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 Second Quarter 2022 Earnings Release Conference Call. My name is Darryl, and I'll be your operator for today's call. (Operator Instructions) As a reminder, this conference is being recorded. I will now turn the call over to Sean Christensen. Sean, you may begin.
歡迎參加 Dexcom 2022 年第二季財報發布電話會議。我叫 Darryl,將擔任今天電話會議的接線員。(接線員指示)提醒各位,本次會議將被錄音。現在我將把電話交給 Sean Christensen。Sean,您可以開始了。
Sean Christensen - Director of Corporate Affairs & Head of IR
Sean Christensen - Director of Corporate Affairs & Head of IR
Thank you, operator, and welcome to Dexcom's second quarter 2022 earnings call. Our agenda begins with Kevin Sayer, Dexcom's Chairman, President and CEO, who will summarize our recent highlights and ongoing strategic initiatives; followed by a financial review and outlook from Jereme Sylvain, our Chief Financial Officer. (Operator Instructions) Please note that there are also slides available related to our second quarter performance on the Dexcom Investor Relations website on the Events and Presentations page.
謝謝您,接線員,也歡迎各位參加 Dexcom 2022 年第二季財報電話會議。我們的議程首先由 Dexcom 董事長、總裁兼執行長 Kevin Sayer 開場,總結近期亮點與持續推動的策略性計畫;接著由我們的財務長 Jereme Sylvain 進行財務回顧與展望。(接線員指示)另請注意,Dexcom 投資人關係網站的「活動與簡報」頁面上也提供與第二季表現相關的投影片。
With that, let's review our safe harbor statement. 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.
接下來,我們來回顧安全港聲明。我們在今天電話會議中所做的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所預期者有重大差異。
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.
可能導致實際結果與任何前瞻性陳述所明示或暗示內容產生重大差異的因素,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.
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。
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 second quarter earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measures.
這些補充資訊的呈現不應被單獨看待,也不應作為依 GAAP 編製之結果的替代,或被視為優於依 GAAP 編製之結果。請參閱我們的財報新聞稿中的表格,以及隨第二季財報簡報提供的投影片,以取得這些衡量指標與其最直接可比之 GAAP 財務衡量指標之調節表。
Now I will turn it over to Kevin.
現在我把電話交給 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. Today, we reported another strong quarter for Dexcom with second quarter organic revenue growth of 16% compared to the second quarter of 2021. Momentum for global CGM adoption remains high, and we once again achieved worldwide record new customer starts in the second quarter. Following some disruption early in the year related to the Omicron wave, office access has continued to improve. And we experienced a return to a more normalized customer journey, which helped us deliver this record.
謝謝你,Sean,也謝謝各位的參與。今天我們公布 Dexcom 再度交出強勁的一季表現,第二季有機營收較 2021 年第二季成長 16%。全球 CGM 採用動能依然強勁,我們在第二季再次創下全球新客戶啟用數的紀錄。年初因 Omicron 疫情帶來的一些干擾之後,診所/辦公室的可進入性持續改善。我們也看到客戶旅程回到較為正常化的狀態,協助我們達成這項紀錄。
Customer satisfaction also continues to reach new levels as our U.S. Net Promoter Score hit another all-time record in the second quarter. Our customers value the differentiated experience that Dexcom provides with consistent praise for our real-world accuracy, connectivity, actionable features and customer support. Product performance has been a hallmark for Dexcom throughout our history. Customers and caretakers alike rely upon the accuracy of Dexcom CGMs and can be confident in performance across all aspects of glucose management, backed by numerous clinical trials and borne out by real-world experience.
客戶滿意度也持續攀升,我們美國的淨推薦值(Net Promoter Score)在第二季再創歷史新高。客戶重視 Dexcom 所提供的差異化體驗,並持續稱讚我們在真實世界的準確度、連線能力、可採取行動的功能以及客戶支援。產品表現一直是 Dexcom 歷史上的標誌。客戶與照護者都仰賴 Dexcom CGM 的準確性,並可對血糖管理各層面的表現充滿信心;這些表現有眾多臨床試驗支持,也在真實世界的使用經驗中得到驗證。
We have long viewed software as an avenue to differentiate, enabling unique user experiences, supporting greater connectivity and enhancing our ability to move more seamlessly into new markets. In support of this vision, we have invested significantly in building our software infrastructure in recent years and now spend more of our R&D budget on software than hardware. A tangible example of this can be found in our rollout of Dexcom ONE. This product leverages our G6 hardware and will use our G7 platform in the future, but uses software to provide a different experience than our G Series systems. This has allowed us to meaningfully expand our market presence in recent months, entering new markets and winning tenders internationally that were previously not available to our G Series product. This is just the beginning of our journey on leveraging software to great products that meet the needs of our end users.
我們長期將軟體視為差異化的途徑,可打造獨特的使用者體驗、支援更高的連線性,並提升我們更無縫進入新市場的能力。為了支持這項願景,近年來我們大幅投資建置軟體基礎設施,目前在研發預算中投入在軟體的比重已高於硬體。一個具體例子是我們推出 Dexcom ONE。該產品沿用我們的 G6 硬體,未來也將使用 G7 平台,但透過軟體提供與 G 系列系統不同的體驗。這使我們在近幾個月得以大幅擴展市場版圖,進入新市場,並在國際上贏得先前 G 系列產品無法參與的標案。這只是我們運用軟體打造優秀產品、滿足終端使用者需求旅程的開始。
Our software infrastructure has also positioned us to be the partner of choice for technology companies looking to build new and innovative experiences around CGM data. Our list of real-time API partners continues to grow as we're the only company that can provide partners real-time CGM data in an FDA-regulated solution.
我們的軟體基礎設施也使我們成為科技公司首選的合作夥伴,協助其圍繞 CGM 數據打造全新且創新的體驗。我們的即時 API 合作夥伴名單持續擴大,因為我們是唯一能在 FDA 監管解決方案中向合作夥伴提供即時 CGM 數據的公司。
Our software capabilities are also laying the foundation for our success beyond the intensively managed population. For example, 2 partners focused on the use of CGM for weight management and metabolic health, Signos and Levels Health, have clinical trials underway that are leveraging our real-time API capabilities. We are excited to see the outcome from these trials as they provide a glimpse into the future for CGM technology that could serve as a much broader end market than today.
我們的軟體能力也正在為我們在高度密集管理族群之外的成功奠定基礎。例如,兩家專注於將 CGM 用於體重管理與代謝健康的合作夥伴 Signos 與 Levels Health,正在進行臨床試驗並運用我們的即時 API 能力。我們很期待看到這些試驗的結果,因為它們讓我們得以一窺 CGM 技術的未來——其服務的終端市場可能遠比今日更為廣泛。
The second quarter saw a number of strategic accomplishments in international markets that continue to strengthen our competitive position. The excitement continues to grow for our portfolio of CGM systems, G6, G7 and Dexcom ONE, and we've made significant strides in both direct and distributor markets to broaden access to our technology. We launched Dexcom ONE in both Spain and the U.K. and have secured reimbursement for key segments of the population. Opening large parts of these markets have previously lacked reimbursement for Dexcom CGM.
第二季在國際市場也達成多項策略性成果,持續強化我們的競爭地位。市場對我們的 CGM 系統組合——G6、G7 與 Dexcom ONE——的期待持續升溫;我們在直營與經銷市場均取得顯著進展,以擴大對我們技術的可及性。我們在西班牙與英國推出 Dexcom ONE,並已為人口中的關鍵族群取得給付。這也開放了這些市場中過去很大一部分缺乏 Dexcom CGM 給付的區塊。
We also announced a partnership with Roche to distribute Dexcom ONE in Italy. This relationship will allow us to leverage Roche's well-established commercial infrastructure to bring Dexcom ONE to a much larger Italian market. In Australia, the government recently committed to providing subsidized access to our G6 system for all people living with type 1 diabetes, which is a significant improvement in coverage and a great win for Australians deserving access to CGM technology.
我們也宣布與 Roche 合作,在義大利經銷 Dexcom ONE。這項合作將使我們得以運用 Roche 成熟的商業基礎設施,把 Dexcom ONE 帶入更大的義大利市場。在澳洲,政府近期承諾為所有第一型糖尿病患者提供我們 G6 系統的補助使用,這在給付覆蓋上是重大改善,也讓值得獲得 CGM 技術的澳洲民眾受益良多。
Our limited launch of G7 in the U.K. continues to be met with significant enthusiasm from our customers who have provided consistently positive feedback on product size, ease of use, the shorter warm-up time, the app experience and more. Many customers shared that they would often forget they were even wearing their G7 during their session and indicated they can't wait to continue wearing the product full time in the future. The period has proven to be incredibly valuable, allowing us to assess the functionality of the sensor and app in a real-world setting and providing feedback on ways to refine our support system to make the broader rollout as streamlined as possible. We are excited to get G7 in the hands of more customers and plan to expand our launch in the third quarter, starting in the U.K.
我們在英國對 G7 的有限度上市持續獲得客戶高度熱烈的反應;客戶對產品尺寸、易用性、更短的暖機時間、App 體驗等方面都給予一致的正面回饋。許多客戶分享,他們在配戴期間常常甚至忘了自己正戴著 G7,並表示迫不及待希望未來能全天候持續配戴。這段期間證明極具價值,使我們能在真實世界情境中評估感測器與 App 的功能,並就如何精進支援系統以讓更大規模的推廣盡可能順暢提供回饋。我們很期待讓更多客戶使用 G7,並計畫在第三季擴大上市,首先從英國開始。
In the U.S., our 510(k) submission for G7 remains under review with the FDA. As part of this process, we are making a subtle change to the G7 software based on feedback from the FDA, slightly delaying our expected time lines for clearance and U.S. launch. We expect FDA clearance and limited launch later this year and a large commercial launch in the U.S. in the first quarter of 2023.
在美國,我們針對 G7 的 510(k) 申請仍在接受 FDA 審查。作為此流程的一部分,我們將依據 FDA 的回饋對 G7 軟體做一項細微調整,因而使我們預期的核准與美國上市時程略為延後。我們預期今年稍晚取得 FDA 核准並進行有限度上市,並於 2023 年第一季在美國進行大規模商業上市。
Encouragingly, our preliminary discussions with payers have progressed very well. They understand what this product will mean for our customers and people with diabetes broadly, giving us increasing confidence in the ability to ramp up commercial coverage quickly.
令人鼓舞的是,我們與保險支付方的初步討論進展非常順利。他們理解這項產品對我們客戶以及更廣泛糖尿病族群的意義,讓我們對於能夠快速提升商業給付覆蓋的能力更具信心。
Finally, we were very proud to showcase our expanded CGM portfolio at 2 of the largest diabetes conferences of the year, ATTD in Barcelona and ADA in New Orleans. These events provide us an opportunity to connect with thought leaders across the diabetes space, and we continue to see a clear consensus on real-time CGM being the standard of care in diabetes management and a growing appreciation of the health and economic benefits of extending the use of this technology beyond the intensively managed population, including the broader type 2 population and use in the hospital. Between these 2 events, there were dozens of presentations, abstracts and posters highlighting success stories of CGM to date and what the future could hold for this technology.
最後,我們也非常自豪能在今年兩個最大的糖尿病會議——巴塞隆納的 ATTD 與紐奧良的 ADA——展示我們擴充後的 CGM 產品組合。這些活動讓我們有機會與糖尿病領域的意見領袖交流;我們持續看到明確共識:即時 CGM 正成為糖尿病管理的照護標準。同時,對於將此技術的使用延伸至高度密集管理族群之外(包括更廣泛的第二型糖尿病族群以及住院場景)的健康與經濟效益,也日益受到重視。在這兩場活動之間,有數十場演講、摘要與海報展示,突顯 CGM 迄今的成功案例,以及這項技術未來可能帶來的發展。
I started attending diabetes conferences almost 30 years ago. As I look back even 2 or 3 years ago, these types of conversations around the broad potential of CGM were nonexistent. Now it's become very apparent that CGM data will become the basis of where diabetes management and glucose control in the future is headed. We're very excited about the opportunities ahead for Dexcom.
我參加糖尿病會議將近 30 年了。回顧即使是 2、3 年前,關於 CGM 廣泛潛力的這類討論幾乎不存在。如今已非常明顯,CGM 數據將成為未來糖尿病管理與血糖控制發展方向的基礎。我們對 Dexcom 未來的機會感到非常振奮。
And with that, I'll turn it over to Jereme for a review of the second quarter financials. Jereme?
接下來,我把電話交給 Jereme,請他回顧第二季財務表現。Jereme?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Thank you, Kevin. 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 in today's earnings release as well as on our IR website. For the second quarter of 2022, we reported worldwide revenue of $696 million, which included $12 million of unfavorable foreign currency impact. This is compared to $595 million for the second quarter of 2021, which represents growth of 16% on an organic basis. We have slightly changed our definition of organic revenue based on feedback from our stakeholders to exclude currency and acquisition-related revenue in the trailing 12-month period. Volume growth for the second quarter came in around the mid-30% range on a global basis.
謝謝你,Kevin。提醒一下,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。2022 年第二季,我們公布全球營收為 6.96 億美元,其中包含 1,200 萬美元的不利外匯影響。相較之下,2021 年第二季為 5.95 億美元,按有機基礎計算成長 16%。我們根據利害關係人的回饋,稍微調整了有機營收的定義,在過去 12 個月期間排除匯率與併購相關營收。第二季的全球出貨量成長約落在 30% 中段區間。
U.S. revenue totaled $511 million for the second quarter compared to $462 million in the second quarter of 2021, representing growth of 11%. Customer demand remained strong in the U.S., and our unit volume growth continued to grow at a very healthy clip this quarter, relatively in line with recent quarters. We have been launching a number of new tools for our sales force in the U.S. that leverage technology to make each physician visit more efficient and effective. These tools inform our team what each doctor is prescribing, the makeup of their payer mix and even compare the out-of-pocket cost for each customer. This data can make each visit more impactful and help us continue to address the competitive mix that still exist in the market.
美國第二季營收合計 5.11 億美元,較 2021 年第二季的 4.62 億美元成長 11%。美國客戶需求仍然強勁,本季我們的單位出貨量成長仍以非常健康的速度持續提升,與近幾季大致一致。我們在美國推出多項供銷售團隊使用的新工具,運用科技讓每次醫師拜訪更有效率且更具成效。這些工具可告訴團隊各位醫師正在開立哪些處方、其付款方組合(payer mix)的構成,甚至可比較每位客戶的自付費用(out-of-pocket cost)。這些資料能讓每次拜訪更具影響力,並協助我們持續因應市場上仍存在的競爭組合。
We continue to see an ongoing impact on revenue growth from our strategic shift to the pharmacy channel. But as discussed previously, we believe this will ultimately set us up to serve meaningful, more customers over time. International revenue grew 39%, totaling $185 million in the second quarter. Organic revenue growth was 34% for the second quarter. Our positive momentum continued this quarter as the number of global initiatives we implemented in the past year has significantly improved our competitive position in international markets.
我們持續看到,因策略性轉向藥局通路而對營收成長帶來的持續影響。但如先前所述,我們相信這最終將使我們能在時間推移下服務更多、且更具意義的客戶。第二季國際營收成長 39%,合計 1.85 億美元。第二季有機營收成長為 34%。我們的正向動能在本季延續,過去一年我們推動的多項全球性措施已顯著改善我們在國際市場的競爭地位。
In addition to the Dexcom ONE new market wins Kevin highlighted before, we also continue to drive greater reimbursement in our initial launch countries in Eastern Europe this quarter. While we previously announced that patient reimbursement in Bulgaria and Estonia, Latvia and Lithuania have now established full or partial reimbursement for individuals with type 1 diabetes. This is a great example of how our CGM portfolio strategy can help us enter completely new markets and be a catalyst for access.
除了 Kevin 先前提到的 Dexcom ONE 新市場斬獲之外,本季我們也持續在東歐的初始上市國家推動更高的給付(reimbursement)。我們先前已宣布,保加利亞的病患給付,以及愛沙尼亞、拉脫維亞與立陶宛,現已為第一型糖尿病患者建立全額或部分給付。這是我們 CGM 產品組合策略如何協助我們進入全新市場並成為提升可近性(access)催化劑的絕佳例子。
Through new product launches and reimbursement efforts over the past 18 months, we are happy to share that we have increased the reimbursed access to our product by more than 3 million customers and look forward to getting this much-needed technology in the hands of as many people as possible.
透過過去 18 個月的新產品上市與給付推動工作,我們很高興分享:我們已將可獲給付的產品可近性提升,覆蓋超過 300 萬名客戶,並期待讓這項迫切需要的技術能交到盡可能多的人手中。
Our second quarter gross profit was $449.5 million or 64.6% of revenue compared to 70.1% of revenue in the second quarter of 2021. Given the initial launch of G7 in the U.K., this is the first quarter where G7 development costs started to flow through COGS, accounting for some of the expected year-over-year step down in gross margin. Additionally, there were greater than 50 basis points of impact from currency in the quarter.
第二季毛利為 4.495 億美元,或占營收 64.6%,相較 2021 年第二季占營收 70.1%。鑑於 G7 在英國的初始上市,這是 G7 開發成本首次開始流入銷貨成本(COGS)的季度,這也解釋了部分預期的毛利率年對年下滑。此外,本季匯率影響超過 50 個基點。
Our second quarter gross margin was a nice step-up from the first quarter and leaves us on track to hit our margin targets for the full year. Operating expenses were $347.6 million for Q2 of 2022 compared to $315 million in Q2 of 2021. Similar to last quarter, we generated meaningful operating expense leverage despite incremental investment to support the G7 launch. We saw OpEx as a percentage of sales this quarter drop by 310 basis points year-over-year as we continue to leverage our R&D and G&A expense lines.
第二季毛利率較第一季有不錯的回升,使我們仍在達成全年毛利率目標的軌道上。2022 年第二季營業費用為 3.476 億美元,較 2021 年第二季的 3.15 億美元增加。與上季類似,儘管為支援 G7 上市而增加投資,我們仍產生了顯著的營業費用槓桿。本季營業費用占銷售比重年對年下降 310 個基點,因我們持續在研發(R&D)與一般及行政(G&A)費用線上發揮規模效益。
Operating income was $101.9 million or 14.6% of revenue in the second quarter of 2022 compared to $101.5 million or 17.1% of revenue in the same quarter of 2021 as a tough year-over-year gross margin comp was partially offset by operating leverage in the quarter.
2022 年第二季營業利益為 1.019 億美元,或占營收 14.6%;相較之下,2021 年同季為 1.015 億美元,或占營收 17.1%。由於毛利率年對年比較基期較為嚴峻,部分被本季的營運槓桿所抵銷。
Adjusted EBITDA was $175.5 million or 25.2% of revenue for the second quarter compared to $156.6 million or 26.3% of revenue for the second quarter of 2021. Net income for the second quarter was $69.5 million or $0.17 per share. We remain in a great financial position, closing the quarter with approximately $2.8 billion worth of cash and cash equivalents. This provides us the flexibility to continue to invest in our organic growth opportunity, including the ongoing build-out this year of our Malaysia manufacturing facility and to assess any compelling strategic investments that present themselves. Along those lines, we announced today a $700 million share repurchase program, which will allow us to offset the dilutive impact from our 2023 convertible notes. We are always assessing the best uses of our capital. And given the recent market pressure, we view this as a great time to invest in our own business as we remain incredibly bullish on the sizable opportunity ahead for Dexcom.
第二季調整後 EBITDA 為 1.755 億美元,或占營收 25.2%;相較 2021 年第二季為 1.566 億美元,或占營收 26.3%。第二季淨利為 6,950 萬美元,或每股 0.17 美元。我們仍處於非常良好的財務狀況,季末持有約 28 億美元的現金及約當現金。這使我們能彈性地持續投資於有機成長機會,包括今年持續擴建馬來西亞製造工廠,並評估任何出現的具吸引力策略性投資。基於此,我們今日宣布 7 億美元的庫藏股回購計畫,將使我們得以抵銷 2023 年可轉換公司債所帶來的稀釋影響。我們一直在評估資本的最佳用途。鑑於近期市場壓力,我們認為這是投資自家業務的好時機,因為我們對 Dexcom 未來龐大的機會仍極度看多。
Turning to guidance. We are updating our full year 2022 revenue guidance to a range of $2.86 billion to $2.91 billion. For margins, we are reaffirming our prior full year guidance of gross profit margins of approximately 65%, operating margins of approximately 16% and adjusted EBITDA margins of approximately 25%. This guidance factors in a significant uptick in currency headwinds relative to the expectations we shared a quarter ago. We now expect around $40 million of foreign currency headwinds for the full year relative to our prior estimate of around $15 million to $20 million.
接著談財測。我們將 2022 年全年營收指引更新至 28.6 億至 29.1 億美元的區間。就利潤率而言,我們重申先前的全年指引:毛利率約 65%、營業利益率約 16%、調整後 EBITDA 利潤率約 25%。此指引已納入相較於我們一季前所分享預期更顯著上升的匯率逆風。我們目前預期全年外匯逆風約 4,000 萬美元,先前估計約為 1,500 萬至 2,000 萬美元。
With that, I will pass it back to Kevin.
接下來我把時間交還給 Kevin。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Thanks, Jereme. As I look at this quarter, our underlying fundamentals remain incredibly strong. We experienced another quarter of solid volume growth, achieved worldwide record new customer starts, recorded our highest-ever customer satisfaction rating. These results were before any material contribution from G7, which we expect to improve the customer experience in every way. We advanced our CGM portfolio outside the United States with a wider rollout of Dexcom ONE, helping us reach more reimbursed lives and serving more new customers.
謝謝你,Jereme。回顧本季,我們的基本面仍然極為強勁。我們又迎來一季穩健的出貨量成長,全球新客戶啟用數創下紀錄,並取得史上最高的客戶滿意度評分。這些成果尚未包含 G7 的任何實質貢獻,而我們預期 G7 將在各方面提升客戶體驗。我們也在美國以外推進 CGM 產品組合,擴大 Dexcom ONE 的推廣,協助我們觸及更多可獲給付的人群並服務更多新客戶。
For G7, the feedback from our limited launch in the U.K. has been fantastic, leaving us incredibly excited for a broader global launch in the coming weeks. And in the U.S., we now have clear visibility to the finish line on G7 clearance. And our preliminary payer discussions are setting the stage for a big launch early next year.
就 G7 而言,我們在英國的有限上市所收到的回饋非常出色,讓我們對未來幾週更廣泛的全球上市感到非常振奮。而在美國,我們現在對 G7 取得核准(clearance)的終點線已有清楚能見度。我們與付款方(payer)的初步討論也正在為明年初的大型上市鋪路。
Despite all the macroeconomic challenges that exist today, runaway inflation, supply chain challenges, FX headwinds, we reiterated our margin guidance, continue to have no delivery delays across our business and remain committed to driving additional operating leverage in the coming years. And finally, we announced a $700 million share repurchase plan today. This will allow us to offset the dilutive impact of our 2023 convertible notes and also provides us an opportunity to send a clear message. We're betting on ourselves and the massive opportunity ahead of us. We're optimistic as we've ever been about our future.
儘管當前存在各種總體經濟挑戰——失控的通膨、供應鏈挑戰、外匯逆風——我們仍重申利潤率指引,整體業務也持續沒有任何交付延遲,並且仍致力於在未來幾年推動更多營運槓桿。最後,我們今日宣布 7 億美元的庫藏股回購計畫。這將使我們得以抵銷 2023 年可轉換公司債的稀釋影響,同時也提供我們一個機會傳達明確訊息:我們押注自己,以及我們面前龐大的機會。我們對未來的樂觀程度前所未有。
With that, I'd now like to open up the call for Q&A. Sean?
接下來,我想開放電話會議進入問答。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,請提供問答說明。
Operator
Operator
(Operator Instructions) And our first question comes from Robbie Marcus from JPMorgan.
(接線員指示)我們的第一個問題來自摩根大通(JPMorgan)的 Robbie Marcus。
Robert Justin Marcus - Analyst
Robert Justin Marcus - Analyst
Great. It was -- when you filed G7 last year, you had a pretty high degree of confidence in the completeness of the filing. So one, wondering if we could get a little more on what it is with the software, what you have to change, and how different it's going to be from the European version? What gives you that level of confidence in how to think about U.S. sales growth until we get a G7 launch?
很好。當你們去年提交 G7 申請時,你們對申請資料的完整性有相當高的信心。所以第一,想請你們多談一點軟體方面到底是什麼問題、需要改哪些地方,以及它會與歐洲版本有多不同?另外,在我們等到 G7 上市之前,你們對美國銷售成長的看法為何能有那樣的信心?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Robbie, this is Kevin. I'll take the G7 questions. The software revisions relate to the management of the alerts and alarms in the U.S. app. FDA had some questions about some of the things that we've done and put in it. We discussed several options that we had. We decided the best option at this time was to revise the software and file it differently, and we've added a few other features to it as well based on our discussions with them.
Robbie,我是 Kevin。我來回答 G7 的問題。軟體修訂與美國 App 中警示與警報(alerts and alarms)的管理有關。FDA 對我們所做並放入其中的一些內容提出了疑問。我們討論了幾個可行選項。我們決定目前最好的選項是修訂軟體並以不同方式提交,同時也根據與他們的討論新增了幾項功能。
We're in the middle of revising the software for that and have to run it through the complete validation and verification process and resubmit. We're not done with it yet, but we're working very quickly to get done with that. And that's really our big major issue. We've talked through everything else.
我們正在修訂該軟體的過程中,並必須完成完整的驗證與確認(validation and verification)流程後重新提交。我們尚未完成,但正非常快速地推進以完成它。而這確實是我們主要的重大議題。其他部分我們都已經逐一討論過了。
We did have a strong level of confidence and we still do in our relationships and our discussions with the FDA on G7. The one thing we figured out as we've been through this process is we changed absolutely everything. We changed the algorithm. We changed the insertion techniques. We changed every manufacturing procedure that we have and completely rewrote the entire app and the software experience, which is a lot for them to digest and a lot for us to submit. If I look at learnings for us over time, I think we'll probably do things a little more incrementally going forward rather than as big as this one was, and we can get things through faster.
我們確實一直、而且現在仍然,對於我們與 FDA 就 G7 的關係與討論抱持很高的信心。我們在走過這個流程後發現的一件事是:我們幾乎把所有東西都改了。我們改了演算法。我們改了植入技術。我們改了我們的每一道製造流程,並且把整個 App 與軟體體驗完全重寫,這對他們來說需要消化的內容很多,對我們來說需要提交的資料也很多。若回頭看我們一路以來的學習,我想未來我們可能會採取更循序漸進的方式,而不是像這次這麼大幅度的變更,這樣也能更快把事情推進完成。
But we're in a good spot. We have a lot of clarity as to where we need to go going forward. And I'll let Robbie handle the growth issues regarding G6 because we're still doing extremely well with that product. Not Robbie -- Jereme, go ahead.
但我們目前處於不錯的位置。我們對於接下來需要往哪裡走有很清楚的方向。至於 G6 的成長議題我會讓 Robbie 來處理,因為我們在那個產品上仍然表現非常好。不是 Robbie——Jereme,你來吧。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
So in the U.S., look, the quarter here, we had about 11% growth. That's generally due to some of what we talked about in prior quarters, us getting into physicians' offices. And as those new patients didn't hit those record levels, you ultimately see that recur -- on a recurring business model such as ours, it plays through.
在美國,這一季我們大約有 11% 的成長。這主要是因為我們在前幾季談到的一些因素,也就是我們進入醫師診所的推進。當那些新病患沒有達到先前的創紀錄水準時,最終你會看到這在我們這種經常性收入的商業模式中反映出來。
What gives us a lot of confidence for the back half of the year is Q2 was a record, and we're back on that record track and we do expect strength for the rest of the year to the point where we expect U.S. growth rates to accelerate in Q3 and Q4 as we come off of this quarter where we see these record new patient starts. And quite frankly, we expect to have record new patient starts going forward for the balance of the year, even without G7. So I hope that gives you that question. We're very confident in G6, and obviously, we're even more confident in G7 once that launches.
讓我們對下半年很有信心的是,第二季創下紀錄,我們又回到創紀錄的軌道上,而且我們預期今年剩餘時間都會維持強勁,強到我們預期美國的成長率會在第三季與第四季加速,因為我們將走出本季、並受惠於這些創紀錄的新病患啟用量。坦白說,即使沒有 G7,我們也預期今年剩餘期間的新病患啟用量會持續創新高。希望這回答了你的問題。我們對 G6 非常有信心,而一旦 G7 上市,我們顯然會更有信心。
Operator
Operator
And our next question comes from Jeff Johnson from Baird.
下一個問題來自 Baird 的 Jeff Johnson。
Jeffrey D. Johnson - Senior Research Analyst
Jeffrey D. Johnson - Senior Research Analyst
Kevin, I just want to go back on your comments about revising some of the software on the alerts and alarms on the G7 product. So it sounds like to me, you're still in the process of that. But I think you also said in your prepared remarks that you were comfortable that you would still have a limited launch in the fourth quarter and a fuller launch in the first quarter of 2023 in the U.S. So one, can I just confirm that's what you said? Two, do you have some better certainty on all the other aspects of the filing from the FDA that gives you that ability to draw that line in the sand? Or at least where is your confidence on that time line?
Kevin,我想回到你剛才提到關於 G7 產品在警示與警報方面軟體修訂的評論。聽起來你們仍在處理當中。但我也記得你在事先準備的講稿中提到,你們仍然有把握在第四季於美國進行有限度上市,並在 2023 年第一季於美國更全面上市。第一,我可以確認你是這樣說的嗎?第二,你是否對於向 FDA 申報的其他面向有更高的確定性,因此能讓你畫出這條明確的時間線?或者至少,你對這個時程的信心來源是什麼?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
We do have great certainty on the other components of the filing with the FDA. We've talked through all the other questions and things that we've discussed, and we're very, very comfortable with that. So really, the outstanding major item is revision and filing of the revised software after we validate and verify it, all of that. So we are very, very comfortable with that. And yes, what I did say is we are anticipating a limited launch in the fourth quarter in the U.S. and then the full-on rollout in -- early in the year in 2023.
我們對於向 FDA 申報的其他組成部分有很高的確定性。我們已經把其他問題與我們討論過的事項都談清楚了,對此我們非常、非常有把握。所以真正尚未完成的主要項目,就是在我們完成驗證與確認後,修訂軟體並提交修訂後的軟體文件等。我們對此也非常、非常有把握。是的,我剛才說的是:我們預期在第四季於美國進行有限度上市,然後在 2023 年初進行全面推廣。
One of the things I said in my prepared remarks is we're very bullish about the progress we've made with the payers as far as getting the G7 reimbursed because they can see how important it's going to be for our patient base. So on the one hand, while we have the delay in the approval and the launch that -- look, none of us -- we'd all like to be faster, the other thing we're seeing on the other side is a lot of cooperation in the payer community and just in the channel in getting this thing positioned for reimbursement very quickly after approval. So we can get the launch out in not too different of a time frame on a reimbursed basis from what we expected in the beginning. So those 2 factors together, again, add to where we think we are.
我在事先準備的講稿中提到的一點是:就讓 G7 取得給付(reimbursed)而言,我們對於與支付方(payers)所取得的進展非常樂觀,因為他們看得出這對我們的病患族群會有多重要。所以一方面,雖然核准與上市有所延後——坦白說,我們都希望能更快——但另一方面,我們也看到支付方社群以及通路端在合作上非常積極,讓這項產品在核准後能很快完成給付定位。因此,在給付基礎上,我們仍能在與一開始預期差異不大的時間框架內推出上市。這兩個因素加在一起,再次強化了我們對目前狀況的判斷。
Operator
Operator
And our next question comes from Margaret Kaczor from William Blair.
下一個問題來自 William Blair 的 Margaret Kaczor。
Malgorzata Maria Kaczor Andrew - Partner
Malgorzata Maria Kaczor Andrew - Partner
I wanted to maybe dive a little bit further into kind of this new patient add growth just because it's important as we get into '23 as well. But any details that you can give in terms of how it looks like within T1, T2 intensive and others? And if there have been any changes, I guess, in the last 6 to 12 months? Are things getting harder or easier? And what kind of efforts you guys put in place to reaccelerate more meaningfully those new patient adds?
我想更深入了解新病患新增(new patient add)的成長,因為這對我們進入 2023 年也很重要。你們能否提供一些細節,例如在第一型(T1)、第二型加強治療(T2 intensive)以及其他族群中的表現如何?另外,在過去 6 到 12 個月是否有任何變化?情況是變得更難還是更容易?以及你們採取了哪些措施,來更有意義地重新加速新病患新增?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. Yes, I can answer that. And thank you for the question. What we saw, and I think this is -- we've really talked about it is we found our folks are most effective when they're able to get into physicians' offices. That's always been the case, and it's continued to show itself time and time again. And so what we found is it rises all tides once we're able to do so.
當然,可以。我可以回答,謝謝你的問題。我們看到的情況——而且我想這點我們其實談過很多——是我們的團隊在能夠進入醫師診所時最有效率。這一直都是如此,而且一次又一次地被證明。所以我們發現,一旦能做到這點,就會帶動整體水位一起上升。
But the predominance of where our new patient adds are coming, if you want to kind of see what the more accelerate is, it's really in the type 2 intensive space. As we get into more primary care physicians' offices, these are folks we've called on really for the first time as we've expanded our sales force in 2021, getting there in-person has really unlocked that market, and that's what you continue to see.
但如果你想看新病患新增主要來自哪裡、也就是加速最明顯的地方,其實是在第二型加強治療(type 2 intensive)領域。隨著我們進入更多基層照護醫師(primary care physicians)的診所,這些是我們在 2021 年擴編業務團隊後,幾乎首次真正開始拜訪的對象;親自到現場拜訪確實打開了那個市場,而你現在持續看到的就是這個結果。
And so now our focus is -- and we talked about it a little bit in the prepared remarks. Now that we're in these offices, a record new patient quarter this quarter, certainly, that's encouraging. But we're also seeing that all of these tools that have been put in place means every call, every visit, every time we're in the office, we're able to be more effective about what might be the prescribers' decision-making around that particular patient.
因此我們現在的重點是——我們在事先準備的講稿中也稍微提到——既然我們已經進入這些診所,本季創下新病患的紀錄,當然令人鼓舞。但我們也看到,所有已經建置到位的工具,讓我們每一次電話、每一次拜訪、每一次在診所裡,都能更有效地影響開立處方者對於特定病患的決策。
And through doing that, whether it's debunking myths around co-pays and what the out-of-pocket is and making sure folks understand the cost, whether it's the ease of use and showing folks that a majority of our patients are able to put it on and use either training online or simple training in the box to ultimately put it on their body. What we're really finding is we're breaking down all of those myths out there, and our sales force continues to get more and more effective. So we're going to continue to do that over time. And we're seeing that continue to play out as better prescriber patterns, more prescriptions per provider and more providers coming over to prescribing Dexcom. So all of those are playing out, which is what gives us confidence for acceleration in the U.S. in the back half of the year.
透過這樣做,不論是澄清對自付額(co-pay)與自費金額(out-of-pocket)的迷思、確保大家理解成本;或是強調易用性,讓大家看到我們多數病患只需要線上訓練或盒內的簡易訓練,就能把產品貼上並使用在身上。我們真正發現的是:我們正在打破外界的各種迷思,而我們的業務團隊也持續變得越來越有效率。因此我們會隨時間持續推進。我們也看到這些努力持續反映在更好的處方行為模式、每位醫療提供者(provider)開立更多處方,以及更多提供者開始改為開立 Dexcom。這些都正在發生,這也是我們對美國下半年加速成長有信心的原因。
Operator
Operator
And our next question comes from Joanne Wuensch from Citigroup.
下一個問題來自 Citigroup 的 Joanne Wuensch。
Joanne Karen Wuensch - MD
Joanne Karen Wuensch - MD
I'm a little bit curious about some of the reimbursement landscape and things which may or may not have changed. Where do you think reimbursement is for bolus? And are you seeing any other changes as it relates to prior authorization or one product versus or another or anything else that we really should be aware of?
我有點好奇給付環境(reimbursement landscape)以及可能有或沒有改變的一些事情。你們認為追加劑量(bolus)的給付進展到哪裡了?另外,你們是否看到任何其他變化,例如事前授權(prior authorization)、某一產品相對於另一產品的差異,或任何我們應該特別留意的事項?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Thanks, Joanne. Yes, I can take the question. So in terms of basal, we continue to make progress there. So as you think about where we're having the conversations, the conversations are both on the government in the U.S., CMS as well as the U.S. commercial providers. We're having conversations with both. And our access team has submitted the data. They've submitted both clinical data, economic data as well as clinician recommendations. And so we are going through those conversations. So it's been submitted. Discussions are ongoing. Timing is hard to peg in all of these, but we are continuing to advance it forward in terms of conversations. So that's basal. We'll certainly be -- as that progresses forward, we'll continue to give you line of sight as to how that goes. In terms of other areas, so existing coverage in areas around prior authorizations or otherwise, we haven't seen a lot of that. Now there are occasionally plans that have a prior authorization pop up or pull out, our goal is through all of the renegotiations that take place to limit those prior authorizations.
謝謝你,Joanne。我來回答這個問題。就基礎胰島素(basal)而言,我們持續在那方面取得進展。當你思考我們正在進行哪些對話時,對話對象同時包含美國政府端(CMS)以及美國的商業保險提供者。我們兩邊都有在談。我們的准入團隊已提交資料,包括臨床資料、經濟資料以及臨床醫師的建議。因此我們正在進行這些討論。也就是說,資料已提交,討論仍在進行中。這些事情的時程很難精準界定,但我們在對話推進上持續向前。這是基礎胰島素的部分。隨著進展,我們也會持續讓你們更清楚掌握後續情況。至於其他領域,例如既有給付範圍中與事前授權等相關的部分,我們沒有看到太多變化。當然,偶爾會有某些方案新增或取消事前授權;我們的目標是在所有重新談判的過程中,盡量降低這些事前授權的要求。
And as we continue to show how CGM can improve patient outcomes, it's becoming very clear that prior authorizations -- we see payers starting to pull those down over time, a better way to put it. And so we continue to expect to see and keep pushing that. We have not seen a material change in any form or factor. In fact, for the most part, we see them coming down, and we'll expect to see that over time in the intensive space.
而且隨著我們持續證明 CGM 能改善病患結果,事前授權的必要性變得越來越不明顯——我們看到支付方開始隨時間逐步下調(更貼切地說,是逐步取消)這些要求。因此我們會持續推動並預期看到這樣的趨勢。我們沒有看到任何形式或因素上的重大變化。事實上,多數情況下我們看到的是要求在下降,而我們也預期在加強治療(intensive)領域會隨時間持續如此。
Operator
Operator
And our next question comes from Matthew O'Brien.
我們的下一個問題來自 Matthew O'Brien。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
Can we just -- as I look at the stock, down 18% in the aftermarket, that's $6 billion-ish in lost market cap, even a little bit more than that. So I think it'd be helpful -- I don't know if the reduction of the top line guidance from 20% down to 19% or maybe it's a little bit more is largely because of G7. But I'm thinking it's like a $60 million headwind, maybe something like that this year versus not getting the approval. So is it about $100 million of incremental pressure you're going to see next year and not having the approval earlier this year that you can't get all the marketing activities up and going next year? Just how do we frame up some of this modest delay? It seems like on the payer side, things are better. But just frame up what this modest delay may do to the top line as we look forward.
我想先問一下——我看這檔股票在盤後下跌 18%,大概蒸發了 60 億美元左右的市值,甚至可能還多一點。所以我覺得釐清一下會很有幫助——我不確定把營收指引從 20% 下修到 19%(或許還略多一些)的原因,是否主要是因為 G7。但我在想,若今年沒有拿到核准,可能造成大約 6,000 萬美元的逆風,類似這樣的量級。所以,是否意味著明年會多出大約 1 億美元的額外壓力?以及今年沒有更早取得核准,導致明年無法把所有行銷活動全面啟動?我們該如何看待這個小幅延遲?看起來在支付方(payer)端情況更好。但請幫我們框架一下,這個小幅延遲對未來營收(top line)可能造成的影響。
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. I can talk about at least for 2022 and how it operates, and we can maybe not get too, too much into 2023, but it can help that conversation. So a lot of the guidance and the pull down of guidance is related to currency. So it's not necessarily related to the G7 and the timing associated with that. So as you look at where we're going and where we pulled that down, currency has, especially outside the U.S., has played a large impact on reported growth rates. And that's one of the reasons why we've shifted in how we talk about organic growth.
好的。我可以先談至少 2022 年以及它如何運作,然後我們也許不要把 2023 講得太、太深入,但這可以幫助那個討論。其實指引以及下修指引的很大一部分與匯率有關。所以不一定與 G7 以及其相關時程有關。當你看我們的走向以及我們下修的幅度時,匯率——尤其是在美國以外——對報告成長率造成了很大的影響。這也是我們改變談論有機成長(organic growth)方式的原因之一。
As you zoom back into the U.S., the G7 delay does have a little bit of an impact on guidance. And so certainly, we would recognize that we had some impact in there and assumed it would launch. The longer-term impact is really determined on how fast we get commercial coverage and how fast we can roll it out.
回到美國市場來看,G7 的延遲確實對指引有一些影響。因此,我們當然承認其中有一些影響,並且原本假設它會上市。長期影響主要取決於我們取得商業保險給付(commercial coverage)的速度,以及我們能多快把它推廣出去。
And so what we believe is by working alongside our coverage teams and trying to get access as fast as possible and while we're working through getting formal approvals, partnering with folks to get quicker access and quicker coverage, we believe we can work on getting those patients back in quicker and faster to where we don't believe it's going to be a material impact on 2023 and beyond. And so a little bit in 2022. Certainly, it could have a little bit of tick in 2023. But for the most part, we're doing all the work now to make sure that we have a major launch where it doesn't impact longer-term growth rates.
因此,我們相信透過與我們的給付團隊(coverage teams)並肩合作、盡可能快速取得給付准入(access),同時在我們推進正式核准的過程中,與各方合作以取得更快的准入與更快的給付覆蓋,我們可以讓那些病患更快回流。我們認為這不會對 2023 年及之後造成重大影響。因此,2022 年會有一點影響;當然,2023 年可能也會有一點點波動。但整體而言,我們現在正在做所有工作,以確保我們能有一個重大的上市推進,不致影響長期成長率。
Operator
Operator
And our next question comes from Jayson Bedford from Raymond James.
我們的下一個問題來自 Raymond James 的 Jayson Bedford。
Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst
Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst
Just 2 questions that require quick answers. Just a clarification. I get the sense that it was a record for new patient starts in both the U.S. and worldwide, if you could just confirm that? And then the second question is, you mentioned expanding the G7 launch in Europe over the coming weeks. And I wasn't clear whether you're going into new countries? Or is this just more expansive in the U.K.?
兩個需要快速回答的問題。第一個是釐清一下:我的理解是,美國與全球(worldwide)的新病患啟用(new patient starts)都創下紀錄,你能否確認?第二個問題是,你提到未來幾週會在歐洲擴大 G7 上市。我不太確定你們是要進入新的國家?還是只是把英國做得更全面?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Yes, this is Kevin, I'll start. Yes, it was record new patients OUS and in our U.S. markets as well. Both teams had new patient add records during this quarter. With respect to the rollout of G7 in Europe, what we had indicated was our first rollout will be in the U.K., and we expect we will add other geographies before the end of the year.
是的,我是 Kevin,我先回答。是的,這一季在美國以外(OUS)以及我們的美國市場,新病患數都創下紀錄。兩個團隊在本季的新病患新增都創了紀錄。至於 G7 在歐洲的推廣,我們先前表示第一波會在英國推出,並且我們預期在年底前會加入其他地區。
Operator
Operator
And our next question comes from Travis Steed from Bank of America.
我們的下一個問題來自美國銀行(Bank of America)的 Travis Steed。
Travis Lee Steed - MD
Travis Lee Steed - MD
One quick clarification. The pricing mix versus volume growth this quarter. And then as you look ahead to next year, will we start to see volume and revenue growth to start to match up a bit more? And I'm thinking about the basal opportunity, is that an opportunity where you're going to have to lower price to get the volume? Or is the basal pricing probably pretty similar to the intensive market?
一個快速釐清:本季價格/組合(pricing mix)相對於銷量成長(volume growth)的情況。然後展望明年,我們是否會開始看到銷量與營收成長更一致一些?我在想基礎胰島素(basal)的機會,那是否是一個你們必須降價才能換取量的機會?還是 basal 的定價大概會和強化治療(intensive)市場相近?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. So I can take those questions. In terms of pricing and what I'd say is more channel mix, but the delta between the 2, it was about the same this quarter as it was in prior quarter, which is what we had signaled at the start of the year. We still expect to migrate in the U.S. channel as we move more DME to pharmacy. That continues as expected. And then we had the OUS pricing where we took down pricing in exchange for access. We expected that to run through the end of Q2 before we lapped our strategy. So it's all gone and aligned with expectations. It was right around $70 million on the quarter.
好的,我來回答。就定價而言,我會說更像是通路組合(channel mix),但兩者之間的差異,本季大致與前一季相同,這也符合我們在年初所傳達的預期。我們仍預期在美國通路會持續遷移,因為我們把更多 DME 轉到藥局(pharmacy)。這如預期持續進行。然後在美國以外(OUS)的定價方面,我們以降價換取准入,原本預期這會持續到第二季末,直到我們的策略進入比較基期(lapped our strategy)。所以一切都符合預期並且對齊。本季大約是 7,000 萬美元。
In terms of basal and beyond, look, basal coverage, we believe, is out there. In terms of what the pricing is, at this point, a lot of the conversations are about category coverage. And currently, category coverage is already relatively defined, defined in pricing today. And so what that means is it could be the same, but would we be willing to talk to folks about increasing access in exchange for price? We'd absolutely entertain the conversation. It'd have to make sense for us for both the returns that we would expect on our performance as well as for our shareholders, but nothing to this point has indicated it would be lower. However, we understand that as more and more folks get access, we will be having those conversations.
至於 basal 以及更長遠的部分,basal 的給付覆蓋我們認為是存在的。就定價而言,目前很多對話是在談「品類給付」(category coverage)。而目前品類給付在今天的定價中已經相對明確。這代表它可能會一樣,但我們是否願意與各方討論以價格換取更高的准入?我們當然願意考慮這樣的對話。它必須對我們有意義,無論是我們對績效的回報預期,或是對股東而言都要合理;但到目前為止,沒有任何跡象顯示它會更低。不過我們也理解,隨著越來越多人取得准入,我們將會進行這些對話。
Operator
Operator
And our next question comes from Marie Thibault from BTIG.
我們的下一個問題來自 BTIG 的 Marie Thibault。
Marie Yoko Thibault - MD and Medical Technology and Digital Health Analyst
Marie Yoko Thibault - MD and Medical Technology and Digital Health Analyst
I wanted to go back to something Kevin said earlier about the new software and app experience for the patient with G7 in the U.S. Can you give us a hint of how meaningful that new app experience might be for patient willingness to try the G7, to switch to the G7, and what it might do for patient demand?
我想回到 Kevin 先前提到的一點:在美國,G7 對病患而言有新的軟體與 App 體驗。你能否提示一下,這個新的 App 體驗對病患願意嘗試 G7、轉換到 G7 的意願有多重要?以及它可能會如何影響病患需求?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
One of the best features of the limited launch in the U.K. has been getting feedback on the software and people absolutely love the app. From the very beginning, when you start, it is much easier to fire it up and get on the system and understand what CGM is going to do for you and how it's going to work. So for a new user, this is a much, much easier experience and much, much easier start.
英國的有限上市(limited launch)其中一個最好的地方,就是我們能收到對軟體的回饋,而大家真的非常喜歡這個 App。從一開始啟用時,它就更容易啟動、連上系統,並理解 CGM 會為你做什麼以及它如何運作。所以對新使用者而言,這是更、更加容易的體驗,也是更、更加容易的開始。
The other thing that's very obvious in the software is another feature that our patients love. It's a 30-minute warmup that actually ends up being about 25 minutes once you put the sensor on. I was speaking with a patient just last week, and I asked her what is your favorite and what is your worst thing about G6? And the 2-hour warmup, this very frequently comes up -- was what came up. And so this half hour warmup is going to be a feature. But the software itself, in addition to the typical graph and the sensor reading and the arrows, we also have CLARITY data built into the app that gives you feedback about how you're doing over 1 day, 3 days, 7 days or even a month. So someone can go down and look and see exactly how they're doing and what their trends are, how much time they are spending in range. So it's much more of a full experience for somebody under diabetes care, and our patients all like it tremendously.
軟體中另一個非常明顯、而且病患很喜歡的功能是:30 分鐘的暖機(warmup),實際上在你把感測器貼上後大約 25 分鐘就結束。我上週才和一位病患聊過,我問她你最喜歡、以及你最不喜歡 G6 的地方是什麼?她提到的——而且這很常被提到——就是 2 小時的暖機。所以這個半小時暖機會是一個亮點。但軟體本身除了典型的圖表、感測器讀值與箭頭之外,我們也把 CLARITY 資料整合進 App,讓你能看到自己在 1 天、3 天、7 天甚至 1 個月的表現回饋。使用者可以往下查看,清楚看到自己的狀況與趨勢、在目標範圍內的時間(time in range)有多少。所以對於接受糖尿病照護的人來說,這是一個更完整的體驗,而我們的病患都非常喜歡。
We'll be ready to go on Android and iOS in launch. We're not going to hold either of them back. The other thing with the app, and it's not really on the app, but it's a feature of this product that's been very well accepted as well, I didn't talk much about. We have a new receiver coming. The patients absolutely have loved and are using it very well. And while -- I figured when we went to the phone in the beginning, everybody would immediately migrate to the phone. There's a very large percentage of our customers who use that receiver. They will be greatly enhanced in their experience by going to the next receiver with us. And on the good news front as well, that new receiver, while a better experience, is a much lower cost offering. So I'll get stuff there on the app.
上市時我們會同時支援 Android 和 iOS,我們不會把任何一個平台延後。App 之外還有一件事——其實不完全是 App 的功能,但也是這個產品一個非常受歡迎的特點——我先前沒有多談:我們會推出新的接收器(receiver)。病患非常喜歡,而且使用得很好。而且——我原本以為一開始我們轉到手機後,大家會立刻全面改用手機。但其實有很大比例的客戶仍在使用那個接收器。他們改用我們下一代接收器後,體驗會大幅提升。還有一個好消息是,這個新的接收器雖然體驗更好,但成本更低。所以以上是關於 App 的補充。
Operator
Operator
And our next question comes from Matthew Blackman.
我們的下一個問題來自 Matthew Blackman。
Mathew Justin Blackman - Analyst
Mathew Justin Blackman - Analyst
International growth did step up even though you had a tougher comp. Is that the broader G7 rollout? Dexcom ONE? Some combination of those 2? And I'm also really curious about Germany, in particular, where I think you are going head-to-head versus the newest sensor from your competitor. Just any commentary about sort of geographic performance within that international number.
國際成長確實加速了,儘管比較基期更具挑戰。這是更廣泛的 G7 推廣?Dexcom ONE?還是兩者的某種組合?另外我也很好奇德國,特別是我認為你們在那裡正與競爭對手最新的感測器正面交鋒。能否就國際營收數字中各地區的表現做一些評論?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. Yes. We can absolutely answer that. And it's interesting, Dexcom ONE and G7 really haven't contributed all that much to this point. So certainly, it's an exciting future contributor, and we're very, very bullish on both G7 and the opportunity in Dexcom ONE. Dexcom ONE really is in the BELL countries and hasn't contributed all that much and G7 was limited launch. And so what you're seeing is G7 with a more meaningful launch and Dexcom ONE with a more meaningful launch in bigger countries in Q3 and beyond. So what you saw in Q2 was really a continuation of our access and going deeper into countries where we had our G Series. And really, it was broad-based. And it's a continuation of broad-based performance outside the U.S., really across all of our countries, including Germany, where we do go head-to-head with Libre 3.
當然。是的。我們絕對可以回答這個問題。而且很有意思的是,到目前為止,Dexcom ONE 和 G7 其實還沒有貢獻太多。所以毫無疑問,它們是令人振奮的未來貢獻來源,我們對 G7 以及 Dexcom ONE 的機會都非常、非常看好。Dexcom ONE 主要是在 BELL 國家,目前貢獻並不多,而 G7 也只是有限度上市。因此,你們看到的是:在第三季及之後,G7 會有更具意義的上市推進,而 Dexcom ONE 也會在更大的國家進行更具意義的上市。第二季你們看到的,其實是我們持續擴大可及性,並在我們已有 G 系列的國家進一步深耕。而且確實是全面性的。這是我們在美國以外各國的全面性表現延續,涵蓋所有國家,包括德國——在那裡我們確實與 Libre 3 正面競爭。
And so I think what you can say is that business is doing incredibly well, and there's new catalysts to ultimately support it for upcoming periods. So we are very excited about that international business. And like I said, in countries where we're going up head-to-head with our competitors' most recent product, we continue to do very well and take share. So very, very bullish on our opportunity going forward.
所以我認為你可以說,這項業務表現非常出色,而且未來幾個期間還會有新的催化劑來最終支撐它。因此我們對國際業務非常興奮。就像我說的,在我們與競爭對手最新產品正面交鋒的國家,我們仍然表現很好並持續取得市占。因此,我們對未來的機會非常、非常看好。
Operator
Operator
And our next question comes from Josh Jennings from Cowen.
下一個問題來自 Cowen 的 Josh Jennings。
Unidentified Analyst
Unidentified Analyst
This is [Brian] here for Josh. Are you currently seeking or planning to seek CE Mark approval for the software changes you're making in the U.S.? And if so, could you share the projected time line there?
我是 [Brian],代 Josh 提問。你們目前是否正在尋求或計畫尋求 CE Mark(歐盟 CE 認證)核准,以涵蓋你們在美國所做的軟體變更?如果是的話,能否分享預計的時間表?
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
We already have the software approved for CE Mark in Europe, and we do not plan immediately on implementing the changes that we're putting into the U.S. app. We'll consider that over time. We'll -- we have the app and the software configured to whereby we can launch the product with what we're doing in Europe to sell it and support it there. And if we feel the need to in some period of time, we can implement those changes into the other software and upgrade patient's apps on the phone, but not immediately, no.
我們在歐洲已經取得該軟體的 CE Mark 核准,而且我們不打算立即導入我們正在美國 App 中加入的那些變更。我們會隨時間再評估。我們——我們的 App 與軟體已經配置好,可以用我們在歐洲所做的版本來上市、銷售並在當地提供支援。如果我們在某個時間點覺得有需要,我們可以把那些變更導入其他軟體,並在手機上升級病患的 App,但不是現在,不會立即。
Operator
Operator
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
As you're moving G7 to full launch in the U.K., where you now also have Dexcom ONE, just wondering how will those 2 offerings be marketed relative to each other. Should we assume that over time, they sort of merge? And with G7 becoming the primary hardware there, obviously, that's going to happen in more and more countries over time. So wondering if you could talk to your thoughts on that.
你們正把 G7 推進到英國全面上市,而那裡你們現在也有 Dexcom ONE。我想了解這兩個產品相對彼此會如何行銷?我們是否應該假設,隨著時間推進,它們會某種程度上合併?而且隨著 G7 成為那裡的主要硬體,顯然這也會在越來越多國家發生。所以想請你談談你們對此的想法。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
No, I appreciate that question. We launched Dexcom ONE in Europe, and we're launching in the U.K. because there are many reimbursement opportunities we've not been able to participate in. Our G Series, our G6 and G7 products, are regarded as very high-end sensors for intensive insulin management, integration with insulin pumps. A lot of pediatrics, they share, they follow the other features that have made our products so endeared to our users.
不,我很感謝這個問題。我們在歐洲推出 Dexcom ONE,也在英國推出,因為有許多我們過去無法參與的給付機會。我們的 G 系列——G6 與 G7——被視為用於密集胰島素管理、與胰島素幫浦整合的高階感測器。很多兒科使用者也在其中,他們重視並追隨那些讓我們產品深受使用者喜愛的其他功能。
The Dexcom ONE app has -- doesn't have many of those features. It's much more simple, and it falls into a different reimbursement category in many of these geographies. In the U.K., for example, our Dexcom ONE system will literally be -- will go through the pharmacy channel for broad-based distribution and broad-based accessibility for everybody. Whereas our G Series, it requires more documentation, more approval and very specific conditions.
Dexcom ONE 的 App——並沒有很多那些功能。它更簡單,而且在許多地區屬於不同的給付類別。以英國為例,我們的 Dexcom ONE 系統將會——真的會——走藥局通路,進行廣泛配銷與廣泛可近性,讓每個人都能取得。相較之下,我們的 G 系列需要更多文件、更多核准,以及非常特定的條件。
As we look at these geographies, we think we have an opportunity with Dexcom ONE to sell a different product and a different system with different features that really won't step over onto our G Series that is fully integrated with other systems and offers all these other features.
當我們看這些地區時,我們認為 Dexcom ONE 讓我們有機會銷售不同的產品與不同的系統,具備不同的功能,基本上不會跨到我們的 G 系列——後者與其他系統完整整合並提供所有這些其他功能。
Ultimately, as I said on the call, we want our Dexcom ONE product to be on the G7 platform as well as we simplify our operating structure over time, but that will take a little while. And so G6 for Dexcom ONE platform, we think, will do very well. And our initial user feedback has been very good.
最終,如我在電話會議中所說,我們希望 Dexcom ONE 產品也能建立在 G7 平台上,隨著時間推進簡化我們的營運架構,但這需要一點時間。因此我們認為,以 G6 作為 Dexcom ONE 的平台會表現得很好。而且我們初期的使用者回饋非常正面。
The software for Dexcom ONE, I would also add, has been designed on the same platform as the G7 software. So it looks and feels a little more -- much more like G7 than it does G6. So our users will have a great experience there. As long as there are 2 reimbursement categories, we do not see these 2 products coming together from a reimbursement perspective. They might look more alike physically and be on the same platform once we get G7 enough capacity to transfer to the other Dexcom ONE platform. But they won't be the same experience. It won't be reimbursed at the same rates.
我也補充一下,Dexcom ONE 的軟體是設計在與 G7 軟體相同的平台上。因此它的外觀與操作感受更——更像 G7,而不是 G6。所以使用者會有很好的體驗。只要仍然存在兩種給付類別,我們就不認為這兩個產品會在給付面合而為一。一旦我們的 G7 產能足以轉移到另一個 Dexcom ONE 平台,它們在外觀上可能會更相似、也可能在同一平台上。但它們不會是相同的體驗,也不會以相同的費率給付。
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。
Nathan Treybeck - Associate Equity Analyst
Nathan Treybeck - Associate Equity Analyst
This is Nathan on for Larry. Can you comment on what drives the margin improvement in the second half, given the launch of G7? And how should we think about margins into 2023?
我是 Nathan,代 Larry 提問。鑑於 G7 的上市,你能否評論一下下半年毛利率改善的驅動因素是什麼?以及我們應該如何看待 2023 年的毛利率?
Jereme M. Sylvain - Executive VP, CFO & CAO
Jereme M. Sylvain - Executive VP, CFO & CAO
Sure. Let me talk about the second half, and we won't get too, too much into 2023 specifically other than we all have -- our long-range plan is 65%. And so that's the way we generally think about things.
好的。我先談下半年,而 2023 年我們不會講得太、太具體,除了我們都有——我們的長期規劃目標是 65%。所以我們一般就是用這個方式來思考。
In terms of the back half of the year, typically, what happens is as we go typical seasonality, as we go through the course of the year, and part of this has to do with who's ultimately purchasing the product, margins typically get better.
就年度後半段而言,通常會發生的是:依照典型季節性,隨著一年進行——其中一部分也與最終由誰採購產品有關——毛利率通常會變得更好。
Now that was thrown on its head a little bit as we were launching G7. I mean we had some timing things about when that would launch and what countries that would go into. So what you're finding is, is for the first half of the year, we obviously had a few different unique items that impacted margins. What you're really finding is the run rate for our margin for the first half of the year, absent these, was just below 65%.
不過在我們推出 G7 時,這個情況有點被顛覆了。我的意思是,我們在何時上市、會進入哪些國家等方面有一些時點因素。因此你會發現,在上半年,我們顯然有幾個不同的特殊項目影響了毛利率。你真正會看到的是:若排除這些因素,我們上半年的毛利率運行水準略低於 65%。
Back half of the year, we expect it to be just the opposite, just north of 65% as we hit that typical seasonality. We will have a little bit of pressure from the launch of G7 outside the U.S. However, that will clearly be offset through the G6 throughput that you ultimately see. And the reason to tick up in the back half of the year in some ways is due to -- with the G7 launch in a meaningful way outside -- inside the U.S. sliding into Q1 of next year, you do see that performance on that G6 platform, which continues to have nice margins play through over the course of the rest of the year. So we have a lot of confidence, 65% for the year, even despite all of the macroeconomic conditions.
下半年,我們預期會相反,隨著進入典型季節性,毛利率會略高於 65%。我們會因為在美國以外推出 G7 而承受一些壓力。然而,這將會明顯被你最終看到的 G6 產出提升所抵銷。而下半年在某些方面之所以會上升,是因為——由於 G7 在美國境內以更具意義的方式上市會延後到明年第一季,你會看到 G6 平台的表現,而該平台仍具備不錯的毛利率,並在今年剩餘期間持續反映出來。因此,即使面對所有總體經濟狀況,我們對全年 65% 仍然很有信心。
Operator
Operator
We have no more questions at this time. I'll turn it back to the speakers for closing comments.
目前沒有更多問題。我將把時間交回給講者做結語。
Kevin Ronald Sayer - Executive Chairman, CEO & President
Kevin Ronald Sayer - Executive Chairman, CEO & President
Well, again, thanks, everybody, for participating on the call. One of the great things that's happened in the second quarter has been my own ability to get out and talk and meet with people going to ADA and also some other conferences where I've spoken. And I've never seen Dexcom more respected and more visible than we are now.
再次感謝各位參與本次電話會議。第二季發生的一件很棒的事,是我自己能夠走出去與大家交流、見面,參加 ADA,也參加了其他一些我有發言的會議。我從未見過 Dexcom 像現在這樣受到更多尊重、也更具能見度。
Our customer satisfaction scores, as I talked earlier, have never been higher, and that's what you hear in real life. People are absolutely thrilled with the performance of our product and the problem that we solve for them. It's never been a better time here. We have a number of Dexcom ONE launches coming out over the next few quarters on top of that with G7 as well, both presenting great revenue and growth opportunities for us. And our operations are running very efficiently and smoothly. Everybody, have a great day, and thanks for participating on the call.
如我先前提到,我們的客戶滿意度分數從未如此之高,而這也是你在現實生活中聽到的。人們對我們產品的表現以及我們為他們解決的問題感到非常滿意。現在從未有比這更好的時刻。接下來幾個季度,除了 G7 之外,我們也將推出多個 Dexcom ONE 的上市計畫,兩者都為我們帶來很好的營收與成長機會。而我們的營運運作得非常有效率且順暢。祝各位有美好的一天,並感謝參與本次電話會議。
Operator
Operator
And 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。您現在可以斷線。