Medtronic - Q3 2023

Transcript

Geoff Martha (Chairman and CEO)

Hello, everyone, and thank you for joining us today. We reported our Q3 results this morning, and we executed to deliver a top and a bottom line that were ahead of our guidance and street expectations. We are urgently forging the path to durable growth, and there are many proof points of our progress in these results. Our Cardiovascular and our Neuroscience portfolios had strong, high single-digit organic growth as we launched new products and demonstrated continued strength in our established market-leading cardiac rhythm management and spine franchises. At the same time, some of the recent revenue headwinds that have held back our growth are subsiding, including product availability in businesses like Surgical Innovations, cardiac diagnostics, aortic, and ENT. The aggressive transformation at Medtronic is advancing.

We're focused on reducing complexity, enhancing our culture, improving capital allocation and portfolio management, and upgrading our global manufacturing operations and supply chain capabilities. At the same time, we're progressing on our plans for significant cost reductions. These are aimed at partially mitigating the continued impacts from macro conditions such as inflation and effects on our profitability and cash flow. These cost reductions also create room on our P&L so that we can increase our growth investments. I'm very encouraged by the rebound in our revenue growth, despite procedure volumes remaining a little softer in a few markets and volume-based procurement in China. Let's take a closer look at our Q3 results.

As I highlighted at an investor conference last month, we're thinking about our portfolio of businesses in three groups: highest growth, synergistic, and established market leaders. I'll start with our established market leaders, a group of our largest businesses that make up about half of our revenue. Both our cardiac rhythm and spine businesses had really good quarters, growing 8% and 5% respectively. In CRM, we continue to see strong market adoption of our Micra leadless pacemakers, which grew 14%, and our defibrillation solutions business grew 7% as replacement headwinds are moderating. Just last week, we received CE mark for our Aurora extravascular ICD. In cranial and spinal technologies, we delivered another strong quarter, with 6% growth in core spine, including 12% growth in the United and 8% growth in neurosurgery.

This is driven by our market-leading ecosystem of AiBLE-enabling technology and the associated pull-through of our best-in-class spinal implants. From our AI-enabled surgical planning platform to our patient-specific and differentiated spine implants to our imaging, our navigation, and robotic technologies, we're differentiating ourselves with spine surgeons around the world. Turning to our surgical innovations business, SI grew sequentially as we made solid progress recapturing the share that we lost due to supply challenges over the last three quarters. Year-over-year, SI declined as a result of expected stapling VBP tenders in China, but excluding China sales, SI grew 5% in Q3. Look, surgeons around the world prefer our advanced surgical products, we expect the momentum we're seeing in SI to continue.

In particular, in our leading advanced energy franchise, we're seeing strong adoption of our recently launched cordless Sonicision 7, and we're preparing to launch our recently approved LigaSure XP. We're on the right path with our established market leader businesses. At the same time, we're advancing our position in high secular growth med tech markets. These businesses are contributing about 20% of our revenue today and collectively growing above our company average. We're investing disproportionately in these businesses and expect them to become an even bigger part of our growth over time. Starting with structural heart, while the TAVR market continued to be impacted by healthcare staffing challenges and COVID in Japan, we drove 11% growth in Q3, including 12% growth in the United States.

We're seeing great physician reception for our Evolut FX system, which just completed its first full quarter of launch in the U.S. Evolut FX combines industry-leading durability with enhanced and predictable valve deployment. In addition, data was presented during the quarter at PCR London Valves, showing Evolut FX's commissural alignment has improved significantly, which is important for coronary access and valve hemodynamics. Now looking ahead, we will continue to bring Evolut FX around the world, and we are currently seeking approval in the Japanese and European markets. In cardiac ablation solutions, we grew 3% globally as provincial China VBP tenders weighed on our results. Outside of China, CAS grew in the high single digits, including low double-digit growth in the United States on the continued strong adoption of our leading Arctic Front cryoablation technology. We're also advancing what we believe will become the leading pulsed field ablation portfolio.

In two weeks, highly anticipated data for our PULSED AF pivotal trial will be released in the late-breaker session at ACC. The trial is evaluating our PulseSelect PFA catheter in both paroxysmal and persistent patients. This will be the first results from an IDE trial in the PFA space. We're on track to be one of the first companies with a PFA catheter in the U.S. market. We also continue to make progress on bringing our Affera mapping and navigation platform and Sphere-9 catheter to the market as we completed enrollment in our pivotal trial during the quarter. Sphere-9 can perform high density mapping and deliver either PFA or RF energy, all from the same catheter. Given Sphere-9 is a focal point PFA catheter, it is highly complementary to our PulseSelect anatomical PFA catheter.

Our CAS business just launched the AcQCross transseptal access system with a zero exchange workflow and the only system approved for both mechanical and RF crossings. When you think about our Arctic Front cryo solution, our DiamondTemp RF catheter, our PFA catheters, our left heart access solutions, and our Affera map nav system, we're assembling a leading ecosystem of technologies to meaningfully increase our participation in the fast growth $8 billion EP ablation space. In surgical robotics, we're making good progress as the second major player in this exciting space. We continue to see positive sales momentum with the rollout of our differentiated Hugo robotic system in many international markets. We started our U.S. IDE trial for our urology indication during the quarter.

Given less than 5% of surgical procedures globally are done robotically, we expect our surgical robotics business to become a meaningful growth driver for Medtronic. In neurovascular, we grew 9% and would have grown a couple of points more if not for the China VBP. We continue to see very strong growth in several categories, including flow diversion, aspiration, and stent retrievers. Given stroke is the number two cause of death globally, and there is still very low therapy penetration, we see a long runway for high growth in this market that is approaching $4 billion. In diabetes, we continue to see strong international growth offset by declines in the U.S., where we lack our latest products. We remain focused on resolving our FDA warning letter and are ready for re-inspection.

We also remain in active review with the FDA on our submission of the MiniMed 780G system with the Guardian 4 sensor. Outside the US, our diabetes business grew 18% on continued strong sales momentum of 780G and Guardian 4. The 780G is now launched in over 90 countries, up from 60 last quarter. We're seeing strong CGM attachment rates, which drove CGM growth of 34% outside the US. We continue to invest heavily in assembling our ecosystem of durable pumps, smart pens, patch pumps, sensors, algorithms, and customer service with multiple programs under development, all with the intent of restoring strong growth of our important diabetes franchise over the coming years. In our synergistic businesses, we also had strong performances across several businesses. We grew double digits in cardiac diagnostics as we ramped up production of LINQ II.

In neuromodulation, we grew 12% in pain stim. The market continues to recover. Our GI business grew high single digits on strong adoption of GI Genius, which uses artificial intelligence to help physicians detect polyps during colonoscopies. With that, I'll turn it over to Karen to discuss our third quarter financial performance and our guidance. Karen.

Karen Parkhill (CFO and EVP)

Thank you, Geoff. Our third quarter organic revenue increased 4.1%, exceeding our guidance and representing a significant acceleration from our first half results as we begin to put the acute supply chain challenges behind us. Our non-GAAP EPS of $1.30 landed above our guidance by $0.03 on higher revenue growth and increased interest income, and $0.06 if we take into account a larger currency headwind than expected at the beginning of the quarter. Looking at our revenue from a geographic perspective, U.S. grew 2% and our non-U.S. developed markets increased 6%, even with a 3% decline in Japan as COVID affected procedure volumes. Excluding Japan, non-U.S. developed markets increased 8%. Emerging markets grew 5%, impacted by an 8% decline in China from COVID and VBP provincial tenders in stapling, cardiac ablation, and neurovascular.

Outside of China, emerging markets actually grew 17%. I would also note that China represented 110 basis point headwind on our total company growth, which highlights the strength of the recovery in our other markets. VBP has affected us more than many of our competitors, given the size and breadth of our business in China. We do expect that we are now through the majority of the impact. Our adjusted gross margin declined in the quarter as we faced impacts from inflation and currency, with currency driving about a third of the change. These declines were expected and a result of inflationary pressures that occurred two to three quarters ago. Our incurred manufacturing variances have continued to be significant in the past few quarters.

As they roll off our balance sheet onto our P&L, we expect continued gross margin pressure in Q4 and next year. The gross margin impact translated into a decline in our adjusted operating margin as well, although this was partially muted by expense control and the benefit of our currency hedging program. Our balance sheet remains strong and we continue to execute our enhanced capital allocation and portfolio management work. Balancing future growth investments with returning a minimum of 50% of our free cash flow to shareholders, primarily in the form of our dividend. We see strong opportunities for organic growth investments internally, leading us to target R&D growth at or above revenue growth. We continue to focus on supplementing our organic investments with tuck-in acquisitions.

We've also announced this fiscal year three businesses we intend to separate that account for about 8% of our revenue. We're making progress towards completing those transactions. We expect to close our renal care joint venture with DaVita here in the fourth quarter and continue to progress with the separation of our patient monitoring and respiratory interventions businesses, which we expect to occur sometime in the second half of next fiscal year. We have also closed on acquisitions that will contribute to our growth in the years ahead, including Affera, which expands our presence in cardiac ablation, and Intersect ENT, which adds unique sinus implants to our ENT portfolio. We have driven these moves to not only focus and streamline our portfolio, but also to improve our weighted average market growth rate over time. Turning to our guidance.

Given our top and bottom line beat in the third quarter, we are raising our full year revenue growth and EPS outlook. The top line, we expect our fourth quarter organic revenue growth to be in the range of 4.5%-5%, which is unchanged from what was implied by our second half guidance that I gave last quarter. I would note that our organic growth guidance excludes the impact of currency and revenue from our Intersect ENT acquisition, and it also now excludes revenue from our renal care solutions business, as we expect the separation to occur during the fourth quarter. If recent exchange rates hold, foreign currency would have a negative impact on our fourth quarter revenue of $165 million-$215 million.

Taking into account currency, Intersect ENT revenue, and the partial quarter of renal care solutions revenue, our guidance would imply reported revenue in the range of $8.2 billion-$8.3 billion. We are also maintaining the fourth quarter revenue growth segment expectations that were implied by the back half guidance I gave last quarter. We continue to expect cardiovascular to be up 5.5%-6%, medical surgical to grow 2.5%-3%, neuroscience to increase 6.5%-7%, and diabetes to decline in the low single digits, all on an organic basis. On the bottom line, we continue to drive significant expense reductions to partially offset the impact of inflation and foreign currency.

Given our third quarter $0.03 beat, we raised the lower end of our fiscal 2023 non-GAAP diluted EPS guidance by $0.03 to the new range of $5.28-$5.30, including an unfavorable currency impact of approximately $0.21 at recent rates. For the fourth quarter, we expect non-GAAP diluted EPS to be in the range of $1.55-$1.57. At recent rates, FX is about a $0.09 headwind to fourth quarter EPS. While we won't give guidance for next fiscal year until our fourth quarter call in May, I did give some color on last quarter's call and will remind you of it today. We're encouraged by our recent progress on revenue growth. At the same time, current macro factors and our imperative to protect R&D investment are expected to create significant EPS headwinds next fiscal year.

At recent rates, FX is a few hundred million dollar tailwind to fiscal 2024 revenue and an approximate $0.27 headwind to EPS, which translates to a 5% headwind to EPS growth. While inflationary pressures are starting to moderate, we still see significant mid-single digit inflationary impacts on our cost of goods sold as wage and raw material price increases continue to roll off our balance sheet and into our P&L. Both inflation and currency, and to a lesser extent interest and tax, are all looking to be headwinds that reduce our earnings power in fiscal 2024

I would summarize by saying that as we navigate this period of increased macro headwinds, we will be driving disciplined cost reduction, and we are committed to investing in our future growth drivers and our turnaround, as we firmly believe these important investments are necessary to drive durable revenue growth and long-term value creation. Before I hand it back to Geoff, I want to take a moment to thank the thousands of employees across Medtronic who delivered this quarter. You are executing with excellence and accountability, leveraging our scale with differentiating capabilities and managing our resources to accelerate innovation. It is because of your efforts that we will create a durable growth company powered by our people as we continue our mission-driven work of alleviating pain, restoring health, and extending life. Back to you, Geoff.

Geoff Martha (Chairman and CEO)

Thank you, Karen. Before we open the lines for questions, I'll make a few closing remarks. Last quarter, I noted that our aggressive agenda to transform this company would take time. That's still true. I hope you'll take away that we are operating with a high sense of urgency, which you can see reflected in our results this quarter. We're reducing our complexity, enhancing our capabilities, and augmenting our management team with new leaders that bring an outside diverse perspective. We're also exercising decisive capital allocation and portfolio management, devoting more capital to high growth opportunities and divesting non-core assets. There is an intense focus from me, our board, our management, and our employees to create a company with sustainable growth that you can count on.

We're in attractive markets with growing populations globally that can benefit from our therapies, and we fully expect to deliver durable revenue growth and turn our scale into a long-term competitive advantage. Through this process, create tremendous value for our shareholders. Let's move to Q&A. We're going to try to get as many analysts as possible, so we ask 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?

Brad Wells (VP of Investor Relations)

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 the Diabetes Operating Unit, Sean Salmon, EVP and President of the Cardiovascular Portfolio, Brett Wall, EVP and President of the Neuroscience Portfolio, and Bob White, EVP and President of the Medical Surgical Portfolio. We'll pause for a few seconds to assemble the queue. We'll take the first question from Robbie Marcus at JPMorgan. Robbie, please go ahead.

Robbie Marcus (Managing Director, Senior Analyst)

Great. Congrats on a nice quarter and good morning. Maybe I could start. I appreciate, Karen, you're not giving formal guidance, but I was hoping you could discuss where the OpEx cuts are coming from. It sounds like you're gonna continue to invest in R&D. What exactly are you cutting? How aggressively are you cutting? Will this prevent any of your competitiveness on the top line? Then I'll ask my follow-up as well. You know, the street has you at 3% EPS growth for next year. Do you think that's the right place for us to be based on your comments today? Thanks.

Karen Parkhill (CFO and EVP)

Yeah, thanks for your question, Robbie. You know, when we look at our higher cost environment that we're facing, like many companies you've seen recently, you know, we really have to evaluate our full cost structure and look for opportunities to reduce both spending and cost. We're in the midst of that right now. We expect to drive a significant expense reduction to help partially offset the headwinds that we're facing and the investment that we believe we need to make. You know, when we look at next fiscal year, I'll just give you a little bit more comments on it. I know there's a desire to give EPS guidance early, but we're still working through our plan, and there are more than a typical number of moving pieces.

That's why we're sticking to our normal timeline of giving guidance in Q4. You know, but, when we look at revenue, we grew 4.1% in Q3. Our guidance for Q4 implies sequential improvement. You know, we've said that we expect to drive greater revenue growth in 2024 than we have in 2023, and we've said that we're focused on delivering durable mid-single digit revenue growth over the longer term. We like the progress that we've made recently, both on, you know, our recent revenue growth performance and on, you know, important things in our pipeline to drive that revenue growth. We always have said that we believe our WAMGR is in the mid-single digit range.

You know, as we move down the P&L, we've got this delayed inflationary impact on our gross margin that you've seen this quarter and that will continue into next quarter and FY 2024. We've seen inflation, the pressures on inflation beginning to improve, as you know, that's got a delayed impact on our P&L. We also have currency interest and tax that are macro headwinds as well. Obviously, we've talked about the fact that we're gonna continue to drive investments to drive the long-term growth and turnaround of this company. We're still in the process of seeing how all that nets out with our significant expense reduction, obviously, we're gonna give guidance on our fourth quarter call in May.

We have said that this will be a tougher year on the bottom line, where our earnings power will be significantly reduced. Hope that helps.

Geoff Martha (Chairman and CEO)

Okay. Thanks, Robbie. Next question, please, Brad.

Brad Wells (VP of Investor Relations)

The next question comes from Larry Biegelsen at Wells Fargo. Larry, please go ahead.

Larry Biegelsen (Managing Director, Senior Medical Technology Analyst)

Good morning. Thanks for taking the question, and I'll echo my congratulations on a nice quarter here. I'd like to focus on China, which declined high single digits in Q3. Can you talk about, you know, what you're seeing there in terms of procedure volumes coming back and the VBP headwind? You gave a lot of helpful color in the JPMorgan slides on the % of the headwind in the first half and the % of products impacted in fiscal 2023 and fiscal 2024. I guess what I'm trying to understand is, you know, what it. You know, overall China growth, fiscal 2023 and fiscal 2024, how much of a headwind will that continue to be with VBP?

You know, how does it impact your ability to grow mid-single digits in fiscal 2024? You know, I heard, Geoff, you talk about durable growth a lot this morning. Should we be thinking more like 4%-5% next year, because of the, you know, VBP headwinds? Thanks for taking the question.

Geoff Martha (Chairman and CEO)

Yeah, thanks. Thanks, Larry. Good to hear from you, and thanks for the question. Obviously, China's a big one for us. Yeah, I'll turn it over to Karen to answer some of the kind of the headwinds, what we're seeing here recently.

Karen Parkhill (CFO and EVP)

Yeah. Just, you know, it's hard for us to parse out this quarter the impact of procedures and VBP. We're not doing that. We have said on VBP that we expect to be 50% done with the impacts of VBP by the end of this fiscal year. As we move into next fiscal year, we still do have some VBP to come, but we expect to be 80% done by the end of next fiscal year. You know, this quarter we had a VBP impact from stapling and cardiac ablation and a little bit in coils from neurovascular.

As we look ahead into next fiscal year, we still do have some stapling provincial tenders coming, and we've got a little bit more neurovascular and some cardio businesses, including cardiac rhythm, structural heart, aortic, peripheral vascular. Again, you know, we're the majority finished by the end of this fiscal year, and we've got a little bit more to go next fiscal year.

Geoff Martha (Chairman and CEO)

I mean, just to clarify one thing. I mean, we think that 80% of our portfolio, as we've taken a step back, could be impacted by VBP. That'll we're 50% of the way through, and, you know, the remaining 30 we'll get in FY 2024. We don't think the remaining 20 will be impacted. Certain things that are nuanced or under the radar screen. You know, what we're doing here is taking out some of our selling and marketing costs to China to offset the lower prices and 'cause this business is now more contracted through these VBPs so that the government is living up to the volume commitments from those VBPs at these lower prices. The discounts have gotten lower as they've gone on.

I think the Chinese government has realized that medtech's not exactly like pharma, and we have more selling expenses than maybe pharma does, 'cause I think they modeled a lot of this off of pharma and based on my discussions with Chinese government officials. That's, that's good. We're basically we'll reset our business and grow from there. FY 2024 will be another year where China's a bit of a headwind. We factor that into our guidance. We're taking on expenses, and we'll rebase our business and grow from there. A lot of thought, you know, a lot of conversations with Chinese government, a lot of thought here. Look, you know, we're comfortable with our strategy.

Larry Biegelsen (Managing Director, Senior Medical Technology Analyst)

Thank you, Larry. Next question please, Brad.

Brad Wells (VP of Investor Relations)

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

Larry Biegelsen (Managing Director, Senior Medical Technology Analyst)

Hey, guys. Congrats on the print, and thanks for taking my question. I had two-part, and I'll ask them upfront. When you look at Q4, what is changing sequentially here, Karen? When I look at Q3, you did 4% organic despite MedSurg declining, continued diabetes headwinds and China headwinds. In Q4, what are these three pieces? What are you assuming for those three buckets? I think you mentioned a renal impact in Q4. Could you specify that? Geoff, for you, I understand you're not giving fiscal 2024 guidance, but when you think about the incremental changes, right? What are the positive tailwinds and negative headwinds? Is China still declining in fiscal 2024? What happens with diabetes? Is that on the plus side or minus side?

Any other, you know, plus and minus at a high level would be helpful.

Karen Parkhill (CFO and EVP)

Yeah. Vijay, let me take the first part of your question. In terms of, you know, our Q4 revenue ramp, when we gave our second half guidance, last quarter, we expected sequential improvement from the third quarter into the fourth quarter. Obviously, we're still expecting sequential improvement. You know, that's gonna be driven by, you know, continued consistency of supply, which we expect, which has already improved across the portfolio and will continue to improve. We also have some recent product launches like Evolut FX and Hugo, which will continue to ramp. You may recall we have our Harmony valve, which will return to market as well. We've also got, you know, some launches into new markets like diabetic neuropathy that will begin to take some hold.

We've got reduced headwinds from things like vents and VBP in the quarter. You asked specifically about renal care. We do expect to close that joint venture with DaVita in the fourth quarter. We simply noted that when we guided so that we didn't force you all to change your models mid-quarter. We just put it in now.

Brad Wells (VP of Investor Relations)

Hope that helps.

Geoff Martha (Chairman and CEO)

Okay, just to finish off that. Just to highlight one thing in Karen's commentary there. A big one will be continued turnaround of our Surgical Innovations business. That was really hit hard, as you guys know, by the supply chain issues. You saw a nice sequential improvement from Q2 to Q3, and you'll see another improvement from Q3 to Q4. That, you know, Karen mentioned supply chain issues subsiding. A big area where you'll see that manifested is in Surgical Innovations. When you look at FY 2024, you know, well, let's start with some of the known risks. You highlighted China VBP, and Karen and I already talked about that a bit.

That'll still be an issue as we go from the 50% of our portfolio that's done in FY 2023 to another 30% that gives us 80% by the end of FY 2024. That'll be a headwind. I don't know that we've said whether China's growing or shrinking, but it's definitely not growing at our historic double digit again next year. The other. You know, look, there's still work to be done on, you know, supply chain. I mean, it's, you know, The supply chain out there is still a bit fragile, although every quarter it's getting better for us.

As you look at some of the momentum, you know, like you've seen from us from Q1 to Q2 to Q3, and then implicit in our guidance is a nice acceleration from Q3 to Q4. We're excited about happy with the momentum. As we look into, you know, FY 2024, some of the specific businesses, you mentioned diabetes, you know, we're optimistic we're gonna get the, you know, 780G on the market here in the U.S., and that'll have a nice impact on diabetes plus continued performance in Europe. That should be, assuming that happens, that should help accelerate some of the growth in diabetes. You know, surgical robotics is doing really well.

As we move into FY 2024, have a bit more, a bit more scale and a bit more impact on our numbers. Cardiac ablation solutions, you know, I'm sure we'll get some questions on, you know, our mapping and navigation system, as well as our various PFA catheters. You know, you'll start to feel some impact, you know, from them. You know, and continued strong performance, you know, across the Neuroscience portfolio, I think. You know, highlighted, you know, the CST or cranial spinal technologies business, as well as, you know, you'll see continued strength in ENT. We'll anniversary the Intersect acquisition at some point, and that goes organic.

Those are some of the things that we look at as in FY 2024. There's some, I think, broad, you know, supply chain recovery, especially in SI, and then a couple of highlights, like I mentioned, CAS, surgical robotics, diabetes in the US.

Brad Wells (VP of Investor Relations)

Okay. Thank you, Vijay. Next question please, Brad.

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

Joanne Wuensch (Managing Director)

Thank you very much, and good morning. Nice sequential growth there. I have two questions. One is specific to the spine business. It was particularly strong this quarter, and I'm just a little bit curious about what you're seeing is driving that and how you think about it going forward. Then the other one is a little bit more esoteric. I heard the word urgent or urgently a couple of times throughout the early presentation. What does urgently forging mean? How does that translate to sort of milestones that we can look forward to? Thank you.

Geoff Martha (Chairman and CEO)

Well, thanks, Joanne, for the question. Maybe I'll start with the second one. You know, look, there is, you know, the word urgent. There is a lot of major change that we've got going on across the business. I think it's important, you know, for people to understand the depth and breadth of those changes. I know there's a desire to see things move quicker. Yes, we're, you know, in some ways, encouraged by the progress, but we'd like to see it go faster as well.

The speed of our progress of, you know, getting the top-line growth and adjusting our cost base to, you know, to reflect the new reality with inflation and FX, you know, on a company our size, the impact of these changes take a bit more time. They take some time. The actions that we're taking are, you know, we are moving quickly on these.

I think that's the idea here, is we're moving quickly on a number of things, whether it be the changes, all the investments and changes to our supply chain, to the divestitures that we're working on, to the integration of these acquisitions like Affera, and moving our cast business forward. There's just a lot going on, and I get it. It's just important to understand that we're moving very quickly on these things, and the results are starting, and we're encouraged by that you're starting to see the results. When it comes to spine, look, this quarter was strong. Last quarter was strong, too. It was just offset by some of the, you know, the last couple of quarters offset a little bit by the China VBP.

If you look underneath it, we've been quoting that US, you know, implant growth rates that have been in the double digits. I mean, that's very strong and something especially for somebody with our level of market share by far, you know, the number one market share player to be growing like that. What's driving that is the enabling technology ecosystem. It's something we've been working on aggressively since 2015. You know, you've got the robot, you've got navigation, you've got interoperative imaging, you've got powered instruments. Now you've got this AI-based surgical planning system that basically it's, you know, we're winning over the hearts and minds of physicians as they see where we're going. Actually a real commitment to changing spine surgery with this arsenal of technology.

We've integrated it, and it's starting to help the workflow and move faster and more efficient. All of this coming together, that's what's driving it. At the same time, we've been able to invest in implants so that the implants are still, you know, the latest and greatest. I think, you know, Brett Wall and Skip Kiil and the team have done a really good job. I don't know, Brett, if you wanna make any further comments on that.

Brett Wall (EVP and President, Neuroscience Portfolio)

Yeah, Geoff, and Joanne, thanks for the question. This has been something we've been working on for a while, the strategy's really coming together with this enabling technology that actually allows for better planning, better execution, better follow-up, and assuming and assuring that you actually get the result that you want in the procedure. That technology, along with best-in-class implants and biologics, is providing this ecosystem that's terrific for the physician and actually institutions that wanna use it. Actually the strategy's playing out like we've wanted it to do with the significant growth in the largest market, which is the U.S. As Geoff mentioned, now we're on the second quarter of double-digit growth there in our core spine business in the U.S. You know, we like our strategy, technology, and how this is playing out for us.

Geoff Martha (Chairman and CEO)

Okay. Thanks, Joanne. Next question, please, Brad.

Brad Wells (VP of Investor Relations)

The next question comes from Matt Miksic at Barclays. Matt, please go ahead.

Matt Miksic (Managing Director, Senior Equity Research Analyst)

Hi. Thanks so much for taking the question. I had two follow-ups, if I could, just quickly on diabetes and TAVR. Geoff, your comments this morning, I don't know if it's just tone or my own impression, but it seemed like, you know, incrementally perhaps more confident and committed to diabetes and just, you know, I know where you're at with the warning letter. But maybe if you could, you know, talk about whether we're incrementally more confident here than you were a few months ago, and maybe talk about what the re-entry to that market looks like, assuming that you can get, assuming that you can get that, you know, the letter lifted and the product back to the market. Then just briefly on TAVR.

As you know, one of your major competitors in that market has talked a lot about staffing and trends in the U.S. Just anything that you would add in terms of sequential improvements or changes in that market or whether you're continuing to see some of the staffing challenges that they've referred to but don't seem to be holding back your growth quite so significantly in the U.S. Thanks.

Geoff Martha (Chairman and CEO)

Sure. Thanks for the questions, Matt. Yeah, I'll start with the diabetes one. I'm not incrementally more committed because I've been committed since day one. I mean, have not blinked on diabetes. So, you know, committed to the business. Yeah. Is there more confidence? Yes. That's because we're continuing to see the impact of our technology. When we have our full suite of technology, you know, outside the US, we're seeing strong growth. It's not just the growth that's encouraging, it's the patient feedback, the clinical results that we're getting, time and range and other important metrics from a clinical standpoint, but it's also the patient experience in terms of ease of use and things like that.

On top of that, you know, we've got this pipeline of technology that that's coming right behind it. You know, new pipeline of sensors. We've submitted our Simplera sensor, you know, for approval, you know, and we've got more behind that and a lot of development programs that I have a view into. Finally, the business is just executing better. All that together is giving me more confidence. I'll ask you to make a comment. You, if you want to add to that.

Que Dallara (EVP and President, Diabetes Operating Unit)

Yeah. I mean, as Geoff said, we continue to expand access for 780G system and Guardian 4 sensor. It's in over 90 markets. Wherever we see 780G launch, we also see higher CGM attachment rates because physicians and patients recognize the value of automation, automated insulin delivery in driving outcomes. We expect to see a similar trajectory when 780G is available in the U.S. market. Just to put a finer point on what Geoff said about our next generation products, we submitted our next generation sensor CGM for CE mark last year, we have also done that on a standalone basis to the FDA. We continue to make, you know, we continue to be very optimistic about the progress we're seeing in the market.

The U.S. market needs new products, we all know that, but I think we're making forward movement on all aspects of the business.

Geoff Martha (Chairman and CEO)

Thank you. On the TAVR question, this is an area that we've been really focused on. Obviously, it's a market where the therapy has a huge impact on patient outcomes. Then financially for us, it's an important driver. We've been really focused on this team and this new model. They really focused on this team and they've done a great job on a number of fronts in terms of training physicians and adding new reps, training new reps, and adding in the field training physicians on the new techniques. More recently here, launching, you know, our Evolut FX and the results we're getting there. Sean.

I think the team has done a great job, and we're starting to make up some ground here with the competition globally, but in particular in the US. Sean, maybe you can add some comments to this.

Sean Salmon (EVP and President, Cardiovascular Portfolio)

Thanks, Geoff. We are seeing sort of mid-single-digit growth underlying for the US market, obviously we're moving faster than that, 12% growth, because of the launch of FX. I think also this recognition that our valve hemodynamics is really playing out for better durability of that valve, over time, which is becoming more and more important. You know, FX really levels the playing field on ease of use, which has been important, but also you can line the commissures up, which is great for coronary access. As people are thinking about the lifetime of the valve, both durability and making sure those coronaries are easy to get back into matters a lot. That combination has played out well for us. We do still see spotty procedure volume challenges.

You know, it's all around the world, most acutely this last quarter in Japan, as we said. There was a wave of COVID that impacted us. Also, we're dependent on a particular faster access sheath that was impacted by supply chain issues last quarter. That's been resolved, so the launch of FX in Japan, returning procedure volumes, you know, no constraint from faster sheaths will help us to grow there. Of course, as Evolut FX rolls out around the world, we'll still perform well. You know, the fundamentals of that market are still very, very strong. It's just all the multiple touch points to the healthcare system that are required to get a patient in for therapy and through that therapy. We expect that's gonna start to bathe and get better with time.

Geoff Martha (Chairman and CEO)

Yeah.

Brad Wells (VP of Investor Relations)

Very helpful. Thanks.

Geoff Martha (Chairman and CEO)

I mean-

Sean Salmon (EVP and President, Cardiovascular Portfolio)

Oh.

Geoff Martha (Chairman and CEO)

You know, whether it be, you know, our structural heart business or in TAVR or diabetes. Joanne asked about spine, and she had mentioned, what do you mean by urgent? What I like about the operating model we have is these businesses, we've segmented them in the right way, where we have clarity, a transparency to their end markets. We're measuring them on, are you growing above? We have clarity on market growth. We're measuring them on, are you growing above or below the market? Comp is tied to that. It creates this sense of urgency that, you know, we think is having an impact.

You know, we was kind of overwhelmed for a while by supply chain challenges, as those mitigate, you're starting to see the impact of some of the changes we made.

Brad Wells (VP of Investor Relations)

Thanks again.

Geoff Martha (Chairman and CEO)

Thanks, Matt. Next question, please, Brett.

Brad Wells (VP of Investor Relations)

The next question comes from Josh Jennings at Cowen and Company. Josh, please go ahead.

Josh Jennings (Managing Director and Senior Analyst)

Hi. Good morning. Thanks for taking the questions. I was hoping to just ask about the JV, renal care JV and the patient monitoring and respiratory spin. Just how we should be thinking about the impact to, I guess, standalone Medtronic earnings in 2024, either from execution of those two moves or just any headwinds in terms of the earnings power in 2024, due to just the initial staging of getting to the finish line on both of those two moves?

Karen Parkhill (CFO and EVP)

Yeah. In terms of the impact on total Medtronic, earnings power, the, you know, the separations are gonna have minimal impact. In terms of, you know, staging the moves so that, you know, we have minimal impact or disruption across the company, we have been very focused on that and have strong teams in place that are managing these separations really well. We've purposely put those teams in place, as part of our new operating model. You know, as we make these portfolio moves, we're focused on being best in class in how we do it.

Josh Jennings (Managing Director and Senior Analyst)

Thanks. Just a follow-up on the patient monitoring and respiratory spin. Is it possible that an unsolicited suitor could come into play? How should investors think about the kind of potential for a parallel path to open up where you're moving forward with the spin, but there could be potential suitors coming in to take their eyes on those two businesses? Thanks for taking the question.

Karen Parkhill (CFO and EVP)

Yeah. Thanks, Josh. You know, we're focused on maximizing shareholder value with the separation. You know, we've announced the spin. We're moving forward with that. Should something come along that maximizes shareholder value, you know, we'll certainly listen to it.

Geoff Martha (Chairman and CEO)

Thanks, Josh. Next question, please, Brett.

Brad Wells (VP of Investor Relations)

The next question comes from Cecilia Furlong at Morgan Stanley. Cecilia, please go ahead.

Cecilia Furlong (Analyst)

Great. Good morning, and thank you for taking the questions. Just two-part question from me. First on Hugo, and the Uro IDE in the U.S. If you could provide an update, just what you've seen early days in enrollment. Separately, we've heard a lot about Italy impact. Just curious if you could frame how you're thinking about the potential impact to your business going forward. Thank you.

Geoff Martha (Chairman and CEO)

Thanks, Cecilia. Good to hear from you. On the first one, I'll let Bob White answer the question on the Hugo urology IDE enrollment and just overall progress, what we're seeing in the U.S., and then turn it over to Karen for the question on Italy.

Brad Wells (VP of Investor Relations)

To Bob?

Bob White (EVP and President, Medical Surgical Portfolio)

Great. Thanks, Geoff. Cecilia, thanks for the question. As you've noted, the trial enrollment is underway for Expand URO. First patients have been enrolled and proceeding nicely on that. So we're pleased with our progress on that IDE specifically. Just more broadly, to Geoff's point, you know, last quarter we saw accelerated installations of Hugo, entered new markets across EMEA, APAC, and LATAM. Again, if you think about where we're at around the world, with the geographic expansion and our CE mark allowing us to expand in the new markets. Then in CE markets, we've also added our general surgery indication on top of urology and gynecology. So now we cover about 80% of robotic procedures in those markets.

What we've been pleased, and you asked a little bit about feedback, we're getting really good feedback. The system's been used now to successfully perform a range of urology, gynecological, general surgery procedures from kind of simple to complex. We're seeing that Hugo is the flexible and versatile tool we designed it to be. It's early innings in terms of, you know, again, this market's got tremendous growth opportunity. Only 5% of procedures are done globally that could be done robotically assisted. We remain very excited about the market and, you know, we're pleased with where we are today.

Karen Parkhill (CFO and EVP)

Cecilia, on the Italy question, there is a law in Italy that requires companies that sell medical devices to make payments to the Italian government if those device expenditures exceed maximum ceilings. The law was put in place in 2015, applies to expenditures from that year onward. You've heard from some of our other competitors on this. The law is obviously applicable to the whole industry. We filed an appeal along with many other companies in our industry on this. In the third quarter, for the first time, actual claims were issued to Medtronic and our peers for the years 15 to 18. We did revise our existing accrual. We already had an accrual, we did add to it in the third quarter.

That accrual is a reduction of revenue. For us, it wasn't too significant, but we do have a reserve on our books.

Brad Wells (VP of Investor Relations)

Thanks, Cecilia. Let's take the next question, please, Brad.

The next question comes from Shagun Singh at RBC. Shagun, please go ahead.

Shagun Singh (Senior Equity Analyst)

Great. Thank you for taking the question. Karen, one for you. Could you just elaborate on the components of the impact of the components of the EPS impact on growth next year? You know, you called out inflation, FX, interest, and taxes. You know, perhaps you can, you know, talk about how large the impact is this year and what the flow-through could be next year. Then I have a follow-up.

Karen Parkhill (CFO and EVP)

Yeah. Thanks, Shagun. Obviously, we said we've got tons of moving pieces on next fiscal year, so we're not ready to give, you know, real guidance. To quantify the impact from EPS growth is difficult. What I would say on currency, you know, we talked about the fact that that is a headwind. I mentioned that in the commentary. Just at recent rates, currency is about a 5% headwind to next fiscal year. We did quantify that. We also said that inflation impacts are about a mid-single digit impact for us next fiscal year. Those are two that we've quantified. In terms of interest and tax, those are more minor headwinds than inflation and currency. Still headwinds that we need to face.

Obviously, we've got investment that we intend to make to drive the long-term growth of this company. Where we see, you know, important investments, we're gonna make them. We've said that we think that we're gonna drive R&D growth at least in line with revenue. You know, when we have important investments to make, in some years that may grow even more than revenue. Hopefully that helps.

Shagun Singh (Senior Equity Analyst)

That's helpful. Thank you. I was just wondering if you could talk a little bit about the PULSED AF data readout at ACC. You know, how meaningful do you think it could be? Just maybe broadly talk about the PFA opportunity and how your platform is differentiated. Thank you so much.

Brad Wells (VP of Investor Relations)

Sure. Yeah, thanks for the question. We're definitely excited about the data that's coming out of ACC and the PFA opportunity. You know, I think Sean's best positioned to answer your question, though. Sean?

Bob White (EVP and President, Medical Surgical Portfolio)

Yeah. Thanks, Shagun. We have a trial coming out on the sixth, which will be the very first IDE trial or done in the rigors of an FDA trial or a study in this field. It's really the first data set, and it is two patient populations in the single trial. Paroxysmal patients as well as persistent patients. The endpoints are a primary safety endpoint, primary efficacy endpoint. You know, the rigorous trial design here under the auspices of a IDE trial mean that you have very frequent monitoring of the patients, and you get a true kind of look at the way this anatomical solution performs. I say anatomical solution because we have really two things in this bag of AF treatments.

One is one where you isolate the pulmonary veins, and then the Affera system

Sean Salmon (EVP and President, Cardiovascular Portfolio)

allows you to also do point-by-point ablation with a highly differentiated catheter. That system is a automatic mapping system that allows you to kind of map a blade and then validate what you've done, we'll put all of our catheters onto that ecosystem over time, including this anatomical catheter, the DiamondTemp, as well as cryo catheters. you know, we'll have a full array of all energies, cryo, radiofrequency, as well as pulsatile ablation to treat a myriad of arrhythmias that occur across the entire space. It really does put us on with the newest technology early in this phase of that highly differentiated on both the mapping system as well as the therapeutic catheter side. Yeah, there's a lot of excitement among physicians for what we're bringing to the field.

Karen Parkhill (CFO and EVP)

Thank you.

Bob White (EVP and President, Medical Surgical Portfolio)

Thanks, Shagun. Brad, we've got time for two more questions, please.

Brad Wells (VP of Investor Relations)

All right. The next question comes from Travis Steed at BofA. Travis, please go ahead.

Travis Steed (Managing Director, Senior Equity Analyst)

Hi. Thanks for taking the question. Karen, I did wanna ask on the Q4 margin step up. you know, Q3 was a little bit light on margins from FX and currency. Just curious if there's anything other than the improving revenue to drive the Q4 margin step up. I know you're not gonna give much on FY 2024, but curious if you could kinda frame the opportunity on the cost side. I don't know if there's enough to offset the mid-single digit inflation or partly offset that or more than offset. Just a little bit of color on the cost saving side would be helpful. Thank you.

Karen Parkhill (CFO and EVP)

Yeah. Thanks, Travis. On Q4 margins, that will be revenue growth obviously helps, we'll start there. We also will be driving cost reduction starting, you know, starting last quarter and even more into the fourth quarter that will help as well. Q4 typically is our highest margin quarter. You know, we're focused on that step up, and it's typical for us. On the cost opportunity for FY 2024, again, we're not gonna size it right now. We've said that we are focused on driving a significant cost reduction to help partially offset the impacts that we've got from the various headwinds and the investment that we need to make.

Travis Steed (Managing Director, Senior Equity Analyst)

Great. Thank you.

Bob White (EVP and President, Medical Surgical Portfolio)

Thanks, Travis. We'll take our final question, please, Brad.

Brad Wells (VP of Investor Relations)

Great. Our final question comes from Rick Wise at Stifel Nicolaus. Rick, please go ahead.

Rick Wise (Managing Director)

Good morning. Thanks, Ryan. Maybe I'll just in interest of time here, just focus on back on one topic, Hugo. Geoff, you know, it seems like you're seeing a good ramp in Europe, but maybe you could quickly update us on supply chain. Is that resolved, resolving, almost resolved? What's your thought about that process and your ability to meet the demand? Last quarter, you talked about backlog. Maybe you could give us more color there. Specifically, just a little more detailed color about once Hugo's in place, the kind of adoption and maybe pull-through of instrumentation you're seeing, so we have a real, a better sense of exactly where you are with Hugo. Thank you so much.

Geoff Martha (Chairman and CEO)

Yeah. It, great to hear from you, Rick. Thanks for the question. Yeah. I'll turn it over to Bob for some of the details there, but I'd say just on Hugo, you know, what the evolution is the feedback that we're getting, right? I mean, we felt confident in the design, and as we got closer to launch, you know, I was spending more time with physicians that were involved with the design that, you know, they don't work for Medtronic, but they were involved, and they were very bullish on it and happy with the way the product turned out.

Now we're getting feedback from physicians that are, you know, that are converting, you know, from the competition or, you know, have both and they're high volume users and they have a high bar for robotic surgery. That feedback's been really strong. That is, you know, I think is very encouraging. That word is spreading. You know, as I talk to U.S. physicians that don't have access to it yet 'cause they're not part of the trial, and they have a pretty detailed understanding of the robot and its features and its capabilities. So we're getting and so that's, thus it's driving really strong adoption.

I'll let Bob talk about, you know, any kind of constraints or supply chain and any other details on adoption, though.

Bob White (EVP and President, Medical Surgical Portfolio)

Thanks, Geoff, and Rick, thanks for the question. A couple of other points I think, Rick, that'll be helpful for you is, you know, we're now starting to fulfill repeat orders by customers, which is nice. Customers have not just bought one, they're coming back to buy additional ones. The other thing is we're seeing a mix really of both early robotic adopters and experienced accounts, which is nice 'cause, you know, we built Hugo with a differentiator, built with physicians' needs in mind, so we're excited what we see there. With respect to the supply chain, as it relates to Hugo, a good pickup that is behind us. I talked in previous quarters about hardening our supply chain and working through those manufacturing processes. That's all in the rearview mirror for us.

As Geoff and Karen had mentioned more broadly, for our surgical business, we've seen our supply chains improve dramatically through the year, and you see that in the sequential quarter on quarter growth in that business. Hopefully that's helpful. Thanks.

Rick Wise (Managing Director)

Encouraging to hear. Thank you.

Geoff Martha (Chairman and CEO)

I think Rick, I think, you know, on the pull-through, for that pull-through to have an impact, it's gonna take a little bit of time. It's a big surgical innovations business we have, you know, $6 billion or so. I will point to the spine business. Joanne asked the question earlier. You know, two quarters in a row of double-digit implant growth in the U.S., which is 80% of the market, that is largely driven by pull-through of an ecosystem of technology that's hard to match, that takes a lot of expertise, a lot of balance sheet, and a lot of time. We've spent a lot of time on this robot, and we've invested a lot into it, and it's not just the robot. It is visualization. It is the digital platform.

We're confident that ecosystem will be a differentiator for Medtronic and pull through instrumentation and be a durable growth driver for the company. That's why we stuck with it, you know, for the last too many years to admit to to get it to this point. And we feel like we have something to build from.

Rick Wise (Managing Director)

Appreciate that, Geoff. Thank you.

Bob White (EVP and President, Medical Surgical Portfolio)

Yeah. Thank you, Rick. Geoff, please go ahead with your closing remarks.

Geoff Martha (Chairman and CEO)

All right. Well, thanks for the questions. Some great questions this morning. Really appreciate your support and continued interest in the company. We hope you'll join us for our Q4 earnings broadcast, which we anticipate holding on Thursday, May 25th, where we'll update you on the progress and how we finished our fiscal year and, of course, a look ahead at fiscal 2024. With that, thanks again for spending time with us today. Please stay healthy and safe, and have a great rest of your day.