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.

早安，歡迎收聽美敦力2023財年第一季財報發表會。我是美敦力副總裁兼投資人關係主管Ryan Weispfenning。

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.

我現在正在美敦力的行動實驗室裡，它正在我們位於明尼阿波利斯的營運總部停靠。這些高科技行動教室每年將為約5,000名美國臨床醫生提供培訓機會，讓他們學習我們一些最先進的技術，包括O型臂和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。我們的行動實驗室卡車車隊讓我們能夠在美國各地穿梭，並發揮真正的大作用。事實上，本財年我們計劃停靠超過200個站點，它們很可能就會抵達您附近的醫院。

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.

在我們進入會議室聆聽準備好的發言之前，我將分享一些關於今天財報發布會的細節。美敦力董事長兼執行長傑夫瑪莎 (Geoff Martha) 和財務長凱倫帕克希爾 (Karen Parkhill) 將與我一同發言。傑夫和凱倫將就我們截至2022年7月29日的第一季業績以及我們對本財年剩餘時間的展望發表評論。在我們準備好的發言結束後，我們四個部門的執行副總裁也將出席，我們將回答負責公司銷售分析師的問題。今天的節目大約持續一個小時。

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各部門和地區收入摘要。我們也發布了一份收益報告，詳細介紹了我們的業績。您可以在我們的收益新聞稿中或造訪我們的網站 investorrelations.medtronic.com 取得該報告。

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的預測有重大差異。有關可能導致實際結果出現差異的因素的更多信息，請參閱我們向美國證券交易委員會 (SEC) 提交的定期報告和其他文件。我們不承擔更新任何前瞻性陳述的義務。

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，所有比較均以同比計算，收入比較按有機基礎進行，不包括外幣的影響和我們最近收購 Intersect ENT 的收入。

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 財年第四季相比，所提及的連續收入變化均以報告為基礎，所有提及的份額收益或損失均指 2022 年第二季度與 2021 年第二季度相比的收入份額，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.

所有非公認會計準則 (Non-GAAP) 財務指標的對帳表可在我們的收益新聞稿或我們的網站 investorrelations.medtronic.com 上查閱。最後，我們的每股盈餘預期不包含任何將在本會計年度以非公認會計準則 (Non-GAAP) 調整收益的費用或收益。

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

接下來，讓我們走進攝影棚，了解一下本季的情況。

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，感謝大家今天加入我們。我們今天上午公佈了第一季業績，本季基本上符合預期。我們公司實現了超出預期的收入，每股盈餘也符合預期。

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.

在過去幾個季度，我們與您討論並預測的宏觀因素，例如供應鏈、通貨膨脹和外匯，以及與去年同期的艱難對比，導致我們的收入和每股收益下降。同時，本季我們的各項業務也出現了一些亮點，包括心律調節器、心臟外科、美國核心脊椎、神經血管和歐洲糖尿病業務的強勁表現，以及許多新興市場的整體強勁成長。

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，我們近期有幾項即將推出的催化劑，將加速成長。我們在品質和營運改善方面的舉措也正在取得進展。在充滿不確定性的經濟環境下，我們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技術市場的領導地位，佔據了有利地位。

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，仔細審視我們第一季的業績，正如預期的那樣，嚴重的供應鏈中斷影響了我們的業績。最顯著的是我們的外科創新業務。隨著本季的推進，我們在封裝和樹脂供應等領域取得了進步。我們也將繼續管理各業務部門的半導體短缺問題，以最大程度地降低其對產品供應和財務表現的影響。我們預計這些晶片短缺問題將持續整個財年。

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，我們的營運團隊已執行並與供應商密切合作，以最大程度地降低影響，並在本季度末改善了訂單積壓情況。我們預計，隨著本財年的推進，整體供應鏈問題將持續改善。

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，我們仍然看到醫療專業人員短缺對手術量的影響。新冠疫情仍在全球部分地區導致手術取消和延期。我們看到我們的醫院和醫生客戶正在竭盡全力應對這些變化。因此，雖然我們大多數市場的手術量仍保持在新冠疫情前的水平，但某些手術或地區的手術量仍然落後。

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.

談到市場佔有率。這是美敦力的一項重要指標，也是我們年度激勵計畫的一部分，與收入成長、獲利能力和自由現金流並列。從季度市佔率表現來看，嚴峻的產品供應挑戰影響了我們在某些​​業務領域的市佔率提昇機會，包括外科創新和高功率 CRM 植入物。我們也面臨骨盆腔健康和糖尿病領域的競爭壓力，主要集中在美國。我們在應對嚴峻的產品供應問題方面取得了良好進展，並制定了後續產品線規劃，以應對未來的競爭壓力。

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，讓我來重點介紹一下我們的一些亮點。在客戶關係管理 (CRM) 方面，我們的起搏業務繼續跑贏大盤，隨著我們進入新的地區並擴大現有市場的滲透率，我們的 Micra 無導線起搏器系列正在全球範圍內推動強勁增長。 Micra 本季成長了 15%，其中日本實現了 70% 以上的高成長，西歐實現了 15% 以上的中成長，新興市場實現了 30% 以上的高成長。

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方面，我們在美國核心脊椎業務（U.S. Core Spine）的季度表現良好，成長了4%。我們憑藉整體產品組合的強勁表現贏得了市場份額，其中包括我們基於人工智慧的UNiD手術計劃平台和患者定制植入物，這些產品在美國用戶群中實現了強勁的兩位數環比增長。

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，我們近期推出的Catalyft PL脊椎系統，專為TLIF和PLIF市場設計，在第一季取得了顯著的表現。我們賦能、成像、導航和機器人技術的廣度是我們的關鍵優勢。

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領域，我們在疼痛刺激 (Pain Stim) 和深部腦電刺激 (DBS) 領域的植入市場份額正在穩步增長。在疼痛刺激領域，市場持續青睞我們的 Vanta 免充電神經刺激器和 Intellis 帶 DTM 充電神經刺激器。在深部腦電刺激 (DBS) 領域，客戶看重我們 Percept PC 系統與 SenSight 定向導線的差異化感測功能。

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 MiniMed 780G 胰島素幫浦搭配 Guardian 4 感測器的用戶群不斷擴大，我們在美國以外市場持續保持顯著成長。過去幾年，用戶群的成長正推動我們 CGM 感測器及其他耗材的經常性收入大幅成長。

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，780G 和我們的 Guardian 4 感測器帶來了非常積極的用戶體驗，無需指尖採血，測量時間更長，範圍更廣。這要歸功於它幾乎即時測量基礎胰島素，並每 5 分鐘自動校正一次推注劑量，以解決碳水化合物攝取量低估和偶爾錯過用餐時間推注的問題。

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.

現在讓我們來看看我們的產品線。我們正在推動多項意義重大的技術，這些技術能夠創造新市場、顛覆現有市場並加速我們的成長。我們持續推動產品線建設，過去12個月在美國、歐洲、日本和中國獲得超過200項監管部門的批准。展望未來，我們即將推出多項近期產品線催化劑，預計這些催化劑將提升美敦力的加權平均市場成長率。

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，我們先從心血管產品組合和經導管瓣膜開始。我們在美國市場限量發售的 Evolut FX 瓣膜獲得了客戶的一致好評。隨著我們即將於今年秋季全面上市，我們對這款新一代瓣膜可能帶來的影響充滿期待。

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 提升了易用性，並為植入者提供了更高的手術精度和控制力，同時保留了 Evolut 平台所有業界領先的血流動力學和耐用性優勢。 FX 在美國上市、PRO+ 在歐洲上市以及 Evolut PRO 在中國上市，我們對全球 TAVR 特許經營業務的前景充滿信心。

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 是美敦力最大的成長動力之一，我們預計該市場規模（目前約為 55 億美元）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，我們非常期待憑藉AURORA血管外ICD顛覆單腔ICD市場。如您所知，我們的一個競爭對手多年來一直在市場上銷售皮下ICD，但由於其與傳統ICD相比存在局限性，它仍然是一種小眾產品。

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.

AURORA 的問世，真正改變了電生理學家和病人的生活。它擁有傳統 ICD 的優勢，包括尺寸相同、電池壽命更長，並且能夠使用成熟的抗心動過速起搏技術，取代痛苦的電擊來終止危及生命的心律不整。

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 無需將導線置入心臟即可完成所有這些操作。我們的 EV-ICD 全球關鍵數據將於本週末在巴塞隆納歐洲心臟學會 (ESC) 大會的最新會議上公佈。我們還在等待 AURORA 的 CE 標誌認證，預計明年將獲得美國認證。

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.

腎臟去神經支配術是我們治療高血壓的突破性療法，目前，我們即將完成 SPYRAL HTN-ON MED 研究所有患者群組的 6 個月追蹤。我們將分析數據，並計劃在未來幾個月內公佈研究結果。這些數據將完成我們向美國 FDA 提交的臨床模組的最終部分，其他所有模組均已提交、審查並完成。

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.

我們的簡易血壓測量程序數據可靠，包括強有力的關鍵試驗結果和來自3000多名患者的令人信服的真實世界註冊數據。最近公佈的數據顯示，住院患者在三年內花費的時間和目標血壓範圍幾乎是接受假手術患者的兩倍。

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.

這可能透過減少心血管事件（包括中風、心臟衰竭和心血管死亡率）對公眾健康產生深遠影響。我們預期成為這一市場的領導者，預計到2026年該市場規模將超過5億美元，到2030年將達到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.

談到我們的外科手術產品組合，其中包括手術機器人。我們繼續推動Hugo機器人的限量市場發布。我們正在批准的地區安裝新系統並收集臨床數據，根據外科醫生的回饋改進系統，提高供應鏈的彈性，並擴大生產規模。反饋和需求持續強勁。我們在過去一個季度取得了進展，並且即將啟動針對泌尿科適應症的美國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.

我們也持續擴大 Touch Surgery Enterprise（一個由人工智慧驅動的手術影片和分析平台）的用戶群。透過 Touch Surgery Enterprise，外科醫生現在可以輕鬆查看手術錄影，從而不斷改進和提升病患照護。總而言之，在手術機器人領域，我們正在大力投資，力求憑藉我們在微創手術領域數十年的經驗和領導地位，成為市場的長期主導者。

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.

現在談談我們的神經科學產品組合。在神經調節領域，我們已經提交了 Inceptive ECAP 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。我們也將繼續加強商業活動，以抓住糖尿病週邊神經病變市場的機會，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 是醫療科技領域最大的機會之一，我們預計到 26 財年市場規模將達到 3 億美元，年總目標市場規模高達 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就搭載Guardian 4感測器的MiniMed 780G的監管申請進行積極溝通，並持續致力於解決警告信問題。我們在履行警告信承諾方面進展順利。我們已完成向FDA承諾的行動的90%以上。這代表我們在解決警告信和準備複檢方面取得了重大進展。

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.

在我們的連續血糖監測 (CGM) 流程中，我們提交了下一代感測器 Simplera 的 CE 認證申請。 Simplera 是一次性的，使用更方便，體積只有 Guardian 4 的一半。 Simplera 文件已準備好提交給美國食品藥物管理局 (FDA)，我們正在等待提交，因為我們正在優先考慮 780G Guardian 4 的審查。

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.

就我們整體糖尿病產品線而言，我們正在進行遠高於公司研發平均水準的大量投資。我們擁有涵蓋多個下一代感測器和泵浦項目的全面產品線，包括貼片泵浦。這些產品線讓我們有信心在未來幾年恢復糖尿病業務的強勁成長。

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

接下來，我將把時間交給凱倫來討論我們第一季的財務表現和指導。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，Geoff。我們第一季的有機收入超出預期，下降了3.6%。調整後每股收益為1.13美元，下降17%，符合我們的預期範圍。正如我們在上次財報電話會議上所述，本季我們面臨嚴峻的供應鏈挑戰，尤其是在外科創新業務方面。我們也面臨更嚴峻的潛在成長挑戰，包括呼吸器銷售強勁以及去年第三波新冠疫情後手術恢復良好。

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，我們的業績表現：美國市場收入下降了9%，美國以外的已開發市場和新興市場均成長了2%。本季度，新興市場的成長受到了中國市場的影響，由於新冠疫情封鎖和批量採購，中國市場收入下降了9%。然而，我們的團隊在許多其他市場實現了強勁成長，包括南亞和拉丁美洲的高雙位數成長、中東和非洲的雙位數成長以及東南亞的低雙位數成長。如果不計中國市場，我們的新興市場成長了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.

談到我們的利潤率。我們的調整後毛利率下降了230個基點。美元走強的影響導致了50個基點的下降，其餘主要歸因於勞動力和材料價格上漲，以及燃油附加費和加急貨運量增加導致的運費上漲。

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.

正如我們年初所說，我們預期通膨和匯率的影響將在未來幾季繼續對我們的毛利率產生負面影響。我想提醒大家，在查看我們的研發線時，我們對上個季度公佈的去年智慧財產權研發情況進行了調整。如果沒有這次調整，調整後的研發費用將會成長4%，因為我們將持續優先投資於各項業務的開發案。

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.

雖然我們的營業利潤率因收入下降和毛利率壓力而下降了320個基點，但隨著全年收入成長加速，我們預期營業利潤率將較上季改善。我們的資產負債表依然強勁，這使我們能夠投資於未來成長並向股東返還資本。我們持續致力於將至少50%的自由現金流返還給股東，主要透過強勁且不斷增長的股息。我們也透過適時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，這是在上一財年25億美元回購的基礎上進行的。我們也繼續利用資產負債表上的現金，進行短期收購和少數股權投資，以推動我們近期和未來的成長。

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.

我們在本季完成了 Intersect ENT 的交易，並啟動了對 Acutus 左心室通路產品組合的結構化收購，預計將於 2023 年上半年開始分銷。其先進的經室間隔通路系統將成為我們為電生理學家和介入性心臟病學家提供的廣泛產品組合的重要組成部分。

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 的聯合推廣協議和收購計劃。我們很高興能與 CathWorks 合作，推廣其創新的 FFRangio 系統，我們相信該系統將顛覆傳統的 FFR 市場。我們相信美敦力能為我們收購的技術帶來巨大的價值，並期待這些收購能補充我們的有機研發投入，並加速我們的長期成長。

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.

現在談談我們的業績預期。一個季度過去了，我們維持全年營收4%至5%的自然成長預期，不包括匯率波動和Intersect ENT收購帶來的營收。若近期匯率不變，外幣將對全年營收產生14億至15億美元的負面影響，較上一季增加4億美元。我們預期有機收入成長每季都會有所改善，本財年下半年的業績將遠強於上半年，這得益於我們預期許多嚴峻的供應鏈挑戰將會消退，以及新產品將推動我們的成長。

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，隨著財年的進展，我們面臨的比較也越來越容易。以細分市場和內生成長計算，我們繼續預期心血管業務將成長5.5%至6.5%，鑑於中國許多省份的帶量採購增加，外科手術業務目前將成長0.75%至2.75%。鑑於神經調節市場前景略有下降，神經科學業務目前將成長4.75%至5.75%。鑑於國際市場成長強勁，糖尿病業務目前將下降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.

就獲利而言，我們繼續預期非公認會計準則稀釋每股收益將在5.53美元至5.65美元之間。通貨膨脹和匯率因素仍在短期內對我們的利潤率產生影響，過去一個季度，原材料和運費的通膨已成為更大的阻力。我們將繼續實施相關舉措，以部分抵銷這些宏觀影響，並優先考慮研發投資，以推動未來成長。

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，以及我們仍處於財年初期，我們建議您更接近每股盈餘指引區間的下限。我們的每股盈餘指引已包含外匯的不利影響，以近期匯率計算，約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，我們預計有機收入成長率將在 3% 至 3.5% 之間，這意味著在產品可用性提高和產品發布節奏的推動下，營收將出現強勁的環比加速成長。

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.

假設近期匯率維持不變，第二季將面臨3.65億美元至4.15億美元的匯率不利影響。按部門劃分，我們預期心血管業務將成長5%至5.5%，外科手術業務將下降0.25個百分點至上升0.25個百分點，神經科學業務將成長5.5%至6%，糖尿病業務將下降3%至6%，所有業務均為內生成長。我們預計每股收益為1.26美元至1.30美元，其中包括以當前匯率計算約0.02美元的匯率不利影響。

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.

儘管我們的市場面臨挑戰，但我們正專注於尋找抵消其對財務影響的方法。我們正準備開拓市場、抓住新機遇，對未來充滿樂觀。此外，我想藉此機會感謝美敦力的員工，他們堅定不移地致力於為世界各地的人們提供拯救生命的治療。回到你這裡，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，凱倫。上個季度，我們在積極的、旨在加速成長的根本性變革議程上取得了巨大進展。供應鏈方面，情況正在改善。我們的積壓訂單正在減少，這不僅是因為外部環境，還因為我們在格雷格史密斯領導下採取的行動。我預計這些改善措施將會持續下去。

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.

我們已將員工與供應商安排在同一辦公地點，並與次級供應商密切合作。我們正在應對這些棘手問題，並在改進方面取得進展，我相信這些改進措施能夠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.

在品質方面，過去幾年，我們一直在對品質系統進行大規模轉型。我們正以創新的方式提升質量，並與監管機構密切合作，並取得了重要進展。隨著這兩項策略的結合，我們的產品線和產品組合也正在取得進展，從而創造有意義的成長動力。

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.

我們正在將新產品融入可靠的高成長業務，例如將 Intersect ENT 併入我們的耳鼻喉業務。我們也正在拓展部分業務的產品組合，使其能夠成為公司整體更有意義的成長動力，例如我們在心臟消融解決方案方面的策略。

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，這條路並不平坦，但我相信，我們在公司內部進行的這些根本性改進，加上我們的營運模式變革、文化變革和激勵機制變革，將使我們能夠實現可持續的更高水準的成長。

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.

隨著我們克服短期問題並開始在產品線中取得進展，我相信美敦力的根本轉型，以及我們過去幾年所做的所有工作將變得越來越明顯，建立一個持久的價值創造引擎，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Karen一起感謝我們的員工。經歷改變從來都不容易，尤其是在充滿挑戰的宏觀環境下。但我們的團隊始終保持專注，並在幫助全球數百萬人減輕病痛、恢復健康、延長壽命方面發揮關鍵作用。

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?

現在我們進入問答環節。我們會盡可能多地聯繫分析師，因此請您只提問一個問題，並且僅在必要時進行相關的後續提問。如果您還有其他問題，可以在電話會議結束後聯繫 Ryan 和投資者關係團隊。 Brad，您能提供一些提問的說明嗎？

(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.

（操作員指示）最後，請注意，本次問答環節正在錄製中。今天的問答環節，除了Geoff、Karen和Ryan之外，還有心血管產品組合執行副總裁兼總裁Sean Salmon、外科產品組合執行副總裁兼總裁Bob White、神經科學產品組合執行副總裁兼總裁Brett Wall以及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，整理發言者。

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

我們將回答摩根大通的羅比·馬庫斯提出的第一個問題。

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?

大家早安，恭喜本季業績。或許我應該把兩個問題放在一起問。本季業績略好於預期，但第二季的指引比華爾街預期的低了0.5%，有機銷售額成長0.75%。能否談談您對今年業績節奏的看法？這包括每季銷售額的大幅成長。是什麼推動了這項成長？

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?

另外，看起來你們縮減或下調了許多產品部門的有機銷售成長預期，其中糖尿病產品佔了很大一部分。能否談談你們遇到的一些供應問題是否帶來了一些影響？是什麼原因導致了這些部門的預期下降？

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，謝謝你的提問。有很多問題需要解答。也許我先開始講，然後再交給凱倫。

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，我認為，本季基本上符合預期，我們克服了宏觀經濟逆風，並在樹脂和包裝等供應鏈問題上取得了進展。相關流程基本上維持在新冠疫情前的水準。我們看到環比成長，本季的業績表現也相當不錯。

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.

說到今年剩下的三個季度，我的意思是，首先，從第一季開始，你會看到一些業績強勁的可比產品即將迎來週年紀念。我認為我們去年第一季的成長速度大概是19%，我們的呼吸器和左心室輔助裝置（LVAD）等產品也面臨一些業績強勁的可比產品。然後我之前提到過，一些嚴重的供應鏈問題，我們正在開始解決。我提到了樹脂和封裝。我們仍在處理半導體業務，涉及許多業務，這些業務將持續一段時間。但很多嚴重的問題，我們正在開始解決。

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.

然後我們得到了一個數字，然後我們會…我會讓凱倫詳細介紹第二季與下半年的具體情況。但下半年我們有很多不錯的成長動力，像是即將全面上市的 Evolut FX 和 EV-ICD。此外，還有許多其他產品的發布，甚至現有的產品也在不斷湧現，它們的發展勢頭也正在持續，並且會在接下來的三個季度中保持一定的節奏。或許我可以把時間交給凱倫，讓她提供一些關於這方面的更多細節。

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，Geoff，早安，Robbie。我想補充一下，關於第二季度，我們確實預計基礎手術基本面會略有改善。例如，我們預期中國手術量會回升。上個季度，我們有一些心臟手術量受到了造影劑供應的輕微影響，我們預計這些手術量也會回升。我們也將繼續考慮中國批量採購可能帶來的增量壓力，包括脊椎領域可能進行的全國性VBP招標，以及持續進行的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.

但需要特別提醒的是，第二季與去年同期相比，我們的業績對比確實更加容易。上財年我們僅成長了2%，這主要是因為受到達美航空疫情和部分勞動力短缺的影響。因此，隨著我們進入下半年，Geoff 提到了我們令人興奮的產品發布，以及我們嚴峻的供應鏈挑戰的持續改善。然後，我還想指出，與第二季相比，我們的同比數據對比變得更加容易。去年第三季和第四季，我們的成長約為1.5%。下半年，通風設備業務的逆風也正在緩解。

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業務的進展而言，是的，我們確實在本季度看到了糖尿病業務的強勁增長，尤其是在國際增長方面，我們預計這種勢頭將持續下去。此外，我們對業績指引整體上持謹慎態度。我們認為現在還處於財年初期。我們仍然面臨許多宏觀不確定性，尤其是在通膨和運費方面。所以，我們只是想保持謹慎。希望以上資訊對您有幫助。

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

謝謝，羅比。布拉德，我們來回答下一個問題。

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

好的。我們接下來將回答 Evercore ISI 的 Vijay Kumar 提出的問題。

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，一個是關於 Ardian 的，一個是關於機器人的。 Ardian，您能不能跟我們聊聊，什麼時候能拿到這些數據？我記得您說過是在接下來的幾個月。這些數據會作為頭條新聞發布嗎？會不會在某個會議上正式發布？ FDA 有沒有可能審查這些數據並舉行廣告溝通會？或者您能談談我們對 Ardian 的期望嗎？

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。謝謝你的提問。好吧，首先我想說的是──我想把這個問題的答案交給肖恩。但正如你們在過去幾個月和一些會議上看到的那樣，越來越多的數據正在湧現。

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.

我看到你採訪過，或者說和這個領域的關鍵意見領袖（KOL）聊過，很高興聽到他的回饋。所以，現在湧現出的數據越來越多，醫生們也越來越興奮，越來越有信心——我們的試驗中心已經與這些患者合作了很長時間，數據也在不斷積累，而且非常積極。

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。肖恩之前也指出過，FDA 自己做過患者偏好研究，他們很清楚患者更喜歡這種療法，而不是藥物治療。所以我知道他們也希望這種療法能夠上市。至於你提出的具體問題，我會請肖恩來回答，關於數據公佈的時間，以及我們是否會進行廣告溝通等等。

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.

維傑，我們完成了註冊，接下來還有6個月的終點，很快就會加速前進。我們的目標是－今年秋天我們能拿到的所有比賽成績，很可能是AHA的。我們會提交給AHA。如果被接受，我們就能在那裡看到結果。

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，我們也會在同一時間段內發布這些結果，並公佈最重要的數據。提醒一下，這是我們提交的最後一部分，對吧？其他所有模組都已審核完畢並完成。只剩下臨床數據尚未完成。所以我們已經非常接近目標了。

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?

明白了。然後是傑夫，也許還有關於手術機器人的。我以為準備好的發言稿和評論都相當樂觀。如果我錯了，請糾正我，我看到訂單情況良好，安裝勢頭強勁，關鍵的供應鏈挑戰已經解決，美國IDE也談到了這家商店。感覺這次的基調與上次通話相比有所變化。所以，您能否評論一下過去三個月發生了什麼變化？

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。 Bob 也會參與進來。沒錯，這個季度對我們來說意義重大，因為我認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，並且在美國 IDE 之前就建立了生產能力，更重要的是，擴大了在歐洲的銷售。我們安裝了許多設備，並持續獲得良好的回饋。外科醫生的回饋也一直非常積極。

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?

事實上，我有機會與我們多位外科創新代表和銷售代表見面。我問他們，你們從外科醫生那裡聽到了什麼？我對聽到的很滿意。而且有很多消息傳開了。他們喜歡這個設計，喜歡我們推向市場的方式。他們意識到，當我們的產品上市時，我們還沒有達到所有的適應症，我們將根據現有的器械數量來開發我們的器械，但他們希望與我們一起參與這段旅程。所以我認為這些期望是合理的。我們已經建立了一些生產能力。正如我在評論中所說，我們非常接近獲得美國醫療器材指令（IDE）。所以，鮑勃，還有什麼想補充的嗎？

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。不用了，謝謝，Geoff。 Vijay，非常感謝你的提問。我認為你說得對，我們的手術機器人生態系統正在穩步推進。我們確實認為這是一個在觸摸手術方面也取得良好進展的生態系統。

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.

但正如傑夫所提到的，我們的Hugo安裝在本季仍在繼續。我們希望它們在本季結束時也能加速發展。正如我在先前的電話會議上所說，我們非常專注於強化我們的供應鏈和營運績效，並且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，我們繼續在全球培訓外科醫生，涵蓋多個專業領域，目前進展穩健。我們的IDE專案即將啟動，我們相信我們將繼續保持在正軌上。謝謝，Vijay。謝謝，Geoff。

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。我們在脊椎領域學到的一點是，不僅要有機器人，還要有圍繞它的所有支援技術，這一點非常重要。我們開始使用——客戶現在開始使用Hugo進行觸摸手術，外科醫生對它的分析能力以及安全的視訊儲存和共享在病例審查、培訓等方面的優勢印象深刻。

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

正如Bob所說，我們的軟組織機器人生態系統進展順利。所以我們這邊一定很興奮。

Thanks, Vijay. Next question, please, Brad.

謝謝，維傑。布拉德，請問下一個問題。

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.

Geoff，我先從投資組合管理開始。你開始強調這一點已經過了大約8個月。我不知道這是否會在2023財年實現。而且看起來，在這個階段，你似乎更專注於解決加權平均市場成長率，而不是其他變數。

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，Karen，我想快速跟進您之前提到的內容。我記得您說過本季結束時會以更好的勢頭結束。所以，我很好奇您能否對8月份的一些趨勢進行一些評論，投資者對假期之類的事情有些擔憂。所以，我很想知道8月的情況。

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。謝謝你的提問，崔維斯。是的，我們肯定會繼續更專注地審視整個投資組合，正如你所提到的，我們已經這樣做了幾個月。首先，我想說，我們真的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.

當我們審視這個投資組合和資本配置時，我們談論的是買方和賣方雙方，並積極審視投資組合管理，正如您所指出的，以真正提高我們的加權平均市場成長率，無論是透過增加還是減少，並確保成長更加持久。

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，你看，我們在策略性地審視每項業務的方法上取得了很大進展。上個季度，我提醒一下，我們確實宣布了與 DaVita 成立腎臟護理解決方案合資公司，在減量方面邁出了第一步，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.

我只是想設定這個預期，並隨著時間的推移逐步實現。所以目標不變，這個過程仍在持續。目標是實現持久成長。所以，當你的加權平均市場成長率也在成長時，成長會容易得多。我就不多說了，接下來的問題交給Karen回答。

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，崔維斯。我們確實以更好的勢頭結束了本季。我們看到積壓訂單有所減少。本季每個月都持續改善。現在來看，8月還為時過早。我們確實——我們仍在努力解決一些業務的供應問題。所以數據有些模糊。

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.

但當我們將這一點納入我們的預期，並觀察8月前三週未受供應問題影響的營運部門時，我們發現其趨勢與去年第二季度基本一致。因此，我們看到了持續的動力和改善。

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

謝謝，崔維斯。布拉德，請回答下一個問題。

The next question comes from Cecilia Furlong at Morgan Stanley.

下一個問題來自摩根士丹利的塞西莉亞·弗隆 (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，也就是今年最新的業績指引。顯然，美國本土業務表現強勁。但是，您現在對美國本土業務以及美國本土業務在競爭壓力下的表現有何預期？

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.

然後我想跟進一下。聽起來你提交 Simplera 的時機改變了你的策略。能不能談談你對提交節奏的看法？

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。好的，謝謝你的提問，塞西莉亞。是的，我的意思是，糖尿病，正如我之前提到的，卡倫在她的評論中也提到過，我們看到美國和歐洲以外的地區增長非常強勁。

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.

更重要的是，季度成長、我們在患者身上看到的臨床結果以及患者對780G+Guardian Sensor 4系統的體驗回饋都非常正面。因此，我們認為，這對我們的特許經營權以及將其引入美國市場後將會看到的良好前景來說是一個好兆頭，因為我們正在與歐洲所有公司競爭。

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.

您問了幾個具體問題。我想說的是，你看，我們——這是一項——兩年前我剛上任執行長時，很多人問我未來該做什麼。我們加倍了投資。我們相信，我們整合了感測器的胰島素輸送系統，也就是胰島素輸送裝置，將對我們未來發展產生正面影響。目前，對我們來說，它是一款耐用的胰島素泵，未來還會推出注射筆，然後，希望還會推出一個貼片。我們認為，憑藉我們市場領先的演算法，我們在這個高成長、高進入障礙的市場中佔據了非常永續的地位。我們一直在努力，在歐洲取得的這些成果非常令人鼓舞。

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?

除此之外，我們最近經歷了從肖恩到奎的過渡。肖恩在穩定業務方面做得非常出色，他真正專注於我們具有競爭優勢的領域，並幫助我們真正聚焦產品路線圖。奎正在從那裡接手。他們的過渡非常順利。接下來，我想介紹一下奎·達拉拉，她已經加入我們14、15週了，她不僅對糖尿病領域，而且對美敦力的領導團隊都產生了巨大的影響。很高興能與她共事。現在，我來介紹奎，並歡迎她參加她的第一次財報電話會議。奎？

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，我和肖恩的交接工作進展非常順利，我們在恢復業務成長和創新路線圖方面取得的進展也讓我感到非常鼓舞。

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.

關於您提到的兩個具體問題，關於我們在美國以及 Simplera 的情況，我想說，我們的短期重點是修復警告信，並與 FDA 就 780G 和 Guardian 4 感測器系統的批准取得進展。我們對此感到鼓舞，並取得了良好的進展。因此，我們希望能夠修復問題並在短期內獲得批准。

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，我們的770G系統和InPen技術確實取得了成長。不僅如此，我們即將推出可延長佩戴的輸液器，該輸液器已獲得FDA批准，可佩戴長達7天，這對患者來說意義重大。這可能是我們在過去20年中在該領域看到的最重大創新，它允許患者根據需要將感測器CGM的變化與輸液器的變化同步，從而改善輸液部位的恢復，並提高患者的舒適度。

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.

事情就是這樣。我們當然期待780G，但對於已經在美國核准的產品，我們不會止步不前。至於Simplera，我們對這款產品非常興奮。它只有Guardian 4感測器的一半大小，而且更薄。我們已經按照承諾在7月提交了CE標誌申請。它已經準備好在美國提交申請了。但我們仍然專注於優先處理警告信以及780G的審批。

Okay. Thank you, Que.

好的。謝謝你，Que。

Thanks, Cecilia. Next question, please, Brad.

謝謝，塞西莉亞。布拉德，請問下一個問題。

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

下一個問題來自富國證券的拉里·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，您說第四季的影響約為2.6億美元。第一季的影響是多少？您對第二季的預期是什麼？您是否認為銷售額的損失會被彌補？

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，Karen，或許可以談談2022財年指引中的外匯對沖收益。我認為應該是4.1億到4.4億美元。那麼，這筆收益在2024財年會如何成長呢？我們該如何看待？

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.

嗯，謝謝你的提問，拉里。我先從第二季及以後的供應鏈預期開始談。正如我所提到的，第四季度和第一季是我們供應鏈問題最嚴重的兩個季度，我很高興我們能夠回顧這兩個季度的情況。

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，但積壓訂單正在減少。我們看到公司樹脂和包裝等領域的情況正在顯著改善。這在很大程度上得益於我們將100多名員工與頂級供應商安排在同一地點，幫助他們優先考慮美敦力。但更重要的是，我們採取了一些措施，確保溝通順暢，規劃週詳。這確實起到了作用。

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，尤其是在某些領域。我之前提到過，半導體的積壓訂單還會持續一段時間。我們正在就此與半導體公司直接合作。此外，除了將員工與頂級供應商安排在同一地點之外，我們還採取了其他措施，例如直接聯繫商品或原材料供應商，而不是透過介於我們和他們之間的供應商（例如，最終加工商或分銷商，中間商）簽訂合約並獲得優先採購權，尤其考慮到這些產品用於醫療領域，對生命至關重要。

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，原料供應商甚至沒有意識到這一點。所以，所有這些肯定都有幫助，而且我們會看到積壓訂單量隨著時間的推移而持續下降。正如我所說，我認為我們已經開始擺脫最嚴峻的情況。

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.

至於彌補損失的銷售額，就像新冠疫情期間一樣，我們不會將大量損失的銷售額納入業績預期。尤其現在，正如您所見所聞，醫護人員短缺的情況似乎有些棘手，雖然情況有所好轉，但客戶仍然難以達到新冠疫情前 110% 甚至 120% 的水平。

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，我們實際上並沒有將銷售額的追趕納入業績指引。您有一些具體的量化問題，我會把這些問題交給凱倫。凱倫，除了我剛才提到的定性評論，您還有什麼想補充的嗎？

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。我認為您在供應鏈方面講得很好。我們確實說過，我們預計情況會先惡化一些，然後才會好轉，第一季的情況確實如此，但我們預計情況會從現在開始好轉。我們的供應鏈確實在改善，但這並不代表我們就能趕上指南中提到的情況。

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.

就外匯而言，如您所見，美元走強持續影響著我們的報告收入，就像許多同行一樣。我們確實存在基於外幣的銷售成本和管理費用。現在我們還有基於外幣的利息支出，這些都在一定程度上抵消了外匯的影響。拉里，您也知道，我們多年的貨幣對沖計劃也為我們帶來了收益，該計劃確實帶來了顯著的收益，從而降低了外匯對本季度利潤的影響。

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.

展望外匯市場，我想說，現在才第一季。我們的外匯匯率一直在波動。所以我們知道接下來還會有變化。但如果我們展望下一財年，根據最近的匯率，如果利率保持不變，我們預計下一財年的逆風將與本財年類似。希望以上資訊對您有幫助。

Thanks, Larry. Next question, please, Brad.

謝謝，拉里。布拉德，請問下一個問題。

The next question comes from Joanne Wuensch at Citi.

下一個問題來自花旗銀行的 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，如果今年剩餘時間內收入逐季提高，那麼營業利潤率和毛利率是否也會提高？

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?

我再快速提一下第二個問題。 Hugo，要把這個技術引進美國需要什麼？在時間安排上有什麼參數或思考過程嗎？

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。關於利潤率，我們確實預計隨著收入的增長，利潤率將全年環比提高。所以這個問題的答案是肯定的。然後，傑夫，對於…

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。關於 Hugo，要把它推廣到美國需要什麼？顯然，你必須啟動我們在美國設立的 IDE。 Bob 之前提到過，我們正在為客戶和試驗點做好準備，並培訓醫生，這些我們一直在努力。 Bob，你能不能再具體說說？

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.

傑夫，你說得完全正確。一切都從我們與美國IDE的合作開始，這將啟動美國申請流程。正如我們所提到的，喬安妮，我們即將啟動這一流程，但這將是一個關鍵的里程碑，我們肯定會不斷更新，以指導投資者。

Okay. Thanks, Joanne. Next question, please.

好的。謝謝，喬安妮。請問下一個問題。

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?

我只想問幾個關於糖尿病的問題。之前提到您希望盡快處理警告信，並在短期內獲得780G的批准。請問在警告信尚未處理的情況下，您是否清楚能否獲得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.

謝謝你的提問。我認為差異化路徑是一個選擇。但正如我之前所說，我們的首要任務是與FDA合作，修復警告信，現在我們要全力以赴。

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，我們非常渴望推出這款產品，但我們更注重患者安全，確保我們的補救計劃是健全的。我們首先要考慮的是採取這些糾正措施。所以這是我們的首要任務。

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.

同時，我們正在與FDA合作，爭取780G和Guardian 4感測器系統的批准。這兩件事都在持續取得進展。我們很難完全預測這些事情何時會發生，但我對這兩件事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。如果我之前沒注意到這一點，我很抱歉。請問您什麼時候會向 FDA 提交 Simplera 的申請？

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.

一旦我們確信在警告信整改和780G審批方面取得了足夠進展，我們就會立即採取行動。如大家所知，我們按照承諾，在7月提交了CE標誌申請。我們只是想確保我們的重點仍然放在短期目標上，即警告信整改和780G批准。

Thanks, Jayson. Next question, please, Brad.

謝謝，傑森。布拉德，請問下一個問題。

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，請您考慮得更長遠。您認為格雷格史密斯和他的團隊在實施您在先前的電話會議上提到的營運變革方面進展如何？您認為這些舉措何時能帶來利潤成長？

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.

這個問題問得好。謝謝你，史蒂夫。他們在相對較短的時間內取得了相當大的進展。格雷格於2021年4月開始工作。所以到現在已經一年多了。在這段時間裡，我們與高階主管團隊合作，集中管理了全球營運和供應鏈職能。

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一個機遇，我們試圖同時兼顧小規模和大目標。某些業務已被分散到各個業務部門，這些業務部門被賦予了更大的權力，我們稱之為營運單位。此外，還有一些業務，我們將利用我們的規模優勢或驅動力——以及/或推動標準——來進行有限的工作。供應鏈無疑是其中之一。

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.

所以我們做出了這個改變，這個組織變革，這可能是我們迄今為止最大的組織變革，甚至比削減20個營運部門的規模還要大。所以它意義重大。此外，我們開始投資新的能力。從公司外部、產業外部招募人才，很多情況下，這些人才在各個子職能領域，或者說在全球營運和供應鏈領域，例如規劃、工廠自動化等方面，都是一流的。

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.

我們一直在招募不少人才，我認為Greg團隊的大部分成員都是去年新加入的。我們一直在技術方面進行投資，包括各種不同的計劃系統、供應計劃系統、需求計劃系統等等。其中，最重要的重點是彈性和品質。我們關注的重點有三：彈性和質量，因為它們對品質以及長期來看的銷售成本和生產力都有很大的影響。如果能實現這一目標，美敦力的銷售成本和生產力將達到我們過去水準的兩倍甚至更高。

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，這一切會隨著時間的推移而顯現。我們目前還沒有看到。另外，還有很多因素在影響我們。通貨膨脹之類的因素，在某種程度上掩蓋了我們所看到的任何銷售成本對生產力的影響，或者說，掩蓋了任何影響。所以——但隨著時間的推移，我們會看到這一點，而且我們有信心。但我們還沒有量化確切的時間。就像我說的，由於通貨膨脹對我們銷售成本的影響，短期內很難解讀。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，也謝謝你的提問。我們在營運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，以抵消我們受到的定價或通膨影響。我們還沒準備好給出下一財年的業績指引，但最初的目標就是抵銷這些影響。

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.

隨著時間的推移，希望能夠抵消這些影響。我想說，Geoff 也提到過，這項營運工作不僅有助於降低銷售成本，還能提高收入，因為我們可以更準確地預測產品的供應情況，更好地控製品質問題。所以我認為這對兩者都有幫助。

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

好的。謝謝，史蒂夫。布拉德，請問下一個問題。

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?

剛才在Spine上，我記得你們提到了導航和機器人技術，它們正在衰落。我希望你能更廣泛地談談你在漏斗、通路和資本環境中看到的情況。你們銷售這些類型的資本產品，尤其是機器人技術的方式有什麼改變嗎？

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.

我們確實看到你們的一家骨科機器人競爭對手談到了改變商業模式，增加了租賃業務，但你們脊椎機器人的直接競爭對手實際上看到了資本購買的連續增長。所以，如果能請您談談目前的資本環境，特別是脊椎機器人領域的發展情況，那就太好了。

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

當然。謝謝你的提問，Rich。我接下來會請神經科學總裁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，Rich。是的，整體來看，我們的CST業務擁有非常廣泛的生態系統和資本體系。我們發現採購時間有所延長，尤其是在接近季度末的時候。

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.

具體來說，就技術和銷售模式而言，我們採用了多種不同的方法。因此，我們處於有利地位。然而，市場似乎在醫院方面運作良好，它們處於一種保留現金的模式。我們有更多機會提出不同的模式，利用植入物和其他一次性產品來融資，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，我們的O型臂或StealthStation機器人的銷量沒有顯著增長——這次是那個型號，但Mazor機器人的銷量略有增長。我們認為，在此期間，我們可能會看到更多這樣的成長。您提到的競爭對手，如果您查看第二季的數據，根據我們的計算，我們在機器人的實際部署和銷售方面繼續超越他們。而且——我們繼續保持這種勢頭，我們在那裡的程序基礎幾乎是他們在上次財報電話會議上報告數量的兩倍。

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.

因此，我們在那裡的定位非常有利。此外，其核心脊椎業務仍頗具吸引力。我們在那裡的核心脊椎業務成長了4%。因此，我們對業務的復甦感到滿意。

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。我們對脊椎業務的定位以及最近在植入物領域推出的產品感到非常興奮，但我們在過去十年中構建的生態系統以及它如何發揮作用，以及市場如何向這種生態系統模式轉變，都讓我們感到非常興奮。因此，我們對脊椎業務的持續發展充滿信心。

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

是的。謝謝，Rich。我想我們還有時間再問一個問題，Brad。

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.

傑夫，最後，我希望您能詳細介紹您目前正在研究的兩個令人興奮的機會。您重點介紹了AURORA，一種無鉛超微結構裝置。我希望您能分享您對該領域機會的最新想法。您提到的明年美國批准是指下一個自然年還是下一個財政年度？這似乎是一個重大機遇，我希望您能談談。

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.

最後，您這次沒有過多談論脈衝場消融的機會。能否請您更新美敦力的內部項目、您青睞的項目，以及美國試驗的時間表、後續提交和審核時間。以上任何內容都很好。

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。謝謝你的提問，里克。這兩個主題我們很喜歡討論──接下來我會把時間交給肖恩，他會給你詳細介紹一下。

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.

但就 AURORA 而言，正如我在評論中提到的，我認為我們可以將這個細分市場從我們目前定義的小眾市場拓展到更大的市場。我們預計到 2030 年市場規模將達到 10 億美元。我們只是認為，有了 AURORA，醫生和患者無需做出取捨，就能獲得我們先前使用（損耗式）ICD 所帶來的傳統影響，而採用的是一種侵入性更小的方法。所以，我將這個問題交給 Sean 來討論。

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?

關於PFA，您提到了Affera，Sean會向您詳細介紹我們內部PFA和Affera專案之間的關係。 Affera加上Acutus，構成了我們整個心臟消融解決方案業務，也就是我們的心房顫動（AFIB）業務。我們認為這筆交易將真正完善我們的業務。我們期待聯邦貿易委員會（FTC）批准收購Affera。我們將積極推進這項業務，因為這確實是一個高成長市場，而我們之前一直比較小眾。收購Affera將使我們的業務更加完善，並使這項業務成為公司真正的成長動力。至於您剛才提到的具體問題，Sean，您能否深入了解Rick提到的一些具體細節？

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。里克，正如傑夫在評論中提到的，如今的皮下ICD市場規模大約在3億到3.5億美元之間，是一個利基市場。我們認為，10年內，這個市場規模可能會達到10億美元。

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.

它之所以能夠擴展，是因為現有設備有許多局限性，而我們可以利用傳統 ICD 的優勢，例如更小的設備、更長的電池壽命，以及能夠透過起搏器控制心律不整（而非電擊）來控制心律不整。這些優勢實際上可以擴大市場，就像我們看到的無導線起搏一樣。當我們進入無導線起搏器市場時，我們開始接收一些因病情嚴重而無法接受治療的新患者，這帶來了強勁的成長。至於時間安排，我們說是明年，更確切地說，我們計劃在明年上半年獲得美國市場的批准。

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，如你所知，我們去年11月完成了試驗，目前正處於後續階段。這意味著我們將在春季獲得數據。這可能是最有可能發布的技術之一。當然，我們的技術申請也會在那時提交。

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 所提到的，我們正在等待 Affera 的監管審批，這確實擴大了它的應用範圍。它讓我們能夠在射頻和脈衝場內進行逐點消融。我們自己的內部 PFA 實際上是用來隔離肺靜脈袖狀血管的，對吧？所以它比較符合解剖學原理。 Affera 隨附的其他導管可用於逐點消融或用於線性導管的傳導阻滯。

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.

所以這對PFA來說確實是一種很好的互補技術。但更重要的是，由於我們無法控制地圖導航系統，我們一直無法參與整個市場。 Biosense Webster和Abbott這兩家公司之間存在著強大的壟斷，他們特別控制並主導著這個領域。

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.

收購Affera讓我們現在所有的導管都具備了地圖導航功能，這確實拓展了我們進入這個目前價值80億美元的市場的機會。等到所有這些產品都推出後，這個市場應該會繼續強勁成長，接近100億美元，到那時我們將全面參與這個市場。因此，我們對這兩個非常重要的成長動力感到興奮，而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——Rick，就這一點而言，短期內，我們會看到從第一季到第二季的環比增長相當可觀，之後還會有更多環比改善。但我們之所以充滿信心，是因為你提到的這兩個領域以及其他許多領域，對吧？ Micra 繼續說道，正如 Sean 所提到的，Micra，我們剛剛談到了 PFA 及其即將推出的產品，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.

但在電話會議上——以及之後，Ardian，看看數據，它對經濟的影響顯然會在今年之後顯現出來，但——在本財年之後，還有另一個——然後——那就是心臟病學領域。我們談到了軟組織機器人方面的Hugo。我忘了提到心臟方面的二尖瓣和三尖瓣。心臟病學有很多內容。你提到了軟組織機器人。

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.

我們圍繞著這個手術生態系統，遠遠不止機器人。神經科學領域有很多進展。我們提到了脊椎手術生態系統。這次我們沒有收到任何關於深部腦部刺激（DBS）的問題，包括感測系統、Percept 產品、配套的導線以及我們正在進行的閉環試驗。我們也談了一些關於ECAP和疼痛的問題。

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.

然後轉換話題，你聽到 Que 談論糖尿病以及我們現在在歐洲看到的系統 780G 以及剛剛向歐盟提交的 Simplera 申請，她告訴你我們何時會在美國這樣做。但這裡有很多事情要做，我們對此感到興奮。

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.

我們經歷的營運問題並非全部都已消失。就像我提到的，半導體短缺就是其中之一。但這確實讓我們變得更強大。所有這些，以及我們所做的改變，都將在未來幾季更加明顯——這些改變帶來的好處也將在未來幾季更加明顯，我們對此充滿期待。

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.

好了，我想問答環節就到這裡了，我們所有的時間都在這裡。我再次感謝大家的提問和參與。一如既往，我們感謝您的支持以及您對美敦力的持續關注。我們期待在下次財報電話會議，也就是第二季財報發表會上，向大家通報我們之前談到的進展。我們預計在11月22日，也就是感恩節前夕舉行。各位，現在剛好是感恩節前夕。

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

所以，感謝您今天的收看，祝您身體健康、平安，度過愉快的一天。