該公司通過專注於提高所有業務的績效來推動增長。重點介紹了公司正在取得強勁進展並有望在中短期內實現增長的一些業務。該公司對 Affera 的收購為其贏得心臟消融市場份額所需的廣度和差異化提供了條件。該公司預計將在本季度完成 Affera pivotal 的註冊,並相信完全集成的系統將是同類產品中第一個提供獨特導管的系統,該導管可以執行高密度映射並在單個設備中提供脈衝場和射頻消融.
該公司預計第三季度將出現增長,比第二季度有所加速。這種增長是由產品發布、放寬比較和改善供應推動的。該公司還推動大幅削減開支,以抵消收入下降和通貨膨脹的影響。
該公司的業績受到匯率影響,每股收益下降 0.01 美元,即 80 個基點。美國收入增長 1%,而非美國發達市場增長 3%,新興市場增長 4%。由於脊柱業務的全國招標和其他業務的省級招標,中國下降了 9%。然而,不包括中國在內的新興市場增長了 15%。該公司的利潤率受到材料、直接人工、貨運和公用事業的通脹壓力的影響。該公司預計整個財政年度的連續改善。美敦力是一家提供醫療技術的公司。公司總部位於明尼蘇達州明尼阿波利斯市,成立於 1949 年。美敦力 (Medtronic) 是紐約證券交易所上市公司,股票代碼為 MDT。公司財政年度於 4 月 30 日結束。
FDA 一直在審查美敦力提交的帶有 Guardian 4 傳感器的 MiniMed 780G 系統。該公司希望該系統能夠獲准在美國使用。與此同時,該系統在 60 多個國家/地區可用,並正在推動美敦力 (Medtronic) 糖尿病業務的中期增長。該公司正在大力投資開發多種下一代胰島素輸送和傳感器技術。
上週,美敦力 (Medtronic) 獲得了 FDA IDE 對其 Hugo 手術機器人產品改進的批准。這使該公司能夠在日曆年年底開始美國泌尿外科臨床試驗。
網絡廣播的目的是提供公司在截至 2022 年 10 月 28 日的財政年度第二季度的最新業績。美敦力報告第二季度收入為 291 億美元,比去年同期增長 5%去年同一季度。該公司還為本財年的剩餘時間提供了指導。
在網絡直播期間,美敦力發表了許多可以被視為前瞻性陳述的陳述。該公司警告說,實際結果可能與任何前瞻性聲明中預測的結果不同。美敦力還表示,他們不承諾更新任何前瞻性聲明。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Ryan Weispfenning - VP of IR
Ryan Weispfenning - VP of IR
Good morning. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations, and welcome to snowing Minneapolis. I appreciate that you're joining us today for Medtronic's Fiscal Year 2023 Second Quarter Earnings Video Webcast.
早上好。我是副總裁兼美敦力投資者關係主管 Ryan Weispfenning,歡迎來到下雪的明尼阿波利斯。感謝您今天加入我們觀看美敦力 2023 財年第二季度收益視頻網絡直播。
Before we go inside to hear our prepared remarks, I'll share a few details about today's webcast. Joining me are Geoff Martha, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide comments on the results of our second quarter, which ended on October 28, 2022. And as well as our outlook for the remainder of the fiscal year. After our prepared remarks, the executive VPs for each of our 4 segments will join us, and we'll take questions from the sell-side analysts that cover the company. Today's program should last about an hour.
在我們進去聽取準備好的發言之前,我將分享有關今天網絡廣播的一些細節。和我一起的是美敦力董事長兼首席執行官 Geoff Martha;和美敦力首席財務官 Karen Parkhill。 Geoff 和 Karen 將對截至 2022 年 10 月 28 日的第二季度業績發表評論。以及我們對本財年剩餘時間的展望。在我們準備好的評論之後,我們 4 個部門中每個部門的執行副總裁將加入我們,我們將回答涵蓋公司的賣方分析師的問題。今天的節目應該持續一個小時左右。
Earlier this morning, we issued a press release containing our financial statements and divisional and geographic revenue summaries. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com.
今天早上早些時候,我們發布了一份新聞稿,其中包含我們的財務報表以及部門和地區收入摘要。我們還發布了一份收益演示文稿,其中提供了有關我們業績的更多詳細信息。可以在我們的收益新聞稿或我們的網站 investorrelations.medtronic.com 上訪問該演示文稿。
During today's program, many of the statements we make may be considered forward-looking statements, and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward-looking statement.
在今天的節目中,我們所做的許多陳述可能被視為前瞻性陳述,實際結果可能與任何前瞻性陳述中預測的結果存在重大差異。有關可能導致實際結果不同的因素的更多信息包含在我們的定期報告和我們向美國證券交易委員會提交的其他文件中,我們不承諾更新任何前瞻性聲明。
Unless we say otherwise, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign currency and revenue from our Q1 acquisition of Intersect ENT.
除非我們另有說明,否則所有比較都是按年比較,收入比較是在有機基礎上進行的,這不包括我們第一季度收購 Intersect ENT 的外彙和收入的影響。
Reference to sequential revenue changes compared to the first quarter of fiscal '23 and are made on an as-reported basis and all references to share gains or losses refer to revenue share in the third calendar quarter of 2022, compared to the third calendar quarter of 2021, unless otherwise stated.
參考與 23 財年第一季度相比的連續收入變化,並在報告的基礎上進行,所有提及份額損益均指 2022 年第三季度的收入份額,與 2022 年第三季度相比2021 年,除非另有說明。
Reconciliations of all non-GAAP financial measures can be found on our earnings press release or on our website at investorrelations.medtronic.com.
所有非 GAAP 財務指標的對賬可在我們的收益新聞稿或我們的網站 investorrelations.medtronic.com 上找到。
And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year. With that, let's head into the studio and hear about the quarter.
最後,我們的 EPS 指引不包括本財年將報告為非 GAAP 收益調整的任何費用或收益。有了這個,讓我們進入演播室,聽聽這個季度的情況。
(presentation)
(介紹)
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Hello, everyone, and thank you for joining us today as we discuss our Q2 results and outlook. Our Q2 organic constant currency revenue growth of 2.2% came in about 1 point below expectations due to a slower-than-expected recovery in both procedure volumes in certain markets and in our supply chain. In terms of reported revenue, the continued strength of the dollar over the course of the quarter drove over half the difference to expectations.
大家好,感謝您今天加入我們討論我們的第二季度業績和展望。由於某些市場和我們供應鏈的程序量恢復慢於預期,我們第二季度的有機恆定貨幣收入增長 2.2%,比預期低約 1 個百分點。就報告的收入而言,美元在本季度的持續走強導致與預期的差距超過一半。
Now despite the top line results, we were able to control expenses and deliver EPS at the high end of our guidance range. We also issued guidance for the back half of our fiscal year this morning. We expect continued acceleration in organic revenue growth in the second half, although less than previously anticipated, and this partially flows through to EPS. Now this is something that I don't take lightly, delivering on our expectations is important to building and maintaining trust and credibility with you.
現在,儘管取得了最高業績,但我們能夠控制費用並在我們的指導範圍的高端交付每股收益。今天上午,我們還發布了本財年下半年的指引。我們預計下半年有機收入增長將繼續加速,儘管低於此前預期,這部分影響到每股收益。現在這是我不能掉以輕心的事情,實現我們的期望對於建立和維持與您的信任和信譽非常重要。
Karen will walk you through the details, but some of our markets and some of our supply constraints recovered more slowly than we expected in the quarter, and that, along with incremental China volume-based procurements, led us to reduce our expectations. While the current operating environment remains challenging, we had strong growth in several businesses in geographies, where our strategy, our operating model and execution are yielding solid results.
Karen 將向您介紹細節,但我們的一些市場和一些供應限制的恢復速度比我們在本季度的預期要慢,而且隨著中國基於數量的採購增加,導致我們降低了預期。雖然當前的運營環境仍然充滿挑戰,但我們在多個地區的業務增長強勁,我們的戰略、運營模式和執行正在產生穩固的成果。
We have near-term product catalysts in our pipeline. We are decisively allocating capital internally and selectively making focused acquisitions. We're making improvements to the operational health of the company, and we're streamlining the company's structure and taking cost out. All of this gives us confidence that we're on the path to creating durable growth and shareholder value.
我們的管道中有近期產品催化劑。我們果斷地在內部配置資本,並有選擇地進行有針對性的收購。我們正在改善公司的運營健康狀況,我們正在精簡公司結構並削減成本。所有這一切讓我們相信,我們正在創造持久增長和股東價值的道路上。
Now diving deeper into our Q2 results. For reported revenue, as I said earlier, currency drove over half the miss to consensus. Organically, the miss was primarily split evenly between 2 challenges. One, procedure volumes in some markets have been slower to return to normal levels. And two, some of our supply challenges have persisted longer than we anticipated.
現在深入研究我們的第二季度結果。對於報告的收入,正如我之前所說,貨幣導致超過一半的未達到共識。有機地,未命中主要在 2 個挑戰之間平分。第一,一些市場的手術量恢復正常水平的速度較慢。第二,我們的一些供應挑戰持續的時間比我們預期的要長。
With regard to procedural volumes, in addition to an incremental China VBP, we are still seeing lower volumes in elective coronary PCI, GI procedures, TAVR, spinal cord stim and some less emergent surgical procedures. The slower-than-anticipated recovery in procedural volumes primarily occurred in developed markets as health care systems continue to work through staffing and other challenges.
關於手術量,除了增加的中國 VBP 外,我們仍然看到擇期冠狀動脈 PCI、胃腸道手術、TAVR、脊髓刺激和一些不太緊急的外科手術的手術量較低。由於醫療保健系統在人員配置和其他挑戰中繼續運作,因此程序量的恢復慢於預期主要發生在發達市場。
Now with regard to supply, we've made meaningful recovery and many of the most acute issues are now behind us, including the acute packaging issues, which we highlighted last quarter. But some of the improvements did come later than we expected in Q2, and as a result, we missed cases in businesses like surgical innovations and it has delayed our expected momentum.
現在關於供應,我們已經取得了有意義的複蘇,許多最嚴重的問題現在已經過去了,包括我們上個季度強調的嚴重包裝問題。但一些改進確實晚於我們在第二季度的預期,因此,我們錯過了手術創新等業務的案例,這推遲了我們預期的勢頭。
Now focusing beyond challenges impacting our markets and product availability, we have a number of businesses where our strategy and execution are yielding results. Recall that we moved to the new operating model 2 years ago, we created highly focused, accountable and empowered operating units that can move with greater speed and decisiveness. And today, we're clearly seeing the benefit of this model across many of our businesses.
現在,除了影響我們的市場和產品可用性的挑戰之外,我們還有許多業務,我們的戰略和執行正在產生成果。回想一下 2 年前我們轉向新的運營模式,我們創建了高度專注、負責和授權的運營部門,這些部門可以更快、更果斷地行動。今天,我們清楚地看到這種模式在我們許多業務中的好處。
Starting with cranial and spinal technologies. CST grew 5%, and this is despite a large negative impact from China VBP. In fact, our U.S. Core Spine business grew 15%. Additionally, this quarter, we launched our spine technology ecosystem, which we call Aible at the NASS conference. From planning to our best-in-class implants, to navigation and robotic assistance, to interoperative imaging and surgical tools up to and including patient follow-up, Aible brings spinal surgery together in one seamless and connected platform.
從顱骨和脊柱技術開始。 CST 增長了 5%,儘管受到了中國 VBP 的巨大負面影響。事實上,我們的美國核心脊柱業務增長了 15%。此外,本季度,我們在 NASS 會議上推出了我們稱之為 Aible 的 spine 技術生態系統。從規劃到我們一流的植入物,再到導航和機器人輔助,再到互操作成像和手術工具,直至並包括患者隨訪,Aible 將脊柱手術整合到一個無縫連接的平台中。
And another highlight was our Structural Heart business, where our TAVR business grew 15% globally, including 17% in the United States. The launch of our Evolut FX valve drove 18% sequential revenue growth in our U.S. TAVR business, despite being at full market launch for only the last month of the quarter. So we expect Evolut FX to drive momentum for us over the coming quarters.
另一個亮點是我們的結構性心臟業務,我們的 TAVR 業務在全球增長了 15%,其中在美國增長了 17%。我們的 Evolut FX 閥的推出推動了我們美國 TAVR 業務收入連續增長 18%,儘管僅在本季度的最後一個月才全面上市。因此,我們預計 Evolut FX 將在未來幾個季度為我們帶來動力。
Our Cardiac Rhythm Management business continues to execute and win share with 4% growth in this quarter. Within CRM, our pacing business grew 6%, well above the market, with 18% growth of our micro family of leadless pacemakers. And we're looking forward to the commercial introduction of our AURORA EV-ICD in the back half of this fiscal year.
我們的心律管理業務繼續執行並贏得市場份額,本季度增長 4%。在 CRM 中,我們的起搏器業務增長了 6%,遠高於市場,我們的微型無引線起搏器系列增長了 18%。我們期待在本財年下半年將 AURORA EV-ICD 商業化。
So while we have businesses where the changes we've made over the past couple of years are clearly having a positive impact, we're also focused on ensuring these efforts translate into improved performance in all of our businesses. It's worth highlighting a few businesses where we are making strong progress to drive future growth over the near to midterm and some of that already have immediate momentum.
因此,雖然我們的業務在過去幾年中所做的改變顯然產生了積極影響,但我們也專注於確保這些努力轉化為我們所有業務的改進績效。值得強調的是,我們在近期和中期推動未來增長方面取得了長足進展的一些業務,其中一些業務已經有了直接的勢頭。
Let's take cardiac ablation solutions, a business that we expect to be a strong future growth driver. Pulsed field ablation represents a large market opportunity and we're looking forward to seeing our PULSED AF pivotal trial results in the first half of the next calendar year, putting us on the path to be one of the first companies with the PFA catheter in the U.S. market, which we think is underappreciated. This is a meaningful growth opportunity for Medtronic in the next 18 to 24 months.
讓我們以心臟消融解決方案為例,我們預計該業務將成為未來強勁的增長動力。脈衝場消融代表著巨大的市場機會,我們期待在下個日曆年上半年看到我們的 PULSED AF 關鍵試驗結果,使我們成為首批在該領域擁有 PFA 導管的公司之一美國市場,我們認為它被低估了。這對美敦力在未來 18 至 24 個月內是一個有意義的增長機會。
And as you know, we closed our acquisition of Affera in August and Affera's differentiated mapping and navigation system gives us the breadth and differentiation that we need to win share in cardiac ablation. And we expect to complete enrollment this quarter in the pivotal. This fully integrated system will be the first of its kind to offer a unique catheter that can perform high-density mapping and deliver both pulse field and radiofrequency ablation in a single device.
如您所知,我們於 8 月完成了對 Affera 的收購,Affera 的差異化映射和導航系統為我們提供了贏得心臟消融市場份額所需的廣度和差異化。我們預計將在本季度完成註冊。這種完全集成的系統將是同類產品中第一個提供獨特導管的系統,該導管可以執行高密度映射並在單個設備中提供脈衝場和射頻消融。
Now in diabetes, we remain focused on resolving our warning letter. We've now completed 100% of our warning letter commitments and have informed the FDA that we're ready for reinspection. We also remain in active review with the FDA on our submission of the MiniMed 780G system with the Guardian 4 sensor. And outside the U.S., we continue to receive positive customer feedback on the performance of the 780G, which is now available in over 60 countries.
現在在糖尿病中,我們仍然專注於解決我們的警告信。我們現在已經完成了 100% 的警告信承諾,並已通知 FDA 我們已準備好接受重新檢查。我們還與 FDA 就我們提交的帶有 Guardian 4 傳感器的 MiniMed 780G 系統進行積極審查。在美國以外,我們繼續收到客戶對 780G 性能的積極反饋,該產品現已在 60 多個國家/地區上市。
In Q2, 780G drove mid-teens growth for our Diabetes business in international markets. And across Diabetes, we're investing heavily in the development of multiple next-generation insulin delivery and sensor technologies, and we remain focused on restoring strong growth to this important franchise over the coming years.
在第二季度,780G 推動了我們在國際市場的糖尿病業務實現了十幾歲的增長。在整個糖尿病領域,我們正在大力投資開發多種下一代胰島素輸送和傳感器技術,並且我們將繼續專注於在未來幾年恢復這一重要特許經營的強勁增長。
Turning to our Hugo surgical robot. Now I'm sure we're going to get into this in Q&A, but we saw a lot of positive momentum this quarter as we scale manufacturing production, expand regulatory approvals and ramp installations. In addition, we just received FDA IDE approval last week on our product enhancements. Now this allows us to start our U.S. urology clinical trial by the end of the calendar year and is a catalyst for continued progress with our international sales.
轉向我們的 Hugo 手術機器人。現在我確定我們將在問答中討論這個問題,但隨著我們擴大製造生產規模、擴大監管批准和斜坡安裝,本季度我們看到了很多積極的勢頭。此外,上週我們的產品增強功能剛剛獲得 FDA IDE 批准。現在,這使我們能夠在日曆年年底開始我們的美國泌尿外科臨床試驗,並且是我們國際銷售持續取得進展的催化劑。
Now before I talk about our capital allocation and portfolio management, let me share my thoughts on the Ardian opportunity. Despite the impact we believe COVID and medication changes had on the ambulatory endpoint in ON MED, the totality of the data is compelling. The large drop in office blood pressure in the Ardian arm was impressive, and it was consistent with what we've seen in our other trials. Importantly, the current standard of care for reducing blood pressure, it just isn't working, which was evident in the long-term SPRINT trial results published just last month in JAMA Cardiology.
現在,在我談論我們的資本配置和投資組合管理之前,讓我分享一下我對 Ardian 機會的看法。儘管我們認為 COVID 和藥物變化對 ON MED 的門診終點產生了影響,但總體數據還是令人信服的。 Ardian 手臂的辦公室血壓大幅下降令人印象深刻,這與我們在其他試驗中看到的情況一致。重要的是,目前降低血壓的護理標準根本不起作用,這一點在上個月發表在《美國醫學會心髒病學雜誌》(JAMA Cardiology) 上的長期 SPRINT 試驗結果中很明顯。
Patients don't seem to stay on multidrug therapy for long periods of time and eventually just stop taking their medications. And that's the advantage of Ardian, it's always on. We've demonstrated that our Ardian procedure, it's safe, it's effective, and it's durable. Physicians are excited and Ardian is preferred by patients. Now we've submitted our PMA to the FDA, and we're looking forward to working with governments and payers in the U.S. and around the world who are searching for improvements to control high blood pressure and avoid the costly and devastating consequences of this disease.
患者似乎不會長時間接受多種藥物治療,最終只是停止服藥。這就是 Ardian 的優勢,它始終在線。我們已經證明我們的 Ardian 程序安全、有效且持久。醫生很興奮,Ardian 受到患者的青睞。現在我們已經向 FDA 提交了 PMA,我們期待與美國和世界各地的政府和付款人合作,他們正在尋求改進以控制高血壓並避免這種疾病的代價高昂和破壞性後果.
In addition to advancing our pipeline, we're focused on decisively allocating capital and streamlining the company to deliver durable growth. We're freeing up resources to invest more in R&D, feeding our fast-growing businesses in areas where we can see the strongest returns. Cardiac ablation solutions and Diabetes are two clear examples of this.
除了推進我們的管道外,我們還專注於果斷地分配資本和精簡公司以實現持久增長。我們正在釋放資源以更多地投資於研發,在我們可以看到最高回報的領域為我們快速發展的業務提供支持。心臟消融解決方案和糖尿病就是這方面的兩個明顯例子。
We're also making moves with our portfolio to focus our company and our capital on opportunities that are better aligned with our long-term growth acceleration strategies. Over the past two quarters, we've announced our intent to separate three businesses, that we believe will thrive outside the company. With our Renal Care Solutions business, we're progressing on the separation, forming a new kidney health technology company together with DaVita.
我們還對我們的投資組合採取行動,將我們的公司和我們的資本集中在更符合我們長期增長加速戰略的機會上。在過去的兩個季度中,我們已經宣布打算拆分三項業務,我們相信這三項業務將在公司之外蓬勃發展。通過我們的腎臟護理解決方案業務,我們正在推進分離,與 DaVita 一起組建一家新的腎臟健康技術公司。
We continue to expect this transaction to close in calendar 2023. And last month, we announced our intention to separate our combined patient monitoring and respiratory interventions business. We remain focused on active portfolio management, evaluating both potential additions and subtractions to further accelerate our growth and create value for our shareholders.
我們繼續預計這筆交易將在 2023 年完成。上個月,我們宣布打算將我們的綜合患者監測和呼吸乾預業務分開。我們仍然專注於積極的投資組合管理,評估潛在的增減,以進一步加速我們的增長並為我們的股東創造價值。
Now with that, I'll turn it over to Karen to discuss our second quarter financial performance and our guidance. Karen?
現在,我將把它交給 Karen 來討論我們第二季度的財務業績和我們的指導。卡倫?
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Thank you, Geoff. Our second quarter organic revenue increased 2.2%, up significantly from Q1, but below our guidance range, given the challenges Geoff mentioned. Yet with a focus on expenses, our adjusted EPS of $1.30 landed at the upper end of our guidance range. Currency had a significantly unfavorable impact of 5.8% on our reported revenue growth.
謝謝你,傑夫。考慮到 Geoff 提到的挑戰,我們第二季度的有機收入增長了 2.2%,較第一季度大幅增長,但低於我們的指導範圍。然而,在關注支出的情況下,我們調整後的 EPS 為 1.30 美元,處於我們指導範圍的上限。貨幣對我們報告的收入增長產生了 5.8% 的顯著不利影響。
Our FX hedges mitigated that impact on the bottom line with EPS down only $0.01 or 80 basis points from currency. Looking at our results from a geographic perspective, our U.S. revenue grew 1%. Our non-U.S. developed increased 3%, and emerging markets grew 4%. Our emerging markets growth continued to be affected by China, which declined 9%, given the impact of a national tender in our spine business and several provincial tenders in certain other businesses.
我們的外匯對沖減輕了對利潤的影響,每股收益僅比匯率低 0.01 美元或 80 個基點。從地理角度來看我們的結果,我們在美國的收入增長了 1%。我們的非美國發達國家增長了 3%,新興市場增長了 4%。我們的新興市場增長繼續受到中國的影響,中國下降了 9%,這是由於我們脊柱業務的全國招標和某些其他業務的幾個省級招標的影響。
However, we continue to see strong double-digit growth in our other markets, including mid-20s growth in Eastern Europe and mid-teens growth in Latin America. In fact, excluding China, our emerging markets grew 15%.
然而,我們繼續看到我們其他市場的強勁兩位數增長,包括東歐 20 多歲的增長和拉丁美洲的 15 多歲中期增長。事實上,不包括中國在內,我們的新興市場增長了 15%。
Turning to our margins. Our adjusted gross margin of 67.6% declined 120 basis points from inflationary pressures in materials, direct labor, freight and utilities.
轉向我們的利潤率。由於材料、直接人工、貨運和公用事業的通脹壓力,我們調整後的毛利率為 67.6%,下降了 120 個基點。
We expect these inflationary pressures to continue and to impact the back half of this fiscal year, more than what we experienced in the first half. Our adjusted operating margin of 26.6% declined 40 basis points, including a 120 basis point benefit from our currency hedging program. Compared to the first quarter, our operating margin improved 270 basis points, given accelerated revenue growth.
我們預計這些通脹壓力將持續下去,並影響本財年的下半年,超過上半年的影響。我們調整後的營業利潤率為 26.6%,下降了 40 個基點,其中包括我們的貨幣對沖計劃帶來的 120 個基點收益。與第一季度相比,由於收入加速增長,我們的營業利潤率提高了 270 個基點。
We expect sequential improvement throughout the fiscal year. We continue to maintain a strong balance sheet. I would note that the vast majority of our debt is fixed at low rates as we move into a higher rate environment.
我們預計整個財政年度的連續改善。我們繼續保持強勁的資產負債表。我要指出的是,隨著我們進入更高利率的環境,我們的絕大多數債務都固定在低利率。
Regarding our capital allocation, we continue to balance investing for the future with returning capital to shareholders, and we remain committed to our dividend and to returning a minimum of 50% of our free cash flow to our shareholders.
關於我們的資本配置,我們繼續在未來投資與向股東返還資本之間取得平衡,我們仍然致力於派發股息,並將至少 50% 的自由現金流返還給股東。
Now turning to our guidance. Today, we set our second half revenue guidance at 3.5% to 4% organic, which excludes currency movement and revenue from our Intersect ENT acquisition. If recent exchange rates hold, foreign currency would now have a negative impact on our back half revenue of $930 million to $1.03 billion.
現在轉向我們的指導。今天,我們將下半年收入目標設定為 3.5% 至 4% 的有機增長,其中不包括我們收購 Intersect ENT 的貨幣變動和收入。如果最近的匯率保持不變,外匯現在會對我們的後半部分收入產生負面影響,從 9.3 億美元到 10.3 億美元。
Our back half guidance translates into a reduction of our annual guidance, driven by a slower pace of market and supply recovery. On market, we are expecting incremental provincial tenders in China, particularly in stapling and cardiac ablation. And Geoff referenced earlier that some procedure volumes in the second quarter didn't recover as quickly as we were expecting. So at this point, we are assuming no incremental improvement in the back half.
由於市場和供應復甦步伐放緩,我們的後半部分指導轉化為我們年度指導的減少。在市場上,我們預計中國會增加省級招標,特別是在吻合和心臟消融方面。傑夫早些時候提到,第二季度的一些手術量沒有我們預期的那麼快恢復。所以在這一點上,我們假設後半部分沒有增量改進。
On supply, while we have had a meaningful recovery, it came later than anticipated, particularly in SI and cardiac diagnostics. And that simply delays our pace of recovery ahead.
在供應方面,雖然我們取得了有意義的複蘇,但比預期的要晚,特別是在 SI 和心臟診斷方面。這只會延遲我們未來的複蘇步伐。
By segment in the back half, the majority of the reduction is in our medical surgical portfolio, which we now expect to be flat to up 0.5%. We expect cardiovascular to grow 5.25% to 5.75%, neuroscience to grow 6% to 6.5% and diabetes to decline in the low single digits, all on an organic basis.
按後半部分劃分,減少的大部分是我們的醫療外科產品組合,我們現在預計該產品組合將持平至增長 0.5%。我們預計心血管疾病將增長 5.25% 至 5.75%,神經科學將增長 6% 至 6.5%,糖尿病將以較低的個位數下降,所有這些都是有機的。
Our total company revenue guidance does assume continued revenue growth acceleration, which we saw in each month of the second quarter. We expect the third quarter growth rate to be better than the second and the fourth quarter better than the third. We will have easing comparisons in ventilators, improving supply in certain businesses like cardiac diagnostics and SI and the benefit from product launches, like Evolut FX and EV ICD.
我們的公司總收入指引確實假設收入持續加速增長,我們在第二季度的每個月都看到了這一點。我們預計三季度增速好於二季度,四季度好於三季度。我們將放寬對呼吸機的比較,改善心臟診斷和 SI 等某些業務的供應,並從 Evolut FX 和 EV ICD 等產品發布中獲益。
In the third quarter, we expect organic revenue growth in the range of 2.5% to 3%, an acceleration from the second quarter. And assuming recent exchange rates hold, the third quarter would have a currency headwind between $460 million and $510 million.
第三季度,我們預計有機收入增長將在 2.5% 至 3% 之間,較第二季度有所加快。假設近期匯率保持不變,第三季度的貨幣逆風將在 4.6 億美元至 5.1 億美元之間。
By segment and on an organic basis, we expect Medical Surgical to be down 2% to 2.5%, an improvement from the second quarter, given lesser event headwinds and the impact of the flu season. Cardiovascular to grow 4.75% to 5.25% on the continued rollout of Evolut FX and LINQ II. Neuroscience to grow 5.75% to 6.25%, improving from the prior quarter with less VBP impact in spine and diabetes to decline in the low single digits.
按細分市場和有機地劃分,我們預計醫療外科業務將下降 2% 至 2.5%,較第二季度有所改善,因為事件不利因素和流感季節的影響較小。隨著 Evolut FX 和 LINQ II 的持續推出,心血管疾病將增長 4.75% 至 5.25%。神經科學增長 5.75% 至 6.25%,較上一季度有所改善,脊柱和糖尿病的 VBP 影響較小,以低個位數下降。
On the bottom line, we are driving significant expense reduction throughout the company to help offset the lower revenue and continued inflation impact and now expect fiscal '23 non-GAAP diluted EPS in the range of $5.25 to $5.30. That range includes an unfavorable impact of currency of approximately $0.18 at recent rates.
最重要的是,我們正在推動整個公司大幅削減開支,以幫助抵消較低的收入和持續的通貨膨脹影響,現在預計 23 財年非 GAAP 攤薄每股收益在 5.25 美元至 5.30 美元之間。該範圍包括按近期匯率計算的大約 0.18 美元的貨幣不利影響。
For the third quarter, we expect non-GAAP diluted EPS to be in the range of $1.25 to $1.27, including an FX headwind of about $0.05 at recent rates. Amidst the macro environmental headwinds we face from inflation, China VBP, softer procedure volumes in certain markets and currency, we are laser-focused on driving operational and expense efficiencies. We are also committed to invest appropriately for the long term, allocating capital to our most promising growth drivers and executing tuck-in acquisitions, design to reach more patients and create value for our shareholders.
對於第三季度,我們預計非 GAAP 稀釋後每股收益將在 1.25 美元至 1.27 美元之間,包括按近期匯率計算的約 0.05 美元的外匯逆風。在我們面臨通貨膨脹、中國 VBP、某些市場和貨幣的疲軟程序量等宏觀環境逆風的情況下,我們專注於提高運營和費用效率。我們還致力於進行適當的長期投資,將資本分配給我們最有前途的增長動力,並進行收購,旨在覆蓋更多患者並為我們的股東創造價值。
As we approach Thanksgiving, I want to share my gratitude to our employees who have been committed, particularly during these challenging times to deliver on our mission, to alleviate pain, restore health and extend life for millions of people around the world.
在感恩節臨近之際,我想對我們的員工表示感謝,尤其是在這個充滿挑戰的時期,他們致力於履行我們的使命,為全球數百萬人減輕痛苦、恢復健康並延長生命。
Back to you, Geoff.
回到你身邊,傑夫。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Thank you, Karen. Now before we open the lines for questions, I want you to know that our growth rate and our consistency are not where we want them to be. That's why I shared with you our aggressive agenda to transform this company 2 years ago when I became CEO. We embarked on a plan of implementing a new operating model, eliminating the bureaucracy of our groups and forming more nimble operating units, while at the same time, learning to leverage our scale.
謝謝你,凱倫。現在,在我們開始提問之前,我想讓你知道我們的增長率和一致性不是我們想要的。這就是為什麼我在 2 年前成為 CEO 時與大家分享了我們改造這家公司的雄心勃勃的議程。我們著手實施新的運營模式計劃,消除我們集團的官僚作風,組建更靈活的運營單位,同時學習利用我們的規模。
We set in motion a new performance-driven culture, and we changed our incentive plans to reward new behaviors and performance. We brought in new leaders to inject new ways of thinking in the organization, and we implemented new capital allocation and portfolio management processes. Now these changes take time, and we face setbacks along the way that have slowed us down. Some are environmental like COVID recovery rates, raw material shortfalls and Chinese procurement policy, while other setbacks are of our own doing, like our quality and operational challenges and the pace of improvement we anticipated.
我們啟動了一種新的以績效為導向的文化,我們改變了激勵計劃以獎勵新的行為和績效。我們引入了新的領導者,為組織注入新的思維方式,並實施了新的資本分配和投資組合管理流程。現在,這些變化需要時間,而且我們在前進的道路上遇到了阻礙我們前進的挫折。有些是環境問題,例如 COVID 回收率、原材料短缺和中國採購政策,而其他挫折是我們自己造成的,例如我們的質量和運營挑戰以及我們預期的改進速度。
Look, I know we have more work to do here, but we understand the root causes that led to the years of underperformance from this company. And our aggressive transformation agenda is designed to fix these issues. I know we will get this right, choosing the right markets, being more efficient and productive with our resources, empowering businesses and increasing accountability, improving our quality, our manufacturing and our supply chain and turning our size and scale into an advantage.
看,我知道我們在這裡還有更多工作要做,但我們了解導致這家公司多年來表現不佳的根本原因。我們積極的轉型議程旨在解決這些問題。我知道我們會做到這一點,選擇正確的市場,利用我們的資源提高效率和生產力,賦予企業權力和加強問責制,提高我們的質量、我們的製造和我們的供應鏈,並將我們的規模和規模轉化為優勢。
And I know we are on the right path. The progress we've made so far gives me that confidence. We have experienced leaders, a compelling pipeline and positions of strength in some of the most attractive MedTech markets, which address significant unmet needs for patients.
我知道我們走在正確的道路上。我們迄今取得的進展給了我這種信心。我們在一些最具吸引力的 MedTech 市場擁有經驗豐富的領導者、令人信服的管道和優勢地位,可滿足患者未滿足的重大需求。
We will execute on our plan to deliver durable growth that we began 2 years ago. And as we do, we will create tremendous value for all of our stakeholders.
我們將執行 2 年前開始的實現持久增長的計劃。當我們這樣做時,我們將為所有利益相關者創造巨大的價值。
So now let's move to Q&A. We're going to try to get to as many analysts as possible, so we ask you to limit yourself to just one question and only if needed, a related follow-up. If you have additional questions, you can reach out to Ryan and the Investor Relations team after the call.
現在讓我們進入問答環節。我們將嘗試接觸盡可能多的分析師,因此我們要求您將自己限制在一個問題上,並且僅在需要時進行相關的跟進。如果您還有其他問題,可以在通話後聯繫 Ryan 和投資者關係團隊。
With that, Brad, can you please give the instructions for asking a question?
有了這個,布拉德,你能給出提問的說明嗎?
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
(Operator Instructions) For today's session, Geoff, Karen and Ryan are joined by Que Dallara, EVP and President of the Diabetes operating unit; Sean Salmon, EVP and President of the Cardiovascular portfolio; Brett Wall, EVP and President of the Neuroscience portfolio; and Bob White, EVP and President of the Medical Surgical portfolio. (Operator Instructions) We'll take the first question from Robbie Marcus, JPMorgan. Robbie, please go ahead.
(操作員說明)對於今天的會議,Geoff、Karen 和 Ryan 與執行副總裁兼糖尿病業務部門總裁 Que Dallara 一起參加;執行副總裁兼心血管產品組合總裁 Sean Salmon;執行副總裁兼神經科學產品組合總裁 Brett Wall;執行副總裁兼醫療外科產品組合總裁 Bob White。 (操作員說明)我們將從摩根大通的 Robbie Marcus 那裡回答第一個問題。羅比,請繼續。
Robert Justin Marcus - Analyst
Robert Justin Marcus - Analyst
Great. Maybe I'll ask in 2 part or upfront. The miss in the top line in the quarter, the guide down was pretty significant for the second half of the year. You point to slowing procedure growth or not a recovery they're hoping for yet it's different from what we're hearing from most of your peers in terms of stabilizing volume growth.
偉大的。也許我會分兩部分或預先詢問。本季度未達到頂線,下半年的指導下降非常重要。你指的是放慢程序增長或不是他們希望的複蘇,但在穩定數量增長方面,這與我們從大多數同行那裡聽到的不同。
So I was hoping you could spend more time. Walk us through what Medtronic is seeing and maybe why it's a little different relative to peers in terms of the recovery and the stabilization in volumes -- and then as we think out to next year and fiscal '24, can you give some thoughts on the last call about FX and how we should be thinking about growth for next year. Any updates to that growth? And does it change with the updated second half guidance range?
所以我希望你能多花點時間。向我們介紹美敦力(Medtronic)所看到的情況,以及為什麼它在復蘇和銷量穩定方面與同行略有不同——然後當我們考慮明年和 24 財年時,您能否就關於外彙的最後一次電話會議以及我們應該如何考慮明年的增長。該增長有任何更新嗎?它會隨著更新的下半年指導範圍而改變嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Okay. Thanks, Robbie. Okay. I saw three parts there. I'm going to ask Karen to chime in to help me here on this one, but provide some details. But on the miss, like we said in the commentary, the primary issue is the pace of the recovery and there's the two buckets. There's the pace of our supply recovery, which we did make quite a bit of progress there and they got over the most acute issues that were plaguing us, but happened a little -- it happened late in the quarter and pushed out our momentum, which gets to the second part of your question, which is the effects the guide down.
好的。謝謝,羅比。好的。我在那裡看到了三個部分。我將請 Karen 插話幫助我解決這個問題,但請提供一些詳細信息。但是關於失誤,就像我們在評論中所說的那樣,主要問題是恢復的速度,還有兩個桶。我們供應恢復的步伐,我們確實取得了相當大的進展,他們克服了困擾我們的最嚴重的問題,但發生了一點——它發生在本季度末,推動了我們的勢頭,這進入問題的第二部分,即影響指南。
The other bucket is part of your second question as well as on the markets. Many of our businesses are back, the majority of them are back to the pre-COVID level of their markets. But there are some that are not. And I'll let Karen walk through those and we were -- we just overstated what that market recovery would be, and we'll walk you through those and how those impact the second quarter -- the second half. Karen, do you want to...
另一個桶是你第二個問題的一部分,也是市場上的一部分。我們的許多企業都回來了,其中大部分都回到了 COVID 之前的市場水平。但也有一些不是。我會讓 Karen 介紹這些,我們只是誇大了市場復甦的情況,我們將向您介紹這些以及它們如何影響第二季度 - 下半年。凱倫,你想不想...
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Yes. Thanks, Geoff, and thanks, Robbie. So let me talk about it more broadly than your question to, Robbie because I know you asked a specific question on procedure growth. So I'll talk about that and a little bit more broadly. So just on those two buckets. First, on our markets. Some of our markets have not returned to normal growth levels and this does account for about -- for over half of the reduction in our second half guide.
是的。謝謝,傑夫,謝謝,羅比。因此,讓我談談它比你的問題更廣泛,羅比,因為我知道你問了一個關於程序增長的具體問題。因此,我將更廣泛地討論這一點。所以就在這兩個桶上。首先,在我們的市場上。我們的一些市場還沒有恢復到正常的增長水平,這確實佔了我們下半年指南減少的一半以上。
You talked about competitors. You've heard from some of our competitors about a slow recovery in the neuro market and the TAVR market. And we're also seeing a slow recovery in basic coronary PCIs and some general surgery procedures that we mentioned in the commentary. And because these markets have not accelerated as quickly as we had anticipated, we've decided to assume volumes in the back half remain at Q2 levels.
你談到了競爭對手。您從我們的一些競爭對手那裡聽說神經市場和 TAVR 市場復甦緩慢。我們還看到我們在評論中提到的基本冠狀動脈 PCI 和一些普通外科手術的恢復緩慢。而且由於這些市場沒有像我們預期的那樣快速增長,我們決定假設後半部分的交易量保持在第二季度的水平。
If those volumes improve in those markets, that would be upside. We also talked about related to markets that we're expecting additional provincial tenders in China. And those were ones that we believed would occur next fiscal year and are occurring sooner, particularly in stapling and cardiac ablation.
如果這些市場的銷量有所改善,那將是有利的。我們還談到了與市場相關的問題,我們期待在中國進行額外的省級招標。這些是我們認為會在下一個財政年度發生的,並且會發生得更快,特別是在吻合和心臟消融方面。
And then on the second bucket of supply that Geoff mentioned, we, obviously, did see meaningful improvement over the second quarter. But some of that happened late in the quarter, as we said, and that pushes out our assumptions for share recapture. For example, and particularly in SI, while we were short on supply, our competitor benefited. They stepped in to fill the shelves with our customers. We're under long-term contracts with those customers, so we will gain our share back. There's just a lag while the shelf inventory comes down.
然後在 Geoff 提到的第二桶供應中,我們顯然確實看到了第二季度的顯著改善。但正如我們所說,其中一些發生在本季度末,這推翻了我們對股票回購的假設。例如,特別是在 SI,當我們供應短缺時,我們的競爭對手卻從中受益。他們介入,用我們的顧客填滿貨架。我們與這些客戶簽訂了長期合同,因此我們將收回我們的份額。貨架庫存下降時會有一個滯後。
So hopefully, that gives you some context on our guide this morning. But just to summarize, in addition to our assumptions on market growth, we assume incremental contribution from products that we've recently launched and supply that has recently improved.
因此,希望這能為您提供有關今天早上我們指南的一些背景信息。但總而言之,除了我們對市場增長的假設之外,我們還假設我們最近推出的產品和最近改進的供應會增加貢獻。
On your question on FY'24, it's still early. We have 2 quarters to go, and we're at the beginning of our planning process. So we're not going to give FY'24 guidance on this call. But I will say a few things, including currency because that was your question. First, on the top line, you can see that we expect to exit the year with mid-single-digit growth, and that's a great place to start the following year.
關於你關於 FY'24 的問題,現在還為時過早。我們還有 2 個季度,我們正處於規劃過程的開始階段。因此,我們不會就此電話會議提供 FY'24 指導。但我會說一些事情,包括貨幣,因為那是你的問題。首先,在最重要的一點,你可以看到我們預計今年將以中個位數的增長結束,這是下一年開始的好地方。
Second, down the P&L, we're still in a challenging operating environment with inflation, interest rates and currency, as you mentioned. And on currency, we now estimate that to be a $0.36 headwind on the bottom line in FY'24. And that's, obviously, worse than the $0.18 that I mentioned for FY'23.
其次,正如您提到的,在損益表中,我們仍然處於通貨膨脹、利率和貨幣等具有挑戰性的經營環境中。在貨幣方面,我們現在估計 24 財年的利潤將出現 0.36 美元的逆風。顯然,這比我提到的 23 財年的 0.18 美元還差。
And third, we're purposely driving significant expense reduction given these headwinds and given our focus on continuing to drive long-term investments for the company. So we've got several puts and takes for next fiscal year, and we plan on giving you more on FY'24 as we move through the back half.
第三,鑑於這些不利因素,並且我們專注於繼續推動公司的長期投資,我們有意推動大幅削減開支。因此,我們在下一個財政年度有幾個看跌期權,我們計劃在下半年為您提供更多的 FY'24。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Travis Steed at Bank of America.
下一個問題來自美國銀行的 Travis Steed。
Travis Lee Steed - MD
Travis Lee Steed - MD
A little bit more color on FY'24 as it relates to China VBP. I don't know if there's any way to think about how much of the China VBP stuff hits in FY'23 versus FY'24, given some of the new ones like EP and even neuro? And then I did want a little bit more color on TAVR as well given the strong U.S. result there. Curious if you could kind of comment a little bit on the TAVR market and also share -- I don't know if you can say how much share you think you took this quarter in U.S. TAVR?
與中國 VBP 相關的 FY'24 有更多顏色。我不知道是否有任何方法可以考慮 23 財年與 24 財年中國 VBP 的內容有多少,考慮到一些新的東西,比如 EP 甚至神經?然後我確實希望在 TAVR 上有更多的顏色,同時考慮到美國在那裡的強勁結果。很好奇你是否可以對 TAVR 市場發表一些評論並分享 - 我不知道你是否可以說你認為你本季度在美國 TAVR 中佔據了多少份額?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes. So thanks for the question, Travis. On the -- why don't we start with the TAVR one because we -- the market didn't grow quite as much as we had hoped, but it still was a strong growth driver for us, and we did do well from a share perspective. And we have Sean maybe comment on that, and then we'll come back and help Karen talk about the VBP part of the question. Sean?
是的。謝謝你的問題,特拉維斯。在——為什麼我們不從 TAVR 開始,因為我們——市場的增長沒有我們希望的那麼多,但它仍然是我們強大的增長動力,我們從分享觀點。我們可能會讓 Sean 對此發表評論,然後我們會回來幫助 Karen 討論問題的 VBP 部分。肖恩?
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Yes. Travis, we think we took about a 0.5 point of share for that for the full quarter, and it was really driven by the late -- the last month of the quarter where we picked up some of that momentum in October with the launch of the Evolut FX we're in about 400 accounts of that so far. So we've got some room to run there for the back half of the year, but that is very strong.
是的。特拉維斯,我們認為我們在整個季度中獲得了大約 0.5 個百分點的份額,這實際上是由本季度的最後一個月推動的,我們在 10 月份推出了一些勢頭Evolut FX 到目前為止,我們有大約 400 個帳戶。所以我們在今年下半年有一些空間可以在那裡運行,但這非常強大。
I think the underlying market is still in the kind of high singles area. And I think that, that's really, as you know, just conspired against by the resource intensity that's required. You get this whole chain of events where you have to have a patient go through imaging prior to their eventual procedure, and there's a lot of handoffs along the way.
我認為底層市場仍然處於那種高單區域。我認為,正如你所知,這真的只是與所需的資源強度密謀。你會得到整個事件鏈,在這些事件中,你必須讓患者在最終手術之前進行成像,並且在此過程中有很多交接。
So those dynamics are continuing to play out around the world, but probably more in Europe and France and Germany than we see in other countries. And then we had a little bit of slowness on our own throughout -- through Japan. Japan had a flare of COVID the summer, which was difficult.
因此,這些動態在世界範圍內繼續發揮作用,但在歐洲、法國和德國可能比我們在其他國家看到的更多。然後我們在整個日本都有一點緩慢。日本在夏天爆發了 COVID 疫情,這很困難。
And we also had a problem where there was a sheet that we use for the procedure that we don't make that became unavailable because of supply challenges, and that led to some share loss in Japan. But overall, the TAVR momentum is really strong for us with FX launching, and we're excited about back half to get to a full release of that product into all the accounts.
我們還遇到了一個問題,即有一張我們用於我們未製作的程序的床單由於供應挑戰而變得不可用,這導致了日本的一些份額損失。但總的來說,隨著 FX 的推出,TAVR 的勢頭對我們來說真的很強勁,我們很高興後半段能夠將該產品全面發佈到所有賬戶中。
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
And on your China VBP question, Travis, about 15% to 20% of our back half guide down is due to the incremental China VBP being pulled forward from next year from our perspective from what we had assumed. China declined 9% in the second quarter. And that was because of an impact of VBP in spine.
關於你的中國 VBP 問題,特拉維斯,我們後半部分指導下調的大約 15% 到 20% 是由於從我們假設的角度來看,從明年開始增加中國 VBP。中國第二季度下降了 9%。那是因為 VBP 對脊柱的影響。
For the rest of this fiscal year, we don't expect China to be a material growth driver for us. And in fact, for the full year, we're expecting low single-digit declines in China. That said, as we look forward into FY'24, we'll continue to have some VBP, but I think the vast majority will be behind us, and China should be a contributor of growth again next fiscal year.
在本財年的剩餘時間內,我們預計中國不會成為我們的物質增長動力。事實上,對於全年,我們預計中國將出現低個位數的下滑。也就是說,當我們展望 24 財年時,我們將繼續有一些 VBP,但我認為絕大多數將落後於我們,中國應該會在下個財政年度再次成為增長的貢獻者。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Just a little bit more color on the VBP. I mean we had visibility to these national tenders, and we factored that in earlier in the year. But what we didn't have real good visibility to some of these provincial tenders that came out here in the last couple of months. And that's part of the change in the guidance. And to Karen's point, look, longer term, we still think China is a growth market, but it's not right now, and we factored that into our guidance.
VBP 上的顏色稍微多一點。我的意思是我們了解這些國家招標,我們在今年早些時候就考慮到了這一點。但是我們對過去幾個月在這裡舉行的一些省級招標並沒有真正的了解。這是指南變化的一部分。就凱倫的觀點而言,從長遠來看,我們仍然認為中國是一個增長市場,但現在不是,我們將其納入了我們的指導方針。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Vijay Kumar at Evercore ISI.
下一個問題來自 Evercore ISI 的 Vijay Kumar。
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
My first question was on the back half guidance. When you look at 2Q, second quarter organic slightly north of 2% and the back half guidance of 3.5% to 4%. How do you risk is that 3.5% to 4%? Can you give us a bridge of what gets easier? I think you had some easier wind comps, et cetera. And I think related to that, is this -- why is Medtronic confident that this is not a firm your share loss in surgical innovations?
我的第一個問題是關於後半部分的指導。當你看第二季度時,第二季度有機增長率略高於 2%,後半部分指導值為 3.5% 至 4%。 3.5% 到 4% 的風險如何?你能給我們一個更容易的橋樑嗎?我想你有一些更簡單的風譜,等等。我認為與此相關的是——為什麼美敦力相信這不是您在外科創新中的份額損失的堅定原因?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Okay. Thanks for the question, Vijay. Let me take the -- well, I'll take the share loss question first and then I'll get to the back half and maybe I have Karen talk to that one as well. But in SI or surgical innovations, this -- first of all, this is a contracted business with health systems and mainly us and our main competitor in that space.
好的。謝謝你的問題,維杰。讓我來——好吧,我會先回答份額損失的問題,然後我會講到後半部分,也許我也會讓 Karen 和那個人談談。但在 SI 或外科創新中,這——首先,這是與衛生系統的合同業務,主要是我們和我們在該領域的主要競爭對手。
And in the past, there have been circumstances when the shoe is on the other foot when our competitor had a recall -- and have had recalls. And we did the same thing where we got -- picked up some incremental revenue and some share because the two big competitors are make up the majority of what the hospitals are buying in the surgery space, but these hospitals do honor these contracts. There's a lot that goes into them and that revenue went back after the supply situation was resolved.
過去,當我們的競爭對手召回並且已經召回時,存在這種情況。我們做了同樣的事情——獲得了一些增量收入和一些份額,因為這兩個大競爭對手佔了醫院在手術領域購買的大部分,但這些醫院確實履行了這些合同。他們投入了很多,在供應情況得到解決後,收入又回來了。
And so that -- we've seen that over the years on multiple times. So these are contracted -- like I said, contracted business for us. And based on our dialogue, with the health systems, we're confident this is going to come back as our supply, which we mentioned. We did get past the most acute part of our supply issues in the Surgical Innovations business, was this packaging issue. It did come later in the quarter and slower momentum, but we do have momentum now, and you should see that business recover.
因此——多年來我們已經多次看到這一點。所以這些都是簽約的——就像我說的,為我們簽約的業務。根據我們與衛生系統的對話,我們有信心這將作為我們提到的供應回來。我們確實解決了外科創新業務中供應問題中最尖銳的部分,即包裝問題。它確實在本季度晚些時候出現並且勢頭放緩,但我們現在確實有勢頭,你應該會看到業務復甦。
On the back half, I'll ask Karen to...
在後半部分,我會請凱倫……
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Yes. Thanks, Vijay. When we look at our back half ramp, we have new products. We've got TAVR with Evolut FX that Sean has mentioned, was only in the market for a month in Q2. So we expect continued growth from that. We've got Hugo starting to ramp. We've got our Harmony valve returning to the market. We've also got our diabetic painful neuropathy opportunity that will be driving more in the back half. And we've got supply returning.
是的。謝謝,維杰。當我們查看我們的後半坡道時,我們有新產品。我們有肖恩提到的帶有 Evolut FX 的 TAVR,在第二季度僅上市一個月。因此,我們預計會繼續增長。我們已經讓 Hugo 開始上線了。我們的 Harmony 閥門已重返市場。我們也有我們的糖尿病疼痛性神經病變機會,這將在後半部分推動更多。我們已經恢復了供應。
We've got supply returning for our LINQ II product in our cardiac diagnostics and also better supply in SI and ICDs. And we've got reduced headwinds. Our sale events and aortic graphs are normalizing. So all of those things really lead to the back half ramp. Hopefully, that's helpful.
我們的心臟診斷中的 LINQ II 產品已經恢復供應,並且在 SI 和 ICD 中也有更好的供應。而且我們的逆風減少了。我們的銷售活動和主動脈圖正在正常化。所以所有這些事情真的導致後半坡道。希望這會有所幫助。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes. So I mean, beyond the supply returning, the back half, as Karen walked through a lot of it, is really powered by very tangible things beyond supply, product-related they're tangible and compelling.
是的。所以我的意思是,除了供應返回之外,後半部分,正如 Karen 經歷的那樣,實際上是由供應之外非常有形的東西提供動力的,與產品相關的它們是有形的和引人注目的。
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
And then maybe one related. I think in the past, Medtronic is thought about itself as a mid-single to your top line company in light of the these (inaudible), is that mid-single-digit LRP still intact? Does Medtronic lead to your supplement this growth with...
然後也許是一個相關的。我認為在過去,美敦力被認為是一家中等單價公司,鑑於這些(聽不清),中等個位數的 LRP 是否仍然完好無損?美敦力 (Medtronic) 是否會導致您通過……來補充這種增長?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
I didn't hear the very last part of it, does Medtronic -- but the answer to your question is yes. I mean, the mid-single-digit growth, we'll exit the year at mid-single digit. You see throughout this year, you're seeing the acceleration from the first quarter, which was the depth of our supply issues. We're really in a tough spot.
我沒有聽到它的最後一部分,美敦力確實如此——但你的問題的答案是肯定的。我的意思是,中等個位數的增長,我們將以中等個位數結束這一年。你看今年全年,你看到第一季度的加速,這是我們供應問題的深度。我們真的處境艱難。
We were down minus 4%. Then this past quarter, on an organic basis, up 2% and then Karen walked you through the back half guide. But we exited the year at mid-single digits, and we believe that's durable. Like I said, based on these product launches that are here now, so no -- immediate drivers.
我們下跌了-4%。然後在上個季度,在有機的基礎上,增長了 2%,然後 Karen 向您介紹了後半部分指南。但我們以中個位數結束了這一年,我們相信這是持久的。就像我說的,基於現在這裡的這些產品發布,所以沒有 - 直接驅動程序。
And then we -- Karen brought up a list of things that are already kind of tangible in the back half, but there's a number of other things that are still coming. The AURORA EV-ICD, PFA and an Afib and inceptive with ECAPs and our SCS business and then there's the whole diabetes discussion with those products coming on in the U.S. in the next year. And the Hugo ramp will go on for a while. So there's a number of things that keep us going. And so that's why we feel good about the mid-single digit.
然後我們——凱倫提出了一份清單,列出了後半部分已經有形的事情,但還有許多其他事情還在發生。 AURORA EV-ICD、PFA 和 Afib 對 ECAP 和我們的 SCS 業務產生了積極影響,然後與明年在美國推出的這些產品進行了整個糖尿病討論。雨果斜坡將持續一段時間。所以有很多事情讓我們繼續前進。這就是為什麼我們對中個位數感覺良好。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Larry Biegelsen at 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
Maybe on diabetes for Que. So Que just a multipart question here. Did you ask for a variance on 780G? And if so, what was the response or when will you know? And if you don't get a variance, do you need reinspection for 780G clearance? And how long do you expect that to take? And just lastly on 780G, do you expect it to have the same impact in the U.S. as you've seen outside the U.S.?
也許關於糖尿病的問題。所以這裡只是一個多部分問題。您是否要求 780G 的差異?如果是這樣,回應是什麼或者你什麼時候知道?如果沒有差異,是否需要復檢780G清關?您預計需要多長時間?最後關於 780G,您是否希望它在美國產生與您在美國以外看到的相同的影響?
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Thanks, Larry. So on your first question, no, we did not ask for a variance. We've been focused on lifting the warning letter. I'm pleased to say that we are 100% complete on the warning letter commitments, and we have welcomed the FDA back in to assess our current status. So I think that's forward progress, and that's the clearest path because, obviously, it's not just 780, but it is a whole pipeline of innovation that we care about from a growth perspective.
謝謝,拉里。所以關於你的第一個問題,不,我們沒有要求差異。我們一直專注於解除警告信。我很高興地說,我們 100% 完成了警告信承諾,我們歡迎 FDA 回來評估我們的現狀。所以我認為這是前進的進步,這是最清晰的道路,因為顯然,它不僅僅是 780,而是我們從增長的角度關心的整個創新渠道。
So there's progress there. It's very hard to say, timing on that. I think that's up to the agency. We know they're working very hard on that. So we anticipate progress there as well. On your question around 780G progress in international markets, we're very pleased with the double-digit performance there. We do expect to see something similar in the U.S. market once approved.
所以那裡有進步。很難說,時間安排。我認為這取決於該機構。我們知道他們正在為此努力工作。因此,我們也期待在那裡取得進展。關於您關於 780G 在國際市場取得進展的問題,我們對那裡兩位數的表現感到非常滿意。一旦獲得批准,我們確實希望在美國市場看到類似的東西。
We are actually doing -- we've been really happy with how 770G has performed in the U.S. market. It's helping to stabilize attrition here. And as you know, our customers have a free upgrade option with 770 once approved in the U.S. market.
我們實際上正在做——我們對 770G 在美國市場的表現非常滿意。它有助於穩定這裡的損耗。如您所知,一旦在美國市場獲得批准,我們的客戶可以免費升級 770。
And sorry, Larry, I missed your third -- your second part of the question.
抱歉,拉里,我錯過了你的第三部分——問題的第二部分。
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Que, that's helpful. I guess, why didn't you ask for variant in the U.S., it seems like a kind of no risk option here? So why not ask for it.
闕,這很有幫助。我想,你為什麼不在美國要求變體,在這裡似乎是一種無風險的選擇?那麼為什麼不要求呢。
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Primarily because as we've stated, we've been focused on really the long-term lifting up the warning letters is critically important. It's not just about 780G, but it's still about the pipeline. You know we submitted Simplera for CE Mark this year. We just submitted 780G with Simplera IDE last week.
主要是因為正如我們所說,我們一直專注於長期解除警告信是至關重要的。不只是780G的問題,還是管線的問題。你知道我們今年提交了 Simplera 以獲得 CE 標誌。我們上周剛剛用 Simplera IDE 提交了 780G。
So there's a long line of innovation that we are interested in. And we were also very pleased with the progress we're making on correcting the warning letter commitment. So with those things progressing at the pace, we did not feel it was necessary to seek a variance.
因此,我們對一系列創新感興趣。我們也對我們在糾正警告信承諾方面取得的進展感到非常高興。因此,隨著這些事情的進展,我們認為沒有必要尋求差異。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Matt O'Brien at Piper Sandler.
下一個問題來自 Piper Sandler 的 Matt O'Brien。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
(technical difficulty).
(技術難度)。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
Okay. There seems to be a problem Matt with your audio.
好的。 Matt 你的音頻似乎有問題。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Maybe we'll take the next question, Brad, and then we'll try to come back to Matt.
也許我們會回答下一個問題,布拉德,然後我們會試著回到馬特。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Josh Jennings at Cowen & Company.
下一個問題來自 Cowen & Company 的 Josh Jennings。
Joshua Thomas Jennings - MD & Senior Research Analyst
Joshua Thomas Jennings - MD & Senior Research Analyst
Can you guys hear me okay?
你們能聽到我說話嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes, we can hear you, Josh.
是的,我們能聽到你的聲音,喬什。
Joshua Thomas Jennings - MD & Senior Research Analyst
Joshua Thomas Jennings - MD & Senior Research Analyst
Okay. Great. So I just want to make sure. Just one maybe for Geoff and maybe Sean as well, just on the renal denervation program and understand, I think it's well understood that the totality of evidence can get the approval. I believe that your team has had preliminary discussions with payers and you might be helpful just in terms of under better understanding your optimism that not just approval could be in hand in the next 6 to 12 months, but payer decisions will ultimately be positive.
好的。偉大的。所以我只是想確定一下。 Geoff 和 Sean 可能只有一個,就腎去神經術計劃而言,我認為這是很好的理解,即所有證據都可以獲得批准。我相信您的團隊已經與付款人進行了初步討論,您可能會有所幫助,更好地理解您的樂觀態度,即在接下來的 6 到 12 個月內不僅可以獲得批准,而且付款人的決定最終將是積極的。
And then the follow-up is just on supply and just want to make sure I'm clear on the dynamics here. And just the recovery and regaining momentum is what's left, but is the supply chain -- are those headwinds gone? And just should we be expecting -- I know you've got your team has executed on the streamlining or consolidation of operations and supply chain functions, and we start to see a benefit from those efforts in fiscal '24?
然後跟進只是供應,只是想確保我清楚這裡的動態。剩下的只是複蘇和恢復勢頭,但供應鏈——那些逆風消失了嗎?我們應該期待——我知道你的團隊已經執行了運營和供應鏈功能的精簡或整合,我們開始看到 24 財年的這些努力帶來的好處?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Maybe I'll start with the supply situation. Are the supply chain issues gone, not completely, but the biggest pain, or if you will, is behind us, especially in surgical innovations with the packaging, as I mentioned, issue. What lingers a bit would be, like we've talked about before, some semiconductor, I'd say, constraints.
也許我會從供應情況開始。供應鏈問題是否已經消失,不是完全消失,但最大的痛苦,或者如果你願意,已經過去了,特別是在包裝的外科創新方面,正如我提到的,問題。揮之不去的是,就像我們之前談到的,一些半導體,我會說,限制。
But the changes that we've made to our supply organization with the new leadership under Greg, the new structure, bringing in new people to help us with capabilities where we thought we weren't -- where we needed to be, implementing new systems and new processes. And these changes, I believe, are durable. I mean they are -- so we're going to get -- we're getting through this.
但是我們在 Greg 領導下的新領導下對我們的供應組織進行了改變,新的結構,引入新的人來幫助我們實現我們認為我們沒有的能力——我們需要的地方,實施新系統和新工藝。我相信,這些變化是持久的。我的意思是他們 - 所以我們會 - 我們正在度過難關。
The worst is behind us. We factored in or update into the guidance, but there are some. I mean, like some issues that are outstanding like the semiconductors, but all that's factored in, and we feel good about going forward, not just FY'24, but beyond that. Regarding Ardian, look, I'll ask Sean to chime in here.
最壞的情況已經過去。我們考慮或更新了指南,但有一些。我的意思是,像半導體這樣一些突出的問題,但所有這些都被考慮在內,我們對未來的發展感到滿意,不僅僅是 24 財年,而是超越這一點。關於 Ardian,看,我會請 Sean 在這裡插話。
But look, the -- as you look at the data, we believe it's very compelling. And you see that the sham arm in the trial increased their medication and the Ardian arm reduced. And the difference is 10x. I mean it's a significant difference. And when you -- when physicians look at it, they understand this and are excited about it and why we're optimistic with payers is because health systems and governments are really focused on.
但是看,當您查看數據時,我們相信它非常引人注目。你會看到試驗中的假手臂增加了他們的藥物劑量,而 Ardian 手臂減少了。差異是 10 倍。我的意思是這是一個顯著的差異。當你 - 當醫生看它時,他們理解這一點並對此感到興奮,以及我們對付款人持樂觀態度的原因是因為衛生系統和政府真正關注。
And payers are focused on hypertension, which -- and like the current standard, as I mentioned in the commentary, just isn't working and more data came out to substantiate that in September a physician -- to substantiate what people already know. And so now there's a new option. And I think payers are going to be compelled to take it seriously, especially with the public health epidemic that we're facing here.
付款人專注於高血壓,正如我在評論中提到的那樣,就像目前的標準一樣,它只是行不通,更多的數據在 9 月份出來證實了醫生的說法——證實了人們已經知道的事情。所以現在有一個新的選擇。而且我認為付款人將被迫認真對待它,尤其是我們在這裡面臨的公共衛生流行病。
Sean, do you want to chime in and add some more color to this?
肖恩,你想插話並為此添加更多顏色嗎?
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Yes, you said it well, Geoff. And Josh, you're right. The totality of the data is really the strength of this program compared to just about any other new therapy I can think of, there's really not a lot of comparisons for just how much good data we have here, it's over 3,000 patients in the real world data on top of the sham-controlled randomized studies. And importantly, we did a patient preference study, which is getting more and more considered by payers because they know that patients have a say in what they want to go do.
是的,你說得很好,傑夫。喬希,你是對的。與我能想到的幾乎任何其他新療法相比,數據的整體性確實是這個項目的優勢,我們這裡有多少好的數據真的沒有太多的比較,現實世界中有超過 3,000 名患者假對照隨機研究之上的數據。重要的是,我們進行了一項患者偏好研究,支付方越來越多地考慮這項研究,因為他們知道患者對他們想去做什麼有發言權。
And there's a large majority of patients that prefer having a procedure versus adding just even one more drug. And of course, we can get their blood pressure down without the addition of drugs, which is a huge benefit. I'll remind you also that Ardian was a breakthrough device had that designation. In the world of MST ruling that would have met automatic coverage. We don't know yet what the (inaudible) pathway is going to look like.
並且有絕大多數患者更喜歡進行手術而不是僅添加一種藥物。當然,我們可以在不添加藥物的情況下降低他們的血壓,這是一個巨大的好處。我還要提醒您,Ardian 是具有該名稱的突破性設備。在 MST 裁決的世界裡,這將滿足自動覆蓋。我們還不知道(聽不清)路徑會是什麼樣子。
We'll find out more about that in the fall time frame, I suppose, or in the spring time frame, but we do think that the novelty of this therapy, the desire of patients, and of course, the public health benefit that this can provide is going to be compelling to both public and private payers around the world.
我想我們會在秋季時間框架或春季時間框架中找到更多相關信息,但我們確實認為這種療法的新穎性、患者的願望,當然還有公共健康益處可以提供將對世界各地的公共和私人付款人具有吸引力。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question will come from Matt O'Brien at Piper Sandler. Matt, are you there?
下一個問題將來自 Piper Sandler 的 Matt O'Brien。馬特,你在嗎?
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
How about now?
現在怎麼樣?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes, we can hear you now.
是的,我們現在可以聽到你的聲音了。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
Sorry about that. I guess, just to follow up a little bit on Josh's question, and I know how enthusiastic you still are about Ardian. But I think the ambulatory number is one that is a little bit more robust in the office-based number. So why would clinicians and payers be so interested in doing these cases or we're paying for them given the ambulatory feedback that we've seen? And are you guys still thinking about the market is $500 million by '26, $3 billion by the end of the decade?
對於那個很抱歉。我想,只是稍微跟進一下 Josh 的問題,我知道你對 Ardian 仍然充滿熱情。但我認為動態數字比基於辦公室的數字更強大一些。那麼,為什麼臨床醫生和付款人會對做這些病例如此感興趣,或者鑑於我們看到的門診反饋,我們要為他們付費呢?你們還在考慮到 26 年市場將達到 5 億美元,到 20 世紀末達到 30 億美元嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Sean, do you want to get into the specifics on the ambulatory versus the office?
肖恩,你想了解門診和辦公室的具體情況嗎?
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Yes. Matt, I think if you just recall how that study was done, the patients were witnessed taking their blood pressure medicine in the morning. And whether they were taking that for the full 6 months or not, they just took it that day, you saw the change in blood pressure that was during the daytime not what we've seen before in these prior trials.
是的。馬特,我想如果你回想一下這項研究是如何進行的,就會看到患者在早上服用降壓藥。不管他們是否服用了整整 6 個月,他們只是在那天服用,你看到的是白天的血壓變化,而不是我們之前在這些試驗中看到的變化。
But at night time, there was still a reduction ambulatory. So I think the simple story here is that patients weren't taking their medications, except on game day and their blood pressure dropped. Now we don't know that for sure, we didn't test blood in urine every day. We just test it on game day and we know that there were more medications in the patients that were in the control arm than in the treated arm.
但在夜間,仍有還原門診。所以我認為這裡的簡單故事是患者沒有服用藥物,除了在比賽日並且他們的血壓下降了。現在我們不確定,我們沒有每天都檢測尿液中的血液。我們只是在比賽日進行了測試,我們知道對照組患者服用的藥物多於治療組患者。
And as Geoff said, the changes increasing medication, decreasing medication, taking even medications for blood pressure that weren't even prescribed maybe from their medicine cabinet, maybe from their spouse or partners medicine cabinet. There's a lot of changes in medicine, which we know were present different than the prior studies. We actually have that proof now that we can measure the drug metabolites.
正如傑夫所說,這些變化增加了用藥量,減少了用藥量,甚至服用了甚至沒有開處方的降壓藥,這些藥物可能來自他們的藥櫃,也可能來自他們的配偶或伴侶的藥櫃。醫學發生了很多變化,我們知道這些變化與之前的研究不同。現在我們實際上已經有了可以測量藥物代謝物的證據。
So cleaner, if you will, measure is that morning blood pressure, we took the office blood pressure. And that blood pressure is the one that's used for all the epidemiology studies that show what the reduction in blood pressure means for the avoidance of events and reduction of cost. And it's also the primary endpoint that's gotten just about every -- I think maybe every pharmaceutical approved for the treatment of high blood pressure.
所以清潔工,如果你願意的話,測量的是早上的血壓,我們測量了辦公室的血壓。血壓是用於所有流行病學研究的血壓,這些研究表明降低血壓對於避免事件和降低成本意味著什麼。它也是幾乎所有的主要終點——我想也許每一種藥物都被批准用於治療高血壓。
So it is the robust standard. In fact, ambulatory is not even reimbursed in this country. So it's not used routinely in clinical practice. So it is a robust measurement that was consistently performed throughout this trial and across the other trials that we've done.
所以它是穩健的標準。事實上,在這個國家,門診甚至都不報銷。所以在臨床實踐中並不常規使用。因此,這是一項穩健的測量,在整個試驗和我們所做的其他試驗中始終如一地進行。
So I'm confident in that part. In terms of the market size, we're very confident in this therapy. There's 1 billion people blood pressure problems around the world, even if very small amount gets you to the kind of market growth that we think is going to be meaningful for the company. So we're very confident in this therapy and that is approval and ultimate uptake.
所以我對那部分很有信心。就市場規模而言,我們對這種療法非常有信心。全世界有 10 億人有血壓問題,即使很少的人也能實現我們認為對公司有意義的市場增長。所以我們對這種療法非常有信心,那就是批准和最終吸收。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
Okay. That makes sense. I appreciate that. And then it's not a related follow-up, but turning over to cardiac rhythm for a second. Just -- I'd love to hear about the competitive dynamics that are going on with Micra because you've got a competitor there now? And then what the expectation is with EV ICD, given the long-standing presence of another one of your competitors in that market. What should we be expecting between those two as we progress over the next 12 months?
好的。那講得通。我很感激。然後這不是相關的後續行動,而是轉向心律一秒鐘。只是 - 我很想听聽 Micra 正在發生的競爭動態,因為你現在在那裡有一個競爭對手?然後,考慮到您的另一個競爭對手在該市場中的長期存在,對 EV ICD 的期望是什麼。隨著我們在接下來的 12 個月中取得進展,我們應該對這兩者有什麼期待?
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Yes. So for Micra, we continue to grow, and you saw 18% globally, 40% of that was from international sales. And really Japan and China, in particular, really drove that great and continued success. And we'll see continued penetration in international markets and in the U.S. and a shift between single chamber to the AV device, which can pick up a larger proportion of patients, it's about 30% of the market there.
是的。因此,對於 Micra,我們繼續增長,您在全球看到 18%,其中 40% 來自國際銷售。尤其是日本和中國,確實推動了這一偉大而持續的成功。我們將看到在國際市場和美國的持續滲透,以及從單室到 AV 設備的轉變,這可以吸引更大比例的患者,大約佔那里市場的 30%。
And in the next 12 months, we're going to refresh both the VR and the AV devices in the coming year around the world. So while we have some competition in the United States, we fared pretty well. I think the ease of use of our micro device in the long-term data that we have as well as just the familiarity with our system has made it pretty durable.
在接下來的 12 個月裡,我們將在來年更新全球的 VR 和 AV 設備。所以雖然我們在美國有一些競爭,但我們表現得很好。我認為我們的微型設備在我們擁有的長期數據中的易用性以及對我們系統的熟悉使得它非常耐用。
On AURORA EV-ICD, as you know, we've got CE Mark coming up. That's a little bit of a different technique. You've got to put a lead underneath the breast bone, which takes some training to learn and we'll be very meticulous in the way we roll that out. But make no mistake that is a product that really offers a huge benefit, getting leads out of the heart, having half the size in the can and twice the battery life compared to the other device that realm and being able to voice shock by pacing people out of their fatal arrhythmia as opposed to having to have a painful shock. Those are all really, really welcome improvements, and we're excited to roll that technology out first in Europe and then the United States, next year.
如您所知,在 AURORA EV-ICD 上,我們即將獲得 CE 標誌。這是一種不同的技術。你必須在胸骨下面放一根導線,這需要一些訓練才能學會,我們會非常小心地推出它。但請不要誤會,這是一款真正提供巨大好處的產品,從心臟中提取線索,與其他設備相比,罐頭大小只有一半,電池壽命是其他設備的兩倍,並且能夠通過調整人們的節奏來發出震撼擺脫他們致命的心律失常,而不是不得不遭受痛苦的休克。這些都是非常非常受歡迎的改進,我們很高興明年首先在歐洲和美國推出該技術。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Chronic Rhythm business has done well and we expect it to continue to do well with products like Micra and EV ICD, but also pioneering conduction system pacing, and we've got a nice pipeline there and really a strong leadership team and strong position.
Chronic Rhythm 業務表現良好,我們預計它會繼續在 Micra 和 EV ICD 等產品上表現出色,但也能開拓傳導系統起搏,我們在那裡有一個很好的管道,真正強大的領導團隊和強大的地位。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Matt Taylor at Jefferies.
下一個問題來自 Jefferies 的 Matt Taylor。
Matthew Charles Taylor - Equity Analyst
Matthew Charles Taylor - Equity Analyst
Sorry, guys. Can you hear me okay?
對不起大家。你能聽到我說話嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes, we can, Matt.
是的,我們可以,馬特。
Matthew Charles Taylor - Equity Analyst
Matthew Charles Taylor - Equity Analyst
Okay. Sorry. So I wanted to just explore you talked about the slower recovery of some of these elective and developed markets. And obviously, there's staffing, you said other challenges.
好的。對不起。所以我想探討一下你談到的一些選擇性和發達市場的複蘇較慢。顯然,還有人員配置,你說其他挑戰。
I guess maybe you could just give us some insight into two things. One is, could you talk a little bit more about procedure trends through the quarter? Did you see any improvement? And then what gives you the confidence or what intelligence do you have to point to whether this is really staffing or I think investors are worried about lack of pent-up demand. Could you just address that?
我想也許你可以讓我們深入了解兩件事。一是,您能否多談談本季度的程序趨勢?你看到任何改善了嗎?然後是什麼讓你有信心或有什麼情報可以指出這是否真的是人員配備,或者我認為投資者擔心缺乏被壓抑的需求。你能解決這個問題嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Sure. I'll ask Karen to comment on the procedure trends through the quarter and then we can talk to the staffing issue.
當然。我將請 Karen 對整個季度的程序趨勢發表評論,然後我們可以討論人員配置問題。
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Karen L. Parkhill - EVP, CFO, IT & Enterprise Excellence
Yes. So I would say, through the quarter, we did see, particularly in the markets that we had mentioned not as robust recovery, but some recovery. But as we ended the quarter with less robust recovery, we're just assuming that in those areas, those procedures stay where they were in the back half.
是的。所以我想說,在整個季度中,我們確實看到了,特別是在我們提到的市場中,復甦不是強勁的,而是一些復甦。但是,由於我們在本季度結束時復蘇不那麼強勁,我們只是假設在這些領域,這些程序保持在後半部分的水平。
We'll see if that's a good assumption or not. As we look at the first few weeks of our current quarter of the third quarter, we are seeing improvement from the second quarter. So that's pointing to some good things, but we'll see.
我們將看看這是否是一個好的假設。當我們回顧第三季度當前季度的前幾週時,我們看到了第二季度的改善。所以這指向了一些好東西,但我們會看到。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes. So just to highlight what Karen is saying there. I mean, we were disappointed that we missed the call on this one for the Q2. And so now in our guidance, we've assumed a prolonged recovery here, especially for those segments that we called out, not all the segments.
是的。所以只是為了強調卡倫在那裡說的話。我的意思是,我們很失望我們錯過了第二季度的電話會議。因此,現在在我們的指導中,我們假設這裡會出現長期復蘇,尤其是對於我們提到的那些細分市場,而不是所有細分市場。
Like we said, many of the segments are back to pre-COVID, but there are a handful of those electives and developed markets that we've called out and Karen walked you through the assumption for the back half of the year. In terms of the staffing, I hear that dynamic in some of the cardiology space is more than others. And maybe I'll have Sean comment on that.
就像我們說的那樣,許多細分市場都回到了 COVID 之前的狀態,但是我們已經指出了一些選修課和發達市場,Karen 向您介紹了今年下半年的假設。在人員配備方面,我聽說某些心髒病學領域的動態比其他領域更多。也許我會讓肖恩對此發表評論。
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Yes, I'd say a couple of things on that, Geoff. First of all, there's -- you take a therapy like TAVR, where there's multiple handoffs. You have to have pre-imaging, you have to get the patient worked up, they get their procedure done. And then there are sometimes even post imaging this done. So a lot of handoffs and the patients tend to be elderly.
是的,我想就此說幾句,Geoff。首先,有——你接受像 TAVR 這樣的治療,那裡有多次交接。你必須有預成像,你必須讓病人振作起來,他們完成他們的程序。然後有時甚至會進行後期成像。所以很多交接和病人往往是老年人。
So there's -- you want to sure you schedule that in a way that's okay that they can get it all done in an efficient way. We don't want them exposed to the health care environment for a long time. And I think that's challenging. It's also true that you can't wait forever. You've got -- with severe aortic stenosis, there's about an 80% mortality rate for 2 years from your diagnosis of that. So it's more lethal than cancer, for example, most cancers. So it's not something you can put off forever, but it is resource intensive.
因此,您要確保以一種可以讓他們以有效方式完成所有工作的方式來安排它。我們不希望他們長時間暴露在醫療保健環境中。我認為這很有挑戰性。你不能永遠等待也是事實。你有 - 患有嚴重的主動脈瓣狹窄,從你診斷出來的 2 年內死亡率大約為 80%。所以它比癌症更致命,例如,大多數癌症。所以這不是你可以永遠推遲的事情,但它是資源密集型的。
And I think the other thing we're seeing with staffing just in general is, there's a prioritization for patients that you can get in and out relatively quickly so they can make downstream staffing available. So whether it's ICU recovery or you've got even transport to (inaudible) move.
而且我認為我們在一般情況下看到的另一件事是,患者可以優先進出,您可以相對快速地進出,以便他們可以提供下游人員。因此,無論是 ICU 恢復,還是您甚至已經轉移到(聽不清)移動。
And I think there's some arbitrage in some countries even on the margin that they make on those procedures. Cardiac surgery have grown like a 5.5% for us. So very robust. There's a lot of margin that comes out of cardiac surgery patients. They tend not to be as deferrable as, say, like a PCI patient, for example.
而且我認為在某些國家/地區存在一些套利行為,即使他們在這些程序上賺取的利潤也是如此。心臟手術對我們來說增長了 5.5%。非常堅固。心臟手術患者有很多利潤。例如,他們往往不像 PCI 患者那樣可延期。
So we hear it in pockets. I mentioned before, France and Germany seem to be some places that are really struggling with staffing in Europe, and we see it just in pockets around the United States and other places. So it is a dynamic situation, and we think it has gotten better, certainly a lot of places, but not everywhere yet.
所以我們在口袋裡聽到它。我之前提到過,法國和德國似乎是一些真正在歐洲人員配置方面苦苦掙扎的地方,而我們只在美國和其他地方的一些地方看到了這種情況。所以這是一個動態的情況,我們認為情況已經好轉,當然是在很多地方,但還不是到處都是。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
The next question comes from Pito Chickering, Deutsche Bank.
下一個問題來自德意志銀行的 Pito Chickering。
Philip Chickering - Research Analyst
Philip Chickering - Research Analyst
I know that you don't have a ton of exposure here, but there has been a healthy debate around hospital demand for capital equipment this year. Can you give us any color on what you're seeing from behavior changes in hospitals for capital ordering in 2Q and what you guys assume in the back half of the year?
我知道你在這裡沒有太多的曝光率,但今年圍繞醫院對資本設備的需求進行了一場健康的辯論。你能告訴我們你從第二季度醫院的資本訂購行為變化中看到的情況,以及你們在今年下半年的假設嗎?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Our capital, first of all, isn't a huge piece yet of our revenue. But it is -- it tends to be tied to profitable procedures, and we actually had a strong capital performance in last quarter. And especially in our cranial and spinal technologies business, CST, our capital there, we had a number of our -- whether it be navigation, intra-operative imaging, I had record capital quarters for us.
首先,我們的資本還不是我們收入的很大一部分。但它是——它往往與盈利程序掛鉤,我們實際上在上個季度有強勁的資本表現。特別是在我們的顱骨和脊柱技術業務,CST,我們在那裡的資本,我們有很多 - 無論是導航,術中成像,我為我們創造了創紀錄的資本季度。
So we're -- we definitely see a bit of -- it takes a little longer to close a deal, but the demand as you're working with the hospital and how they're going to pay or finance this, but we're having strong demand in those areas. And then, of course, we mentioned Hugo. Hugo is still new for us, but we are very happy with the placements we've been able to make on Hugo here. Of course, those are outside the U.S. but very pleased with that.
所以我們 - 我們肯定會看到 - 完成交易需要更長的時間,但是你與醫院合作的需求以及他們將如何支付或資助這件事,但我們'在這些領域有強勁的需求。然後,當然,我們提到了雨果。 Hugo 對我們來說仍然是新手,但我們對能夠在 Hugo 上進行的展示感到非常滿意。當然,那些是在美國以外的地方,但對此非常滿意。
Unidentified Company Representative
Unidentified Company Representative
We've got time for one more question, please, Brad.
布拉德,我們還有時間再問一個問題。
Brad Welnick - Senior Director of IR
Brad Welnick - Senior Director of IR
Our final question comes from Joanne Wuensch, Citi.
我們的最後一個問題來自花旗銀行的 Joanne Wuensch。
Joanne Karen Wuensch - MD
Joanne Karen Wuensch - MD
Early happy Thanksgiving. This led straight into my Hugo question. Could you give us a little bit of an update on how you feel about the market potential for the product, the timing of U.S. approval? And at one stage, several years ago, you were talking about the potential contribution. Is there a way to start thinking about that again?
提前感恩節快樂。這直接導致了我的雨果問題。您能否向我們介紹一下您對該產品的市場潛力以及美國批准時間的看法?在某個階段,幾年前,你在談論潛在的貢獻。有沒有辦法重新開始考慮這個問題?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Sure. Well, thanks for the question, Joanne. Yes, like I said, we have good news on Hugo. We're kicking off the U.S. IDE with our first case is scheduled for December based on getting these instruments enhancements approved. And like I just said to Pito, we are pleased with the system placements. And in terms of the other color commentary on that, I'll ask Bob White to chime in.
當然。好吧,謝謝你的問題,喬安妮。是的,就像我說的,我們有關於雨果的好消息。我們正在啟動美國 IDE,我們的第一個案例計劃在 12 月進行,基於獲得這些儀器增強功能的批准。就像我剛剛對 Pito 說的那樣,我們對系統佈置感到滿意。關於其他顏色的評論,我會請 Bob White 插話。
Robert John White - Executive VP & President of Medical Surgical Portfolio
Robert John White - Executive VP & President of Medical Surgical Portfolio
Yes. Thanks, Geoff, and thanks, Joanne. Couple of thoughts here. First, on the overall market for Hugo, we continue to be really excited about it. Remember, there's -- around the world still 95% arousable cases are not done. That could be done robotically [assistedly]. So we believe this is a true market expansion opportunity. So we're still really excited about the continued term of the market and excited to be the #2 player in this space.
是的。謝謝,傑夫,謝謝,喬安妮。這裡有幾個想法。首先,在 Hugo 的整體市場上,我們仍然對此感到非常興奮。請記住,全世界仍有 95% 的可喚醒案件尚未完成。這可以通過機器人 [輔助] 完成。所以我們相信這是一個真正的市場擴張機會。因此,我們仍然對市場的持續發展感到非常興奮,並很高興成為該領域的第二大玩家。
With respect to the timing of U.S. approval, as Geoff mentioned, we expect to begin our U.S. IDE by the end of this calendar year. So that's exciting. Actual approval in the U.S., of course, depends upon the agency and the process there. So I really can't comment on that. And overall, with respect to the contribution, as you mentioned, I think it's early to call that, but given our system is now installed around the world in markets in APAC, EMEA, LATAM, we just received regulatory approvals and indication expansions in Japan, which is the third largest robotics market in the world.
關於美國批准的時間,正如 Geoff 提到的,我們預計將在本日曆年年底開始我們的美國 IDE。所以這很令人興奮。當然,美國的實際批准取決於那裡的機構和流程。所以我真的不能對此發表評論。總的來說,關於貢獻,正如你提到的,我認為現在這麼說還為時過早,但鑑於我們的系統現在已安裝在世界各地的亞太地區、歐洲、中東和非洲、拉丁美洲市場,我們剛剛在日本獲得了監管批准和適應症擴展,這是世界第三大機器人市場。
We have general surgery approval in the EU, Canada and Australia, which opens up the hernia market for us. And we've started to see really strong presence and some really key congresses in Europe where live stream cases, et cetera. So a little early to call it contribution, Joanne, but we're starting to see the momentum in the acceleration that we talked about.
我們在歐盟、加拿大和澳大利亞獲得了普外科批准,這為我們打開了疝氣市場。我們已經開始在歐洲看到非常強大的存在和一些非常重要的會議,在這些會議上直播案例等等。喬安妮,稱其為貢獻還為時過早,但我們開始看到我們談到的加速發展勢頭。
Ryan Weispfenning - VP of IR
Ryan Weispfenning - VP of IR
Geoff, please go ahead with your closing remarks.
Geoff,請繼續您的結束語。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Okay. Thanks, Ryan. Well, first of all, thank you, everybody, for the questions. And we do really appreciate your support and continued interest in Medtronic. And we look forward to updating you on our progress on our Q3 earnings broadcast, which we anticipate holding on February 21.
好的。謝謝,瑞安。嗯,首先謝謝大家的提問。我們非常感謝您對美敦力的支持和持續關注。我們期待著向您通報我們預計在 2 月 21 日舉行的第三季度財報廣播的最新進展。
So with that, thanks again for tuning in today. Please stay healthy and safe. I understand there's a lot of people traveling this holiday. And for those of you in the U.S., I'd like to wish you and your families a very happy Thanksgiving.
因此,再次感謝您今天的收聽。請保持健康和安全。我知道這個假期有很多人旅行。對於在美國的你們,我想祝你們和你們的家人感恩節快樂。