美敦力第二季業績強勁,多個業務和地區的收入實現中個位數成長。他們對自己繼續實現成長的能力充滿信心,並專注於加強營運和投資創新技術。
該公司上調了全年營收成長和每股收益指引,並對未來的成長前景表示樂觀。他們討論了 GLP-1 藥物對醫療技術市場的潛在影響,但相信這不會顯著影響他們的成長前景。他們專注於推動持久的中個位數最高成長並實現兩位數的股東總回報。
他們提供了有關產品批准、報銷工作和機器人計劃的最新資訊。他們對自己在手術機器人市場的競爭力充滿信心,也專注於互通成像、導航和基於人工智慧的規劃。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Ryan Weispfenning - VP & Head of IR
Ryan Weispfenning - VP & Head of IR
Good morning. Welcome to a crisp fall morning here in Minnesota. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. And I appreciate that you're joining us this morning for Medtronic's fiscal '24 second quarter video earnings webcast.
早安.歡迎來到明尼蘇達州一個秋高氣爽的早晨。我是瑞安‧韋斯芬寧 (Ryan Weispfenning),美敦力 (Medtronic) 副總裁兼投資者關係主管。我很高興您今天早上加入我們,觀看美敦力 (Medtronic) 的 24 財年第二季度視訊收益網路廣播。
Before we go inside to hear our prepared remarks, I'll share a few details about today's webcast. Joining me are Geoff Martha, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide comments on the results of our second quarter, which ended on October 27, 2023 and our outlook for the remainder of the fiscal year. After our prepared remarks, the Executive VPs covering our segments will join us, and we'll take questions from the sell-side analysts that cover the company. Today's program should last about an hour.
在我們進去聽取準備好的發言之前,我將分享有關今天網路廣播的一些細節。與我一起出席的還有美敦力 (Medtronic) 董事長兼執行長 Geoff Martha;和美敦力財務長 Karen Parkhill。 Geoff 和 Karen 將就我們截至 2023 年 10 月 27 日的第二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之後,負責我們各部門的執行副總裁將加入我們,我們將回答負責該公司的賣方分析師的問題。今天的節目應該持續大約一個小時。
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.
今天早些時候,我們發布了一份新聞稿,其中包含我們的財務報表以及部門和地區收入摘要。我們還發布了一份收益報告,提供了有關我們業績的更多詳細資訊。您可以在我們的收益新聞稿或我們的網站 Investorrelations.medtronic.com 上存取該簡報。
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. 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 second quarter revenue in the current and prior year reported as other, which stems from prior business separations.
在今天的節目中,我們所做的許多陳述可能被視為前瞻性陳述,實際結果可能與任何前瞻性陳述中預測的結果有重大差異。有關可能導致實際結果出現差異的因素的更多資訊包含在我們向 SEC 提交的定期報告和其他文件中,並且我們不承諾更新任何前瞻性聲明。除非我們另有說明,所有比較都是按年比較,收入比較是在有機基礎上進行的,不包括外幣和本年度和上一年報告為其他的第二季度收入的影響,這源於之前的業務分離。
There were no acquisitions made in the last 4 quarters that had a significant impact on total company or individual segment quarterly revenue growth. References to sequential revenue changes compared to the first quarter of fiscal '24, and are made on an as-reported basis and all references to share gains or losses refer to revenue share in the third calendar quarter of 2023 compared to the third calendar quarter of 2022 unless otherwise stated.
過去 4 個季度沒有發生對公司整體或個別部門季度收入成長產生重大影響的收購。所提及的與24 財年第一季相比的連續收入變化是在報告的基礎上進行的,所有提及份額收益或損失的內容均指與2023 年第三季度相比的2023 年第三季度的收入份額除非另有說明,2022 年。
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 GAAP 財務指標的調整表可在我們的收益新聞稿或我們的網站 Investorrelations.medtronic.com 上找到。最後,我們的每股盈餘指引不包括本財政年度收益的非公認會計原則調整報告的任何費用或收益。
With that, let's head into the studio and hear about the quarter.
接下來,讓我們走進工作室,聽聽這個季度的情況。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Hello, everyone, and thank you for joining us today. Q2 was another good quarter for us as we executed and delivered mid-single-digit revenue growth. The underlying fundamentals of our business are strong, and our growth was broad-based across multiple businesses and geographies with Cardiovascular, Neuroscience and Medical Surgical, all growing mid-single digits and Diabetes accelerating to high single-digit growth.
大家好,感謝您今天加入我們。第二季度對我們來說又是一個好季度,因為我們執行並實現了中個位數的收入成長。我們業務的基本面強勁,我們的成長基礎廣泛,涉及多個業務和地區,其中心血管、神經科學和醫療外科領域均實現中個位數成長,糖尿病業務則加速實現高個位數成長。
Our new product launches are performing well and driving growth across many businesses. And we look ahead to the back half of our fiscal year. Those launches, combined with several recent regulatory approvals, give us confidence in our ability to continue delivering dependable growth.
我們的新產品發布表現良好,並推動了許多業務的成長。我們展望了本財年的後半段。這些產品的推出,加上最近幾項監管的批准,讓我們對繼續實現可靠成長的能力充滿信心。
And at the same time, we're executing on our comprehensive transformation, including enhancing our global operations, quality and supply chain. And we're decisively allocating capital into fast-growth med tech markets and fueling innovative technologies in areas like robotics, AI and closed loop systems that will drive our growth over the next decade. We're forging the path to durable growth as we execute on the actions needed to create long-term value for our shareholders.
同時,我們正在實施全面轉型,包括加強我們的全球營運、品質和供應鏈。我們果斷地將資金投入快速成長的醫療技術市場,並推動機器人、人工智慧和閉環系統等領域的創新技術,這些技術將推動我們在未來十年的成長。當我們執行為股東創造長期價值所需的行動時,我們正在開闢持久成長的道路。
So now let's get into the details behind our Q2 results. We continue to look at our portfolio of businesses in 3 categories: established market leader businesses, synergistic businesses and highest growth businesses. Looking first at the established market leaders. We had very strong performances across Cranial & Spinal Technologies, Surgical and Cardiac Rhythm Management. Combined, they made up just under half of our revenue and grew 6% organic again this quarter.
現在讓我們詳細了解第二季業績背後的細節。我們繼續將我們的業務組合分為三類:既定的市場領導者業務、協同業務和最高成長業務。首先關注已確立的市場領導者。我們在顱腦和脊椎技術、外科和心律管理方面表現非常出色。它們合計占我們收入的一半以下,本季有機成長再次達到 6%。
Starting with Cranial & Spinal Technologies, continued adoption of our AiBLE ecosystem is driving consistent above-market growth. In Q2, we grew 7%. Digitization is transforming the competitive landscape in Spine, and we're leading the way with AiBLE. With our global footprint of over 10,000 systems, we're over 4x greater than the nearest competitor. We are the first and only solution with integrated AI-based surgical planning with unit-adaptive spine intelligence.
從顱腦和脊椎技術開始,我們的 AiBLE 生態系統的持續採用正在推動持續高於市場的成長。第二季度,我們成長了 7%。數位化正在改變 Spine 的競爭格局,我們透過 AiBLE 引領潮流。我們的全球覆蓋範圍超過 10,000 個系統,我們的效能是最接近的競爭對手的 4 倍以上。我們是第一個也是唯一一個將基於人工智慧的手術規劃與單元自適應脊椎智慧相結合的解決方案。
Our Mazor Robotic system is the first and only to offer bone cutting, a feature that was well received when we unveiled it at the North American Spine Society Conference in Los Angeles just last month. And we remain the clear leader in the intraoperative imaging and navigation space with our O-arm and StealthStation technologies, both of which grew double digits in the quarter. As surgeons adopt AiBLE, and we continue to expand our sales teams and invest in future innovation, we expect to maintain our leadership and extend our share gains in Spine.
我們的 Mazor 機器人系統是第一個也是唯一一個提供骨切割功能的系統,上個月我們在洛杉磯舉行的北美脊椎協會會議上推出該功能時,該功能受到了好評。憑藉我們的 O 型臂和 StealthStation 技術,我們在術中成像和導航領域仍然處於明顯的領先地位,這兩項技術在本季度都實現了兩位數的成長。隨著外科醫生採用 AiBLE,我們將繼續擴大銷售團隊並投資於未來的創新,我們希望保持我們的領先地位並擴大我們在 Spine 的份額成長。
Now moving to Surgical. We grew 6% here. There was broad-based strength across our surgical franchise. Hernia and electrosurgery both grew in the double digits on strong sales of our ProGrip and Dextile Mesh and Valleylab smoke evacuation systems. Advanced Stapling and Wound Management both grew mid-single digits. Cardiac Rhythm grew 4% with high single-digit growth in Cardiovascular Diagnostics and Cardiac Pacing. In pacing, our Micra leadless pacemaker franchise grew 13%, driven by our U.S. launch of our next-generation Micra AV2 and VR2 devices. We're also seeing strong growth in conduction system pacing, an alternative to traditional single or dual chamber pacing.
現在轉向外科。我們這裡成長了 6%。我們的外科專營權具有廣泛的實力。由於 ProGrip、Dextile Mesh 和 Valleylab 排煙系統的強勁銷售,疝氣和電外科手術均以兩位數成長。高級縫合和傷口管理業務均實現中個位數成長。心律成長 4%,其中心血管診斷和心臟起搏業務實現高個位數成長。在起搏方面,受我們在美國推出下一代 Micra AV2 和 VR2 設備的推動,我們的 Micra 無引線起搏器系列增長了 13%。我們也看到傳導系統起搏的強勁成長,這是傳統單腔或雙腔起搏的替代方案。
Our 3830 lead, the only approved lead for this novel form of pacing grew strong double digits again this quarter. And late in the quarter, we received FDA approval for our AURORA EV-ICD system, a game changer for the single-chamber ICD space. Now we're ramping up our training of implanting cardiologists on the AURORA technology. So AURORA delivers the benefits of a traditional ICD including similar size, longevity and pacing features, but without the leads in the heart or veins. And these benefits can be realized with one device and only one implant procedure.
我們的 3830 領先優勢是這種新穎起搏形式唯一獲得批准的領先優勢,本季再次實現兩位數強勁成長。在本季末,我們的 AURORA EV-ICD 系統獲得 FDA 批准,該系統改變了單腔 ICD 領域的遊戲規則。現在,我們正在加強植入心臟科醫生的 AURORA 技術培訓。因此,AURORA 具有傳統 ICD 的優點,包括相似的尺寸、壽命和起搏功能,但在心臟或靜脈中沒有引線。只需使用一台設備和一次植牙手術即可實現這些優勢。
And just to drive this point home on size, there's a big difference here versus the competitor's device, I mean big. Here's an X-ray of an AURORA EV-ICD patient with the competitor's right next to it just for comparison. So in addition to all the clinical benefits of our EV-ICD, you can see that it's meaningfully smaller and of course lighter than the competitors. And here's the model that we're giving our reps to explain the difference to customers.
為了在尺寸上強調這一點,這裡與競爭對手的設備有很大的區別,我的意思是大。這是 AURORA EV-ICD 患者的 X 光片,旁邊是競爭對手的 X 光片,僅供比較。因此,除了我們的 EV-ICD 的所有臨床優勢之外,您還可以看到它比競爭對手更小,當然也更輕。這是我們為代表提供的模型,用於向客戶解釋差異。
Now this is the size of the competitor's device. And we can actually pop out the AURORA to show how much smaller it actually is. So it's like those nesting dolls. Except here, we just pop up -- we get to start with a big guy and then we go right to the small guys. So let me pop this out. So you see inside the model, here's AURORA, much smaller, much lighter. And speaking of wait, we actually had to put a series of weights inside of here to get the bigger device to exactly replicate the weight of our competitor's. So we're really excited about this as we've got a meaningfully better option for patients.
現在這是競爭對手設備的尺寸。我們實際上可以彈出 AURORA 來顯示它實際上小了多少。就像那些嵌套娃娃一樣。除了這裡,我們只是突然出現——我們從一個大人物開始,然後我們直接到小人物。所以讓我把這個彈出來。所以你可以看到模型內部,這是 AURORA,更小,更輕。說到等待,我們實際上必須在這裡放置一系列重物,以使更大的設備能夠精確複製競爭對手的重量。因此,我們對此感到非常興奮,因為我們為患者提供了更好的選擇。
Our advantages will not only displace the competitor's device but will expand the population far beyond the existing saving. We think this can grow to become a $1 billion-plus segment.
我們的優勢不僅會取代競爭對手的設備,還會擴大人口規模,遠遠超出現有的儲蓄。我們認為這可以發展成為一個價值超過 10 億美元的細分市場。
Turning to our synergistic businesses. Combined, they grew mid-single digits in Q2 and we had several standout performances. Aortic grew 9% on strong momentum in our Endurant AAA franchise following the 10-year real-world durability data presented at the Charing Cross Symposium earlier this year.
轉向我們的協同業務。總的來說,他們在第二季實現了中個位數的成長,我們也取得了一些出色的表現。繼今年稍早在 Charing Cross 研討會上公佈 10 年實際耐久性數據後,我們的 Endurant AAA 特許經營業務的強勁勢頭使 Aortic 增長了 9%。
Our Coronary business grew 6% as we gained share in international markets on the continued rollout of our Onyx Frontier drug-eluting stent. Cardiac Surgery grew 9%, driven by strength in perfusion and cannula as well as the Nautilus ECMO Oxygenator.
隨著我們繼續推出 Onyx Frontier 藥物洗脫支架,我們在國際市場上獲得了份額,我們的冠狀動脈業務增長了 6%。在灌注和插管以及 Nautilus ECMO 氧合器強度的推動下,心臟手術增加了 9%。
Our Endoscopy business grew 13% driven by continued adoption of GI Genius. GI Genius uses the power of artificial intelligence to detect polyps in real-time during a colonoscopy, integrating seamlessly into a GI Doc's existing workflow. GI Genius results in a 50% reduction in mispolyps versus a standard colonoscopy, which plays an important role in the prevention of colon cancer.
由於 GI Genius 的持續採用,我們的內視鏡業務成長了 13%。 GI Genius 利用人工智慧的力量在大腸鏡檢查期間即時檢測息肉,無縫整合到 GI Doc 的現有工作流程中。與標準大腸鏡檢查相比,GI Genius 可使誤息肉減少 50%,這在預防大腸癌方面發揮重要作用。
Turning to businesses in our highest growth markets. Cardiac Ablation Solutions grew 6% on strong market procedure growth. Now over the coming years, we expect this business to be a very meaningful growth driver for Medtronic. We are leading the way in bringing pulse field ablation catheters to market in both the focal and single-shot segments.
轉向我們成長最快的市場中的企業。由於市場手術的強勁增長,心臟消融解決方案增長了 6%。未來幾年,我們預計這項業務將成為美敦力非常有意義的成長動力。我們在將脈衝場消融導管推向焦點和單次細分市場方面處於領先地位。
In focal PFA, we continue to ramp manufacturing of the Sphere 9 catheter and remain in limited market release in Europe. Sphere 9 can perform both PFA and RF ablation and drives high-density mapping, all from the same catheter, and it integrates seamlessly with our differentiated Affera mapping system. In the U.S., we expect to complete the 12-month follow-up in the pivotal trial for Sphere 9 in the coming weeks, and then we'll prepare for FDA submission.
在焦點 PFA 方面,我們繼續提高 Sphere 9 導管的生產量,並在歐洲保持有限的市場投放。 Sphere 9 可以執行 PFA 和 RF 消融,並驅動高密度標測,所有這些都來自同一根導管,並且它與我們差異化的 Affera 標測系統無縫整合。在美國,我們預計將在未來幾週內完成 Sphere 9 關鍵試驗的 12 個月隨訪,然後準備向 FDA 提交。
In single-shot PFA, we just received CE Mark for our PulseSelect catheter, and it will be commercially available early next calendar year. We are now the only company with approved catheters for both single-shot and focal PFA. And in the U.S., the FDA is reviewing our PulseSelect submission, and we expect to be one of the first companies with a PFA catheter in the U.S. market.
在單次 PFA 中,我們的 PulseSelect 導管剛剛獲得了 CE 標誌,並將於明年初投入商業使用。我們現在是唯一一家擁有經批准可用於單次 PFA 和局部 PFA 導管的公司。在美國,FDA 正在審查我們提交的 PulseSelect,我們希望成為美國市場上第一批擁有 PFA 導管的公司之一。
Now with our PFA catheters and the Affera map/nav system, combined with our leading Arctic Front Cryo solution and differentiated FlexCath cross-transseptal system, we expect to drive strong long-term growth in the fast-growing $8 billion EP ablation space.
現在,憑藉我們的PFA 導管和Affera 地圖/導航系統,再加上我們領先的Arctic Front Cryo 解決方案和差異化的FlexCath 跨間隔系統,我們預計將在快速增長的80 億美元EP 消融領域推動強勁的長期增長。
Now turning to Structural Heart. Overall, the TAVR space continues to grow in the high single, low double-digit range. In Q2, we grew mid-single digits, which was below the market. Now we declined slightly in the U.S., comping difficult prior year comparisons when we initially launched Evolut FX and customers purchased for stock. Yet we grew 4% sequentially, evidence of the strength of our product. In Europe, we grew high single digits and received CE Mark for Evolut FX at the end of the quarter. And in Japan, we continued to win share and grew in the mid-30s on the continued adoption of Evolut FX and expanded ESRD indication.
現在轉向結構心臟。總體而言,TAVR 空間持續在高個位數、低兩位數範圍內成長。第二季度,我們實現了中個位數成長,低於市場水準。現在,我們在美國的業務略有下降,與我們最初推出 Evolut FX 和客戶購買股票的前一年相比,情況比較困難。然而我們環比成長了 4%,這證明了我們產品的實力。在歐洲,我們實現了高個位數成長,並在本季結束時獲得了 Evolut FX 的 CE 標誌。在日本,由於繼續採用 Evolut FX 和擴大 ESRD 適應症,我們在 30 年代中期繼續贏得市場份額並實現成長。
Our Evolut platform has now shown superior valve performance compared to surgery in randomized trials that extend to 5 to 10 years after initial procedure. And last month, our landmark Evolut low-risk trial was presented at TCT and published in JACC. The trial randomized patients to Evolut or best-in-class surgery.
現在,我們的 Evolut 平台在隨機試驗中顯示出優於手術的瓣膜性能,這些試驗持續到初次手術後 5 至 10 年。上個月,我們具有里程碑意義的 Evolut 低風險試驗在 TCT 上展示並在 JACC 上發表。該試驗將患者隨機分配至 Evolut 或同類最佳手術組。
As you can see in this chart, Evolut, which is the blue line, had a lower rate of death or disabling stroke and the difference continues to diverge each year, going from a 2% difference at 2 years to 2.9% at 3 years and growing to a 3.4% difference at 4 years. This resulted in a 26% reduction in death or disabling stroke with Evolut at 4 years. And no other transcatheter valve has shown better valve performance and outcomes compared to surgery.
正如您在此圖表中所看到的,Evolut(即藍線)的死亡率或致殘性中風的發生率較低,並且這種差異每年都在不斷變化,從2 年的2% 差異到3年的2.9%, 4 年時差異成長至 3.4%。 Evolut 使 4 年時死亡或致殘性中風的發生率降低了 26%。與手術相比,沒有其他經導管瓣膜表現出更好的瓣膜性能和結果。
Valve design matters, and this differentiates us competitively. Physicians understand this data. This is compelling to them and it's compelling to patients. So as we look ahead, we expect the combination of this data, coupled with the global rollout of Evolut FX to drive our TAVR growth above market.
閥門設計很重要,這使我們具有競爭優勢。醫生了解這些數據。這對他們和患者都很有吸引力。因此,展望未來,我們預期這些數據的結合,再加上 Evolut FX 的全球推出,將推動我們的 TAVR 成長高於市場水平。
In Neurovascular, we grew high single digits when you exclude sales in China where the coils market is subject to volume-based procurement. We continue to see very strong growth in flow diversion, which was up low 20s globally. This is being driven by our innovative Shield Technology for treating brain aneurysms, which is available on both the Pipeline Flex and Pipeline Vantage flow diverters.
在神經血管領域,如果排除中國的銷售,我們的成長將達到高個位數,因為中國的線圈市場是基於數量的採購。我們持續看到流量轉移的強勁成長,全球成長了 20 多分。這是由我們用於治療腦動脈瘤的創新 Shield 技術推動的,該技術可用於 Pipeline Flex 和 Pipeline Vantage 分流器。
In Robotic Surgical Technologies, we increased our installed base as we continue the international launch of our differentiated Hugo Robotic system. In the U.S., our Expand URO pivotal trial continues to enroll and is on plan. And we're happy to announce that we have FDA approval to start our U.S. Hernia indication pivotal trial for Hugo.
在機器人手術技術領域,隨著我們繼續在國際上推出差異化的 Hugo 機器人系統,我們增加了我們的安裝基礎。在美國,我們的 Expand URO 關鍵試驗繼續入組並正在按計劃進行。我們很高興地宣布,我們已獲得 FDA 批准,可以啟動 Hugo 的美國疝氣適應症關鍵試驗。
Adoption of Hugo is positive with surgeons appreciating features that are core to the system, including Touch Surgery Enterprise digital technology. This AI-powered video solution currently available for both robotic and laparoscopic surgery, creates a new paradigm for case review and performance improvement. We've already deployed it in over 20 countries and we're continually developing our connected digital ecosystem, and we're excited about the upcoming launch of Touch Surgery live stream to enable live streaming and sharing of procedures securely and seamlessly. We expect Hugo, equipped with advanced digital capabilities, to be a meaningful growth driver for us in the years ahead.
Hugo 的採用是積極的,外科醫生欣賞該系統的核心功能,包括 Touchurge Enterprise 數位技術。這種由人工智慧驅動的視訊解決方案目前可用於機器人和腹腔鏡手術,為病例審查和性能改進創造了新的範例。我們已經在 20 多個國家/地區部署了它,並且正在不斷開發我們的互聯數位生態系統,我們對即將推出的 Touch Surgery 直播感到非常興奮,該直播可以安全、無縫地實現直播和手術共享。我們預計,配備先進數位功能的 Hugo 將在未來幾年成為我們有意義的成長動力。
We believe surgeon preference with our open console and modular design, our leading position in minimally invasive surgery and instrumentation, our connected digital ecosystem and data-enabled insights, along with our world-class surgical training program and partnerships, will meaningfully advance the low penetration of robotic surgery around the world.
我們相信,外科醫生對我們開放式控制台和模組化設計的偏好、我們在微創手術和器械方面的領先地位、我們互聯的數位生態系統和數據支援的見解,以及我們世界一流的手術培訓計劃和合作夥伴關係,將有意義地推動低滲透率的發展世界各地的機器人手術。
And in Diabetes, our customer base is expanding sequentially as users around the world purchase the MiniMed 780G system. 780G is the only AID system to make correction boluses every 5 minutes, offer flexible glucose targets as low as 100 and feature meal detection technology. This combination is resulting in high time and range. Users are achieving or exceeding their glycemic targets, and importantly, realizing the relief that comes from burden reduction in their diabetes management.
在糖尿病領域,隨著世界各地的用戶購買 MiniMed 780G 系統,我們的客戶群正在擴大。 780G 是唯一每 5 分鐘進行一次校正推注的 AID 系統,提供低至 100 的彈性血糖目標,並具有進餐檢測技術。這種組合導致了較長的時間和範圍。使用者正在達到或超過他們的血糖目標,更重要的是,他們意識到減輕糖尿病管理負擔所帶來的緩解。
In Q2, our Diabetes business grew 7%, its highest growth in 10 quarters or 5 years when you exclude the COVID comp in Q4 of FY '21. In international markets, we continue to see robust mid-teens growth driven by the recurring revenue from CGM and consumable sales to customers that have adopted our AID technology. And in the U.S., this was our first full quarter of the 780G launch and we're meeting or exceeding our launch goals.
第二季度,我們的糖尿病業務成長了 7%,如果排除 21 財年第四季的新冠疫情影響,這是 10 個季度或 5 年來的最高成長。在國際市場上,我們繼續看到強勁的十幾歲左右的成長,這是由 CGM 的經常性收入和向採用我們的 AID 技術的客戶銷售的消耗品所推動的。在美國,這是我們發布 780G 的第一個完整季度,我們正在達到或超越我們的發布目標。
Our U.S. pump sales increased over 30% sequentially. The number of unique 780G prescribers has increased over 20% since last quarter, with many returning to Medtronic as they learn about the differentiated outcomes users are getting with 780G. And we also continue to see very high CGM attachment rates in our 780G installed base, meaningfully above the rates prior to launch.
我們在美國的泵浦銷量比上一季成長了 30% 以上。自上個季度以來,獨特的 780G 處方者數量增加了 20% 以上,其中許多人在了解用戶透過 780G 獲得的差異化結果後返回美敦力。我們也繼續看到 780G 安裝基礎中的 CGM 連線率非常高,明顯高於發布前的比率。
All of these leading indicators give us confidence that we'll see a significant ramp in our CGM and consumable sales in the U.S. and return to year-over-year growth in the back half of this fiscal year. We've been driving this turnaround, and as we look ahead, we expect Diabetes to drive even more meaningful growth for us. We expect the majority of the intensive insulin management space to move to smart dosing through either AID systems or smart MDI.
所有這些領先指標都讓我們有信心,我們將看到美國的 CGM 和消耗品銷售大幅成長,並在本財年後半段恢復年成長。我們一直在推動這一轉變,展望未來,我們預計糖尿病將為我們帶來更有意義的成長。我們預期大部分強化胰島素管理領域將透過 AID 系統或智慧 MDI 轉向智慧劑量。
And we're well positioned to take advantage of this trend as we're the only company investing in a complete ecosystem of differentiated technology for people living with diabetes, including next-generation durable pumps, smart pens, patch pumps, sensors and algorithms.
我們完全有能力利用這一趨勢,因為我們是唯一一家為糖尿病患者投資完整的差異化技術生態系統的公司,包括下一代耐用泵、智慧筆、貼片泵、感測器和演算法。
So with that, let's go to Karen for a deeper look at our Q2 financial performance in our fiscal '24 guidance raise. Karen?
因此,讓我們請凱倫在我們的 24 財年指導上調中更深入地了解我們第二季度的財務業績。凱倫?
Karen L. Parkhill - Executive VP & CFO
Karen L. Parkhill - Executive VP & CFO
Thanks, Geoff. Looking at our financials. Overall, it was another good quarter. Our revenue grew 5% ahead of expectations. And adjusted EPS was $1.25, $0.07 above the midpoint of our guidance range with about $0.03 from stronger-than-expected revenue, $0.03 from better gross margin and approximately $0.01 coming below the operating profit line.
謝謝,傑夫。看看我們的財務狀況。總體而言,這又是一個不錯的季度。我們的營收成長 5%,超出預期。調整後每股收益為 1.25 美元,比我們指導範圍的中點高出 0.07 美元,其中約 0.03 美元來自強於預期的收入,0.03 美元來自更好的毛利率,約 0.01 美元低於營業利潤線。
As Geoff mentioned, we remain focused on delivering durable growth. Based on the changes we've made, including our operating model, incentives and capital allocation, we've positioned the company to deliver sustainable mid-single-digit growth on the topline. And you are seeing that play out for 4 quarters in a row now.
正如傑夫所提到的,我們仍然專注於實現持久成長。根據我們所做的改變,包括我們的營運模式、激勵措施和資本配置,我們將公司定位為實現永續的中個位數成長。現在你會看到這種情況已經連續四個季度上演。
Looking at our second quarter revenue growth. You can see the diversification coming through, which is important to driving long-term durability. As Geoff stated, our 3 portfolios grew mid-single digits and Diabetes accelerated to high single-digit growth. The broad-based growth also came through on a geographic basis. Western Europe grew high single digits, with strength across many cardiovascular businesses, Diabetes, Neurovascular and Pelvic Health. And Japan grew mid-single digits and was also driven by strong results in many cardiovascular businesses as well as surgical and neurovascular.
看看我們第二季的營收成長。您可以看到多元化的發展,這對於推動長期耐用性非常重要。正如 Geoff 所說,我們的 3 個投資組合實現了中個位數成長,而糖尿病則加速到了高個位數成長。廣泛的成長也體現在地域基礎上。西歐實現了高個位數成長,在許多心血管業務、糖尿病、神經血管和骨盆健康領域表現強勁。日本實現了中個位數成長,這也是受到許多心血管業務以及外科和神經血管業務強勁業績的推動。
Emerging markets grew 9% or 13% when excluding Russia, given the sanctions. We had low 20s growth in the Middle East and Africa, high teens growth in South Asia, mid-teens growth in Southeast Asia and low double-digit growth in Latin America. China grew high single digits as some of the VBP that we expected was delayed until later in the fiscal year.
考慮到製裁,新興市場成長了 9%,排除俄羅斯則成長了 13%。我們在中東和非洲的成長率為 20 多歲,在南亞的成長率為 10 多歲,在東南亞的成長率為 10 多歲,在拉丁美洲的成長率為兩位數。由於我們預期的一些 VBP 被推遲到本財年晚些時候,中國實現了高個位數成長。
While our adjusted gross and operating margins declined in the quarter, both were ahead of expectations with gross margin, about 1/3 of the year-over-year change was due to currency and the remainder was driven by inflation. And our adjusted op margin decline was entirely driven by currency. On a constant currency basis, it increased 40 basis points. We're executing to implement efficiencies in our expense structure, and you can see this in the 90 basis point improvement in SG&A. Below the operating margin line, we benefited from higher global interest rates on our investments, and this was partially offset by a higher-than-expected tax rate mainly due to jurisdictional mix of profits as well as a lower benefit from stock-based compensation.
雖然本季調整後的毛利率和營業利潤率均有所下降,但毛利率均超出預期,但同比變化約 1/3 是由貨幣造成的,其餘則由通膨推動。我們調整後的營運利潤率下降完全是由貨幣驅動的。以固定匯率計算,上漲了 40 個基點。我們正在努力提高費用結構的效率,您可以從 SG&A 90 個基點的改進中看到這一點。在營業利潤率線以下,我們受益於全球投資利率的上升,但這被高於預期的稅率部分抵消,這主要是由於司法管轄區的利潤組合以及股票薪酬的收益較低所致。
Turning to capital allocation. We continue to prioritize investments in innovation to fuel and sustain our long-term growth. We're disproportionately investing in some of the fastest growth markets in med tech, and we have a long-standing track record of returning capital to our shareholders, primarily through our strong and growing dividend.
轉向資本配置。我們繼續優先考慮創新投資,以推動和維持我們的長期成長。我們在醫療技術領域的一些成長最快的市場進行了不成比例的投資,並且我們在向股東返還資本方面有著長期的記錄,主要是透過我們強勁且不斷增長的股息。
And to the extent that we don't find high-growth, high-return, tuck-in M&A, we would expect to return additional capital to our shareholders by retiring shares.
如果我們沒有找到高成長、高回報、增值的併購,我們希望透過退役股票的方式向股東返還額外的資本。
Now turning to our guidance. Given our second quarter outperformance and continued strength in our underlying fundamentals, we're raising our full year guidance today on both the top and the bottom line. We expect fiscal '24 organic revenue growth of 4.75%, an increase from the prior 4.5%. For the third quarter, we're expecting organic revenue growth to be in the range of 4% to 4.5%. And while the impact of currency is fluid, based on recent rates, foreign currency would have an unfavorable impact on full year revenue of $100 million to $200 million, including an unfavorable impact of $0 to $50 million in the third quarter.
現在轉向我們的指導。鑑於我們第二季的優異表現以及基本面的持續走強,我們今天上調了全年營收指引。我們預計 24 財年有機收入將成長 4.75%,高於先前的 4.5%。對於第三季度,我們預計有機收入成長將在 4% 至 4.5% 之間。雖然貨幣的影響是不穩定的,但根據最近的匯率,外幣將對全年收入產生 1 億至 2 億美元的不利影響,其中包括第三季 000 至 5,000 萬美元的不利影響。
On a comp adjusted basis, our third quarter guidance represents acceleration from the second quarter, and we expect this trend to continue into the fourth quarter as we're ramping a number of recent product launches in the back half of the year.
在調整後的基礎上,我們的第三季指引比第二季度有所加速,我們預計這種趨勢將持續到第四季度,因為我們將在今年下半年推出一些近期產品。
In Diabetes, we're projecting the U.S. to return to growth in the second half of the year on the continued adoption of 780G and the associated CGM and consumable sales. In Medical-Surgical, we have the continued rollout of the Hugo surgical robot and GI Genius. In Neuroscience, there's our AiBLE ecosystem in Spine, our inceptive closed-loop Pain Stim device in Europe. And we're awaiting FDA approval for both inceptive and our Percept RC DBS device.
在糖尿病領域,我們預計,由於 780G 的持續採用以及相關的 CGM 和耗材銷售,美國將在今年下半年恢復成長。在醫療外科領域,我們繼續推出 Hugo 手術機器人和 GI Genius。在神經科學領域,我們的 Spine 有 AiBLE 生態系統,這是我們在歐洲的初始閉環疼痛刺激設備。我們正在等待 FDA 對 inceptive 和 Percept RC DBS 設備的批准。
In Cardiovascular, we're ramping our TAVR and PFA launches in Europe, starting the rollout of EV-ICD in the U.S. and Europe, and we are now starting our Ardian sales in the U.S. This all gives us confidence in the continued durability of our topline growth.
在心血管領域,我們正在歐洲加大TAVR 和PFA 的推出力度,開始在美國和歐洲推出EV-ICD,並且我們現在開始在美國銷售Ardian。這一切都讓我們對我們的產品的持續耐用性充滿信心。營收成長。
Moving down the P&L. Our margins this year continue to reflect the impact of currency and inflation and some of the volume-based procurement tenders in China that were expected in the first half have shifted to later in the year. That said, we're focused on continuing to drive efficiencies in our expense base, and we've got our global operations and supply chain centralized to take advantage of our scale. As you know, stabilizing our margins and then improving from there remains a top priority.
損益表向下移動。我們今年的利潤率繼續反映了貨幣和通貨膨脹的影響,預計上半年在中國進行的一些基於數量的採購招標已轉移到今年稍後。也就是說,我們致力於繼續提高費用基礎的效率,並且我們已經集中了我們的全球營運和供應鏈,以利用我們的規模優勢。如您所知,穩定我們的利潤率並在此基礎上進行改進仍然是首要任務。
On the bottom line, we're raising our fiscal '24 non-GAAP diluted EPS guidance to a new range of $5.13 to $5.19, an increase from the prior range of $5.08 to $5.16. While we expect FX and tax to be a few pennies more unfavorable in the second half, we are pleased with the momentum we have demonstrated and our pipeline from here. For the third quarter, we expect EPS of $1.25 to $1.27. And on foreign currency, based on recent rates, we're seeing an unfavorable impact of 6% on full year EPS, including an unfavorable 5% impact in the third quarter.
總而言之,我們將 24 財年非 GAAP 攤薄後每股收益指引上調至 5.13 美元至 5.19 美元的新範圍,高於先前 5.08 美元至 5.16 美元的範圍。雖然我們預計下半年外匯和稅收將更加不利,但我們對我們所展示的勢頭和我們的管道感到滿意。我們預計第三季每股收益為 1.25 美元至 1.27 美元。就外幣而言,根據最近的匯率,我們預計全年每股收益將受到 6% 的不利影響,其中包括第三季 5% 的不利影響。
Before sending it back to Geoff, in the spirit of Thanksgiving, I want to extend my gratitude to our 95,000 employees around the world who come to work every day to deliver on our mission. You all play important roles in alleviating pain, restoring health and extending life for 2 patients every second, which makes this world a far better place. Back to you, Geoff.
在將其寄回給傑夫之前,本著感恩節的精神,我想向世界各地每天上班以實現我們使命的 95,000 名員工致以謝意。你們每一秒都在為 2 名患者減輕痛苦、恢復健康和延長生命方面發揮著重要作用,這讓這個世界變得更加美好。回到你身邊,傑夫。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Okay. Thank you, Karen. Now I know GLP-1s have been on your mind as the promise of these drugs has certainly had an outsized impact on med tech stocks, including ours over the past 4 months. So I thought it would be helpful to share with you our view on their potential impact on our markets.
好的。謝謝你,凱倫。現在我知道 GLP-1 一直在您的腦海中,因為這些藥物的前景肯定對醫療科技股票產生了巨大的影響,包括我們在過去 4 個月的股票。因此,我認為與您分享我們對其對我們市場的潛在影響的看法會有所幫助。
Now GLP-1s are clearly an exciting class of drugs for patients, and the SELECT data presented at AHA suggests the potential for a large market. That said, the key takeaway from our analysis is that outside of a modest impact on the bariatric surgery market, which we believe will be temporary, we don't see these drugs impacting Medtronic's growth outlook, even long term.
現在,GLP-1 顯然是一類令患者興奮的藥物,AHA 上發表的 SELECT 數據顯示了巨大的市場潛力。也就是說,我們分析的主要結論是,除了對減肥手術市場產生適度影響(我們認為這將是暫時的)之外,我們認為這些藥物不會影響美敦力的成長前景,即使是長期的。
This expectation is based on our extensive science-based work. Like many of you, we've modeled potential uptake and impact based on epidemiology, based on what we've seen historically with other drugs and based on the relative risk reductions and adherence rates seen in SELECT.
這一期望是基於我們廣泛的科學工作。就像你們中的許多人一樣,我們根據流行病學、我們在其他藥物的歷史上看到的情況以及在 SELECT 中看到的相對風險降低和依從率,對潛在的吸收和影響進行了建模。
So given the SELECT results showed smaller impacts on the more obese patients, we believe that bariatric surgery will remain the gold standard for addressing obesity. We also know that many of the patients that try these drugs do not stay on them for more than a year, likely due to durability, side effects or affordability, which creates opportunities for new patients to consider surgery. For these reasons, we believe the current headwinds on U.S. bariatric procedures will stabilize over the next several quarters and return to growth by calendar year 2025. And this is modest and manageable within our broader diversified surgical business.
因此,鑑於 SELECT 結果顯示對肥胖患者的影響較小,我們相信減重手術仍將是解決肥胖問題的黃金標準。我們也知道,許多嘗試這些藥物的患者不會堅持使用超過一年,可能是由於藥物的耐久性、副作用或負擔能力,這為新患者考慮手術創造了機會。基於這些原因,我們相信美國減重手術目前面臨的阻力將在未來幾季穩定下來,並在2025 年恢復成長。在我們更廣泛的多元化外科業務中,這種情況是溫和且可控的。
Now with Diabetes, our customers are primarily type 1 with only 10% of our installed base in type 2 insulin-dependent patients. We do expect growth in our type 2 business going forward. But type 2 pump penetration rates are so low that even using aggressive GLP-1 modeling assumptions, we don't see any meaningful change in our Diabetes growth outlook through 2030. Now we'd be happy to discuss this in more detail in Q&A, including our view on the SELECT trial and its potential implications for med tech.
現在,我們的糖尿病客戶主要是第 1 型糖尿病,只有 10% 的客戶是第 2 型胰島素依賴型患者。我們確實預計我們的 2 類業務將繼續成長。但2 型幫浦的普及率如此之低,以至於即使使用積極的GLP-1 建模假設,我們也看不到2030 年糖尿病成長前景出現任何有意義的變化。現在我們很樂意在問答中更詳細地討論這一點,包括我們對 SELECT 試驗的看法及其對醫療技術的潛在影響。
Now before we go to the analyst questions, I'd like to close with a few brief concluding thoughts on our progress. You're seeing in our results that many of the challenges that have held back our growth have largely been mitigated, whether that's Diabetes, China or the issues in our supply chain. And we've established a track record of delivering durable mid-single-digit revenue growth, which we expect to continue in the back half of the fiscal year.
現在,在我們回答分析師問題之前,我想對我們的進展做一些簡短的總結性思考。從我們的業績中可以看到,許多阻礙我們成長的挑戰已在很大程度上得到緩解,無論是糖尿病、中國還是我們供應鏈中的問題。我們已經建立了實現持久的中個位數收入成長的記錄,我們預計這種成長將在本財年後半段繼續下去。
We have some really compelling product approvals that drive our growth not only in the back half but for years to come. There's been a number of things that have happened recently, big things, in the last 4 weeks in particular, with our TAVR data that gives us just such an advantage in the marketplace, new product approvals like EV-ICD, geographic and indication expansions.
我們獲得了一些真正引人注目的產品批准,這些產品不僅推動了我們下半年的成長,而且還推動了未來幾年的成長。最近發生了很多大事,特別是在過去 4 週內,我們的 TAVR 數據為我們帶來了市場優勢、EV-ICD 等新產品批准、地理和適應症擴展。
And last Friday, we got already an approval. This opens up a multibillion-dollar market opportunity for us. And with over 1 billion people worldwide with hypertension, the opportunity is massive. In fact, just 1% penetration of the target market represents over $1 billion of revenue.
上週五,我們已經獲得了批准。這為我們開闢了數十億美元的市場機會。全球有超過 10 億高血壓患者,機會是巨大的。事實上,光是 1% 的目標市場滲透率就代表了超過 10 億美元的收入。
So we're focused on executing to deliver the topline. And at the same time, we're taking action to run our businesses more efficiently to counter the impacts that inflation and currency are having on our margins. And we've been implementing an extensive transformation to improve the durability of our growth. We've changed our operating model, brought in extensive new leadership, increased capital allocation to our highest growth opportunities and are implementing a culture based on execution, speed and playing to win. And now we're positioning the company to take advantage of our scale in areas of operations and supply chain, core technology and how we go to market with large customers around the globe.
因此,我們專注於執行以實現營收。同時,我們正在採取行動更有效地經營我們的業務,以應對通貨膨脹和貨幣對我們利潤的影響。我們一直在實施廣泛的轉型,以提高成長的持久性。我們改變了我們的營運模式,引入了廣泛的新領導層,增加了對我們最高成長機會的資本配置,並正在實施一種基於執行、速度和博取勝利的文化。現在,我們對公司進行定位,以利用我們在營運和供應鏈、核心技術以及如何與全球大客戶打交道等領域的規模優勢。
You're already seeing results from this today. And as we go forward, our focus is on translating the durable revenue growth that we've established into durable earnings' power. This is a winning formula for creating value for shareholders and we are laser-focused on making that happen.
今天您已經看到了結果。隨著我們前進,我們的重點是將我們已經建立的持久收入成長轉化為持久獲利能力。這是為股東創造價值的勝利法則,我們正全力以赴地實現這一目標。
Now with that, let's move to Q&A where we're going to try to get to as many analysts as possible.
現在,讓我們進入問答環節,我們將嘗試聯繫盡可能多的分析師。
So we ask that you limit yourself to just one question and only if needed, a related follow-up. If you have additional questions, you can reach out to Ryan and the Investor Relations team after the call. With that, Brad, can you please give the instructions for asking a question?
因此,我們要求您只提出一個問題,並且僅在需要時提出相關的後續問題。如果您還有其他問題,可以在電話會議後聯絡 Ryan 和投資者關係團隊。那麼,布拉德,您能給予提問的說明嗎?
Brad Welnick - VP of IR
Brad Welnick - VP of IR
For the sell-side analysts that would like to ask a question, please select the Participants button and click Raise Hand. If you're using the mobile app, press the More button and select Raise Hand. Your lines are currently on mute. When called upon, you will receive a request to unmute your line, which you must respond to before asking your question.
對於想要提問的賣方分析師,請選擇「參與者」按鈕並點擊「舉手」。如果您使用的是行動應用程序,請按“更多”按鈕並選擇“舉手”。您的線路目前處於靜音狀態。當被呼叫時,您將收到取消線路靜音的請求,您必須在提問之前回覆該請求。
Lastly, please be advised that this Q&A session is being recorded. For today's session, Geoff, Karen and Ryan are joined by Que Dallara, EVP and President of Diabetes; Mike Marinaro, EVP and President of the Surgical and Endoscopy businesses; Sean Salmon, EVP and President of the Cardiovascular portfolio; Brett Wall, EVP and President of the Neuroscience portfolio; and Bob White, EVP and President of the Medical Surgical portfolio.
最後,請注意,本次問答環節正在錄製中。出席今天的會議的有 Geoff、Karen 和 Ryan,執行副總裁兼糖尿病業務總裁 Que Dallara 也參加了今天的會議。 Mike Marinaro,執行副總裁兼外科和內視鏡業務總裁; Sean Salmon,執行副總裁兼心血管產品組合總裁; Brett Wall,執行副總裁暨神經科學產品組合總裁;以及執行副總裁兼醫療外科產品組合總裁鮑伯懷特 (Bob White)。
We'll pause for a few seconds to assemble the queue. We'll take the first question from Robbie Marcus at JPMorgan.
我們將暫停幾秒鐘來組裝隊列。我們將回答摩根大通的羅比·馬庫斯提出的第一個問題。
Robert Justin Marcus - Analyst
Robert Justin Marcus - Analyst
Maybe I'll ask both of them upfront. The first, Geoff, you talked about how most of the headwinds are largely mitigated. I look at the guidance implied in the second half of the year. It's a point of growth or so below the first half. So maybe just talk about how we should think about the lower growth in the second half versus the first half and the reasons for that?
也許我會提前問他們兩個。首先,傑夫,您談到了大部分的不利因素是如何在很大程度上緩解。我看看下半年暗示的指導。比上半年大約有一個增長點。那麼也許我們該如何看待下半年成長率低於上半年的情況以及原因呢?
And then part b, if I look to 2025 or fiscal year '25, the Street has you pretty close to your long-range plan of 5% plus on the top and 8% plus on the bottom. Is that the right way to think about next year?
然後,b 部分,如果我展望 2025 年或 25 財年,華爾街認為您非常接近您的長期計劃,即頂部 5% 以上,底部 8% 以上。這是思考明年的正確方式嗎?
Are there any headwinds or tailwinds we should be thinking about here like potential dilution from the monitoring business? Just want to try and get Street numbers correct as we head into year-end.
我們是否應該考慮任何不利因素或有利因素,例如監控業務的潛在稀釋?只是想在年底時嘗試獲得正確的街道號碼。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Sure. Well, let me kick it off and I'll -- thanks for the questions, Robbie. I'll kick it off and then hand it over to Karen. In terms of the headwinds being mitigated, what I'd say is the markets are pretty stable, especially relative to what we've seen over the last couple of years with procedures, I think, back to normal growth and the staffing issues that were hurting the procedural growth are, I think, more or less under control. Pricing has been stable. We can talk China later. We're working through the China VBP, but that's largely behind us. Still a little bit more to go, but largely behind us.
當然。好吧,讓我開始吧,謝謝你的提問,羅比。我會把它踢掉然後交給凱倫。就不利因素的緩解而言,我想說的是,市場相當穩定,特別是相對於我們過去幾年所看到的程序,我認為,恢復了正常增長以及人員配置問題我認為,對程序增長的損害或多或少已經得到控制。定價一直穩定。我們可以稍後再談中國。我們正在透過中國 VBP 開展工作,但這基本上已經過去了。還有一點路要走,但基本上已經落後了。
So -- and then our own internal -- the changes to our global operations and supply chain, that was a big one for us and has been a big one. And we're seeing our teams perform much better.
所以——然後是我們自己的內部——我們的全球營運和供應鏈的變化,這對我們來說是一件大事,而且一直都是一件大事。我們看到我們的團隊表現得更好。
And like I said, we're turning that into a strength for us, a strategic long-term strength. And our supply is in a much better situation. So that's -- and then, of course, our pipeline is coming in, and I'm sure, we'll get into that in the call here with a lot of new approvals plus the prior approvals we're starting to launch, and they're having meaningful uptake. So there's where the optimism is. In terms of how to think about the back half versus the first half and then getting into FY '25, I'll turn that over to Karen.
正如我所說,我們正在將其轉變為我們的優勢,一種策略性的長期優勢。我們的供應狀況好得多。那麼,當然,我們的管道即將進入,我確信,我們將在此處的電話會議中討論這一問題,並獲得許多新的批准以及我們開始啟動的先前批准,並且他們正在進行有意義的吸收。這就是樂觀的地方。至於如何考慮後半段與前半段以及然後進入 25 財年,我會將其交給凱倫。
Karen L. Parkhill - Executive VP & CFO
Karen L. Parkhill - Executive VP & CFO
Yes. Thanks, Geoff and Robbie. So just on the back half, Robbie, our comps do get a little tougher, as you know. But we've got a really strong innovation pipeline that we talked about, and that's driving growth acceleration actually from the first half to the second half. We've got our Diabetes business returning to growth in the second half. We talked about our extensive pipeline, EV-ICD, PFA, Hugo, Evolut FX and now the Ardian approval. And so we're confident in this growth acceleration and we're confident that, that's going to continue beyond the back half of next year.
是的。謝謝,傑夫和羅比。所以,羅比,在後半段,我們的比賽確實變得更加艱難,如你所知。但我們擁有我們談到的非常強大的創新管道,這實際上推動了從上半年到下半年的成長加速。我們的糖尿病業務在下半年恢復成長。我們討論了我們廣泛的產品線、EV-ICD、PFA、Hugo、Evolut FX 以及現在 Ardian 的批准。因此,我們對這種成長加速充滿信心,並且我們相信這種成長將持續到明年下半年。
When we think about FY '25, you know it's still early. We have 2 quarters left in this fiscal year and we're laser-focused on delivering the rest of this year. We're also at the beginning of our planning process so we're not ready to give specifics. But I do know that all of you are working on your calendar year models for our competitors, so happy to give you some perspective based on what we know today and what we're thinking about. And I'll start with revenue because we've been focused on consistently delivering that mid-single-digit revenue growth. And you've seen us do that for 4 quarters now.
當我們想到 25 財年時,您知道現在還為時過早。本財年還剩 2 個季度,我們將專注於今年剩餘時間的交付。我們還處於規劃過程的開始階段,因此我們還沒有準備好提供具體細節。但我確實知道你們所有人都在為我們的競爭對手製定日曆年模型,因此很高興根據我們今天所知道的和我們正在思考的內容為您提供一些觀點。我將從收入開始,因為我們致力於持續實現中個位數的收入成長。您已經看到我們這樣做已經四個季度了。
Our new full year guide for this fiscal year is 4.75%. And as I mentioned, we've got the strength of those numerous product approvals in big markets that are launching around the world to help drive our back half growth. And obviously, we're confident that strength will continue into next year and beyond. On margins and down the P&L, there are some puts and takes.
我們本財年新的全年指引值為 4.75%。正如我所提到的,我們在全球大市場中獲得了眾多產品的批准,這些產品正在世界各地推出,以幫助推動我們的後半部分成長。顯然,我們有信心這種勢頭將持續到明年及以後。在利潤率和損益表下方,有一些看跌期權和賣出期權。
We've got inflation stabilizing a bit but it's still higher than historical. But again, it's stabilizing. Currency is dynamic. And as you know, the U.S. dollar has been strong. So we're likely facing a headwind from FX, but we'll see how that shakes out.
通膨有所穩定,但仍高於歷史水準。但再次,它正在穩定下來。貨幣是動態的。如您所知,美元一直堅挺。因此,我們可能會面臨來自外匯的阻力,但我們將拭目以待。
Global tax reform will likely be a headwind. But as always, we're focused on driving offsets everywhere that we can. Geoff talked about it. We've made progress on cost of goods sold and cost out, starting with centralizing our global ops team. We have work to do, but those teams now have tangible programs in place to drive that work, and we'll continue to drive pricing as an important lever. We've built a new muscle on pricing and our focus is to keep it strong. We've been working hard on controlling expenses, and that includes maintaining discipline on our largest driver of our expense, which is our headcount.
全球稅收改革可能會成為阻力。但一如既往,我們致力於盡可能地推動抵銷。傑夫談到了這一點。從集中我們的全球營運團隊開始,我們在銷售成本和成本支出方面取得了進展。我們還有工作要做,但這些團隊現在已經制定了切實的計劃來推動這項工作,我們將繼續推動定價作為一個重要的槓桿。我們在定價方面建立了新的力量,我們的重點是保持它的強大。我們一直在努力控制開支,其中包括對我們最大的開支驅動因素(即我們的員工人數)保持紀律。
So I hope that gives you some color on just the puts and takes. But to summarize, I'll remind you what hasn't changed, and that's our long-range commitment of driving durable, mid-single-digit top growth, driving leverage down the P&L, of driving a strong free cash conversion and a growing dividend, which, all combined, ultimately delivers a double-digit total shareholder return. What has changed, though, is our progress toward that commitment. You've already seen us at mid-single-digit topline. We've talked about the strong pipeline that gives us confidence in its durability. And obviously, we've talked about the programs we have in place, whether it's in headcount management, COGS, cost down, pricing discipline, and they're all levers to help us offset the headwinds and, over time, establish that same durability on the bottom line.
所以我希望這能讓你對看跌期權有一些了解。但總而言之,我會提醒您什麼沒有改變,那就是我們的長期承諾,即推動持久的中個位數最高增長、降低損益表槓桿率、推動強勁的自由現金轉換和不斷增長的增長。股息,所有這些加起來最終帶來兩位數的股東總回報。然而,改變的是我們在實現這項承諾方面所取得的進展。您已經看到我們的營收處於中個位數。我們已經討論過強大的管道,這讓我們對其耐用性充滿信心。顯然,我們已經討論了我們已經實施的計劃,無論是在人員管理、銷貨成本、成本下降、定價紀律方面,它們都是幫助我們抵消不利因素的槓桿,並隨著時間的推移,建立相同的耐久性在底線。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
The next question comes from Travis Steed at Bank of America.
下一個問題來自美國銀行的 Travis Steed。
Travis Lee Steed - MD
Travis Lee Steed - MD
Congrats on the good quarter. Karen, just to sum up all those comments on FY '24. I heard the leverage down the P&L comment.
恭喜季度表現良好。凱倫,總結一下 24 財年的所有評論。我聽到槓桿率降低了損益表評論。
It sounds like based on what we know today, unless there's some kind of major surprise, there's still a good ability for them to be enough offsets to drive EPS growth faster than revenue growth. Just wanted to kind of make sure that's a fair comment. And then -- and Geoff, I did want to follow up on your thoughts on GLP-1s post the SELECT trial. Curious if there's any color you'd add on the SELECT trial and the cardio endpoints and diabetes prevention that maybe you didn't mention in the prepared remarks.
聽起來,根據我們今天所了解的情況,除非出現某種重大意外,否則它們仍然有足夠的能力進行足夠的抵消,以推動每股收益成長快於收入成長。只是想確保這是一個公平的評論。然後,Geoff,我確實想在 SELECT 試驗後跟進您對 GLP-1 的想法。很好奇您是否會在 SELECT 試驗以及有氧運動終點和糖尿病預防上添加任何您在準備好的評論中可能沒有提到的顏色。
Karen L. Parkhill - Executive VP & CFO
Karen L. Parkhill - Executive VP & CFO
Yes, Travis, thanks for the question. Clearly, next year and beyond, we're focused on driving that leverage down the P&L that I talked about. And obviously, when you drive leverage, it's -- your bottom line is faster than your topline. But at this stage, it's still early. We're at the beginning of our planning process, and we're going to give you more on FY '25 as we are ready to guide.
是的,特拉維斯,謝謝你的提問。顯然,明年及以後,我們的重點是降低我談到的損益表的槓桿率。顯然,當你提高槓桿率時,你的利潤比你的收入更快。但就現階段而言,還為時過早。我們正處於規劃過程的開始階段,我們將在準備好指導時為您提供有關 25 財年的更多資訊。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Travis, good to hear from you. On GLP-1s, so first of all, I just want to make it clear that we see that it's an exciting class of drugs with a large opportunity. And I'm sure just like you -- I talked to many patients that are benefiting from these drugs from a weight perspective, from a mental health perspective. It's pretty amazing. That being said, we've done a lot of work. And outside of the near term, temporary impact on bariatric surgery market, we don't see these drugs impacting our growth outlook even in the long term.
崔維斯,很高興收到你的來信。關於 GLP-1,首先,我想明確表示,我們認為這是一類令人興奮的藥物,擁有巨大的機會。我確信就像您一樣 - 我與許多從體重角度和心理健康角度受益於這些藥物的患者進行了交談。這真是太神奇了。話雖這麼說,我們已經做了很多工作。除了短期內對減重手術市場的暫時影響之外,我們認為這些藥物即使長期來看也不會影響我們的成長前景。
And then on the bariatric piece, that -- as we mentioned, it's a small part of our revenue, low single digits, and the rate of decline has stabilized there. And I think we see that coming back here in the coming year even. So we did do a lot of work here and I'm going to -- it was, like I said, science-based and looking at epidemiology and really digging in a SELECT. And we do have on the call here our Chief Medical Officer, Dr. Laura Mauri, and I thought I'd maybe kind of call her in here bringing a relief picture here on that question to talk a little bit more about SELECT and kind of what we're seeing out of that.
然後在減肥方面,正如我們所提到的,它只占我們收入的一小部分,較低的個位數,而且下降率已經穩定下來。我認為我們甚至會在明年看到這種情況再次出現。所以我們確實在這裡做了很多工作,我將——就像我說的那樣,這是基於科學的,著眼於流行病學,並真正進行選擇。我們確實有首席醫療官 Laura Mauri 博士在這裡打電話,我想我可能會打電話給她,帶來一張關於這個問題的救濟圖片,以更多地談論 SELECT 和某種我們從中看到了什麼。
So Laura, can you chime in here?
蘿拉,你能插話一下嗎?
Laura Mauri - Senior VP and Chief Scientific, Medical & Regulatory Officer
Laura Mauri - Senior VP and Chief Scientific, Medical & Regulatory Officer
Sure. Thanks, Geoff. Yes, Travis, the SELECT trial results that were presented at AHA gave us a lot more detail beyond the topline that we heard about back in August to really look at the end points and look at the drug adherence, understand the details of the trial results. And as you know, these were obese patients with a history of cardiovascular disease. And as Geoff said, this is a very important advance for this patient population, but the results didn't change our overall impression that there will be a negligible effect on the growth of cardiovascular procedure volumes.
當然。謝謝,傑夫。是的,Travis,在 AHA 上公佈的 SELECT 試驗結果為我們提供了超出我們 8 月份聽到的頂線之外的更多詳細信息,以便真正查看終點並查看藥物依從性,了解試驗結果的詳細信息。如您所知,這些都是有心血管疾病史的肥胖患者。正如傑夫所說,這對該患者群體來說是一個非常重要的進步,但結果並沒有改變我們的整體印象,即對心血管手術量的增長影響可以忽略不計。
And that's based on a couple of things that we saw in the detailed results. First, the number needed to treat was much higher and that means it's setting a higher bar for treatment compared with other things that are used in guidelines. And then we were -- we saw that there was a lack of effect on cardiovascular death, and that's something that, if it had been present, would have spurred more adoption. And the lack of that is important because it will not spur the wide adoption and coverage that we might have been looking at if that had been positive.
這是基於我們在詳細結果中看到的一些事情。首先,需要治療的人數要高得多,這意味著與指南中使用的其他內容相比,它設定了更高的治療標準。然後我們發現它對心血管死亡缺乏影響,如果它存在的話,將會刺激更多的採用。缺乏這一點很重要,因為如果這是積極的,它不會刺激我們可能一直在關注的廣泛採用和覆蓋。
And then the only effect on the composite endpoint was nonfatal MI, not stroke or cardiovascular death, as I mentioned. And as you know, the discontinuation rates were in nearly 1/3 of patients due to the nausea and GI side effects. And clearly, we know from practice that rates of adherence are even lower, and that results in lower treatment effects. And then there are a couple of interesting findings in the trial. As Geoff mentioned earlier, the higher BMI population didn't seem to have as much benefit and there was no significant treatment effect in the North American subgroup, which is certainly something that I think we'll want to understand better going forward.
正如我所提到的,對複合終點的唯一影響是非致命性心肌梗塞,而不是中風或心血管死亡。如您所知,近 1/3 的患者因噁心和胃腸道副作用而停藥。顯然,我們從實踐中知道,堅持率甚至更低,這導致治療效果更低。試驗中有一些有趣的發現。正如 Geoff 之前提到的,BMI 較高的人群似乎沒有那麼大的益處,並且在北美亞組中沒有顯著的治療效果,我認為我們未來需要更好地了解這一點。
So using a range of assumptions, we updated our models across the major cardiovascular procedures and the inputs to that. We're looking at U.S. procedure volume across different procedure areas, using data on the prevalence of obesity for each of these procedure populations and then a range of penetration and adherence assumptions all the way up to and including what we've seen over time with statins, which, as you know, are really well tolerated and just freely available and part of guidelines for the past 30 years.
因此,使用一系列假設,我們更新了主要心血管手術的模型及其輸入。我們正在研究美國不同手術領域的手術量,使用每個手術人群的肥胖盛行率數據,然後進行一系列滲透率和依從性假設,一直到並包括我們隨著時間的推移所看到的情況他汀類藥物,如你所知,它的耐受性非常好,並且可以免費獲得,並且是過去30 年指南的一部分。
And then we also input obviously the risk reduction seen in each of the endpoints for the SELECT trial or a literature based on weight loss to look at treatment effects. And the bottom line is that the reduction to TAM growth over the next 10 to 30 years is really negligible on the cardiovascular procedure outlook. I think it's really important to also note what this analysis doesn't include, and that's there will probably be offsets in the markets that are really underpenetrated or new like PFA or Ardian because of the growth -- the rapid growth in those areas.
然後,我們也顯然輸入了 SELECT 試驗的每個終點中看到的風險降低或基於體重減輕的文獻,以觀察治療效果。最重要的是,未來 10 到 30 年 TAM 增長的減少對於心血管手術前景來說實際上可以忽略不計。我認為,值得注意的是,這個分析沒有包括什麼,那就是,由於這些領域的快速成長,真正滲透不足或像 PFA 或 Ardian 這樣的新興市場可能會出現抵銷。
And then there is, in fact, potential upside for patients and procedure growth because of the potentially longer survival or lower BMI that makes a greater funnel of patients eligible for cardiovascular procedures.
事實上,患者和手術成長還有潛在的好處,因為存活期可能更長或體重指數更低,這使得更多的患者有資格接受心血管手術。
So I'll pass it back to Geoff. I know there was a question as well about the effect on hemoglobin A1c.
所以我會把它傳回給傑夫。我知道還有一個關於對糖化血紅蛋白的影響的問題。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Well, thank you, Laura. And while we're on the topic, maybe on that one. I mean, Que, any comments on Diabetes relative to GLP-1s?
嗯,謝謝你,蘿拉。當我們談論這個話題時,也許就是那個話題。我的意思是,Que,對於與 GLP-1 相關的糖尿病有什麼評論嗎?
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Que Thanh Dallara - Executive VP & President Diabetes Operating Unit
Yes. I mean we -- like Laura mentioned, we spent quite a bit of time studying this. And I think there's some evidence from SELECT that would say, there may be a slowdown in the prediabetic population towards insulin dependency. And maybe some in type 2 will come up insulin, but we believe this number to be very small and more than offset by the fact that there is a low penetration of type 2 using AID and the fact that when you look at the funnel of 3 million to 4 million who require basal insulin with 25 million non-insulin type 2s as well as the -- over 100 million prediabetic population, it doesn't change our point of view on the long-term size of the market as well as the growth rates. And as Geoff mentioned at the beginning, the majority of our business, more than 90%, is in type 1. And so we remain pretty optimistic about the growth and market profile in Diabetes.
是的。我的意思是,就像勞拉提到的那樣,我們花了相當多的時間來研究這個問題。我認為 SELECT 的一些證據表明,糖尿病前期族群對胰島素的依賴可能會放緩。也許2 型中的一些人會提出胰島素,但我們認為這個數字非常小,並且被以下事實所抵消:使用AID 的2 型的滲透率較低,並且當您查看3 的漏斗時,這一事實足以抵消100 億至 400 萬人需要基礎胰島素,2500 萬人需要非胰島素 2 型胰島素,以及超過 1 億糖尿病前期人群,這不會改變我們對市場長期規模以及市場規模的看法。增長率。正如 Geoff 在開頭提到的,我們的大部分業務(超過 90%)屬於 1 型。因此,我們對糖尿病的成長和市場狀況仍然非常樂觀。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
All right. Thanks, Que. I mean, so -- I mean, Travis and others, I mean, as you can see, beyond the fact that the areas that we get questions on, type 2 intensive, hypertension, afib, obesity, besides the fact these are just woefully underpenetrated from a med tech perspective, we've done all the analysis that Laura and Que just gave you the tip of the iceberg of. And that's why we're -- we feel strongly that we don't see these drugs impacting Medtronic's growth medium or long term. So I hope that answers your question and then some.
好的。謝謝,闕。我的意思是,所以——我的意思是,特拉維斯和其他人,我的意思是,正如你所看到的,除了我們收到問題的領域之外,2型強化、高血壓、心房顫動、肥胖,除了這些領域的情況令人遺憾之外從醫學技術的角度來看,我們已經完成了勞拉和奎剛剛向您提供的冰山一角的所有分析。這就是為什麼我們強烈認為這些藥物不會影響美敦力的中長期成長。所以我希望這能回答你的問題以及一些問題。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
We'll take the next question from Larry Biegelsen at Wells Fargo Securities.
我們將回答富國銀行證券公司 Larry Biegelsen 提出的下一個問題。
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Just 2 product questions for me. One for Sean. On Ardian, congratulations. Sean, can you talk about the ASP, the reimbursement pathway and the ramp? And for Brett, the slides talked about completing the 6-month primary endpoint on the pivotal TITAN 2 ITNS trial, does FDA want 12-month data? Could you talk about the form factor here and how you see ITNS being positioned relative to sacral neuromodulation?
我只有 2 個產品問題。一份給肖恩。在 Ardian 上,恭喜。 Sean,您能談談 ASP、報銷途徑和坡道嗎?對於 Brett 來說,幻燈片談到了完成關鍵 TITAN 2 ITNS 試驗的 6 個月主要終點,FDA 是否需要 12 個月的數據?您能否談談這裡的外形因素以及您如何看待 ITNS 相對於骶神經調節的定位?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Well, Larry, it's Geoff. Good to hear from you, and thanks for the question. On -- before I turn it over to Sean, on Ardian, I just -- I do want to just say, look, congratulate the team here in the cardiovascular space at Medtronic and leaders past. I mean, this has been -- have been involved -- this has been a long journey, and we are really, really excited about the approval. We have a lot of data here in our RCTs. We consistently saw a mean 9 to 10 millimeters of mercury absolute office blood pressure drops at the initial primary endpoints in this case of 3 and 6 months and actually more in the real-world setting and additional drops over time from these primary assessments. So this is a game changer.
好吧,拉里,我是傑夫。很高興收到你的來信,謝謝你的提問。在我把它交給 Sean 之前,關於 Ardian,我只是想說,看,祝賀美敦力心血管領域的團隊和過去的領導者。我的意思是,這是一個漫長的旅程,我們對獲得批准感到非常非常興奮。我們的隨機對照試驗中有大量數據。在本例中,在3 個月和6 個月的情況下,我們始終看到初始主要終點的絕對辦公室血壓平均下降9 至10 毫米汞柱,實際上在現實環境中下降更多,並且隨著時間的推移,這些主要評估還會進一步下降。所以這是一個遊戲規則的改變者。
And look, this is compelling as the data is and as much as we have, it doesn't even tell the whole story. I mean, you talk to physicians out there that are involved in our trials, and the excitement is palpable. And patients, we have a number of patients been on this for years, and talking to them how it's changed their life. And we're actually having a patient come in and talk to the entire company here in a couple of weeks. It's very exciting.
看,儘管數據和我們掌握的數據一樣令人信服,但它甚至沒有講述整個故事。我的意思是,當你與參與我們試驗的醫生交談時,興奮是顯而易見的。對於患者來說,我們有很多患者多年來一直在研究這個問題,並與他們談論它如何改變了他們的生活。實際上,我們將在幾週內讓一名患者進來並與整個公司進行交談。這是非常令人興奮。
And so a big opportunity for patients and a real big opportunity for us, too. And so getting into some of the specifics, you asked about reimbursement, I'll turn that over to Sean. And then we can go to Brett to talk about -- I believe you're asking about the tibial opportunity and -- but why don't we start with Sean.
這對患者來說是一個巨大的機會,對我們來說也是一個真正的巨大機會。因此,談到一些具體細節,您詢問報銷問題,我會將其轉交給肖恩。然後我們可以去找布雷特談談──我相信你問的是脛骨機會──但我們為什麼不從肖恩開始。
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Sean M. Salmon - Executive VP & President of Cardiovascular Portfolio
Larry, thanks for the question. As you know, the ramp is going to be highly gated by reimbursement and we've been working that in parallel with the regulatory approval all along. We see the player split to be roughly 50-50 between Medicare and commercial payers or private insurance. And we've been, of course, pursuing both local and national coverage determinations from Medicare, and that's an important input into the private payer decisions that will happen state by state and payer by payer. We've been in contact with those private payers, the largest ones certainly.
拉里,謝謝你的提問。如您所知,斜坡將受到報銷的嚴格控制,我們一直在與監管部門批准同時進行。我們發現醫療保險和商業付款人或私人保險之間的比例約為 50-50。當然,我們一直在尋求醫療保險的地方和國家承保範圍決定,這是對各州、各付款人做出的私人付款人決策的重要投入。我們一直在與那些私人付款人保持聯繫,當然也是最大的付款人。
And the response so far have been very open and willing to engage with us to understand our data. And what's particularly of interest to them is the long-term data, which is atypical for a new therapy like this to have thousands of patients out 3 years from the therapy. So that's encouraging.
到目前為止,反應非常開放,願意與我們互動以了解我們的數據。他們特別感興趣的是長期數據,對於像這樣的新療法來說,有數千名患者在 3 年內退出治療,這是不典型的。所以這是令人鼓舞的。
Of course, the Medicare population is the most important for us. And to your question, there are these alternative pathways that have been established by Medicare for temporary add-on payments, both in the inpatient setting with NTAP, or the new technology add-on payment as well as in that outpatient setting for transitional pass-through payments, or TPP. And given that the Symplicity Spyral system is a breakthrough device designation, we will avail ourselves to those pathways for approval over that 2- and 3-year period as we work to establish more permanent reimbursement for like a national coverage determination.
當然,醫療保險人口對我們來說是最重要的。對於你的問題,醫療保險已經為臨時附加付款建立了這些替代途徑,無論是在 NTAP 的住院環境中,還是新技術的附加付款,以及在門診環境中的過渡通行證-通過支付(TPP)。鑑於 Symplicity Spyral 系統是一個突破性的設備名稱,我們將在 2 到 3 年期間利用這些途徑獲得批准,同時我們努力建立更永久的報銷,例如國家覆蓋範圍的確定。
On that front, there is this TSAT pathway, or the transitional coverage for emerging therapies, that we're going to avail ourselves to. It's not finalized yet. We look forward to that ruling coming out. We've seen the commentary has been largely very, very positive along the way and in line with what we had been suggesting both to CMS and the Biden administration as well as other stakeholders along the way. And of course, CMS is also considering other refinements to coverage with evidence development programs that we've used successfully as we've established many, many therapies, as you know, including TAVR, Micra, ICD, CRT devices over time. And we'll avail ourselves to those as well.
在這方面,我們將利用 TSAT 途徑,或新興療法的過渡覆蓋。它還沒有最終確定。我們期待該裁決的出台。我們看到,一路上的評論在很大程度上非常非常積極,並且與我們一直以來向 CMS 和拜登政府以及其他利益相關者提出的建議是一致的。當然,CMS 也在考慮對證據開發計劃的覆蓋範圍進行其他改進,我們已經成功使用了這些計劃,因為我們已經建立了許多療法,如您所知,隨著時間的推移,包括TAVR、Micra、ICD 、CRT 設備。我們也會利用這些。
So rest assured, we're working hard on reimbursement. It's really critical for the ramp of this technology, and we're getting into reception so far.
所以請放心,我們正在努力解決退款問題。這對於這項技術的發展確實至關重要,到目前為止我們已經開始接受。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Okay. Thanks, Sean. Brett, do you want to answer part 2 here?
好的。謝謝,肖恩。 Brett,你想在這裡回答第二部分嗎?
Brett A. Wall - Executive VP & President of Neuroscience Portfolio
Brett A. Wall - Executive VP & President of Neuroscience Portfolio
Yes, absolutely, Larry, good to hear your voice. Thanks for the question. The TITAN 2 study was a 6-month follow-up with the actual study design, and we will follow those patients for 24 months. So we'll be following those patients and have additional data as well. The form factor is about 2.8 cubic centimeters, really about the size of roughly half a stick of gum and it fits in the ankle, same place for everyone. This opens up a significant patient population. There's over 4 million people in the United States that have discontinued their dual drug therapy or failed 2 drugs, and they are now receiving continence devices at all-adult continence products as opposed to seeking additional therapy. This is a 15-minute procedure.
是的,當然,拉里,很高興聽到你的聲音。謝謝你的提問。 TITAN 2研究是根據實際研究設計進行的為期6個月的隨訪,我們將追蹤這些患者24個月。因此,我們將追蹤這些患者並獲得更多數據。其外形尺寸約為 2.8 立方厘米,大約相當於半塊口香糖的大小,並且適合每個人的腳踝。這開闢了相當大的患者群體。在美國,有超過 400 萬人已停止雙重藥物治療或兩種藥物都無效,他們現在正在接受全成人節制產品中的節制裝置,而不是尋求額外的治療。這是一個 15 分鐘的過程。
We now have established Category 3 reimbursement and we'll be utilizing that to further develop the reimbursement profile. This particular product and technology opens up a substantial population that is not seeking help or seeking a therapy right now. We're in a modular submission. We'll be submitting the data here shortly. And this is an exciting new technology that opens up this field and will contribute to its ongoing growth.
我們現在已經建立了第 3 類報銷,我們將利用它來進一步開發報銷資料。這種特殊的產品和技術為目前不尋求幫助或治療的大量人群提供了機會。我們正在進行模組化提交。我們很快就會在這裡提交數據。這是一項令人興奮的新技術,它開闢了這一領域,並將為其持續發展做出貢獻。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes. Thanks, Brett, and thanks, Larry. And a reminder to the analysts to stick to one question and one related follow-up if needed. We'll take the next question please, Brad.
是的。謝謝,布雷特,謝謝,拉里。並提醒分析師堅持一個問題和一個相關的後續行動(如果需要)。我們將回答下一個問題,布拉德。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
The next question comes from Vijay Kumar at Evercore ISI.
下一個問題來自 Evercore ISI 的 Vijay Kumar。
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
I had 2 product-related questions here. First one, just at a high level, right, you had 3 pretty meaningful product approvals in the past few months between EV-ICD, PFA and your Ardian approval, right? You're already doing mid-singles. With all of these incremental growth drivers coming in, is that now a mid-single plus? I'm just curious how you're thinking about this new product opportunities.
我在這裡有 2 個與產品相關的問題。第一個,只是在高水準上,對吧,在過去的幾個月裡,你們在 EV-ICD、PFA 和 Ardian 批准之間獲得了 3 個相當有意義的產品批准,對吧?你已經在打中單打了。隨著所有這些增量成長動力的加入,現在這是一個中單加號嗎?我只是好奇您如何看待這個新產品機會。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Well, thanks for the question, Vijay, and thanks for pointing out the robust nature of the approvals. And these are really, we believe, and as you saw in the commentary, unquestionably differentiated products and in large markets and growing markets that we have a high confidence in. And this gets to our commitment to make this growth durable. And as we've seen over the last couple of years, whether it be market conditions or internal things, which I am -- we are working so hard to make sure these internal boogie men just disappear through changing our fundamentals.
好吧,謝謝 Vijay 提出的問題,也感謝您指出批准的穩健性。我們相信,正如您在評論中看到的那樣,這些確實是毫無疑問的差異化產品,並且在我們充滿信心的大型市場和不斷增長的市場中。這兌現了我們使這種增長持久的承諾。正如我們在過去幾年中所看到的,無論是市場條件還是內部因素(我就是這樣),我們都在努力確保這些內部的布吉人透過改變我們的基本面而消失。
This is -- these -- this breadth of approvals in these high-growth markets, I believe, will help me for the first time sleep well. Because it gives you the durability that we're talking about in that revenue number, which is so important. Everything flows from there. So at this point, before we start talking about plus, I just want to make sure that we are very durable and reliable mid-single-digit growers in different types of environments, good and less good. And then we can flow from there about leverage on the P&L and things like that. So that's my overview on those 3 -- on the pipeline in general.
我相信,這些高成長市場的廣泛批准將幫助我第一次睡個好覺。因為它為您提供了我們在收入數字中談論的持久性,這非常重要。一切都從那裡流動。因此,在這一點上,在我們開始談論加號之前,我只想確保我們在不同類型的環境(良好和較差的環境)中都是非常耐用且可靠的中位數種植者。然後我們可以從那裡開始討論損益表的槓桿作用以及類似的事情。這就是我對這三個面向的概述——整體的流程。
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team
And maybe my related product question here, perhaps for Mike on robotics here. You mentioned installed base went up in Europe. Any sense on what the size of that installed base is? In this U.S. clinical trial, you said it's on plan. But any sense on when this trial might end, perhaps timing for an FDA approval?
也許我的相關產品問題在這裡,也許是關於機器人技術的麥克。您提到歐洲的安裝基數增加。對安裝基礎的規模有什麼了解嗎?在這個美國臨床試驗中,你說它正在按計劃進行。但這項試驗何時結束有什麼意義嗎?也許是 FDA 批准的時間?
Mike Marinaro - Executive VP & President of Surgical Operating Unit
Mike Marinaro - Executive VP & President of Surgical Operating Unit
So thanks for the question, Vijay. First, we will continue -- we are continuing forward with our installs, have added to the installed base. We're not quoting numbers of installations at this time but we are increasing on a quarter-on-quarter basis. Our procedure volume is picking up on a quarter-on-quarter basis as we work through availability of our instruments and then getting the system into the U.S. will really start to see acceleration of our program.
謝謝你的提問,維傑。首先,我們將繼續進行——我們正在繼續進行安裝,並已添加到安裝基礎中。我們目前沒有引用安裝數量,但我們正在逐季度增加。隨著我們努力提高儀器的可用性,然後將系統引入美國,我們的程序量將逐季度增加。我們的計劃將真正開始加速。
Geoff commented and you just noted that the Expand URO study is on track, and we're very excited in speaking with our investigators there, and they're enthusiastic about the product and the program. And so that continues forward. We're not going to give time lines of U.S. approval for that, but I will tell you it's proceeding according to plan.
Geoff 評論道,您剛剛注意到 Expand URO 研究已步入正軌,我們非常高興與那裡的研究人員交談,他們對產品和計劃充滿熱情。就這樣繼續下去。我們不會給出美國批准的時間表,但我會告訴你,事情正在按計劃進行。
And then as Geoff noted, we're very excited about the Hernia IDE approval, which allows us to take a big step in the general surgery more quickly than we had anticipated and to start to engage the general surgeons with Hugo here in the United States in a segment where we are very active today.
然後,正如 Geoff 指出的那樣,我們對 Hernia IDE 的批准感到非常興奮,這使我們能夠比預期更快地在普外科領域邁出一大步,並開始與美國的普外科醫生與 Hugo 合作在我們今天非常活躍的領域。
Of course, we have a large business and sales channel in the area of Hernia Repair. There's a real hunger for capacity and a growing volume there in hernia in the United States. And so now running these IDEs in parallel will allow us to start to really pick up momentum as we contemplate the entry into the U.S. market. So we are on plan. I'm not giving specific dates for approval yet, but also very excited about the opportunity to move into general surgery and in with the general surgeon with this Hernia IDE approval.
當然,我們在疝氣修復領域擁有龐大的業務和銷售管道。在美國,對容量的需求確實很大,而且疝氣的數量也不斷增加。因此,現在並行運行這些 IDE 將使我們在考慮進入美國市場時開始真正獲得動力。所以我們正在按計劃進行。我還沒有給出批准的具體日期,但我也非常高興有機會進入普通外科並與普通外科醫生一起獲得疝氣 IDE 的批准。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Thanks, Mike. I mean, I know there's a lot of interest in this. And look, I just emphasize Mike's comments. Step one was to have a robot that has the capabilities and strong physician acceptance. And we feel strongly that we have that. And now we're building up our experience primarily in Europe and -- of operating the robot out in the wild and then really, as Mike had mentioned, building out that instrument portfolio and executing on the U.S. trial so that we can launch in the U.S., that will be between the U.S. and some new instruments that will really drive a lot of growth here. So anyway, more to come on that. But thanks for the question, Vijay.
謝謝,麥克。我的意思是,我知道大家對此很感興趣。看,我只是強調麥克的評論。第一步是擁有一個具有能力且具有強烈醫生接受度的機器人。我們強烈感覺到我們已經做到了。現在,我們主要在歐洲積累經驗,在野外操作機器人,然後真正,正如邁克提到的那樣,構建儀器組合併在美國進行試驗,以便我們可以在美國推出美國,這將是美國和一些新工具之間的關係,這些新工具將真正推動這裡的大量成長。所以無論如何,還有更多的事情要做。但謝謝你的提問,維傑。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
The next question comes from Kristen Stewart with CL King.
下一個問題來自克里斯汀·史都華 (Kristen Stewart) 和 CL King。
Kristen Marie Stewart - MD & Senior Research Analyst
Kristen Marie Stewart - MD & Senior Research Analyst
I was just wondering if you could provide any updates on the patient monitoring respiratory interventions spin.
我只是想知道您是否可以提供有關患者監測呼吸幹預旋轉的最新資訊。
Karen L. Parkhill - Executive VP & CFO
Karen L. Parkhill - Executive VP & CFO
Yes. Thanks, Kristen, for the question. We're continuing to work on the separation of that and our focus through all of it is to maximize shareholder value. No big updates.
是的。謝謝克里斯汀提出這個問題。我們正在繼續努力將其分離,我們的重點是最大化股東價值。沒有大的更新。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
The next question comes from Matt O'Brien at Piper Sandler.
下一個問題來自 Piper Sandler 的 Matt O'Brien。
Matthew Oliver O'Brien - MD & Senior Research Analyst
Matthew Oliver O'Brien - MD & Senior Research Analyst
So just one question, Geoff, for you specifically. It's -- you're a $30-plus billion revenue company but you talked about more tuck-in acquisitions historically. Just given your size, given the strength in terms of new product flow, I'm just wondering if now is the time to be more aggressive from an M&A perspective just given the pullback that we've seen in some of these on the public company side of things, just to be able to do a bigger deal to really solidify your growth algorithm going forward? Is now the time to be more aggressive? Are you more amenable to doing bigger deals now, just given strong balance sheet, kind of got the operating model together, et cetera?
傑夫,我只想問你一個問題。這是——你是一家營收超過 300 億美元的公司,但你談到了歷史上更多的隱藏收購。考慮到你們的規模,考慮到新產品流方面的實力,我只是想知道現在是否是時候從併購的角度採取更加積極的態度,考慮到我們在上市公司的一些交易中看到的回調一方面,只是為了能夠做更大的事情來真正鞏固你未來的成長演算法?現在是時候變得更加激進了嗎?只要考慮到強勁的資產負債表、整合營運模式等等,您現在是否更願意進行更大的交易?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes. Thanks for the question, Matt. And yes, clearly, I think you're seeing asset prices come down. And it's a tough operating environment. I think they're going to continue to come down, in the mid-cap space in particular and below. And we definitely have the capabilities, as you pointed out, to do bigger deals. All that being said, our focus still is on tuck-ins. And we've got a lot of big organic -- or now organic programs between just Ardian, the Robot, PFA, Diabetes, I mean, the list goes on. There's a lot of big organic pipeline going up against these high-growth markets that we're really focused on. And I would augment that with the appropriate tuck-ins. So I'm not going to -- I don't think we're really focused on, and we're not going to signal that we're focused on any kind of bigger deals at this point.
是的。謝謝你的提問,馬特。是的,顯然,我認為你會看到資產價格下降。這是一個艱難的營運環境。我認為它們將繼續下跌,特別是在中型股及以下的領域。正如您所指出的,我們絕對有能力進行更大的交易。話雖如此,我們的重點仍然是折疊。我們有很多大型有機項目——或者現在只是 Ardian、機器人、PFA、糖尿病等有機項目,我的意思是,這樣的例子不勝枚舉。有許多大型有機管道正在對抗我們真正關注的這些高成長市場。我會透過適當的折邊來增強這一點。所以我不會——我認為我們並沒有真正專注於,我們也不會表示我們目前正在專注於任何更大的交易。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
The next question comes from Rich Newitter at Truist.
下一個問題來自 Truist 的 Rich Newitter。
Richard Samuel Newitter - Research Analyst
Richard Samuel Newitter - Research Analyst
Just on -- we saw just more broadly in med tech a little bit of seasonality or weaker, I think, third quarter for a number of your competitors play out. Just wondering if you could comment on the trend throughout the quarter. Was August unseasonally kind of weaker than what you would have thought? And what's been the normal pickup? Is it stronger than expected into the 4Q, especially if you could talk about kind of exit trends from September into October?
就在 - 我們看到更廣泛的醫療技術領域有一點季節性或更弱,我認為,許多競爭對手的第三季度表現不佳。只是想知道您是否可以評論整個季度的趨勢。八月是否反常地比你想像的要弱一些?正常的接送狀況是怎樣的?第四季的表現是否強於預期,特別是如果您能談談從 9 月到 10 月的退出趨勢?
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Sure. Thanks for the question, Rich. I'm going to ask Karen to answer that one.
當然。謝謝你的提問,里奇。我要請凱倫回答這個問題。
Karen L. Parkhill - Executive VP & CFO
Karen L. Parkhill - Executive VP & CFO
Yes. Thanks, Rich. I would say, we saw strength throughout the second quarter, no matter what month you looked at. And I think that's driven in part by just the strength of our product offering. When we look at the first few weeks of this quarter and how that's been trending, it's been trending well. We're tracking to the expectations that we set in our guidance at this stage.
是的。謝謝,里奇。我想說,無論你看哪個月份,我們都在第二季看到了強勁的勢頭。我認為這在一定程度上是由我們產品的實力所推動的。當我們查看本季度的前幾週及其趨勢時,會發現趨勢良好。我們正在追蹤現階段我們在指導中設定的期望。
Brad Welnick - VP of IR
Brad Welnick - VP of IR
Final question comes from Shagun Singh from RBC Capital.
最後一個問題來自 RBC Capital 的 Shagun Singh。
Shagun Singh Chadha - Research Analyst
Shagun Singh Chadha - Research Analyst
Just, I guess, a follow-up on Hugo. One of your competitors recently showcased their surgical robot that had an invisible design and twin motion capabilities. I'm just wondering what your thoughts are on the competitive landscape? Do you see it as a rising tide? Or just how do you think about your technology offering versus competition? And then I was just wondering if it's possible to get any more specific color on how October and November is shaping out.
我想,這只是雨果的後續行動。您的一位競爭對手最近展示了他們的手術機器人,該機器人具有隱形設計和雙運動功能。我只是想知道您對競爭格局有何看法?您認為這是一個上漲的浪潮嗎?或者您如何看待您的技術產品與競爭?然後我只是想知道是否有可能獲得關於 10 月和 11 月的情況的更具體的顏色。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Well, I'll ask -- thanks for the question. I'm going to ask Mike to take the Hugo question and I'll follow-up on that one.
好吧,我會問——謝謝你的問題。我將請麥克回答雨果的問題,我會跟進這個問題。
Mike Marinaro - Executive VP & President of Surgical Operating Unit
Mike Marinaro - Executive VP & President of Surgical Operating Unit
Thanks, Shagun. So we were very interested to see the latest developments from our competitor here relative to their program. And I'll say that they were about as expected, no surprises there. We continue to be very excited and optimistic about the differentiation of our program with an open console, with a modular design, with the ability to have flexibility in terms of location or site of care, which is highly differentiated from what we heard there in their discussions as well as what we see in the market today.
謝謝,沙貢。因此,我們非常有興趣了解我們的競爭對手與其計劃相關的最新進展。我想說的是,它們與預期相符,沒有什麼意外。我們仍然對我們的程序的差異化感到非常興奮和樂觀,它具有開放式控制台,採用模組化設計,能夠在位置或護理地點方面具有靈活性,這與我們在他們那裡聽到的有很大不同討論以及我們今天在市場上看到的情況。
And so we see that differentiation continue and the reasons that our customers like Hugo to continue to be differentiated reasons. More broadly speaking, though, the good news is that there continues to be just real interest in expanding the penetration of robotics across multiple fields in surgery. And we're seeing continued increase in procedural volumes on a quarter-on-quarter basis. And so it's good news for the field as that interest grows. So we're well positioned and the field continues to expand, which is a good story for Medtronic.
因此,我們看到差異化仍在繼續,而我們的客戶喜歡 Hugo 的原因仍然是差異化的原因。不過,更廣泛地說,好消息是,人們仍然對擴大機器人技術在外科手術多個領域的滲透產生真正的興趣。我們看到程序量逐季度持續增加。因此,隨著人們興趣的增長,這對該領域來說是個好消息。因此,我們處於有利位置,並且該領域不斷擴大,這對美敦力來說是一個好故事。
Geoffrey Straub Martha - Chairman of the Board & CEO
Geoffrey Straub Martha - Chairman of the Board & CEO
Yes, and just to build on that, I mean, we talked about -- we call it robotics, but I would argue it's broader than that. And this isn't the first time we're out to change the dynamics of an entire market. That's what we're doing in the spine market right now. And it goes beyond robotics. It gets into interoperative imaging or visualization, navigation, presurgical, AI-based planning. And like with -- and Mike's role here with Hugo, we've got Touch Surgery Enterprise, which is a leading digital platform with AI-driven digital platform.
是的,我的意思是,在此基礎上,我們討論了——我們稱之為機器人技術,但我認為它的範圍比這更廣泛。這並不是我們第一次改變整個市場的動態。這就是我們現在在脊椎市場所做的事情。它超越了機器人技術。它涉及互通成像或視覺化、導航、術前、基於人工智慧的規劃。就像 Mike 在 Hugo 中扮演的角色一樣,我們擁有 Touchurge Enterprise,這是一個領先的數位平台,擁有人工智慧驅動的數位平台。
And like you're seeing in spine that's played out over the last couple of years, it's changing the competitive dynamics or what's important in the marketplace for our physicians and even patients. And you're seeing the impact as what you're seeing in the spine market as many competitors.
就像您在過去幾年中看到的脊椎領域一樣,它正在改變競爭動態,或者改變市場上對我們的醫生甚至患者來說重要的東西。您所看到的影響就像您在脊椎市場上看到的許多競爭對手一樣。
It takes a lot of expertise. It takes a lot of capital to make this happen. And you're seeing competitors fall by the wayside. And I know there's been a big one here recently with NuVasive and Globus coming together, and we'll see how that plays out. But I believe we've demonstrated an ability to do this. And this is the kind of experience. And I know we're up against a big competitor in Intuitive in the surgical space, but we believe we've got a lot to offer here. And we are going to drive a change in how people think about the space and the competitive dynamics, and we're really confident and excited about that.
這需要大量的專業知識。要實現這一點需要大量的資本。你會看到競爭對手半途而廢。我知道最近 NuVasive 和 Globus 的結合發生了一件大事,我們將看看結果如何。但我相信我們已經展示了做到這一點的能力。這就是一種體驗。我知道我們在外科手術領域面臨著 Intuitive 的一個大競爭對手,但我們相信我們在這裡可以提供很多東西。我們將推動人們對這個領域和競爭動態的看法改變,我們對此非常有信心和興奮。
So with that, I think we'll bring the call to close. Thanks for sticking with us a little longer. And I really appreciate the questions and the support and continued interest in Medtronic. And we look forward to updating you on our continued progress on our Q3 earnings broadcast, which we anticipate holding on Tuesday, February 20.
因此,我認為我們將結束通話。感謝您與我們一起堅持一段時間。我非常感謝大家提出的問題以及對美敦力的支持和持續關注。我們期待向您通報第三季財報廣播的持續進展情況,預計將於 2 月 20 日星期二舉行。
With that, thanks for joining us today. And for those in the U.S., I'd like to wish you and your families a very happy Thanksgiving this week and enjoy the holiday and stay safe. Thank you.
至此,感謝您今天加入我們。對於那些在美國的人,我祝您和您的家人本週感恩節快樂,享受假期並保持安全。謝謝。