. There could be a Gen5.5 algorithm; but in all reality, that will depend upon the timing of a Gen6 sensor. And, if a Gen6 sensor comes, that algorithm would be completely different anyway. So, we don't want to do things that aren't going to lead to increased profitability. And this algorithm, we believe, will lead to increased profitability; because it again, makes the system more accurate and more reliable for our customers, so --
所以,它不會跟那個綁在一起。可能會有一個 Gen5.5 的演算法;但實際上,這將取決於 Gen6 感測器的時程。而如果 Gen6 感測器推出,那個演算法反正也會完全不同。所以,我們不想做那些不會帶來更高獲利能力的事情。我們相信這個演算法會帶來更高的獲利能力;因為它再次讓系統對客戶而言更精準、更可靠,所以——
- Analyst
- Analyst
Okay. A pipeline embarrassment of riches, that's a nice problem to have.
好的。研發管線豐富到有點「幸福的煩惱」,這是個不錯的問題。
Kevin, let me -- again, you mentioned profitability, so I feel compelled to ask this question because we've seen a growing number of companies raising money. This question has been asked of you on past conference calls. Do you feel, and you're making, obviously from a non-cash standpoint, very good progress towards profitability? Can you just talk about that in general? And, how you feel comfortable with the balance sheet, and where you feel like you sit, right now?
Kevin,讓我——你又提到了獲利能力,所以我覺得不得不問這個問題,因為我們看到越來越多公司在募資。這個問題在過去的電話會議上也有人問過你。你是否覺得——而且你們顯然在非現金的角度上,朝獲利能力有非常好的進展?你能否就整體談談?以及你對資產負債表的舒適度如何、你覺得你們目前所處的位置是什麼?
- President & COO
- President & COO
It's funny, if somebody were to ask me my favorite number that I ever cited in all these numbers, it would be 6 -- that would be the $6 million that dropped to the bottom line, $9.2 million in increased sales. Our operating income cash loss was only $3.7 million this quarter, compared to a number closer to $10 million one year ago. And, our working capital progressed exactly the way wanted it to.
很有趣,如果有人問我,在這些數字裡我最喜歡引用的數字是哪一個,那會是 6——也就是那 600 萬美元直接落到最終損益的部分,來自 920 萬美元的銷售增加。我們本季營運現金損失只有 370 萬美元,相較於一年前接近 1,000 萬美元的水準。而且,我們的營運資金也完全依照我們希望的方式在改善。
We have debt capacity of close to $30 million that we could take down later this year if we needed cash. And, we have made a commitment, internally to ourselves, to our management team and to our investors, that we are not going to go raise more equity money. We are going to turn this thing where needs to be, and with growth like this, we believe we can do it. So, that is our plan, today.
我們有接近 3,000 萬美元的舉債額度,如果今年稍晚需要現金,我們可以動用。而且,我們在內部對自己、對管理團隊以及對投資人做出承諾:我們不會再去募集更多股權資金。我們會把這件事扭轉到應有的狀態;以這樣的成長幅度,我們相信做得到。所以,這就是我們今天的計畫。
- Analyst
- Analyst
Awesome. All right, thanks very much.
太棒了。好,萬分感謝。
Operator
Operator
We have no further questions at this time.
目前沒有其他問題。
- CEO
- CEO
Okay, I would like to wrap it up. I've got a few 35,000-foot level kind of comments.
好的,我想做個總結。我有幾點比較「三萬五千英尺高度」的概括性評論。
In March of this year, the American Diabetes Association released new data, which estimates the total cost of diagnosed diabetes in the United States has risen to $245 billion per year in 2012, from $174 billion per year in 2007. It was a 41% increase over just a five-year period. Today, nearly 26 million adults and children are living with the disease in the United States, and an additional 79 million are estimated to have pre-diabetes. Direct medical costs totaled $176 billion last year for hospital and emergency care, office visits and medications. Indirect medical costs, including absenteeism, reduced productivity, unemployment caused by diabetes, related disability, and lost productivity due to early mortality totaled $69 billion last year.
今年三月,美國糖尿病協會發布了新數據,估計美國已確診糖尿病的總成本在 2012 年已上升至每年 2,450 億美元,較 2007 年每年 1,740 億美元增加。在短短五年期間增加了 41%。目前,美國約有將近 2,600 萬名成人與兒童罹患此疾病,另估計還有 7,900 萬人處於糖尿病前期。去年,住院與急診照護、門診就醫與藥物等直接醫療成本合計達 1,760 億美元。包含缺勤、生產力下降、因糖尿病造成的失業、相關失能,以及因早逝造成的生產力損失等間接醫療成本,去年合計達 690 億美元。
We have gone from 12.1 million people diagnosed with diabetes in the US in 2002, to 17.5 million in 2007, to nearly 26 million people with diabetes in the United States in 2012. The high cost of complications has increased the economic burden over $70 billion annually in just the last five years. And yet, we know that CGM can improve outcomes, and delay, or perhaps even prevent, the onset of many of these complications. So, there is absolutely no wonder why I am so excited about the current and the future prospects of DexCom. Thank you.
美國在 2002 年已確診糖尿病的人數為 1,210 萬,2007 年增至 1,750 萬,到了 2012 年,美國糖尿病患者已接近 2,600 萬人。併發症的高成本在過去短短五年內,已使經濟負擔每年增加超過 700 億美元。然而,我們知道 CGM 能改善結果,並延後,甚至可能預防許多這些併發症的發生。因此,我對 DexCom 目前與未來的前景感到非常振奮,絕非沒有原因。謝謝。
Operator
Operator
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。