Medtronic Plc (MDT) — Q4 2024 Earnings Call Transcript

Good morning. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations and I appreciate that you're joining us this morning for our Fiscal '24 Fourth Quarter Video Earnings Webcast. 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 fourth quarter and fiscal year 2024, which ended on April 26th, 2024, and our outlook for fiscal year '25. 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. Earlier this morning, we issued a press release containing our financial achievements 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. 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 statements. 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 statements. 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, prior year revenue from a one-time IP agreement in Structural Heart and fourth quarter revenue in the current and prior year reported as other, which stems from prior business separations. There were no acquisitions made in the last four quarters that had a significant impact on total company or individual segment quarterly revenue growth. References to sequential revenue changes compared to the third 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 first calendar quarter of 2024 compared to the first calendar quarter of 2023, unless otherwise stated. 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. With that, let's head into the studio and hear about the quarter and the year.

Hello, everyone, and thank you for joining us today. We delivered a strong finish to the fiscal year with broad strength across our businesses. Each of our four segments delivered mid-single-digit or higher revenue growth and this was on top of a strong mid-single-digit performance last year. Throughout fiscal '24, we delivered consistent mid-single-digit revenue growth with over 5% for the full year. At the same time, we're making progress on our commitment to restore our earnings power, which is evident in our fiscal '25 guidance. We're executing COGS cost-out programs while maintaining pricing and maximizing efficiencies in our operating overhead. And we're translating our earnings into strong and improving cash flow, which we're investing to drive future growth and return to our shareholders. We also continue to enhance our operating model to make the company even more resilient, and our global workforce is embracing a performance-driven culture that is translating into durable results. We made solid progress in fiscal '24, and the momentum we're building into the new year has me very excited for '25. We're at the beginning stages of new product cycles. The runway from the differentiated technologies we've recently launched, along with the innovation we will launch over the next 12 months, give me significant confidence in our ability to drive durable growth. These launches put us in a strong position in some of MedTech's most attractive markets like AFib, Structural Heart, robotics, neuromodulation, hypertension and diabetes. And this is further enhanced as we apply AI across our portfolio. All that to say, we are very optimistic about what we can achieve here in fiscal '25 and beyond. Now let's turn to the details of our Q4 results, where we had a number of standout performances. We look at our businesses in three categories. Established market leaders, Synergistic and Highest Growth. Our Established Market Leader and Synergistic businesses both grew mid-single digits, while our Highest Growth businesses delivered high single-digit growth. Looking first at our Established Market Leaders, combined, they made up just under half of our revenue and grew 5%. The highlight of the quarter was Cranial & Spinal Technologies. After growing 6% or higher every quarter this year, CST accelerated to 9% growth in Q4. I want to say that one more time, 9% growth in Q4. This was driven by an outstanding quarter for capital sales with Neurosurgery growing 14%. We had double-digit revenue growth in Mazor Robotics, StealthStation navigation, O-arm Imaging and Midas Rex powered surgical instruments. And this pulled through Spine Implants and Biologics, with high-single-digit growth in Biologics and mid-single-digit growth in Core Spine, including 8% Core Spine growth in the US. We also continue to see strong adoption of UNiD Adaptive Spine Intelligence our integrated AI surgical planning solution. Here, we're taking data and building deep learning models that see patterns and create personalized outcomes for patients. As I've been sharing for several quarters now, our strategy of combining best-in-class implants and biologics with our best-in-class enabling technology, and then adding our unique intelligence into the procedure, is a winning formula in Spine. We call it the AiBLE ecosystem, and it's a big competitive differentiator for us. AiBLE is creating value for patients. It's winning over surgeons all around the world. And it's changing the competitive dynamics of the Spine marketplace. And it's attracting the best reps to Medtronic to expand our business. Next, in Cardiac Rhythm Management, Cardiac Pacing Therapies delivered another strong quarter of high-single-digit growth. Our Micra leadless pacemaker franchise grew over 20%, driven by the adoption of our latest generation, Micra AV2 and VR2, which improved procedure efficiency and increased battery longevity by 40% to 16 or 17 years. Now we hold the vast majority of share in the leadless pacing space. We also continue to expand our pacing leadership as the only company to offer an approved lead for an innovative alternative form of pacing called Conduction System Pacing. Our 3830 conduction system pacing lead grew over 40%. In Defibrillation Solutions, we're seeing good early adoption of our innovative Aurora EV-ICD, which requires no leads in the heart. Now as more implanters complete their training, we expect EV-ICD sales to ramp and become a significant driver of CRM growth, taking share from the competitor's S-ICD system. Next, in Surgical, we grew 5%. Our Advanced Energy product lines grew high-single-digits on the continued launch of our Ligasure XP Maryland vessel sealer. We've now taken energy share from our main competitor for six quarters in a row. Our Wound Management business also grew high-single-digits as strong sales of our V-Loc barbed sutures also resulted in continued share gains from our main competitor. In Q4, we expanded the capabilities of our Touch Surgery digital ecosystem. Just as our AiBLE ecosystem is transforming Spine, Touch Surgery is transforming laparoscopic and robotic surgical procedures. We collect robust datasets from surgeries, including video, to create models that inject intelligence into these procedures. We've launched 14 new AI-based algorithms on our Touch Surgery Performance Insights platform just at SAGES last month. These first-in-class algorithms automatically analyze surgical procedures from anatomy to critical structures, enabling surgeons to objectively assess performance. We also launched Touch Surgery Live Stream, which enables secure and seamless telepresence, including training and proctoring, from a procedure room to really anywhere in the world. Overall, adoption of our Touch Surgery ecosystem is accelerating, and it's becoming a very important differentiator for our Surgical Franchise. Now turning to our Synergistic businesses, combined, they grew 5% in Q4. Cardiac Surgery, ENT, and Endoscopy all grew high-single-digits. Pelvic Health, Coronary, Peripheral Vascular and Neuromodulation all grew mid-single-digits. In Neuromod, Brain Modulation had an outstanding quarter, growing low-single-digits. This was the first quarter of benefit from the launch of Percept RC with BrainSense technology, the only complete sensing-enabled DBS system on the market. Here, we are seeing a strong uptake and excitement for this exclusive technology, and it's extending our number one leadership position in DBS in both Europe and in the US. Our Neuromod business also received really great news at the end of Q4, with the US FDA approving the Inceptiv closed-loop spinal cord stimulator. The Inceptiv platform is a game changer in chronic pain therapy. The device automatically senses and adjusts stimulation, 50 times a second, 24/7, with no required interaction from the patient. And the therapy is delivered from the smallest and thinnest closed-loop SCS device on the market, along with the best 3T and 1.5T full-body conditional MRI access. Given all these advantages will now be carried in the bags of our very large SCS salesforce, we expect Pain Stim to grow above market in the coming quarters. Now let's cover the highlights from the businesses in our Highest Growth Markets. Combined, they made up 20% of revenue and grew high-single-digits. And we expect that their contribution to overall growth will accelerate over the coming quarters as we launch new technology. I'll start this quarter with Cardiac Ablation Solutions, which delivered 21% sequential growth in the quarter, including 23% in the US. This was driven by our Pulse Field ablation products, which are more than offsetting declines in our cryo product line. Q4 marked the first quarter of our PulseSelect PFA catheter launch. It's off to a great start, with strong adoption from both focal RF and single-shot users. As we expand the PulseSelect launch, we also continue to advance our robust pipeline of PFA technology. Last week, US pivotal data for our Sphere-9 focal catheter presented at HRS and published in Nature Medicine. These data were impressive, especially when you consider we were studying persistent AF patients, the most challenging to treat. We showed Sphere-9 has an excellent safety profile, superior efficiency, and numerically higher freedom from recurrent AFib compared head-to-head with the market-leading traditional RF ablation technology. Sphere-9 can perform both PF and RF ablation as well as high-density mapping, all from a single device. And we're looking forward to offering US clinicians this first of its kind wide focal catheter. The output of all this is that we expect our CAS business to continue to accelerate its growth throughout the coming fiscal year as we increase our PFA account training and catheter production to meet the high demand. And over time, we expect our CAS business will reach market growth and then win share. And this will be driven by our PFA launches and the pull-through of our broader portfolio, treating the growing population of patients with AFib. Next, in Structural Heart, TAVR continues to be a very important growth driver for Medtronic. And we grew high-single-digits in the quarter. Structural Heart had two meaningful developments during Q4. First, data from our SMART trial was published in The New England Journal of Medicine and presented at ACC last month. SMART clearly showed our valve was better than Edward Sapien in small annulus patients who are primarily women. This is a large segment of the TAVR space, about 40%, which is larger than most realized. Now while it takes time to broadly change clinical practice and change customer contracting, we're seeing early signs from many loyal Sapien users that they expect to increase their usage of Medtronic valves, and we're building our business for that growth. The second important development in Q4 was receiving US FDA approval for Evolut FX+, our newest TAVR valve. FX+ has large windows in the frame to allow easy coronary access, while providing the same exceptional valve performance of our Evolut platform. We've just started the limited launch now and are receiving really strong positive feedback from physicians. Full market release is expected in August. So when you consider our four-year low-risk data, our SMART data and our new FX+ valve, we expect this combination to drive our TAVR growth at or above the market, especially as the FX+ launch ramps in our second fiscal quarter. Turning to Robotics Surgical Technologies. We're establishing a strong foundation here and we continue to expand the Hugo system install base. In the US, we are nearing completion of our Urology pivotal trial. We also have now started enrollment in two new indication studies, hernia and gynecology. In addition, our development teams are making progress bringing our advanced surgical technologies to Hugo, such as ICG and our Ligasure vessel sealing technology. In Diabetes, our team delivered another strong quarter, growing 11% globally. In the US, we grew 12% as the rollout of the MiniMed 780G system continues. New US users doubled year-over-year again this quarter. And since launch, we've seen a significant increase in CGM attachment rates, resulting in high-teens growth in US CGM revenue in Q4. Users are choosing our differentiated 780G system for the outcomes it delivers, all with less effort and less burden. 780G is the only AID system that provides both basal insulin adjustments and correction doses every five minutes. It offers flexible glucose targets as low as 100 and features our proprietary Meal Detection technology. This all leads to 780G users achieving a high time in range as well as spending more time in automation with our SmartGuard technology. In Europe, we began the limited launch of Simplera Sync with 780G, and we're preparing for commercial launch this summer. The early users and their healthcare providers are giving us fantastic feedback. Simplera Sync is half the size of our current sensor, is disposable and it's a lot easier to put on. And in the US, I'm pleased to announce that we have now submitted Simplera Sync to the FDA. Look, the turnaround in Diabetes is palpable and now becoming a sustained growth story. We're committed to getting the business back to market leadership. This is why we're investing heavily in expanding indications for 780G system and developing next-generation differentiated technology. This includes durable pumps, smart pens, patch pumps, CGM and software and algorithms. You've seen us execute a steady drumbeat of submissions, product approvals and expanded indications, and this is a cadence we expect to continue. We're the only company building out a complete ecosystem of leading technology for patients who require intensive insulin management. We believe this strategy positions us well and will drive our growth as the market continues to shift to Automated Insulin Delivery and Smart Dosing. Finally, turning to hypertension. We believe Simplicity will become an important growth driver for Medtronic. Since gaining approval last year, we've been training physicians, and we're getting very favorable feedback from both clinicians and patients. We've also been working very closely with both CMS and private payers in the United States, and expect to make significant progress on coverage and payment here in fiscal '25. With over 1 billion people worldwide living with hypertension and every 1% penetration into the target market is over $1 billion of revenue, our Simplicity procedure represents a massive opportunity. Now with that, let's go to Karen for a deeper look at Q4 financial performance and our fiscal '25 guidance. Karen, over to you.

Thanks, Geoff. So recapping our financials. The fourth quarter was yet another where we delivered on our commitments, growing 5.4%, ahead of expectations. We continue to drive durable mid-single-digit revenue growth, as committed, with more than 5% in fiscal '24. Importantly, we accelerated our comp-adjusted growth every quarter. And adjusted EPS in the fourth quarter was $1.46, at the upper end of our guidance range and exceeding consensus. The strength of our global business was apparent with broad-based growth around the world. As I noted last quarter, we expected our US growth to improve as we launch new products, and we delivered that with mid-single-digit growth. Our non-US developed markets also grew mid-single-digits, including 7% growth in Western Europe and 5% growth in Japan. And Emerging Markets remained strong, growing 13% and now comprises 18% of our total revenue. Looking down the P&L, our adjusted gross margin was roughly stable at 65.8% as our cost-out programs offset inflation. And our adjusted operating margin declined slightly more than expected, given higher sales incentives on the higher revenue, along with increased investments we've made in SG&A to support upcoming product launches. That said, we delivered operating profit in line with expectations. We also continued to drive strong improvement in our free cash flow during the quarter, as we focused across the organization on working capital. In fact, our free cash flow increased by 14% over last year to $5.2 billion, with a conversion rate well north of 100% in the back half of the year. Looking ahead to fiscal '25, we expect to continue to drive a year-over-year increase in both free cash flow and our conversion rate. Turning to capital allocation. Our robust balance sheet allows us to operate from a position of strength. As you know, we prioritize both investing in our future growth and returning capital to our shareholders. We continue to evaluate tuck-in M&A opportunities against a high bar as we prioritize profitable growth. And to our shareholders, we remain committed to returning a minimum of 50% of our free cash flow. In fact, in FY'24, we returned $5.5 billion through both dividends and share repurchases. And over the past few months, we've repurchased over $2.5 billion in the open market, reflecting the confidence we have, as we finalized our plan, in our ability to deliver ahead. This confidence is also evident in the decision by our Board to increase our dividend for the 47th consecutive year, which we announced this morning. The yield from our growing dividend is an important component of the total return we generate for our shareholders. It's worth noting that we've been able to grow our dividend by 30% over the past five years and 130% over the past decade. Now turning to our guidance. After six quarters in a row, we firmly established a track record of delivering durable mid-single-digit revenue growth. And as Geoff mentioned, we're at the beginning stages of many new product cycles that enable confidence in our top line. Given this backdrop, we'd have you start the year modeling our fiscal '25 organic revenue growth at 4% to 5% including 4% to 4.5% in the first quarter. Our product launches will be ramping through the year, so we expect revenue growth to accelerate through the quarters as well. By segment, we'd expect our three portfolios to be roughly aligned with the corporate average and Diabetes to grow above the corporate average. Our organic growth guidance continues to exclude revenue reported in other as well as foreign exchange. And I direct you to the guidance slide in our earnings presentation for additional details. Regarding currency, based on recent rates, we would see a full year unfavorable impact to revenue in the range of $275 million to $375 million, including an unfavorable impact of $85 million to $135 million in the first quarter. Down the P&L, we expect expansion in our operating margin as we drive efficiencies in our overhead spend. At the same time, we continue to appropriately invest in R&D to drive future growth. Taking all of this together, we're guiding our fiscal '25 non-GAAP diluted EPS in the range of $5.40 to $5.50, including $1.19 to $1.21 in the first quarter. This includes an unfavorable 5% impact from foreign currency for the full year, with an unfavorable 6% impact in the first quarter, based on recent rates. Our fiscal '25 outlook reflects our commitment to restore our earnings power, with EPS growth at the midpoint of about 5%. Importantly, at current rates, the impact from currency lessens through the year, so we expect to be ending the year with high-single-digit EPS growth on a reported basis, in line with our longer-term objective. Now, as we close this important fiscal year, I want to take a moment to express my gratitude to the employees of Medtronic around the world. The important results we delivered this year are all due to your hard work, dedication, and commitment to Medtronic and our mission. Thank you for being the driving force behind our success. Geoff, sending it back to you.

All right. Thank you, Karen. Now before we go to the analyst questions, I'll close with a few brief remarks. I hope you're feeling what we are, that the momentum at Medtronic is building. Momentum that was set in motion by the comprehensive transformation we embarked on a few years ago. We streamlined our operating model. We put in place a performance-driven culture and we changed incentives. We brought in new leaders. We improved how we allocate capital. And we started the work of driving significant operational efficiencies to leverage our scale. This transformation is taking hold, and you're seeing it in our results, and just in time for a very important Medtronic milestone. We're celebrating our company's 75th anniversary this year. It was back in 1949 that a medical electronics repair business was started in a garage in Minneapolis. Now certainly, a lot has changed over the past 75 years, but what hasn't stopped from the humble beginnings in that garage is our spirit of innovation and our dedication to delivering life-transforming health technology that alleviates pain, restores health and extends life. As we celebrate our past, we are even more excited about our future. That legacy of invention and market creation continues today and you see it. You see it with our PFA products in AFib, our sensing products in Neuromodulation, our 780G and Simplera Sync system. You see it with our robotics with our Evolut TAVR system, and our Simplicity hypertension procedure and the dozens of new products across our businesses. Our pipeline of breakthrough innovation is impressive. And I'm incredibly excited about the impact that these products will have on patients, on physicians and on our performance. It's these new product cycles, combined with exposure to secular growth markets and an aging population, that put us in a great spot to continue delivering durable revenue growth. And when you add this to our improving earnings power, our strong free cash flow and dividend growth, you have a great formula for creating shareholder value. Finally, I'd like to join Karen in expressing my gratitude to our employees watching today. We've been through a lot of change. But through it all, your unwavering focus on our mission and performance has propelled our company forward. Your contributions matter, not just for Medtronic, but for the millions of patients around the world that depend on us. And as we continue to innovate and grow, I'm confident that, together, we will achieve even greater heights in fiscal '25. So 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. With that, Brad, can you please give the instructions for asking a question.

Hey, good morning, everybody. Thanks for the question. I wanted to ask about the EPS guidance, ex-currency, 9% to 11%. I guess buyback maybe adds 1% to 2% there, but still kind of above kinds of what Medtronic historically has done. So wanted to kind of understand the puts and takes better on your EPS guidance and how you're going to get there. And then kind of longer term, you're talking a lot about restoring earnings power. How should we think about kind of the pathway on growing kind of EPS beyond FY'25? Thanks for the question.

Thank you for the question, Travis. I'll pass this to Karen shortly, but I want to start with a few initial comments. We've been focused on enhancing our earnings power for several years now. For instance, our global operations and supply chain transformation began over three years ago, and we've been making improvements in pricing, which you can see in our FY'24 results. We're building on our momentum in pricing as we approach FY'25. We've also made significant adjustments to our portfolio, such as exiting the ventilation business and divesting from dialysis. These are just a couple of examples that Karen will elaborate on. Overall, we are implementing structural and programmatic changes within the enterprise that are enabling us to achieve top-line growth while also enhancing our earnings power. These changes give us confidence looking into FY'25 and beyond in terms of improving our earnings. So, Karen, could you please share some detailed insights on this?

Sure. Thanks, Geoff, and Travis. So I would say in '25, we're focused on three key things. Delivering continued mid-single-digit top line growth while executing on our strong pipeline, investing in our high-priority growth drivers and restoring the earnings power of the company as Geoff talked about. And our guidance all starts with confidence and durability on our top line. We've got really high confidence given the track record that we've had over the last six quarters and the fact that we've got this very robust pipeline coming to market. Much of it has already been approved by regulators and much of it is also moving from limited market release to full market release. So we expect on gross margins it to be flat year-over-year on a constant currency basis because we've got cost down and pricing offsetting inflation. And on operating expenses, we continue to make appropriate investments in R&D to drive our future growth. And we'll really drive leverage in SG&A and that's through programmatic changes that we've implemented throughout the company, including discipline on headcount, focus on discretionary expenses. We've always got increased use of automation and digitization, and we've elevated the review and reporting on our expenses and our margins and we've driven some structural changes, too, like eliminating our respiratory interventions operating unit. And on this expense, we've taken costs out already, and you're seeing the full benefit of it this year. We actually drove this kind of leverage in '24, it was just masked by the impact of the true-up and incentive compensation that we did from '23 to '24. And then on top of operating leverage, you'll see a large benefit from reduced share count, which will be a bit offset by incremental interest and tax. But when you put it all together, we expect this 4% to 5% top line growth, along with operating leverage and share count, to deliver that high-single-digit EPS growth for the year. And as our currency headwinds abate, we've said we expect high-single-digit actual or reported EPS in the back half of the year. And that goes beyond this fiscal year. So beyond FY'25 we're focused on maintaining this mid-single-digit revenue growth and continuing to drive leverage down the P&L to deliver that high-single-digit EPS growth.

Great. Thanks a lot.

Great. Good morning, everyone. Thanks for taking the questions. Maybe to start, I wanted to zero in, in the guide, you have accelerating revenue growth, it feels like, throughout the year, with first quarter where it is, probably second half better than first half. I was hoping you could spend a minute on some of the products there because there's a lot of moving pieces and how we should think about the sources for upside and your confidence levels around that upside? And then I have one follow-up.

Sure. I'll address this, and Karen can add any details I might miss. First, there have been numerous approvals in high-growth areas recently, and we’re just beginning to launch these products. Specifically regarding FY'25, one key area is Structural Heart with Evolut FX transitioning from a limited market release to a full market release, showing notable growth. The SMART trial results are enhancing our clinical evidence and are altering referral patterns, making it clear how to treat these patients, which represent a larger market share than anticipated at 40%. Another significant area is PFA, specifically PulseSelect, which experienced over 20% sequential growth, with more advancements expected soon. We also remain the market leader in leadless pacemakers and have recently launched Micra AV2 and VR2, with the market expanding, especially following the policy updates from UnitedHealth Group, the largest commercial insurer in the US, to cover leadless pacemakers. These are some key developments in the cardiovascular segment. Similarly, Neuroscience is also positioned well for growth, particularly with Spine, where we expect continued acceleration driven by a combination of implants, enabling technology, and AI. Our performance is outpacing competitors, evidenced by our 9% growth compared to Globus's 3%. On a pro forma basis, when considering the combined performance of NuVasive and Globus, we’re demonstrating a notable difference in growth. We also hold a significantly larger installed base, which is critical for future growth in this market. In ENT, we’re observing strong adoption of Propel and Sinuva following the Inceptiv acquisition. Our Neuromod segment, with the closed-loop Technology, Percept RC, is also seeing double-digit growth in DBS. Recently, we received approval for Inceptiv, our ECAPs closed-loop stimulator for pain, and we believe it will outperform other market offerings. In the diabetes sector, the 780G continues to grow in the US at low double-digits, and we expect to exceed expectations as we show ongoing strength. Finally, Hugo and Ardian are promising indicators of growth for later in the year. Overall, there are numerous growth opportunities across our businesses, which is why we are confident in achieving mid-single-digit revenue growth, as Karen highlighted in relation to the bottom line.

Yes. And I would just add just briefly that our end markets are growing, our back orders are down. Our supply chain has improved. The impact of VBP in China is largely behind us. And then obviously, we've got the long list of products that Geoff talked about.

Yes. In other words, we are starting the year with fewer uncertainties regarding risks. A year ago, there was significant uncertainty in China. We achieved high-single-digit growth for the year, which accelerated, reaching double digits in the last two quarters. Moving past these concerns, along with the introduction of new products, collectively contributes to a positive outlook as we enter the year.

Great. Maybe a quick follow-up here. Karen, I appreciate the high-level building blocks down the P&L. I was hoping you could put a little more meat on the bone. You talked about gross margin expansion, how should we think about that? It sounds like R&D deleverage, SG&A, you have a lot of costs. I think that drove the miss in operating margin in the fourth quarter. So how do we think about the level of investment versus savings in SG&A? It sounds like that does get us to a positive operating margin expansion. And then how do we think about the level of tax? I know it's gone higher, but how much higher? Thanks.

Sure, Robbie. So just on the detail on gross margin, I said we expect it flat on a constant currency basis. We will have some currency headwinds, about 0.5 point of downward pressure on gross margin at recent rates. But as I said, we've got good cost down and pricing offsetting inflation there. And as those currency wins on the gross margin line should abate as we move through the year and be away be gone as we exit the year. As we look at R&D and SG&A, I would say in R&D, we're focused on continuing to invest. It's a critical priority to us. I've talked about it being the one line item that's allowed to grow in line or more than revenue in certain years. And we've been focused on driving efficiencies across the company, including in R&D to enable these levels of investment. Some of the recent portfolio moves we've made like setting up the JV for our renal care or shutting down our ventilator business has allowed us to reallocate investment in our highest strategic priorities in R&D. So that remains an area of investment. And then on SG&A, we are focused on driving continued significant leverage in SG&A. And I talked about the programmatic savings that we've been driving that you're seeing more this fiscal year than you saw last year. We actually drove this kind of leverage in '24. I said it was just masked by the impact of the true-up in incentive compensation. So we're excited about what we're going to continue to drive in SG&A. And then on tax, we expect tax to be a bit of a headwind given global tax reform. We're pleased with the work that we've done to offset some of this, both on the tax line and above the tax line, but we expect it to be about one point higher than we had this past fiscal year.

Thank you, Karen.

So, Robbie, when you think about FY'25 on the bottom line, as Karen mentioned, that's going to come from operating margin actions. And it goes beyond expense management. These are programmatic changes we've made in FY'24. And we'll see the full benefit of these changes, and you'll see the full benefit of that in FY'25. On the gross margin line, which is super important, those programs are underway. And as Karen mentioned, it's hard to see that because of some of the inflation and FX. But as we get into FY'26 as those abate, you'll see that gross margin start to expand as well. So we think we've laid this out the right way and got the programs lined up against it and have been working on it for some time. And we'll see those benefits accrue over the next couple of years.

Hey, guys. Thanks for taking my question and congrats on a nice sprint here. Geoff, one on your restoring EPS power comments. What does it mean? What is the right base we should be thinking of? Are we thinking of operating margins perhaps getting back to upper 20s? Is there a time frame for that? And maybe some clarification on what that means.

Well, I'll have Karen address that. She touched on it a bit in our prepared remarks, and I've asked her to elaborate. As I mentioned earlier, we have a lot of confidence in the operating margin for the year due to the changes we've already implemented, especially in the gross margin line, which are set to expand. These improvements will start to be realized in the latter part of the year and will carry into next year. I'll let Karen provide more specific details.

Yes. And just on restoring the earnings power, Vijay, it means that we are focused on driving that durable mid-single-digit top line. It starts there, but then driving leverage down the P&L to deliver high-single-digit EPS. And you'll see us exit the year of FY'25 doing that, and we're focused on maintaining it and driving it continued from there.

Understood. And just related to that, when you say operating margin leverage this year, is that on an ex-FX basis? Or what's the implied operating margins on a reported basis for fiscal '25?

Yes. We're expecting margins around 26% in '25, and that's on a reported basis or up from where we were, yes.

Thanks, Vijay. Next question please, Brad.

Good morning. Thanks for taking the questions. Congrats on a nice quarter here. Sean, it was great to see the mid-single-digit growth in AF Solutions in Q4 and congrats on the Affera data. How should we be thinking about the AF business before the Affera launch in the US. Just remind us in the launch timing there and where you are with supply and your ability to get mapping equipment and personnel out there in the field. Thanks for taking the question.

Thanks, Larry. First of all, the business is doing exceptionally well in the sequential growth that we've seen and the demand and interest coming out of both HRS and ERA for our new technologies is really astonishingly great. It's really, really high. And I'd say in the United States, Pulse Field is moving pretty fast there and we're catching that wave, obviously, with our first entry here. And I'd say that there's, as we scale up for further penetration of therapy, there's lots of other approvals we're getting around the world. There's expansion of capacity. And the most important thing to get it fair to the United States was that last module of clinical data, as you saw, that was really pristine taking on head-to-head the market leading technology and just narrowly missing on superior efficacy. So that's all boding well. To your point, though, the things we have to get right are scaling up manufacturing, and that's something we've put a lot of effort toward. We moved into new Medtronic facilities, away from the sort of acquired clean room that we purchased with Affera. And the last point, you'd asked about capital, and that's certainly not going to be a barrier to our success. We have all kinds of ways of helping with capital acquisition, including placing capital, leasing, catheter costs, things like that, that will be availing ourselves to throughout the launch of that product as well. So look I think all things are going up. We're really excited about Pulse Field ablation and the customers are really kind of beating the door down for it every single day. So it's exciting to be part of.

Thanks for taking the question.

Thanks, Larry. Next question please, Brad.

Hey, good morning, guys. Quick questions on margins this quarter. The operating margins are a little bit softer expected due to SG&A pressures. Can you just walk through what the variance was services expectations. Like you talked about higher comp and support for product launches. Just want to make sure I understand what happened versus what you're expecting.

Yes. Thanks, Pito, for the question. You're right. So with the outperformance that we had on the top line, we did have some incremental incentive accruals in the quarter on sales incentive comp. And we've purposely driven investments in our strategic growth drivers as we work to commercialize many of the exciting innovations that we've got heading into '25. We did all this and absorbed the incremental incentive comp and investments while still delivering on our financial commitments and beating the bottom line, but that was it was driven by.

You bet. Hey, Pito, it's Brett Wall. Thanks for the question. We think it's very durable. If you look at where this business is going, as Geoff mentioned, we grew three times our nearest competitor in the space and that's on a very large base of business. We are recruiting the best sales reps. We have this technology system with AiBLE that is allowing us to change how spine surgery is being done. We are recruiting physicians, sales reps and our technology is making a difference in the marketplace. We see that as durable for several, several quarters here.

Yes, Pito, one final point is that the industry is shifting towards capital equipment and enabling technology. These technologies need to be effective, well-integrated, and valuable, with AI playing a significant role. Companies are now investing in ecosystems like Medtronic's AiBLE, which are limited in number. This emphasizes the importance of our installed base. The industry structure is also evolving because creating these ecosystems requires considerable expertise and capital, leading to the decline of small spine companies that used to target doctors. This is why we believe our position is sustainable, and we have been heavily investing in this area for years.

Great. Thanks so much.

Thank you, Pito. Next question please, Brad.

Hi. Good morning. Thanks for taking the question. I had trouble with the mute button there. I wanted to ask about emerging markets, almost just under 20% of the revenue base grew double-digits in fiscal '24. Maybe just help us understand some of the puts and takes there. And I think, Karen, you said most of the VBP headwinds are behind Medtronic now heading into fiscal '25. China is almost 40% of the emerging market revenue base. Can you just talk about overall emerging market trends, expectations for sustainable double-digit growth and specifics around China? Can we see acceleration in Medtronics performance growth in China? Thanks for taking the question.

Sure, Josh. Thanks for the question. As many of you know, we have been focused on emerging markets for a long time, and it has been a significant growth driver for us until COVID hit, particularly when some markets like China shut down, leading to VBP challenges. The past few years have been somewhat inconsistent in emerging markets. However, those fundamentals are returning. The situation in China, as well as VBP issues, are mostly behind us—about 80% resolved. We've observed accelerating growth throughout the year, with double-digit growth in the last two quarters for China. There are still some lingering VBP concerns and the timing of tenders in a few smaller segments like aortic and peripheral vascular, along with some remaining issues in neurovascular, which could potentially bring down growth from double digits to mid-single digits in certain quarters. Nevertheless, China is largely recovering, and procedural activity is strong, playing a major role in our emerging market business. We have a mix of import and local products which strengthens our product investments. Additionally, products developed locally can be exported to other regions. Over the past couple of years, we have empowered our emerging market leaders more than before, allowing them to allocate resources effectively, given that healthcare needs are local and vary by market. Some markets may have more cath labs than others, which is important. The increased influence and control our emerging market leaders have had has also contributed to accelerating our growth. The fundamentals are indeed improving, especially in China. Changes we’ve implemented in our model and incentives, combined with our ongoing investment in value products, support this trajectory. Overall, I see this as a sustained strength and source of growth for the company for many years to come. Karen, anything else?

Yes. I would just say on VBP, that can affect the quarter at an OU level, but we don't necessarily expect it to affect total Medtronic.

Great. Just maybe one quick follow-up. Are there any product launches we should consider as we update our models for fiscal '25, particularly in these emerging markets, especially in China? Thanks.

In China, we recently received approval for Ardian, which will take some time to implement in hospitals, but we believe it will perform well. Our CST business is performing strongly, separate from some trends in the US. We have a solid local portfolio and a good cycle of local innovation, including a local version of Mazor and our cell station navigation. Additionally, we have started local manufacturing for some of our cardiology products. A couple of weeks ago, I visited our facility, where I saw our local pacemaker being produced next to the large Tesla plant. While our plant may not be as massive, it produces excellent implantable technology, and we are proud of that. These are some key areas to highlight in China.

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

Hi. Thanks for the question. Congratulations on the quarter. First, regarding Spine, the turnaround in that franchise continues to show high-single-digit growth. Following up on an earlier question, it's clear that you're growing faster than your closest competitor. However, you've mentioned potential disruption from recent mergers and acquisitions in the spine sector, describing it as a once-in-a-decade opportunity. Can you share what contribution you've seen from the M&A environment to your advantage so far and what lies ahead? You mentioned hiring representatives and competitive conversions. I'm trying to understand if we're at a point where you're experiencing those benefits or if there are still more to come that could potentially accelerate these growth rates.

Yes, Rich, it's Brett Wall. Thanks for the question. We are seeing contribution now from some of those conversions that we're seeing really across the United States, as you know, which is the largest spine market. And we see that continuing over the next several quarters here. And as Geoff mentioned, it's a combination of this technology portfolio, including AI surgical planning, including robotics, including power and surgical instrumentation imaging and navigation, putting that all together is creating this very attractive place where very good teams and reps and groups of people want to come together to work with Medtronic. So we have a very active program there. We're getting good contribution now, and we see that contribution continuing as we move forward. We have a very compelling story for those individuals to come along. And as was mentioned earlier, it's a lot more difficult now for companies that don't have that ecosystem to bring the customers and these individual teams of reps and others along in that process. So we see that continuing. We're going to continue to invest there. And as I mentioned, we have a compelling story for them to join Medtronic.

Yes. Taking a broader view, the entire ecosystem strategy, including capital, consumables, and CST, significantly influences our surgical operations as well. Innovative financing and earn-outs play a crucial role in how we obtain capital, boosting our confidence in our surgical segment as we integrate robotics with Hugo. Additionally, there is a noticeable improvement in both diabetes and CST. By concentrating on these opportunities, we are achieving results, and the same level of focus will apply to Hugo and our wider surgical and AFib CAS businesses. These areas present substantial opportunities, and we frequently receive inquiries about them. Given the attention we are directing towards CST and diabetes at the leadership level, I am optimistic that these will become key growth drivers for the company as we advance. This is already evident in CAS.

Thank you.

All right. Thank you for your comments. Now, before we move to the last question, I just want to reiterate my appreciation for our Medtronic team, especially during these times of transformation and execution. It’s invaluable as we work to unlock our future growth potential. Thank you for your continued support of Medtronic.

Thanks, Geoff. We are just past the top of the hour. So we'll take one more question, please, Brad.

Great. Thanks so much. Maybe just a couple of follow-ups on some of the pipeline programs that you talked about. Just to frame expectations around for Ardian, Simplicity, when does that, do you think, start to noticeably show up and start to demonstrate some of the potential that you were describing earlier, Geoff? And then on diabetes, you filed. I wasn't sure if I recall whether you filed Simplera with 780G for repeats, for adults, for both? And I guess the question is, is that mean that before this coming fiscal is out that we'll start to see some traction with that new sensor in the US? Thanks.

Thanks for the questions, Matt. I'll have the subject matter experts answer those. I'll start with Sean on Simplicity.

Yes, thank you, Matt. It's crucial for us to establish reimbursement, as it's the key factor that will drive our progress. We are looking forward to the final inpatient rule for outpatient reimbursement, expected around late July, although I cannot confirm that timeline. Most of our procedures will take place in the outpatient setting, and we are actively working on transition payments as well as national coverage determination with evidence development. We are in ongoing discussions with CMS and private payers about this. We anticipate contributing to this process starting this year, as Geoff mentioned earlier, although there isn't a specific date for these developments. However, we are making significant efforts to secure reimbursement. Additionally, we are updating guidelines in Europe, which we expect to happen late this summer, facilitating adoption in that market. We also have new approvals from both China and Health Canada, which will serve as catalysts. Ultimately, the primary focus is on securing reimbursement, and we are fully committed to this effort.

Okay. Que, you want to answer the diabetes one?

Yes. We filed the Simplera Sync, which is the integrated sensor with 780G system in the US in line with expectations. It's hard to comment on the timing with the agency, but we're eagerly awaiting approval for that system. And just to remind everyone that we had limited launch of the Simplera Sync with 780 in Europe in five countries. That's going well and we're looking forward to expanding that to a full commercial launch in the summer. And then, of course, Simplera within InPen, we launched late last year. It's now in 15 countries, also doing quite well. So we anticipate that what we're seeing in the OUS markets will also happen in the US.

Excellent. Thank you.

Thanks, Matt. Geoff, please go ahead with your closing remarks.

Thanks, Ryan. And thanks for the questions, everybody. We definitely appreciate your continued interest in Medtronic. And we hope you'll join us for our Q1 earnings broadcast, which we anticipate holding on Tuesday, August 20th. We'll update you on our progress against all these strategies and our commitments. So with that, thanks for spending time with us today, and have a great rest of your day.