Medtronic - Q3 2024

Transcript

Ryan Weispfenning (VP and Head of Investor Relations)

Good morning, and welcome to Minnesota, where we finally have some snow. 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 2024 third 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 third quarter, which ended on January 26th, 2024, and our outlook for the remainder of the fiscal year. After our prepared remarks, the executive VPs covering our segments will join us, and we'll take questions from the sell-side analysts that cover the company. Today's program should last about an hour.

Earlier this morning, we issued a press release containing our financial statements and divisional and geographic revenue summaries. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com. During today's program, many of the statements we make may be considered forward-looking statements, and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward-looking statement.

Unless we say otherwise, all comparisons are on a year-over-year basis, and revenue comparisons are made on an organic basis, which excludes the impact of foreign currency and third 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 second quarter of fiscal 2024 and are made on an as reported basis, and all references to share gains or losses referred to revenue share in the fourth calendar quarter of 2023 compared to the fourth calendar quarter of 2022, 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.

Geoff Martha (Chairman and CEO)

Hi, everyone, and thank you for joining us today. Our momentum and solid execution continued this quarter as we establish a track record of consistently delivering mid-single-digit organic revenue growth. Diabetes took another step forward with double-digit growth, supported by a return to growth in the U.S. I'd also note the particular strength we saw in multiple businesses like core spine, cardiac surgery, structural heart, and cardiac pacing. And we had strong growth across international markets as we expand access to our innovative healthcare technologies all around the globe. At the same time, we've had a rapid cadence of new product approvals, and we're continuing to differentially invest in our pipeline of highest growth opportunities. We're advancing innovative core technologies like robotics, AI, and closed loop systems. And with five AI products already FDA approved, we're leading the way in bringing the tech into med tech.

We also continue to make progress on our comprehensive transformation of the company. We're incorporating a performance-driven culture that's based on execution, speed, and playing to win, and we're leveraging our scale to drive efficiencies. So when you look at our financials this quarter, you're seeing the early results of our focus on restoring earnings power and converting our earnings into strong cash flow. And we're using that cash to both invest in high return opportunities and return value to our shareholders. So we're executing and we're delivering, and we expect to continue over the coming quarters and years, given our momentum, our ongoing transformation, our breakthrough innovation, our exposure to strong secular growth markets, and our numerous catalysts across the business.

Now, before I get into the details of our Q3 results, I do want to mention that we provided a portfolio management update this morning on our patient monitoring and respiratory interventions businesses. After a comprehensive review, we have decided to exit our unprofitable ventilator product line and retain and bring together our remaining PMRI businesses into one business, which we're calling Acute Care and Monitoring. Now, we've determined it is in the best interest of Medtronic, its stakeholders, the ACM business, both near and long term, to exit vents because of its increasing unprofitability and market preference shift to lower acuity ventilators.... Now, as we exit Vents, I want to recognize the strong legacy of our business and the Puritan Bennett brand. We're committed to serving the needs of our customers and honoring our ventilator service contracts.

I also want to thank the employees in our ventilator business, who played an incredible role during the pandemic to dramatically expand production, to get ventilators to the communities around the world that needed them. And while we exit, we do believe that existing manufacturers can meet the customer demand for new ventilators going forward. At the same time, we decided to retain and refocus the remaining PMRI businesses. Three main factors have driven this decision. First, we have strong conviction in our ability to lead and drive growth in acute care and monitoring, given our improved competitive position and our ability to properly fund this business with savings from exiting Vents. Second, the importance of data in this space is changing rapidly. It's becoming the basis of innovation, and this fact further improves our competitive differentiation.

Lastly, as a company, more broadly, we continue to prioritize profitable, innovation-driven growth and category leadership, and ACM can deliver both. That does not mean we will shy away from additional portfolio moves going forward, but the bar is high for any strategic activity that dilutes our focus on our profit and growth. So when you take these decisions together, we're able to provide increased investment for acute care and monitoring, using the savings from Vents and bringing two businesses together, all without creating dilution to our PNL. Now let's get into the details behind our Q3 results. We continue to look at our portfolio in three categories: established market leaders, synergistic, and highest growth businesses. In this quarter, all three grew in line with our expected growth algorithm.

Our established market leader and synergistic businesses grew mid-single digits, while our highest growth businesses posted high single-digit growth, and we expect their contribution to our overall growth to further accelerate in the quarters ahead. Now, looking first at the established market leaders. Combined, they made up just under half of our revenue and grew 4%. Starting with Cranial and Spinal Technologies, we're driving consistent above-market growth on the continued adoption of our AiBLE ecosystem. CST delivered high single-digit growth in core spine, mid-teens growth in biologics, and high single-digit growth in enabling technology. We had strong double-digit unit growth in StealthStation navigation, O-arm imaging, and Mazor Robotic Systems, a leading indicator for future growth in this business. We also continue to see strong adoption of UNiD Adaptive Spine Intelligence, our integrated AI-based surgical planning solution.

Now, with AiBLE, we're offering a complete, robust ecosystem of enabling technologies and associated implants for spine surgeons. Our global footprint, which includes over 10,000 systems, is over 4x greater than the nearest competitor. And with this scale and extensive and rapidly increasing install base, we're transforming the spine industry. We are leading the way. As more surgeons adopt our integrated spine technologies and in an environment where there is disruption from consolidation, we're attracting the best sales teams to Medtronic to grow and expand our business. Next, in surgical, we grew 3%. Our wound management business won share, growing in the high teens on the strength of our V-Loc barbed sutures. We also had solid mid-single-digit growth in hernia products as we won share in synthetic permanent mesh with our ProGrip platform.

As expected, our surgical growth continued to have a modest impact from declines in bariatric surgery. Now, we still believe this impact will be temporary as more patients become eligible for surgery and as patients seek a more permanent treatment to weight loss. To wrap up our established market leaders, cardiac rhythm also grew 3%, driven by high single-digit growth in cardiac pacing. Our Micra leadless pacemakers continued to post strong results, growing 15%, driven by the launch of our next generation Micra AV2 and VR2 devices. We're also benefiting from the adoption of conduction system pacing, an alternative to traditional single or dual-chamber pacing. Our 3830 lead, the only one on the market approved for conduction system pacing, continue to grow strong double digits. In CRM, we also began training and the limited launch of our Aurora EV-ICD.

Now, we expect the EV-ICD to re-accelerate our defibrillation solutions growth in the coming quarters. As I've shared with you in the past, Aurora is a game changer in the ICD space. It delivers the benefits of a traditional ICD, including similar size, longevity, and pacing features, but without the leads in the heart or veins. These benefits can be realized with one device and only one implant procedure. We expect our advantages will not only displace the competitor's device, we will expand the population far beyond the existing segment and be a strong growth driver for CRM. Now, turning to our synergistic businesses, combined, they grew mid-single digits in Q3, and I'll highlight some of the drivers here... Let's start with aortic, which grew 13% on supply recovery and continued momentum of our Endurant AAA franchise.

Cardiac surgery grew 10%, driven by strength in perfusion and cannula and ECLS oxygenators, given competitor quality issues and the strong sales in international markets of our Avalus surgical valve. Coronary grew 7%, driven by double-digit growth in both guide catheters and balloons, and we increased our drug-eluting stent share in the U.S. and in Europe on the continued rollout of our Onyx Frontier drug-eluting stent. Now turning to businesses in our highest growth markets. As I mentioned earlier, together, these businesses grew in the high single digits this quarter, and we expect their contribution to our growth to accelerate going forward. Now, diabetes led the way, growing double digits on the global adoption of our game-changing MiniMed 780G system. We're seeing strong sequential momentum, growing 5% over the prior quarter. Our customer base is growing sequentially, and we're driving more revenue per customer.

In the U.S., we not only returned to growth, we grew mid-single digits, driven by nearly 50% revenue growth in insulin pumps. We doubled our new users year-over-year, attracting those on multiple daily injection, as well as users of competitor systems. Users are choosing 780G for the outcomes it delivers. With intensive insulin users, these outcomes matter, and the 780G is highly differentiated. It's the only AID system to automatically adjust and correct sugars every five minutes. It offers flexible glucose targets as low as 100 and features our proprietary meal detection technology. This leads to high time and range for users, and this type of glycemic control is coming with less effort and burden. As users realize the relief that comes from spending more time in automation with our SmartGuard technology.

It's worth pointing out that in a recent third-party survey of nearly 2,000 U.S. diabetes pump users, the 780G scored number one in overall pump satisfaction. Among Type 1 CGM users, our Guardian 4 sensor mirrored competitor sensors in overall satisfaction. During the quarter, we secured CE Mark for our Simplera Sync sensor for use with the 780G, and we look to begin the limited release this spring. In the U.S., we're planning to submit the 780G with Simplera Sync to the FDA in the first half of this calendar year. Simplera Sync is half the size of our current sensor. It has a disposable design and is much easier to put on. Now, we've been driving the diabetes turnaround for some time, and I got to tell you, it certainly feels really good to return to double-digit growth. But we're not finished here.

There is definitely more work to be done as we work to bring to market an even more robust ecosystem of differentiated technology for people living with diabetes, including next-generation durable pumps, smart pens, patch pumps, sensors, and algorithms. As the intensive insulin management space moves to using smart dosing through either AID or Smart MDI, we expect an acceleration in the growth contribution from our diabetes business. Now, turning to cardiac ablation solutions, we delivered 11% growth in international markets, including 9% growth in Western Europe. Our strong international growth, as well as our overall performance, continues to be driven by our leading Arctic Front cryo solution, as pulsed field ablation is still in the early stages. We're seeing, though, a lot of enthusiasm in the market for our PFA products.

In Europe, we're the only company with PFA offerings for both the single shot and the focal segments. In single shot, we have now started the limited market release of our PulseSelect PFA system here in fiscal Q4. We're seeing very efficient procedures and after just a couple of cases. So the learning curve is really short. The catheter handling and maneuverability has been excellent due to its small shaft and our custom 10 French bidirectional sheath. Clinicians are also reporting no noticeable muscle contraction with our PFA product, which is beneficial for patient experience. In focal, we continue to ramp manufacturing of the Affera Mapping System and Sphere-9 catheter and remain in limited market release in Europe. Sphere-9 is the only catheter that can perform both pulsed field ablation and radiofrequency ablation and high-density mapping. It's really an all-in-one catheter.

In the U.S., our CAS business declined in the quarter. We faced the first full quarter of competition in the cryoablation space, which is a space we created and had been the only player. In addition, many customers actually held back purchases as they awaited the launch of our PulseSelect PFA catheter, which is now commercially available. We do expect to improve from here as we roll out the recently approved next generation Nitron CryoConsole and PulseSelect, the only PFA catheter FDA approved for both paroxysmal and persistent AF. And in addition to the European feedback, clinicians have consistently commented on how well it's visualized and how easily it connects to their mapping system. So we're also making progress in bringing our Affera Mapping System and Sphere-9 catheter to the U.S., with the last patient follow-up in our SPHERE Per-AF pivotal trial now completed.

We expect to see the results at a medical meeting in the first half of this calendar year. You know, with an $8 billion market size, expanding our share in this under-penetrated cardiac ablation space is a big opportunity for us. We expect our growth profile to improve over time, first moving towards market growth and then winning share, as we bring our rich pipeline of innovation to patients who need this technology. In neurovascular this quarter, we grew high single digits when you exclude sales in China, where the market is subject to volume-based procurement. We continue to have strong double-digit growth in flow diversion globally. This is being driven by our innovative Shield Technology for treating brain aneurysms, which is available on both Pipeline Flex and Vantage flow diverters.

In robotic surgical technologies, we continued growing the install base for our differentiated Hugo robotic system in international markets. In the U.S., our Expand EU pivotal trial continues to enroll, and we expect to have first enrollment in our hernia trial very soon. We expect Hugo, equipped with advanced digital capabilities, to be a meaningful growth driver for us in the years ahead. We believe surgeon preference for our open console and modular design, our leading position in minimally invasive surgery and instrumentation, our connected digital ecosystem and data-enabled insights, along with our world-class surgical training program and partnerships, will meaningfully advance the low penetration of robotic surgery around the world. Now turning to structural heart. We grew high single digits in the quarter, including mid-single digits sequentially, as we see ongoing adoption of Evolut FX and its improved design and market-leading valve performance.

In Europe, where FX was launched for the first full quarter, we grew double digits, and Japan grew in the low 20s on the continued adoption of FX. I'm pleased to share the news today that we have submitted Evolut FX+ to the FDA for approval. FX+ has three windows in the frame to allow easy coronary access while providing the same dependable valve performance of our Evolut platform. We were also pleased to hear that one-year trial results of our SMART Trial will be presented as a late breaker at ACC on April 7. We're excited to see the results and are looking forward to having both FX+ and the SMART Trial, as well as the continued strength of our four-year low-risk data, as catalysts for our structural heart business.

Now, with that, let's go to Karen for a deeper look at our Q3 financial performance and our fiscal 2024 guidance raise. Karen?

Karen Parkhill (CFO)

So looking at our financials, our third quarter was another quarter where we delivered on our commitments. Our revenue grew 4.6%, ahead of expectations, and adjusted EPS was $1.30, $0.04 above the midpoint of our guidance range. We attribute the beat to stronger-than-expected revenue growth and gross margin, offset by $0.04 from greater-than-anticipated currency impact, primarily from the devaluation in the Argentine peso in December. We're delivering durable mid-single-digit revenue growth and have now for several quarters. As Geoff mentioned, international markets were an important driver for us. Our non-U.S. developed markets grew 6%, including 8% growth in Western Europe and 7% growth in Japan. In fact, we had double-digit growth in several of our businesses across both of those regions. Emerging markets grew 10%.

We had high-teens growth in the Middle East and Africa and mid-teens growth in South Asia. China grew low double digits as some of the VBP we expected there continues to be delayed. Eastern Europe grew in the low single digits, given Russian sanctions. In the U.S., we grew 2%. We have several new product approvals that are at the earliest stages of their launches and expect those launches to positively impact our U.S. growth over the next couple of quarters and beyond. Looking down the P&L, we delivered a strong quarter. Both our adjusted gross and operating margins were ahead of expectations. Our adjusted gross margin of 66.1% improved year-over-year, overcoming a 60 basis point headwind from foreign exchange and continued elevated inflation. We attribute the favorability primarily to the delayed China VBP and lower freight costs.

We also continue to see traction from our pricing efforts and an early benefit from our comprehensive COGS efficiency efforts. While our adjusted operating margin of 25.2% declined 70 basis points, it was entirely driven by currency. In fact, operating margin on a constant currency basis was up 160 basis points from improvement in gross margin and strong SG&A leverage as we continue to drive efficiencies across the enterprise. Below the operating margin line, our adjusted tax rate was a little higher than anticipated, mainly due to the jurisdictional mix of profits. On the flip side, income on our investments was also a little better than expected, with higher rates. It's worth noting that while our adjusted EPS was flat year-over-year, it grew 8.5% on a constant currency basis from the leverage we drove down the P&L.

We also significantly improved our free cash flow and conversion in the quarter. Now turning to guidance. Given our top and bottom line beat and continued strength in our underlying fundamentals, we're raising our full year revenue and EPS guidance. We now expect full year organic revenue growth of 4.75%-5%. For the fourth quarter, we're expecting organic revenue growth to be in the range of 4%-4.5%. On a comp adjusted basis, this is an acceleration from the third quarter as we continue to ramp our recent product launches. With the exit of ventilators that we announced today, we are moving the associated revenue to the other segment starting in the fourth quarter.

As is the case with all revenue and other, we will exclude it from our organic revenue growth, and additional details can be found in our third quarter earnings presentation. Regarding currency, based on recent rates, we would see a full year revenue impact in the range of an unfavorable $15 million to a favorable $35 million, including an unfavorable impact of $70 million-$120 million in the fourth quarter. On the bottom line, with the beat in the third quarter, we're raising our full year EPS guidance by $0.04 at the midpoint to a new range of $5.19-$5.21. I'd point out that given our durable performance, we've been able to increase this guidance by $0.15 at the midpoint from where we initially started the year.

For the fourth quarter, we expect adjusted EPS of $1.44-$1.46. And regarding currency, based on recent rates, we're seeing an unfavorable impact of 7% on full year EPS, including an unfavorable 5% impact in the fourth quarter. Lastly, while we'll give our fiscal year 2025 guidance on our earnings call in May after we finish our planning, I want to share our early thoughts. You've seen us deliver durable revenue growth for several quarters, and we expect that to continue. Down the P&L, inflation, currency, and tax are currently headwinds to earnings growth, and we expect to continue to increase our investments in R&D. That said, we're very focused on driving offsets where we can and improving the earnings power of the company.

Regarding the portfolio management decisions we announced today, while the Street's FY 2025 numbers didn't yet reflect the potential separation, with today's decision, we're able to increase investment in innovation-driven growth without near-term earnings dilution or an ongoing impact to cash flow, all with a focus on optimizing long-term shareholder value. I want to close by expressing my sincere gratitude to all of our employees for your hard work and unwavering commitment to the Medtronic mission. Your dedication was instrumental in achieving our results this quarter and making a difference for so many people around the world. Thank you. Geoff, turning it back to you to take it home.

Geoff Martha (Chairman and CEO)

Okay, thank you. But before I wrap up, I want to note that Tom Holloran passed away last week at the age of 94. Tom provided decades of leadership to our company, first as General Counsel, then as President, and as a director on our board for many, many years. In the early 1960s, Tom was one of the instrumental people who created our Medtronic mission, together with our founder, Earl Bakken. Tom was also a significant leader in the Twin Cities and beyond and served on several company boards. Our thoughts are with Tom's family as they celebrate his life. Now, before we go to analyst questions, I'll close with a few brief concluding comments on our progress. You've seen now for several quarters in a row that we're delivering on our commitments with durable mid-single-digit revenue growth.

When you look over the last couple of quarters, we've had a rapid cadence of meaningful, innovative product approvals, many of which are just getting started, including EV-ICD, both PulseSelect and Affera in PFA, Inceptiv for SCS, Percept RC for DBS, and of course, our new Simplera Sync sensor in diabetes. We can't forget Symplicity for hypertension. When you combine these with our investments to enter surgical robotics, along with the strong execution we're having in businesses like spine and diabetes, this is what gives us confidence in our ability to continue delivering durable growth. At the same time, we've been sharing with you our efforts to restore the earnings power of the company, and we're seeing those efforts begin to show up in our financials.

The comprehensive transformation that we've been working on, streamlining our operating model, aligning incentives, revamping our capital and portfolio management activities, and instilling a performance-driven culture, well, this is also having an impact. These changes take time, and we're certainly not done, but it's very encouraging to see our progress and where we stand today. Equally exciting are the catalysts that we see coming, which we believe will lead to significant advancements for patients and value creation for both healthcare systems around the world and our shareholders. With that, let's move to Q&A, where we're going to try to get to as many analysts as possible. 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?

Operator (participant)

For the sell-side analysts that would like to ask a question, please select the Participants button and click Raise Hand. If you're using the mobile app, press the More button and select Raise Hand. Your lines are currently on mute. When called upon, you will receive a request to unmute your line, which you must respond to before asking your question. Lastly, please be advised that this Q&A session is being recorded. For today's session, Geoff, Karen, and Ryan are joined by Que Dallara, EVP and President of Diabetes; Mike Marinaro, EVP and President of the Medical Surgical Portfolio; Sean Salmon, EVP and President of the Cardiovascular Portfolio; and Brett Wall, EVP and President of the Neuroscience Portfolio. We'll pause for a few seconds to assemble the queue. All right. We'll take the first question from Larry Biegelsen at Wells Fargo. Larry, please go ahead.

Larry Biegelsen (Managing Director and Senior Medical Device Equity Research Analyst)

Good morning. Thanks for taking the questions, and congratulations on another nice quarter here. I, I wanted to just focus my one question on the fiscal 2025 comments, Geoff and Karen. You talked about durable growth. You know, is that—should we think about that as mid-single-digit organic growth? And just help us... I think there'll be some concerns about what we're seeing in the AFib business, you know, given the low double-digit decline in the U.S.. What are the, you know, puts and takes to consider there? And on earnings, Karen, can you quantify those headwinds, inflation, tax, and FX in fiscal 2025? And consensus is at about 5%. You know, are you comfortable with consensus, EPS growth? Thank you for taking the question.

Geoff Martha (Chairman and CEO)

You know, hey, well, first of all, thanks for the question, questions, Larry. You know, maybe I'll start with the CAS one, and then Karen, maybe Sean and I will take the AFib one, and then Karen can talk about the FY 2025 questions. So, you know, I, I'm gonna phone a friend and tap Sean here in a second here, but on our AFib business, you know, look, we're confident in the investments that we made that are gonna bear fruit here. Yet, we haven't seen it translate into financials yet, but there's lots of leading indicators here that we're seeing that give us confidence, both in, you know...

Well, one in, you know, continued, yeah, I think stronger performance than people might think in cryo, but you know, importantly, in PFA for both PulseSelect, our organic program, and then Affera. But, Sean, do you want to comment on this a little more specifically for Larry?

Sean Salmon (EVP and President of the Cardiovascular Portfolio)

Yeah, sure, Geoff. So, Larry, in the U.S., what we had experienced was the first time ever a competitor in the cryo segment, so we had a 100% market share, and we had the competitor ramp up their production. We felt that in the fourth quarter. I think there's also some, some anticipation for some new products we're launching, including a Nitron CryoConsole, a refresh on our capital equipment for cryo, and of course, the PulseSelect, which just started its launch in the United States after the quarter closed. And that's doing very, very well. The feedback has been exceptional. Doing well in the United States, doing well outside the United States, and I think those catalysts to growth of pulsed field for both the PulseSelect, that's the single-shot technology, as well as our point-by-point ablation, is driving a lot of enthusiasm.

So I think we're gonna see a return to growth, and into next year, we'll really feel the full force of those launches. So, you know, it's a step back, certainly in the United States, but the 11% growth worldwide, or outside the United States, I should say, is giving us a lot of confidence. This is a pipeline that's poised to return us to growth in that segment.

Geoff Martha (Chairman and CEO)

Thanks, Sean.

Karen Parkhill (CFO)

On FY 2025, Larry, I would just start with the fact that we're really pleased with our performance through these last several quarters. You know, Q3 was another solid quarter, our fifth consecutive quarter of solid mid-single digits, and I would point out that, you know, we drove that mid-single-digit growth this quarter off of mid-single-digit comps last year. And that's what we expect to continue into FY 2025. You know, we've been working through our planning process, and we expect to wrap that up in advance of our Q4 earnings call. So we'll give our guidance in May. You know, not ready to give you real specifics, but from a high level, we've had no major changes to the puts and takes for next year that we discussed on our earnings call in Q2.

We're focused on obviously setting up guidance that, that sets us up for success, prioritizes innovation, and, and allows us to deliver on our commitments. But just, just on margins and down the PNL, you know, there are puts and takes. We've got inflation that's stabilizing a bit, but it's still higher than historical. Currency is always dynamic, but at recent rates, we are facing a decent headwind from FX, and, and we'll just have to see how that shakes out. Global tax reform is likely to be a headwind, but as always, you know, we're focused on driving offsets where we can.

And as you know, we've made, we've made good and real progress on our COGS cost out work, and that started with centralizing our global ops and supply chain and, you know, focusing those teams on putting in place tangible programs that we now have in place, to drive that cost out work. And always, you know, we're continuing to focus on driving pricing as an important lever. You know, we've built a new muscle around pricing, and we're just making it stronger and stronger. And then, you know, we're always focused on controlling expenses. We've got, you know, discipline on our largest driver of our expense, which is our headcount, and we expect that to continue. So, you know, really, no major changes from what we laid out, last quarter.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay. Okay, thanks, Larry. And I'll remind the analysts, please, stick to one question and a related follow-up if needed. Brad, can we take the next question, please?

Operator (participant)

The next question comes from Robbie Marcus at JPMorgan. Robbie, please go ahead.

Robbie Marcus (Medtech Senior Analyst)

Oh, great. Thanks, and good morning, everyone. Wanted to ask on the patient monitoring business, the original intent was to try and sell it or spin it. You're now keeping it and exiting the ventilator business. Just maybe walk us through the thought process, what happened in the market, and why this is the best outcome for Medtronic. Thanks.

Geoff Martha (Chairman and CEO)

Sure. I'll take that one, Robbie. So, you know, a couple of things, I'll start with... You know, a couple things have changed, and I'll start with what we have- we do have strong conviction in driving, you know, profitable category leadership, in this, what we're calling Acute Care and Monitoring business. And a couple of dynamics have changed. And just a reminder, the monitoring component, the patient monitoring component, is the biggest part of this, of that, of those businesses that we intended to spin. I think the biggest thing that changed is our, you know, two things. Our improved competitive positioning, you know, is in our monitoring business in particular, changed over the last year.

You know, as we are working on the process, we continue to run the business. It performed well, and the competitive dynamics versus our, you know, main competitor, Masimo, changed significantly for the positive for us. And we believe that we can ensure that that change is durable with the increased investment. And, you know, we found a way to make that increased investment, which leads to, you know, the decision to wind down the vents business. It's a very difficult decision, but the business became increasingly unprofitable throughout the last year. You know, the growth slowed even more, and the dynamics within the vent segment are changing, you know, moving to lower acuity ventilators.

You know, our kind of, I'd say, unique and worthy contributions are more in the higher acuity hospital-based. So with that market changing and it becoming increasingly unprofitable, our decision to wind that down creates the oxygen, the investment if you will, that we can fund the monitoring side of the equation here, and ensure that this, our competitive positioning versus Masimo, we feel like we can extend it. Another dynamic that has emerged is the use of data and the importance of data in this space, and that's been changing and becoming increasing. Actually, I'd say, it's the basis for innovation.

Our confidence in taking that data and translating that into meaningful iteration, rapid iterations, as well as disruption over time, is pretty, is pretty high, given what we've been able to do with, with AI and other parts of the company. So, you know, you add all this together. I'd probably say the, you know, the last thing I'll make a comment on is, as a company more broadly, we continue to prioritize, you know, profitable growth and category leadership. And when you take all these factors together, you know, we believe we're able to provide increased investment for this acute care monitoring business, or we're calling it ACM now, using the savings from vents and also bringing the two. There, these were two separate businesses, our respiratory interventions business with ventilators in it and our monitoring business.

Bringing them together at the leadership level, also creates us some savings, and then we can fund the incremental investment needed for the monitoring business, all without dilution to our P&L. So, you know, the last thing I want to say is, This was a difficult decision, and, it doesn't take anything away from, our employees, who played such a pivotal role during COVID in driving ventilator innovation and responding to the global needs, during the COVID, pandemic. And I also wanna give a nod to the legacy of the Puritan Bennett brand, which has been so strong and, and we're proud of the rich legacy of this business and Puritan Bennett ventilators, and, this decision has not been easy.

You know, last thing I'll say is, this does not mean that, you know, we're gonna shy away from additional portfolio moves, so don't read anything into that. But the bar is high for any strategic activity that's gonna dilute our focus or our earnings.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay, thank you, Robbie.

Great.

We'll take the next question, please, Brad.

Operator (participant)

The next question comes from Joanne Wuensch at Citi. Joanne, please go ahead.

Joanne Wuensch (Managing Director and Head of U.S. Healthcare Research)

Good morning, and thank you for taking the question. There are a lot of products that I could ask about, so I'm just gonna throw a couple of headline ones out there. Diabetes, congratulations on a return to U.S. growth. Is there a way to peel that apart a little bit on, new accounts or new patients versus renewals? And I guess my second question, has to do with Hugo, and if you can give us a little bit of a state of an update on how those launches are going outside the United States. Thanks.

Geoff Martha (Chairman and CEO)

Well, thanks, Joanne, for the questions. You know, obviously, we're... We've been working this diabetes turnaround for some time, and it hasn't been a straight line, but we definitely have some momentum here on 780G, that platform, and just our capabilities here to use the data, like I was talking about in the patient monitoring business, here as well, to create, you know, algorithms that really are differentiated and drive differentiated outcomes for patients. And that's playing out globally, and now in the United States. So I'll have Que, if you'd come in and answer Joanne's... If you could, quote, unquote, "peel it apart" a little bit more for Joanne, I'd appreciate it.

Que Dallara (EVP and President of the Diabetes Operating Unit)

Yes, look, we're very pleased with the progress that we've made every quarter since 780G was launched, and we are seeing new patients grow significantly as well as renewals. So both are progressing very well. Look, it will take time to rebuild our install base, but you can see with the pump growth that we saw in the U.S., 40% - you know, high 40s year-over-year. That's gonna be followed by consumables and CGM growth as well. So we expect to continue to make progress every quarter, but pretty pleased with how the market's reacted to the product introduction.

Geoff Martha (Chairman and CEO)

Okay, thanks, Que. Mike Marinaro, can you jump in on Hugo here?

Mike Marinaro (EVP and President of the Medical Surgical Portfolio)

Yeah, thanks, Joanne, for the question. So we continue to see very good progress with Hugo outside the United States with an expansion of installations in countries around the globe. In fact, we entered into two new sub-regions in Central and Eastern Europe. And are continuing to see very good response to the things we've talked about previously. So the open console, the very crisp visualization, and increasingly very good feedback around our Touch Surgery enterprise platform, which on its own continues to expand and had a very good quarter with installations both with Hugo and in our broader surgical business.

As also as Geoff noted during the commentary, we continue very good progress with our Expand URO IDE here in the U.S., and are preparing for our first patient enrollment in the hernia IDE. So in total, you know, good reception, a sharpening sort of appreciation for the features of Hugo, I think, and an emergence of the digital ecosystem and an appreciation for that, as well.

Geoff Martha (Chairman and CEO)

Yeah, I'd say, Joanne, on this one. Thanks, Mike, first of all. I'd say on this one, you know, the robotic system has been well-received, and the features are differentiated. But it's broader than that, as Mike pointed out. I mean, it's about the digital platform that comes with it and as well as the instrumentation as we transition, you know, instrumentation in our laparoscopic business onto the robot, particularly stapling and energy. You know, all these moves build momentum, build capabilities and momentum over time. And we're seeing. You know, we saw that play out in the spine business. You know, we bought Mazor, and it wasn't an overnight change to. You know, you saw where our last couple of quarters have been.

But it, you know, it took the integration of these things, you know, Mazor with our navigation and then imaging, and then getting these AI-guided surgical planning systems. All these things coming together, you know, every quarter more progress have built the ecosystem we have today that's really driving the not just the growth for Medtronic, but the growth for the spine industry right now. And we expect to do the same thing in soft tissue surgery.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay, thank you, Joanne. We'll take the next question, please, Brad.

Operator (participant)

The next question comes from Travis Steed at Bank of America. Travis, please go ahead.

Travis Steed (Managing Director of Equity Research and Medical Technology)

Hey, thanks for taking the question. Can you hear me okay?

Geoff Martha (Chairman and CEO)

Yeah. Hey, Travis. How you doing?

Travis Steed (Managing Director of Equity Research and Medical Technology)

Good. Good, good. Hey, hey, Geoff, curious if you could talk a little bit more on the gross margin productivity, some of the things you're driving there. And can you still get the kind of 2x-3x annual cost savings on the gross margin line? And last month, at the investor conference, you talked a lot about leverage EPS growth. I'm curious if that's a comment that applies to FY 2025 or if that was more of a longer-term comment.

Geoff Martha (Chairman and CEO)

Sure. Let me tell you. I'll start off and transition to Karen. You know, on the gross margin, you know, a couple of things that I'd point out. One is pricing, Karen talked about that. I do think, you know, what we're seeing here is a lot of innovation in the industry, and a lot at Medtronic. And this innovation, we're finding, is valued. It drives value in the health system. And I think we've gotten better at showing the health economics of the innovation that applies from the innovation, in addition to the clinical value. I think in the past, we were pretty indexed on clinical value, and more recently, we keep that focus, and then add the health economics. And it's getting paid for.

And we're doing a better job of making those points and getting that pricing, and I do think it's durable. So the pricing has increased, I'd say, for the company overall, 200 basis points or so relative to the past. And I think, you know, we're gonna keep pushing for even more. On the converse, you know, if you don't have the innovation, you know, be prepared for that as well, because I think hospitals have gotten more sophisticated in their purchasing. You know, your pricing is gonna pay for that if you're not keeping up with the innovation.

But we given where we are on the product cycles and given this pricing muscle, we feel good about that being incremental, especially to the historical baseline. The other you asked about is cost of goods sold productivity, and the answer, the short answer to your question is yes, we do think it's sustainable. We've got lots of opportunity here. You know, if you think about it, we have this pretty big footprint of factories and distribution centers, and too many suppliers, I've said in the past. Now, with Greg Smith coming in a couple of years ago, and we've centralized that, we can take a strategic look across that portfolio. And we have a long list of cost down programs, and then we've ensured that we've effectively contracted those between our global operations supply chain team and our operating units.

Because it takes release product engineering to make sure that these things, these cost programs can happen that are in our operating units. So we feel good about that, and we feel that that's sustainable. So those are two big changes that impact positively gross margins now and into the future. And speaking of the future, I'll turn it over to Karen to talk about your FY 2025 leverage question.

Karen Parkhill (CFO)

Yeah. So just on—I'll, I'll just add on gross margins, too. You know, we're pleased with our performance that we had this quarter. We overcame, you know, a 60 basis point headwind from FX and continued inflationary pressures. And, you know, a lot of that was driven by strong pricing, which Geoff talked about. We also did have some continued delays in China VBPs in aortic and peripheral vascular and stapling. And, you know, those VBPs could be coming through this coming fourth quarter, this current fourth quarter, you know, and potentially into next year. So that's just something going on in gross margins. You know, as we talk—as we think about leverage down the P&L, clearly, we're focused on driving leverage.

You know, I think we talked about it last quarter, Travis, you know, clear leverage is where your bottom line grows faster than your top line. You know, we're focused on getting there eventually. We're not ready to talk about that for FY 2025. It's still too early for our planning guidance, and I've already pointed out, you know, lots of different puts and takes for next year.

Geoff Martha (Chairman and CEO)

Yeah. Like Karen said, you know, pricing, you know, on the gross margin side, pricing, cost of goods, over productivity, a lot of focus there. Karen mentioned earlier in the call about discipline around our G&A. You know, our people are the number one driver of our cost there, and so we've put a discipline in there that we're holding to. And then finally, just setting up the portfolio for profitable growth. And the decision on, you know, with the changing dynamics, the decision to hold our monitoring business, 'cause of the confidence and the profitable growth, you know, is evidence of that, is setting up the portfolio the right way.

So, I'll leave it there on the focus of recovering the earnings power of the company, and, you know, we'll provide more details on that, FY 2025 look next quarter.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay. Thank you, Travis. Next question, Brad.

Operator (participant)

The next question comes from Vijay Kumar at Evercore ISI. Vijay, please go ahead.

Vijay Kumar (Senior Managing Director)

Hi, guys. Thanks for taking my question, and, Geoff, good morning to you. I guess one on earnings question here. A look at your peers, you know, their earnings have grown versus, fiscal 2019 pre-pandemic levels. Medtronic earnings have essentially been flattish. Can Medtronic commit to, you know, perhaps above-trend earnings growth over the medium term as you play catch-up, similar to what your peers have done? And I think related to that, Geoff, in the past, you've mentioned about a $400 million drag from investments in Ardian, Hugo. Where are we on those investments? Are they still a drag? When can those be profitable to the business?

Geoff Martha (Chairman and CEO)

Thanks, Vijay, for the questions. I'll start with the latter question on Ardian and Hugo, and let Karen handle the earnings growth ones and further comment on the Ardian and Hugo. I'd say on... Look, Hugo, the way we're looking at Hugo is a part of our broader surgical franchise, an important part of that, and it needs investment. And it's, it is a, it is- if you look at Hugo specifically, it is taking a meaningful amount of investment to keep it going here. We've reached... I love the milestone that we're at now in terms of a robot that's out there, that's performing well, and it's got great, you know, features that are valued by, you know, physicians globally.

The feedback's been strong, but we still got more work to do. We've got to get our instruments on there. We've got to complete the U.S. trial. We've got to continue to build out a U.S., you know, a capital equipment U.S. sales force. You know, so this is a tall order, but our confidence in executing there is high. And it's important to this, this huge business, our surgical business, which is our biggest business, and drives a lot of profit and cash flow. I say our confidence is high. I know we're up against a strong competitor in Intuitive. But you know, we like our competitive positioning overall, and especially against the other, you know, potential robotic companies there.

The dynamics of this market, we think, you know, play in our favor. So there is investment there. On Ardian—and by the way, we're really trying to call it Symplicity now. We gotta get ready for some consumer education on this hypertension therapy. So we're trying to get rid of the Ardian term as much as possible, so we've got a swear jar going on around here on that one. But on hypertension, this one, we believe will start to show some profits here. So it's much less of a drag, and we hope to, in the next couple of quarters or, you know, in the medium term, this to, you know, generate not just revenue, but income.

It's a highly profitable, product line for us, with high gross margins, and it'll be a positive to our overall mix. Like I said, you know, Hugo is gonna take investment, but this one, I think, will provide oxygen, not, you know, in the next quarter or two, but over the medium term here. So I'll leave it there, but it's, and turn it over to Karen.

Karen Parkhill (CFO)

Yeah, and I would just say on the earnings, you know, we've made good progress on driving the earnings part of the company just in this year. You know, I noted that, we've been able to increase our guidance on the bottom line by $0.15 at the midpoint from where we initially started the year, and that's driven by the strong track record that we've driven in the last, you know, the first three quarters of this year. And we do expect, you know, that to continue. You know, over the medium and long term, we are committed to the right earnings growth. You know, there's no debate about that. And we're focused on, you know, overcoming the headwinds that we've got, over that timeframe and, you know, delivering on that growth.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay, thanks, Vijay. We probably have time for two more questions, Brad. Take two more.

Operator (participant)

Sure. The next question goes to Matt Miksic at Barclays. Matt, please go ahead.

Matt Miksic (Equity Research Analyst)

Hi, thanks so much-

Geoff Martha (Chairman and CEO)

Matt, you there?

Matt Miksic (Equity Research Analyst)

for taking the question. Can you hear me okay?

Geoff Martha (Chairman and CEO)

Yeah, we can now.

Matt Miksic (Equity Research Analyst)

Great. Thank you. So maybe just a follow-up here on some of the products that you've mentioned, recently approved, and I think some of the products that you hope to see approved in the coming quarters. And I'm thinking of, like, Aurora and PulseSelect and maybe some additions to the U.S.-approved products in diabetes. And I know Sean mentioned sort of the, you know, rough trajectory for AF ablation, but maybe, you know, on that business, for example, you know, any additional color around cadence? You know, is this something that we start to see improve in the fourth quarter, or is this sort of like an early to mid-2025 kind of process?

Some of the same commentary for sort of cadence and trajectory in Aurora and, for example, maybe the diabetes business would be super helpful. Thanks.

Geoff Martha (Chairman and CEO)

Sure. So maybe I'll start with Sean. You know, and before I turn it over to Sean, I, as I pointed out in the commentary, you know, all the puts and takes in our ablation business, we call Cardiac Ablation Solutions, our AFib business. We do see an acceleration in this business in even the fourth quarter here. But I'll turn it over to Sean to talk about, you know, AFib and then Aurora.

Sean Salmon (EVP and President of the Cardiovascular Portfolio)

Yeah. Thanks, Geoff. And Matt, the trajectory is obviously gonna be upward for both the EV-ICD as well as the CAS business in total. As you launch these new technologies, there is some training that you have to do to make sure that the physicians are comfortable with, you know, how to use the products. And that's, you know, of course, something we're very deliberate about to make sure that there's a good patient outcome and good acceptance of the technology. And that's something we do, you know, pretty frequently in our business, so, you know, we're really, really good at it, and the feedback has been excellent. The procedure efficiency on PulseSelect has been... You know, we're getting these cases done in, like, a half an hour. And the acceptance on Aurora has been exceptional, too.

As I said, I think it's the same story for both those technologies, where they push growth now, but into next year, we'll feel the full impact of these innovations.

Geoff Martha (Chairman and CEO)

You know, Que-

Mike Marinaro (EVP and President of the Medical Surgical Portfolio)

Great

Geoff Martha (Chairman and CEO)

... do you wanna comment on diabetes?

Que Dallara (EVP and President of the Diabetes Operating Unit)

Yeah, look, we continue to push the pipeline in diabetes, starting with Simplera, approved with CE Mark last September, followed by Simplera Sync, recently approved, that we announced at JPMorgan. And we completed our clinical trials for 780G with Simplera Sync in the U.S., which we expect to submit in this first half of the calendar year. So that's the cadence that you should expect. And as Geoff mentioned in his opening comments, we have next-generation products that we discussed at ADA last year that we continue to make progress on and aggressively moving to get next-generation tethered pumps and patch pumps out to the market.

Geoff Martha (Chairman and CEO)

Okay. Thanks, Que.

Matt Miksic (Equity Research Analyst)

Great. Thank you.

Geoff Martha (Chairman and CEO)

Thanks, Sean. Thanks, Matt.

Ryan Weispfenning (VP and Head of Investor Relations)

I apologize to the analysts that we weren't able to get to. We have time, though, for one more, Brad.

Operator (participant)

The final question comes from Anthony Petrone at Mizuho Securities. Anthony, please go ahead.

Anthony Petrone (Managing Director)

Thanks. Can you hear me okay?

Geoff Martha (Chairman and CEO)

Yep, Anthony, we can.

Anthony Petrone (Managing Director)

Hello? Okay, great.

Geoff Martha (Chairman and CEO)

Yep, Anthony, we can hear you.

Anthony Petrone (Managing Director)

Just one, condolences on passing of Tom to the team and his family. And maybe one just going to structural heart, maybe just the setup on the SMART Trial. Quick two-part question: One, was that ahead of schedule? Was it expected to be at TCT instead of ACC? So was the late breaker getting approved a surprise? And then, maybe just high level, how do you think that study will play out, you know, once we have the results? It is head-to-head in TAVR, in high-risk, symptomatic, severe, so just thoughts on how you think that data is received once it's out there post-ACC at that session in the coming weeks. Thanks.

Geoff Martha (Chairman and CEO)

Well, thanks. First of all, Anthony, thanks for the comment on Tom Holloran. He's a real legend around here, and just a great guy, so we're gonna miss him. On structural heart, you know, two comments before I turn it over to Sean. First, I really applaud the business for their evidence generation in total. You know, we just did our low-risk data, and we publish it every year... not just when it's convenient. And then they had the courage to do a head-to-head, which is not, you know, something that's often done in our space. And so I can tell you that I, for one, love that, just the commitment to data and the competitiveness to go head-to-head.

I'm very much looking forward to the results that are gonna come out in early April at ACC. But in terms of the specifics of what you're asking on how it might play out, I'll turn that over to Sean.

Sean Salmon (EVP and President of the Cardiovascular Portfolio)

Yeah, thanks, Anthony. The completion of enrollment happened in October of 2022. So that's a 12-month endpoint for the study, and that pushes you really out of the window for TCT. So I think we're on schedule, I'd say. You know, pleased to have been accepted as a late breaker at ACC. But, you know, that's really as expected, I'd say. In terms of the trial itself and how it'll be received, I think just right, the momentum that we have on data from the NOTION 10-year data, that's low-risk patients out to 10 years, showing superior durability of our valve compared to surgical implants. And then our four-year low-risk study with, you know, hard endpoint benefits and a widening benefit on serious outcomes like mortality and disabling stroke.

And then, of course, going head-to-head in a really important patient population, those with a small annulus. We say that's about 40% of the global market, really prevalent among women and within smaller patient populations, like in Japan, for example. So that's. I think it's really important and compelling data. It's a one-year outcome, which portends long-term outcomes. And I think that, you know, we're excited for the reception of those results, and we do think that that's a catalyst for growth for us with our really unique position in that particular subset of patients, which is a big chunk of the market at 40%.

Geoff Martha (Chairman and CEO)

Okay. Thanks, Sean. And so just to wrap it up here, you know, you know, one final comment, you know, on the ventilation, the monitoring and ventilation decisions. You know, as a result of these portfolio decisions, Bob White will be leaving Medtronic, and he's been, you know, just such an impactful and important leader for the company for a long time. And although the friendship will remain strong, we're definitely gonna miss working with him day to day, and I wanna wish him- I wanna wish him well. And I know that comes from the board of directors and the executive committee and everybody at Medtronic that's interacted with Bob. Just a high ethical leader and just a good guy, and we wish him well. And in terms of...

And so, in terms of today, I just wanna thank everybody for the questions. Definitely appreciate your support and and continued interest in Medtronic, and we hope you'll join us again for our Q4 earnings broadcast, which we anticipate holding on Thursday, May 23. And again, we'll update you on our progress and how we finish the fiscal year, but also look ahead to fiscal 2025. So with that, thanks for spending time with us today, and have a great rest of your day.