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 First Quarter 2021 Earnings Release Conference Call. My name is Adrian, and I'll be your operator for today's call. (Operator Instructions) Please note this conference is being recorded.
歡迎參加 DexCom 2021 年第一季財報發布電話會議。我是 Adrian,將擔任今天會議的接線員。(接線員指示)請注意,本次電話會議將被錄音。
I'll now turn the call over to Sean Christensen. Sean, you may begin.
現在我將把電話交給 Sean Christensen。Sean,您可以開始。
Sean Christensen - Director of Corporate Affairs & Head of IR
Sean Christensen - Director of Corporate Affairs & Head of IR
Thank you, operator, and good afternoon, everyone. Welcome to DexCom's First Quarter 2021 Earnings Call. Our agenda begins with Kevin Sayer, DexCom's Chairman, President and CEO, who will provide a summary of our progress; followed by a financial review and outlook from Jereme Sylvain, our Chief Financial Officer; and then an update from Quentin Blackford, our Chief Operating Officer, on the company's strategic initiatives and scaling progress. (Operator Instructions) Please note that there are also slides available related to our first quarter performance on the DexCom Investor Relations website on the Events and Presentations page. With that, let's review our safe harbor statement.
謝謝,接線員,各位下午好。歡迎參加 DexCom 2021 年第一季財報電話會議。我們的議程首先由 DexCom 董事長、總裁兼執行長 Kevin Sayer 開場,提供我們進展的摘要;接著由我們的財務長 Jereme Sylvain 進行財務回顧與展望;然後由營運長 Quentin Blackford 就公司的策略性計畫與規模化進展提供最新資訊。(接線員指示)另外請注意,DexCom 投資人關係網站的「活動與簡報」頁面上也提供與第一季表現相關的投影片。接下來,我們先回顧安全港聲明。
Some of the statements we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs and expectations about future events, strategies, competition, products, operating plans and performance. All forward-looking statements included in this presentation are made as of the date hereof based on information currently available to DexCom, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in DexCom's annual report on Form 10-K, most recent quarterly report on Form 10-Q and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this presentation or to conform these forward-looking statements to actual results.
我們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、策略、競爭、產品、營運計畫與績效的意圖、信念與預期。本簡報中所包含的所有前瞻性陳述,均以本簡報日期為準,係基於 DexCom 目前可得資訊作出,並受各種風險與不確定性影響,實際結果可能與前瞻性陳述中所預期者有重大差異。可能導致實際結果與任何前瞻性陳述所明示或暗示者有重大差異的因素,已詳載於 DexCom 的 Form 10-K 年度報告、最近一期 Form 10-Q 季度報告,以及向美國證券交易委員會提交的其他文件中。除法律要求外,我們不承擔在本簡報日期後更新任何此類前瞻性陳述,或使該等前瞻性陳述與實際結果一致的義務。
Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP and cash-based results. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. 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. Please refer to the tables in our earnings release and the slides accompanying our first quarter earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure.
此外,在本次電話會議中,我們將討論若干未依 GAAP 編製的財務衡量指標,涉及我們的非 GAAP 與以現金為基礎的結果。除非另有說明,所有對財務指標的引用均以非 GAAP 基礎呈現。提供這些額外資訊不應被視為可單獨解讀,亦不應作為依 GAAP 編製之結果的替代,或被認為優於依 GAAP 編製之結果。請參閱我們的財報新聞稿中的表格,以及第一季財報簡報所附投影片,以取得這些衡量指標與其最直接可比的 GAAP 財務衡量指標之調節表。
Now I will turn it over to Kevin.
現在我把時間交給 Kevin。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Thank you, Sean, and thank you, everyone, for joining us.
謝謝你,Sean,也謝謝各位今天加入我們。
Today, we reported strong first quarter results with total revenue growth of 25% over the first quarter of 2020. As I often tell our employees, our ability to thrive as a company ultimately comes down to solving significant problems with a great product. And that is what we continue to see with G6. We hear incredible stories of improved glucose control, reduced disease burden and people being empowered, and those responses have only increased as we've enhanced tools to better drive our customer experiences. These stories are coming from multiple sources as well, whether it is coming from G6 users or their family members who are gaining better control of their glucose levels to real-time data or clinicians who are empowered by the ability to gather unique insights into the diabetes treatment of their type 1 or type 2 patients and optimize therapy accordingly, and even new settings like nurses and doctors in the inpatient setting who are deploying CGM and learning about its potential to optimize workflows and benefit from our remote monitoring technology.
今天我們公布了強勁的第一季業績,總營收較 2020 年第一季成長 25%。我經常告訴員工,我們作為一家公司的茁壯成長,最終取決於能否用優秀的產品解決重大問題。而這正是我們在 G6 上持續看到的成果。我們聽到許多令人振奮的故事:血糖控制改善、疾病負擔降低,以及人們獲得更大的自主能力;而隨著我們強化工具以更好地推動客戶體驗,這些回饋只增不減。這些故事也來自多個來源:不論是 G6 使用者,或其家人因能取得即時數據而更好地掌握血糖;或是臨床醫師因能蒐集對其第一型或第二型糖尿病患者治療的獨特洞見而得以相應優化療法;甚至是在住院照護等新場域中,護理師與醫師正在部署 CGM,並了解其優化工作流程的潛力,以及我們遠端監測技術所帶來的效益。
New customer additions are off to a great start in 2021, especially in the U.S., as we continue to see growth across all channels, building from the increased access that we've gained over the past several years. This includes continued traction for people with type 1 diabetes and type 2 intensively managed diabetes, both of which have continued the strong growth momentum that we've seen over the past couple of years. We're also seeing a growing number of type 2 nonintensive customers on G6, not only through our partnerships like UnitedHealthcare's Level2 program, but also including the other innovative programs and providers that are establishing early access to DexCom CGM.
2021 年新客戶增加有了非常好的開端,尤其是在美國;隨著我們持續受惠於過去幾年所取得的更廣泛可近性,我們看到所有通路皆呈現成長。這包括第一型糖尿病以及第二型需密集管理的糖尿病族群持續取得進展,兩者都延續了我們過去幾年所見的強勁成長動能。我們也看到越來越多第二型非密集管理客戶使用 G6,不僅透過我們與 UnitedHealthcare 的 Level2 計畫等合作夥伴關係,也包括其他正在建立 DexCom CGM 早期可近性的創新計畫與服務提供者。
We're also progressing our strategic commercial efforts, with the remainder of our commercial sales force expansion completed in the first quarter and our direct-to-consumer marketing efforts generating new levels of brand awareness. The Super Bowl commercial featuring Nick Jonas was a highlight for the company in the first quarter. We were able to generate significant excitement for our employees and customers, many of whom have sent us pictures and stories of their pride and feeling represented during one of the biggest annual events in the world. We also contribute to a broader conversation in the diabetes community that we hope will help facilitate broader access to CGM in the future. The ad drove a record number of visitors to our website, a record for single-day new customer leads and significantly more media impressions than we generated in all of 2020.
我們也在推進策略性的商業化工作:第一季完成了其餘商業銷售團隊的擴編,而我們的直面消費者行銷也帶來了全新層級的品牌知名度。第一季公司的一大亮點,是由 Nick Jonas 主演的超級盃廣告。我們成功為員工與客戶帶來高度的興奮感,許多人在全球一年一度最大型活動之一期間,傳來照片與故事,分享他們的自豪感與被代表的感受。我們也為糖尿病社群帶來更廣泛的對話,希望能在未來促進 CGM 更廣泛的可近性。該廣告帶動我們網站單日訪客數創新高、單日新客戶線索數創紀錄,且媒體曝光量顯著高於我們 2020 年全年的總和。
And we are confident that there will be ongoing benefits that will come from the ad. In fact, according to the independent Harris Poll, DexCom led all Super Bowl advertisers in brand equity growth. Overall, it was a great investment for the company, and I'm really proud of our team for pulling it together. Our commercial efforts also include a strong push from our teams to expand access to DexCom CGM technology internationally, both deeper in existing markets as well into new geographies. With DexCom in the strongest inventory position in the company's history as a result of our scaling initiatives, we are aggressively advocating for broader access to our G6 systems for people with type 1 diabetes and intensively managed type 2 diabetes, similar to what we have done here in the United States.
我們也有信心,該廣告將持續帶來後續效益。事實上,根據獨立的 Harris Poll,DexCom 在所有超級盃廣告主中,品牌資產成長居於領先。整體而言,這對公司是一項很好的投資,我也為團隊能把它完成而感到非常自豪。我們的商業化工作也包括:團隊大力推動在國際市場擴大 DexCom CGM 技術的可近性,既在既有市場更深入滲透,也拓展至新的地理區域。由於我們的規模化計畫使 DexCom 目前擁有公司史上最強的庫存水位,我們正積極倡議讓第一型糖尿病與需密集管理的第二型糖尿病族群,能更廣泛取得我們的 G6 系統,類似我們在美國所做的努力。
Since we last reported in February, we have received confirmation from 3 additional Canadian provinces that they will begin covering DexCom CGM. This is a great step forward in expanding access for people with diabetes. There is significant demand from customers and clinicians, and we are optimistic that we will continue this positive momentum in Canada with both the public and private payers over the coming months.
自我們上次於 2 月報告以來,我們已收到加拿大另外 3 個省份的確認,將開始給付 DexCom CGM。這是在擴大糖尿病患者可近性方面向前邁出的重要一步。客戶與臨床醫師的需求相當強勁,我們也樂觀預期,未來幾個月在加拿大的公私部門支付方方面,我們將能延續這股正向動能。
In certain reimbursed markets, we are proactively lowering price to significantly expand access to incremental customer populations. This positions us well to continue to grow sensor volume significantly now and into the future, and we believe the incremental volumes will more than offset the impact of price in the near term.
在某些已納入給付的市場中,我們正主動下調價格,以大幅擴大更多客戶族群的可近性。這使我們在現在與未來都具備良好條件,得以持續顯著提升感測器出貨量;我們相信,新增的出貨量在短期內將足以抵銷價格調整的影響。
In conjunction with our commercial initiatives and the growing CGM category awareness, we are advancing the clinical and regulatory path for our next-generation G7 CGM system. As a reminder, we expect G7 to improve all aspects of the current customer experience offered with G6 in a disposable wearable that is less than half the size. We are working to prepare the submission for CE Mark in accordance with the new medical device reporting standard in the EU. At this point, we remain on track for our target launch of G7 in the second half of 2021.
配合我們的商業化計畫以及 CGM 類別認知度的提升,我們正推進下一代 G7 CGM 系統的臨床與法規路徑。提醒各位,我們預期 G7 將在一款可拋棄式穿戴裝置中,全面改善目前 G6 所提供的客戶體驗,且體積不到其一半。我們正依據歐盟新的醫療器材申報標準,準備 CE Mark 的送件資料。目前我們仍按計畫推進,目標是在 2021 年下半年推出 G7。
We also plan to present preliminary data on G7 performance at the upcoming ATTD conference in early June. Our trial that will support our U.S. iCGM filing is also well underway. And we have received outstanding feedback from the investigators and patients involved. We expect to complete that trial in the current quarter, and we'll keep you updated as we progress towards regulatory approvals and launch.
我們也計畫在 6 月初即將舉行的 ATTD 會議上,發表 G7 表現的初步數據。我們用以支持美國 iCGM 申請的試驗也在順利進行中,且我們已從參與的研究者與患者那裡獲得非常正面的回饋。我們預期在本季完成該試驗,並將在朝向法規核准與上市推進的過程中,持續向各位更新進展。
Even as we advance our strategic plans and have seen continued customer growth over the past year, the evidence of the global pandemic remains with us. We continue to navigate certain closures in territories that have seen cases spike, and our team remains focused on the 3 priorities that we have emphasized throughout the past year: the health and safety of our employees, continued supply of our customers and service to our communities. Towards this end, we were pleased to recently work with the state of Arizona to open the first indoor mass vaccination facility in Arizona to help the community as it transitions to the heat of the summer months. This facility rests within our Mesa distribution facility and has the capacity to support several thousand appointments per day. I am proud to lead a company whose employees are so dedicated to the service of our customers and willing to think creatively about what it means to be a leader in the communities that we serve.
即使我們推進策略計畫,且過去一年客戶持續成長,全球疫情的影響仍然存在。我們仍在應對部分病例激增地區的封鎖措施,而我們的團隊也持續聚焦於過去一年我們反覆強調的三項優先事項:員工的健康與安全、持續供應客戶,以及服務我們的社區。為此,我們很高興近期與亞利桑那州合作,在亞利桑那州開設第一個室內大型疫苗接種設施,以協助社區在進入夏季高溫月份時順利過渡。該設施位於我們位於 Mesa 的配送中心內,每日可支援數千個預約名額。我很自豪能領導一家公司的員工如此致力於服務客戶,並願意以創新方式思考,如何在我們所服務的社區中成為領導者。
As we come back to first quarter results, I want to welcome a new voice to our earnings call, those familiar to many of you already. Last month, we announced the promotion of Jereme Sylvain to the role of Chief Financial Officer. And I'm pleased to have Jereme joined Quentin and I for his first DexCom earnings call this afternoon. Jereme?
回到第一季業績,我想歡迎一位新的聲音加入我們的財報電話會議,對許多各位而言他其實已相當熟悉。上個月,我們宣布 Jereme Sylvain 晉升為財務長。我也很高興 Jereme 今天下午與 Quentin 和我一同參與他在 DexCom 的首次財報電話會議。Jereme?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Thank you, Kevin. I'm excited to be with you today and in the new role as we advance our work together for people with diabetes. As a reminder, unless otherwise noted, the financial metrics presented today will be discussed on a non-GAAP basis. Reconciliations to GAAP can be found on today's earnings release as well as on our IR website.
謝謝你,Kevin。我很高興今天能與各位在一起,也很高興在新職務上與大家共同推進我們為糖尿病患者所做的工作。提醒各位,除非另有說明,今天所呈現的財務指標將以非 GAAP 基礎進行討論。與 GAAP 的調節表可在今日的財報新聞稿以及我們的投資人關係(IR)網站上查閱。
For the first quarter of 2021, we reported worldwide revenue of $505 million compared to $405 million for the first quarter of 2020, representing growth of 25% on a reported basis and 23% on a constant currency basis. This is our seventh consecutive quarter of revenue growth of $100 million or more. Impressively, our revenue performance came against our toughest quarterly comparison in 2020 for both our U.S. and international businesses as the first quarter of 2020 was largely unaffected by the COVID-19 pandemic. We also saw nearly 40% global unit volume growth in the quarter, demonstrating the continued customer growth in the business.
2021 年第一季,我們的全球營收為 5.05 億美元,較 2020 年第一季的 4.05 億美元成長,按報告基礎成長 25%,按固定匯率基礎成長 23%。這是我們連續第七個季度營收成長達 1 億美元或以上。令人印象深刻的是,我們的營收表現是在 2020 年最具挑戰性的季度比較基期下達成的,無論是美國或國際業務皆然,因為 2020 年第一季基本上未受到 COVID-19 疫情影響。我們在本季也看到全球出貨量(unit volume)接近 40% 的成長,顯示業務持續的客戶成長。
U.S. revenue totaled $381 million for the first quarter compared to $292 million for the first quarter in 2020, representing growth of 30%. Our U.S. business was the primary driver of growth in the first quarter, with our commercial efforts in rising CGM awareness driving solid volumes and an acceleration from our fourth quarter growth percentage. We believe that we are well positioned to continue this momentum. Our DTC efforts are driving awareness of DexCom CGM. We have new connected systems coming to market that build from years of collaborative work with our partners, and we have an expanded field sales force equipped with the products that our customers love.
美國第一季營收合計 3.81 億美元,較 2020 年第一季的 2.92 億美元成長 30%。第一季成長的主要驅動力來自美國業務;我們在提升 CGM 認知度方面的商業推廣帶動了穩健的出貨量,且成長率較第四季進一步加速。我們相信我們具備良好條件可延續這股動能。我們的 DTC(直面消費者)推廣正在提升 DexCom CGM 的認知度。我們也有新的互聯(connected)系統即將上市,這些系統建立在我們與合作夥伴多年協作的成果之上;同時我們也擴編了外勤銷售團隊,並配備客戶喜愛的產品。
Our international business reached another quarterly high watermark with a revenue of $124 million or 10% growth on a reported basis compared to the first quarter of 2020. As we saw in the final 3 quarters of 2020, the impact of COVID-19 lockdowns has had a greater impact on new customer growth in certain international markets, which has a compounding effect on our reoccurring revenue model. Nevertheless, we delivered growth against our toughest quarterly comp of 2020, where international revenue grew 61% before the pandemic.
我們的國際業務再度創下單季新高,營收達 1.24 億美元,較 2020 年第一季按報告基礎成長 10%。如同我們在 2020 年最後三個季度所見,COVID-19 封鎖對部分國際市場的新客戶成長造成較大影響,並對我們的經常性收入模式產生疊加效應。儘管如此,我們仍在 2020 年最具挑戰性的季度比較基期下實現成長;在疫情前,國際營收於該季度曾成長 61%。
We continue to see strong growth across a number of our markets, particularly in countries where the administrative requirements to access CGM are minimized via our e-commerce channel or via broad reimbursement. As many of you have seen, we've successfully reduced our manufacturing costs and intentionally increased sensor production capacity. Through these manufacturing efficiencies and increased capacity, we are no longer restricted to focusing on high-risk, high-reimbursement populations. With this increased commercial flexibility, we are executing on our strategy to broaden access to our CGM technology by pushing deeper into existing markets we previously could not address. Through the incremental volumes generated by these efforts, we believe we will offset any near-term price impact while better positioning the company for long-term growth.
我們持續在多個市場看到強勁成長,特別是在那些可透過我們的電商通路或廣泛給付(reimbursement)來降低取得 CGM 行政要求的國家。如各位所見,我們已成功降低製造成本,並有意提高感測器產能。透過這些製造效率與產能提升,我們不再受限於只聚焦高風險、高給付族群。憑藉更高的商業彈性,我們正執行策略以擴大 CGM 技術的可及性,進一步深入我們先前無法觸及的既有市場。透過這些措施所帶來的增量出貨量,我們相信可抵銷任何短期價格影響,同時讓公司在長期成長上具備更佳定位。
Our first quarter gross profit was $343.9 million or 68.1% of revenue compared to 63.9% of revenue in the first quarter of 2020. The fact that we are driving margin expansion, despite absorbing the channel mix impact associated with the acceleration of our U.S. business to the pharmacy channel, is a testament to the work of our teams to drive down material and production costs. Operating expenses were $297.5 million for the first quarter of 2021 compared to $215.4 million for the first quarter of 2020. The increase in operating expenses as a percentage of sales in the first quarter of 2021 is a result of several of the key initiatives that we outlined in our original 2021 guidance in February. This includes our expanded commercial efforts with the doubling of our U.S. sales force and increased global DTC marketing efforts, both reflected in the quarterly results.
第一季毛利為 3.439 億美元,佔營收 68.1%,相較 2020 年第一季佔營收 63.9%。我們在吸收因美國業務加速轉向藥局通路所帶來的通路組合影響之下仍能推動毛利率擴張,這證明我們團隊在降低材料與生產成本方面的努力。2021 年第一季營業費用為 2.975 億美元,較 2020 年第一季的 2.154 億美元增加。2021 年第一季營業費用占銷售額比重上升,源於我們在 2 月提出的 2021 年初始財測中所概述的幾項關鍵計畫,包括擴大商業推廣(美國銷售團隊倍增)以及提升全球 DTC 行銷投入,這些都反映在本季結果中。
In addition, the first quarter research and development expense includes costs associated with our large U.S. iCGM trial for G7, which will continue into the second quarter as we generate the data necessary to support our regulatory filing. Offsetting those strategic investments, we continue to gain leverage in our general and administrative expenses in the quarter, demonstrating the benefits of our scaling initiatives. To that end, as we've previously indicated, we have launched a global business services facility in Lithuania, which is now officially live in servicing our customers.
此外,第一季研發費用包含我們在美國針對 G7 進行的大型 iCGM 試驗相關成本;該試驗將延續至第二季,以產出支持我們監管申報所需的數據。抵銷這些策略性投資的同時,我們在本季持續在一般與行政費用上取得規模效益,展現我們擴張(scaling)計畫的成果。為此,如我們先前所指出,我們已在立陶宛啟用全球商業服務中心,且目前已正式上線為客戶提供服務。
Operating income was $46.4 million or 9.2% of revenue in the first quarter of 2021 compared to $43.3 million or 10.7% of revenue in the same quarter of 2020, with 150 basis point decrease resulting from our strategic investments offset by our gross margin improvement. Adjusted EBITDA was $94.4 million or 18.7% of revenue for the fourth quarter compared to $77.8 million or 19.2% of revenue for the first quarter of 2020. Net income for the first quarter was $32.8 million or $0.33 per share. We remain in a great financial position, closing the first quarter with more than $2.6 billion in cash and cash equivalents and well positioned to continue our G7 scale-up and remain opportunistic as we look to expand our growth opportunities.
2021 年第一季營業利益為 4,640 萬美元,佔營收 9.2%,相較 2020 年同季為 4,330 萬美元、佔營收 10.7%;其中 150 個基點的下降,來自我們的策略性投資,並由毛利率改善部分抵銷。調整後 EBITDA 為 9,440 萬美元,佔營收 18.7%,相較 2020 年第一季為 7,780 萬美元、佔營收 19.2%。第一季淨利為 3,280 萬美元,或每股 0.33 美元。我們仍維持非常穩健的財務狀況,第一季結束時持有超過 26 億美元的現金及約當現金,並具備良好條件持續推進 G7 擴產,同時在尋求擴大成長機會時保持彈性、把握機會。
Turning to guidance. We expect some impact to new customer starts to continue during the ongoing global vaccine rollout, particularly in certain international markets as well as continued higher-than-usual volumes in our U.S. Medicaid channel as the economy recovers. With the strong first quarter performance as well as the currency benefit that we saw in the first quarter and continue to anticipate, we are pleased to be in a position to raise our full year 2021 revenue guidance. We now expect 2021 revenue to be between $2.26 billion to $2.36 billion, representing growth of 17% to 22% over 2020. This growth continues to factor in strong unit growth volumes, which are offsetting the impact of lower revenue per customer channels and our recent efforts to broaden access to G6 in international markets as well as the impact of currency.
接著談財測。我們預期在全球疫苗持續推廣期間,新客戶啟用(new customer starts)仍會受到一些影響,特別是在部分國際市場;同時,隨著經濟復甦,我們美國 Medicaid 通路的量能仍將維持高於以往的水準。基於第一季的強勁表現,以及我們在第一季看到並預期將持續的匯率利多,我們很高興能上調 2021 年全年營收指引。我們目前預期 2021 年營收介於 22.6 億至 23.6 億美元,較 2020 年成長 17% 至 22%。此成長仍納入強勁的出貨量成長,並抵銷每位客戶營收較低的通路影響、我們近期在國際市場擴大 G6 可及性的努力,以及匯率影響。
Turning to margins. We are affirming the full year 2021 targets previously established on our fourth quarter call. This includes non-GAAP results to be approximately at the following levels: gross profit margins of approximately 65%, operating margins of approximately 13%. We continue to expect that adjusted EBITDA margins to be approximately 23%. And finally, as you may have noticed, from a tax perspective, we have transitioned to profitability and we'll have a tax rate applicable to earnings going forward. Our expectation
接著談毛利率與利潤率。我們重申在第四季電話會議上先前建立的 2021 年全年目標。非 GAAP 結果預計約為以下水準:毛利率約 65%,營業利益率約 13%。我們仍預期調整後 EBITDA 利潤率約為 23%。最後,如各位可能已注意到,從稅務角度來看,我們已轉為獲利,未來將適用於盈餘的稅率。我們的預期
(technical difficulty)
(技術問題)
the call over to Quentin for a scale and strategy update.
把電話會議交給 Quentin,請他更新擴產與策略進展。
Quentin S. Blackford - COO
Quentin S. Blackford - COO
Thank you, Jereme. It's been a pleasure to work alongside Jereme for the last 7 years of our careers, and I am thrilled for him as he now steps into the CFO role. I look forward to watching you and take this next step in his career and look forward to the many contributions that he'll make in his new role while also excited by the opportunity to turn my attention much more broadly to our strategic and scaling efforts across the organization.
謝謝你,Jereme。過去 7 年能與 Jereme 共事是我的榮幸,我也為他如今接任 CFO 一職感到非常高興。我期待看到你在職涯中邁出下一步,也期待他在新職務上做出許多貢獻;同時我也很期待能把我的注意力更廣泛地投入到我們在全組織的策略與規模化(scaling)推進工作上。
Our teams remain incredibly focused on our strategic initiatives and are making great progress on several fronts. As Kevin mentioned, we are advancing our regulatory and clinical efforts for G7 and will present the first set of G7 data at the upcoming ATTD conference in early June. As we press forward toward our G7 goals, we are making steady progress in our effort to scale G7 manufacturing to support our launches and the continued growth of our global customer base. In the near term, this includes the lines that we are building in our San Diego and Mesa, Arizona facilities. We've also broken ground on our manufacturing site in Malaysia, which we expect to enable us to significantly scale our G7 production capacity to serve meaningfully more customers as we continue to grow our business in the years to come.
我們的團隊仍高度聚焦於策略性計畫,並在多個面向取得良好進展。如 Kevin 所提到,我們正在推進 G7 的監管與臨床工作,並將於 6 月初即將舉行的 ATTD 會議上發表第一批 G7 數據。在朝 G7 目標邁進的同時,我們也在擴大 G7 製造規模方面穩步推進,以支援上市並滿足全球客戶基礎持續成長。短期內,這包括我們在聖地牙哥以及亞利桑那州梅薩(Mesa)廠區正在建置的產線。我們也已在馬來西亞的製造基地動工,預期將使我們能大幅擴增 G7 產能,在未來幾年業務持續成長之際,服務顯著更多的客戶。
Even with G7 on the horizon, we remain committed to building on the leading customer experience that we have established for users of our G6 system. Following the December regulatory approval in the U.S., we rolled out an update to the G6 algorithm in the first quarter. We believe this update will drive further reductions to times in which data is temporarily unavailable and have seen excellent results from the initial launch of this updated algorithm in Canada in 2020. These are the kinds of incremental improvements that we are always looking to provide, and they are contributing to our strong customer retention and satisfaction levels reflected in our industry-leading Net Promoter Scores.
即使 G7 即將到來,我們仍致力於在 G6 系統使用者已建立的領先客戶體驗基礎上持續精進。在美國於 12 月取得監管核准後,我們在第一季推出了 G6 演算法更新。我們相信此更新將進一步降低資料暫時不可用的時間,且我們已在 2020 年於加拿大初期推出該更新演算法時看到極佳成果。這些正是我們持續提供的漸進式改良,並促成我們強勁的客戶留存與滿意度,反映在我們業界領先的淨推薦值(Net Promoter Scores)上。
On the insulin delivery front, we were encouraged to see the great results from the Omnipod 5 pivotal trial presented at ENDO 2021, and look forward to the upcoming launch of that system for our DexCom customers using the Omnipod pump. With this launch in Omnipod's differentiated patch pump form factor as well as Tandem's continued market traction with their DexCom-connected Control-IQ, we believe that we are very well positioned to continue to benefit from the growing appreciation for these automated insulin delivery systems.
在胰島素輸送方面,我們很受鼓舞地看到 Omnipod 5 關鍵性試驗在 ENDO 2021 上發表的優異結果,並期待該系統即將為使用 Omnipod 幫浦的 DexCom 客戶推出。隨著 Omnipod 以其差異化的貼片式幫浦外型推出,以及 Tandem 透過其與 DexCom 連線的 Control-IQ 持續獲得市場動能,我們相信我們已處於非常有利的位置,能持續受惠於市場對這些自動化胰島素輸送系統日益提升的認可。
Similarly, we continue to advance our development with Eli Lilly, Novo Nordisk, and more recently, Ypsomed, leaving us in a strong position in future years as people with diabetes stand to benefit from greater variety in their choices for Bluetooth-connected insulin delivery options that integrate DexCom CGM.
同樣地,我們也持續推進與禮來(Eli Lilly)、諾和諾德(Novo Nordisk),以及近期與 Ypsomed 的開發合作,使我們在未來幾年處於強勢地位;糖尿病患者將可受惠於更多樣化的選擇,包含可透過藍牙連線、並整合 DexCom CGM 的胰島素輸送方案。
We've discussed the excellent first quarter performance in our U.S. IIT market as well as some of the key strategic initiatives that we are undertaking to expand access in our international markets. We are also making excellent progress in our effort to drive the third pillar of near-term growth that we highlighted at our 2020 Investor Day, the nonintensive type 2 market.
我們已討論過美國 IIT 市場第一季的優異表現,以及我們為擴大國際市場可近性所推動的一些關鍵策略性計畫。我們也在推動我們於 2020 年投資人日所強調的短期成長第三支柱——非密集治療的第二型糖尿病市場——方面取得極佳進展。
As we've mentioned before, we are taking multichannel approach to enabling access to DexCom CGM in the absence of widespread reimbursement. This involves direct work with payers, digital health programs, health care providers, and integrated networks as well as the patients themselves. The early rollout of Level2 is progressing well as we continue to see that program expand and our teams are working well with the UnitedHealthcare team to optimize the experience for members using our G6 system as part of that program.
如同我們先前提到的,在缺乏廣泛給付的情況下,我們採取多通路方式來促進 DexCom CGM 的可近性。這包括與支付方的直接合作、數位健康計畫、醫療照護提供者與整合式網路,以及病患本身的互動。Level2 的早期推行進展順利,該計畫持續擴大;我們的團隊也正與 UnitedHealthcare 團隊密切合作,為在該計畫中使用我們 G6 系統的會員優化使用體驗。
We also worked with several partners to expand their use of G6 in their respective type 2 populations in the first quarter. This includes the initiation of commercial pilots with Teladoc Health's Livongo for Diabetes platform as well as with WellDoc. Everside Health also announced that it will offer G6 to its members with type 2 diabetes in its Healthstat business unit, and we are proceeding there now in a pilot phase. This relationship builds from our initial work with Healthstat over the previous 2 years, including the use of DexCom CGM in a pilot for health screenings at on-site clinics. Each of these relationships is expanding the pool of customers who can access our technology while generating evidence of the utility of DexCom CGM for the broader type 2 market that we believe will drive access and awareness in the future.
第一季我們也與多個合作夥伴合作,擴大其在各自第二型糖尿病族群中使用 G6。這包括與 Teladoc Health 的 Livongo for Diabetes 平台以及 WellDoc 啟動商業試點。Everside Health 也宣布將在其 Healthstat 事業單位中,向其第二型糖尿病會員提供 G6,而我們目前正以試點階段推進。此合作關係建立在我們過去兩年與 Healthstat 的初期合作之上,包括在院內診所進行健康篩檢試點時使用 DexCom CGM。上述每一項合作都在擴大可使用我們技術的客戶群,同時也產生 DexCom CGM 對更廣泛第二型糖尿病市場效用的證據;我們相信這將在未來推動可近性與認知度。
Beyond these core growth initiatives, our teams continue to advance innovative research and product development that we feel will contribute to long-term growth for DexCom. This includes the hospital market, where we are generating data via our patient registry and receiving great feedback as many hospitals across America continue to take advantage of the FDA's temporary allowance to use DexCom CGM in the inpatient setting during the pandemic. This also includes several clinical studies assessing the use of DexCom CGM for better management of gestational diabetes, a solution that we believe can enhance the outcomes for both the mother and the child. And finally, we continue to access next-generation technologies that we believe can build from the sensor platform that we've established with G6 and G7. We look forward to updating you as we progress.
除了這些核心成長計畫之外,我們的團隊也持續推進創新研究與產品開發,我們認為這將有助於 DexCom 的長期成長。其中包括醫院市場:我們透過病患登錄系統產生數據,並獲得非常正面的回饋,因為美國許多醫院在疫情期間持續利用 FDA 的臨時允許,在住院環境中使用 DexCom CGM。這也包括多項臨床研究,評估使用 DexCom CGM 以更好管理妊娠糖尿病;我們相信這項解決方案可改善母親與孩子的結局。最後,我們也持續評估下一代技術,我們相信可在我們以 G6 與 G7 建立的感測器平台基礎上進一步發展。我們期待在進展過程中向各位更新。
With that, I will pass it back to Kevin.
接下來,我把時間交回給 Kevin。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Thanks, Quentin. As you can see, we're off to a great start to the year and working hard to execute on the strategic pathway that we've laid out for 2021. I would now like to open up the call for Q&A. Sean?
謝謝你,Quentin。如各位所見,我們今年開局非常好,並正努力執行我們為 2021 年規劃的策略路徑。現在我想開放電話會議進入問答環節。Sean?
Sean Christensen - Director of Corporate Affairs & Head of IR
Sean Christensen - Director of Corporate Affairs & Head of IR
Thank you, Kevin. (Operator Instructions) Operator, please provide the Q&A instructions.
謝謝你,Kevin。(接線員指示)接線員,請提供問答指示。
Operator
Operator
(Operator Instructions) And our first question comes from Jeff Johnson from Baird.
(接線員指示)我們的第一個問題來自 Baird 的 Jeff Johnson。
Jeffrey D. Johnson - Senior Research Analyst
Jeffrey D. Johnson - Senior Research Analyst
Let me -- I'll put it into a multipart question, I guess. But Kevin, I think it's officially one question. But on the channel mix headwinds that we've been talking about here in the last 6 to 8 quarters or so, is it still fair to be thinking around $200 million, plus or minus, this year? And given the exit rate from 4Q of '20, still fair to think a little bit of that as front-end loaded? And then when I look at your 30% U.S. growth, it would seem like if I ex out the channel headwinds, the pricing headwinds there, volumes must have grown well north of 40%. So if you could just kind of confirm that from a pricing versus volume mix in 1Q U.S. number, that would be helpful as well.
我——我想把它拆成一個多段式問題。不過 Kevin,我想這正式上算一個問題。關於我們在過去大約 6 到 8 個季度一直在談的通路組合逆風,今年仍然可以用大約 2 億美元、上下浮動來思考嗎?另外,考量 2020 年第四季的退出水準,是否仍可認為其中有一部分會較偏向前期集中?再者,當我看你們美國 30% 的成長時,似乎如果把通路逆風、以及其中的價格逆風剔除,量的成長應該遠高於 40%。所以如果你們能就第一季美國數字中價格與量的組合,稍微確認一下,會很有幫助。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Jereme will take that one, Jeff.
Jeff,這題由 Jereme 來回答。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Yes, Jeff. So to your question on what the channel mix headwinds are, we'll just tell you what the numbers were for the quarter. It was about $50 million for the quarter. And if you recall, we talked about it being a little bit more straight-lined over the course of 2021 due to comps. The one thing we have talked about, and Kevin referred to it on the call as did I, is that we are going to be a little more aggressive in international markets. And so because of that, we're raising what we call channel mix/pricing headwinds to about $250 million on the year. And that obviously takes into account the aggressive steps we've taken outside the U.S.
好的,Jeff。關於你問到的通路組合逆風,我們先告訴你本季的數字:本季大約是 5,000 萬美元。你若記得,我們曾談到由於比較基期的因素,2021 年整體會更接近線性分布。我們也一直提到——Kevin 在電話會議上提到、我也提到——我們將在國際市場採取更積極的作法。因此,我們把所謂的通路組合/價格逆風上調至全年約 2.5 億美元。這顯然也反映了我們在美國以外採取的更積極步驟。
In terms of your question in terms of growth and unit volume, we talked about unit volume approaching 40% on a global basis. When you take the channel mix headwinds we talked about, you are correct. The U.S. unit volume growth was well in excess of that, obviously, being the stronger point of the quarter from a growth perspective. So you are seeing that performance on the quarter.
至於你關於成長與出貨量(unit volume)的問題,我們談到全球出貨量成長接近 40%。若把我們提到的通路組合逆風納入,你的判斷是正確的:美國的出貨量成長明顯高於這個水準,且顯然是本季在成長面最強的部分。因此你在本季看到的就是這樣的表現。
Operator
Operator
And our next question comes from Joanne Wuensch from Citibank.
下一個問題來自花旗銀行(Citibank)的 Joanne Wuensch。
Joanne Karen Wuensch - MD
Joanne Karen Wuensch - MD
Can I go back to what you just said, please? To be clear, the $50 million in the quarter, how much of that was U.S. versus OUS?
我可以回到你剛才說的內容嗎?為了確認清楚,本季的 5,000 萬美元,其中有多少是美國、多少是美國以外(OUS)?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Yes. So Joanne, we generally don't break down the two. What we did talk about was $50 million is the global now. A majority of that has traditionally been the channel mix from pharmacy or from DME into pharmacy. But when we give that number, we give a global number. So that was $50 million globally on the quarter, again, heavily weighted U.S.
好的。Joanne,我們一般不會把這兩者拆開來說。我們提到的 5,000 萬美元現在是全球數字。傳統上其中大部分來自通路組合,也就是從藥局或從 DME 轉到藥局。但當我們提供這個數字時,我們提供的是全球數字。因此本季全球是 5,000 萬美元,再次強調,權重主要在美國。
Joanne Karen Wuensch - MD
Joanne Karen Wuensch - MD
Okay. I'm going to sneak one more because that was a clarification. Is there any reason that it's not possible for G7 to be in the U.S. by the end of this year?
好的。我再偷偷問一個,因為剛剛那只是釐清:是否有任何原因,使得 G7 不可能在今年年底前於美國上市?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
We're not giving any G7 timelines other than we will launch it by the end of the year. As I said in the earlier portion of our remarks, our U.S. pivotal study will conclude this quarter, and then we'll file. We're working on our filing in Europe under MDR rules for CE Mark, and we'll go from there. Time will tell, but everything is going well. We're happy with the progress of the product. We're extremely happy with the feedback we've gotten from clinicians and patients. In fact, one clinician called me this morning in between our prep for this call to tell me how great the product was. So we're very happy with it, but we're not going to give any other timelines on what we have so far.
除了我們會在年底前推出之外,我們不提供任何 G7 的時間表。正如我在先前談話中提到的,我們在美國的關鍵性試驗將於本季結束,之後我們會送件。我們也正在依據 MDR 規則準備在歐洲申請 CE Mark 的送件,接著再往下推進。時間會給答案,但目前一切進展順利。我們對產品的進度很滿意,也對臨床醫師與病患給予的回饋非常滿意。事實上,今天早上在我們為這通電話會議準備的空檔,有位臨床醫師打電話給我,告訴我這個產品有多棒。所以我們對它非常滿意,但除了目前已分享的內容之外,我們不會再提供其他時間點。
Operator
Operator
And our next question comes from Robbie Marcus from JPMorgan.
下一個問題來自摩根大通(JPMorgan)的 Robbie Marcus。
Robert Justin Marcus - Analyst
Robert Justin Marcus - Analyst
Great. Congrats on nice quarter. I wanted to talk about the guidance raise. It was more than the beat you had in the first quarter. So maybe walk us through your new patient assumptions and what's driving that U.S. versus OUS. And if you could comment at all on how the early trends of the Super Bowl and increased DTC spend and sales force doubling has benefited the company so far and what to expect in 2021.
很好。恭喜本季表現不錯。我想談談你們上調財測指引的部分。上調幅度大於你們第一季的超預期表現。所以能否帶我們了解一下你們對新增病患的假設,以及是什麼在驅動美國相對於美國以外(OUS)的表現?另外,如果可以的話,也請評論一下超級盃早期趨勢、增加 DTC 投入,以及銷售團隊倍增,迄今為止如何讓公司受益,以及 2021 年可期待什麼。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. Yes. So we can walk you through it. The guidance raise was approximately $25 million of it was currency. So we referenced some of the foreign currency tailwinds associated with the other half was related to volume growth, expected both in the first quarter and on the balance of the year. In terms of what we saw in terms of new patient adds in the first quarter, new patient adds were slightly ahead of expectations. And so that's really -- as we look to the balance of the year, certainly, those repeat customers obviously play through in the balance of revenue for the year. And so we've added that to the guidance.
當然可以。是的,我們可以帶你走一遍。這次上調指引中,大約有 2,500 萬美元來自匯率。我們提到了一些外匯順風;其餘部分則與出貨量成長有關,這些成長預期反映在第一季以及今年剩餘期間。就第一季新增病患數而言,新增病患略高於預期。因此——當我們看今年剩餘期間時,這些回購客戶顯然會反映在全年其餘營收中,所以我們也把這部分納入指引。
We still are bullish on the year. We still expect to have a very strong year. I don't think there was any question there. And I think if you see the performance in the U.S. result, I think you're obviously seeing a lot of, to your second question, a lot of the DTC, a lot of the Super Bowl ads as well as the new sales force ads starting to really play through, not to mention the fact that we have a sampling program that's out there that is starting to allow folks to trial the product, which we think is garnering interest as well.
我們對今年仍然看多。我們仍然預期今年會非常強勁。我認為這點毫無疑問。而且我想,如果你看美國的業績表現,你顯然會看到——呼應你第二個問題——很多DTC(直接面向消費者)的投入、很多超級盃廣告,以及新的銷售團隊廣告都開始真正發揮效果;更不用說我們還有一個正在推行的試用(sampling)計畫,開始讓大家能夠試用產品,我們認為這也正在帶動市場興趣。
So that's all been contemplated in the guidance as we lay it out. And I think what you'd say is for the balance of the year, I do think you are seeing the momentum continue to support raising what we raised it by.
因此,當我們提出指引時,這些都已經納入考量。我想你可以說的是,在今年剩餘期間,我確實認為你會看到這股動能持續,並支持我們把指引上調到目前這個幅度。
Quentin S. Blackford - COO
Quentin S. Blackford - COO
And Robbie, I would just -- the one thing I'd add to that is, as Jereme laid out in the prepared remarks, our decision on the international markets with respect to opening up access, I do expect you're going to see that new patient number continue to perform very nicely in the back half of the year as we're accessing markets that are 5 to 6x larger than what we had coming into the year in some of these markets. So very excited about where that new patient number potentially goes to.
Robbie,我只想——補充一點:正如Jereme在事先準備的發言中所說,我們在國際市場、就開放取得(access)的決策方面,我確實預期你會看到下半年新病患數持續表現得非常好,因為我們正在進入的市場,在其中一些地區,其規模是我們年初進入時所能觸及市場的5到6倍。所以我們對新病患數可能達到的水準感到非常興奮。
Operator
Operator
And our next question comes from Matthew O'Brien from Piper Sandler.
下一個問題來自Piper Sandler的Matthew O'Brien。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
Just a follow-up on the pricing commentary. The $200 million to $250 million is obviously a pretty meaningful increase. We've got Libre 3 over in Germany now. You're talking about being more aggressive in terms of lowering pricing OUS, I think, for more access. I mean does that -- is it a function of Libre 3? You're trying to be aggressive in front of a more broad launch there with G6 over there. Is that a reason why you're increasing the pricing concessions right now? And then what does that say about when 3 comes to the U.S.? And how can G7 kind of offset that?
我想就定價的評論再追問一下。2億到2.5億美元顯然是相當顯著的增加。我們現在在德國已經有Libre 3。你提到為了取得更多使用權(access),在美國以外(OUS)會更積極地下調價格。我是說,這——是Libre 3所導致的嗎?你們想在那邊更廣泛推出G6之前先採取更積極的策略嗎?這是否是你們現在提高價格讓利(pricing concessions)的原因?另外,這對於Libre 3何時進入美國意味著什麼?以及G7要如何抵銷這些影響?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
We've not made our decisions based on Libre 3, Matt. We've looked at what we accomplished in the U.S. here. What we've done is we've increased access by going to the pharmacy channel by looking at Medicare approval, for example, which came in at a lower price than what our DME price was before as we've set up Medicaid pricing structures in the U.S. that are yet once again a pricing structure lower than what we had before, but to increase access to a number of patients.
Matt,我們並沒有基於Libre 3來做決策。我們看的是我們在美國這裡所達成的成果。我們所做的是透過進入藥局通路來提高可及性,例如爭取到Medicare核准;其價格低於我們先前的DME價格。同時,我們也在美國建立了Medicaid的定價架構,而那又是另一個低於我們先前水準的定價架構,但目的在於讓更多病患能夠取得產品。
We then have looked at our OUS business in several of our key geographies and said, you know what, our access is not broad enough. Our access is very much focused on very intensively managed type 1s, oftentimes just children or adults with pumps or adults with an incredibly bad hypoglycemia awareness or something along those lines. And it's more important to us to reach more patients. So we've taken the strategy we've used in the U.S., and we're deploying it in other places as well to increase our access. We won't let Libre 3 drive our decisions. We'll drive our own.
接著我們檢視了我們在美國以外(OUS)幾個關鍵地區的業務,並認為:你知道嗎,我們的可及性不夠廣。我們的可及性非常集中在高度密集管理的第一型糖尿病患者,很多時候只是兒童,或是使用幫浦的成人,或是對低血糖缺乏警覺性非常嚴重的成人,或類似族群。對我們而言,觸及更多病患更重要。因此,我們把在美國採用的策略,也部署到其他地區,以提升可及性。我們不會讓Libre 3來主導我們的決策;我們會做我們自己的決策。
Quentin S. Blackford - COO
Quentin S. Blackford - COO
I think one important thing to note there is the pricing point. It's always been part of our global pricing strategy and the level that we're going to is still very much in line with where we're at in the U.S. pharmacy channel, to be honest with you. So we're just stepping down as we've had inventory availability now. We're in the best position we've ever been in from that perspective. We know we got to reduce the burdens to get on the product. We're in a position now to continue to execute against that global pricing strategy. So this is very much part of where we were heading. It doesn't create risk elsewhere globally. Like I mentioned, it's right in line with our U.S. pharmacy pricing if you get into the comps. So excited about what this has a potential to create for us.
我認為其中一個重要點是定價水準。這一直都是我們全球定價策略的一部分,而我們目前要達到的水準,坦白說,仍然與我們在美國藥局通路的水準非常一致。所以,隨著我們現在的庫存供應能力到位,我們只是把價格往下調整。我們在這方面的狀態是史上最好。我們知道必須降低使用產品的門檻。現在我們有能力持續執行這個全球定價策略。因此,這非常符合我們原本的方向。它不會在全球其他地區造成風險。就像我提到的,如果你去做比較,它與我們美國藥局定價是高度一致的。所以我們對這可能為我們帶來的成果感到很興奮。
Operator
Operator
And our next question comes from Bob Hopkins from Bank of America.
下一個問題來自美國銀行(Bank of America)的Bob Hopkins。
Robert Adam Hopkins - MD of Equity Research
Robert Adam Hopkins - MD of Equity Research
I just wanted to ask a question on G7. I was wondering if you could comment on 2 things. First thing, I just want to clarify, when do you expect to file CE Mark in Europe? I thought that was something that was going to happen or might have happened already. And then secondly, I was wondering if you just could comment on the upcoming data that we're going to see on G7, just maybe help give us a sense of just what we're going to see and how meaningful it might be? And just a little bit more detail there would be great.
我想問一個關於G7的問題。我想請你們就兩件事做評論。第一,我想確認一下,你們預期何時在歐洲提交CE Mark申請?我原本以為這件事應該會發生,或可能已經發生了。第二,我想請你們談談今年夏天我們將看到的G7相關數據,或許幫我們了解一下大概會看到什麼、它可能有多重要?如果能多一點細節就太好了。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Well, G7, we have not filed yet. We will file it in the not-too-distant future. We want to -- we need all our ducks in a row. For example, we want to file both the Android and the iOS app at the same time, not file one and then do another filing. So making sure our software is validated and verified is really one of the bigger tasks. The clinical data is in, and we're ready with that part of the filing, and we've had direct discussions with our authorities over there, and we feel we're in good shape. But we'll file when we're ready. We don't want to do it twice and spend a lot of time answering questions.
關於G7,我們尚未提交申請。我們會在不久的將來提交。我們想要——我們需要把所有事項都準備妥當。舉例來說,我們希望Android與iOS的App能同時提交,而不是先提交一個、再做另一個申請。因此,確保我們的軟體完成驗證(validated)與確認(verified)是其中一項較大的工作。臨床數據已經完成,我們在申請所需的那部分也已準備就緒;我們也已與那邊的主管機關直接討論過,並且覺得狀況良好。但我們會在準備好時才提交。我們不想做兩次,並花很多時間回覆問題。
With respect to the data that we'll present here in the summer, it will be on some of the smaller studies that we've done. It will not be on any of the U.S. pivotal data, obviously, but you'll see how the product performs and how consistent and how happy we are with it. Obviously, I'm happy with the data and as is our team. I've made the comment on several times when all said and done, everything you love about G6, you're going to love more about G7. And when that product comes to market, that's exactly how we're going to feel about it not only from the smaller wearable and the easier insertion and all the other wonderful patient ease of use features we're putting in there, but the software, the app and the performance of the system, we believe, is going to be spectacular and again, set a real standard for people to go over.
至於我們將在夏天發表的數據,會是我們做過的一些較小型研究的結果。顯然不會是任何美國的關鍵性(pivotal)數據;但你會看到產品的表現、它的一致性,以及我們對它有多滿意。很明顯,我對這些數據很滿意,我們團隊也是。我曾多次評論:最終來看,你喜歡G6的一切,你會更喜歡G7。而當這個產品上市時,我們的感受也會是如此——不僅因為它更小的穿戴裝置、更容易的置入方式,以及我們加入的其他各種讓病患更易用的優點,還包括軟體、App與系統表現;我們相信它將會非常出色,並再次為市場樹立一個真正的標準,讓大家去追趕。
Operator
Operator
And our next question comes from Kyle Rose from Canaccord.
下一個問題來自Canaccord的Kyle Rose。
Kyle William Rose - Senior Analyst
Kyle William Rose - Senior Analyst
Great. Wanted to talk about a few of the commercial initiatives in the U.S. I mean, obviously, still early in the sampling program. You've just completed the doubling of the sales force and kind of shifting some of the focus to more on the primary care. So maybe just help us understand how some of those initiatives have played out in the early days with respect to the Q1 and early into Q2. And just, are there any metrics? Or is there any sort of goalpost you can help me frame the early execution on those initiatives for us? And how do we think about that as we move through '21?
好的。我想談談美國市場的一些商業推動措施。我的意思是,顯然試用(sampling)計畫仍在早期階段。你們剛完成銷售團隊倍增,並把部分重點轉向更多的基層醫療(primary care)。所以也許請協助我們理解,這些措施在早期、就第一季以及第二季初的表現如何?另外,有沒有任何指標?或是有沒有任何里程碑可以幫我框定這些措施早期執行的成效?以及當我們走過2021年時,應該如何看待這些?
Quentin S. Blackford - COO
Quentin S. Blackford - COO
Sure. I'll take a quick shot at the sampling and then hand it over to Kevin here. There aren't any metrics that we're going to disclose, particularly to sampling, in and of itself, although I will tell you, the early response to this program has been beyond our expectations, both from a physician's perspective of just how easy we've enabled these PCPs to get products into the hands of our patients and then also from a patient perspective when they realize just how easy it is to use the DexCom product. So the sampling program has been beyond what we imagined coming out of the gate. It will continue to be a big part of what we do into the future. But in terms of giving specific metrics around it, that's not something we will do. I will tell you, it's one of the better investments that we look to make at this point.
當然。我先簡單談一下試用(sampling),然後交給Kevin。關於試用本身,我們不會披露任何指標;不過我可以告訴你,這個計畫的早期反應超出我們的預期——不論是從醫師角度,因為我們讓這些基層照護醫師(PCPs)能非常容易地把產品交到病患手上;或是從病患角度,當他們意識到DexCom產品有多容易使用時。總之,試用計畫一開始的表現就超出我們的想像。未來它也會持續成為我們工作的重要一部分。但就提供具體指標而言,我們不會這麼做。我可以告訴你的是,就目前來看,這是我們認為最值得投入的投資之一。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Yes, I'd agree with that. With respect to the sales force, we've added everybody we were going to add. Everybody's in place. And everybody is getting up to speed. And some of the people came from a diabetes background, so they get it to speed easier because they have relationships already established in these offices, possibly from another company. Others, it's going to take a little while longer, and we plan for that as we do this expansion. But as far as calling on more voices, we are learning that, in all fairness, we've been underserved with respect to our ability to call on people.
是的,我同意。至於銷售團隊,我們已經把原本要增加的人員都加進來了。所有人都已到位,也都在加速上手。有些人有糖尿病領域背景,所以他們上手更快,因為他們可能在這些診所已經建立了關係,可能是從其他公司帶來的。其他人則需要多一點時間,我們在擴編時也已把這點納入規劃。但就拜訪更多對象而言,公平地說,我們也正在了解到,我們過去在拜訪能力方面確實是供給不足的。
There's a great story we heard from down in Texas. One of our reps called on a physician or -- and talked to them about our product and the doctor said, I know nothing about your product. I've put people on your competitors' product because they come and ask me for it. So again, using the sample program that Quentin described with Hello Dexcom, we put this patient on the system, introduce the physician to it, and now he's prescribing DexCom all the time because of the experience that patient had. We needed a deeper reach. We'll get that deeper reach with what we've done, and we'll continue to evaluate over time. And we've got tremendous metrics on our salespeople. We have an incredible commercial organization that monitors that. But we also very much understand it takes a while to get up to speed.
我們在德州那邊聽到一個很棒的故事。我們的一位業務代表拜訪了一位醫師,跟他談到我們的產品,醫師說:我對你們的產品一無所知。我之所以讓病人用你們競爭對手的產品,是因為他們會來找我、要求我開那個。於是,再次透過 Quentin 所描述、搭配 Hello Dexcom 的試用計畫,我們讓這位病人使用我們的系統,並讓醫師認識它;現在他因為那位病人的使用體驗,已經一直在開立 DexCom。我們需要更深入的觸及。我們會透過我們所做的事情達到更深入的觸及,並且會隨時間持續評估。我們也有非常強的業務人員指標。我們有一個很出色的商業組織在監控這些。但我們也非常清楚,讓團隊完全上手需要一段時間。
The other great thing I can tell you about this expansion, we literally have thousands of people apply for these jobs. And a lot of very, very qualified people that we did not hire. This is a place that people want to work and a product that they really want to represent, and we want to continue that culture and maintain that.
關於這次擴編,我還可以告訴你另一件很棒的事:實際上有成千上萬的人來應徵這些職缺。而且有很多、非常非常合格的人我們最後沒有錄用。這是一個大家想來工作的地方,也是他們真的想代表的產品;我們希望延續並維持這樣的文化。
Operator
Operator
And our next question comes from Mathew Blackman from Stifel.
下一個問題來自 Stifel 的 Mathew Blackman。
Mathew Justin Blackman - Analyst
Mathew Justin Blackman - Analyst
I wanted to follow-up on the OUS pricing strategy and sort of a multipart question here. But is the incremental $50 million headwind you called out isolated to 2021? Or will these price headwinds continue beyond 2021 outside the U.S.? And then if I think about the full year guidance range -- raise of about $50 million, I think about half of that you said is underlying outperformance. But that's also in the face of another $50 million headwind on price. So is it fair to say that the guidance rate is actually closer to, call it, $75 million ex FX on an underlying basis?
我想追問一下美國以外(OUS)的定價策略,這是一個多段式的問題。你們提到的額外 5,000 萬美元逆風,是只發生在 2021 年嗎?還是 2021 年之後在美國以外,這些價格逆風仍會持續?另外,如果我看全年財測區間——上調大約 5,000 萬美元,其中你說大概一半是基本面超預期的表現。但這同時也面臨另一個 5,000 萬美元的價格逆風。所以這樣說是否合理:若以基本面、排除匯率(ex FX)來看,財測上調其實更接近約 7,500 萬美元?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Yes. So good question. So let's go step by step. So in terms of your question on the international pricing, a majority of the raise is our strategy outside the U.S. And so what you are seeing is we are taking an incremental $50 million of, call it, mix headwinds as a result of going into there. And we still -- yes, you're right. We did raise guidance in the face of that by $50 million, of which $25 million was currency. So absent that incremental, yes, you would have seen a $75 million. Now we are going to be taking those pricing headwinds, and we're going to be taking those pricing headwinds and making up for an incremental volume. So it's obviously net neutral to the full year guide. But you are correct. Absent taking on that strategy -- or because of that strategy, we expect to add new patients to the point where it increases our full year outlook.
是的。這是個好問題。我們一步一步來。就你問到的國際定價而言,上調的大部分來自我們在美國以外的策略。因此你看到的是:因為我們進入那些市場,我們承受了額外約 5,000 萬美元、可稱為產品組合(mix)逆風。而且我們仍然——是的,你說得對——我們在面對這個逆風的情況下,仍把指引上調了 5,000 萬美元,其中 2,500 萬美元來自匯率。所以如果沒有那個額外因素,是的,你會看到 7,500 萬美元。接下來我們會承受這些定價逆風,並透過額外的出貨量(volume)來彌補。因此對全年指引來說,顯然是淨中性(net neutral)。但你說得沒錯:若不採取那個策略——或者說正因為那個策略——我們預期能新增病人,進而提高我們的全年展望。
Operator
Operator
And our next question comes from Matt Taylor from UBS.
下一個問題來自 UBS 的 Matt Taylor。
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
Okay. So I'd like to ask one just about the U.S. momentum improvement. That was impressive, and you called out the factors. Is it possible for you to say which of the DTC, sampling and sales force, you think, contributed more to that? And which of those is still more to come? Or is it just all equal?
好。我想問一個關於美國動能改善的問題。那很令人印象深刻,你也點出了相關因素。你能否說明在 DTC、試用(sampling)以及銷售團隊這三者之中,你認為哪一項對改善貢獻更大?以及哪一項後續還有更多動能可期待?還是其實三者差不多?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
I think there are all more to come, and I think they're relatively equal. As I called out on the call, the effect of the Super Bowl, the ad was more than just short-term sales growth, in our minds. The awareness we generated, the text messages I was getting during the Super Bowl from industry and technology executives that I've met over the years made it all worth it. I'm just sitting on the couch saying, "hey, this is really cool." It really created a lot of awareness for our company, awareness we hadn't had before, and that was really the goal, as we talked about. We developed more brand equity from our ad than anybody else. So that was important to us. The DTC remains important.
我認為三者後續都還有更多可期待,而且相對而言差不多。如同我在電話會議中提到的,我們認為超級盃的廣告效果不只是短期銷售成長。我們所帶來的知名度——我在超級盃期間收到我多年來認識的產業與科技高階主管傳來的簡訊——讓這一切都很值得。我就坐在沙發上想著:「嘿,這真的很酷。」它確實為我們公司創造了大量的知名度,是我們以前沒有的知名度,而那正是我們所談到的目標。我們從這支廣告累積的品牌資產(brand equity)比任何人都多。這對我們很重要。DTC 仍然很重要。
As you watch our ads, you'll see certainly more with Nick and certainly other campaigns as well. And then on top of that, having more feet on the Street is good. We needed it. But it will take time to develop those relationships. I think of the 3, I couldn't quantify one of them, but I think, ultimately, the sales force expansion will be extremely helpful in this. We probably got less bang out of that just because we were ramping it up in the first quarter, but the DTC work and the Super Bowl ad, that was probably the biggest. And then Hello Dexcom and the reps will come more throughout the rest of the year.
你如果持續看我們的廣告,會看到更多 Nick 的內容,也會有其他活動。同時,讓更多業務在外跑(more feet on the Street)是好事。我們需要這樣做。但建立這些關係需要時間。在這三者之中,我無法量化哪一個最大,但我認為最終銷售團隊擴編會非常有幫助。我們可能從這部分得到的即時效益較少,因為第一季我們還在擴編爬坡;但 DTC 的工作與超級盃廣告,可能是最大的。接下來 Hello Dexcom 與業務代表的效果,會在今年剩下的時間逐步顯現。
Operator
Operator
And our next question comes from Jayson Bedford from Raymond James.
下一個問題來自 Raymond James 的 Jayson Bedford。
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
Somewhat similar to the last question. The first quarter strength in the U.S., much better than historical seasonality. I'm just wondering, is this more a function of just channel shifts that gone on the business? Or a function of the new momentum that you've seen kind of perhaps from some of these new initiatives? I know it's a tough question, but if there's any way to parse that out, that would be helpful.
有點類似上一題。美國第一季的強勁表現,遠優於過去的季節性。我想了解,這比較像是業務通路轉移所造成的結果?還是你們從一些新措施中看到的新動能所帶來的結果?我知道這題很難,但如果能用任何方式拆解一下,會很有幫助。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. Yes. So good question. Some of that is a bit of a change in shift in dynamics, and you're absolutely right, as more and more goes to the pharmacy. I think you are seeing that neutralization, if you will, of the Q4, Q1 dynamic. One thing we did see this quarter, and we thought it was certainly a testament to the work that our customer experience team is doing is we saw a slight decline in attrition -- a slight decline in attrition and a slight increase in utilization. And so as you think about the customer experience that we're trying to create here, we've been talking about increases in Net Promoter Scores. That's starting to play through and customer utilization have it. So that's certainly something we saw a little bit of.
當然。是的,這是個好問題。其中一部分確實是動態上的一些轉變;你說得完全正確,隨著越來越多轉向藥局通路,我想你看到的是第四季、第一季之間那種動態被「中和」(neutralization)了。這一季我們也看到一件事,我們認為這確實證明了客戶體驗團隊所做的工作:我們看到流失率(attrition)小幅下降——流失率小幅下降,同時使用率(utilization)小幅上升。因此當你思考我們想打造的客戶體驗時,我們一直在談 NPS(淨推薦值)的提升。這開始反映出來,也帶動了客戶使用率。所以這確實是我們看到的一部分。
And then I think what we also saw is just a little bit of incremental performance. We saw some of the performance outpaced expectations. I think what we talked about is an expectation of new patient growth, slightly outpacing it as a result of increased awareness as a result of DTC. So I think it's all 3 of those coming together.
另外,我們也看到一些額外的表現提升,有些表現超出預期。我想我們談到的是:由於 DTC 帶來的知名度提升,新病人增長略微超出原先預期。所以我認為這三者是一起發生、共同促成的。
Operator
Operator
And our next question comes from Christopher Pasquale from Guggenheim.
下一個問題來自 Guggenheim 的 Christopher Pasquale。
Christopher Thomas Pasquale - Director and Senior Analyst
Christopher Thomas Pasquale - Director and Senior Analyst
Two quick questions for Jereme on the margin front. First, just given how strong gross margin was in 1Q, I was hoping you could talk about why 65% is the right number for the full year. And then your audio cut out a little bit when you were talking about the tax rate. If you could just go back to that and what you're expecting for an overall tax rate this year, that would be great.
有兩個關於毛利率的快速問題想問 Jereme。第一,考量 1Q 毛利率非常強,我希望你能談談為什麼全年用 65% 這個數字是合理的。第二,你在談稅率時音訊有點斷斷續續;如果你能再說一次你們今年預期的整體稅率,會很棒。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. I'll start with the latter first. We expect the tax rate for the year to be between -- the non-GAAP tax rate between 23% and 25%. Back to your question on margins, we did have a great quarter in Q1. Certainly, we're very proud of the 68%. The one thing we do want to do is, first off, is the first quarter. So we think about it from a first quarter and really thinking about before, taking a look at changing anything, being mindful that we won't see things play out over time. But there's really 2 components you have to be aware of. We do expect to take on incremental channel mix headwinds in our international markets for the back half of the year. So we have to contemplate that in light of some of the efficiencies you're starting to see.
好的。我先回答後者。我們預期今年的稅率——非 GAAP 稅率——會在 23% 到 25% 之間。回到你關於毛利率的問題,我們第一季確實表現很好,我們當然也為 68% 感到非常自豪。但我們想先強調,這是第一季。因此我們在思考是否要調整任何東西之前,會以第一季的角度來看,並且要留意很多事情需要隨時間推移才會顯現。不過你需要注意兩個組成因素:我們確實預期在今年下半年,國際市場會承受額外的通路組合(channel mix)逆風。因此在你開始看到一些效率提升的同時,我們也必須把這點納入考量。
And then getting back to the -- our previous discussions about the drivers when we set guidance is, in the back half of the year, it's when we're going to launch G7. And when we launched G7, the yield that you get on some of these lines generally is a little lower. You saw it also happen with our launch of G6. There's a little bit of step back as you start to work out the kinks of these lines and the yields start to play out. So as those play out in the back half of the year, that's why we don't -- we feel comfortable, very comfortable with our guidance, but we didn't feel any need to raise it at this point and let the year play out.
再回到——我們先前在設定指引時討論過的驅動因素:今年下半年我們將推出 G7。而當我們推出 G7 時,某些產線的良率(yield)通常會稍微低一些。你在我們推出 G6 時也看到同樣情況。當你開始把產線的問題逐步排除、良率逐步展開時,會有一點回落。因此當這些在下半年發生時,這就是為什麼我們——我們對指引感到安心、非常安心,但現階段不覺得有必要上調,讓今年的情況自然發展。
Operator
Operator
And our next question comes from Cecilia Furlong from Morgan Stanley.
下一個問題來自 Morgan Stanley 的 Cecilia Furlong。
Cecilia E. Furlong - Equity Analyst
Cecilia E. Furlong - Equity Analyst
Great. I guess I just wanted to go back to the pricing headwinds, but just in light of increasing ex-U.S. headwinds. Should we expect your 2Q ex-U.S. results to look more like they did in 2019, just in terms of relatively flat sequential performance? Or can you really still grow ex-U.S. revenues quarter-over-quarter before G7?
了解。我想我只是想回到定價逆風這個議題,尤其是在美國以外市場的逆風正在加劇的情況下。我們是否應該預期你們第二季美國以外(ex-U.S.)的表現會更像2019年,也就是就相對持平的季比表現而言?或者在G7推出之前,你們仍然可以讓美國以外營收季對季成長?
Quentin S. Blackford - COO
Quentin S. Blackford - COO
Yes. I don't think we're going to get into details of providing specific guidance around U.S. versus OUS, particularly at a quarterly level. I think we're incredibly bullish on where the international business can go. There's so much runway that continues to sit in front of us. A big part of that is continuing to step into this global pricing strategy that we've laid out over a multiyear basis. And really, what you're seeing with the pricing decisions today is that we're in a position now where we can pull some of those decisions forward where we couldn't have historically.
是的。我認為我們不會深入到提供美國與美國以外(OUS)之間的具體指引細節,特別是在季度層級。我們對國際業務的發展非常看多,前方仍有很長的成長跑道。其中很大一部分在於持續推進我們已規劃的多年期全球定價策略。實際上,你們今天看到的定價決策,反映出我們現在有能力把一些過去在歷史上做不到的決策提前落地。
And a lot of that comes down to having inventory available to us, being highly confident in the ability to continue to grow and scale the levels of production as we go into the future. So I'm confident you're going to see terrific results coming out of that international business over time. And with some of these decisions that we've made, we're now opening up access to patient volumes that are 5 or 6x larger than what we were really addressing historically. So I think all of that sets up very well for a very strong international business here into the future.
而這在很大程度上取決於我們有可用的庫存,並且對未來持續成長並擴大產能的能力非常有信心。因此,我有信心你們會隨時間看到國際業務帶來非常出色的成果。隨著我們做出的部分決策,我們現在正在開啟對病患量的觸及,規模是我們過去實際所能覆蓋的5到6倍。所以我認為這一切都為未來打造非常強勁的國際業務奠定了很好的基礎。
Operator
Operator
And our next question comes from Danielle Antalffy from SVB Leerink.
下一個問題來自SVB Leerink的Danielle Antalffy。
Danielle Joy Antalffy - MD of Medical Supplies and Devices & Senior Analyst
Danielle Joy Antalffy - MD of Medical Supplies and Devices & Senior Analyst
I was just wondering if you could talk a little bit about the potential impact from doubling the sales force and specifically as it relates to the primary care physician. I'm curious if you guys have this detail as to what percentage of your prescribing physicians are coming from primary care today so we can sort of have a sense of with the sales force doubling and better calling on the primary care, how many more physicians you could potentially capture.
我想請你們談談將銷售團隊擴增一倍的潛在影響,特別是與基層照護醫師(primary care physician)相關的部分。我很好奇你們是否有這方面的細節:目前你們的開立處方醫師中,有多少比例來自基層照護?這樣我們就能大致了解,隨著銷售團隊倍增、且更有效地拜訪基層照護醫師,你們可能還能新增觸及多少醫師。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Well, this is Kevin. I'll take that. Very little comes from that channel right now. That's why we added them, and that's why we've expanded. If you take a look at the type 2 intensive insulin users, most of them are found in those offices. And that's why we needed to get out there. Over time, this will certainly increase. We expect it to, and those are the expectations of the team we brought on board.
好的,我是Kevin,我來回答。目前從那個通路來的比例非常少。這也是我們新增這些人員、並擴編的原因。如果你看看第二型糖尿病的重度胰島素使用者(type 2 intensive insulin users),大多都在那些診所裡。這就是為什麼我們需要走出去。隨著時間推進,這個比例肯定會提高;我們預期會如此,這也是我們新加入團隊的目標與期待。
We're hearing good anecdotal stories and things are starting to heat up and all reality. And with a large book of business we already have and the recurring orders from our current patients, it's -- we got a ways to go. We think they'll do great, and we'll monitor it. If we see great returns, we'll just keep giving them tools to get great returns is the best way to describe it. And I think Hello Dexcom is going to be the best one that we have for that group.
我們也聽到一些不錯的口碑案例,整體情況確實開始升溫。而且我們已經有很大的既有業務基礎,以及現有病患的持續性回購訂單,所以——我們還有很長的路要走。我們認為他們會做得很好,我們也會持續監測。如果看到很好的投資報酬,我們就會持續提供工具,讓他們取得更好的回報;這是最貼切的描述。我也認為Hello Dexcom會是我們針對那個族群最好的工具。
Operator
Operator
And our next question comes from Ravi Misra from Berenberg Capital.
下一個問題來自Berenberg Capital的Ravi Misra。
Ravi Misra - Analyst
Ravi Misra - Analyst
Congrats, Jereme and Quentin on the moves. A lot of management changes over at DexCom -- or rotations, I guess, over the last year or so. The question I had, I guess I wanted to go after the gross margin and pricing commentary from maybe a different angle. When you had the similar type of pricing impact in the U.S. when you started going into pharma channel, we really saw a pretty strong level of uptake through that to that arena, albeit the pricing headwind continues. So I guess what I'm trying to ask is, do you -- does guidance factor in that type of kind of immediate impact from the price cut, I guess, in Europe? And do you think that $50 million is the kind of extent of it as we kind of go forward here?
恭喜Jereme和Quentin的人事調整。DexCom這一年左右有很多管理層變動——或說輪調。我想從不同角度問一下毛利率與定價的評論。當你們在美國開始進入藥局通路(pharma channel)時,也出現過類似的定價影響,我們看到那個領域的採用率相當強勁,儘管定價逆風仍在延續。所以我想問的是:你們的指引是否已納入歐洲降價可能帶來那種相對立即的影響?以及往後來看,那5,000萬美元是否就是影響的大致上限?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Yes. Sure. I can take that. So our gross margin certainly contemplates the impact of pricing impacts in our international markets. And so I wouldn't expect any changes there. In terms of the extent of it, as we go after these incremental markets and open up access, we almost look at that as new patients. And so when we go after new patients and new markets, certainly, pricing is going to change over time. So there could be impacts that drag out over time in the future years as a result of just going after incremental pockets of patients and any sort of knock along impact, certainly not anything that we would expect to be significant. But that will always be contemplated in our guidance, and it will all be something that we certainly talk to on these calls. I wouldn't expect anything that we provide hasn't been thought through and contemplated in any of the targets that we provide to you guys.
是的,當然,我可以回答。我們的毛利率確實已經考量到國際市場定價影響所帶來的衝擊,所以我不預期那方面會有任何變動。至於影響的範圍,當我們開拓這些增量市場、並擴大可及性時,我們幾乎把它視為新病患。因此,當我們爭取新病患與新市場時,定價當然會隨時間而變化。所以未來年度可能會有一些影響隨時間拉長,原因只是我們持續開拓更多病患族群,以及可能產生的連帶效應;但我們不預期會是重大的影響。不過這些都會納入我們的指引之中,也會是我們在這些電話會議上會談到的內容。我不預期我們提供的任何內容沒有經過充分思考,並已在我們對各項目標的設定中納入考量。
Operator
Operator
And our next question comes from Marie Thibault from BTIG.
下一個問題來自BTIG的Marie Thibault。
Marie Yoko Thibault - Director & Digital Health Analyst
Marie Yoko Thibault - Director & Digital Health Analyst
Congrats to you as well, Jereme. I wanted to ask a question on OUS. I understand that the impact of COVID last year, obviously, having an impact on revenue this year. But curious if you're still seeing a COVID impact in this Q1 quarter as well as the existing quarter here in terms of that still affecting new patient starts. We certainly heard from other companies that Europe is lagging on the vaccine rollout. So would love to hear if that's been contemplated in guidance. And if so, how you expect that to change over the year?
也恭喜你,Jereme。我想問一個關於美國以外(OUS)市場的問題。我理解去年COVID的影響,顯然會影響到今年的營收。但我想了解的是,你們在第一季以及目前這一季,是否仍然看到COVID的影響,仍在影響新病患啟用(new patient starts)?我們確實聽到其他公司提到歐洲疫苗推進較慢。所以想請你們分享這是否已納入指引?如果有,你們預期全年會如何變化?
Quentin S. Blackford - COO
Quentin S. Blackford - COO
Yes. I think from our perspective, all that we know right now is kind of the environment we operate within with respect to COVID, which we know from an international perspective has certainly created some incremental pressure in pockets of that business, particularly those that require in clinic visit to get onto the product or some of those administrative hurdles that have been put there. In other channels where we have e-commerce, for example, we're seeing incredible results. And so I think one thing to point out on that first quarter international result is that when you look at it from a 2-year growth perspective, it's an incredibly strong number. Last year was an absolute record growth for us in that first quarter from an international perspective. So I think you got to normalize that when you're looking at that first quarter growth.
是的。從我們的角度來看,我們目前所知道的就是我們在COVID相關環境下的營運狀況;從國際角度而言,COVID確實在部分業務區塊帶來額外壓力,特別是那些需要到院內就診才能開始使用產品,或是存在一些被加上的行政門檻的市場。但在其他通路,例如我們有電商(e-commerce)的地方,我們看到非常亮眼的成果。我想指出的是,第一季的國際業績若以兩年成長的角度來看,是非常強勁的數字。去年第一季在國際市場對我們而言是創紀錄的成長。所以在看第一季成長時,你必須把這點納入正常化的比較。
But in terms of the remainder of the year, on an international basis and patient adoption, a big part of stepping price down in line with kind of our global pricing strategy was the fact that we had to see administrative requirements reduced or eliminated altogether to get patients onto the product. And so in these markets where we've done that, the hurdle to get onto the product has been removed. And so we absolutely would expect to see patient -- new patient acquisition become much easier for us and see that start to take off in a very positive way. So I do think you're going to see that uptick over the course of the year, even in the COVID environment with, of course, the caveat being that it kind of stays stable to where it's at today. If we were to get worse in some case, then we might have to think about that differently. But we're trying to look at the future based upon what we see today and how it's impacted the markets here in the moment.
至於今年剩餘時間,在國際市場與病患採用方面,將價格下調以符合我們的全球定價策略,其中一個重要原因是:我們必須看到行政要求被降低,甚至完全取消,才能讓病患更容易開始使用產品。因此,在我們已經這麼做的市場中,開始使用產品的門檻已被移除。所以我們絕對預期病患——新病患獲取——會變得更容易,並且會以非常正面的方式開始起飛。因此,我確實認為你們會在今年過程中看到那個上升趨勢,即使在COVID環境下也是如此;當然前提是疫情大致維持在今天的穩定狀態。如果在某些情況下變得更糟,那我們可能就得用不同方式來思考。但我們會基於今天所看到的情況,以及它此刻對市場造成的影響,來看待未來。
Operator
Operator
And our next question comes from Larry Biegelsen from Wells Fargo.
下一個問題來自Wells Fargo的Larry Biegelsen。
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
So on pricing, once G7 and Libre 3 are competing with each other, how much of a price premium do you think is sustainable? And how close do you think you are to that premium today in the U.S. and outside the U.S.? And do you see the opportunity to price G6 as a value brand?
關於定價,一旦G7與Libre 3彼此競爭,你們認為能維持多少的溢價(price premium)?你們覺得目前在美國以及美國以外市場,距離那個溢價水準有多接近?另外,你們是否看到把G6定位為價值品牌(value brand)的機會?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Larry, thanks for your question. We have numerous opportunities here, but I'm not going to give our pricing strategy on earnings call. We -- we're very thoughtful about this. We run several models. We know what our technology is worth, and we know what great benefit we provide. We'll price it accordingly, but we're also going to price our products in a manner to whereby our patients have access to it as well. And I think our commercial team combined with our finance team and everybody who's done a wonderful job balancing that, we'll continue to balance, but we'll continue to grow as well. I mean look at the volume growth versus our dollar growth this quarter, and we already said our U.S. volumes were in excess of the overall volume growth. We've managed it extremely well, and we'll continue to do so.
Larry,謝謝你的問題。我們在這裡有很多機會,但我不會在財報電話會議上公開我們的定價策略。我們——對此非常審慎。我們跑了好幾套模型。我們知道我們的技術價值,也知道我們提供了多大的效益。我們會據此定價,但同時也會以能讓病患取得(access)產品的方式來定價。我認為我們的商務團隊與財務團隊,以及所有做得非常出色、在兩者間取得平衡的人,會持續把這個平衡做好,同時也會持續成長。看看本季的出貨量成長相對於美元成長,我們也已經說過,美國的出貨量增幅超過整體出貨量成長。我們管理得非常好,未來也會繼續如此。
Operator
Operator
And our next question comes from Anthony Petrone from Jefferies.
下一個問題來自Jefferies的Anthony Petrone。
Anthony Charles Petrone - Healthcare Analyst
Anthony Charles Petrone - Healthcare Analyst
A couple of questions, one on G7 and one on margins as well. Just on G7, trying to get a sense when you look at U.S. timing to entry and efforts to get iCGM, do you think the market actually behaves differently? In other words, new patient starts potentially slow a bit as the new form factor is coming to market. And then on margins, taking the other side, the COGS side, specifically, breaking down -- breaking ground in Malaysia. Maybe just an update on timing as to when FDA inspections will take place for that facility and just a recap of what that can do on the COGS side for sensors on a per unit basis.
我有兩個問題,一個關於 G7,另一個也關於毛利。先談 G7,想了解當你們看美國上市切入時點以及取得 iCGM 的努力時,你們是否認為市場實際上會有不同的表現?換句話說,當新的外形規格即將上市時,新病患的起始使用可能會稍微放緩。再談毛利,從另一端也就是 COGS 端來看,特別是你們在馬來西亞動土/破土開工。能否更新一下該廠何時會進行 FDA 稽核檢查的時程,並簡要回顧一下這對感測器每單位成本(COGS)可能帶來的影響。
Quentin S. Blackford - COO
Quentin S. Blackford - COO
I'll take the latter part of that with respect to Malaysia. We're clearly well into that project, making great progress. We'll have a building in place as we exit the year, with plans in place to have a clean room up and ready for validation, either at the turn of the year into the first quarter -- sorry, first quarter of next year. So the expectation is we'll be producing product out of that in the first half of next year there in Malaysia. So very excited about what we're seeing there.
我來回答後半段、關於馬來西亞的部分。我們顯然已經在該專案中進展很深,且進度非常好。我們預期在今年結束時會有建物到位,並且規劃在跨年進入第一季時——抱歉,是明年第一季——讓無塵室建置完成並準備好進行驗證。因此,我們的預期是在明年上半年於馬來西亞開始生產產品。對於我們在那裡看到的進展,我們非常振奮。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Yes. And I'll take the G6, G7 and the cutover question. Again, with respect to U.S. timing, we've not disclosed anything. One of our great learnings on G6 was have enough product ready to go when you go and really be fully ready for launch, and we've made that commitment to our customers that we will be ready when we do launch this product, that we will be able to literally flip the switch and go over.
是的。我來回答 G6、G7 以及切換(cutover)相關的問題。再次就美國時程而言,我們尚未揭露任何資訊。我們在 G6 上的一個重要學習是:在推出時要準備足夠的產品,並且在上市前真正做到萬全準備;我們也已向客戶承諾,當我們推出這項產品時,我們會準備就緒,能夠真正做到「一鍵切換」並完成轉換。
As far as patients slowing their purchases of G6, in particular, in the pharmacy channel, you're buying 1 month of product at a time. So it's not like you're going in there and loading up with 3 to 6 months as we did in the past in the DME channel. And even in the DME channel today, there's less of that loading up by patients with G6 than there was in G5 and G4 prior to that.
至於病患是否會放慢購買 G6,特別是在藥局通路,你一次是買 1 個月的產品。因此不像過去在 DME 通路時,你會一次買 3 到 6 個月的量來囤貨。即使在目前的 DME 通路,相較於之前的 G5、G4 時期,病患對 G6 的囤貨行為也少了很多。
We don't view that, that people will quit purchasing their G6 is when G7 is announced because in all fairness, our customers can't live without it. And when we have the opportunity to take care of them all, what we'll do is organize but as rapid a migration as we possibly can. And as far as G6 future plans, we do see a lot of opportunity here, but we really haven't disclosed anything.
我們不認為在宣布 G7 之後,人們就會停止購買 G6,因為坦白說,我們的客戶離不開它。而當我們有能力照顧到所有客戶時,我們會進行規劃,盡可能快速地完成移轉。至於 G6 未來的規劃,我們確實看到很多機會,但我們目前還沒有對外揭露任何內容。
Operator
Operator
And our next question comes from Steven Lichtman from Oppenheimer.
下一個問題來自 Oppenheimer 的 Steven Lichtman。
Steven Michael Lichtman - MD & Senior Analyst
Steven Michael Lichtman - MD & Senior Analyst
Just had a question on your international expansion efforts. What are some of the key countries and focus for you here over the near term? And are you anticipating any contribution from these new regions in this year's guidance? Or is that more -- really more of a driver for 2022?
我想問一下你們的國際擴張策略。短期內你們重點聚焦的主要國家有哪些?另外,你們是否預期這些新區域會對今年的財測指引有所貢獻?還是說這更多——其實更像是 2022 年的成長驅動因素?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Yes, I think that will be more of a driver for future years. We've talked about our launch in Japan with Terumo, and that's scheduled to happen in the second half of the year. We got reimbursement in France, as many of you know. So we do expect France to be a bigger part of our business than it has in the past. But a lot of large numbers in our businesses, things have gotten so big, they can't give us a whole lot that moves the needle when we start.
是的,我認為這會更像是未來幾年的驅動因素。我們談過與 Terumo 在日本的上市計畫,預計在今年下半年發生。我們也在法國取得了給付,如各位所知。因此我們確實預期法國在我們業務中的占比會比過去更大。但由於我們的業務規模已經很大,很多事情即使開始推動,也很難在一開始就帶來足以「顯著改變數字」的貢獻。
Hence, the discussion we've had about increasing access in our more mature markets and looking at how we follow similar paths in these other geographies. With the operating capability we have now, there's no sense in going through and selling just the top end of this market. We want to get more aggressive and be more broad. So I think you'll see as we go into these geographies, over time, we'll start as we started in the past, but we are going to get more reimbursement and try to get more patients more rapidly.
因此,我們才會討論在較成熟市場中提升可近性(access),並思考如何在其他地理區域複製類似路徑。以我們目前的營運能力來看,沒有必要只去銷售市場的高端族群。我們希望更積極、覆蓋更廣。因此我認為你會看到,隨著我們進入這些地區,隨時間推進,我們一開始會像過去一樣起步,但我們會爭取更多給付,並嘗試更快速地讓更多病患使用。
Operator
Operator
And our next question comes from Brandon Vazquez from William Blair.
下一個問題來自 William Blair 的 Brandon Vazquez。
Brandon Vazquez - Associate
Brandon Vazquez - Associate
I just wanted to go back to one of the comments made during the prepared remarks. And it sounded like there was maybe a little hinting at new connected systems coming this year. Just curious if you could talk about those and specifically, what those kind of products. I'm thinking, is there something outside of the regular hardware upgrades that we see maybe somewhere on the software side that could be a catalyst maybe for growth within maybe some of the TAM expansion opportunities like the type 2 non-intensives or gestational diabetes or anything like that. So is there anything we're kind of not thinking out of the box here from the normal hardware that will be important in the coming 12 months or so?
我想回到你們在事先準備的講稿中提到的一個評論。聽起來你們似乎暗示今年會有新的連網系統推出。我想請你們談談這些系統,特別是這類產品是什麼。我在想,是否有一些不同於我們常見的硬體升級的東西——也許在軟體端——可能成為成長催化劑,並帶動一些 TAM 擴張機會,例如第二型糖尿病非強化治療族群、妊娠糖尿病等。也就是說,在未來 12 個月左右,是否有任何跳脫傳統硬體框架、但很重要的事情,是我們目前沒有想到的?
Quentin S. Blackford - COO
Quentin S. Blackford - COO
No, I don't think that there's anything that you guys are missing in terms of the prepared remarks and speaking to some of those systems. The one thing that we certainly are excited about has to be the Omnipod 5 product in the back half of the year. And we'll let Insulet speak to the exact timing of when we're ready to put that product into the marketplace. But having connectivity into a product like that is something that we're very excited about and believe that they'll have success with, and we'll have success with as well.
不,我不認為你們在解讀講稿或我們提到的那些系統時,有漏掉什麼。我們確實非常期待的一件事,是今年下半年推出的 Omnipod 5 產品。我們會讓 Insulet 來說明確切的上市時點,也就是我們何時準備好把該產品推向市場。但能與那樣的產品建立連結(connectivity)是我們非常興奮的事情,我們相信他們會成功,而我們也會因此受益。
I think with respect to the whole type 2 population and the opportunity there, we couldn't be more bullish on the opportunity that sits in front of us. And I think by the day, we learn more and more that increases that bullishness for us and the confidence that there's going to be some real opportunity there to create value coming from it. And you're going to see a study a little bit later this year, midyear, at some of the midyear society meetings that's going to start to really lay out the benefit of using CGM relative to BGM in this type 2 population, particularly the nonintensive population that just demonstrates the sort of impact we can have on patients who say they're on basal only. And that's a 4 million patient population in the U.S.
我認為就整個第二型糖尿病族群及其機會而言,我們對眼前的機會再怎麼看多都不為過。我想我們每天都在學到更多,這也讓我們更看多,並更有信心那裡確實存在能創造價值的重大機會。今年稍晚、年中左右,在一些年中學會會議上,你們會看到一項研究,將開始更清楚地呈現,在第二型糖尿病族群中使用 CGM 相對於 BGM 的效益,特別是非強化治療族群;它會展示我們對那些自述僅使用基礎胰島素(basal only)的病患能帶來的影響。而在美國,這是一個 400 萬人的病患族群。
So I think that sort of data starts to really accumulate in favor of opening up a whole another market segment that doubles the existing core U.S. intensive market today that we're very excited about. So you'll see that data here midyear. But I think all of it starts to point to the fact that this type 2 space is going to open up in a significant way, and we're well positioned to take advantage of it.
因此我認為,這類數據的累積會越來越有利於開啟另一個市場區隔——其規模可使目前美國核心的強化治療市場加倍——這讓我們非常興奮。你們會在年中看到這些數據。但我認為,所有跡象都指向第二型糖尿病這個領域將以顯著的方式開放,而我們也已做好充分準備把握這個機會。
Operator
Operator
And that concludes our question-and-answer session. I'll turn the call back over to Kevin Sayer for final remarks.
以上為問答環節的結束。我將把電話交回給 Kevin Sayer 作結語。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Thank you, and thanks, everybody, for participating. As we wrap up our call today, I want to take a minute to acknowledge some very important recognition that DexCom received this week. Forbes recently published their 100 company list of America's Best Employers for Diversity. DexCom was honored to be #66 on that list. While we consider this a perpetual journey, we're very happy to have been recognized for some of the work that we've done so far.
謝謝,也感謝各位的參與。在我們結束今天的電話會議之前,我想花一點時間提及 DexCom 本週獲得的一項非常重要的肯定。Forbes 最近發布了「美國最佳多元共融雇主」100 家公司名單,DexCom 很榮幸在名單中排名第 66 名。雖然我們認為這是一段持續不斷的旅程,但我們很高興目前所做的一些努力能獲得肯定。
As far as our outlook on the business going forward, our great quarter fuels our continued belief that best is yet to come. I recently caught up with a friend who's a long-time health care industry executive and the gist of his message to me was very simple. Everything important in diabetes care is going to revolve around CGM. For example, there are numerous instant delivery devices and algorithms available for automated insulin delivery. But there's only one CGM commercially capable of delivering the patient experience and outcomes that we've all envisioned for a very long time. And that's only the beginning.
就我們對未來業務的展望而言,本季的優異表現強化了我們持續的信念:最好的還在後頭。我最近與一位在醫療保健產業深耕多年的高階主管朋友聊到,他給我的訊息重點非常簡單:糖尿病照護中所有重要的事情都將圍繞 CGM 展開。舉例來說,自動化胰島素輸注已有許多即時輸送裝置與演算法可用;但在商業上能夠提供我們長久以來所設想之病患體驗與臨床結果的 CGM,只有一個。而這才只是開始。
There are incredible new compounds, treatments and programs stepping forward for the treatment of type 2 diabetes, and we are very confident that the right CGM experience will become an integral part of all these solutions, and we haven't even started talking about the difference we can make as part of our pre-diabetes program. We've never been more excited and engaged in our opportunity than we are today. Thank you again, everyone, and have a great day.
在第二型糖尿病的治療方面,有許多令人驚豔的新化合物、療法與方案正在推進;我們非常有信心,正確的 CGM 體驗將成為所有這些解決方案不可或缺的一部分,而我們甚至還沒開始談到在糖尿病前期(pre-diabetes)計畫中我們能帶來的改變。我們從未像今天這樣,對我們的機會感到如此興奮並全心投入。再次感謝各位,祝大家有美好的一天。
Operator
Operator
Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating, and you may now disconnect.
謝謝各位女士先生。今天的電話會議到此結束。感謝各位參與,現在可以掛線。