美敦力 (MDT) 2020 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Medtronic Second Quarter Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

女士們，先生們，感謝你們的支持，歡迎參加美敦力第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。（操作員指示）

I would now like to hand the conference over to Ryan Weispfenning, Vice President, Investor Relations. Please go ahead, sir.

現在，我想將會議交給投資人關係副總裁 Ryan Weispfenning。先生，請繼續。

Thank you. Good morning, and welcome to Medtronic's Fiscal Year 2020 Second Quarter Conference Call and Webcast. During the next hour, Omar Ishrak, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer, will provide comments on the results of our second quarter, which ended on October 25, 2019. After our prepared remarks, we'll be happy to take your questions.

謝謝。早安，歡迎參加美敦力 2020 財年第二季電話會議和網路廣播。在接下來的一個小時裡，美敦力董事長兼執行長 Omar Ishrak 和美敦力首席財務長 Karen Parkhill 將對截至 2019 年 10 月 25 日的第二季業績發表評論。在我們準備好發言之後，我們很樂意回答您的問題。

First, a few logistical comments. Earlier this morning, we issued a press release containing our financial statements and the revenue by division summary. We also issued an earnings presentation that provide additional details on our performance and outlook.

首先，談幾點後勤方面的評論。今天早些時候，我們發布了一份新聞稿，其中包含我們的財務報表和各部門的收入摘要。我們也發布了一份收益報告，提供有關我們的業績和前景的更多詳細資訊。

During today's earnings call, many of the statements made 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.

在今天的財報電話會議上，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不同的因素的更多資​​訊包含在我們向美國證券交易委員會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聲明。

For this call, unless we say otherwise, rates and ranges are given on a constant currency basis, which compares to the second quarter of fiscal year 2019 after adjusting for foreign currency. References to organic revenue growth exclude the impact of our Titan Spine acquisition and currency. Reconciliations of all non-GAAP financial measures can be found in the attachment to our earnings press release or on our website at investorrelations.medtronic.com. 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.

對於本次電話會議，除非我們另有說明，利率和範圍均以固定貨幣為基礎給出，與 2019 財年第二季度相比，進行了外匯調整。提及有機收入成長時不包括收購 Titan Spine 和貨幣的影響。所有非 GAAP 財務指標的對帳表可在我們的收益新聞稿附件中或我們的網站 investorrelations.medtronic.com 上找到。最後，我們的每股盈餘指引不包括任何將作為財政年度非公認會計準則收益調整報告的費用或收益。

With that, I'm now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishrak. Omar?

現在，我很高興將電話轉給美敦力公司董事長兼執行長 Omar Ishrak。奧馬爾？

Thank you, Ryan, and thank you to everyone for joining us.

謝謝你，瑞安，也謝謝大家的參與。

This morning, we reported another quarter of solid results, with organic revenue growth and EPS both coming in ahead of Street expectations, reflecting our continued focus on executing to our commitments across Medtronic. Q2 revenue grew 4.3% constant currency and 4.1% organic, an acceleration from the first quarter, with outperformances in RTG, MITG and Diabetes. We also delivered another quarter of double-digit growth in emerging markets. Our adjusted operating margin expanded approximately 20 basis points, in line with expectations and included key investments ahead of several major new product launches.

今天上午，我們報告了另一個季度的穩健業績，有機收入成長和每股盈餘都超出華爾街預期，這反映出我們繼續專注於履行對美敦力的承諾。第二季營收以固定匯率計算成長 4.3%，有機成長 4.1%，較第一季有所加速，其中 RTG、MITG 和糖尿病表現優異。我們在新興市場也實現了另一個季度的兩位數成長。我們的調整後營業利潤率擴大了約 20 個基點，符合預期，並包括在幾款主要新產品發布之前的關鍵投資。

Our enterprise excellence initiatives, where we leverage our size and scale to improve our effectiveness and efficiency, continued to benefit our P&L, particularly on the SG&A line. On the bottom line, our diluted EPS grew 7.4% or 9% at constant currency despite the headwind on EPS growth from the increase in our non-GAAP nominal tax rate. Overall, our broad-based performance this quarter demonstrates the consistency of our execution, the strength of our innovation and the benefit of our business and geographic diversification.

我們的企業卓越計畫利用我們的規模和範圍來提高我們的效率和效益，這繼續使我們的損益表受益，特別是在銷售、一般和行政管理方面。從底線來看，儘管非公認會計準則名目稅率的提高對每股收益增長造成了阻力，但我們的稀釋每股收益仍增長了 7.4%，按固定匯率計算增長了 9%。總體而言，我們本季的全面業績體現了我們執行力的一致性、創新力以及業務和地理多元化的優勢。

Let's take a look now at the drivers of our quarterly performance, starting with our Restorative Therapies Group. RTG delivered a particularly impressive performance, posting 6% organic growth, which was 150 basis points ahead of our expectations. Strong sales in spine and brain therapies more than offset slower growth in pain therapies. Our Surgical Synergy strategy for spine surgery, which combines the enabling capital equipment in our Brain Therapies division or the implants in our Spine division, is having an exceptional and sustained impact on RTG's growth.

現在讓我們來看看我們季度業績的驅動因素，首先是我們的恢復性治療集團。RTG 的表現特別出色，有機成長率達到 6%，比我們的預期高出 150 個基點。脊椎和腦部治療領域的強勁銷售足以抵消疼痛治療領域的成長放緩。我們的脊椎外科手術協同策略將我們腦部治療部門的輔助資本設備或脊椎部門的植入物結合起來，對 RTG 的成長產生了卓越而持續的影響。

Our Spine division grew 5.5% organic in the U.S. and 3.5% organic globally. This excludes the early contribution from our Titan Spine acquisition, which is off to a good start. Organic revenue growth in Spine hit its highest level in 2.5 years, with strong double-digit growth in infused bone graft sales as well as 3% organic core spine growth, both globally and in the U.S. This was driven by our Surgical Synergy strategy, precision use of our capital equipment, in particular our Mazor robot, is resulting in increased sales of our core spine implants. In fact, when you combine our Spine division sales with the sales of our capital equipment from our Brain Therapies division that are used in spine surgery, which is how our spine competitors report results, our Spine division grew a robust 6.7% organic, with our U.S. Spine business growing 7.7% organic, well above the market.

我們的 Spine 部門在美國實現了 5.5% 的有機成長，在全球範圍內實現了 3.5% 的有機成長。這還不包括我們收購 Titan Spine 的早期貢獻，該收購開局良好。脊椎業務的有機收入成長達到了兩年半以來的最高水平，其中，全球和美國的注入骨移植銷售額均實現了強勁的兩位數成長，核心脊椎有機銷售額也實現了 3% 的成長。這得益於我們的外科協同策略，我們對資本設備的精準使用，特別是我們的 Mazor 機器人，從而增加了核心脊椎植入物的銷售額。事實上，如果將我們的脊椎部門銷售額與腦部治療部門用於脊椎手術的資本設備銷售額（我們的脊椎競爭對手報告的業績）結合起來，我們的脊椎部門有機成長率達到 6.7%，而我們的美國脊椎業務有機成長率達到 7.7%，遠高於市場水平。

As I just mentioned, our Surgical Synergy strategy is also benefiting our Brain Therapies division, which sells the capital equipment used in spine surgery. Brain Therapies delivered another above-market quarter of 11.3% growth. In Neurosurgery, we had double-digit growth in all 3 of our offerings: Robotics, navigation and imaging. Our Midas Rex-powered surgical instruments also grew double digits, as we fully launched the new Midas Rex MR8 system in the U.S. during the quarter.

正如我剛才提到的，我們的外科協同策略也使我們的腦部治療部門受益，該部門銷售脊椎手術中使用的資本設備。腦部治療業務再次實現高於市場水平的 11.3% 的季度成長。在神經外科領域，我們的三項產品均實現了兩位數的成長：機器人、導航和成像。由於我們在本季在美國全面推出了新的 Midas Rex MR8 系統，我們的 Midas Rex 動力手術器械也實現了兩位數成長。

In Brain Therapies, our market-leading Neurovascular business also had a very strong quarter with high-teens growth, reflecting strength in both ischemic and hemorrhagic stroke. Our ischemic stroke business grew in the high 20s on strong adoption of our Solitaire X stent retriever, Riptide Aspiration System and React catheters. In hemorrhagic stroke, we grew low double digits as expanded indications of our pipeline flex flow diversion system continued to drive growth.

在腦部治療領域，我們市場領先的神經血管業務也表現強勁，成長率高達十幾歲，反映了缺血性和出血性中風的強勁表現。由於 Solitaire X 支架取栓器、Riptide 抽吸系統和 React 導管的廣泛採用，我們的缺血性中風業務成長了 20 倍以上。在出血性中風方面，我們的管線柔性流量轉移系統的擴大適應症持續推動成長，實現了低兩位數的成長。

This was Geoff Martha's last quarter leading RTG before taking over as President of Medtronic earlier this month. Over his 4-year tenure, Geoff revitalized the group. He implemented a strong strategy, built a robust management team and invested in an innovative pipeline. It is also noteworthy that he named his successor from within RTG. Brett Wall has done an outstanding job leading our Brain Therapies division, and he has played a vital role in the turnaround of RTG. We look forward to his leadership of the group.

這是傑夫瑪莎 (Geoff Martha) 在本月初接任美敦力總裁之前領導 RTG 的最後一個季度。在四年的任期內，傑夫重振了該集團。他實施了強有力的策略，建立了強大的管理團隊並投資了創新管道。值得注意的是，他從 RTG 內部任命了繼任者。布雷特沃爾 (Brett Wall) 在領導我們的腦部治療部門方面做得非常出色，他在 RTG 的轉型中發揮了至關重要的作用。我們期待他領導該集團。

In the Minimally Invasive Therapies Group, we had another very strong quarter, growing 6.1% and ahead of expectations, driven by a very good performances in both Surgical Innovations and RGR. In Surgical Innovations, we grew mid-single digits in both Advanced Stapling and Advanced Energy. Advanced Stapling growth was driven by new products in our Tri-Staple line, including our EEA circular stapler and Tri-Staple 2.0 reloads. Advanced Energy growth benefited from continuous innovation in our LigaSure franchise, including our LigaSure exact dissector.

在微創治療集團，我們又度過了一個非常強勁的季度，成長了 6.1%，超出了預期，這得益於外科創新和 RGR 的出色表現。在外科創新方面，我們在先進縫合技術和先進能量技術方面均實現了中等個位數的成長。先進訂書釘業務的成長得益於我們 Tri-Staple 系列的新產品，包括我們的 EEA 圓形訂書機和 Tri-Staple 2.0 裝訂器。Advanced Energy 的成長得益於 LigaSure 特許經營權的持續創新，包括我們的 LigaSure 精確解剖器。

Respiratory, GI & Renal delivered another exceptional quarter, growing 6.1%. The GI Solutions business grew high single digits, led by a strong sales of Bravo calibration-free reflux systems, EndoFLIP imaging systems and PillCam systems. Respiratory and patient monitoring also grew high single digits on strength in Nellcor pulse oximetry, Microstream capnography and BIS brain monitoring consumables, Puritan Bennett 980 ventilators and McGRATH video laryngoscopes.

呼吸、胃腸和腎臟科又一個季度表現出色，增加了 6.1%。胃腸道解決方案業務實現了高個位數成長，其中 Bravo 免校準反流系統、EndoFLIP 成像系統和 PillCam 系統的強勁銷售尤為突出。呼吸和病人監測領域也實現了高個位數成長，其中 Nellcor 脈搏血氧儀、Microstream 二氧化碳圖和 BIS 腦監測耗材、Puritan Bennett 980 呼吸器和 McGRATH 視訊喉鏡表現強勁。

In our Cardiac and Vascular Group, we grew 1.3% this quarter, which was in line with our expectations. CVG has gone through a series of below-trend quarters, which we believe are coming to an end. CVG's growth this quarter reflects the challenges of the last few quarters in LVADs and DCBs, as well as the sustained headwind in CRM replacement devices, given the longer-life batteries we launched several years ago. In addition, during the quarter, we implemented a number of changes to our manufacturing processes for our TYRX product line, which temporarily limited supply and affected our revenue growth in CRHF High Power.

在我們的心臟和血管集團，本季成長了 1.3%，符合我們的預期。CVG 經歷了一系列低於趨勢的季度，我們認為這些季度即將結束。CVG 本季的成長反映了過去幾季 LVAD 和 DCB 面臨的挑戰，以及 CRM 替代設備持續面臨的阻力，因為我們幾年前推出了更長壽命的電池。此外，在本季度，我們對 TYRX 產品線的製造流程進行了一些更改，這暫時限制了供應並影響了 CRHF High Power 的收入成長。

We're seeing clear signs of overcoming these headwinds. U.S. DCBs and LVADs both grew in the teens quarter-over-quarter. We have now passed the 1-year anniversary of the step down in LVADs and we expect to anniversary the DCB challenges in March. With our CRM replacement devices, both pacemakers and CRT-D replacement implants grew sequentially for the first time in several years. We expect CRM replacement devices to be a net neutral impact to CRHF growth next fiscal year after several years of being a headwind to growth.

我們看到了克服這些阻力的明顯跡象。美國 DCB 和 LVAD 的數量比上季均增加了十幾個百分點。我們已經度過了 LVAD 逐步淘汰一周年，預計三月將是 DCB 挑戰的周年紀念。隨著我們的 CRM 替代設備的發展，起搏器和 CRT-D 替代植入物的數量在幾年內首次實現連續增長。我們預計，在經歷了數年的成長阻力之後，CRM 替代設備將在下一財年對 CRHF 的成長產生淨中性影響。

Regarding TYRX, we launched our new manufacturing process late last month, and expect production volumes in Q3 to return to normal levels. Despite these areas of pressure on CVG growth, we're seeing strong performance in other CVG businesses, including pacing and TAVR, which combined, represent over 25% of CVG revenue. Our pacing business grew mid-single digits globally and high single digits in the U.S. as our Micra single-chamber transcatheter pacing system continues to take share and expand the market.

關於 TYRX，我們上個月底啟動了新的製造流程，預計第三季的產量將恢復到正常水平。儘管這些領域對 CVG 成長構成壓力，但我們看到其他 CVG 業務表現強勁，包括起搏和 TAVR，它們合計佔 CVG 收入的 25% 以上。隨著我們的 Micra 單腔經導管起搏系統繼續佔據份額並擴大市場，我們的起搏業務在全球範圍內實現了中等個位數成長，在美國實現了高個位數成長。

Beyond Micra, our global pacemaker share is benefiting from unique feature differentiation in our conventional pacemakers, including our reactive ATP feature, which resulted in differential reimbursement in Japan, as well as the increasing popularity of His-bundle and left-bundle branch pacing, where Medtronic offers unique lead and lead delivery products that enable such procedures.

除了 Micra 之外，我們的全球起搏器份額還受益於我們傳統起搏器的獨特功能差異化，包括我們的反應性 ATP 功能，這導致了日本的差異化報銷，以及希氏束和左束支起搏的日益普及，美敦力提供獨特的導線和導線輸送產品，支持此類程序。

In our TAVR business, we grew in the low 20s, but mid 20s growth in the U.S., driven by expansion into the low-risk patient population. We launched our Evolut PRO+ TAVR System in the U.S. late in the quarter, and this drove some of the highest procedural implant volumes that we have ever had in the final 2 weeks of the quarter.

在我們的 TAVR 業務中，我們的成長率在 20% 出頭，但在美國，成長率達到了 20% 左右，這得益於向低風險患者群體的擴張。我們在本季末在美國推出了 Evolut PRO+ TAVR 系統，這推動了我們在本季最後兩週內實現的歷史最高植入量。

We see an accelerating growth profile for CVG over the back half of our fiscal year, with the anniversary of the LVAD challenges, improving sequential growth in DCBs, improvements in pacemaker and CRT-D replacement volumes and the benefit of multiple important new product launches.

隨著 LVAD 挑戰週年紀念日、DCB 的連續增長、起搏器和 CRT-D 更換量的改善以及多個重要新產品發布的好處，我們看到 CVG 在本財年下半年的增長勢頭將加速。

In Diabetes, we grew 4.3%, slightly ahead of our expectations. Our U.S. business declined in the high single digits, which is anticipated and resulted from competitive challenges while we await our new products. At the same time, our international business, which represents just under half of our Diabetes revenue, grew 19%. The MiniMed 670G, which drove strong growth in the U.S. last year, is experiencing that same strong consumer demand as we launch and receive reimbursement in select international markets. This demand is not only driving double-digit growth in insulin pumps, but is also resulting in double-digit growth in recurring revenue from CGM and other consumables.

在糖尿病領域，我們的成長了 4.3%，略高於我們的預期。我們的美國業務出現了高個位數的下滑，這是可以預料到的，也是我們在等待新產品時面臨的競爭挑戰所導致的。同時，我們的國際業務（占我們糖尿病業務收入的近一半）成長了 19%。MiniMed 670G 去年在美國實現了強勁成長，隨著我們在部分國際市場推出並獲得報銷，它也面臨著同樣強勁的消費者需求。這種需求不僅推動了胰島素幫浦的兩位數成長，而且還導致 CGM 和其他消耗品的經常性收入達到兩位數成長。

Late last month, we announced that Sean Salmon, who has successfully led our Coronary & Structural Heart division, is taking over leadership of the Diabetes group. Sean has an excellent track record in developing and executing competitive business strategies, including the successful launches of several important new technologies for Medtronic. Sean is actively engaged, and we look forward to the impact that he will make on the business.

上個月底，我們宣布成功領導冠狀動脈和結構性心臟部門的 Sean Salmon 將接任糖尿病部門的領導職務。肖恩在製定和執行競爭性商業策略方面有著出色的記錄，包括為美敦力成功推出幾項重要的新技術。肖恩積極參與，我們期待他對業務的影響。

Now turning to emerging markets, which represents 16% of our revenue. In Q2, we grew emerging markets 12%, with contributions from geographies around the globe. China grew 13%. South Asia grew 14%, as did Eastern Europe, which included 20% growth in Russia. In addition, Southeast Asia grew 12%; the Middle East and Africa, 10%; and Latin America, 9%. We continue to drive strong growth in these markets as we optimize the distribution channel and in certain markets localize R&D and manufacturing. In addition, the diversified growth in markets around the world is important. We believe the geographic breadth of our business and the rapid expansion of health care across these markets typically insulates us from country-specific economic cycles. As a result, we expect continued and consistent double-digit growth in emerging markets.

現在轉向新興市場，這占我們收入的 16%。在第二季度，我們的新興市場成長了 12%，這得益於來自全球各地的貢獻。中國成長了13%。南亞成長了 14%，東歐也成長了 14%，其中俄羅斯成長了 20%。此外，東南亞成長了 12%；中東和非洲成長了 10%；拉丁美洲成長了 9%。隨著我們優化分銷管道並在某些市場實現研發和製造在地化，我們繼續在這些市場推動強勁成長。此外，全球市場的多元化成長也很重要。我們相信，我們業務的地理廣度和這些市場醫療保健的快速擴張通常使我們免受特定國家經濟週期的影響。因此，我們預期新興市場將持續保持兩位數的成長。

The first half of this fiscal year has gone well as we've executed to our commitments and delivered better than expected results. Now as we look forward, we're even more excited about what lies ahead as the investments we've made in our pipeline begin to pay off by accelerating our revenue growth and creating value for our shareholders.

本財年上半年進展順利，我們履行了承諾並取得了好於預期的業績。現在，當我們展望未來時，我們對未來更加興奮，因為我們在產品線中所做的投資開始透過加速我們的收入成長和為股東創造價值來獲得回報。

In CVG, as I mentioned earlier, we just launched our next-generation Evolut PRO+ TAVR valve, and we expect to see a full quarter's contribution starting in Q3. In addition, we're expecting imminent U.S. approval for our IN. PACT Admiral AV fistula indication. As we look to the fourth quarter and into the start of fiscal '21, we're anticipating U.S. approval and launch of our Micra AV pacemaker, our next-generation cobalt and chrome families of ICDs and CRT-Ds and our Reveal LINQ 2.0 insertable cardiac monitor.

在 CVG，正如我之前提到的，我們剛剛推出了下一代 Evolut PRO+ TAVR 瓣膜，我們預計從第三季開始將看到整個季度的貢獻。此外，我們期待美國即將批准我們的 IN。PACT Admiral AV 瘻管指徵。展望第四季和 21 財年初，我們預計美國將批准並推出我們的 Micra AV 起搏器、下一代鈷和鉻系列 ICD 和 CRT-D 以及我們的 Reveal LINQ 2.0 可插入式心臟監視器。

Outside the U.S., we're also expecting multiple new product introductions, including the European launch of DiamondTemp ablation catheter and Japanese approvals for our Valiant Navion thoracic stent graft, our Percepta Quad CRT-P family and Attain Stability Quad, active fixation, CRT pacing lead.

在美國以外，我們也期待推出多款新產品，包括在歐洲推出的 DiamondTemp 消融導管和日本批准的 Valiant Navion 胸腔支架移植物、Percepta Quad CRT-P 系列和 Attain Stability Quad、主動固定、CRT 起搏導線。

In MITG, as we discussed in September during our event in Hartford, we're starting the global launch sequence of our soft tissue robotic system, with first-in-human use and commercial sales commencing later this fiscal year. Next fiscal year, we plan to submit for CE mark in Q1 as well as submit for U.S. IDE approval in the first half, which when approved, will allow for system placements and surgeon training so we can begin gathering clinical data in the United States.

在 MITG，正如我們 9 月在哈特福德活動中討論的那樣，我們將開始軟組織機器人系統的全球發布順序，首次人體使用和商業銷售將於本財年晚些時候開始。下一財年，我們計劃在第一季提交 CE 標誌申請，並在上半年提交美國 IDE 批准，獲得批准後，將允許進行系統安置和外科醫生培訓，以便我們開始在美國收集臨床數據。

In RTG, as I mentioned earlier, the Midas Rex MR8 drill platform is being launched now in the U.S. and will be introduced to international markets in the back half of this fiscal year. We're also planning to launch our Stealth AutoGuide cranial robotic system in Q3. In Pelvic Health, we filed our PMA supplement with the U.S. FDA last month for our InterStim in SureScan MRI leads and our InterStim Micro with MRI, which is 3 cc in volume and rechargeable.

在 RTG 方面，正如我之前提到的，Midas Rex MR8 鑽井平台目前正在美國推出，並將於本財年下半年推向國際市場。我們也計劃在第三季推出 Stealth AutoGuide 顱腦機器人系統。在骨盆健康領域，我們上個月向美國 FDA 提交了 SureScan MRI 導線中的 InterStim 和 MRI 中的 InterStim Micro（容量為 3 cc 且可充電）的上市前批准補充文件。

In ENT, we are preparing for a fiscal year-end launch of our next-generation intraoperative nerve monitoring system, NIM VITAL. In pain therapies, we plan to unveil our next-generation spinal cord stimulator at the NANS conference in January.

在耳鼻喉科，我們正準備在財政年度結束時推出下一代術中神經監測系統 NIM VITAL。在疼痛治療方面，我們計劃在一月份的 NANS 會議上推出我們的下一代脊髓刺激器。

In Diabetes, we continue to prepare for the launch of the MiniMed 780G, our advanced hybrid closed-loop system with Bluetooth connectivity. We expect our 780G pivotal data to be presented at the ATTD conference in February. Earlier this month, to bridge the time before our next-generation technologies is available in the U.S., we put in place a next-tech pathway program which allows customers who are out of warranty or new to pump therapy to purchase the MiniMed 670G while accessing our next-generation pump technology at no additional cost when it becomes available.

在糖尿病領域，我們繼續準備推出 MiniMed 780G，這是我們具有藍牙連接功能的先進混合閉環系統。我們預計我們的 780G 關鍵數據將在 2 月的 ATTD 會議上展示。本月初，為了縮短我們的下一代技術在美國上市的時間，我們推出了一項下一代技術途徑計劃，該計劃允許已過保固期或剛開始接受泵治療的客戶購買 MiniMed 670G，同時在我們的下一代泵技術上市時免費使用。

These are some of the highlights from our pipeline. There are of course several more product launches that we're preparing for across the company while we continue to invest in building out a robust, long-term pipeline of continuous innovation, invention and disruption.

這些是我們管道中的一些亮點。當然，我們全公司也正在籌備推出更多產品，同時我們將繼續投資建立強大、長期的持續創新、發明和顛覆管道。

As I've noted before, we expect our growth rate to accelerate, with the second half of FY '20 growing faster than the first as we anniversary recent headwinds and launch multiple new products. And in FY '21, we expect our top line momentum to accelerate as we get the increasing benefit of the FY '20 product launches as well as the products slated to launch next fiscal year.

正如我之前提到的，我們預計我們的成長率將會加快，隨著我們克服最近的逆風並推出多款新產品，20 財年下半年的成長速度將超過上半年。在 21 財年，隨著 20 財年產品發布以及計劃於下一財年推出的產品帶來越來越多的好處，我們預計我們的營收成長動能將會加速。

With that, let me now ask Karen to take you through a discussion of our second quarter financials. Karen?

現在，請容許我請凱倫 (Karen) 帶您討論一下我們的第二季財務狀況。卡倫？

Thank you.

謝謝。

As Omar mentioned, we delivered second quarter organic revenue growth of 4.1%, and adjusted EPS was $1.31, growing 7.4%. We came in $0.03 above the midpoint of our guidance, driven by our operational outperformance.

正如奧馬爾所提到的，我們第二季的有機收入成長了 4.1%，調整後的每股盈餘為 1.31 美元，成長了 7.4%。由於我們出色的營運表現，我們的獲利比預期中點高出 0.03 美元。

Our adjusted operating margin was 28.1%, reflecting improvement of approximately 20 basis points. We delivered strong improvement in adjusted SG&A of approximately 90 basis points as we implement and drive efficiencies and improvements across the company under our Enterprise Excellence Program. Our improvement in SG&A was offset by declines in gross margin, reflecting the negative impact of foreign currency and China tariffs.

我們的調整後營業利益率為 28.1%，提高了約 20 個基點。隨著我們根據企業卓越計劃在全公司範圍內實施和推動效率和改進，調整後的銷售、一般和行政費用 (SG&A) 大幅提高了約 90 個基點。銷售、一般及行政費用的改善被毛利率的下降所抵消，反映了外匯和中國關稅的負面影響。

Below the operating profit line, our adjusted interest expense declined 32%, driven by our successful debt issuance and tender transactions earlier this calendar year. As you know, our cost of debt reduction is helping to offset an increase in our annual tax rate from U.S. tax reform.

在營業利潤線以下，我們的調整後利息支出下降了 32%，這得益於我們今年稍早成功發行債務和招標交易。如您所知，我們的債務削減成本有助於抵消美國稅制改革帶來的年度稅率的增加。

Generating strong free cash flow remains a priority across the company. Second quarter free cash flow was $1.6 billion, up 66% from last year. We are tracking nicely toward our full year conversion ratio target of 80%-plus.

創造強勁的自由現金流仍然是整個公司的首要任務。第二季自由現金流為 16 億美元，比去年同期成長 66%。我們正在順利實現全年轉換率 80% 以上的目標。

We remain committed to disciplined capital deployment, balancing investment in R&D and tuck-in acquisitions to drive future growth, with returning a minimum of 50% of our annual free cash flow to our shareholders. In the second quarter, we returned over $1.1 billion or 71% of the cash we generated, resulting in a total shareholder payout of 64% on adjusted net earnings.

我們將繼續致力於嚴謹的資本配置，平衡研發投資和補充收購以推動未來成長，並將每年至少 50% 的自由現金流返還給股東。在第二季度，我們返還了超過 11 億美元，占我們所產生現金的 71%，導致股東總支出達到調整後淨收益的 64%。

Before I turn the call back to Omar, I would like to update our annual revenue growth and EPS guidance.

在我將電話轉回給奧馬爾之前，我想更新我們的年度收入成長和每股盈餘指引。

For the year, we continue to expect organic revenue growth to approximate 4%, with revenue growth accelerating in the back half relative to the first. While the impact of currency is fluid, if recent exchange rates hold, foreign currency would have a negative impact on full year revenue growth of approximately 80 to 120 basis points.

今年，我們繼續預期有機收入成長率約為 4%，下半年營收成長將比上半年加快。雖然貨幣的影響是不斷變化的，但如果最近的匯率保持不變，外幣將對全年收入成長產生約 80 至 120 個基點的負面影響。

With the strength we are seeing across several of our businesses, from Neurosurgery and Neurovascular to Spine, Surgical Innovations and TAVR, we are raising the organic growth guidance for our 3 largest business groups. We now expect CVG to grow 2.5% to 3%, up from 2.5%; MITG to grow 5% to 5.5%, up from 5%; and RTG to grow 4.5% to 5%, up from 4% to 4.5% previously. These 3 groups combined contribute 92% of our revenue. In Diabetes, which represents 8% of our sales, we now expect low single-digit organic growth, reflecting competitive pressures in the U.S. while we await new product approvals.

鑑於我們在神經外科、神經血管、脊椎、外科創新和 TAVR 等多個業務領域所展現的強勁實力，我們正在提高三大業務集團的有機成長預期。我們現在預計 CVG 將成長 2.5% 至 3%，高於先前的 2.5%；MITG 將成長 5% 至 5.5%，高於先前的 5%；RTG 將成長 4.5% 至 5%，高於先前的 4% 至 4.5%。這三個群體合計貢獻了我們92%的收入。糖尿病占我們銷售額的 8%，我們目前預計其有機成長率將達到低個位數，這反映了我們在等待新產品批准期間在美國面臨的競爭壓力。

For the third quarter, we anticipate organic revenue growth of 4%-plus, with currency having a negative impact of 50 to 120 basis points at recent rates. By group, we expect CVG to accelerate to 3.5% to 4%, Diabetes to be flat to slightly down and MITG and RTG to grow 4.5% to 5%, all on an organic basis.

對於第三季度，我們預計有機收入將成長 4% 以上，而以近期匯率計算，貨幣將產生 50 至 120 個基點的負面影響。以組別來看，我們預期 CVG 將加速至 3.5% 至 4%，糖尿病將持平或略有下降，MITG 和 RTG 將成長 4.5% 至 5%，全部為有機成長。

As Omar mentioned, we are anticipating either U.S. or European approval on a long list of products, starting in the fourth quarter and building into the early part of next year: Our Micra AV transcatheter pacemaker; Percept PC deep brain stimulator; InterStim Micro 3-cc [sacral] nerve stimulator; MiniMed 780G advanced hybrid closed loop; DiamondTemp RF ablation catheter; an AV fistula indication for our IN. PACT Admiral drug-coated balloon; and next generations for our Intelis SCS system, LINQ 2.0 insertable cardiac monitor and cobalt and chrome family ICDs and CRT-Ds. I'm sure I left some off here. But as you can see, we have a lot that's coming, which is why we expect fourth quarter growth to accelerate as we begin to see the early impact of some of these launches.

正如奧馬爾所提到的，我們預計從第四季度開始到明年年初，美國或歐洲將批准一系列產品：我們的 Micra AV 經導管起搏器；Percept PC 深部腦刺激器；InterStim Micro 3-cc [骶] 神經刺激器；MiniMed 780G 先進混合閉環；DiamondTemp 骶] 神經刺激器；MiniMed 780G 先進混合閉環；DiamondTemp 骶] 神經刺激器；MiniMed 780G 先進混合閉環；DiamondTemp 骶骨] 導管；PACT Admiral 藥物塗層球囊；以及我們的下一代 Intelis SCS 系統、LINQ 2.0 插入式心臟監視器以及鈷和鉻系列 ICD 和 CRT-D。我確信我在這裡遺漏了一些內容。但正如您所看到的，我們還有很多事情要做，這就是為什麼我們預計第四季度的成長將會加速，因為我們開始看到其中一些產品的早期影響。

Turning to margins. We continue to expect our full year operating margin to expand by roughly 40 basis points on a constant currency basis, driven by our Enterprise Excellence initiatives. For the third quarter, we would expect slight improvement in operating margin, offset by a currency headwind.

轉向利潤。在企業卓越計畫的推動下，我們預計全年營業利潤率將以固定匯率計算擴大約 40 個基點。對於第三季度，我們預計營業利潤率將略有改善，但將被貨幣逆風所抵銷。

Below the operating line, we expect our quarterly non-GAAP interest expense to be similar to the second quarter for the remainder of the year. In addition, we now expect our third quarter adjusted nominal tax rate to be in the range of 15% to 15.25% and an annual range of 15% to 15.5%. We remain focused on optimizing our underlying operating tax rate over time.

在營業線以下，我們預計今年剩餘時間的季度非公認會計準則利息支出將與第二季相似。此外，我們現在預計第三季調整後的名目稅率將在 15% 至 15.25% 之間，年度稅率將在 15% 至 15.5% 之間。我們將繼續致力於長期優化我們的基礎營業稅率。

We are raising our FY '20 EPS guidance to a range of $5.57 to $5.63 to reflect the second quarter's outperformance, a $0.03 increase from the prior range of $5.54 to $5.60. This includes a negative $0.09 impact of currency at recent rates. For the third quarter, we expect EPS of $1.37 to $1.39, including a $0.02 currency headwind at recent rates.

我們將 20 財年每股收益預期上調至 5.57 美元至 5.63 美元的範圍，以反映第二季的優異表現，較之前的 5.54 美元至 5.60 美元範圍增加 0.03 美元。這包括近期匯率造成的 0.09 美元的負面影響。對於第三季度，我們預計每股收益為 1.37 美元至 1.39 美元，其中包括近期匯率的 0.02 美元貨幣逆風。

Now I will return the call back to Omar.

現在我將回電給奧馬爾。

Thanks, Karen. As I mentioned earlier, Geoff Martha became President of Medtronic earlier this month. And at the start of the next fiscal year, I will retire as CEO and Geoff will take my place. I'm excited with the Board's selection of Geoff as the next leader of Medtronic. Geoff has proven himself as a leader who can execute and deliver strong financial performance, develop our people and enhance our company's culture. I know he will take Medtronic to new levels of performance and growth. We're working together closely to ensure a very smooth transition.

謝謝，凱倫。正如我之前提到的，傑夫瑪莎本月初成為美敦力總裁。在下一個財政年度開始時，我將退休擔任首席執行官，傑夫將接替我的職位。我很高興董事會選擇傑夫作為美敦力的下一任領導者。傑夫已經證明自己是一位能夠執行並提供強勁財務業績、培養員工並提升公司文化的領導者。我知道他將帶領美敦力達到新的業績和發展水準。我們正在密切合作以確保順利過渡。

Before we go to the Q&A, I'll ask Geoff to say a few words. Geoff?

在我們進入問答環節之前，我想請傑夫說幾句話。傑夫？

Thanks, Omar. Well first, I want to reiterate what an honor it is to have been selected by the Board as Medtronic's next CEO, and I'm really looking forward to leading this great company.

謝謝，奧馬爾。首先，我想重申一下，能夠被董事會選為美敦力下一任執行長是我的榮幸，我非常期待領導這家偉大的公司。

Now looking at this past quarter's results, I'm particularly pleased to see our strategies are working in Spine, with strong growth in that business, driven by enabling technology like our Mazor robot. And the transition with Brett as the head of RTG has been incredibly smooth. While he officially took over earlier this month, Brett really led the execution down the stretch in Q2 for RTG. Look, RTG is in good hands, I'll just say that.

現在回顧過去一個季度的業績，我特別高興地看到我們的策略在 Spine 中發揮了作用，在 Mazor 機器人等技術的推動下，該業務實現了強勁增長。布雷特擔任 RTG 負責人的過渡非常順利。儘管 Brett 於本月初正式接任，但他在第二季度真正領導了 RTG 的執行工作。瞧，RTG 掌握在可靠的人手中，我只想說。

Now as I look ahead, I'm incredibly excited about Medtronic's future. We have several product launches coming up, and you can be assured that executing on these is top of my list of priorities. Actually, the entire Medtronic leadership team is focused and committed to delivering on our pipeline, allowing us to build momentum as we head into the back half of the fiscal year and into the next.

現在，當我展望未來時，我對美敦力的未來感到無比興奮。我們即將推出幾款產品，您可以放心，執行這些產品是我的首要任務。實際上，整個美敦力領導團隊都集中精力並致力於實現我們的產品線，使我們能夠在進入本財年下半年和下一財年時積累動力。

Also during this transition period, I'm connecting with many important Medtronic stakeholders in thinking about how our strategy will evolve and how we will achieve that next level of performance. For starters, I'm spending a lot of time meeting with our business leadership and customers beyond RTG. I also plan to meet with and listen to the investment community over the coming months.

此外，在此過渡期間，我正在與美敦力的許多重要利益相關者進行聯繫，思考我們的策略將如何發展以及如何實現更高的績效水準。首先，我花了很多時間與 RTG 以外的業務領導和客戶會面。我還計劃在未來幾個月與投資界會面並聽取他們的意見。

The transition with Omar is going great. We've worked together for a long time and we know how to build off each other's strength. Additionally, I am thrilled with the support from the Board and my colleagues on the Executive Committee. Having continuity in a transition like this makes life a lot easier. While it's still too early to comment on specifics on how our strategy will evolve, I'd like to share a few initial thoughts.

與奧馬爾的過渡進展順利。我們已經合作了很長時間，我們知道如何發揮彼此的優勢。此外，我對董事會和執行委員會同事的支持感到非常高興。在這樣的過渡時期保持連續性會讓生活變得輕鬆很多。雖然現在評論我們的策略將如何發展的具體細節還為時過早，但我想分享一些初步想法。

First, one thing that won't change is our focus on the Medtronic mission, which drives us to use technology to alleviate pain, restore health and extend life. In fact, we're looking to place even more emphasis on innovation-driven growth. Technology has always been the lifeblood of this company, and growth is the name of the game in MedTech. We will be laser-focused on getting our organic revenue growth rates up, getting more aggressive with tuck-in M&A and being decisive with capital allocation to the highest-growth segments. All of these will increase our weighted average market growth rate, or our WAMGR.

首先，有一件事不會改變，那就是我們對美敦力使命的關注，這促使我們利用科技來減輕疼痛、恢復健康和延長壽命。事實上，我們希望更加重視創新驅動的成長。科技一直是這家公司的命脈，而成長是醫療科技領域的遊戲規則。我們將集中精力提高有機收入成長率，更積極地進行內部併購，並果斷地向成長最快的領域進行資本配置。所有這些都將提高我們的加權平均市場成長率，即 WAMGR。

Reinvigorating our Diabetes business is also a priority. This is a rapidly growing market that has huge long-term potential. And I'm confident in our ability to leverage our strength to get back to leading the innovation in this space. We have a strong foundation with which to work and a really exciting pipeline of innovation on both the pump and the sensor side. Also, I am really confident that Sean, along with the rest of the diabetes business, will get this right. Most importantly, he is committed to improving the patient experience.

重振我們的糖尿病業務也是我們的首要任務。這是一個快速成長且具有巨大長期潛力的市場。我相信我們有能力利用我們的優勢重新引領這一領域的創新。我們擁有堅實的工作基礎，並且在泵浦和感測器方面擁有真正令人興奮的創新管道。此外，我非常有信心肖恩以及糖尿病領域的其他同事能夠做好這件事。最重要的是，他致力於改善患者體驗。

Now as we do this, along with executing on our product pipeline, we expect to return to share-taking mode. In fact, we see opportunities for share gains throughout the Medtronic portfolio, and we'll be measuring ourselves on just that.

現在，當我們這樣做時，隨著我們產品線的執行，我們希望恢復分享模式。事實上，我們看到了美敦力產品組合中份額成長的機會，我們將以此為基礎進行自我衡量。

I like to keep things simple: Grow our WAMGR and measure our business performance on whether we are taking share or not. You'll hear more on these priorities over time, and I look forward to sharing our full plans with you when we host Medtronic's Investor Day next June.

我喜歡讓事情變得簡單：擴大我們的 WAMGR，並根據我們是否佔據份額來衡量我們的業務績效。隨著時間的推移，您將聽到更多關於這些優先事項的信息，我期待在明年 6 月舉辦美敦力投資者日時與您分享我們的完整計劃。

So at this point, I'll turn it back to Omar.

因此現在我將話題轉回給奧馬爾。

Thanks, Geoff. Let's now move on to Q&A. In addition to Karen and Geoff, 2 of our group presidents, Mike Coyle and Bob White, are also here to answer your questions. As Brett Wall and Sean Salmon are new to their roles of running RTG and Diabetes, respectively, they won't join the earnings call until next quarter. Karen, Geoff and I will answer the questions related to those 2 groups today.

謝謝，傑夫。現在我們進入問答環節。除了 Karen 和 Geoff，我們的兩位小組主席 Mike Coyle 和 Bob White 也在這裡回答您的問題。由於 Brett Wall 和 Sean Salmon 分別剛上任負責 RTG 和糖尿病業務，他們要到下個季度才會參加財報電話會議。今天，Karen、Geoff 和我將回答與這兩個群體相關的問題。

(Operator Instructions) If you have additional questions, please contact Ryan and our Investor Relations team after the call.

（操作員指示）如果您還有其他問題，請在通話後聯絡 Ryan 和我們的投資者關係團隊。

Operator, first question, please.

接線員，請問第一個問題。

Your first question comes from the line of David Lewis with Morgan Stanley.

您的第一個問題來自摩根士丹利的戴維‧劉易斯。

Just a quick one for Karen and then maybe a follow-up for Mike. So Karen, just thinking about the back half of your revenue, kind of 2-part related question. If we think about -- I appreciate the updated guidance for Diabetes. But if you look at the back half of the year, you had nice acceleration here in the second quarter and a sort of deceleration implied for the third and the back half. So anything other than Diabetes that suggests why the business would decelerate in the back half?

先向 Karen 簡單問一句，然後再向 Mike 提問。所以 Karen，我只是在考慮你的收入的後半部分，這是一個由兩部分組成的相關問題。如果我們考慮一下——我很欣賞關於糖尿病的最新指導。但如果你看一下今年下半年，你會發現第二季經濟加速成長，而第三季和下半年則會出現一定程度的減速。那麼，除了糖尿病之外，還有什麼可以解釋為什麼下半年業務會放緩呢？

And sort of related on earnings, great expansion so far this year, its' not implying much expansion in the back half of the year, and you've got non-op tailwinds in interest and tax. So kind of into the back half of the year, anything we should think about form the top or bottom line? Because it looks, on the margin, a little conservative. Then a quick one for Mike.

與收益相關的是，今年迄今的大幅擴張並不意味著下半年會有太大的擴張，而且在利息和稅收方面有非經營性的順風。那麼，進入下半年，我們該從頂線或底線角度考慮什麼呢？因為它看起來，從邊緣上來說，有點保守。然後 Mike 再簡單說一下。

Yes, thanks for the question, David. Let me touch on the comps first because I know there's a question about that. And the FY '19 comps alone can be a little bit misleading. What dictated the cadence in FY '19 is really what happened in FY '18. If you'll recall in the first half of FY '18, we faced some significant but transitory issues: The IT outage, the Puerto Rico hurricane. And for that reason, I would say, a double stack of FY '18 and '19 would be a good base comparison, where our growth by quarter with that double stack was 4.5%, 5.3%, 5.5%, 5%. But comps aside, what is really going to drive our acceleration in the back half is our pipeline. And we have indicated you should start seeing that in 4Q and continuing into next year.

是的，謝謝你的提問，大衛。讓我先談談比較，因為我知道對此有疑問。僅憑 2019 財年的業績可能會有點誤導。決定 2019 財年節奏的其實是 2018 財年發生的事。如果您還記得 2018 財年上半年，我們面臨一些重大但短暫的問題：IT 中斷、波多黎各颶風。因此，我想說，將 2018 財年和 2019 財年進行雙重比較將是一個很好的基礎，其中我們每季的成長率分別為 4.5%、5.3%、5.5%、5%。但除了同類產品之外，真正推動我們下半年加速發展的是我們的管道。我們已經指出，您應該會在第四季度開始看到這種情況，並持續到明年。

Related to EPS. Yes, we're pleased that we were able to raise our EPS guidance by a total of $0.13 so far this year, $0.03 on the heels of Q2. And while interest, tax and FX are a little more favorable, we do plan to reinvest those benefits to ensure that we can fully support our upcoming launches because they do drive our future revenue growth.

與 EPS 相關。是的，我們很高興今年迄今能夠將每股收益預期提高 0.13 美元，比第二季提高了 0.03 美元。雖然利息、稅收和外匯稍微優惠一些，但我們確實計劃重新投資這些收益，以確保我們能夠全力支持即將推出的產品，因為它們確實推動了我們未來的收入成長。

Okay. Very helpful, Karen. Mike, just real quickly for me. Can you just talk to us about how share is faring in the low-risk expansion markets prior to the approvals? And any comments you want to make this weekend on data that suggests the relative differences in valve performance?

好的。非常有幫助，凱倫。麥克，對我來說，速度很快。您能否跟我們談談在獲得批准之前低風險擴張市場的份額表現如何？本週末您想針對顯示閥門性能相對差異的數據發表什麼評論嗎？

Sure. In terms of overall growth, we were globally growing in the low 20s; and in the U.S., mid-20s. So it was a little slower than the overall market, principally because of the presence now with another competitor in the space who has taken some modest share in the U.S. as well as the rate of ramp for the new centers that are coming on stream with the NCD. So we think that's going to bounce around a little bit, but we were very pleased with the growth profile, clearly accelerated from where we've been in the earlier part of the year and late part of last year.

當然。就整體成長而言，我們在全球的成長率在 20% 出頭，而在美國則達到 20% 左右。因此，它比整體市場要慢一些，主要是因為現在該領域出現了另一個競爭對手，該競爭對手在美國佔據了一些適度的份額，以及隨著 NCD 的推出而投入使用的新中心的增長速度。因此，我們認為這將會反彈，但我們對成長情況非常滿意，明顯比今年稍早和去年年底的成長速度有所加快。

And then in terms of the data that was shared at the AHA, we're still digesting those data sets. These were non-randomized data sets that were coming out of France that basically were concentrated in accounts that were heavily users of the Edwards product line. So we're not sure that the propensity mapping that -- or matching that they did is appropriate to what we've seen. But I think the other piece of it is they were not using a Evolut PRO and they're certainly not using Evolut PRO+ in those data sets, where the addition of the bovine pericardial wrap has really improved the PVL performance.

就 AHA 共享的數據而言，我們仍在消化這些數據集。這些是來自法國的非隨機資料集，基本上集中在大量使用 Edwards 產品線的使用者帳戶中。所以我們不確定他們所做的傾向映射或匹配是否適合我們所看到的情況。但我認為另一個原因是他們沒有使用 Evolut PRO，而且他們在這些數據集中肯定沒有使用 Evolut PRO+，其中添加牛心包包裹確實改善了 PVL 性能。

And now with Evolut PRO, we have the lowest-profile devices and we have those pericardial wraps into the large 34-millimeter size segment. So we know that there have been multiple randomized data sets that have done these comparisons, and we've not seen that kind of mortality difference. So we're going to have to continue just to understand it and digest it.

現在有了 Evolut PRO，我們擁有了最低調的設備，並且我們將這些心包膜包裹放入了 34 毫米的大尺寸部分。因此，我們知道已經有多個隨機資料集進行了這些比較，但我們沒有看到那種死亡率差異。所以我們必須繼續去理解和消化它。

Your next question comes from the line of Bob Hopkins with Bank of America.

您的下一個問題來自美國銀行的鮑伯霍普金斯。

Just wanted to focus on the change of guidance in Diabetes for a minute. I guess the specific question would be maybe you could just go into a little more detail on what specifically has changed and driven the reduction in the guidance here. Maybe a sense for U.S., OUS assumptions in the back half.

我只是想花一點時間關註一下糖尿病指導的變化。我想具體的問題是，也許您可以更詳細地說明一下具體發生了什麼變化並導致了指導意見的減少。也許對美國、OUS 後半部的假設有所了解。

And then more broadly on Diabetes, does -- how does this impact your view on the future growth rate of Diabetes, say, in fiscal 20-21?

那麼更廣泛地討論糖尿病，這會對您對未來糖尿病成長率的看法產生什麼影響，例如 20-21 財年？

Yes. Thanks for the question, Bob. We -- Omar did talk about the fact that we're facing competitive challenges in the U.S. in Diabetes while we await new product launches. But international growth continues to grow well, you saw that in our results, and we expect that strong international growth to continue. In the meantime, in the U.S., Omar mentioned we did initiate a next-tech pathway, which you also may have seen advertised. That means that we'll defer some revenue until we can upgrade those patients to the new technology.

是的。謝謝你的提問，鮑伯。我們——奧馬爾確實談到了這樣一個事實：在等待新產品發布的同時，我們在美國糖尿病領域面臨著競爭挑戰。但國際成長持續保持良好，您可以從我們的業績中看到這一點，我們預計強勁的國際成長將持續下去。同時，在美國，奧馬爾提到我們確實啟動了一條下一代科技途徑，你可能也看到了這條途徑的宣傳。這意味著我們將推遲一些收入，直到我們能夠為這些患者升級到新技術。

And in terms of future growth for Diabetes, we believe that, that will follow our robust pipeline, and we expect growth acceleration in that business with the pipeline as we do in many of our other businesses.

就糖尿病的未來成長而言，我們相信，這將遵循我們強大的產品線，並且我們預計該業務的成長將隨著產品線的完善而加速，就像我們在許多其他業務中所做的那樣。

Bob, let me just -- a little bit. I just want to make it very clear that we're very excited about this pipeline. The 780G promises to be an outstanding product. We're making good progress in terms of our enrollment in the pivotal trial. We've already submitted for our next-generation hardware for approval with the FDA. And so that whole pipeline is on track. And we're going to go through a period of some pressure, especially with new patients in the U.S. But look, there should be no doubt about our enthusiasm for this pipeline and what we see into the future in Diabetes. As Geoff pointed out earlier, this is an area of focus for us and one that we will win in.

鮑勃，讓我——稍微說一下。我只是想明確表示，我們對這條管道感到非常興奮。780G 有望成為一款出色的產品。我們在關鍵試驗的招募方面取得了良好的進展。我們已經向 FDA 提交了下一代硬體的批准。這樣整個流程就步入正軌了。我們將會經歷一段壓力時期，特別是美國的新患者。但是，我們對這條研發線的熱情以及我們對糖尿病未來發展的前景是毫無疑問的。正如傑夫之前指出的那樣，這是我們關注的領域，也是我們將取得勝利的領域。

Great. And then just one quick follow-up, Omar, for you is just I just wanted to gauge your confidence in the outlook for growth in China. And the reason I ask is that another device company this quarter talked about pricing in China for medical devices being a little more pressured than they anticipated. And while it sounded like a bit of a one-off, I just wanted to make sure we got your opinion on the subject and the outlook for growth in China for your business.

偉大的。奧馬爾，我只想快速跟進你對中國經濟成長前景的信心。我之所以問這個問題，是因為本季另一家設備公司表示，中國醫療器材的定價壓力比他們預期的要大一些。雖然這聽起來像是一次性的事情，但我只是想確保我們了解您對這個問題的看法以及貴公司在中國的業務成長前景。

Look, we're very confident about China. We've had consistent results there and one that we expect to continue and continue to depend on in terms of double-digit growth coming out of China. There are some different purchasing processes that are in place, and most of the are really around more commoditized products, some of which we play in. But the government has been really thoughtful about which products were put into these big tenders. And we feel that the majority of our product line is separated clinically.

瞧，我們對中國非常有信心。我們在那裡取得了持續的成果，我們預計這一成果將繼續並繼續依賴中國市場的兩位數成長。目前存在一些不同的採購流程，其中大多數實際上圍繞著更商品化的產品，我們也參與其中的一些產品。但政府對於哪些產品應該納入這些大型招標已經深思熟慮。我們認為我們的大部分產品線在臨床上是分開的。

In any case, even in those situations, there are optimizations we can do in the distribution channel to which we can cover that. So look, we're completely confident about our growth in China. The team there has performed in a very consistent fashion quarter-after-quarter, and we're pretty confident that we can maintain that.

無論如何，即使在這種情況下，我們也可以在分銷管道中進行最佳化。所以，我們對在中國的成長充滿信心。那裡的團隊每季都表現得非常穩定，我們非常有信心能夠保持這種狀態。

Your next question comes from the line of Robbie Marcus with JPMorgan.

您的下一個問題來自摩根大通的羅比馬庫斯。

Karen, I was wondering if you could touch on the cadence of growth in the back part of the year. You talked about 4-plus percent in third quarter. In the press release, you talked about accelerating top line growth in the back half of the year. What does that imply for fourth quarter?

凱倫，我想知道您是否可以談談今年下半年的成長節奏。您談到了第三季 4% 以上的成長。在新聞稿中，您談到了下半年加速營收成長。這對第四季意味著什麼？

Yes. So thanks, Robbie, for the question. We do expect growth acceleration in the fourth quarter as we continue to launch important new products. It's hard to sit here in November and know exactly which products will hit when. And so -- and you also have the possibility that some doctors may be holding some patients as they await approvals for some important things in our pipeline like DBS. So it's hard to predict and pin down fourth quarter at this point, but we'll have a better view when we get to the call in February. And in the meantime, just know that we do expect to see growth acceleration from third quarter.

是的。所以，謝謝羅比提出這個問題。隨著我們繼續推出重要的新產品，我們確實預計第四季度的成長將會加速。十一月的時候很難確切知道哪些產品會在什麼時候上市。因此 — — 也有可能一些醫生正在等待一些病人等待我們管道中一些重要項目的批准，例如 DBS。因此，目前很難預測和確定第四季度的情況，但我們在二月召開電話會議時會有更清楚的了解。同時，我們確實預計從第三季開始成長將會加速。

Got it. And I was hoping -- the spine business came in, very impressive growth rate here. If you could just talk about a little more detail into robotic placements. What sort of centers are buying here? What percentage of your base has a robot? Any data points you could give us so we could think about the pull-through going forward.

知道了。我希望——脊椎業務能夠實現非常令人印象深刻的成長率。如果您能更詳細地談談機器人的放置情況的話。什麼樣的中心在這裡購買？你們基地有多少比例擁有機器人？您可以向我們提供任何數據點，以便我們考慮未來的發展。

I'll take -- this is Geoff. I'll take this one, Robbie. Well, yes, first, the results in the Spine business, which the best we've seen in, I don't know, a long, long, long time, it really is a direct result of the Surgical Synergy strategy, which has real staying power here and has meaningfully improved the intrinsic value of our Spine franchise. It's -- as you pointed out, it's the capital equipment, the Mazor, O-arm navigation. Significant placements, both placements and sales and the pull-through of the Spine implants, it's created a great competitive differentiation and a really nice business model for us.

我接聽——我是傑夫。我要這個，羅比。嗯，是的，首先，脊椎業務的表現是我們長期以來看到的最好的，我不知道，這實際上是外科協同策略的直接結果，該策略在這裡具有真正的持久力，並顯著提高了我們脊椎特許經營的內在價值。正如您所指出的，它是資本設備，Mazor，O 型臂導航。大量的植入，包括植入和銷售以及脊椎植入物的拉動，都為我們創造了巨大的競爭差異和非常好的商業模式。

And look, we're not giving specifics on how many Mazor placements. But I can tell you, it's like the last several quarters, meaningfully more than the competition. And so when you stack quarter after quarter after quarter of meaningfully more placements than the competition, our installed base has gotten pretty big. And this is -- we've got a lot of momentum here. And when you have an organization like RTG that, with the resources and the capabilities, if you can get some of the -- an organization like that focused on something like this, with this kind of momentum, it's going to continue. So we feel very good about it.

而且，我們並沒有給出關於 Mazor 安置數量的具體資訊。但我可以告訴你，就像過去幾季一樣，比競爭對手更有意義。因此，當我們一個季度又一個季度地累積比競爭對手更多的展示位置時，我們的安裝基礎就變得相當大了。這就是——我們在這裡獲得了很大的發展勢頭。當你擁有像 RTG 這樣的組織時，如果你能獲得一些資源和能力，像這樣的組織可以專注於這樣的事情，憑藉這樣的勢頭，它就會繼續下去。所以我們對此感覺非常好。

Your next question comes from the line of Larry Biegelsen with Wells Fargo.

您的下一個問題來自富國銀行的拉里·比格爾森。

One 2-part question for Mike on CVG and one Pain Stim question for Geoff.

向 Mike 詢問有關 CVG 的一個兩部分的問題，向 Geoff 詢問一個有關疼痛刺激的問題。

So Mike, first on Micra AV, your confidence in approval based on the MARVEL 2 data. Just -- that's an important product for you, but it's a small data set.

那麼 Mike，首先關於 Micra AV，您根據 MARVEL 2 數據對批准抱有信心。只是——這對您來說是一個重要的產品，但它是一個小數據集。

And second, the sustainability of the TAVR growth you saw this quarter. It sounds like, based on your comments, that could potentially accelerate from here.

其次，本季 TAVR 成長的可持續性。根據您的評論，聽起來這可能會從現在開始加速。

And just lastly, Geoff, do you think we've turned the corner on the Pain Stim market for your business and the market?

最後，傑夫，您認為我們已經為您的業務和市場扭轉了疼痛刺激市場的情況嗎？

Thanks, Larry. On the Micra AV, we're very pleased with the MARVEL 2 data that we're showing to AHA. We had essentially median of AV synchrony levels of 94%, which is pretty close to what you would see with a standard pacemaker system. So obviously, all the benefits that we will get on complication reduction from no pocket, no lead, are coming at very little trade-off in terms of AV Synchrony. So we think that's going to be very helpful. We believe the data set is fully consistent with what the FDA wanted to see and have seen, so we have now submitted. And so we have a high degree of confidence of having this product available in the marketplace in the U.S. in the fourth quarter.

謝謝，拉里。在 Micra AV 上，我們對向 AHA 展示的 MARVEL 2 數據非常滿意。我們的 AV 同步水平中位數基本上為 94%，這與標準起搏器系統的同步水平非常接近。因此，顯然，我們在無需花錢、無需導線的情況下減少併發症所帶來的所有好處，在 AV 同步方面幾乎沒有什麼損失。所以我們認為這會非常有幫助。我們相信該數據集與 FDA 希望看到的和已經看到的完全一致，所以我們現在已經提交。因此，我們非常有信心該產品將於第四季在美國市場上銷售。

And in terms of the sustainability of the TAVR market. Obviously, we have -- we're very pleased with the acceleration of growth that we saw as we headed into the low-risk data set. I would say we still maintain an expectation for the overall market growth of the TAVR market to be in that $5 billion range in calendar '21. So we're very comfortable that everything is tracking in terms of how we have expected it to happen over the last several years. And so we feel good about that growth engine for us for the next period of time.

就 TAVR 市場的可持續性而言。顯然，我們對進入低風險資料集時看到的成長加速感到非常高興。我想說，我們仍然預計 TAVR 市場的整體市場成長將在 21 年達到 50 億美元左右。因此，我們非常放心，一切都按照我們過去幾年的預期進行。因此，我們對未來一段時間的成長引擎充滿信心。

Okay. On the -- Larry, it's Geoff. On the Pain Stim business, I'll split it in 2 pieces here: There's the market and then our performance.

好的。在——拉里，我是傑夫。關於疼痛刺激業務，我將其分為兩部分：首先是市場，然後是我們的表現。

On the market, obviously, it's -- as you can see from our larger competitors that have reported, the market's come down. And in the short term, I think it's going to be, I'll call it, flattish. Over the medium and longer term, we do see this getting back to mid-single to high single-digit growth in the SCS space. But it has been -- I'd say we're anticipating a flattish market here for the next quarter or 2.

從市場上的情況來看，顯然——正如您從我們較大的競爭對手的報告中所看到的那樣，市場已經下滑。而在短期內，我認為它將是，我稱之為，持平的。從中期和長期來看，我們確實看到 SCS 領域將恢復到中個位數至高個位數的成長。但事實是——我想說我們預計下一季或第二季的市場將持平。

And in terms of -- and I do think there's things that can be done to better position the SCS space with payers. But in the short term, it is an innovation-driven segment. And we're very excited about our next-generation Intellis. As you know, the first generation did very well over the last year-plus, and we already have the next generation, which we'll be talking about, we were rolling out in NANS in January. So we're excited.

就這一點而言——我確實認為可以採取一些措施來更好地定位 SCS 領域與付款人的關係。但從短期來看，這是一個創新驅動的領域。我們對於下一代 Intellis 感到非常興奮。如您所知，第一代產品在過去一年多的時間裡表現非常出色，而且我們已經有了下一代產品，我們將在一月份討論它，我們將在 NANS 中推出它。所以我們很興奮。

And over the last quarter, we have seen our trialing implants and evaluations have grown the last couple of quarters as well as our Intellis sales, we're seeing strong Intellis sales as well. So it is picking up, we do see it trending in the right way, but I don't see it getting back to the high single digits here for a bit.

在過去的一個季度中，我們看到我們的試驗植入物和評估以及 Intellis 銷售都有所增長，我們也看到了強勁的 Intellis 銷售。所以它正在回升，我們確實看到它朝著正確的方向發展，但我不認為它會很快回到高個位數。

Your next question comes from the line of Vijay Kumar with Evercore ISI.

您的下一個問題來自 Evercore ISI 的 Vijay Kumar。

Maybe one on the 3Q guidance here. Sequentially, organic seems to be flattish. I'm curious why, MITG, would that moderate? Comps don't -- seem to be okay in that segment.

也許這裡有一個關於第三季度的指導。依序來看，有機物似乎比較平淡。我很好奇，MITG 為什麼會這樣？同行業公司在這一領域表現似乎並不理想。

And then more importantly, on Diabetes flat to down. How much of that flat to down is are you assuming a share loss versus the new upgrade program, which I assume is you're deferring revenue recognition? Maybe parse out the share loss versus this upgrade program impact.

更重要的是，糖尿病發生率持平甚至下降。您認為與新的升級計劃相比，持平或下降的幅度是多少？我假設您正在推遲收入確認？也許可以分析出份額損失與升級計畫的影響。

Are you seeing any delays in FDA approvals? Because one of your other competitors seems to be having issues on the diabetes side from a regulatory perspective.

您是否發現 FDA 批准有任何延遲？因為從監管角度來看，您的另一個競爭對手似乎在糖尿病方面有問題。

Thanks for the questions, Vijay. So first, on MITG. We had a very strong quarter in MITG. And we're not going to extrapolate a very strong quarter in 2Q onto the back half. We still see strength in MITG and we're pleased with that strength. We did have some share gains from a competitor stapler recall in the second quarter, and we'll see if that continues.

謝謝你的提問，維傑。首先，關於 MITG。本季度，MITG 的業績表現非常強勁。我們不會將第二季的強勁表現推斷到下半年。我們仍然看到 MITG 的優勢，並且我們對這種優勢感到滿意。我們在第二季確實因競爭對手的訂書機召回事件而獲得了一些市場份額，我們將拭​​目以待這種勢頭是否會持續下去。

In terms of Diabetes, the upgrade program is an impact for us in the third quarter. And in terms of market share, our installed base is increasing, particularly as we put 670Gs in Europe. So we're seeing an installed base increase and we're pleased with that.

就糖尿病而言，升級計畫對我們第三季產生了影響。就市場佔有率而言，我們的安裝基數正在增加，特別是當我們在歐洲投放 670G 時。因此，我們看到安裝基數增加，我們對此感到高興。

And then in terms of product launches, I'll let Omar comment.

然後就產品發布而言，我會讓奧馬爾發表評論。

Yes. No. I think in terms of product launches, look, right now, as I said, we're on track. The most important product launch we have is the 780G. And like I mentioned earlier, we've already submitted our next-generation hardware for approval with the FDA. We've completed adult enrollment and we expect to see the initial -- the pivotal trial results at the ATTD meeting in Europe in February. And we expect adult approvals first and ped approval will follow that. Look, the exact timing is up to the FDA. There's no signal to us that things will be unnecessarily delayed or anything like that. So as far as we can see, things are progressing as normal. They have their normal questions and we go through this process. So I don't see anything out of the ordinary there.

是的。不。我認為就產品發布而言，現在，正如我所說，我們正走在正軌上。我們推出的最重要的產品是 780G。正如我之前提到的，我們已經向 FDA 提交了下一代硬體的批准。我們已經完成了成人招募，我們預計將在二月歐洲的 ATTD 會議上看到初步的關鍵試驗結果。我們預計首先會獲得成人的批准，然後再獲得兒童的批准。具體時間由 FDA 決定。沒有任何跡象表明事情將會被不必要地拖延或發生類似情況。據我們所知，一切進展正常。他們有正常的疑問，我們會經歷這個過程。所以我沒有發現任何異常。

That's helpful, Omar. And just one quick one on SG&A. Some of the comments you made on OpEx management, it looks like these trends are sustainable. So just curious on OpEx trends going forward.

這很有幫助，奧馬爾。關於銷售、一般和行政費用 (SG&A)，我只想簡單說一下。您對營運支出管理的一些評論看起來這些趨勢是可持續的。所以只是對未來的營運支出趨勢感到好奇。

Yes. Thanks, Vijay. We have said that we expect to deliver 40 basis points of op margin improvement this fiscal year, and that hasn't changed. You've seen us drive greater improvement in SG&A throughout this year, and that shouldn't change. We've had some gross margin pressure, driven mainly by FX. But we've been offsetting that and continue to deliver the margin expansion that we've committed.

是的。謝謝，維傑。我們曾表示，預計本財年的營業利潤率將提高 40 個基點，這一點沒有改變。您已經看到我們今年在銷售、一般及行政開支方面取得了更大的進步，而且這種情況不會改變。我們的毛利率面臨一些壓力，主要受外匯影響。但我們一直在抵消這一影響，並繼續實現我們承諾的利潤率擴張。

Your next question comes from the line of Matt Taylor with UBS.

您的下一個問題來自瑞銀的馬特泰勒 (Matt Taylor)。

So a question for Geoff. You talked a little bit about some growth priorities that you have and really talked about being more aggressive on tuck-in M&A. I guess I was wondering if we should view that as a little bit of a pivot, and if you could expound on the areas that you think are really kind of ripe for those tuck-ins. And what kind of characteristics would you look for in the deals that you'd like to do?

我想問傑夫一個問題。您稍微談了一下您的一些成長重點，並真正談到了在內部併購方面採取更積極的態度。我想知道我們是否應該將其視為一個小轉折點，以及您是否可以闡述您認為真正適合進行這些調整的領域。在您想要達成的交易中，您會尋找什麼樣的特徵？

First of all, I don't know if I [called or said that. We'd be leaning] towards more of a focus on innovation-driven growth here for the last year or so and building up this pipeline. And Omar's got the whole company focused on pipeline execution. So that, first and foremost, is our top priorities, executing on that pipeline that we've built.

首先，我不知道我是否[打過電話或說過那句話。在過去一年左右的時間裡，我們更傾向於專注於創新驅動的成長並建立這個管道。奧馬爾讓整個公司專注於管道的執行。因此，我們的首要任務是執行我們已經建立的管道。

And then I've been working closely with the group -- the 4 group leaders, including Sean and Brett that are new to it, on a capital allocation strategy that moves to the highest-growth segments that isn't done necessarily at the group level, it's done at a more granular level. And our goal is to -- through R&D investments and through using our balance sheet for tuck-in M&A, to increase the WAMGR of the company.

然後，我一直與集團密切合作——包括新加入的 Sean 和 Brett 在內的 4 位集團領導，制定一項資本配置策略，將資金轉向增長最快的部分，這不一定是在集團層面完成的，而是在更細緻的層面完成的。我們的目標是－透過研發投資和利用我們的資產負債表進行補充併購，來提高公司的 WAMGR。

And so when we're looking at tuck-in M&A, I'm not going to comment on specific segments, but it's going to be those areas that, whether it be within the groups or even adjacencies to the groups, that are going to grow our WAMGR. And so that's the -- answer that.

因此，當我們考慮內部併購時，我不會對特定的細分市場發表評論，但無論是在集團內部還是在集團相鄰區域，這些領域都將增加我們的 WAMGR。這就是——答案。

And just had a follow-up on the ischemic stroke market. As you seem to have really strong results this quarter, one of your competitors talked about a slowdown in that market. Are you seeing any slowdown? Are you gaining share? Can you talk about the dynamics there?

並且剛剛對缺血性中風市場進行了追蹤。由於您本季的業績似乎非常強勁，您的一位競爭對手談到了該市場放緩的情況。您發現有任何放緩嗎？您的市佔率正在增加嗎？能談談那裡的動態嗎？

Well, the market is still going pretty strong, maybe a little bit slightly less than it's grown over the last -- the recent few quarters. But our performance -- and our performance has been, I'd say, better than the competition. And it's coming -- it comes down to the strategy that Brett and Stacy Pugh put in place, that's really having a broad portfolio across both the ischemic side and the hemorrhagic side, having good products in all those areas, it matters in this space. And that strategy is paying off. And we recently launched the new stentriever, on top of -- in the ischemic space. And then on top of the new aspiration system with our 2 catheters. You combine that with the breadth of the portfolio, that's what's driving our results.

嗯，市場仍然表現強勁，但增幅可能比過去幾季略低。但我想說，我們的表現比競爭對手好。它即將到來——這取決於 Brett 和 Stacy Pugh 制定的策略，即在缺血性和出血性方面擁有廣泛的產品組合，在所有這些領域都有好的產品，這在這個領域很重要。這項策略正在取得成效。我們最近推出了新型支架取栓器，用於治療缺血性病變。然後在新的抽吸系統上安裝 2 根導管。將其與投資組合的廣度結合起來，這就是推動我們取得成果的因素。

And so yes, the market grew a little bit less than it has in the past. We still see this as a very strong market going forward. I mean everywhere I go in the world, outside the U.S., in the U.S., you get asked about stroke. And outside the U.S., you have health ministers asking about how we can help them build out their system. It's just a very robust segment for us right now.

是的，市場成長確實比過去慢了一點。我們仍然認為這是一個未來非常強勁的市場。我的意思是，無論我走到世界哪個角落，在美國以外，在美國，都會有人問起中風的問題。在美國以外，各國衛生部長也詢問我們如何幫助他們建立自己的體系。對我們來說，這是一個目前非常強大的領域。

Your next question comes from the line of Josh Jennings with Cowen.

您的下一個問題來自 Cowen 的 Josh Jennings。

Omar, just a question for you. I think when you took the seat at Medtronic [many years] and creating the term economic value creation, if you will, and the evolution of the value-based health care delivery system has been a little bit slower than expected. Can you give us your view on how the -- of the trajectory of the evolution of the health care delivery system?

奧馬爾，我只想問你一個問題。我認為，當您在美敦力公司任職多年並創造了“經濟價值創造”這個術語時，如果您願意的話，基於價值的醫療保健服務系統的發展比預期的要慢一些。您能否就醫療保健體系的演變軌跡談談您的看法？

And then just for Mike, just TAVR question. Asymptomatic data, the RECOVERY trial was presented at AHA over the weekend. You've been a little bit less vocal than one of your competitors on the asymptomatic opportunity. Can you give us your read-through on the RECOVERY trial data? And then any plans for an asymptomatic trial with Evolut -- with the Evolut platform?

然後只針對 Mike，僅針對 TAVR 問題。無症狀數據，RECOVERY 試驗於週末在 AHA 上發表。在無症狀感染者機會方面，您的發言比競爭對手稍微少一些。能為我們介紹一下 RECOVERY 試驗數據嗎？那麼，有沒有計劃使用 Evolut 平台進行無症狀試驗？

Okay. Let me go first on that value-based health care stuff. Yes, it's true that when I first started, that was an area that we looked at. But really, what we were focused on was what we call economic value. In other words, we knew how to create clinical value with our products, and we need to understand how that translated into economic value for the system. And while doing so, we quickly understood that a lot of the economic value was created outside of the providers themselves who are purchasing our devices.

好的。首先讓我談談基於價值的醫療保健問題。是的，當我剛開始工作時，我們確實關注過這個領域。但實際上，我們關注的是所謂的經濟價值。換句話說，我們知道如何利用我們的產品創造臨床價值，我們需要了解如何將其轉化為系統的經濟價值。在這樣做的同時，我們很快就意識到，許多經濟價值是在購買我們設備的供應商之外創造的。

And so we tried to understand that. And through this process, we realized that there's lots of stakeholders here. There's a lot of unknowns in this system. And in the end, we focused on areas where the technology had a direct impact on value creation. And those models, we put in place, and they have been very successful and they continue to be successful, led by TYRX being the most -- the biggest example of that, and that continues to be good.

因此我們嘗試去理解這一點。透過這個過程，我們意識到這裡有很多利害關係人。這個系統中有很多未知數。最後，我們專注於科技對價值創造有直接影響的領域。我們實施的這些模型非常成功，並且將繼續取得成功，其中 TYRX 就是其中最成功的例子，並且將繼續保持良好的發展勢頭。

In terms of the broader evolution of these models. Look, this needs complete stakeholder alignment. That's not something that Medtronic can do on its own. That's just not possible. And it needs a clear leadership in that direction. I've got no doubt that at some point in the future, the health care models have to move to one that's based on paying for value. But like I said, that requires a lot of alignment and it's probably going to take some time.

就這些模型的更廣泛的演變而言。看，這需要利害關係人的完全協調。這不是美敦力公司能夠獨自完成的事。這根本不可能。並且需要在這個方向上有明確的領導。我毫不懷疑，在未來的某個時候，醫療保健模式必須轉向基於價值付費的模式。但就像我說的，這需要大量的協調，而且可能要花費一些時間。

In the meantime, our understanding of the direct relationship between technology and value, we will continue to have and be prepared to go into risk-based models where we have direct control because we have clinical evidence that proves that we can take those risks. And those have been successful.

同時，我們理解技術與價值之間的直接關係，我們將繼續並準備進入我們擁有直接控制權的基於風險的模型，因為我們有臨床證據證明我們可以承擔這些風險。這些都取得了成功。

And then, Josh, in response to your question about the RECOVERY trial. Obviously, we view it as good news that there was a positive outcome for intervention, earlier intervention, in aortic stenosis with the -- in this case, obviously, SAVR showing a mortality benefit versus conservative management. So we think that's good for the overall space in terms of intervention.

然後，喬希，回答你關於 RECOVERY 試驗的問題。顯然，我們認為這是一個好消息，幹預，早期幹預，對主動脈瓣狹窄有積極的結果——在這種情況下，顯然，SAVR 顯示出比保守治療更低的死亡率。因此我們認為這對於介入的整體空間是有利的。

We have been a little cooler on the idea of using a lot of investment into the asymptomatic group just based on experiences that we've had over the years with, for example, ICDs, where the market was really driven by incidence pool as opposed to prevalence pool. And so the availability of the patients to come in when they're asymptomatic is a little bit more of a question. So when we've done this work, we viewed it as a relatively smaller driver of overall TAVR market growth. In fact, we don't include it in our overall estimates for the market growth. So again, this would only be good news.

基於我們多年來在 ICD 等領域的經驗，我們對向無症狀人群投入大量資金的想法持比較冷靜的態度，因為 ICD 的市場實際上是由發病率池而不是患病率池驅動的。因此，當患者沒有症狀時，他們是否可以來就診是一個更大的問題。因此，當我們完成這項工作時，我們認為它是整個 TAVR 市場成長的相對較小驅動力。事實上，我們並沒有將其納入市場成長的整體估計中。所以，這再說一遍，這只是個好消息。

And we're going to continue to look at, as we head into the operating plan period here, for the work that we're doing in spaces like mitral -- replacement mitral repair, these are large clinical trial requirements as well. Is this the best use of dollars to go after asymptomatic? We'll make that call as part of our sort of normal planning process.

隨著我們進入營運計畫期，我們將繼續關注我們在二尖瓣置換修復等領域所做的工作，這些也是大型臨床試驗的要求。這是用金錢追蹤無症狀感染者的最佳方式嗎？我們會將該決定作為我們正常規劃流程的一部分。

Your next question comes from the line of Matt Miksic with Crédit Suisse.

您的下一個問題來自瑞士信貸的 Matt Miksic。

Just one on TYRX and just one follow-up based on your last comment, Mike, on mitral.

僅就 TYRX 而言有一條，並且僅根據您最後一條關於二尖瓣的評論進行跟進，Mike。

So you mentioned TYRX manufacturing, I was wondering if you could give us an update on uptake there or potential plans for guidelines or enhanced reimbursement or any of the things that you had talked about a little earlier in the year related to WRAP-IT?

所以您提到了 TYRX 製造，我想知道您是否可以向我們介紹那裡的吸收情況或指導方針或增強報銷的潛在計劃，或者您在今年早些時候談到的與 WRAP-IT 相關的事情？

Yes. So in this past quarter, we were completing the move of the manufacturing facility from the manufacturing site in New Jersey that we acquired as part of that acquisition of TYRX into the Rice Creek facility here in Minnesota, where we have extensive experience in drug-device combinations. As we were ramping that, and obviously, we had to ramp it significantly relative to the WRAP-IT results being out in last quarter's Q1 growth of -- in the mid-30s, we began to see yields not where we wanted them, and so we were reengineering processes associated with that move.

是的。因此，在上個季度，我們完成了將製造工廠從收購 TYRX 時獲得的位於新澤西的製造基地遷移到明尼蘇達州的 Rice Creek 工廠的工作，我們在藥物-設備組合方面擁有豐富的經驗。當我們加大這一力度時，顯然，我們必須相對於上一季度 WRAP-IT 公佈的第一季增長結果大幅提高——在 30 年代中期，我們開始看到收益率沒有達到我們的預期，因此，我們正在重新設計與這一舉措相關的流程。

As you know, this business -- that original facility was under a warning letter, so we're being very careful about making sure we have very robust validation and verification activities taking place, which took some of our manufacturing capacity offline while we did that work. That has now been completed at the end of last month. We have implemented these new processes and we are ramping nicely in terms of production to a point where I think we're back to normalized production here for the full quarter 3. That certainly is our expectation. So that's behind us and we're now driving growth.

如您所知，這項業務——原始設施受到了警告信的約束，因此我們非常小心地確保我們進行了非常嚴格的驗證和核實活動，這使得我們的部分製造能力在我們進行這項工作時處於離線狀態。該工作已於上個月底完成。我們已經實施了這些新流程，並且生產正在順利提升，我認為我們將在整個第三季恢復正常生產。這當然是我們的期望。我們已經擺脫了這些困境，現在我們正在推動成長。

In terms of guidelines, we continue to work with the professional societies around guidelines, and we'll have more to say about that as decisions roll out. But clearly, the availability of the robust evidence that came from WRAP-IT has really helped us in terms of being able to drive adoption of the technology as we saw in Q1, and I expect that will continue to be valuable to us here in the second half and beyond.

在指導方針方面，我們將繼續與專業協會合作制定指導方針，隨著決策的出台，我們將對此有更多發言權。但顯然，WRAP-IT 提供的強有力證據確實幫助我們推動了該技術的採用，正如我們在第一季看到的那樣，我預計這將在下半年及以後繼續對我們產生價值。

That's great. And then, Mike, you mentioned you're sort of picking your spots investing in structural heart and mitral and replacement and repair. Just any color or update on either of those fronts, if you would.

那太棒了。然後，麥克，你提到你正在選擇投資結構性心臟和二尖瓣以及更換和修復領域。如果您願意的話，只需在這些方面中的任何一個上添加任何顏色或更新即可。

Well, obviously, we continue to think we have a leadership position in the mitral valve replacement market. And in fact, we now have our transfemoral system locked down in terms of design. And we have approval for the feasibility IDE in that space, and so we're going to certainly be prosecuting those clinical trials.

嗯，顯然，我們仍然認為我們在二尖瓣置換市場中處於領先地位。事實上，我們現在已經確定了股動脈系統的設計。我們已經獲得了該領域可行性IDE的批准，因此我們肯定會進行這些臨床試驗。

We have important investments going on internally in the repair space. We're not really prepared yet to discuss those publicly, but we do think there are some very interesting opportunities for us in that space that would be complementary to where others are investing in that space.

我們在內部維修領域進行了重要的投資。我們還沒有準備好公開討論這些問題，但我們確實認為，該領域對我們來說有一些非常有趣的機會，可以補充其他人在該領域的投資。

And then obviously, we continue to roll out labeling indications in the TAVR space. The bicuspid market, for example, is -- that enrollment has been completed, and we will be pursuing labeling indications or removal of labeling restrictions in that area.

然後顯然，我們將繼續在 TAVR 領域推出標籤指示。例如，雙尖牙市場—註冊已經完成，我們將在該地區尋求標籤適應症或取消標籤限制。

So as I said, we're looking at a number of other things as part of our sort of preparation work, the work we're doing in strat plan and preparation for next year's operating plan. And we'll probably have more to say about that around the time of the analyst meeting in June.

正如我所說，我們正在考慮許多其他事情作為我們準備工作的一部分，我們正在製定策略計劃並為明年的營運計劃做準備。我們可能會在六月分析師會議期間對此進行更多討論。

Your next question comes from the line of Matthew O'Brien with Piper Jaffray.

您的下一個問題來自 Piper Jaffray 的 Matthew O'Brien。

Just 2 here together. It sounds like a lot of the products are on schedule for introduction as expected, but the one that seems a little bit aggressive to me is InterStim II. So would just love to hear why you're so confident in the timing of that product coming out?

這裡只有 2 個人在一起。聽起來很多產品都如預期準時推出，但在我看來，有點激進的是 InterStim II。那我很想聽聽您為什麼對該產品的上市時間如此有信心？

And then secondly, Mike, on the TAVR side of things, you mentioned a little bit of impact competitively. Was that impact level less than you expected, more than you expected, kind of in line? Just any kind of color there would be helpful.

其次，麥克，就 TAVR 方面而言，您提到了一點競爭影響。影響程度是否低於您的預期，高於您的預期，還是符合您的預期？任何一種顏色都會有幫助。

Go ahead, Geoff.

繼續吧，傑夫。

Yes. So Matt, on the first one, we have InterStim II and MicroStim. I'm not sure, did you mean MicroStim or InterStim II or both?

是的。那麼 Matt，首先，我們有 InterStim II 和 MicroStim。我不確定，您指的是 MicroStim 還是 InterStim II 還是兩者？

Yes. Sacral nerve.

是的。骶神經。

All right. Well, so the MicroStim, as we've announced, we've submitted that to the FDA, and we believe that's on track for a mid-calendar 2020 approval. And then also InterStim II, which is our -- that's our -- so MicroStim is our rechargeable platform. Again, this is the -- this would be our first rechargeable platform. It'll be a 3 3 c -- a 3-cc device, fully -- a full body MR labeling with our proven overdrive battery chemistry on there. So this is going to be a great product. That's the MicroStim, that is mid-calendar 2020. And then our InterStim II, which will have improved -- which is our primary cell device or recharge-free device, the next-generation -- or that will come out with MR labeling around the same time.

好的。嗯，正如我們所宣布的那樣，我們已經將 MicroStim 提交給 FDA，我們相信它預計將在 2020 年中期獲得批准。還有 InterStim II，這是我們的——這是我們的——MicroStim 是我們的可充電平台。再說一次，這是我們的第一個可充電平台。它將是一個 3 3 c（3 cc 設備），一個全身 MR 標籤，上面裝有我們經過驗證的超速電池化學成分。所以這將會是一款很棒的產品。這就是 MicroStim，預計於 2020 年中期推出。然後是我們的 InterStim II，它將有所改進 - 這是我們的主要電池設備或免充電設備，下一代 - 或者將在同一時間推出 MR 標籤。

So we're feeling here, we'll have a full portfolio, both recharge-free and recharge, and are feeling really good about that based on the timing of our submissions and the normal FDA review.

因此，我們感覺我們將擁有完整的產品組合，包括免充值和充值產品，並且根據我們提交的時間和正常的 FDA 審查，我們對此感覺非常好。

And then in terms of your question about competitive product entry to the TAVR space. Obviously, it was March that the third competitor came into the market. And so we're now into about the third quarter of their presence in the marketplace. And we'd estimate they have somewhere between 1% and 2% market share, and that is in line, maybe a little lower than we had expected when we put together our operating plan for the entrant. There's certainly trialing going on of the product and we would expect that to continue, but we think we've done a good job securing our share positions in the face of now a third competitor.

然後關於您關於競爭產品進入 TAVR 領域的問題。顯然，第三家競爭對手是在三月進入市場的。現在我們已經進入了他們在市場上的第三季。我們估計他們的市佔率在 1% 到 2% 之間，這與我們在為新進業者制定營運計畫時所預期的相符，可能略低一些。該產品確實正在進行試用，我們預計試用會繼續下去，但我們認為，面對現在的第三個競爭對手，我們已經很好地確保了我們的份額地位。

Your next question comes from the line of Danielle Antalffy with SVB Leerink.

您的下一個問題來自 SVB Leerink 的 Danielle Antalffy。

Just a quick question on the U.S. piece of the business. It looks like that was pretty strong. We're coming to almost 300 basis points of growth acceleration on a comp-adjusted basis. Was wondering if you could talk about how sustainable you think that is as we look over the next few quarters. And maybe you'd point out what what's sort of driving that. And I have one follow-up on CVG.

我只是想問一下有關美國業務的一個簡單問題。看起來相當強大。經過調整後，我們的增長加速度接近 300 個基點。我想知道您是否可以談談，展望未來幾個季度，您認為這種狀況的可持續性如何。也許您可以指出是什麼導致了這種情況。我對 CVG 還有一個後續問題。

Okay. Let me take the U.S. growth. Look, overall, it's in line with what we were expecting. As we've mentioned many times before, growth, particularly in the U.S., is driven by innovation. So when there's a new product that comes in that increases procedures for the right reasons, then we get clear growth, and we expect that dynamic to continue. The baseline growth remains pretty consistent, the number of procedures and all of that remains pretty consistent. And whenever we have new product entries, that drives the growth rate up, and we don't expect that dynamic to change looking into future.

好的。讓我來談談美國的成長。看起來，總體而言，它符合我們的預期。正如我們之前多次提到的，成長，尤其是在美國，是由創新驅動的。因此，當有新產品出現並能出於正確的原因增加程序時，我們就會獲得明顯的成長，而我們預期這種動態將會持續下去。基線增長保持相當一致，程序數量以及所有這些都保持相當一致。每當我們有新產品推出時，成長率就會上升，我們預計這種動態在未來不會改變。

And we expect with the pipeline that we have, and they're all on track and we've got lots of exciting products, all the way from the Micra AV pacemaker to the 780G insulin pump to the InterStim Micro and all of the other stuff that we've talked about, all of those things, when launched in the U.S., will drive the market up and we'll get share gains as a result of that. So that's the way I look at the U.S. market, it's really innovation-driven.

我們預計，憑藉我們現有的產品線，它們都進展順利，我們擁有許多令人興奮的產品，從 Micra AV 起搏器到 780G 胰島素泵，再到 InterStim Micro 以及我們討論過的所有其他產品，所有這些產品在美國推出後，都將推動市場增長，我們的份額也將因此增加。這就是我看待美國市場的方式，它確實是創新驅動的。

Okay. Got it. And then on CVG, Mike, was hoping you could talk a little bit about what's driving the modest guide higher in the back half of the year. I get that it feels like LVADs should start to anniversary some of their tough comps, maybe DCBs start to stabilize. But otherwise, just curious if you could point to what's really driving the upside in the back half of the year in CVG.

好的。知道了。然後在 CVG 上，麥克，希望您能稍微談談是什麼推動了下半年適度指導的上漲。我感覺 LVAD 應該開始紀念其一些艱難的競爭，也許 DCB 開始穩定下來。但除此之外，我只是好奇您是否可以指出真正推動 CVG 下半年上漲的因素。

Sure, Danielle. The headwinds that you talk about, especially the LVAD one, is clearly now behind us, and that we've anniversaried that sort of step-change in the market that happened at the end of Q2 a year ago. So that really helps in terms of overall prior year comps. And as you mentioned, with DCB, we have now begun to see the sequential growth that we've been expecting as more data sets are available that basically help address this question about the safety signal that has been raised. And obviously, the availability of the AV fistula data, which we've shown at the CIRSE meeting, basically showed we did not see that mortality signal in the 1-year data for those data sets and we saw very significant reductions in reintervention rates, more than 50% reductions in reintervention in that AV fistula patient population, which we think will help not just in AV fistulas, which obviously expands the DCB market, but also it's going to help us with the confidence in the SFA position. So those headwinds basically becoming mitigated is helpful.

當然，丹妮爾。您談到的不利因素，尤其是 LVAD 因素，顯然已經過去了，而且我們已經紀念了去年第二季末市場上發生的那種階躍變化。因此，這對於與去年同期的整體情況相比確實有幫助。正如您所提到的，對於 DCB，我們現在已經開始看到我們一直期望的連續增長，因為更多的數據集可用，基本上有助於解決有關已提出的安全信號的問題。顯然，我們在 CIRSE 會議上展示的 AV 瘻管數據的可用性基本上表明，我們在這些數據集的 1 年數據中沒有看到死亡信號，並且我們看到再乾預率顯著降低，AV 瘻管患者群體的再乾預率降低了 50% 以上，我們認為這不僅有助於 AV 瘻管，這顯然會擴大 DCB 市場，而且有助於我們對 SFA 地位的信心。因此，這些不利因素的緩解基本上是有幫助的。

We also have the headwinds associated with the replacement cycle in especially pacemakers and in CRT-D devices, that has begun to mitigate. And even though we still see pressure in the traditional ICD segment, CRT-D is the biggest single replacement component of our market, and obviously pacemakers are a big component as well. So whereas we've had the last couple of years of very significant headwinds, as we head into FY '21, we are beginning to see that turn into a neutral impact on our overall growth market -- or growth trends, which then allows us to see the benefits of the new products that are coming into the market.

我們也面臨著與更換週期相關的阻力，尤其是起搏器和 CRT-D 設備的阻力，但這種阻力已經開始減輕。儘管我們仍然看到傳統 ICD 領域存在壓力，但 CRT-D 是我們市場上最大的單一替代組件，顯然起搏器也是一個重要組件。因此，儘管過去幾年我們遇到了非常大的阻力，但隨著我們進入 21 財年，我們開始看到這對我們的整體成長市場或成長趨勢產生了中性影響，這讓我們看到了進入市場的新產品帶來的好處。

Obviously, we talked about the Evolut PRO+ and the low-risk indication. We also will -- are expecting imminently the AV fistula indication for the IN. PACT Admiral. We'll be introducing our new ICD family on the Galaxy platform, which the cobalt and chrome product lines which are going to add numerous feature set benefits that we'll talk about as we launch the product. We also have LINQ 2.0 moving into the market here as we get to the end of the year. But probably the most important of those products is the Micra AV, which we expect to have in the fourth quarter, and that should help us with that fourth quarter acceleration that Karen was talking about.

顯然，我們討論了 Evolut PRO+ 和低風險指徵。我們也將—期待著動靜脈瘻管 (AV) 指徵盡快出現在 IN 中。PACT 海軍上將。我們將在 Galaxy 平台上推出新的 ICD 系列，該系列的鈷和鉻產品線將增加許多功能集優勢，我們將在推出產品時討論這些優勢。隨著年底的臨近，LINQ 2.0 也將進入市場。但這些產品中最重要的可能是 Micra AV，我們預計將在第四季度推出，這應該有助於我們實現 Karen 所說的第四季度加速成長。

Your final question will come from the line of Raj Denhoy with Jefferies.

您的最後一個問題來自 Jefferies 的 Raj Denhoy。

Maybe a couple of questions. First, for Karen, the -- I think you described the decline in gross margins was because of currency but also because of China tariffs. And I'm curious if you could maybe parse out what is -- what each of those is contributing to the decline in gross margins. And is there any view to any improvement in that? Could any of the tariffs get reduced or any relief there?

也許有幾個問題。首先，對於 Karen 來說，我認為您所描述的毛利率下降不僅是因為貨幣原因，也是因為中國關稅。我很好奇，您是否可以分析一下，哪些因素導致了毛利率的下降。對此有沒有什麼改進的看法？關稅是否會降低或減免？

Yes. Thanks for the question, Raj. We did see the most significant impact from FX, it was about 70 basis points on the gross margin. And then the China tariffs was a smaller impact. In terms of gross margin going forward, we expect gross margin to be relatively stable to where it is today in the second quarter going forward. And we anticipate continuing to offset that with SG&A improvement as we further drive margin expansion.

是的。謝謝你的提問，Raj。我們確實看到了外匯帶來最顯著的影響，毛利率下降了約 70 個基點。而中國關稅的影響較小。就未來的毛利率而言，我們預計第二季的毛利率將相對穩定在目前的水平。隨著我們進一步推動利潤率的擴大，我們預期銷售、一般及行政費用的改善將持續抵銷這種影響。

Okay. That's helpful. And maybe just lastly on Diabetes. I mean I appreciate the confidence in recovery there, returning to growth as you move into next year. But I guess when one thinks about the competitive landscape in diabetes, there's going to be some developments from your competitors on automated insulin delivery systems as well. And so the question is really, how confident you are that 780G can get you where you need to go? And whether you still need to have improvements on the CGM side of that business in particular in order to see improving results.

好的。這很有幫助。最後再談談糖尿病。我的意思是，我很欣賞你們對那裡經濟復甦的信心，以及明年恢復成長的信心。但我想，當人們考慮糖尿病領域的競爭格局時，競爭對手也會在自動胰島素輸送系統方面取得一些進展。所以真正的問題是，你對 780G 能帶你到你需要去的地方有多大信心？以及您是否仍需要在該業務的 CGM 方面進行改進才能看到更好的結果。

Yes. I think the 780G will take us a long way. And it actually differentiates us in terms of the algorithm over anything that anyone has or from what we can see projecting. And so the advanced hybrid closed-loop system is really going to separate us from that dimension.

是的。我認為 780G 將幫助我們走得更遠。實際上，從演算法的角度來看，它使我們與任何人擁有的或我們所能看到的投影有所不同。因此，先進的混合閉環系統確實會將我們與那個維度分開。

I think with the sensor area, we still have work to do. And I think that's going to take a little longer. In reducing the number of fingersticks, we continue to make progress, but that's going to be an area of pressure even going into next year. But we expect that the -- there are many other benefits of the 780G in terms of not only the algorithm, but in terms of its capabilities that we will benefit from.

我認為在感測器領域我們還有很多工作要做。我認為這還需要更長的時間。在減少指尖採血次數方面，我們不斷取得進展，但即使到了明年，這仍將是一個壓力領域。但我們預期 780G 不僅在演算法方面有許多其他優勢，而且在其功能方面也值得我們借鏡。

So that's the way I'd look at it. The sensor area, it's going to take a little longer to completely resolve. We'll make incremental progress, but that's going to take just a little longer.

這就是我的看法。感測器區域需要更長的時間才能完全解決。我們將逐步取得進展，但這將需要更長的時間。

Omar, any final word?

奧馬爾，還有什麼要說的嗎？

Well, listen, thank you all for your questions. And on behalf of the entire management team, I'd like to thank you again for your continued support and interest in Medtronic. We look forward to updating you on our progress on our Q3 earnings call, which we currently anticipate holding on Tuesday, February 18. So thank you all very much.

好吧，聽著，謝謝大家的提問。我謹代表整個管理團隊再次感謝您對美敦力的持續支持與關注。我們期待在第三季財報電話會議上向您通報我們的進展情況，目前我們預計將於 2 月 18 日星期二舉行電話會議。非常感謝大家。

Ladies and gentlemen, this does conclude today's call. Thank you all for joining, and you may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入，現在可以斷開連線了。