美敦力 (MDT) 2023 Q1 法說會逐字稿

Good morning, and welcome to Medtronic's Fiscal Year 2023 First Quarter Earnings Broadcast. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations.

早上好，歡迎收看美敦力 2023 財年第一季度收益廣播。我是 Ryan Weispfenning，副總裁兼美敦力投資者關係負責人。

I'm inside one of our Medtronic mobile labs, which is making a stop here at our operational headquarters in Minneapolis. These high-tech mobile classrooms will give about 5,000 U.S. clinicians every year the opportunity to train on some of our most advanced state-of-the-art technology, including our O-arm and StealthStation.

我在我們的一個美敦力移動實驗室內，該實驗室正在我們明尼阿波利斯的運營總部停留。這些高科技移動教室每年將為大約 5,000 名美國臨床醫生提供培訓我們一些最先進的最先進技術的機會，包括我們的 O 形臂和 StealthStation。

As you can see, it's on 18 wheels. Our fleet of mobile lab trucks allows us to play big literally as they traverse the United States. In fact, with over 200 stops planned this fiscal year, they're likely coming to a hospital near you.

如您所見，它有 18 個輪子。我們的移動實驗室卡車車隊使我們能夠在穿越美國時大放異彩。事實上，本財年計劃有超過 200 次停靠，他們很可能會來到您附近的醫院。

Now before we go inside to hear our prepared remarks, I'll share a few details about today's earnings broadcast. 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 first quarter, which ended on July 29, 2022, and 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.

現在，在我們進去聽我們準備好的講話之前，我將分享一些關於今天的收益廣播的細節。加入我的還有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 將就我們於 2022 年 7 月 29 日結束的第一季度的業績以及我們對本財年剩餘時間的展望發表評論。在我們準備好發言後，我們 4 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理收入摘要。我們還發布了一份收益報告，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.

在今天的計劃中，我們做出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大不相同。有關可能導致實際結果不同的因素的其他信息包含在我們向 SEC 提交的定期報告和其他文件中，我們不承諾更新任何前瞻性陳述。

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 recent acquisition of Intersect ENT.

除非我們另有說明，否則所有比較都是按年進行的，收入比較是在有機基礎上進行的，這不包括我們最近收購 Intersect ENT 的外彙和收入的影響。

References to sequential revenue changes compared to the fourth quarter of fiscal '22 and are made on an as-reported basis, and all references to share gains or losses refer to revenue share in the second calendar quarter of 2022 compared to the second calendar quarter of 2021, unless otherwise stated.

與 '22 財年第四季度相比，提及的連續收入變化是在報告的基礎上進行的，所有對份額收益或損失的提及均指 2022 年第二季度與第二季度相比的收入份額2021 年，除非另有說明。

Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. 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.

所有非公認會計原則財務指標的對賬可以在我們的收益新聞稿或我們的網站investorrelations.medtronic.com 上找到。最後，我們的每股收益指引不包括任何費用或收益，這些費用或收益將被報告為本財年的非公認會計準則收益調整。

With that, let's head into the studio and hear about the quarter.

有了這個，讓我們進入工作室，聽聽這個季度的情況。

Hello, everyone, and thank you for joining us today. We reported our Q1 results this morning, and the quarter played out largely as expected. Our organization executed to deliver revenue ahead of our guidance and EPS that was in line with our guidance.

大家好，感謝您今天加入我們。我們今天早上報告了第一季度的業績，該季度的表現基本符合預期。我們的組織執行以在我們的指導和每股收益符合我們的指導之前交付收入。

Macro factors that we discussed with you and forecasted over the past few quarters, like supply chain, inflation and foreign exchange, along with difficult comparisons to the prior year, caused our revenue and EPS to decline. At the same time, there were several bright spots in the quarter across our businesses, including strength in Pacing, Cardiac Surgery, U.S. Core Spine, Neurovascular, Diabetes in Europe and strong overall growth in many emerging markets.

我們與您討論並在過去幾個季度預測的宏觀因素，如供應鏈、通貨膨脹和外匯，以及與上一年的難以比較，導致我們的收入和每股收益下降。與此同時，本季度我們的業務有幾個亮點，包括在歐洲的起搏、心臟外科、美國核心脊柱、神經血管、糖尿病領域的實力以及許多新興市場的強勁整體增長。

And as we look to the future, we have several near-term pipeline catalysts approaching that will accelerate growth. We're also making progress on our initiatives around quality and operating improvement. And in an uncertain economy, our business is well positioned with our robust balance sheet, strong and growing dividend and leadership positions in many secular growth health care technology markets.

展望未來，我們有幾個短期的管道催化劑即將到來，這將加速增長。我們還在圍繞質量和運營改進的舉措方面取得進展。在不確定的經濟環境中，我們的業務憑藉穩健的資產負債表、強勁且不斷增長的股息以及在許多長期增長的醫療保健技術市場中的領導地位而處於有利地位。

So taking a closer look at our Q1 results, as expected, acute supply chain disruptions impacted our performance. Most notably, our Surgical Innovations business. We saw improvement in areas like packaging and resin supply as we progressed through the quarter. We also continue to manage semiconductor shortages across our businesses to minimize their impact on product availability as well as our financial results, and we're expecting these chip shortages to linger throughout our fiscal year.

因此，正如預期的那樣，仔細查看我們的第一季度業績，嚴重的供應鏈中斷影響了我們的業績。最值得注意的是，我們的外科創新業務。隨著本季度的進展，我們看到包裝和樹脂供應等領域有所改善。我們還繼續管理我們業務中的半導體短缺，以盡量減少它們對產品可用性和財務業績的影響，我們預計這些芯片短缺將在我們的整個財年中持續存在。

Overall, our operations teams have executed and worked closely with our suppliers to minimize impact, improving our order backlogs as we exited the quarter. We expect our overall supply chain issues to continue to improve as we move through the fiscal year.

總體而言，我們的運營團隊已經執行並與我們的供應商密切合作，以盡量減少影響，在我們退出本季度時改善我們的訂單積壓。我們預計，隨著本財年的推進，我們的整體供應鏈問題將繼續改善。

On the demand side, we're still seeing impacts to procedure volumes due to health professional labor shortages. And COVID is still causing procedure cancellations and deferrals in some pockets around the world. We see our hospital and physician customers are doing all they can to manage these dynamics. So while procedure volumes in most of our markets remain at pre-COVID levels, we do have certain procedures or geographies where volumes are still lagging.

在需求方面，由於衛生專業人員短缺，我們仍然看到對手術量的影響。 COVID 仍在世界各地的一些地區造成程序取消和延期。我們看到我們的醫院和醫生客戶正在盡其所能來管理這些動態。因此，儘管我們大多數市場的程序量仍處於 COVID 之前的水平，但我們確實有某些程序或地區的數量仍然滯後。

Turning to market share. This is an important metric at Medtronic and is part of our annual incentive plan, along with revenue growth, profitability and free cash flow. And when we look at our quarterly market share performance, acute product availability challenges impacted our share capture opportunities in certain businesses, including Surgical Innovations and high-power CRM implants. We're also facing some competitive pressures in pelvic health and in diabetes, predominantly in the U.S. We're making good progress on the acute product availability issues and have pipeline plans in place to address competitive pressures over time.

轉向市場份額。這是美敦力的一個重要指標，也是我們年度激勵計劃的一部分，以及收入增長、盈利能力和自由現金流。當我們查看季度市場份額表現時，嚴峻的產品供應挑戰影響了我們在某些業務中的份額捕獲機會，包括 Surgical Innovations 和大功率 CRM 植入物。我們在骨盆健康和糖尿病方面也面臨一些競爭壓力，主要是在美國。我們在急性產品可用性問題上取得了良好進展，並製定了管道計劃來應對隨著時間的推移所面臨的競爭壓力。

Now let me highlight some of our bright spots. In CRM, our pacing business continues to outperform the market as our Micra leadless pacemaker family is driving strong growth around the globe as we enter new geographies and expand penetration in existing markets. Micra grew 15% in the quarter, including high 70s growth in Japan, mid-teens growth in Western Europe and high 30s growth in emerging markets.

現在讓我強調一下我們的一些亮點。在 CRM 方面，隨著我們進入新的地區並擴大在現有市場的滲透率，我們的 Micra 無引線起搏器系列正在推動全球強勁增長，我們的起搏業務繼續跑贏市場。 Micra 在本季度增長了 15%，其中包括日本 70 多歲的高速增長、西歐的 10 歲中期增長和新興市場 30 多歲的高速增長。

In CST, we had a good quarter in U.S. Core Spine, which grew 4%. We won market share on the strength of our overall portfolio, including our UNiD AI-enabled surgical planning platform and patient-specific implants, which had strong double-digit sequential growth in our U.S. user base.

在 CST，我們在美國核心脊柱有一個不錯的季度，增長了 4%。我們憑藉整體產品組合的優勢贏得了市場份額，包括我們支持 UNiD AI 的手術計劃平台和患者專用植入物，這些產品在我們的美國用戶群中實現了兩位數的強勁連續增長。

In addition, our recently launched Catalyft PL spinal system designed to target the TLIF and PLIF markets drove meaningful results in Q1. And the breadth of our enabling, imaging, navigation and robotic technologies is a key differentiator.

此外，我們最近推出的針對 TLIF 和 PLIF 市場的 Catalyft PL 脊柱系統在第一季度取得了有意義的成果。我們的支持、成像、導航和機器人技術的廣度是一個關鍵的差異化因素。

In our Neuromodulation business, we are gaining initial implant share in both Pain Stim and DBS. In Pain Stim, the market continues to gravitate toward our Vanta recharge-free and Intellis with DTM rechargeable neurostimulators. And in DBS, customers value the differentiated sensing capabilities of our Percept PC system with our SenSight directional lead.

在我們的神經調節業務中，我們在 Pain Stim 和 DBS 中獲得了初始植入物份額。在 Pain Stim 中，市場繼續傾向於我們的 Vanta 免充電和帶有 DTM 可充電神經刺激器的 Intellis。在 DBS 中，客戶重視我們的 Percept PC 系統與我們的 SenSight 定向引線的差異化傳感能力。

In Diabetes, we continue to see significant growth in markets outside the U.S. due to the increasing user base of our MiniMed 780G insulin pump, combined with our Guardian 4 sensor. The increase in this user base over the past couple of years is now driving significant recurring revenue growth for our CGM sensors and other supplies.

在糖尿病領域，由於我們的 MiniMed 780G 胰島素泵的用戶群不斷增加，再加上我們的 Guardian 4 傳感器，我們繼續看到美國以外市場的顯著增長。過去幾年用戶群的增加正在推動我們的 CGM 傳感器和其他供應品的經常性收入顯著增長。

In markets outside the U.S. were launched, the 780G and our Guardian 4 sensor has a very positive user experience with no fingersticks and more time and range. Now this is due to its near real-time basal insulin and auto correction boluses every 5 minutes to address underestimated carb counts and occasional missed mealtime boluses.

在美國以外的市場推出時，780G 和我們的 Guardian 4 傳感器具有非常積極的用戶體驗，沒有手指刺，時間和範圍更大。現在這是由於其每 5 分鐘近乎實時的基礎胰島素和自動校正推注，以解決低估的碳水化合物數量和偶爾錯過的進餐時間推注。

Now let's move to our product pipeline, where we're advancing several meaningful technologies that can create new markets, disrupt existing ones and accelerate our growth. We continue to execute on our pipeline, having received over 200 regulatory approvals in the U.S., Europe, Japan and China over the past 12 months. And looking ahead, we have several near-term pipeline catalysts approaching that we expect will enhance the weighted average market growth rate of Medtronic.

現在讓我們轉向我們的產品線，我們正在推進幾項有意義的技術，這些技術可以創造新市場、顛覆現有市場並加速我們的增長。我們繼續執行我們的管道，在過去 12 個月中已在美國、歐洲、日本和中國獲得了 200 多項監管批准。展望未來，我們有幾個近期管道催化劑即將到來，我們預計這將提高美敦力的加權平均市場增長率。

Now starting with our Cardiovascular portfolio and transcatheter valves. The limited U.S. market release of our Evolut FX valve is receiving an overwhelmingly positive customer reception. And we're excited about the impact this next-gen valve can have as we move to full market release this fall.

現在從我們的心血管產品組合和經導管瓣膜開始。我們的 Evolut FX 閥門在美國市場的有限發布獲得了壓倒性的客戶好評。隨著我們今年秋季全面投放市場，我們對這款下一代閥門可能產生的影響感到興奮。

Evolut FX enhances ease of use and provides implanters with greater precision and control during the procedure, and it maintains all the industry-leading hemodynamic and durability benefits of the Evolut platform. When you combine the FX launch in U.S., PRO+ launch in Europe and Evolut PRO launch in China, we feel really good about the opportunities in our TAVR franchise around the globe.

Evolut FX 增強了易用性，並在手術過程中為植入者提供了更高的精度和控制力，並保持了 Evolut 平台的所有行業領先的血液動力學和耐用性優勢。當您將美國的 FX 發布、歐洲的 PRO+ 發布和中國的 Evolut PRO 發布結合起來時，我們對我們在全球的 TAVR 特許經營權的機會感到非常滿意。

TAVR is one of the largest growth drivers for Medtronic, and we expect the market, which is roughly $5.5 billion today, to exceed $7 billion within the next 3 years and reach $10 billion in the next 5 years.

TAVR 是美敦力最大的增長動力之一，我們預計目前約為 55 億美元的市場將在未來 3 年內超過 70 億美元，並在未來 5 年內達到 100 億美元。

In cardiac rhythm management, we're really looking forward to disrupting the single-chamber ICD market with our AURORA extravascular ICD. Now as you may know, one of our competitors has had a subcutaneous ICD in the market for many years, but it's remained a niche device given its limitations compared to conventional ICDs.

在心律管理方面，我們非常期待通過我們的 AURORA 血管外 ICD 顛覆單腔 ICD 市場。現在您可能知道，我們的一個競爭對手已經在市場上推出皮下 ICD 多年，但鑑於其與傳統 ICD 相比的局限性，它仍然是一種利基設備。

With AURORA, we've created a true game changer where the electrophysiologist and the patient don't have to make trade-offs. It will deliver the benefits of a traditional ICD, including having the same size, battery longevity and ability to use proven antitachy pacing in lieu of delivering a painful shock to terminate life-threatening arrhythmias.

借助 AURORA，我們創造了一個真正的遊戲規則改變者，電生理學家和患者無需進行權衡取捨。它將提供傳統 ICD 的優點，包括具有相同的尺寸、電池壽命和使用經過驗證的抗心動過速起搏的能力，而不是提供痛苦的電擊來終止危及生命的心律失常。

AURORA does all of this without having to place leads inside the heart. Our EV-ICD global pivotal data will be presented this weekend in a late-breaking session at the ESC Congress in Barcelona. We're also awaiting CE Mark approval for AURORA, and we expect U.S. approval next calendar year.

AURORA 無需在心臟內放置引線即可完成所有這些工作。我們的 EV-ICD 全球關鍵數據將於本週末在巴塞羅那 ESC 大會的最新會議上公佈。我們還在等待 AURORA 的 CE 標誌批准，我們預計下個日曆年將獲得美國的批准。

In renal denervation, our breakthrough procedure to treat hypertension, we're nearing completion of the 6-month follow-up for the full cohort of patients in our SPYRAL HTN-ON MED study. We'll then analyze the data and plan to present the findings in the next few months. This data will complete the final piece of our clinical module submission to the U.S. FDA as every other module has been submitted, reviewed and closed.

在腎去神經支配這一我們治療高血壓的突破性手術中，我們即將完成對我們 SPYRAL HTN-ON MED 研究中全部患者隊列的為期 6 個月的隨訪。然後，我們將分析數據併計劃在接下來的幾個月內展示調查結果。這些數據將完成我們向美國 FDA 提交的臨床模塊的最後一部分，因為所有其他模塊都已提交、審查和關閉。

The data on our simplicity blood pressure procedure is robust, including strong pivotal trial results and compelling real-world registry data from over 3,000 patients. And more recently, data has been presented that show already in-patient spend nearly double the time and target blood pressure range through 3 years than those who received a sham procedure.

我們簡單的血壓程序的數據是強大的，包括強大的關鍵試驗結果和來自 3,000 多名患者的令人信服的真實世界註冊數據。最近的數據顯示，與接受假手術的患者相比，住院患者花費的時間和目標血壓範圍在 3 年內幾乎增加了一倍。

This could have a profound effect on public health through the reduction of cardiovascular events, including stroke, heart failure and CV mortality. And we expect to be a leader in this market, which we project to exceed $500 million by calendar year 2026 and $2 billion to $3 billion by 2030.

通過減少心血管事件，包括中風、心力衰竭和心血管死亡率，這可能對公眾健康產生深遠影響。我們預計將成為這個市場的領導者，我們預計到 2026 年將超過 5 億美元，到 2030 年將超過 20 億至 30 億美元。

Moving to our Medical Surgical portfolio, which includes surgical robotics. We continue to execute on the limited market release of our Hugo robot. We're installing new systems and collecting clinical data in approved geographies, enhancing the system based on surgeon feedback, improving supply chain resiliency and scaling manufacturing production. Feedback and demand continue to be very strong. We've made progress over the last quarter, and we're nearing the start of the U.S. IDE clinical trial for our urology indication.

轉向我們的醫療外科產品組合，其中包括手術機器人。我們繼續執行 Hugo 機器人的有限市場發布。我們正在批准的地區安裝新系統並收集臨床數據，根據外科醫生的反饋增強系統，提高供應鏈彈性並擴大製造生產規模。反饋和需求仍然非常強勁。我們在上個季度取得了進展，我們即將開始針對我們的泌尿科適應症進行美國 IDE 臨床試驗。

We also continue to increase our user base of Touch Surgery Enterprise, our AI-powered surgical video and analytics platform. With Touch Surgery Enterprise, surgeons can now easily review film from their surgeries to continuously improve and advance patient care. Overall, when it comes to surgical robotics, we're investing heavily to become a major player in the market for the long term, leveraging our decades of experience and leadership in minimally invasive surgery.

我們還繼續增加我們的人工智能手術視頻和分析平台 Touch Surgery Enterprise 的用戶群。借助 Touch Surgery Enterprise，外科醫生現在可以輕鬆地查看手術中的影片，以不斷改進和推進患者護理。總體而言，在外科機器人技術方面，我們正在大力投資，以長期成為市場的主要參與者，利用我們在微創手術方面數十年的經驗和領導地位。

Now turning to our Neuroscience portfolio. In neuromodulation, we've submitted our inceptive ECAPs closed-loop stimulator. We expect inceptive's closed-loop therapy, which optimizes pain relief for patients to revolutionize the SCS market. We're also continuing to ramp our commercial activities to go after the diabetic peripheral neuropathy opportunity with our first cohort of DPN market development reps now trained.

現在轉向我們的神經科學產品組合。在神經調節方面，我們已經提交了我們的初始 ECAPs 閉環刺激器。我們期待 Inceptive 的閉環療法能夠優化患者的疼痛緩解，從而徹底改變 SCS 市場。我們還將繼續擴大我們的商業活動，以抓住糖尿病周圍神經病變的機會，我們的第一批 DPN 市場開發代表現已接受培訓。

We believe DPN is one of the largest opportunities in med tech, and we expect the market to reach $300 million by FY '26 with an annual total addressable market of up to $2 billion.

我們相信 DPN 是醫療技術領域最大的機會之一，我們預計到 26 財年市場將達到 3 億美元，每年的潛在市場總額高達 20 億美元。

In Diabetes, we're in active dialogue with the FDA on our regulatory submission for the MiniMed 780G with the Guardian 4 sensor and we remain focused on resolving our warning letter. We're making good progress on our warning letter commitments. We've completed more than 90% of the actions we committed to the FDA. This represents substantial progress toward resolving the warning letter and preparing for reinspection.

在糖尿病領域，我們正在與 FDA 就我們提交的帶有 Guardian 4 傳感器的 MiniMed 780G 的監管提交進行積極對話，我們將繼續專注於解決我們的警告信。我們在警告信承諾方面取得了良好進展。我們已經完成了向 FDA 承諾的 90% 以上的行動。這代表著在解決警告信和準備重新檢查方面取得了實質性進展。

In our CGM pipeline, we submitted our next-generation sensor, Simplera for CE Mark. Simplera is disposable. It's easier to apply, and it's half the size of Guardian 4. The Simplera file is ready to submit to the U.S. FDA, and we're waiting to submit it as we're prioritizing the 780G Guardian 4 review.

在我們的 CGM 管道中，我們提交了我們的下一代傳感器 Simplera for CE Mark。 Simplera 是一次性的。它更容易申請，大小只有 Guardian 4 的一半。 Simplera 文件已準備好提交給美國 FDA，我們正在等待提交，因為我們正在優先考慮 780G Guardian 4 審查。

And with regards to our overall Diabetes pipeline, we're making considerable investments well above our corporate R&D average. We have a comprehensive pipeline of multiple next-gen sensor and pump programs, including patch pumps. This pipeline gives us confidence that we can restore strong growth to our Diabetes business over the coming years.

關於我們的整體糖尿病管道，我們正在進行大量投資，遠高於我們的企業研發平均水平。我們擁有多個下一代傳感器和泵程序的綜合管道，包括貼片泵。這條管道讓我們相信，我們可以在未來幾年恢復我們糖尿病業務的強勁增長。

With that, I'll turn it over to Karen to discuss our first quarter financial performance and our guidance. Karen?

有了這個，我將把它交給凱倫來討論我們第一季度的財務業績和我們的指導。凱倫？

Thank you, Geoff. Our first quarter organic revenue exceeded guidance, decreasing 3.6%. Adjusted EPS of $1.13 decreased 17%, in line with our guidance range. As we outlined on our last earnings call, we faced acute supply chain challenges in the quarter, particularly in our Surgical Innovations business. We also faced tougher underlying growth comparisons, including both strong ventilator sales and good procedure recovery following the third wave of COVID last year.

謝謝你，傑夫。我們第一季度的有機收入超過了預期，下降了 3.6%。調整後每股收益為 1.13 美元，下降 17%，符合我們的指導範圍。正如我們在上次財報電話會議上概述的那樣，我們在本季度面臨著嚴峻的供應鏈挑戰，尤其是在我們的外科創新業務中。我們還面臨著更嚴峻的潛在增長比較，包括強勁的呼吸機銷售和去年第三波 COVID 之後良好的程序恢復。

Looking at our results from a geographic perspective, our U.S. revenue declined 9% and our non-U.S. developed and emerging markets both grew 2%. Our emerging markets growth was impacted this quarter by China, which declined 9% given COVID lockdowns and volume-based procurement. However, our teams drove strong growth in many other markets, including high teens growth in South Asia and Latin America, mid-teens growth in the Middle East and Africa, and low double-digit growth in Southeast Asia. And when you exclude China, our emerging markets grew 13%.

從地理角度來看，我們的美國收入下降了 9%，我們的非美國發達市場和新興市場均增長了 2%。本季度我們的新興市場增長受到中國的影響，由於 COVID 封鎖和基於數量的採購，中國下降了 9%。然而，我們的團隊推動了許多其他市場的強勁增長，包括南亞和拉丁美洲的青少年高增長、中東和非洲的青少年增長，以及東南亞的兩位數低增長。如果排除中國，我們的新興市場增長了 13%。

Turning to our margins. Our adjusted gross margin declined 230 basis points. The impact of the strengthening dollar drove 50 basis points of the decline, and the rest was primarily due to inflation on labor and materials as well as freight, given fuel surcharges and increased expedited shipments.

轉向我們的利潤。我們調整後的毛利率下降了 230 個基點。美元走強的影響推動了 50 個基點的下跌，其餘的主要是由於勞動力和材料以及運費的通貨膨脹，考慮到燃料附加費和加急裝運的增加。

As we said at the beginning of the year, we expect the impact from inflation and currency to continue to negatively affect our gross margin in the quarters ahead. I want to remind you, when you look at our R&D line, we had a recast of last year's IP R&D that we told you about last quarter. Without that recast, adjusted R&D expense would have grown 4% as we continue to prioritize investment into development programs across our businesses.

正如我們在年初所說，我們預計通脹和貨幣的影響將繼續對我們未來幾個季度的毛利率產生負面影響。我想提醒您，當您查看我們的研發線時，我們對上個季度告訴您的去年 IP 研發進行了重鑄。如果沒有重新調整，調整後的研發費用將增長 4%，因為我們將繼續優先投資於我們業務的發展計劃。

While our operating margin declined 320 basis points on lower revenue and gross margin pressures, we do expect to show sequential improvement as our revenue growth accelerates through the year. And our balance sheet remains strong, allowing us to invest in future growth and return capital to shareholders. We continue to target returning a minimum of 50% of our free cash flow to our shareholders, primarily through our strong and growing dividend. And we supplement these returns through opportunistic share repurchases.

雖然由於收入和毛利率壓力下降，我們的營業利潤率下降了 320 個基點，但我們確實預計隨著全年收入增長加速，我們的營業利潤率將出現連續改善。我們的資產負債表依然強勁，使我們能夠投資於未來的增長並將資本返還給股東。我們繼續致力於將至少 50% 的自由現金流返還給我們的股東，主要是通過我們強勁且不斷增長的股息。我們通過機會性的股票回購來補充這些回報。

This past quarter, we repurchased $336 million, which is on top of the $2.5 billion we repurchased last fiscal year. We also continue to put the cash on our balance sheet to work, investing in tuck-in acquisitions and minority investments that help fuel our near-term and future growth.

上個季度，我們回購了 3.36 億美元，高於我們上一財年回購的 25 億美元。我們還繼續將資產負債表上的現金投入使用，投資於有助於推動我們近期和未來增長的收購和少數股權投資。

We closed Intersect ENT in the quarter, and we also began the structured acquisition of the Acutus left-heart access portfolio and expect to begin distribution by the first half of calendar '23. Their advanced Transseptal Access Systems will be an important part of our broad offering to electrophysiologists and interventional cardiologists.

我們在本季度關閉了 Intersect ENT，我們還開始了對 Acutus 左心通路產品組合的結構化收購，預計將在 23 年上半年開始分銷。他們先進的 Transseptal Access Systems 將成為我們為電生理學家和介入心髒病學家提供的廣泛產品的重要組成部分。

Last month, we announced a co-promotion agreement and path toward acquisition with CathWorks. We're excited to partner with CathWorks and promote their innovative FFRangio System, which we believe can disrupt the traditional FFR market. We believe that Medtronic can add a lot of value to the technologies that we acquire, and we expect tuck-ins to supplement our organic R&D investment and long-term growth acceleration.

上個月，我們宣布了與 CathWorks 的共同推廣協議和收購途徑。我們很高興與 CathWorks 合作並推廣他們創新的 FFRangio 系統，我們相信這可以顛覆傳統的 FFR 市場。我們相信美敦力可以為我們獲得的技術增加很多價值，並且我們希望補充我們的有機研發投資和長期增長加速。

Now turning to our guidance. With one quarter behind us, we are maintaining our full year revenue guidance at 4% to 5% 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 full year revenue of $1.4 billion to $1.5 billion, an increase of $400 million over the past quarter. We expect organic revenue growth to improve each quarter, with the second half of our fiscal year much stronger than the first, driven by our expectation that many of the acute supply chain challenges subside and new products drive our growth.

現在轉向我們的指導。在我們落後四分之一的情況下，我們將全年收入指引維持在 4% 至 5% 的有機增長，這不包括我們收購 Intersect ENT 的貨幣變動和收入。如果近期匯率保持不變，外匯將對全年收入產生 14 億至 15 億美元的負面影響，比上一季度增加 4 億美元。我們預計每個季度的有機收入增長都會有所改善，我們財政年度的下半年比第一季度要強勁得多，這是因為我們預計許多嚴峻的供應鏈挑戰會消退並且新產品會推動我們的增長。

It's worth noting that we also face increasingly easier comparisons as we go through the fiscal year. By segment and on an organic basis, we continue to expect Cardiovascular to grow 5.5% to 6.5%, Medical Surgical to now grow 0.75% to 2.75%, given increased volume-based procurement in many of the Chinese provinces. Neuroscience to now grow 4.75% to 5.75%, given a slightly lower outlook for the neuromodulation market. And Diabetes to now decline 3% to 6%, given stronger growth in international markets.

值得注意的是，隨著財政年度的進行，我們也面臨著越來越容易的比較。按細分市場和有機基礎，我們繼續預計心血管將增長 5.5% 至 6.5%，醫療外科目前將增長 0.75% 至 2.75%，因為中國許多省份的基於數量的採購增加。鑑於神經調節市場的前景略低，神經科學現在將增長 4.75% 至 5.75%。鑑於國際市場的強勁增長，糖尿病現在下降了 3% 至 6%。

On the bottom line, we continue to expect non-GAAP diluted EPS in the range of $5.53 to $5.65. Inflation and currency are still creating near-term impacts on our margins, and we've seen inflation on raw materials and freight become larger headwinds over the past quarter. We also continue to execute on initiatives to partially offset these macro impacts as well as prioritize our R&D investments to drive future growth.

歸根結底，我們繼續預計非 GAAP 攤薄後每股收益在 5.53 美元至 5.65 美元之間。通貨膨脹和貨幣仍在對我們的利潤率造成短期影響，我們已經看到原材料和運費的通貨膨脹在過去一個季度成為更大的阻力。我們還將繼續執行部分抵消這些宏觀影響的舉措，並優先考慮我們的研發投資以推動未來的增長。

Given these dynamics, and the fact that we are still early in our fiscal year, we would suggest you model closer to the lower end of our EPS guidance range. Our EPS guidance includes an unfavorable impact of foreign currency, which is approximately $0.17 to $0.22 at recent rates.

鑑於這些動態，以及我們仍處於財政年度初期的事實，我們建議您將模型設置為更接近我們每股收益指導範圍的下限。我們的每股收益指引包括外幣的不利影響，按近期匯率計算約為 0.17 美元至 0.22 美元。

In the second quarter, we expect organic revenue growth in the range of 3% to 3.5%, implying a strong sequential acceleration driven by improved product availability and the cadence of our launches.

在第二季度，我們預計有機收入增長在 3% 至 3.5% 之間，這意味著由於產品可用性的提高和我們發布的節奏推動了強勁的連續加速增長。

Assuming recent exchange rates hold, the second quarter would have a currency headwind between $365 million and $415 million. By segment, we expect Cardiovascular to grow 5% to 5.5%, Medical Surgical to be down 0.25 point to up 0.25 point, Neuroscience to grow 5.5% to 6%, and Diabetes to be down 3% to 6%, all on an organic basis. And we expect EPS of $1.26 to $1.30, including an FX headwind of about $0.02 at current rates.

假設最近的匯率保持不變，第二季度的貨幣逆風將在 3.65 億美元至 4.15 億美元之間。按細分市場，我們預計心血管將增長 5% 至 5.5%，內科外科將下降 0.25 點至上升 0.25 點，神經科學將增長 5.5% 至 6%，糖尿病將下降 3% 至 6%，所有這些都基於有機增長基礎。我們預計每股收益為 1.26 美元至 1.30 美元，包括按當前匯率計算的約 0.02 美元的外匯逆風。

While our markets are facing challenges, we're focused on identifying ways to offset their impact to our financials, and we are optimistic about our future as we prepare to create markets and realize new opportunities. In addition, I want to take a moment to recognize and thank our employees at Medtronic, who are unwavering in their commitment to deliver life-saving treatment to people around the world. Back to you, Geoff.

雖然我們的市場面臨挑戰，但我們專注於尋找方法來抵消它們對我們財務的影響，並且在我們準備創造市場和實現新機遇時，我們對未來持樂觀態度。此外，我想花一點時間來認識和感謝我們在美敦力的員工，他們堅定不移地致力於為世界各地的人們提供挽救生命的治療。回到你身邊，傑夫。

Thank you, Karen. Now this last quarter, we made a lot of progress on our aggressive agenda of underlying changes that are needed to ultimately accelerate our growth. With supply chain, it's getting better. And our back orders are coming down, not just because of the external environment, but because of the actions we are taking under Greg Smith's leadership, and I expect these improvements will continue.

謝謝你，凱倫。現在在上個季度，我們在最終加速增長所需的基本變革的激進議程上取得了很大進展。有了供應鏈，情況就會變得更好。我們的延期交貨訂單正在減少，這不僅是因為外部環境，還因為我們在 Greg Smith 的領導下採取的行動，我預計這些改進將繼續下去。

We've co-located our employees with suppliers and are also working closely with sub-tier suppliers. We're managing through the acute issues and making progress on improvements that I'm confident can enhance the resiliency of our end-to-end supply chain.

我們已經將我們的員工與供應商放在一起，並且還與次級供應商密切合作。我們正在解決嚴重問題並在改進方面取得進展，我相信這些改進可以增強我們端到端供應鏈的彈性。

On quality, we've been conducting a large transformation of our quality system over the past couple of years. We're advancing quality in innovative ways, working very closely with our regulators, and this is leading to important progress. We're also making progress on our pipeline and portfolio as these 2 strategies come together to create meaningful growth drivers.

在質量方面，在過去的幾年裡，我們一直在對質量體系進行大規模轉型。我們正在以創新的方式提高質量，與我們的監管機構密切合作，這正在取得重要進展。隨著這兩項戰略共同創造有意義的增長動力，我們也在管道和投資組合方面取得了進展。

We're tucking new products into dependable higher growth businesses like we did by adding Intersect ENT to our ENT business. We're also broadening the product portfolio of some of our businesses so they can become more meaningful growth drivers for the total company, like our strategy in cardiac ablation solutions.

我們通過將 Intersect ENT 添加到我們的 ENT 業務中，將新產品投入到可靠的高增長業務中。我們還在擴大我們一些業務的產品組合，以便它們能夠成為整個公司更有意義的增長動力，例如我們在心臟消融解決方案方面的戰略。

Overall, the path has not been easy, but I'm confident that these fundamental enhancements that we're making in the company, combined with our op model change, culture changes and incentive changes, are positioning us to deliver a higher level of growth that can be sustained.

總的來說，這條道路並不容易，但我相信，我們在公司所做的這些根本性改進，再加上我們的運營模式變化、文化變化和激勵變化，使我們能夠實現更高水平的增長這是可以持續的。

And as we overcome the near-term issues and start to put points on the board with the pipeline, I believe the underlying transformation of Medtronic, all the work that we've been doing over the past couple of years will become increasingly apparent setting up a durable value creation engine to fully capitalize on the mega trends in the health care and technology markets, which will benefit all stakeholders.

隨著我們克服近期問題並開始在管道上提出要點，我相信美敦力的潛在轉型，我們在過去幾年所做的所有工作將變得越來越明顯一個持久的價值創造引擎，以充分利用醫療保健和技術市場的大趨勢，這將使所有利益相關者受益。

So to close, I want to join Karen in thanking our employees. It's never easy going through change, especially in a challenging macro environment, but our teams have stayed focused and are playing critical roles in helping to alleviate pain, restore health and extend life for millions of people around the globe.

最後，我想和凱倫一起感謝我們的員工。經歷變革絕非易事，尤其是在充滿挑戰的宏觀環境中，但我們的團隊始終保持專注，並在幫助全球數百萬人減輕痛苦、恢復健康和延長生命方面發揮著關鍵作用。

Now let's move to Q&A. We're going to try to get to as many analysts as possible, so we ask that you limit yourself to just 1 question and only if needed, a related follow-up. If you have additional questions, you can reach out to Ryan and the Investor Relations teams after the call. With that, Brad, can you please give the instructions for asking a question?

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 1 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。有了這個，布拉德，你能給出提問的說明嗎？

(Operator Instructions) Lastly, please be advised that this Q&A session is being recorded. For today's session, Geoff, Karen and Ryan are joined by Sean Salmon, EVP and President of the Cardiovascular portfolio; Bob White, EVP and President of the Medical Surgical portfolio; Brett Wall, EVP and President of the Neuroscience portfolio; and Que Dallara, EVP and President of the Diabetes operating unit. We'll pause for a few seconds to assemble the queue.

（操作員說明）最後，請注意，此問答環節正在錄製中。對於今天的會議，執行副總裁兼心血管產品組合總裁 Sean Salmon 加入了 Geoff、Karen 和 Ryan； Bob White，執行副總裁兼醫療外科產品組合總裁； Brett Wall，執行副總裁兼神經科學產品組合總裁；和糖尿病運營部門執行副總裁兼總裁 Que Dallara。我們將暫停幾秒鐘以組裝隊列。

We'll take the first question from Robbie Marcus at JPMorgan.

我們將回答摩根大通的 Robbie Marcus 提出的第一個問題。

Good morning, everyone, and congrats on the quarter. Maybe I'll ask both my questions upfront in one. The quarter came in a little better than expected, but second quarter guide is lower than where the street was thinking by maybe 0.5%, 0.75% on organic sales growth. So maybe you could walk us through how you're thinking about the cadence of the year. It includes a pretty material dollar step-up each quarter. What's driving that?

大家早上好，祝賀本季度。也許我會同時提出兩個問題。該季度的業績略好於預期，但第二季度的指引低於市場預期的水平可能為 0.5%，有機銷售增長為 0.75%。所以也許你可以告訴我們你是如何考慮今年的節奏的。它包括每季度一個相當實質性的美元增長。是什麼驅動了它？

And then also, it looks like you narrowed or lowered a lot of the product segment organic sales growth guidance with Diabetes the big offset. Maybe talk to if you're seeing any impact to share from some of the supply issues you had? And what's driving those moderated outlooks on the segment basis?

然後，看起來你縮小或降低了很多產品部門的有機銷售增長指導，而糖尿病是很大的抵消。如果您發現您遇到的一些供應問題有任何影響可以分享，也許可以談談？是什麼推動了這些細分市場的緩和前景？

Robbie, well, thanks for the question. There's a lot there to unpack. Maybe I'll start and then hand it over to Karen.

羅比，嗯，謝謝你的問題。有很多東西要解壓。也許我會開始，然後把它交給凱倫。

I mean, look, I think, look, the quarter played out largely as expected, managing through these macro headwinds and making progress on supply chain issues like resins and packaging. And the procedures largely remain at pre-COVID levels. And we are seeing month-over-month improvement and had a pretty good exit coming out of the quarter.

我的意思是，看，我認為，看，這個季度的表現基本上符合預期，克服了這些宏觀逆風，並在樹脂和包裝等供應鏈問題上取得了進展。並且這些程序在很大程度上保持在 COVID 之前的水平。而且我們看到逐月改善，並且在本季度有一個相當不錯的退出。

Getting to the remaining 3 quarters of the year, I mean, one, you see coming out of this first quarter, you'll see some tough comps anniversarying. I think we grew like 19% in Q1 last year, and we have vents and LVADs, certain tough comps anniversarying there. And then I mentioned earlier, some of these acute supply chain issues, we're starting to put them behind us. I mentioned resins and packaging. We have semiconductors that we're still dealing with across many businesses that will be with us for a little longer. But a lot of the acute issues we're starting to put behind us.

進入今年剩餘的 3 個季度，我的意思是，一個，你會看到第一季度的到來，你會看到一些艱難的周年紀念日。我認為我們去年第一季度增長了 19%，我們有通風口和 LVAD，那裡有一些艱難的周年紀念日。然後我之前提到過，其中一些嚴重的供應鏈問題，我們開始將它們拋在腦後。我提到了樹脂和包裝。我們有半導體，我們仍在與許多業務打交道，這些業務將與我們合作更長時間。但是我們開始把很多尖銳的問題拋在腦後。

And then we've got a number, and we'll get -- I'll let Karen get into the specifics of the Q2 versus the second half. But we have a number of nice growth drivers in the second half of the year, like the full market release of Evolut FX and EV-ICD coming as well. And it's -- and there's a whole -- there's a number of other launches as well or even existing products that are out there that pick up momentum, and the cadence as they go through the 3 quarters. Maybe I'll turn it over to Karen to provide a little more details on that.

然後我們有一個數字，我們會得到 - 我會讓凱倫了解第二季度與下半場的細節。但我們在下半年有一些不錯的增長動力，比如 Evolut FX 和 EV-ICD 的完整市場發布也即將到來。它是——而且是一個整體——還有許多其他的發布，甚至是現有的產品，它們正在加速發展勢頭，以及它們在三個季度中的節奏。也許我會把它交給凱倫提供更多的細節。

Yes. Thanks, Geoff, and good morning, Robbie. So I would add on Q2 that we do also expect some modest improvement in underlying procedural fundamentals. For example, we expect China procedures to come back. And we had some cardio procedures that were slightly impacted from contrast supply last quarter, that we expect to come back. We also continue to factor in the potential for incremental pressure from volume-based procurement in China, including a potential national VBP tender in spine and continued provincial tenders in SI.

是的。謝謝，傑夫，早上好，羅比。因此，我要在第二季度補充一點，我們確實預計基本程序基本面會有所改善。例如，我們預計中國程序會回來。上個季度我們有一些心臟手術受到對比劑供應的輕微影響，我們預計會回來。我們還繼續考慮中國基於數量的採購可能帶來的增量壓力，包括潛在的國家級 VBP 招標和持續的 SI 省級招標。

But just an important reminder, in Q2, we do have much easier comparisons versus the prior year. We grew only 2% last fiscal year, and that was given the impact of the Delta variant and some labor shortages on procedure volumes. So then as we move into the back half of the year, Geoff mentioned the exciting product launches that we have and the continued improvement in our acute supply chain challenges. And then I would also just note that our year-over comparisons continue to get easier from where they were in Q2. We had roughly 1.5% growth in Q3 and Q4 last year. And we also have the vent headwind easing in the back half.

但只是一個重要的提醒，在第二季度，與上一年相比，我們確實更容易進行比較。上一財年我們僅增長了 2%，這是考慮到 Delta 變體的影響以及一些勞動力短缺對手術量的影響。因此，當我們進入下半年時，Geoff 提到了我們推出的令人興奮的產品，以及我們面臨的嚴峻供應鏈挑戰的持續改進。然後我還要注意，我們的全年比較從第二季度開始變得更加容易。去年第三季度和第四季度我們的增長率約為 1.5%。而且我們在後半部分也有排氣逆風緩和。

And in terms of what's going on with our portfolios and the Diabetes offset, yes, we did see greater strength in Diabetes in this quarter, particularly in international growth, and we expect that to continue. And then we're just being overall prudent with our guidance. We think it's early in the fiscal year. We've still got a lot of macro uncertainties, particularly with inflation and freight. And so again, we just wanted to be prudent. I hope that helps.

就我們的投資組合和糖尿病抵消的情況而言，是的，我們確實在本季度看到了糖尿病的更大優勢，特別是在國際增長方面，我們預計這種情況將繼續下去。然後我們只是整體謹慎地接受我們的指導。我們認為這是在本財年初期。我們仍然有很多宏觀不確定性，特別是通貨膨脹和運費。同樣，我們只是想保持謹慎。我希望這會有所幫助。

Thanks, Robbie. We'll take the next question, Brad.

謝謝，羅比。我們將回答下一個問題，布拉德。

Okay. We'll take the next question from Vijay Kumar at Evercore ISI.

好的。我們將回答 Evercore ISI 的 Vijay Kumar 的下一個問題。

Geoff, I had two product-related questions, maybe one on Ardian and one on the robot. Ardian, can you just talk to us and when can we expect this data? I think you said it's in the upcoming months. Is that going to be a headline press release? Will that be a formal presentation at a conference? Is there any chance that the FDA looks at the data and could hold an ad comm? Or any sense on what we can expect from Ardian?

Geoff，我有兩個與產品相關的問題，一個關於 Ardian，一個關於機器人。 Ardian，你能和我們談談嗎？我們什麼時候可以期待這些數據？我想你說的是在接下來的幾個月裡。這會成為頭條新聞嗎？那會是在會議上的正式演講嗎？ FDA 是否有機會查看數據並進行廣告宣傳？或者我們對 Ardian 的期望有什麼意義？

Sure. Thanks for the question. Well, I'll start by saying -- I think I may hand over to Sean here for the answer on this one. But we're, as you've seen over the last couple of months and a number of conferences, more and more data is coming out.

當然。謝謝你的問題。好吧，我首先要說- 我想我可以在這裡交給肖恩來回答這個問題。但是，正如您在過去幾個月和許多會議上所看到的那樣，我們正在發布越來越多的數據。

I saw you did an interview or whatever, a session with the KOL in the space, and it was good to hear his feedback. So there is a lot, more and more data emerging, more and more physician excitement and confidence as they -- our sites, our trial sites have been working with these patients for quite a long time, and the data continues to build and be super positive.

我看到你進行了一次採訪或其他什麼活動，與該領域的 KOL 進行了一次會議，很高興聽到他的反饋。因此，出現了越來越多的數據，越來越多的醫生興奮和信心，因為他們——我們的站點，我們的試驗站點已經與這些患者合作了很長時間，並且數據繼續建立並變得超級積極的。

So we're optimistic. And Sean's pointed this out before, the FDA has done their own kind of patient preference studies, and it's clear to them that patients prefer this to medical management. So I know that they're looking for this to hit the market as well. But the specifics on your questions, I'll open up to Sean here to answer those on the timing of the data and will we have an ad comm or what have you.

所以我們很樂觀。肖恩之前指出，FDA 已經進行了他們自己的患者偏好研究，他們很清楚患者更喜歡這種方式而不是醫療管理。所以我知道他們也在尋找這個來打入市場。但是關於你的問題的細節，我會在這裡向肖恩敞開心扉回答那些關於數據時間的問題，我們會不會有一個廣告通訊或者你有什麼。

So Vijay, we finished enrollment and then a 6-month endpoint to get to, which will be ramping up very, very shortly, and we target the -- whatever comps we have this fall, which was most likely in the AHA. So we'll submit to AHA. And if it gets accepted, that would be the place that we'd see the results.

所以 Vijay，我們完成了註冊，然後是 6 個月的終點，這將很快增加，我們的目標是 - 我們今年秋天擁有的任何比賽，這很可能在 AHA 中。所以我們將提交給 AHA。如果它被接受，那將是我們看到結果的地方。

Now we'd also publish those results and make the top line available in that same period of time. And that is -- just a reminder, that is the last part of what we've submitted, right? So every other module has been reviewed and closed. It's just the clinical data that's outstanding. So we're as close as we've ever been.

現在，我們還將發布這些結果，並在同一時間段內提供頂線。那就是——提醒一下，這是我們提交的最後一部分，對吧？因此，所有其他模塊都經過審查和關閉。只是臨床數據非常出色。所以我們和以往一樣親密。

Got you. And then Geoff, maybe one on the surgical robot. I thought the prepared remarks, the commentary was pretty bullish. And correct me if I'm wrong, I saw a healthy order book, momentum with installations, key supply chain challenges have been addressed, U.S. IDE about the store. This feels like a change in tone versus the last call. So perhaps can you comment on what's changed in the last 3 months?

得到你。然後是 Geoff，也許是手術機器人上的一位。我認為準備好的評論，評論非常樂觀。如果我錯了，請糾正我，我看到了一份健康的訂單，安裝勢頭強勁，關鍵供應鏈挑戰已得到解決，美國 IDE 關於商店。這感覺就像上次通話時語氣的變化。那麼，也許您能評論一下過去 3 個月的變化嗎？

Sure. And I'll have Bob chime in as well. But yes, this quarter was a big quarter for us as we made, I think, quite a bit of progress on some of the supply chain concerns that we had, in some cases some specific issues that we had to resolve and building our manufacturing capacity as well ahead of the U.S. IDE and more importantly, expanded sales in Europe. We had a number of installs and continue to get good feedback. And the surgeon feedback continues to be really strong.

當然。我也會讓 Bob 插話。但是，是的，這個季度對我們來說是一個重要的季度，因為我們在一些供應鏈問題上取得了相當大的進展，在某些情況下，我們必須解決一些具體問題並建立我們的製造能力領先於美國 IDE，更重要的是，擴大了在歐洲的銷售。我們進行了多次安裝，並繼續獲得良好的反饋。外科醫生的反饋仍然非常強烈。

And I actually had a chance to meet with a number of our surgical innovations reps, sales reps. And I was asking them, like what are you hearing from your surgeons? I was pleased with what I heard. And there's a lot of -- the word is out. They like the design. They like the approach we're taking to the market. And they realize that when we launch, we won't have all the indications yet, and we're going to be building out our instrument on the number of instruments we have with it, but they want to be part of this journey with us. So I think the expectations are appropriately set. We built out some manufacturing capacity. And like I said in the commentary, we are real close to this U.S. IDE. And so I don't know, Bob, what do you want to add to that?

實際上，我有機會與我們的一些外科創新代表、銷售代表會面。我問他們，你從你的外科醫生那裡聽到了什麼？我對我聽到的很滿意。還有很多——這個詞已經傳出去了。他們喜歡這個設計。他們喜歡我們對市場採取的方法。他們意識到，當我們推出時，我們還沒有所有的跡象，我們將根據我們擁有的儀器數量來構建我們的儀器，但他們希望與我們一起參與這一旅程.所以我認為期望值是適當的。我們建立了一些製造能力。就像我在評論中所說的那樣，我們非常接近這個美國 IDE。所以我不知道，鮑勃，你想補充什麼？

Yes. No, thanks, Geoff. And Vijay, thanks a lot for the question. And I think you're right to characterize we're making solid progress with our surgical robotic ecosystem. And we really do think about it as an ecosystem with really good progress with touch surgery as well.

是的。不，謝謝，傑夫。還有維杰，非常感謝這個問題。而且我認為你正確地描述了我們在手術機器人生態系統方面取得了堅實的進展。我們確實認為它是一個生態系統，在觸摸手術方面也取得了很好的進展。

But as Jeff mentioned, our Hugo installations continued in the quarter. We liked it if they accelerated as we closed the quarter as well. And as I've spoken on previous calls, we were really focused on hardening our supply chain and our operations performance, and we've seen progress there.

但正如 Jeff 所說，我們在本季度繼續安裝 Hugo。如果他們在本季度結束時加速，我們會喜歡它。正如我在之前的電話會議上所說的那樣，我們真的專注於加強我們的供應鍊和運營績效，我們已經看到了進展。

And then third, we continue to train surgeons across the globe and across multiple specialties, and so solid progress there. So we're near the start of our IDE, and so we believe we continue on track. So thanks, Vijay. Thanks, Geoff.

第三，我們繼續在全球範圍內培訓多個專業的外科醫生，並在那裡取得了堅實的進展。因此，我們的 IDE 即將啟動，因此我們相信我們會繼續走上正軌。所以謝謝，維杰。謝謝，傑夫。

Bob mentioned the touch surgery. That's another big piece here with this ecosystem. That's something we learned in the spine space, how important it is to have not just the robot, but the all enabling technologies around it. We're starting to use -- customers are starting to use touch surgery with Hugo now and surgeons are impressed with the kind of analytical capabilities and the benefits of the secure video storage and sharing for case review and training and whatnot.

Bob提到了觸摸手術。這是這個生態系統的另一個重要組成部分。這是我們在脊柱領域學到的東西，不僅擁有機器人，而且擁有圍繞它的所有支持技術是多麼重要。我們開始使用——客戶現在開始使用 Hugo 的觸摸手術，外科醫生對這種分析能力以及安全視頻存儲和共享用於案例審查和培訓等的好處印象深刻。

So the ecosystem for our soft tissue robot is coming along nicely, as Bob mentioned. So there's definitely some excitement on our end.

因此，正如 Bob 所說，我們的軟組織機器人的生態系統發展良好。所以我們肯定有一些興奮。

Thanks, Vijay. Next question, please, Brad.

謝謝，維杰。下一個問題，拜託，布拉德。

The next question comes from Travis Steed at Bank of America, Global Research.

下一個問題來自美國銀行全球研究部的 Travis Steed。

So Geoff, I'll start with the portfolio management, portfolio stuff. It's been about 8 months since you started highlighting that. I didn't know if that was something we could see in FY '23. And it seems like you're highlighting solving for your weighted average market growth rate more than other variables at this stage of the process.

所以Geoff，我將從投資組合管理開始，投資組合的東西。自您開始強調這一點以來，已經過去了大約 8 個月。我不知道這是否是我們在 23 財年可以看到的。在這個過程的這個階段，你似乎比其他變量更強調解決你的加權平均市場增長率。

And then, Karen, a quick follow-up on something you said earlier. I think you said exiting the quarter with better momentum. So curious if you could comment a little bit on some of the August trends, and there's been some concern with investors about vacations and stuff like that. So would love to get any color on August.

然後，凱倫，對你之前所說的事情進行快速跟進。我認為您說以更好的勢頭退出本季度。很好奇您是否可以對 8 月份的一些趨勢發表一些評論，並且投資者對假期和類似的事情有些擔憂。所以很想在八月得到任何顏色。

Okay. Yes. Thanks for the question, Travis. Yes, we're definitely continuing to look at the whole portfolio more intently, and we've been doing that for several months now, as you mentioned. And look, I'll start by saying, look, we're really deeply committed to doing the right things for shareholders and all Medtronic stakeholders.

好的。是的。謝謝你的問題，特拉維斯。是的，我們肯定會繼續更專注地審視整個投資組合，正如您所提到的，我們已經這樣做了幾個月了。看，我首先要說，看，我們真的非常致力於為股東和所有美敦力利益相關者做正確的事情。

And when we're looking at this portfolio and capital allocation, we are talking about both the buying and the selling side and actively looking at, as you pointed out, portfolio management to really improve our weighted average market growth rate, whether it be through addition or subtraction and to make sure that the growth is more durable.

當我們研究這個投資組合和資本配置時，我們正在談論買方和賣方，並積極關注，正如您所指出的，投資組合管理以真正提高我們的加權平均市場增長率，無論是通過加法或減法，以確保增長更持久。

So look, we're making -- we made -- we're making a lot of progress on the approach here to look strategically at each business. And last quarter, we -- I'll remind you, we did announce an initial step on the subtraction side of things with the Renal Care Solutions JV with DaVita, but this process will be a continuous process.

所以看，我們正在 - 我們已經 - 我們在這裡的方法上取得了很大進展，以戰略性地看待每項業務。上個季度，我們 - 我會提醒你，我們確實宣布了與 DaVita 的腎臟護理解決方案合資企業在減法方面的第一步，但這個過程將是一個持續的過程。

I just want to also set that expectation and will play out over time. So the goals are unchanged. The process continues. And like the goal is this durable growth. So it's a lot easier to grow when your weighted average market growth rate is increasing as well. And I'll leave it at that and turn it over to Karen for the other question.

我只想設定這個期望，並且會隨著時間的推移而發揮作用。所以目標不變。該過程繼續進行。就像目標是這種持久的增長一樣。因此，當您的加權平均市場增長率也在增加時，增長會容易得多。我將把它留在那裡，然後交給凱倫回答另一個問題。

Yes. Thanks, Travis. We did exit the quarter with better momentum. We saw a reduction in our backlogs. We saw continued improvement each month of the quarter. And as we look at August, it's still early. And we do have -- we're still managing through some supply issues in some of our businesses. So the numbers are a little cloudy.

是的。謝謝，特拉維斯。我們確實以更好的勢頭退出了本季度。我們看到我們的積壓工作減少了。我們看到本季度每個月都在持續改善。當我們看到八月時，還為時過早。我們確實有——我們仍在處理一些業務中的一些供應問題。所以數字有點模糊。

But when we took that into account in our guidance and when we look at the operating units that are not impacted by supply issues through the first 3 weeks of August, we're trending largely in line with the second quarter of last year. So seeing continued momentum and improvement.

但是，當我們在指導中考慮到這一點時，以及當我們查看在 8 月前 3 週內不受供應問題影響的運營單位時，我們的趨勢與去年第二季度基本一致。因此，看到了持續的勢頭和改善。

Thanks, Travis. Take the next question, please, Brad.

謝謝，特拉維斯。請回答下一個問題，布拉德。

The next question comes from Cecilia Furlong at Morgan Stanley.

下一個問題來自摩根士丹利的 Cecilia Furlong。

I wanted to ask about the Diabetes business, the updated guidance for the year. Obviously, OUS came in stronger. But just what you're expecting now, both OUS, but then also in the U.S. from competitive pressures?

我想問一下糖尿病業務，今年的更新指南。顯然，OUS 的實力更強。但正是你現在所期待的，無論是 OUS 還是美國的競爭壓力？

And then I wanted to follow up. It sounded like your timing for submission of Simplera shifted your strategy there. Just if you could comment on how you're thinking about the cadence of submission.

然後我想跟進。聽起來你提交 Simplera 的時機改變了你的策略。如果您可以評論一下您對提交節奏的看法。

Sure. Well, thanks for the question, Cecilia. Yes, I mean, look, Diabetes, as mentioned and Karen mentioned it in her comments, I mean, we're seeing really strong growth in -- outside the U.S. and Europe in particular.

當然。好吧，謝謝你的問題，塞西莉亞。是的，我的意思是，看，糖尿病，正如提到的和凱倫在她的評論中提到的，我的意思是，我們看到了非常強勁的增長——尤其是在美國和歐洲以外。

And more -- even more importantly than that, the quarterly growth, it's the clinical results we're seeing in patients and the feedback on the patient experience is really positive with the 780G plus Guardian Sensor 4 system. So that, we think, bodes well for the franchise and what we'll see when we get it into the U.S. because we're competing with everybody there in Europe.

還有更多——更重要的是，季度增長，這是我們在患者身上看到的臨床結果，780G plus Guardian Sensor 4 系統對患者體驗的反饋非常積極。因此，我們認為，這對特許經營權以及當我們進入美國時我們會看到的情況是個好兆頭，因為我們正在與歐洲的每個人競爭。

And you had a couple of specific questions. And the other thing I'll say is, look, we -- this is a business that -- I got a lot of questions when I first became CEO 2 years ago about what we're going to do. We doubled down on investment. We believe that the integrated insulin delivery system that we have with the sensors, the insulin delivery device. And right now, for us, it's a durable pump and down the road with the pen and then, and hopefully a patch, we think is -- we've got -- in our market-leading algorithms, we think we've got a very sustainable position in a high-growth market that has high barriers to entry. And we've been powering through, and these results in Europe are very encouraging.

你有幾個具體的問題。我要說的另一件事是，看，我們——這是一家企業——兩年前我第一次成為首席執行官時，我遇到了很多關於我們將要做什麼的問題。我們加倍投資。我們相信我們擁有的帶有傳感器的集成胰島素輸送系統，即胰島素輸送設備。現在，對我們來說，它是一個耐用的泵，用筆在路上，然後，希望有一個補丁，我們認為是——我們有——在我們市場領先的算法中，我們認為我們有在進入門檻高的高增長市場中處於非常可持續的地位。我們一直在努力，歐洲的這些結果非常令人鼓舞。

On top of that, we recently had a -- the transition from Sean to Que. And Sean did a great job stabilizing this business and really focusing it where we have a competitive advantage and helping really focus our product road map. Que's picking it up from there. They had a great transition. And with that, maybe I'll introduce Que Dallara, who's been with us now 14, 15 weeks and is already having a big impact on not just diabetes, but on the leadership team at Medtronic. And it's a delight to be working with her. And why don't I introduce Que and welcome her to her first earnings call. Que?

最重要的是，我們最近進行了從 Sean 到 Que 的過渡。肖恩在穩定這項業務方面做得很好，並真正將其集中在我們具有競爭優勢的地方，並幫助真正專注於我們的產品路線圖。闕從那裡撿起來。他們有一個偉大的轉變。有了這個，也許我會介紹 Que Dallara，他現在已經和我們在一起了 14 到 15 週，並且已經對糖尿病產生了重大影響，而且對美敦力的領導團隊也產生了重大影響。很高興能和她一起工作。我為什麼不介紹 Que 並歡迎她參加她的第一次財報電話會議。闕？

Thanks, Geoff. Yes, I would say the transition with Sean has gone really well, and I'm really encouraged with the progress we're making on restoring this business to growth as well as innovation road map.

謝謝，傑夫。是的，我想說 Sean 的過渡非常順利，我對我們在恢復這項業務的增長以及創新路線圖方面所取得的進展感到非常鼓舞。

And to address your 2 specific questions around what we see in the U.S. as well as around Simplera, I would say that, look, our short-term focus is remediating the warning letter and also making progress with the FDA around approval of the 780G and Guardian 4 sensor system. We continue to be encouraged by that, making good progress. And so our hope is that we can remediate that and secure approval in the near term.

為了解決您關於我們在美國和 Simplera 周圍看到的兩個具體問題，我想說，看，我們的短期重點是糾正警告信，並在 FDA 批准 780G 和Guardian 4 傳感器系統。我們繼續受到鼓舞，取得了良好的進展。因此，我們希望我們能夠在短期內糾正這一問題並獲得批准。

Now -- but we're not standing still. In the U.S., we do see growth in our 770G system as well as our InPen technology. And not only that, we are very close to launching the extended-wear infusion set, which has been approved by the FDA for up to 7 days wear and this is a game changer for patients. It's probably the biggest innovation we've seen in the last 20 years in this area and allows patients to be able to synchronize, if you like, their sensor CGM changes with the infusion set changes, leading to better site recovery and the comfort for our customers.

現在——但我們並沒有停滯不前。在美國，我們確實看到了 770G 系統以及 InPen 技術的增長。不僅如此，我們非常接近推出延長佩戴輸液器，它已獲得 FDA 批准，可佩戴長達 7 天，這對患者來說是一個遊戲規則的改變者。這可能是過去 20 年來我們在該領域看到的最大創新，如果您願意，患者可以同步他們的傳感器 CGM 隨著輸液器的變化而變化，從而更好地恢復部位並為我們的患者帶來舒適感。顧客。

So that's happening. We obviously anticipate 780G, but we're not standing still with respect to the products that we do have approved in the U.S. And with regards to Simplera, I mean, we're very excited about this product. It's half the size of the Guardian 4 sensor. It's thinner. We've submitted a CE Mark in July as we said we would. It is ready to go for submission in the U.S. But we are -- we remain focused on prioritizing the efforts around the warning letter as well as 780G approval.

所以這正在發生。我們顯然預計 780G，但對於我們在美國批准的產品，我們並沒有停滯不前。關於 Simplera，我的意思是，我們對這個產品感到非常興奮。它的大小只有 Guardian 4 傳感器的一半。它更薄。正如我們所說，我們已在 7 月提交了 CE 標誌。它已準備好在美國提交。但我們仍然專注於優先處理警告信和 780G 批准方面的工作。

Okay. Thank you, Que.

好的。謝謝你，闕。

Thanks, Cecilia. Next question, please, Brad.

謝謝，塞西莉亞。下一個問題，拜託，布拉德。

The next question comes from Larry Biegelsen at Wells Fargo Securities.

下一個問題來自富國銀行證券的拉里·比格爾森。

First, on supply constraints, I think in Q4, you said it was about a $260 million impact. How much was the impact in Q1? What are your expectations for Q2? And are you assuming some catch-up from lost sales?

首先，關於供應限制，我認為在第四季度，您說影響約為 2.6 億美元。 Q1的影響有多大？您對 Q2 的期望是什麼？你是否假設從銷售損失中得到一些追趕？

And just lastly, Karen, maybe talk about the FX hedging gain in the guidance now for '22. I think it was $410 million to $440 million. And how that rolls off in fiscal 2024, how we should think about that?

最後，凱倫，也許現在在 22 年的指導中談論外匯對沖收益。我認為是 4.1 億到 4.4 億美元。以及如何在 2024 財年實現這一目標，我們應該如何考慮？

Well, look, thanks for the question, Larry. I'll start on the expectations for Q2 and beyond on the supply chain stuff. Like I mentioned, Q4, Q1 were the most acute for us on these supply chain issues, and I'm definitely glad that we're looking in the rearview mirror on those quarters.

好吧，看，謝謝你的問題，拉里。我將從對第二季度及以後供應鏈方面的預期開始。就像我提到的那樣，在這些供應鏈問題上，第四季度和第一季度對我們來說是最尖銳的，我很高興我們正在審視這些季度的後視鏡。

We're not out of the -- totally out of the woods yet, but our back orders are coming down. We're seeing particular improvement in areas like resins and packaging across the company. A lot of this is a result of us taking well over 100 of our employees and co-located them with our top suppliers to help them prioritize Medtronic, but more importantly, kind of work through, make sure that communication is tight, the planning is tight. And that's really making a difference.

我們還沒有完全擺脫困境，但我們的延期交貨訂單正在減少。我們在整個公司的樹脂和包裝等領域看到了特別的進步。這在很大程度上是因為我們僱傭了超過 100 名員工並將他們與我們的頂級供應商放在一起，以幫助他們優先考慮美敦力，但更重要的是，通過工作，確保溝通緊密，計劃是緊的。這真的很重要。

The macro market is getting a little better. I mean, in some of these areas, in particular. I mentioned earlier that semiconductors are still going to be with us for a while, that back order. We're working directly with the semiconductor companies on this. And just across the board also, one of the things we've done in addition to co-locating our employees with our top suppliers is going out to -- directly to the commodity or raw material suppliers versus the supplier that's between us and them, if you will, the finisher or the distributor, the middleman, and locking in contracts and getting prioritization, especially given that these products go into medical products and are life-preserving and life-saving.

宏觀市場正在好轉。我的意思是，特別是在其中一些領域。我之前提到過，半導體仍將伴隨我們一段時間，即延期交貨。我們正在與半導體公司直接合作。此外，除了將我們的員工與我們的頂級供應商共處一地之外，我們所做的一件事是直接向商品或原材料供應商，而不是我們和他們之間的供應商，如果您願意，完成者或分銷商，中間人，並鎖定合同並獲得優先級，特別是考慮到這些產品進入醫療產品並且可以挽救生命和挽救生命。

And in some cases, those raw material suppliers weren't aware of that. So all of this is definitely helping, and we'll continue to see this back order go down over time. As I said, I think we're starting to put the most acute piece of this behind us.

在某些情況下，這些原材料供應商並沒有意識到這一點。所以所有這一切肯定是有幫助的，隨著時間的推移，我們將繼續看到這個延期交貨的訂單減少。正如我所說，我認為我們開始將最尖銳的部分拋在腦後。

In terms of catching up on lost sales, kind of like COVID, we don't put a bolus of lost sales coming through into our guidance. And right now, in particular, as you've seen and heard is, there is kind of a little bit of a governor out there on procedures with the health care worker shortage, which has gotten better, but it's still hard for customers to run at 110%, 120% of pre-COVID levels.

在彌補銷售損失方面，有點像 COVID，我們不會將大量銷售損失納入我們的指導。尤其是現在，正如你所見所聞，在醫療人員短缺的程序上，有一點點州長，情況已經好轉，但客戶仍然很難運行為 COVID 之前水平的 110%、120%。

So because of that, we haven't really baked a catch-up on sales into the guidance. You had some specific quantification questions on, and I'll turn those over to Karen. And Karen, anything else you want to add to the qualitative comments that I made.

因此，正因為如此，我們並沒有真正將銷售情況納入指導。你有一些具體的量化問題，我會把這些問題交給凱倫。還有凱倫，你想在我所做的定性評論中添加任何其他內容。

Thank you. I think you covered it well on supply chain. We did say that we expect it to get a little worse before it got better, and that's what happened in the first quarter, but we expect it to get better from here. We do have the supply chain improving, but again, not necessarily a bolus catch-up built into the guide.

謝謝你。我認為你在供應鏈上很好地涵蓋了它。我們確實說過，我們預計它會在好轉之前變得更糟，這就是第一季度發生的情況，但我們預計它會從這裡變得更好。我們確實改善了供應鏈，但同樣，指南中不一定有快速追趕。

In terms of FX, as you've seen, we've had the strengthening dollar continue to impact our reported revenue, just like it has for many of our peers. We do have foreign currency-based cost of sales and overhead. And now we have foreign currency-based interest expense as well, and those all provided some offset. And as you know, Larry, we also have the benefit of our multiyear currency hedging program, which did produce significant gains, and that resulted in a smaller FX impact to the bottom line in the quarter.

在外匯方面，正如您所見，美元走強繼續影響我們報告的收入，就像我們的許多同行一樣。我們確實有基於外幣的銷售成本和管理費用。現在我們也有基於外幣的利息費用，這些都提供了一些抵消。正如你所知，拉里，我們還受益於我們的多年貨幣對沖計劃，該計劃確實產生了可觀的收益，並且對本季度的利潤產生了較小的外匯影響。

As we look ahead for FX, I would say, keep in mind, it's only Q1 now. We've got foreign exchange rates that are continually volatile. So we know they're going to move from here. But if we look at next fiscal year, based on recent rates, we would expect the headwind next fiscal year to be similar to the headwind this fiscal year, again, if rates stay the same. I hope that helps.

當我們展望外匯時，我想說，請記住，現在只是第一季度。我們的外匯匯率一直在波動。所以我們知道他們會從這裡搬走。但是，如果我們看看下一個財政年度，根據最近的利率，如果利率保持不變，我們預計下一個財政年度的逆風將與本財年的逆風相似。我希望這會有所幫助。

Thanks, Larry. Next question, please, Brad.

謝謝，拉里。下一個問題，拜託，布拉德。

The next question comes from Joanne Wuensch at Citi.

下一個問題來自花旗的 Joanne Wuensch。

Briefly, the -- if revenue is improving quarter-over-quarter throughout the remainder of the year, do operating margins and gross margins also improve?

簡而言之，如果在今年剩餘時間裡收入環比增長，那麼營業利潤率和毛利率也會提高嗎？

And I'll just throw my second one quickly. Hugo, what does it take to bring that into the United States? And is there a parameter or a thought process on the timing?

我會很快扔掉我的第二個。雨果，把它帶到美國需要什麼？是否有關於時間的參數或思考過程？

Yes. Thanks, Joanne. On margins, we do expect margins to improve sequentially through the year as revenue improves. So the answer to that one is yes. And then, Geoff, for...

是的。謝謝，喬安妮。在利潤率方面，我們確實預計隨著收入的提高，利潤率將在全年連續提高。所以這個答案是肯定的。然後，傑夫，為...

Yes, sure. On Hugo, what does it take to get it to United States? Obviously, you got to start our U.S. IDE, which is set up here. And our -- Bob's mentioned in the past getting our customers, our trial sites ready for that and physicians trained, which we've been working on. But Bob, do you want to give some more specifics on that?

是的，當然。在 Hugo 上，將它送到美國需要什麼？顯然，您必須啟動我們在此處設置的 U.S. IDE。我們的 - Bob 過去提到過讓我們的客戶、我們的試驗場所為此做好準備，並對醫生進行培訓，我們一直在努力。但是鮑勃，你想給出更多的細節嗎？

You're exactly right, Jeff. It begins with our U.S. IDE that will start the U.S. process. And as we mentioned, Joanne, we're nearing the start of that, but that will be the key milestone that we'll certainly update to guide investors on.

你完全正確，傑夫。它從我們的美國 IDE 開始，它將啟動美國進程。正如我們提到的，喬安妮，我們即將開始，但這將是我們肯定會更新以指導投資者的關鍵里程碑。

Okay. Thanks, Joanne. Next question, please.

好的。謝謝，喬安妮。下一個問題，請。

The next question comes from Jayson Bedford at Raymond James.

下一個問題來自 Raymond James 的 Jayson Bedford。

Just a couple of Diabetes questions. It was mentioned that you hope to remediate the warning letter and secure approval for 780G in the near term. Do you have clarity on if you can get approval for 780G while the warning letter is still outstanding?

只是幾個糖尿病問題。有人提到您希望在短期內修復警告信並獲得 780G 的批准。您是否清楚在警告信仍未解決的情況下是否可以獲得 780G 的批准？

I think the -- thanks for the question. I think the variance path is an option. But as I said earlier, I think our primary priority is to work with the FDA and remediate the warning letter, now focus entirely on doing that.

我認為——謝謝你的問題。我認為方差路徑是一種選擇。但正如我之前所說，我認為我們的首要任務是與 FDA 合作並修復警告信，現在完全專注於這樣做。

Obviously, we'd love to, we're very eager to launch the product, but we were focused on patient safety, making sure that our remediation plans are robust. It's really the first and foremost in our mind that we make those corrective actions. So that's our primary focus.

顯然，我們很樂意，我們非常渴望推出該產品，但我們專注於患者安全，確保我們的補救計劃是穩健的。採取這些糾正措施確實是我們首先想到的。所以這是我們的主要關注點。

In parallel to that, we are engaged with the FDA on getting the 780G and Guardian 4 sensor system approved. Those -- both those things continue to make progress. It's obviously very hard for us to be completely predictive around when those things will happen, but I'm really pleased with the progress that we're making on both of those.

與此同時，我們正在與 FDA 合作，讓 780G 和 Guardian 4 傳感器系統獲得批准。那些——這兩件事都在繼續取得進展。顯然，我們很難完全預測這些事情何時會發生，但我對我們在這兩方面取得的進展感到非常滿意。

Okay. And I apologize if I missed this earlier. But when will you submit Simplera to the FDA?

好的。如果我早些時候錯過了這一點，我深表歉意。但是您何時將 Simplera 提交給 FDA？

We will do that as soon as we feel confident that we've made sufficient progress on the warning letter remediation as well as progress on the 780G. So as you know, we submitted for CE Mark in July, as we said we would. And we just want to make sure that our focus remains on those immediate short-term goals of warning letter remediation and approval for the 780G.

一旦我們確信我們在警告信整治和 780G 方面取得了足夠的進展，我們就會這樣做。如您所知，我們在 7 月提交了 CE 標誌，正如我們所說的那樣。我們只是想確保我們的重點仍然放在警告信修復和批准 780G 的那些近期短期目標上。

Thanks, Jayson. Next question, please, Brad.

謝謝，傑森。下一個問題，拜託，布拉德。

The next question comes from Steve Lichtman of Oppenheimer & Co.

下一個問題來自 Oppenheimer & Co. 的 Steve Lichtman。

Geoff, thinking a little longer term. How far along would you say are Greg Smith and his team and making them more durable changes in operations you've talked about in prior calls, and when do you think we could start seeing margin benefits from those initiatives?

傑夫，考慮長遠一點。您認為 Greg Smith 和他的團隊會走多遠，並使他們在您之前的電話會議中談到的運營變革更加持久，您認為我們什麼時候可以開始看到這些舉措帶來的利潤收益？

That's a great question. Thanks for that one, Steve. They're -- they've made quite a bit of progress in a relatively short period of time. Greg started in April of 2021. So it's been a little over a year. In that time, we've -- working with the executive team, we've centralized, if you will, the global operations and supply chain function.

這是一個很好的問題。謝謝你，史蒂夫。他們是——他們在相對較短的時間內取得了相當大的進步。 Greg 於 2021 年 4 月開始工作。所以已經一年多一點了。在那段時間裡，我們與執行團隊合作，如果你願意的話，我們已經集中了全球運營和供應鏈功能。

This is one of those opportunities in our new model where we're trying to play small and play big at the same time. Certain things have been decentralized into the businesses and the businesses are more empowered, refer to them as operating units. And then certain things, a limited list where we'll leverage our scale or drive -- and/or drive standards. And the supply chain is definitely one of those.

這是我們新模式中的機會之一，我們試圖同時玩小遊戲和大遊戲。某些事情已經分散到業務中，業務更加授權，將它們稱為運營單位。然後是某些事情，一個有限的列表，我們將在其中利用我們的規模或驅動力——和/或驅動器標準。供應鏈絕對是其中之一。

So we've made that change, that organizational change, which is probably the biggest organizational change we've made, even more than going to the 20 operating units. And so it's significant. In addition, we started to invest in new capabilities. Hiring people from outside the company, outside the industry, and in many cases, that are best-in-class in the various sub functions, if you will, or capabilities within the global operations and supply chain, things like planning, things like factory automation, et cetera.

所以我們做出了改變，組織改變，這可能是我們做過的最大的組織改變，甚至超過了 20 個運營單位。所以這很重要。此外，我們開始投資於新的能力。從公司外部、行業外部招聘人員，在許多情況下，這些人員在各種子職能方面是一流的自動化等。

And we've been -- so we've hired quite a few, and I think the majority of Greg's team is new in the last year. And we've been making investments in technology, various different systems on planning and supply planning, demand planning, et cetera. And the #1 focus has been resiliency and quality. There's 3 things we're looking at from this function: resiliency, quality because they have a big impact on quality and over time, cost of goods sold productivity that you're getting to that would be 2x or more of what we've seen historically at Medtronic.

而且我們一直 - 所以我們僱傭了很多人，我認為格雷格團隊的大部分人都是去年的新人。我們一直在技術、各種不同的計劃和供應計劃系統、需求計劃等方面進行投資。第一重點是彈性和質量。我們從這個功能中看到了 3 件事：彈性、質量，因為它們對質量有很大影響，隨著時間的推移，您所獲得的商品銷售成本將是我們所見的 2 倍或更多歷史上在美敦力。

And so that will play out over time. We haven't seen that yet. The other thing you've got a lot going on in there. You've got you've got inflation and things like that, that are kind of masking any kind of or overshadowing, if you will, any kind of cost of goods sold productivity that we are seeing. So -- but we will see that over time and we're confident. But we haven't quantified the exact timing of it. And like I said, it's been a little kind of hard to decipher here in the short term because of the inflationary impact on our cost of goods sold. I don't know, Karen, do you want to...

所以這將隨著時間的推移而發揮作用。我們還沒有看到。另一件事你在那裡有很多事情要做。你已經得到了通貨膨脹和類似的事情，如果你願意的話，這有點掩蓋或掩蓋我們所看到的任何類型的商品銷售成本。所以 - 但隨著時間的推移，我們會看到這一點，我們有信心。但我們還沒有量化它的確切時間。就像我說的那樣，由於通貨膨脹對我們的商品銷售成本的影響，短期內有點難以解讀。我不知道，凱倫，你想...

Yes. Thanks, Geoff, and thanks for the question. We are making a lot of progress in the ops front. And our shorter-term goal is going to be a focus on driving enough cost offset to offset the impacts that we've got, either in pricing or inflation. We're not ready to give guidance for next fiscal year, but that's the initial goal just to offset.

是的。謝謝，傑夫，謝謝你的問題。我們在運營方面取得了很大進展。我們的短期目標是專注於推動足夠的成本抵消，以抵消我們在定價或通貨膨脹方面的影響。我們還沒有準備好為下一財年提供指導，但這是最初的目標，只是為了抵消。

And then over time, to hopefully more than offset. I would say, Geoff mentioned, too, that this work in operations is not just going to help on the cost of goods sold line, but also on the revenue line, as we can more predictably have products available and get quality issues and better stead. So I think it will help on both.

然後隨著時間的推移，希望不僅僅是抵消。我想說，Geoff 也提到，這項運營工作不僅有助於降低銷售成本線，還有助於提高收入線，因為我們可以更可預測地提供產品並解決質量問題和更好的解決方案.所以我認為這對雙方都有幫助。

Okay. Thanks, Steve. Next question, please, Brad.

好的。謝謝，史蒂夫。下一個問題，拜託，布拉德。

The next question comes from Rich Newitter at Truist Securities.

下一個問題來自 Truist Securities 的 Rich Newitter。

Just on Spine, I think you guys called out navigation and robotics, it decline. I was hoping you could talk a little bit about what you're seeing there on the funnel, the pipeline and the capital environment more broadly. Any changes that are taking place in the way you're selling these types of capital items, especially robotics?

就在 Spine 上，我認為你們呼籲導航和機器人技術，它拒絕了。我希望你能更廣泛地談談你在漏斗、管道和資本環境中看到的東西。您銷售這些類型的資本項目（尤其是機器人技術）的方式發生了哪些變化？

And then we did see one of your orthopedics robotic competitors talk about changing business models, more rentals, meanwhile, but your direct spine robotics competitor actually saw a sequential pickup in capital purchases. So it would be great to get your color on the capital environment and specifically what's going on in the spine robotics.

然後我們確實看到你的一個骨科機器人競爭對手談論改變商業模式，同時增加租金，但你的直接脊柱機器人競爭對手實際上看到了資本購買的連續回升。因此，讓您了解資本環境，特別是脊柱機器人技術的發展情況會很棒。

Sure. Thanks for the question, Rich. I'm going to have Brett Wall, President of Neuroscience field that question.

當然。謝謝你的問題，里奇。我將請神經科學領域的總裁 Brett Wall 來回答這個問題。

Sure, Rich. Yes, looking overall, the capital, we have a very extensive ecosystem and capital system within our CST business. And what we saw was extended purchasing times, particularly as we move through to the end of our quarter.

當然，里奇。是的，從總體上看，資本，我們在 CST 業務中擁有非常廣泛的生態系統和資本系統。我們看到的是購買時間延長，尤其是在我們進入季度末的時候。

Now specifically, as it relates to the technology and the selling models, we have a variety of different approaches that we use. And so we're well positioned. However, the markets seem to work at hospitals, they are in a mode of preserving cash. We have more opportunities to put forth different models where we actually utilize the implantables and other disposable products as a way of financing this particular capital, and that works very well.

現在具體來說，由於它與技術和銷售模式有關，我們使用了各種不同的方法。所以我們處於有利地位。然而，市場似乎在醫院運作，它們處於一種保存現金的模式。我們有更多的機會提出不同的模型，我們實際上利用植入物和其他一次性產品作為為這一特定資本融資的一種方式，而且效果很好。

We didn't see a significant uptick in our O-arms or StealthStations during the time -- this time with that model, but we saw a little bit of an uptick with Mazor in that particular model. And we think during these times, we'll probably see more of that. The competitor you referenced there, if you look at calendar Q2, per our calculations, we continue to outstrip them in our actual placement and sales of robots. And -- so we continue to do that, and our procedural base there is nearing almost double the amount that they reported in their last earnings call.

在此期間，我們沒有看到我們的 O 型臂或 StealthStation 有顯著提升——這次是使用該型號，但我們看到 Mazor 在該特定型號中略有提升。我們認為，在這些時期，我們可能會看到更多這樣的情況。您在那裡引用的競爭對手，如果您查看日曆 Q2，根據我們的計算，我們在機器人的實際放置和銷售方面繼續超過他們。而且 - 所以我們繼續這樣做，我們的程序基礎幾乎是他們在上次財報電話會議上報告的數量的兩倍。

So we are very well positioned there. And then the underlying spine business remains pretty attractive. We saw a 4% increase in our core spine business there. So we're pleased with how that's recovering.

所以我們在那裡的位置非常好。然後，潛在的脊柱業務仍然很有吸引力。我們在那裡的核心脊柱業務增長了 4%。因此，我們對恢復情況感到滿意。

Yes. We're really excited about the positioning of our spine business with the recent product launches in the implant side, but the ecosystem that we've built over the last decade and how that's come to bear and how the market is shifting to that ecosystem approach. So we're feeling good about spine as we move forward here.

是的。我們對脊柱業務的定位感到非常興奮，最近在植入物方面推出了產品，但我們在過去十年中建立的生態系統以及它是如何實現的，以及市場如何轉向這種生態系統方法.因此，當我們在這裡前進時，我們對脊椎感覺良好。

Yes. Thanks, Rich. I think we've got time for one more question, Brad.

是的。謝謝，里奇。我想我們還有時間再問一個問題，布拉德。

Our final question comes from Rick Wise at Stifel, Nicolaus & Company.

我們的最後一個問題來自 Stifel, Nicolaus & Company 的 Rick Wise。

I was hoping, Geoff, just in closing, you'd expand on 2 of your exciting, I think, pipeline opportunities. You highlighted AURORA, the leadless subcu device. I was hoping you'd share your latest thinking in terms of the opportunity there. And when you talk about U.S. approval next year, are you saying next calendar year or next fiscal year? And this seems like a major opportunity, I was hoping you could talk about that.

我希望，傑夫，剛剛結束，你會擴展你的兩個令人興奮的，我認為，管道機會。您突出顯示了 AURORA，即無引線的 subcu 設備。我希望你能就那裡的機會分享你的最新想法。當你談到明年美國的批准時，你是說下一個日曆年還是下一個財政年度？這似乎是一個重大機會，我希望你能談談。

And just last, you didn't talk as much this time about the opportunity in pulsed field ablation. Maybe just update us on your internal Medtronic program and the favored programs and just some timelines on the U.S. trial, follow-up submission and approval timing. Any of that would be great.

就在最後，你這次沒有過多地談論脈衝場消融的機會。也許只是向我們介紹您的內部美敦力計劃和受青睞的計劃，以及美國試驗的一些時間表、後續提交和批准時間。任何一個都會很棒。

Yes, sure. Yes. Thanks for the question, Rick. And those are 2 topics we like to talk about with -- and I'm going to hand it over to Sean here to give you some details.

是的，當然。是的。謝謝你的問題，瑞克。這些是我們喜歡談論的 2 個話題——我將在此將其交給 Sean，以便為您提供一些細節。

But on AURORA, like I mentioned in the commentary, I mean, this -- we think we can take this segment and shift it from what up to now has been what we would define as somewhat nichey to a bigger segment. We're talking about $1 billion by 2030. We just don't think you're -- with our AURORA, we don't think you're making -- the physicians or the patients have to make the trade-offs here and you get that traditional impact that we had from [attritional] ICD with much less invasive approach here. And so I'll turn it over to Sean on that.

但是在 AURORA 上，就像我在評論中提到的那樣，我的意思是，我們認為我們可以把這個細分市場從迄今為止我們定義為有點小眾的東西轉移到更大的細分市場。我們談論的是到 2030 年達到 10 億美元。我們只是不認為你是 - 有了我們的 AURORA，我們不認為你在做 - 醫生或患者必須在這裡做出取捨和你會得到我們從 [attritional] ICD 獲得的傳統影響，這裡採用侵入性更小的方法。所以我會把它交給肖恩。

And then on PFA, you mentioned Affera, and Sean will give you the details between our internal program on PFA and Affera. But again, Affera plus Acutus, it's that whole cardiac ablation solutions business, our Afib business. We think this really rounds out that business. We're anticipating an approval on -- from FTC on the Affera acquisition here. And we'll move forward on that aggressively because it really is a high growth market where we've been a little bit nichey, I would say. And this would round out that and make this -- that business a real growth driver for the company. But on your specific question, I don't know, Sean, do you want to dive into the -- some of Rick's specifics?

然後在 PFA 上，您提到了 Affera，Sean 將向您介紹我們關於 PFA 和 Affera 的內部計劃之間的詳細信息。但同樣，Affera 加上 Acutus，它是整個心臟消融解決方案業務，我們的 Afib 業務。我們認為這確實完善了該業務。我們期待 FTC 對 Affera 的收購獲得批准。我們將積極推進這一點，因為它確實是一個高增長的市場，我們一直有點小眾，我會說。這將完善這一點，並使該業務成為公司真正的增長動力。但是關於你的具體問題，我不知道，肖恩，你想深入了解瑞克的一些細節嗎？

Yes, sure. So Rick, as Jeff mentioned in the commentary, today's subcutaneous ICD market is, it's a niche around $300 million, $350 million -- $300 million to $350 million annually. And we think that within 10 years, this could be $1 billion segment.

是的，當然。所以 Rick，正如 Jeff 在評論中提到的那樣，今天的皮下 ICD 市場是一個大約 3 億美元、3.5 億美元——每年 3 億到 3.5 億美元的利基市場。我們認為，在 10 年內，這可能是 10 億美元的細分市場。

And the reason that it expands is all those limitations of the current device where we can get sort of the benefits of traditional ICD, smaller devices, longer battery life, the ability to pace out of the arrhythmia rather than having to shock out of arrhythmia. That's really both that can expand the market, like we saw the leadless pacing. When we went to that, we started picking up new patients that weren't being treated because of the acuity of disease and leads to that strong growth. With regard to timing, we're saying next calendar year, to kind of put a finer point on that, it's the first half of next calendar year is what we're targeting for approval for the U.S.

它擴展的原因是當前設備的所有這些限制，我們可以獲得傳統 ICD 的好處，更小的設備，更長的電池壽命，能夠擺脫心律失常而不是不得不休克心律失常。這兩者都可以擴大市場，就像我們看到了無鉛的節奏一樣。當我們這樣做時，我們開始接受由於疾病的嚴重性而沒有接受治療的新患者，並導致了強勁的增長。關於時間安排，我們說的是下一個日曆年，為了更好地說明這一點，我們的目標是下個日曆年的上半年獲得美國的批准。

Pulsed field ablation, we have completed the trial, as you know, last November, and that's been in its follow-up period. So that would put us for availability of data in the spring time. That's probably one of the most likely to be presented. And of course, the filing of our technology would be at that point in time.

脈衝場消融，如您所知，我們已經在去年 11 月完成了試驗，並且一直處於後續階段。因此，這將使我們在春季獲得數據。這可能是最有可能出現的情況之一。當然，我們的技術歸檔將在那個時間點進行。

As Geoff mentioned, we're waiting the regulatory closure of Affera, and that really expands out the fuller bag. It gives us within both RF and pulsed field, point-by-point ablation. And what we have with our own internal PFAs really for the isolation of pulmonary vein sleeve, right? So it's more anatomically based. And then the other catheters that come with Affera would be for point-by-point ablation or for lines of conduction block that you do with a linear catheter.

正如 Geoff 提到的，我們正在等待 Affera 的監管關閉，這確實擴大了更充實的範圍。它為我們提供了射頻和脈衝場內的逐點消融。我們自己的內部 PFA 真正用於隔離肺靜脈套管，對嗎？所以它更基於解剖學。然後 Affera 附帶的其他導管將用於逐點消融或用於您使用線性導管進行的傳導線阻滯。

So really nice complementary sort of technologies for PFA. But more importantly, where we've been restrained from being able to participate in the full market because we don't control the mapping navigation systems. There's a strong monopoly between 2 players, Biosense Webster and Abbott, they particularly really control and dominate that field.

對於 PFA 來說，這是一種非常好的補充技術。但更重要的是，由於我們無法控制地圖導航系統，因此我們無法參與整個市場。 Biosense Webster 和 Abbott 這兩個玩家之間存在很強的壟斷性，他們特別真正地控制和統治了這個領域。

So that Affera acquisition allows us to have all of our catheters now with mapping navigation really expands the opportunity into that, what is today $8 billion market. Should be, by the time all this stuff rolls out, it continues to grow robustly close to $10 billion, and we'll then fully participate in that market. So 2 really important growth drivers we're excited about, and we're making meaningful progress on both of them.

因此，收購 Affera 使我們現在能夠擁有所有帶有映射導航的導管，這確實將機會擴大到今天 80 億美元的市場。應該是，當所有這些東西推出時，它會繼續強勁增長接近 100 億美元，然後我們將充分參與這個市場。因此，我們對兩個非常重要的增長驅動力感到興奮，並且我們在這兩個方面都取得了有意義的進展。

Yes. So yes just -- and Rick, on this, one in the short term, we'll see a pretty nice uptick in sequential growth going from our Q1 to our Q2, and then see more sequential improvement from there. But the reason we're confident is things like these 2 areas that you mentioned, along with a host of others, right? Micra continues, as Sean mentioned, Micra, we just hit PFA and what's coming there, and EV-ICD in the cardiac space. .

是的。所以是的 - 瑞克，在短期內，我們將看到從第一季度到第二季度的連續增長相當不錯，然後從那裡看到更多的連續改善。但是我們有信心的原因是您提到的這兩個領域以及其他許多領域，對嗎？ Micra 繼續說，正如 Sean 所提到的，Micra，我們剛剛研究了 PFA 和即將發生的事情，以及心臟領域的 EV-ICD。 .

But on the call -- and then down the road, Ardian, see the data, the economic impact of that will be a little bit out there beyond this year, obviously, but -- out of this fiscal year, but there's another -- and then you -- that's just in the cardiology area. We hit on Hugo on soft-tissue robotics side. I forgot to mention mitral and tricuspid on the cardiac side. There's a lot in cardiology. You got the soft tissue robot.

但是在電話會議上——然後在路上，阿迪安，看看數據，顯然，今年之後的經濟影響會有點，但是——在這個財政年度之外，但還有另一個——然後你——那隻是在心髒病學領域。我們在軟組織機器人方面遇到了 Hugo。我忘了提到心臟一側的二尖瓣和三尖瓣。心髒病學有很多。你得到了軟組織機器人。

And that whole surgical ecosystem that we're surrounding that with that's way more than the robot. You've got a lot going on in neuroscience. We mentioned the spine surgical ecosystem. And we didn't get any questions on DBS this time with the sensing and the Percept product and the leads that go with it and the closed loop trial that we're doing there. And we talked a little bit about ECAPs and pain.

我們所圍繞的整個外科生態系統不僅僅是機器人。你在神經科學方面做了很多工作。我們提到了脊柱外科生態系統。這次我們沒有收到關於 DBS 的任何關於傳感和 Percept 產品以及隨之而來的線索以及我們在那裡進行的閉環試驗的問題。我們談到了 ECAPs 和疼痛。

And then shifting, you heard Que talk about Diabetes and what we're seeing in Europe with the system now, the 780G and just sending in the Simplera submission into the EU and she gave you the dynamics on when we would do it in the U.S. But there's a lot going on here, and we're excited about it.

然後轉變，你聽到 Que 談論糖尿病以及我們現在在歐洲看到的系統，780G 和剛剛向歐盟提交的 Simplera 提交，她給了你關於我們何時在美國做這件事的動態。但是這裡發生了很多事情，我們對此感到很興奮。

And the operational issues that we've gone through, not all of them are completely in the rearview mirror. Like I mentioned, semiconductor shortages. But it's made us stronger. And all this, the changes that we made will become more apparent in the quarters -- the benefits of those changes will become more apparent in the quarters ahead here, and we're looking forward to it for sure.

而我們所經歷的運營問題，並不是所有的都完全在後視鏡中。就像我提到的，半導體短缺。但它讓我們變得更強大。所有這一切，我們所做的改變將在這些季度變得更加明顯——這些改變的好處將在接下來的幾個季度變得更加明顯，我們肯定會期待它。

So with that, I think that is all for Q&A, all the time we have. And I just, again, want to thank you for the questions, the engagement. As always, we appreciate your support and your continued interest in Medtronic. And we look forward to updating you on our continued progress that we've talked about here on our next earnings call, our Q2 earnings broadcast, which we anticipate holding on November 22, so just before Thanksgiving. Those here in -- it's just before Thanksgiving.

因此，我認為這就是問答的全部內容，我們一直都有。我只想再次感謝您提出的問題和參與。一如既往，我們感謝您的支持和您對美敦力的持續關注。我們期待著向您更新我們在下一次財報電話會議上討論的持續進展，我們的第二季度財報廣播，我們預計將於 11 月 22 日舉行，也就是感恩節之前。這裡的人——就在感恩節之前。

And so with that, thanks for tuning in today, and please stay healthy and safe, and have a great rest of your day.

因此，感謝您今天收看，請保持健康和安全，並度過美好的一天。