美敦力 (Medtronic) 公佈了強勁的第二季業績,每股收益成長 8%,有機收入成長達到中個位數。該公司專注於 TAVR、糖尿病和神經調節等關鍵成長領域的創新和多元化。
儘管面臨挑戰,美敦力仍對本財年下半年加速成長充滿信心。該公司致力於恢復獲利能力,並利用每股盈餘槓桿實現中個位數的有機收入成長。他們正在應對貨幣波動、投資管道並尋求併購機會以實現未來成長。
分析師對該公司在醫療技術市場的表現持樂觀態度,尤其是在結構性心臟病和糖尿病等領域。美敦力專注於推動持久成長並為股東帶來回報。
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 - Vice President - Investor Relations
Ryan Weispfenning - Vice President - Investor Relations
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Good morning. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations, and I appreciate that you're joining us for our fiscal '25 second-quarter video earnings webcast.
早安.我是美敦力副總裁兼投資者關係主管 Ryan Weispfenning,感謝您加入我們的 25 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, Chairman and Chief Executive Officer; and Gary Corona, Interim Chief Financial Officer. Geoff and Gary will provide comments on the results of our second quarter. After our prepared remarks, the executive VPs from each of our four 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。與我一起的還有董事長兼執行長傑夫瑪莎 (Geoff Martha);臨時財務長加里‧科羅納 (Gary Corona)。傑夫和加里將對我們第二季的業績發表評論。在我們準備好的發言之後,我們四個部門的執行副總裁將加入我們,我們將回答涵蓋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, divisional and geographic revenue summaries, and non-GAAP reconciliations. 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、部門和地區收入摘要以及非公認會計準則調節表。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 our actual results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward-looking statement.
在今天的節目中,我們所做的許多陳述可能被視為前瞻性陳述,實際結果可能與任何前瞻性陳述中預測的結果有重大差異。有關可能導致我們的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。
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. References to sequential revenue changes compared to the first quarter of fiscal '25 and are made on an as-reported basis.
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。所提及的收入與 25 財年第一季相比的連續變化是在報告的基礎上進行的。
All references to share gains or losses are on a revenue and year-over-year basis and compare our second fiscal quarter against our competitors' third calendar quarter. 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.
所有對股票收益或損失的引用均以收入和年比為基礎,並將我們的第二個財季與競爭對手的第三季進行比較。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,了解本季的情況。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Hello, everyone, and thanks for tuning in today. Our momentum is building as we keep executing on our commitments, delivering yet another quarter of strong results that came in ahead of expectations and another guidance raise. This makes it eight quarters in a row now of solid mid-single-digit organic revenue growth.
大家好,感謝您今天的收看。隨著我們繼續履行我們的承諾,我們的勢頭正在增強,又一個季度的強勁業績超出了預期,並再次上調了指引。這使其連續八個季度有機收入實現穩定的中個位數成長。
And we translated that 5% organic top-line growth into 8% EPS growth on a constant currency basis and we remain on track to deliver high single-digit EPS growth on a reported basis in the back half of the fiscal year.
我們將 5% 的有機營收成長轉化為以固定匯率計算的 8% 每股收益成長,並且我們仍有望在本財年後半段實現按報告計算的高個位數每股收益成長。
We know that innovation matters, and innovation is what really is driving our growth today across multiple areas. We're seeing strong performance from franchises like TAVR, PFA, leadless pacemakers, diabetes, spine, and neuromodulation, just to name a few. And we're confident that this diversified growth will keep going, especially with the strength of our pipeline in high-impact markets like hypertension, which is a big, exciting opportunity for us.
我們知道創新很重要,而創新才是當今推動我們在多個領域成長的真正動力。我們看到 TAVR、PFA、無引線起搏器、糖尿病、脊椎和神經調節等特許經營業務表現強勁,僅舉幾例。我們相信,這種多元化成長將持續下去,特別是考慮到我們在高血壓等高影響力市場的產品線實力,這對我們來說是一個巨大的、令人興奮的機會。
If you look at our recent performance, it's clear. We've integrated a real performance mindset alongside our mission-driven culture and it's making a difference. And as we continue to drive durable top-line growth, use our scale to deliver leveraged earnings, generate strong free cash flow and grow our dividend, we're setting ourselves up to create strong long-term returns for our shareholders.
如果你看看我們最近的表現,就很清楚了。我們將真正的績效思維與我們的使命驅動文化結合,這正在發揮作用。隨著我們繼續推動持久的營收成長,利用我們的規模來提供槓桿收益,產生強勁的自由現金流並增加股息,我們正在為股東創造強勁的長期回報。
Now let's turn to the details of our Q2 business results and discuss our performance. Combined, they grew 8% again this quarter and made up 20% of our revenue. Starting with structural heart, we grew high single digits on the strength of our TAVR franchise. In the US, we launched Evolut FX+, and we're seeing strong customer adoption.
現在讓我們詳細了解第二季的業務業績並討論我們的業績。本季它們合計再次成長 8%,占我們營收的 20%。從結構心臟開始,我們憑藉 TAVR 特許經營權的實力實現了高個位數成長。在美國,我們推出了 Evolut FX+,並且我們看到了強大的客戶採用率。
We also received CE Mark for FX+ last month and began commercializing in Europe last week. FX+ is important not only for the lifetime management benefit of offers, but also because it creates an additional opportunity for us to reiterate our positive SMART trial results.
我們上個月也獲得了 FX+ 的 CE 標誌,並在上週開始在歐洲商業化。 FX+ 不僅對於優惠的終身管理效益很重要,還因為它為我們創造了額外的機會來重申我們積極的 SMART 試驗結果。
Now you'll recall that SMART demonstrated our superior valve performance in small annulus patients who are primarily women, and they make up about 40% of the TAVR segment. With this combination of FX+, low-risk data, and now SMART data, we expect to continue to grow at or above market in the quarters ahead.
現在您可能還記得,SMART 在小瓣環患者(主要是女性)中展示了我們卓越的瓣膜性能,她們約佔 TAVR 段的 40%。憑藉 FX+、低風險數據和目前的 SMART 數據的結合,我們預計未來幾季的成長將繼續達到或高於市場水平。
Next, in cardiac ablation solutions, our technology is helping to drive the rapid shift of the market to pulse field ablation. We've been significantly expanding our manufacturing capacity to meet this growing demand and we're well positioned as the only company with both single shot and focal PFA catheters.
接下來,在心臟消融解決方案中,我們的技術正在幫助推動市場向脈衝場消融的快速轉變。我們一直在大幅擴大我們的製造能力,以滿足不斷增長的需求,並且我們是唯一一家同時擁有單次和焦點 PFA 導管的公司。
We continue to drive our growth of our PulseSelect PFA single-shot catheter. This is offsetting cryoablation declines and our rate of cryo sequential decline significantly improved versus what we saw in Q1, the number of physicians using PulseSelect and we more than doubled the total number of patients treated with this catheter in Q2.
我們繼續推動 PulseSelect PFA 單次導管的發展。這抵消了冷凍消融的下降,與我們在第一季看到的情況相比,我們的冷凍連續下降率顯著改善,使用PulseSelect 的醫生數量以及我們在第二季度使用該導管治療的患者總數增加了一倍多。
That said, our overall cash growth did not accelerate as expected this quarter due to a third-party component supplier interruption. They've now expanded capacity, allowing us to continue to ramp PulseSelect availability and activate new accounts.
也就是說,由於第三方零件供應商的中斷,本季我們的整體現金成長並未如預期加速。他們現在已經擴大了容量,使我們能夠繼續提高 PulseSelect 的可用性並啟動新帳戶。
On top of PulseSelect, we were pleased to receive FDA approval late last month for our Affera mapping and ablation system, and Sphere-9 focal catheter. This all-in-one catheter was designed from the ground up to perform high-density mapping as well as pulse field and RF ablations.
除了 PulseSelect 之外,我們很高興在上月底獲得 FDA 批准我們的 Affera 標測和消融系統以及 Sphere-9 局部導管。這種一體化導管是從頭開始設計的,用於執行高密度標測以及脈衝場和射頻消融。
Sphere-9 replaces competitors' mapping and RF catheters, having already entered some of the top US centers by volume and this will accelerate over the coming weeks and quarters to meet the significant demand. And we continue to rapidly hire mapping specialists in advance of entering new centers, giving us confidence in our ability to accelerate account activations.
Sphere-9 取代了競爭對手的測繪和射頻導管,已進入美國一些頂級中心的銷量,並將在未來幾周和幾個季度加速,以滿足巨大的需求。我們繼續在進入新中心之前快速聘請地圖專家,這讓我們對加速帳戶啟動的能力充滿信心。
With the strong customer response to the breadth of our new PFA portfolio, we expect our overall CASK growth rate to accelerate through the back half of the fiscal year, including strong double-digit growth in Q3, and we expect to reach and then exceed market growth in this large and fast-growing $9 billion cardiac ablation space.
隨著客戶對我們新的 PFA 產品組合的強烈反應,我們預計我們的整體 CASK 成長率將在本財年後半段加速,包括第三季度強勁的兩位數成長,我們預計將達到並超越市場在這個巨大且快速成長的90 億美元心臟消融領域中取得成長。
Next, in surgical robotics. We continue to invest in our Hugo platform. building a strong foundation for future growth. In the US, we've completed capturing the necessary data for urology submission and expect to file with the FDA in the first quarter of calendar '25. We're also seeing fast enrollment in our next two US indication studies, hernia and gynecology.
接下來是外科手術機器人。我們繼續投資 Hugo 平台。為未來的發展奠定堅實的基礎。在美國,我們已經完成了泌尿科提交所需數據的收集,並預計在 2025 年第一季向 FDA 提交文件。我們也看到接下來兩項美國適應症研究(疝氣和婦科)的入組人數很快。
In digital, we commenced commercial rollout of our Touch Surgery live stream remote connectivity solution across the US and Western Europe as we continue to digitize operating rooms globally. And we're making progress bringing our advanced surgical technologies to Hugo. We expect ICG fluorescent imaging to be available in certain countries soon, followed by adding our market-leading LigaSure vessel sealing technology to Hugo next calendar year.
在數位化方面,隨著我們繼續在全球範圍內實現手術室數位化,我們開始在美國和西歐商業推出觸摸手術直播遠端連接解決方案。我們正在取得進展,將先進的外科技術引入雨果。我們預計 ICG 螢光成像將很快在某些國家推出,然後明年將我們市場領先的 LigaSure 血管密封技術添加到 Hugo 中。
Next, in diabetes, we delivered another quarter of double-digit growth, growing 11% despite more difficult comparisons from the 780G US launch last year. Our CGM sales grew over 20% in both the US and international markets, driven by the high CGM attachment rates to the 780G.
接下來,在糖尿病領域,儘管與去年在美國推出的 780G 進行比較更加困難,但我們仍實現了另一個季度的兩位數增長,增長了 11%。受 780G 高 CGM 附著率的推動,我們的 CGM 銷售額在美國和國際市場成長了 20% 以上。
In addition, our Simplera Sync sensor, which is half the size and much easier to apply than our previous sensor is gaining strong acceptance in international markets.
此外,我們的 Simplera Sync 感測器尺寸僅為先前感測器的一半,並且更易於應用,在國際市場上獲得了廣泛認可。
On the Smart MDI front, we just secured FDA clearance for our InPen app, which paves the way for a limited US release of our Smart MDI system with our Simplera CGM. So we continue to add new patients with the 780G system. The majority are coming from MDI, and we're also seeing success from our competitive switch programs. Patients are attracted to 780G's highest time and range of any commercial AID system and achieving this control with less burden.
在智慧 MDI 方面,我們的 InPen 應用程式剛剛獲得 FDA 批准,這為我們在美國有限發布帶有 Simplera CGM 的智慧 MDI 系統鋪平了道路。所以我們繼續用780G系統增加新的患者。大多數來自 MDI,我們也從我們的競爭性轉換計劃中看到了成功。患者被 780G 的商業 AID 系統中最高的時間和範圍所吸引,並以更少的負擔實現這種控制。
In the dQ&A survey of over 1,500 AID users in the US, the 780G had the highest user satisfaction of any AID system including scoring 20 percentage points higher than the Tandem-Dexcom combination and 25 points higher than the insulin-Dexcom combination.
在對美國 1,500 多名 AID 用戶進行的 dQ&A 調查中,780G 的用戶滿意度是所有 AID 系統中最高的,比 Tandem-Dexcom 組合高 20 個百分點,比胰島素 - Dexcom 組合高 25 個百分點。
We're investing heavily in diabetes to expand manufacturing capacity and advance our robust technology pipeline, including our partnership with Abbott on an integrated sensor. These activities support our strategy to be number one in the fast-growing AID and Smart MDI space with a technology ecosystem that is focused on achieving better control with less burden.
我們在糖尿病領域投入巨資,以擴大生產能力並推進我們強大的技術管道,包括我們與雅培在整合感測器方面的合作。這些活動支持我們的策略,透過專注於以更少的負擔實現更好的控制的技術生態系統,在快速成長的 AID 和智慧 MDI 領域成為第一。
Now turning to hypertension, and the large future growth opportunity of our Symplicity blood pressure procedure. With a proven track record of long-term efficacy and safety and unique design, this innovative solution is poised to transform hypertension management. We're pleased that CMS earlier this month finalized the outpatient transitional pass-through payment, which will take effect on January 1.
現在轉向高血壓,以及我們 Symplicity 血壓程序未來巨大的成長機會。憑藉長期療效和安全性的良好記錄以及獨特的設計,這項創新解決方案有望改變高血壓管理。我們很高興 CMS 本月稍早最終確定了門診過渡性轉嫁付款,該付款將於 1 月 1 日生效。
With coding and sufficient Medicare payment now in place, the key step for broader adoption is to establish standardized coverage. On this front, we continue to engage with CMS to facilitate access for patients to this important therapy. And we're working with private payers to advance coverage as well.
隨著編碼和足夠的醫療保險支付到位,更廣泛採用的關鍵步驟是建立標準化的覆蓋範圍。在這方面,我們繼續與 CMS 合作,以方便患者獲得這項重要的治療。我們也正在與私人付款人合作以提高保險範圍。
Hypertension is a global health challenge and the leading cause of cardiovascular disease and premature death worldwide. In fact, it impacts more than 1 billion people globally, including nearly half of all US adults, despite the availability of numerous medications. Only one in four adults with hypertension in the US have it under control, and the direct cost to the US healthcare system for hypertension are massive, somewhere between $100 million and $200 billion a year. So our Symplicity procedure can play a very important role in cost-effectively improving public health.
高血壓是全球健康挑戰,也是全世界心血管疾病和過早死亡的主要原因。事實上,儘管有多種藥物可供使用,但它仍影響著全球超過 10 億人,其中包括近一半的美國成年人。在美國,只有四分之一的高血壓成年人能夠得到控制,而美國醫療保健系統因高血壓而付出的直接成本是巨大的,每年在 1 億至 2000 億美元之間。因此,我們的 Symplicity 程序可以在經濟高效地改善公共衛生方面發揮非常重要的作用。
Now looking at our established market leaders. Combined, they made up nearly half of our revenue and grew mid-single digits. In many cases, we've innovated on the technology and business models to reinvent these businesses over the past few years, and we continue to invest in them to ensure durable growth. They are a key part of our financial model, helping us to consistently deliver on the top line, and they contribute a disproportionate amount of profit and cash flow.
現在看看我們既定的市場領導者。它們加起來占我們收入的近一半,並且實現了中個位數的成長。在許多情況下,我們在過去幾年中對技術和商業模式進行了創新,以重塑這些業務,並且我們繼續對其進行投資以確保持久成長。它們是我們財務模式的關鍵部分,幫助我們持續實現營收,並貢獻了不成比例的利潤和現金流。
In Cranial and Smile Technologies, we grew 6% worldwide, including 7% growth in US Core Spine and Biologics. In a market that rewards scale, we're continuing to win. This is driven by our leading able ecosystem of differentiated spine implants and enabling technologies, including AI-driven, preop planning software, imaging, robotics, navigation and powered surgical instruments.
在 Cranial 和 Smile Technologies 領域,我們在全球成長了 6%,其中美國 Core Spine 和 Biologics 領域成長了 7%。在一個注重規模的市場中,我們將繼續獲勝。這是由我們領先的差異化脊椎植入物和支援技術生態系統推動的,包括人工智慧驅動的術前規劃軟體、影像、機器人、導航和動力手術器械。
Our large global able installed base is changing the competitive dynamics in spine, and we continue to expand its features and its capabilities. At the NASS conference in September, we announced a new partnership with Siemens Healthineers to co-market and integrate their imaging technologies for spine care.
我們龐大的全球安裝基礎正在改變脊椎領域的競爭動態,我們將繼續擴展其特性和功能。在 9 月的 NASS 會議上,我們宣布與西門子 Healthineers 建立新的合作夥伴關係,共同行銷和整合他們的脊椎護理影像技術。
We expect CST to continue to deliver sustained above-market growth with able and its differentiated best-in-class solutions, attracting not only spine surgeons around the world, but also the best sales reps and distributors who continue to leave the competition to join our winning team.
我們預計 CST 將繼續憑藉其強大且差異化的一流解決方案實現持續高於市場的增長,不僅吸引世界各地的脊柱外科醫生,還吸引繼續離開競爭對手加入我們的最佳銷售代表和分銷商。隊。
Next, in surgical, we had flat results. As I mentioned last quarter, we had difficult year-over-year comparisons given the supply recovery last year as well as the Korean market slowdown from the ongoing physician strikes. We had outsized strength in advanced energy driven by accelerated adoption of our LigaSure XP Maryland vessel sealer.
接下來,在外科手術中,我們得到了平淡的結果。正如我上季度提到的,鑑於去年的供應復甦以及持續的醫生罷工導致韓國市場放緩,我們很難進行同比比較。由於加速採用我們的 LigaSure XP 馬裡蘭血管密封劑,我們在先進能源方面擁有巨大的實力。
Overall, we continue to expect Surgical to return to more normalized growth starting next quarter as these comparisons ease.
總體而言,隨著這些比較的緩解,我們繼續預期 Surgical 從下個季度開始將恢復更正常的成長。
In cardiac rhythm management, we had another strong quarter, growing in the mid-single digits, including high single-digit growth in both defibrillation solutions and in cardiac pacing therapies. Our Micra leadless pacemaker franchise, grew high teens with broad strength around the world.
在心律管理方面,我們又經歷了一個強勁的季度,實現了中個位數增長,其中除顫解決方案和心臟起搏治療均實現了高個位數增長。我們的 Micra 無引線起搏器系列產品在全球成長為具有廣泛實力的青少年。
Now turning to our synergistic businesses, which collectively grew mid-single digits and represented over 30% of our revenue. The highlight again this quarter was neuromodulation, where growth accelerated to 12% and the business continues to grow well above the market. We're seeing broad-based growth across product lines, including pain stim and brain modulation.
現在轉向我們的協同業務,這些業務總體實現了中個位數成長,占我們收入的 30% 以上。本季的亮點再次是神經調節,其成長加速至 12%,且業務成長持續遠高於市場水平。我們看到各個產品線的廣泛增長,包括疼痛刺激和大腦調節。
In pain stim, we grew 10%, including 12% growth in the US on the continued launch of the Inceptiv closed-loop spinal cord stimulator. The innovation in Inceptiv is transforming the treatment of chronic pain for patients. It automatically keeps therapy at the optimal dose and allows patients to focus on everyday life, not on managing their chronic pain.
在疼痛刺激方面,我們成長了 10%,其中由於持續推出 Inceptiv 閉環脊髓刺激器,我們在美國實現了 12% 的成長。 Inceptiv 的創新正在改變患者慢性疼痛的治療方法。它自動將治療保持在最佳劑量,讓患者專注於日常生活,而不是控制慢性疼痛。
In addition, has the best full-body MRI conditional access on the market and the competition really isn't even close. This is important given that over 80% of these patients need an MRI within five years and nearly all of them need 1 within 10 years. In brain modulation, growth accelerated to 17%, the third quarter in a row of double-digit growth. This innovation-driven growth is built on the ongoing launch of our Percept RC with BrainSense technology.
此外,擁有市場上最好的全身 MRI 條件訪問,而且競爭確實不那麼激烈。這一點很重要,因為超過 80% 的患者在五年內需要進行 MRI 檢查,幾乎所有人都需要在 10 年內進行 1 次 MRI 檢查。在大腦調節方面,成長加速至17%,連續第三季達到兩位數成長。這種創新驅動的成長建立在我們不斷推出採用 BrainSense 技術的 Percept RC 的基礎上。
Percept is having a huge impact for patients with movement disorders like Parkinson's, essential tremor, dystonia, and epilepsy. It not only delivers therapy to specific brain targets, but it is the only DBS system that captures and records brain signals. Now this equips physicians with valuable data and the insights needed to personalize the therapy. And just like in pain stim, our DBS devices have differentiated MRI advantages versus the competition.
Percept 對帕金森氏症、特發性震顫、肌張力失調和癲癇等運動障礙患者產生了巨大影響。它不僅可以針對特定的大腦目標提供治療,而且是唯一捕獲和記錄大腦訊號的 DBS 系統。現在,這為醫生提供了個人化治療所需的寶貴數據和見解。就像疼痛刺激一樣,我們的 DBS 設備與競爭對手相比具有獨特的 MRI 優勢。
In addition to neuromod, we also had strong performances in other synergistic businesses. Cardiac surgery grew 10%, with the broad strength coming from innovative products like our Avalus Ultra surgical valve, Penditure LAA exclusion system, and VitalFlow ECMO system. Acute care and monitoring grew 3%, including 9% in Nellcor pulse oximetry, and pelvic health accelerated its growth to 5%.
除了 Neuromod 之外,我們在其他協同業務上也有強勁表現。心臟手術成長了 10%,這主要得益於我們的 Avalus Ultra 手術瓣膜、Penditure LAA 排除系統和 VitalFlow ECMO 系統等創新產品。急性護理和監測增加了 3%,其中 Nellcor 脈搏血氧飽和度增加了 9%,骨盆健康則加速成長至 5%。
Now with that, let's go to Gary, who will give you a deeper look at our Q2 financial performances and our outlook. Gary, over to you.
現在,讓我們邀請加里,他將讓您更深入地了解我們第二季度的財務表現和前景。加里,交給你了。
Gary Corona - Interim Chief Financial Officer
Gary Corona - Interim Chief Financial Officer
Thanks, Geoff. We delivered a strong top line performance again this quarter with revenue growth of 5%, 50 basis points above our guidance.
謝謝,傑夫。本季我們再次實現了強勁的營收業績,營收成長 5%,比我們的指導水準高出 50 個基點。
On the bottom line, adjusted EPS was $1.26, $0.01 above the midpoint of our guidance. We continue to invest in our pipeline and behind our emerging growth drivers while also delivering bottom-line growth, which was up 8% on a constant currency basis. The EPS beat was driven by $0.02 from greater operating profit on the revenue beat, partially offset by $0.01 from tax. The sources of our revenue growth continue to be diversified, both by business and geography, which gives us confidence in its durability.
總而言之,調整後每股收益為 1.26 美元,比我們指導值的中點高出 0.01 美元。我們繼續投資於我們的產品線和新興成長動力,同時實現淨利潤成長,以固定匯率計算成長了 8%。每股收益超出預期的原因是營業利潤增加 0.02 美元,而收入超出預期,部分被稅收 0.01 美元所抵銷。我們的營收成長來源持續多元化,無論是業務還是地域,這讓我們對其持久性充滿信心。
From a segment perspective, we had double-digit growth in diabetes, high single-digit growth in neuroscience, and mid-single-digit growth in cardiovascular. The low single-digit growth in our medical surgical portfolio was expected, given the comparisons in surgical that Geoff addressed. It's worth noting that MedSurg grew 7% sequentially and we expect to return to more normalized year-over-year growth starting next quarter.
從細分市場的角度來看,我們在糖尿病領域實現了兩位數成長,在神經科學領域實現了高個位數成長,在心血管領域實現了中個位數成長。考慮到傑夫提到的外科手術比較,我們預期醫療外科產品組合的低個位數成長是可以預期的。值得注意的是,MedSurg 環比增長了 7%,我們預計從下個季度開始將恢復到更正常的同比增長。
From a geographic perspective, our international markets grew revenue high single digits, including mid-single-digit growth in Western Europe and Japan and low double-digit growth in emerging markets.
從地理角度來看,我們的國際市場收入實現了高個位數成長,其中西歐和日本實現了中個位數成長,新興市場實現了低兩位數成長。
Moving down the P&L, our adjusted gross margin was 65.2%, down 70 basis points, but in line with our expectations. The decline was entirely driven by foreign currency as our adjusted gross margin was up 40 basis points on a constant currency basis, 4.3%, also in line with our expectations. The 90 basis point year-over-year decline was entirely driven by FX. On a constant currency basis, operating margins increased 100 basis points.
從損益表來看,我們調整後的毛利率為 65.2%,下降了 70 個基點,但符合我們的預期。下降完全是由外匯推動的,因為我們調整後的毛利率按固定匯率計算增長了 40 個基點,達到 4.3%,也符合我們的預期。年比下降 90 個基點完全是由外匯推動的。以固定匯率計算,營業利潤率增加了 100 個基點。
The organization remains extremely focused on improving our margins. We're more than doubling our underlying productivity in the COGS line through centralizing operations, consolidating factories and suppliers, and driving the Medtronic performance system across our manufacturing network. We are also laser focused on our pricing discipline and optimization, particularly behind our new innovation.
該組織仍然非常注重提高利潤率。透過集中營運、整合工廠和供應商以及在整個製造網路中推動美敦力績效體系,我們將 COGS 生產線的基本生產力提高了一倍以上。我們也高度關注我們的定價規則和優化,特別是在我們的新創新背後。
At the same time, we're very early in a number of new product launches that aren't fully at scale, including Affera, Simplera, and Hugo, which can create a mix headwind for us. That said, on the SG&A line, we're focused on growing at less than sales like we did again this quarter as we drive efficiency and productivity gains, particularly in our back-office functions. Given all the levers we have, we have line of sight to improving our margins over time while continuing to prioritize and make significant investments in our organic pipeline and product launches.
同時,我們很早就推出了一些尚未完全規模化的新產品,包括 Affera、Simplera 和 Hugo,這可能會為我們帶來混合阻力。也就是說,在SG&A方面,我們專注於以低於銷售額的速度成長,就像我們本季再次所做的那樣,因為我們提高了效率和生產力,特別是在我們的後台職能方面。考慮到我們擁有的所有槓桿,我們的目標是隨著時間的推移提高我們的利潤率,同時繼續優先考慮並在我們的有機管道和產品發布方面進行大量投資。
Now regarding capital allocation. We continue to make choices and invest to drive future profitable growth, while also returning capital to shareholders primarily through our dividend and from time to time, opportunistic share repurchases.
現在關於資本配置。我們繼續做出選擇和投資,以推動未來的獲利成長,同時主要透過股利和不時的機會性股票回購向股東返還資本。
As I mentioned last quarter, we've increased our focus on tuck-in M&A. We're also continuing to work to evaluate our portfolio. Overall, we view active portfolio management as an important lever to delivering on our long-term strategic and financial objectives.
正如我上個季度提到的,我們加強了對併購的關注。我們也將繼續努力評估我們的產品組合。整體而言,我們認為主動投資組合管理是實現我們長期策略和財務目標的重要槓桿。
Now turning to guidance. Given our continued outperformance and positive momentum, we're raising our full-year revenue and EPS guidance. We now expect fiscal '25 organic revenue growth of 4.75% to 5%, an increase from the prior range of 4.5% to 5%.
現在轉向指導。鑑於我們持續出色的表現和積極的勢頭,我們正在提高全年收入和每股收益指引。我們現在預計 25 財年的有機收入成長率為 4.75% 至 5%,高於先前的 4.5% 至 5%。
For Q3, we're expecting to deliver another quarter of mid-single-digit growth on the top line, and we'd have you model organic revenue growth of approximately 4.75%. Based on recent rates, FX would have an unfavorable impact to fiscal '25 in the range of $225 million to $325 million, including $100 million to $150 million in the third quarter.
對於第三季度,我們預計營收將再實現一個中個位數的成長,並且我們會讓您建立約 4.75% 的有機收入成長模型。根據最近的匯率,外匯將對 25 財年產生 2.25 億至 3.25 億美元的不利影響,其中包括第三季的 1 億至 1.5 億美元。
Moving down the P&L, we expect our third and fourth quarter gross margins to improve sequentially as currency becomes much less of an impact. We also continue to expect our full-year operating margins to expand as we balance driving efficiencies with investing behind our product launches and in our long-term pipeline.
從損益表來看,我們預期第三季和第四季的毛利率將持續改善,因為貨幣的影響將大大減輕。我們也繼續預計,隨著我們在提高效率與產品發布和長期管道投資之間取得平衡,我們的全年營業利潤率將會擴大。
On the bottom line, we're raising our fiscal '25 non-GAAP diluted EPS guidance to a new range of $5.44 to $5.50, an increase from the prior range of $5.42 to $5.50. For the third quarter, we expect EPS of $1.35 to $1.37. The fiscal year '25 guidance range continues to include an unfavorable 5% impact from foreign currency including an unfavorable 1% impact in Q3. Further details on our annual guidance can be found in the guidance slide in our presentation.
總而言之,我們將 25 財年非 GAAP 攤薄後每股收益指引上調至 5.44 美元至 5.50 美元的新範圍,高於先前的 5.42 美元至 5.50 美元的範圍。我們預計第三季每股收益為 1.35 美元至 1.37 美元。 25 財年的指導範圍繼續包括外幣帶來的 5% 的不利影響,其中包括第三季 1% 的不利影響。有關我們年度指導的更多詳細信息,請參閱我們簡報中的指導幻燈片。
So to conclude, we remain focused on restoring our earnings power having just delivered another quarter of leveraged EPS growth on a constant currency basis. We continue to expect to report high single-digit adjusted EPS growth in the back half of our fiscal year in line with our long-term commitment to deliver durable mid-single-digit organic revenue growth with EPS leverage.
總而言之,我們仍然專注於恢復獲利能力,剛剛在固定匯率基礎上實現了另一個季度的槓桿每股收益成長。我們繼續預期本財年後半段調整後每股盈餘將實現高個位數成長,這符合我們利用每股盈餘槓桿實現持久中個位數有機收入成長的長期承諾。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Now before we go to analyst questions, I want to close with a few thoughts.
現在,在我們回答分析師問題之前,我想以一些想法作為結束。
We're delivering durable mid-single-digit revenue growth, which we've been doing consistently now for two years. This is the direct result of all the changes we've made to the company over the past few years from the resiliency of our operations and supply chain to our performance incentive plans, to our culture and our people.
我們正在實現持久的中個位數收入成長,兩年來我們一直在這樣做。這是過去幾年我們對公司所做的所有變革的直接結果,從我們的營運和供應鏈的彈性到我們的績效激勵計劃,再到我們的文化和員工。
We've also been investing to position ourselves in high-growth markets, and this has led to a wave of recent product approvals across many of our businesses. Look, it's exciting, and it creates a tailwind that this company hasn't had in a while. We've been working hard to put ourselves in a position to win with revenue growth tailwinds on top of a strong foundation. And now it's up to us -- it's just up to us to execute and deliver on these opportunities.
我們也一直在投資,以將自己定位於高成長市場,這導致了我們許多業務最近的一波產品批准浪潮。看,這很令人興奮,它創造了這家公司一段時間以來從未有過的順風。我們一直在努力讓自己能夠在堅實的基礎上憑藉收入成長的順風車贏得勝利。現在就取決於我們了——只取決於我們來執行和實現這些機會。
And then as we go down the P&L, the significant work that we've been implementing to drive cost savings and earnings power will start to show up in our reported results in the back half of this fiscal year. And when our organization delivered strong earnings, we translate this into strong free cash flow. This creates a virtuous cycle with incremental firepower, and when you combine all of this with the work that we've been doing with portfolio management, we expect to deliver significant long-term value for our shareholders.
然後,當我們降低損益表時,我們為推動成本節約和獲利能力而實施的重大工作將開始體現在我們本財年後半段報告的業績中。當我們的組織實現強勁的獲利時,我們會將其轉化為強勁的自由現金流。這創造了一個具有增量火力的良性循環,當你將所有這些與我們一直在進行的投資組合管理工作結合起來時,我們期望為我們的股東帶來顯著的長期價值。
Finally, I want to thank all of our employees around the world. I know many of you are watching today and it's because of your efforts and those that came before you that Medtronic has accomplished so much in the 75 years since this company was founded. Your work directly benefits the lives of over 78 million people this year. That's an incredible accomplishment.
最後,我要感謝我們在世界各地的所有員工。我知道你們很多人都在觀看今天的節目,正是由於你們和前輩的努力,美敦力公司自成立以來 75 年來取得瞭如此巨大的成就。今年,您的工作直接造福了超過 7800 萬人的生活。這是一項令人難以置信的成就。
And when I think about the work you're doing to create our future, the innovations that you're inventing, engineering, manufacturing and preparing to sell, this work has the potential to alleviate pain, restore health and extend life for hundreds of millions of people and create tremendous value for many other stakeholders. Thank you for everything that you do.
當我想到你們為創造我們的未來所做的工作,你們正在發明、設計、製造和準備銷售的創新,這項工作有可能減輕數億人的痛苦、恢復健康和延長生命並為許多其他利益相關者創造巨大價值。感謝您所做的一切。
With that, let's move to Q&A where we're going to try to get to as many analysts as possible, 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.
接下來,讓我們進入問答環節,我們將嘗試聯繫盡可能多的分析師,因此我們要求您只提出一個問題,並且僅在需要時才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。
With that, Brad, can you please give the instructions for asking a question.
布拉德,請您給予提問的說明。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
(Event Instructions) Lastly, please be advised that this Q&A session is being recorded.
(活動說明)最後,請注意,本次問答環節正在錄製中。
For today's session, Geoff, Gary and Ryan are joined by Que Dallara, EVP and President of Diabetes; Mike Marinaro, EVP and President of the Medical Surgical portfolio; Sean Salmon, EVP and President of the Cardiovascular portfolio; and Brett Wall, EVP and President of the Neuroscience portfolio.
出席今天的會議的有 Geoff、Gary 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,執行副總裁兼醫療外科產品組合總裁; Sean Salmon,執行副總裁兼心血管產品組合總裁;執行副總裁兼神經科學業務總裁 Brett Wall。
We'll pause for a few seconds to assemble the queue.
我們將暫停幾秒鐘來組裝隊列。
Larry Biegelsen, Wells Fargo.
拉里·比格爾森,富國銀行。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
Good morning. Thanks for taking the question. Congrats on a nice quarter here. I heard you guys talk about the hypertension opportunity a few times on this call. I think we saw video before the call highlighting real innovation. So I wanted to ask Sean about that.
早安.感謝您提出問題。恭喜您度過了一個愉快的季度。我在這次電話會議上多次聽到你們談論高血壓的機會。我想我們在電話會議之前看到了強調真正創新的視訊。所以我想問肖恩這件事。
Sean, you have the TPT for already beginning in January. How much of a benefit are you expecting from that? And when are you anticipating the national coverage decision? And are you planning to use the new TSAT process for that? And Sean, I think it's been a while since we've heard you talk about just kind of your overall thoughts on the renal denervation opportunity. Thanks for taking the question.
Sean,您已經在一月開始了 TPT。您期望從中獲得多少好處?您預計什麼時候會做出全國覆蓋決定?您是否計劃為此使用新的 TSAT 流程?肖恩,我想我們已經有一段時間沒有聽到您談論您對腎臟去神經支配機會的總體想法了。感謝您提出問題。
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Okay. Thanks, I appreciate the question.
好的。謝謝,我很欣賞這個問題。
Look, we continue to make really great progress on the reimbursement front. As you mentioned, the TPT or the outpatient coverage for devices.
看,我們在報銷方面繼續取得巨大進展。正如您所提到的,TPT 或設備的門診保險。
And what that really addresses is a proportion of the patients in Medicare, roughly half of the Medicare patient population, those on fee-for-service would now be covered with this transitional pass-through payment, which is certainly going to be an accelerator for the therapy. But as you noted, getting broader coverage will get us out of sort of the prior authorization loop allowing you to just build to the codes that have already been established.
這真正解決的是醫療保險中的一部分患者,大約是醫療保險患者群體的一半,那些按服務收費的人現在將受到這種過渡性轉手付款的覆蓋,這肯定會成為加速器治療。但正如您所指出的,獲得更廣泛的覆蓋範圍將使我們擺脫事先授權循環,使您可以只建立已經建立的程式碼。
So making that headway is important. We also have to go further with the private payer universe. That does take longer. You go payer by payer, state by state.
因此,取得這項進展很重要。我們還必須在私人付款人領域更進一步。這確實需要更長的時間。您可以逐一付款人、逐州付款。
In terms of the efforts on coverage, what we're doing is going for coverage with evidence development, there are numerous pathways for that, and we'll be giving an update on that in the future. But I've got no incremental update today.
在覆蓋方面的努力方面,我們正在做的是透過證據開發來進行覆蓋,有很多途徑可以實現這一點,我們將在未來提供最新情況。但我今天沒有增量更新。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Travis Steed, Bank of America.
特拉維斯·斯蒂德,美國銀行。
Travis Steed - Analyst
Travis Steed - Analyst
(technical difficulty) To grow earnings high single digits longer term, despite maybe some potential for -- you've got maybe a stronger dollar tariff potential, it sounds like some of the initial could be negative on margins initially, but is there enough upside on some of those programs to offset potential headwinds? Is there a potential cushion on some of the COGS productivity? I just kind of want to know your flexibility and your commitment to continue to grow earnings despite some of those potential headwinds that investors have been starting to worry about.
(技術難度)為了長期實現高個位數的獲利成長,儘管可能有一些潛力——你可能有更強的美元關稅潛力,聽起來一些最初的利潤率可能會出現負值,但有足夠的上行空間嗎?部分銷貨成本生產力是否有潛在緩衝?我只是想知道您的靈活性以及您對繼續增加收益的承諾,儘管投資者已經開始擔心一些潛在的阻力。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah, Travis, thanks for the question. And yeah, we are definitely committed to the earnings. I'll let Gary walk you through some of your specifics of your questions.
是的,特拉維斯,謝謝你的提問。是的,我們絕對致力於獲利。我將讓加里向您詳細介紹您的問題。
Gary Corona - Interim Chief Financial Officer
Gary Corona - Interim Chief Financial Officer
Thanks, Geoff. We're pleased to raise our guidance on both revenue and EPS for the year as we continue to move kind of build momentum. There's a lot to be excited about and we're focused on driving durable, both revenue growth as well as restoring the earnings power of the company.
謝謝,傑夫。隨著我們繼續推動發展勢頭,我們很高興提高對今年收入和每股收益的指導。有很多值得興奮的事情,我們專注於推動持久的收入成長以及恢復公司的獲利能力。
On the margin front, what I want you to hear from us is there's no change to our margin expectations. In Q3, we expect margins of 25.6%, up 30 basis points year over year. Full year, we expect operating margins to be 25.7%, up both -- up year over year by 10 basis points. Gross margins will be up sequentially in both Q3 and Q4 and that will deliver our guidance.
在利潤率方面,我希望您從我們這裡聽到的是我們的利潤率預期沒有變化。我們預計第三季利潤率為 25.6%,年增 30 個基點。我們預計全年營業利益率為 25.7%,年增 10 個基點。第三季和第四季的毛利率將連續上升,這將提供我們的指導。
On the SG&A front, we'll drive leverage through our focus on our highest priorities, leveraging what we talked about before automation and digitization. We'll make some structural changes, and we have strong discipline on our discretionary expenses to help drive that margin expansion. You mentioned the early launches, and we're committed to investing behind those, both commercially and in R&D.
在SG&A方面,我們將透過專注於我們的最高優先事項來推動槓桿作用,利用我們在自動化和數位化之前討論過的內容。我們將進行一些結構性改變,並且我們對可自由支配的支出有嚴格的紀律,以幫助推動利潤率的擴張。您提到了早期的發布,我們致力於在商業和研發方面進行投資。
So taken together, that mid-single-digit revenue growth will deliver upwards of 10% EPS on a constant currency basis. You mentioned the foreign exchange. That will be a 5 point headwind in line with what we've talked about before. and that will get us to the $5.44 to $5.50 guidance that we gave today.
總而言之,以固定匯率計算,中等個位數的營收成長將帶來 10% 以上的每股盈餘。你提到了外匯。這將是 5 個點的逆風,與我們之前討論過的一致。這將使我們得到今天給出的 5.44 美元至 5.50 美元的指導。
So overall, we feel good and worth mentioning wants to set guidance up that sets us up for success.
因此,總的來說,我們感覺良好,值得一提的是,我們希望制定指導方針,為我們的成功奠定基礎。
Robert Marcus - Analyst
Robert Marcus - Analyst
Great. Sorry about that. I forgot to unmute before. So thanks for taking the question. I wanted to ask kind of as a counter to Travis' question. Some of the products you mentioned that were important growth drivers on sales, but early in their life cycle on margin expansion, renal denervation, both PulseSelect, which had the supplier issue this quarter, and the upcoming or ongoing Sphere-9, Affera launch, and Hugo robotic and renal denervation.
偉大的。對此感到抱歉。我之前忘記取消靜音了。感謝您提出問題。我想以此來反駁崔維斯的問題。您提到的一些產品是銷售成長的重要驅動力,但在其生命週期的早期,它們的利潤擴張、腎去神經術、PulseSelect(本季出現了供應商問題)以及即將推出或正在進行的Sphere -9、Affera,和 Hugo 機器人和腎臟去神經術。
Maybe you could just talk about, especially over the next 6 to 12 months as some of these products start to launch and progressively launch how you're thinking about the cadence of growth for them and then also the margin implications as we think about some of these lower-margin products, maybe adding some of the most incremental growth? Thanks a lot.
也許您可以談談,特別是在接下來的 6 到 12 個月內,隨著其中一些產品開始推出並逐步推出,您如何考慮它們的成長節奏,以及當我們考慮一些產品時對利潤率的影響這些利潤率較低的產品,也許會帶來一些最大的增量成長?多謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah. Thanks, Robbie. Thanks for the question. Yeah, I mean, look, on the margin side, obviously, you're asking a question around mix. That's a piece of it. But in addition to that, the pricing is -- continues to be an opportunity for us. I think that's been a positive here over the last couple of quarters. And I think there's more upside for us there in pricing, and our cost-down programs have kicked in and are helping as well. So those are, I think, both tailwinds for us.
是的。謝謝,羅比。謝謝你的提問。是的,我的意思是,看,在邊緣方面,顯然,你在問一個關於混合的問題。這就是其中的一部分。但除此之外,定價對我們來說仍然是一個機會。我認為過去幾個季度這是積極的。我認為我們在定價方面有更多的優勢,而且我們的成本降低計劃已經啟動並正在發揮作用。所以我認為這些對我們來說都是有利的。
So on the mix side, it is a bit of a mixed bag. And Gary gave you some details, but some of the programs like Hugo and Affera that involve capital can be a little -- can be lower, especially earlier in the cycle, as you're ramping them up. But then we have some others like Ardian and neuromod, which are -- neuromod's out there now having a pretty big positive impact on price and on our margins and our mix and Ardian would do the same.
所以在混合方面,它有點魚龍混雜。蓋瑞給了你一些細節,但像 Hugo 和 Affera 這樣涉及資本的項目可能會有點——可能會更低,尤其是在周期的早期,因為你正在加大它們的力度。但我們還有其他一些產品,例如 Ardian 和 Neuromod,它們現在對價格、我們的利潤和我們的組合產生了相當大的正面影響,Ardian 也會做同樣的事情。
I don't know if you -- how you want to add to that, Gary.
我不知道你是否想補充這一點,加里。
Gary Corona - Interim Chief Financial Officer
Gary Corona - Interim Chief Financial Officer
Yeah, not much to add, Geoff. I would just say, first of all, all of the -- all of this is contemplated in our guidance. And for '25, we're expecting gross margins to be flat on a constant currency with foreign exchange driving about 0.5 point of headwind.
是的,沒什麼好補充的,傑夫。我只想說,首先,所有這些都在我們的指導中考慮。對於 25 年,我們預計毛利率將與固定匯率持平,而外匯將帶來約 0.5 個百分點的阻力。
I talked about the sequential improvement that we expect in both Q3 and Q4 and our focus on stabilizing and improving from there. Geoff talked about some of the headwinds, but I also say we're really laser-focused on cost reduction on price, especially behind our innovation across the board, to fund the investment to ensure commercial success of these critical launches.
我談到了我們預計第三季和第四季的連續改進,以及我們在此基礎上穩定和改進的重點。傑夫談到了一些不利因素,但我也說,我們確實非常注重降低價格成本,特別是在我們全面創新的背後,為投資提供資金,以確保這些關鍵發布的商業成功。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Vijay Kumar, Evercore ISI.
維傑·庫馬爾,Evercore ISI。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Hey, guys. Thanks for taking my question and congratulations on a steady execution here. Geoff, maybe I wanted to focus on ablation here. You mentioned flattish growth in the quarter due to some disruption, what was the issue? When was it resolved? What gives us the confidence of strong double-digit growth in third quarter? Is that some revenue catch-up from second quarter? When do you think cryo could bottom out, is that in third quarter? And you did -- I thought it was interesting, you mentioned the revenue per case in Affera? Is that a 3x increase versus cryo? Thank you.
嘿,夥計們。感謝您提出我的問題,並祝賀這裡的穩定執行。傑夫,也許我想在這裡重點關註消融。您提到由於一些幹擾導致本季成長持平,問題是什麼?什麼時候解決的?是什麼給了我們第三季強勁兩位數成長的信心?第二季度的營收是否有所回升?您認為冷凍技術什麼時候會觸底,是在第三季嗎?你確實這麼做了——我覺得這很有趣,你提到了 Affera 中每個案例的收入?與冷凍相比,這是否增加了 3 倍?謝謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah. So as I said in the commentary, CAS, our ablation business didn't accelerate as we expected this quarter because of this third-party component supplier that experienced an interruption in their supply. That supplier is back on track. That issue is resolved. They've expanded their capacity as well, and which is allowing us to ramp the PulseSelect supply and activate new accounts.
是的。正如我在評論中所說,CAS,我們的消融業務本季並沒有像我們預期的那樣加速,因為這家第三方零件供應商的供應出現了中斷。該供應商已重回正軌。該問題已解決。他們還擴大了產能,這使我們能夠增加 PulseSelect 的供應並啟動新帳戶。
PulseSelect is doing well. I mean -- and it's in a good spot from a supply perspective going forward. Like we literally saw the unit we had in Q2. And as I mentioned, we did double -- or close to double the physicians using PulseSelect, and we'll now have confidence to open more accounts, so that should continue. And then we more than doubled the number of procedures, a number of patients treated.
PulseSelect 表現良好。我的意思是——從未來供應的角度來看,它處於一個很好的位置。就像我們確實看到了第二季的單位一樣。正如我所提到的,我們使用 PulseSelect 的醫生人數增加了一倍或接近兩倍,現在我們有信心開設更多帳戶,因此這種情況應該會繼續下去。然後我們的手術數量增加了一倍以上,治療了一些患者。
And as for cryo, the declines actually got better sequentially. And so cryo wasn't the issue, Q2 versus -- I'm sorry, Q1 versus Q2 because in Q2 the declines got better than Q1. And so it really was the supply issue that's been resolved.
至於冷凍技術,下降幅度其實逐年有所改善。因此,低溫不是問題,第二季度與 - 對不起,第一季與第二季度,因為第二季度的下降比第一季度更好。所以供應問題確實已經解決了。
So we now have -- we expect PulseSelect to continue to ramp. We have this -- and now we have Sphere-9, and that gives us all this combined the supplier issue should being resolved and what we're seeing on PulseSelect demand and a fair of demand. That gives us the confidence in the strong double-digit growth in Q3.
因此,我們現在預計 PulseSelect 將繼續成長。我們有了這個——現在我們有了 Sphere-9,這給了我們所有這些,將供應商問題應該得到解決,以及我們在 PulseSelect 上看到的需求和公平的需求。這讓我們對第三季強勁的兩位數成長充滿信心。
So this is an important area for us. It's an area of focus. And we feel like we're well positioned with both the single shot and the only player with single shot and focal going forward.
所以這對我們來說是一個重要的領域。這是一個重點領域。我們覺得我們在單鏡頭和唯一一個單鏡頭和焦點前進的球員方面都處於有利位置。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
And sorry, the revenue per case on Affera, is that 3x versus cryo?
抱歉,Affera 的每箱收入是冷凍的 3 倍嗎?
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Sean, do you want to handle that one? The revenue per case on Affera?
肖恩,你想處理那個嗎? Affera 上每個案例的收入是多少?
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Yeah. So Vijay, when you do cryo is really just the balloon catheter that you're using and when you're doing thermal with RF or non-thermal with PFA, there's additional components that can be used, including like a mapping catheter, the patches that you use for a navigation system. So the case revenue goes up.
是的。因此,Vijay,當您進行冷凍時,實際上只是您正在使用的球囊導管,而當您使用RF 進行熱治療或使用PFA 進行非熱治療時,還可以使用其他組件,包括標測導管、貼片等用於導航系統的。所以案件收入就會增加。
And there's also the use of other technologies like crossing needles that we sell as well. So the revenue per case does go up. I don't think it's 3x quite, but it's certainly more. And that correlates to that too is with the Sphere-9 catheter since you don't need a dedicated mapping catheter. It actually saves them for the hospital. So it's the value proposition of having one catheter that can do the entire job with a single stick across transseptal is really appealing to physicians.
還有其他技術的使用,例如我們也銷售的交叉針。所以每個案例的收入確實增加了。我不認為是 3 倍,但肯定更多。這也與 Sphere-9 導管相關,因為您不需要專用的標測導管。這實際上為醫院節省了時間。因此,一根導管只需一根棍子穿過房間隔就能完成全部工作,這一價值主張對醫生來說確實很有吸引力。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Better workflow and better workflow for them. And even though as excited as hospitals are about PFA, they are still conscious on the price. And so the fact that if you can save them the catheters, like Sean just mentioned, that helps.
為他們提供更好的工作流程和更好的工作流程。儘管醫院對 PFA 感到興奮,但他們仍然對價格很在意。事實上,如果你能保留他們的導管,就像肖恩剛才提到的那樣,那就有幫助了。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Shagun Singh, RBC Capital Markets.
Shagun Singh,加拿大皇家銀行資本市場。
Shagun Singh Chadha - Analyst
Shagun Singh Chadha - Analyst
Great. Thank so very much for taking the question. Geoff, I was wondering if you could share your thoughts on the med tech landscape, under the Trump administration. Specifically, what are your thoughts on tariffs, how do you plan to navigate your supply chain? And perhaps you can touch on your exposure to imports from China?
偉大的。非常感謝您提出這個問題。傑夫,我想知道您是否可以分享您對川普政府領導下的醫療技術格局的看法。具體來說,您對關稅有何看法?也許您可以談談您對中國進口產品的曝險?
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Well, first, before I jump into the election questions, the medtech landscape, the underlying market is healthy. We're seeing good procedure growth, and we think that's steady going forward, really driven by innovation, whether it be growth of minimally invasive procedures like TAVR or innovation and pacing like leadless and conduction system pacing or we just -- the PFA conversation we just added, that's pooling patients from drug solution to a medtech solution, all these things are -- this innovation is what's driving a lot of this growth plus just demographics.
好吧,首先,在我開始討論選舉問題之前,醫療科技領域的基礎市場是健康的。我們看到了手術的良好增長,我們認為這一趨勢正在穩步向前發展,這實際上是由創新驅動的,無論是像TAVR 這樣的微創手術的增長,還是像無引線和傳導系統起搏這樣的創新和起搏,或者我們只是——我們的PFA 對話剛才補充說,這將患者從藥物解決方案匯集到醫療技術解決方案,所有這些都是——這種創新是推動這種增長的因素,再加上人口統計。
So I think it's a healthy market, and under any administration, if you back decades, whether it be in the US or other countries, healthcare is an important priority for any government, and so we feel good in that way.
所以我認為這是一個健康的市場,在任何政府的領導下,如果你支持幾十年,無論是在美國還是其他國家,醫療保健對於任何政府來說都是一個重要的優先事項,所以我們在這方面感覺很好。
When you come to the specific election. I do think it's with the President of Elect Trump coming in, I do think it's still a bit early to speculate about different policies, whether it be healthcare policy or exactly what's going to happen or not going to happen to tariffs.
到了具體選舉的時候。我確實認為隨著當選總統川普的上任,我確實認為現在猜測不同的政策還為時過早,無論是醫療保健政策還是關稅將會發生或不會發生。
It's -- like I said, it's still too early. We're running different scenarios here, obviously, in preparing for different scenarios, but I don't want to get into that speculation. In terms of though our exposure to importing products from China, it's small. It's less than 1% of our revenue.
正如我所說,現在還為時過早。顯然,我們在這裡運行不同的場景,為不同的場景做準備,但我不想陷入這種猜測。就我們從中國進口產品的風險而言,它很小。這還不到我們收入的 1%。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Chris Pasquale, Nephron.
克里斯·帕斯誇萊,尼弗龍。
Christopher Pasquale - Analyst
Christopher Pasquale - Analyst
Thanks. I wanted to ask about the Diabetes segment and your upcoming FDA submission for a type 2 label expansion, how much of your current insulin pump installed base maybe in the US that's easier is made up of type 2 patients? And how do you think about your opportunity in that segment without a more discrete on-body form factor, which seems to be a priority for many of those users.
謝謝。我想問糖尿病領域以及你們即將向 FDA 提交的 2 型標籤擴展申請,你們目前在美國安裝的胰島素幫浦有多少是由 2 型患者組成的?您如何看待在沒有更離散的貼身外形因素的情況下在該細分市場中的機會,這似乎是許多用戶的優先考慮事項。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
I'll let Que answer the question on diabetes, Que.
我請闕回答關於糖尿病的問題,闕。
Que Dallara - Executive Vice President and President Diabetes Operating Unit
Que Dallara - Executive Vice President and President Diabetes Operating Unit
Thanks for the question. On type 2, we finished enrollment. We expect to submit to FDA with expanded indication in the first half of next calendar year. So that's progressing very well. Today, as a percentage of our installed base, we are still largely a type 1 business. We do see type 2 as being quite a large opportunity, and the clinical data that we've generated for type 2 is extremely good. So we are actually quite optimistic about the type 2 opportunity.
謝謝你的提問。在類型 2 上,我們完成了註冊。我們預計在明年上半年向 FDA 提交擴大適應症的報告。所以進展非常順利。如今,就我們已安裝客戶群的百分比而言,我們在很大程度上仍屬於第一類業務。我們確實認為 2 型是一個相當大的機會,而且我們為 2 型產生的臨床數據非常好。所以我們其實對第二類機會相當樂觀。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Pito Chickering, Deutsche Bank.
皮托·奇克林,德意志銀行。
Pito Chickering - Analyst
Pito Chickering - Analyst
Going back to the 2025 guidance, in your updated guidance, you're absorbing more FX headwinds on increasing our EPS guidance. I think you told Travis that your margin guidance is 25.7% for the year. I think it was 25.8% last quarter or so with revenue guidance up a little bit, FX headwinds increasing, EPS moving up, is tax rate a positive tail end of the back half of the year versus the previous guidance? I'm just trying to bridge the moving parts into the EPS guidance raise. Thank you.
回到 2025 年指導,在更新的指導中,您在提高每股收益指引時吸收了更多的外匯阻力。我想您告訴 Travis,您今年的利潤指導值為 25.7%。我認為上個季度約為 25.8% 左右,收入指引略有上升,外匯不利因素增加,每股收益上升,與先前的指引相比,今年下半年的稅率是否會是正值?我只是想將移動部分與 EPS 指導提高聯繫起來。謝謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Gary, do you want to take that?
加里,你想接受這個嗎?
Gary Corona - Interim Chief Financial Officer
Gary Corona - Interim Chief Financial Officer
Yeah, happy to take that. What I would say is FX on an EPS basis is very much in line with what we've been sharing all year, and that's really the power of our hedging program, giving us good visibility. Revenue is up, gross margins are essentially in line with our expectations.
是的,很高興接受。我想說的是,以每股收益為基礎的外匯與我們全年分享的情況非常一致,這確實是我們對沖計劃的力量,為我們提供了良好的可見性。收入上升,毛利率基本上符合我們的預期。
And we are, as I mentioned, investing behind the power of these launches, both commercially as well as R&D. Tax is up a little bit. We're navigating Pillar 2. But all in all, EPS up $0.01 at the midpoint, and we're pleased with that.
正如我所提到的,我們正在對這些產品的推出進行投資,包括商業方面和研發方面。稅費漲了一點。我們正在探索第二支柱。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Anthony Petrone, Mizuho Securities.
安東尼‧佩特龍,瑞穗證券。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Thanks and congrats on the quarter here. Back to renal denervation, just looking at some data. CMS is quoting 16 million patients, [65 plus] that have uncontrolled hypertension, but they're also on medication. So just maybe a recap here. With the NTAP and TPT in place now, how much of that population can you go after and how much is still out there that you would need an NCD to sort of address that patient population?
感謝並祝賀這個季度。回到腎臟去神經術,看看一些數據。 CMS 引用了 1600 萬名患者 [65 歲以上] 的高血壓不受控制的情況,但他們也在接受藥物治療。所以也許在這裡回顧一下。現在 NTAP 和 TPT 已經到位,您可以追蹤多少人需要 NCD 來解決該患者族群的問題?
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Sean is going to take this one.
肖恩要拿這個。
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
So the payer mix is roughly 50-50 between those in Medicare and those not in Medicare, Medicare and Medicaid, I'd say. The TPT addresses the fee-for-service component of the Medicare-eligible patients that does not include those on Medicare Advantage. So that's roughly split evenly between the two of those. So the base population is obviously very, very large here for those uncontrolled high retention, those with taking drugs still having elevated blood pressure.
因此,我想說,參加 Medicare 的人和未參加 Medicare、Medicare 和 Medicaid 的付款人比例約為 50-50。 TPT 涉及符合 Medicare 資格的患者的按服務付費部分,但不包括 Medicare Advantage 患者。所以這兩者之間大致平分。因此,對於那些不受控制的高保留率、那些服用藥物但血壓仍然升高的人來說,這裡的基數顯然非常非常大。
As Geoff noted in the beginning, it's really the minority of patients that actually get control despite the availability of those drugs. So Medicare, if it's [$16 million], if that's the baseline, our numbers are more like [$18 million] for the uncontrolled hypertension patients, greater than [150] that are drug treated. The addressable market with in and outpatient is about half the Medicare population. Medicaid is going to be a state-by-state.
正如傑夫一開始指出的那樣,儘管有這些藥物,但真正得到控制的患者實際上是少數。因此,醫療保險,如果它是[1600萬美元],如果這是基線,那麼對於不受控制的高血壓患者,我們的數字更像是[1800萬美元],大於接受藥物治療的[150]。住院和門診的潛在市場約佔醫療保險人口的一半。醫療補助計劃將由各州負責。
But suffice to say, hey, there are a lot of patients that could be addressed with this therapy. The demand is really not the issue. It's going to be making sure we get that coverage and we establish centers that can do the procedure.
但我只想說,嘿,有很多患者可以透過這種療法得到治療。需求確實不是問題。我們將確保我們獲得覆蓋範圍,並建立可以進行該程序的中心。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Rich Newitter, Truist Securities.
里奇紐特 (Rich Newitter),Truist 證券公司。
Richard Newitter - Analyst
Richard Newitter - Analyst
Hi. Thanks for taking the question. Maybe just going to spine. That continues to be a strong business for you guys. You're growing above market, especially in the US. I guess, can you parse out a little bit? The market has been stronger here, so I'd just love to hear how much of the underlying market strength or the pickup in recent quarters or years is attributable to that? And I'm just trying to get a sense for how sustainable a high single-digit growth profile for your US core spine franchise could be.
你好。感謝您提出問題。也許只是要脊柱。這對你們來說仍然是一項強勁的業務。你的成長速度高於市場水平,尤其是在美國。我想,你能稍微解析一下嗎?這裡的市場一直走強,所以我很想知道近幾個季度或幾年的潛在市場走強或回昇在多大程度上歸因於這一點?我只是想了解一下您的美國核心脊椎特許經營業務的高個位數增長狀況的可持續性如何。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah. I'll let -- first of all, look, it is a bit of -- we're seeing a bit of market expansion here. We're also seeing a bit of market consolidation. There's a large tail of spine companies out there that are going away. And as I said in the commentary, this market is leaning towards those with scale and technology. But I'll let Brett go into some of the details here.
是的。首先,我要說的是,我們在這裡看到了一些市場擴張。我們也看到了一些市場整合。有一大批脊椎公司正在消失。正如我在評論中所說,這個市場正在向具有規模和技術的市場傾斜。但我會讓布雷特在這裡討論一些細節。
Brett Wall - Executive Vice President and President, Neuroscience Portfolio
Brett Wall - Executive Vice President and President, Neuroscience Portfolio
Yeah. Thanks. The market itself still remains strong. And as Geoff said, it really benefits companies with scale because of the consolidation and technology with the able system. And if you look at the technology that we're bringing to this, it recruits the best reps, it recruits the best physicians, and it brings together more market opportunity, much more significant opportunity across the world. So we see this as sustainable and we see this as a platform that we will continue to take share and continue to grow this business.
是的。謝謝。市場本身仍然保持強勁。正如傑夫所說,由於功能強大的系統的整合和技術,它確實有利於規模化的公司。如果你看看我們為此帶來的技術,它招募了最好的代表,它招募了最好的醫生,它帶來了更多的市場機會,全世界更重要的機會。因此,我們認為這是可持續的,我們認為這是一個我們將繼續分享並繼續發展這項業務的平台。
Richard Newitter - Analyst
Richard Newitter - Analyst
Okay. Maybe just as a follow-up to that. You have a competitor -- the other main consolidator right now in the space who's approaching the anniversary of what feels like it could be the worst case for disruption in the marketplace. You talked about opportunity to take share as consolidation disruption is unfolding. Can you just update us on what you're seeing on that front? Thank you.
好的。也許只是作為後續行動。你有一個競爭對手——該領域目前的另一個主要整合者,他即將迎來週年紀念日,感覺這可能是市場中斷的最糟糕情況。您談到了隨著整合顛覆的展開而獲得份額的機會。您能否向我們介紹一下您在這方面所看到的最新情況?謝謝。
Brett Wall - Executive Vice President and President, Neuroscience Portfolio
Brett Wall - Executive Vice President and President, Neuroscience Portfolio
Yeah. You bet, Rich. We have a good pipeline there, and we have had a good pipeline there of strong growth and good consolidation with more high-quality reps and other people coming towards Medtronic. And we're continuing to see that develop, and we have a pipeline and significant opportunity into the future. And once again, it benefits companies with scale and benefits with technology, and we see that continuing to occur and continuing to happen.
是的。你敢打賭,里奇。我們在那裡有一個良好的管道,我們在那裡有一個良好的管道,有強勁的成長和良好的整合,有更多高品質的銷售代表和其他人加入美敦力。我們將繼續看到這種情況的發展,我們在未來擁有一條管道和重要的機會。再一次,它使具有規模和技術優勢的公司受益,我們看到這種情況正在持續發生。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Danielle Antalffy, UBS.
丹妮爾·安塔菲,瑞銀集團。
Danielle Antalffy - Analyst
Danielle Antalffy - Analyst
Thanks so much. Good morning, everyone. Thanks for taking the question. Just a question on TAVR. There's been a lot of data over the last few weeks here in TAVR, you guys still are benefiting from the SMART trial. I'd just love to get a state of the nation on the TAVR market. And where do you see that grow -- going from here, especially with a recent asymptomatic data that we saw. And also one of your potential competitors at the very least delayed from entering the US market. Thanks so much.
非常感謝。大家早安。感謝您提出問題。只是關於 TAVR 的問題。過去幾週 TAVR 出現了大量數據,你們仍然從 SMART 試驗中受益。我只是想了解一下 TAVR 市場的情況。從這裡開始,你會看到這種增長在哪裡,特別是我們最近看到的無症狀數據。而且您的潛在競爭對手之一至少也推遲進入美國市場。非常感謝。
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Yeah. Thanks, Danielle. I think the market is in good shape. I think in line with what we've been saying in prior quarters, it's in that high single-digit range for growth. The expansion of the patient population, there's continued opportunities for that. As you mentioned, the asymptomatic patient population, which I think fixes as a class effect would increase that.
是的。謝謝,丹妮爾。我認為市場狀況良好。我認為,與我們在前幾個季度所說的一致,成長處於高個位數範圍內。患者群體的擴大,還有持續的機會。正如你所提到的,無症狀患者群體,我認為作為階級效應來解決會增加這一點。
But the bigger unlock would be moderate or stenosis down the road where we get with our trials read out there. And then there's sort of tab and TAV indications that would also help expand that along with continued global growth of the therapy.
但更大的解鎖將是我們在試驗中讀出的道路上的適度或狹窄。隨著該療法在全球的持續成長,片劑和 TAV 適應症也將有助於擴大這一範圍。
So look, I think the evidence base that we've got, the strength of our product just gets better and better. And the longer-term data really starts to distinguish what we've got, and we've got certain use conditions like small annulus that clearly the hemodynamics of our valve are better.
所以看,我認為我們所擁有的證據基礎,我們產品的優勢正在變得越來越好。長期數據確實開始區分我們所擁有的東西,我們有某些使用條件,例如小環,顯然我們的瓣膜的血流動力學更好。
And what's really opened up the aperture for us as well as really eliminating the concerns of coronary access with the new FX+ product, which we've launched in the United States, just began launching also this quarter in Europe, and we'll be pursuing that technology into other world markets, including Japan within the year.
我們在美國推出的新 FX+ 產品真正為我們打開了大門,真正消除了冠狀動脈通路的擔憂,本季度也剛開始在歐洲推出,我們將追求這一點該技術將在年內進入其他世界市場,包括日本。
So I think we're well positioned. The market is healthy, and we still see lots of room for growth for a long time.
所以我認為我們處於有利位置。市場是健康的,我們在很長一段時間內仍然看到很大的成長空間。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Joanne Wuensch, Citi.
喬安妮‧溫施,花旗銀行。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Thank you so much and good morning. It's been a while, I think, since we've heard an update on your mitral valve replacement and repair programs. Could you sort of just give us an update on where you're thinking about that as well as tricuspid opportunities? Thank you very much.
非常感謝,早安。我想,自從我們聽到你們二尖瓣置換和修復計劃的最新消息以來,已經有一段時間了。您能給我們介紹一下您對此的看法以及三尖瓣機會的最新情況嗎?非常感謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Well, we'll stick with Sean on the structural heart questions.
好吧,我們將繼續與肖恩討論結構性心臟問題。
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Sean Salmon - Executive Vice President and President - Cardiovascular Portfolio
Yeah. Thanks for the question. So the Intrepid valve which is used in both the mitral position as well as in the tricuspid position continues in its trial for US and European approval, that's the [top] trial. We're doing well in that study. I think the acceleration for the trial is really had by going to a [29 French] version of the transseptal side of that.
是的。謝謝你的提問。因此,用於二尖瓣位置和三尖瓣位置的 Intrepid 瓣膜繼續進行美國和歐洲批准的試驗,這就是[頂級]試驗。我們在這項研究中做得很好。我認為試驗的加速確實是透過[29 French]版本的房間隔側進行的。
And we've seen really, really good results when we completely eliminate the regurgitation, which is very different than what we see with repair technologies. The clinical outcomes have been really excellent. We've taken on a population of those who are not clippable, those who can't get surgery and patients with severe mitral annual calcification or MAC. So that's really going to be the first indication for that.
當我們完全消除反流時,我們看到了非常非常好的結果,這與我們透過修復技術所看到的非常不同。臨床結果非常好。我們接受了無法進行夾閉手術的患者、無法接受手術的患者以及患有嚴重二尖瓣年度鈣化或 MAC 的患者。所以這確實是第一個跡象。
On the tricuspid front, it is the same, we are making some modifications for that in the future. But right now, we're using the existing Intrepid valve and the tricuspid position in the early feasibility study. The iterations that we'll make are, include sizes and just making it more fit for purpose in that location.
在三尖瓣前端,也是一樣的,我們將來會對此做一些修改。但現在,我們在早期可行性研究中使用現有的 Intrepid 瓣膜和三尖瓣位置。我們將進行的迭代包括尺寸,並使其更適合該位置的用途。
But we continue to do well. We believe that elimination of regurgitation is better for patients. And that's been our primary focus. And we have some other investments in repair technologies as well.
但我們繼續做得很好。我們相信消除逆流對患者來說更好。這是我們的首要關注點。我們也在維修技術方面進行了一些其他投資。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
I think just overall, just kind of recapping the last two questions. Our structural heart business is in a good spot. It's -- as Sean mentioned, we built on our TAVR franchise with data and product improvements, and then in the pipeline, he just went through mitral and tricuspid with Intrepid. And this is getting back to other questions on mix, this is a good guy on our mix. It's a very profitable franchise for us. So it's good to see that it's doing well, and the underlying market is also doing well.
我認為總的來說,只是回顧一下最後兩個問題。我們的結構心臟業務處於有利位置。正如 Sean 所提到的,我們透過數據和產品改進建立了 TAVR 專營權,然後在管道中,他剛剛使用 Intrepid 完成了二尖瓣和三尖瓣手術。這又回到了關於混音的其他問題,這是我們混音中的一個好人。這對我們來說是一個非常有利可圖的特許經營權。所以很高興看到它表現良好,而且基礎市場也表現良好。
Ryan Weispfenning - Vice President - Investor Relations
Ryan Weispfenning - Vice President - Investor Relations
I think we have time for two more questions. So Brad, we'll take the next question, please.
我想我們還有時間再問兩個問題。布拉德,我們將回答下一個問題。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Matt Miksic, Barclays.
馬特·米克西奇,巴克萊銀行。
Matthew Miksic - Analyst
Matthew Miksic - Analyst
Yeah. Thanks for taking question. So I was hoping to keep in the Q&A here, just maybe clarify a couple of things, and come up during Q&A and questions you get often from investors. So just on a couple of the key pipeline programs.
是的。感謝您提出問題。因此,我希望繼續在這裡進行問答,也許只是澄清一些事情,並在問答和投資者經常提出的問題中提出。就幾個關鍵的管道項目而言。
So maybe pace and timing for Affera in the US, I think, Sean, you talked about the NCD, but it wasn't clear for RDN whether that's sort of -- in calendar '25, I know that's a tough process to now down. And in diabetes, the patch pump is a topic we get off and when and what can you tell us.
所以,也許 Affera 在美國的節奏和時機,我想,肖恩,你談到了 NCD,但 RDN 並不清楚這是否是——在 25 年日曆中,我知道這是一個艱難的過程。對於糖尿病,貼片幫浦是我們的一個主題,您可以告訴我們什麼時候以及什麼。
And just to again clarify something, I think it's come up a couple of times is on earnings growth in the back half. So the 5% head with EPS is about $0.26, $0.27, I think, if we do the math on that right, and you got about $0.10 of that left and the impact of the back half or most of the impact that FX headwind on EPS growth has been in the first half? Just any color or cadence or mechanics, you can help us understand how that plays out in Q3 and Q4. I guess that's for Gary. Thanks so much.
為了再次澄清一些事情,我認為它已經出現了幾次是關於下半年的獲利成長。因此,每股收益的5% 頭頂約為0.26 美元、0.27 美元,我想,如果我們在右邊進行數學計算,你會得到大約0.10 美元的剩餘部分,以及後半部分的影響或外匯逆風對每股收益的大部分影響上半年有成長嗎?無論是任何顏色、節奏或機制,你都可以幫助我們了解第三季和第四季的表現。我想那是給加里的。非常感謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah, I think -- thanks for the question, Matt. Look, on Affera, look, it's part of our PFA story. Obviously, we just got the approval. And this is one that we're in the process of ramping. We didn't quantify that exactly. But when you put it all together with PulseSelect, which is at a more scale position, that's where we're getting the strong double-digit growth in Q3 and beyond. So it's -- we're not breaking out of Affera specifically, but we are in the process of scaling that.
是的,我想——謝謝你的提問,馬特。看,在 Affera 上,這是我們 PFA 故事的一部分。顯然,我們剛剛獲得批准。這是我們正在努力推進的一項工作。我們沒有準確量化這一點。但是,當您將所有這些與規模更大的 PulseSelect 放在一起時,我們將在第三季度及以後實現強勁的兩位數增長。所以,我們並不是專門突破 Affera,但我們正在擴展它。
Already in the coverage, Sean went through the ins and outs of that. But to your point, Matt, it is difficult to predict exactly when -- how -- when CMS gives some indication on coverage. We got like, as you know, a strong indication or strong approval from the FDA with a broad indication. And so we've got to see where CMS ends up. And as we've talked about, the conversations have been very constructive. But it's -- we don't want to -- it's hard to predict timing on when they'll get back to us and publicize something.
肖恩已經在報道中詳細介紹了此事的來龍去脈。但就你的觀點而言,馬特,很難準確預測 CMS 何時、如何、何時給出有關覆蓋範圍的一些指示。如您所知,我們得到了 FDA 的強烈適應症或強烈批准,具有廣泛的適應症。所以我們必須看看 CMS 的最終結果。正如我們所討論的,對話非常有建設性。但我們不想——很難預測他們什麼時候會回覆我們並公佈一些東西。
As far as diabetes goes, I think the patch programs remain dynamic. We've got a couple of shots on goal there. I don't believe we've given any timing on that other than what we've been investing heavily in diabetes across the entire -- one of our strengths is just -- and it's -- but we have not given a timing on that.
就糖尿病而言,我認為補丁程序仍然是動態的。我們在那裡有幾次射門。我不認為我們已經在這方面給出了任何時機,除了我們在整個糖尿病領域投入了大量資金之外——我們的優勢之一就是——而且確實是——但我們還沒有給出這方面的時機。
And then as far as the earnings growth, as Gary mentioned, we -- in the back half of the year -- and we mentioned in the commentary as well, we see a high single digit. We see that earnings growth that you saw on a constant currency basis that was high single digit, even double digit, we see that trend translating into the back half of the year, high single-digit realized EPS growth. I don't know if you have anything to add to that.
至於獲利成長,正如加里所提到的,我們在今年下半年,我們也在評論中提到,我們看到了很高的個位數。我們看到,以固定匯率計算的獲利成長是高個位數,甚至是兩位數,我們看到這一趨勢轉化為今年下半年,實現了高個位數的每股盈餘成長。我不知道你是否還有什麼要補充的。
Gary Corona - Interim Chief Financial Officer
Gary Corona - Interim Chief Financial Officer
Yeah. You hit the EPS, Matt. The foreign exchange headwind is pretty much spot on 5 points for the year and about $0.10 in the second half. I know currencies on a lot of folks' mind. We're a global company. And historically, it has been a thorn for us. But this is where you see the benefit of our hedging program. And it's a key part of our strategy as we think about the impact going forward.
是的。你達到了每股收益,馬特。今年的外匯逆風幾乎是 5 個點,下半年約為 0.10 美元。我了解很多人心目中的貨幣。我們是一家全球性公司。從歷史上看,它一直是我們的眼中釘。但這就是我們對沖計劃的好處的地方。當我們考慮未來的影響時,這是我們策略的關鍵部分。
One of the best things we can do is grow our US business. We're also looking aggressively at dynamically pricing in devaluing currency environments, and we're seeing that in our results. And we're also looking at balancing our cost base around the world. So we're taking action. It's a priority of mine. And as Geoff said, we'll see that high single-digit EPS in the second half.
我們能做的最好的事情之一就是發展我們的美國業務。我們也積極研究貨幣貶值環境中的動態定價,我們在結果中看到了這一點。我們也正在考慮平衡我們在世界各地的成本基礎。所以我們正在採取行動。這是我的首要任務。正如傑夫所說,我們將在下半年看到高個位數的每股盈餘。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Yeah. No, I think on the currency thing, it's important -- I just want to reemphasize what Gary said. I mean, yes, our hedging program can delay impact and help with stability in a given year. But we're really attacking this the underlying issue so that we don't -- we aren't exposed to it as much.
是的。不,我認為在貨幣問題上,這很重要——我只是想再次強調加里所說的話。我的意思是,是的,我們的對沖計劃可以延遲影響並有助於特定年份的穩定性。但我們確實是在解決這個根本問題,這樣我們就不會——我們不會那麼多地接觸到它。
And whether it's prioritizing, putting a lot more investment into US growth, but also a number of other actions, like Gary mentioned, like in some of these devalued countries that have constant devaluation of currency, a whole different pricing regimen there, that's much more dynamic.
無論是優先考慮,對美國經濟成長投入更多投資,還是像加里提到的那樣,採取一些其他行動,例如在一些貨幣不斷貶值的貨幣貶值國家,那裡有一種完全不同的定價制度,這要多得多。
And this is something that we really committed to. Gary is really championing this and yelling from the mountain tops as you can tell from his voice on this call. This is a priority for him and for us.
這是我們真正致力於的事情。加里真的很支持這一點,你可以從他在這次電話會議上的聲音中看出,他在山頂上大喊大叫。這是他和我們的首要任務。
Ryan Weispfenning - Vice President - Investor Relations
Ryan Weispfenning - Vice President - Investor Relations
We'll take our last question, please.
我們將回答最後一個問題。
Brad Welnick - Vice President, Investor Relations
Brad Welnick - Vice President, Investor Relations
Patrick Wood, Morgan Stanley.
派崔克‧伍德,摩根士丹利。
Patrick Wood - Analyst
Patrick Wood - Analyst
Beautiful. Thank you. I'll keep it tied on this one. Given the focus on tuck-in M&A, I'm just curious, the kind of assets you're most interested on that side. And then obviously, there's language around looking at the portfolio of assets that you're running. Should we expect the potential for any slightly more radical repositioning of the business over the next coming years? Thanks.
美麗的。謝謝。我會把它綁在這一個上。鑑於人們對固定併購的關注,我只是很好奇,您在這方面最感興趣的是哪種資產。顯然,還有一些關於您正在運行的資產組合的語言。我們是否應該期待在未來幾年內對業務進行稍微更徹底的重新定位?謝謝。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Okay. Thanks, Patrick. In terms of M&A, this is something we talked about in the last quarter as well. I mean this is an important part of our growth algorithm. And the type of assets or the type of M&A we want to do is more tuck-in, and don't want to forecast exactly where we're prioritizing, but it is more of a top-down approach here where we're looking at the -- our leadership team looking at the areas that we're prioritizing and really looking to those areas for that to be the priority areas for M&A.
好的。謝謝,派崔克。在併購方面,這也是我們上季談到的。我的意思是這是我們成長演算法的重要組成部分。我們想要做的資產類型或併購類型更加集中,並且不想準確預測我們要優先考慮的領域,但我們正在尋找的地方更多是一種自上而下的方法我們的領導團隊正在研究我們優先考慮的領域,並真正將這些領域視為併購的優先領域。
So our high-growth markets, but also our high-growth segments that we've talked about, but also some of our well-established businesses from time to time need some tuck-in support to keep them going because we're counting on a minimum amount of growth from them and a disproportionate amount of profits and cash flow. So we want to make sure they're healthy. So that's it.
因此,我們的高成長市場,以及我們所討論的高成長細分市場,以及我們的一些成熟業務,時不時地需要一些補充支持來保持它們的發展,因為我們依靠它們帶來的最低增長量以及不成比例的利潤和現金流量。所以我們要確保他們健康。就是這樣。
And then in terms of portfolio management, look, I just can't emphasize enough how important it is for us to -- this portfolio management is an ongoing process, not a destination.
然後就投資組合管理而言,我無法充分強調它對我們的重要性——這種投資組合管理是一個持續的過程,而不是一個目的地。
We're constantly looking at the portfolio to make sure it's constructed in a way that's aligned with our mission, align with our strengths. I mean it's a competitive world out there. We want to make sure we're playing to our strengths, and we've got a number of those. But it also is constructed in a way that can give the company from a financial performance perspective, that reliable, durable mid-single-digit innovation-driven growth at that mid-single-digit level.
我們不斷地審視產品組合,以確保其建構方式符合我們的使命、符合我們的優勢。我的意思是,這是一個競爭激烈的世界。我們希望確保發揮自己的優勢,而且我們已經擁有很多優勢。但從財務表現的角度來看,它的建構方式也可以為公司帶來可靠、持久的中位數創新驅動型成長。
On the top line, that can translate with the profitability mix. Like we went through some of the mix dynamics where we have some points or negative on the mix and some that are businesses that are a good guy on the mix, we want to make sure that all adds up to that earnings leverage down the P&L and the translation to cash flow that gets you to the dividend and get you to that double-digit shareholder return.
從營收來看,這可以轉化為獲利能力組合。就像我們經歷了一些混合動態,其中我們在混合中存在一些點或負面因素,而有些企業是混合中的好人,我們希望確保所有這些加起來都能降低損益表的盈利槓桿率,並且轉化為現金流,讓您獲得股息並獲得兩位數的股東回報。
So we are really actively looking at the portfolio to make sure it's constructed in a way to durably deliver that. And that's about as far as I can go on context on portfolio.
因此,我們正在積極研究該產品組合,以確保其建構方式能夠持久地實現這一目標。這就是我所能了解的關於投資組合的背景。
Ryan Weispfenning - Vice President - Investor Relations
Ryan Weispfenning - Vice President - Investor Relations
Thanks, Patrick. And we apologize if we weren't able to get to everyone in the queue this morning. So feel free to follow up with me or anyone on the IR team after the call. So with that, Geoff, please go ahead with your closing remarks.
謝謝,派崔克。如果今天早上我們無法聯繫到隊列中的每個人,我們深表歉意。因此,請在通話結束後隨時與我或 IR 團隊的任何人聯繫。那麼,傑夫,請繼續您的結束語。
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Geoffrey Martha - Executive Chairman of the Board, Chief Executive Officer
Okay. Well, thanks to all the analysts for the questions.
好的。好的,感謝所有分析師提出的問題。
And to all of you that joined us today, and like always, we certainly appreciate your support and your continued interest in Medtronic. And we hope you'll join us for our Q3 earnings broadcast, which we anticipate holding on Tuesday, February 18, where we'll update you on our continued progress against our long-term strategies and our commitments.
對於今天加入我們的所有人,一如既往,我們非常感謝您的支持以及您對美敦力的持續關注。我們希望您能參加我們的第三季財報廣播,我們預計將於 2 月 18 日星期二舉行,屆時我們將向您通報我們在長期策略和承諾方面的持續進展。
So with that, again, thanks for joining us, and have a great rest of your day. And for those of you in the US, wishing you and your family is all a very happy Thanksgiving next week.
再次感謝您加入我們,祝您有個愉快的一天。對於那些在美國的人,祝您和您的家人下週感恩節快樂。
So thank you and have a good day.
謝謝你,祝你有美好的一天。