Medtronic PLC

NYSE:MDT

Earnings Call Transcript 2023-Q3

[Ryan Weispfenning, Investor Relations]

Good morning. I am Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. Welcome to Minnesota where signs of spring are in the air. I appreciate that you are joining us today for Medtronic’s Fiscal 2023 Third Quarter Earnings Video Webcast.

Before we go inside to hear our prepared remarks, I will 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 27, 2023 as well as our outlook for the remainder of the fiscal year. After our prepared remarks, the Executive VPs from each of our four segments will join us. And we will 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 maybe considered forward-looking statements and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors to 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 revenue from our Q1 acquisition of Intersect ENT. References to sequential revenue changes compared to the second quarter of fiscal ‘23 and are made on an as-reported basis and all references to share gains or losses refer to revenue share in the fourth calendar quarter of 2022 compared to the fourth calendar quarter of 2021, 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 Chief Executive Officer]

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 launch new products and demonstrated continued strength in our established market leading cardiac rhythm management and spine franchises. And 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 are 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 are 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 and I am 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. We are confident in delivering durable revenue growth over the coming quarters as recent revenue headwinds continue to dissipate and we execute across our businesses.

So, let’s take a closer look at our Q3 results. As I highlighted at an investor conference last month, we are thinking about our portfolio of businesses in three groups: highest growth, synergistic and established market leaders. So I will 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 micro-leadless pacemakers, which grew 14% and our Defibrillation Solutions business grew 7% as replacement headwinds are moderating. And just last week, we received CE Mark for our Aurora Extravascular ICD.

In Cranial & Spinal Technologies, we delivered another strong quarter, with 6% growth in Core Spine, including 12% growth in the United States 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 are 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 and we expect the momentum we are seeing in SI to continue. In particular, in our leading advanced energy franchise, we are seeing strong adoption of our recently launched cordless Sonicision 7 and we are preparing to launch our recently approved LigaSure XP. So we are on the right path with our established market leader businesses. And at the same time, we are 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 are investing disproportionately in these businesses and expect them to become an even bigger part of our growth over time.

So 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 are seeing great physician reception for our Evolut FX system, which just completed its full quarter of launch in the U.S. Evolut FX combines industry leading durability with enhanced and predictable valve deployment. And in addition, data was presented during the quarter at PCR London Valves, showing Evolut FX’s Commissure 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 are also advancing what we believe will become the leading pulsed field ablation portfolio. And in 2 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 PULSE Select PFA catheter in both paroxysmal and persistent patients and this will be the first results from an IDE trial in the PFA space and we are 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. And given Sphere-9 is a focal point PFA catheter, it is highly complementary to our PULSE Select anatomical PFA catheter.

Finally, 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. So when you think about our Arctic Front crysolution, our DiamondTemp RF catheter, our PFA catheters, our left heart access solutions and our Affera map nav system, we are assembling a leading ecosystem of technologies to meaningfully increase our participation in the fast growth 8 billion EP ablation space.

In Surgical Robotics, we are 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 and 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.

And 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 reinspection. We also remain in active review with the FDA on our submission of the MiniMed 780G system with the Guardian 4 sensor. Outside the U.S., 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 are seeing strong CGM attachment rates, which drove CGM growth up 34% outside the U.S. 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.

And 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 and the market continues to recover. And 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, Chief Financial Officer]

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 a 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. However, 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 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. And as they roll off our balance sheet on to 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. And 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. And 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.

Now 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. On the top line, we expect our fourth quarter organic revenue growth to be in the range of 4.5% to 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 to $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 to $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% to 6%, Medical Surgical to grow 2.5% to 3%, neuroscience to increase 6.5% to 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 ‘23 non-GAAP diluted EPS guidance by $0.03 to the new range of $5.28 to $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 to $1.57. At recent rates, FX is about a $0.09 headwind to fourth quarter EPS. While we won’t give guidance this fiscal year until our fourth quarter call in May, I did give some color on last quarter’s call, and we 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 ‘24 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. We are working to partially mitigate these headwinds through significant cost reductions. But 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 ‘24.

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 Chief Executive Officer]

Thank you, Karen. Now 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, and that’s still true. But 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. And through this process, create tremendous value for our shareholders.

Now 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?

[Operator]

[Operator Instructions] 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. [Operator Instructions] We will take the first question from Robbie Marcus at JPMorgan. Robbie, please go ahead.

[Robbie Marcus, JPMorgan]

Great. Congrats on a nice quarter, and good morning. Maybe I could start, and 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 going to continue to invest in R&D. So what exactly are you cutting? How aggressively are you cutting? Will this prevent any of your competitiveness on the top line? And then I’ll ask my follow-up as well. The street has you with 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, Chief Financial Officer]

Yes. Thanks for your question, Robbie. When we look at our higher cost environment that we’re facing, like many companies you’ve seen recently, we really have to evaluate our full cost structure and look for opportunities to reduce both spending and cost. So 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. When we look at next fiscal year, I’ll just give you a little bit more comments on it. I know there is 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. So that’s why we’re sticking to our normal time line of giving guidance in Q4. But when we look at revenue, we grew 4.1% in Q3 and our guidance for Q4 implies sequential improvement. We expect – we’ve said that we expect to drive greater revenue growth in ‘24 than we have in ‘23, and we’ve said that we’re focused on delivering durable mid-single-digit revenue growth over the longer term. So we like the progress that we’ve made recently, both on our recent revenue growth performance and on important things in our pipeline to drive that revenue growth. And we always have said that we believe our WAMGR is in the mid-single-digit range. But 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 in the next quarter in FY ‘24. We’ve seen inflation – the pressures on inflation beginning to improve. But 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. And obviously, we’ve talked about the fact that we’re going to continue to drive investments to drive the long-term growth and turnaround of this company. We are still in the process of seeing how all that nets out with our significant expense reduction. And obviously, we’re going to give guidance on our fourth quarter call in May. But we have said that this will be a tougher year on the bottom line where our earnings power will be significantly reduced. I hope that helps.

[Ryan Weispfenning, Investor Relations]

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

[Operator]

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

[Larry Biegelsen, Wells Fargo]

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 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 percent of your – the headwind in the first half and the percentage products impacted in fiscal ‘23 and fiscal ‘24. I guess what I’m trying to understand is what would overall China growth, fiscal ‘23 and fiscal ‘24? How much of a headwind will that continue to be with VBP? And how does it impact your ability to grow mid-single digits in fiscal ‘24? I heard Geoff, you talked about durable growth a lot this morning. Should we be thinking more like 4 to 5 next year because of the VBP headwinds? Thanks for taking the question.

[Geoff Martha, Chairman and Chief Executive Officer]

Yes. Thanks, Larry. Good to hear from you, and thanks for the question. Obviously, China is a big one for us. And yes, I’ll turn it over to Karen to answer some of the kind of the details on the headwinds, what we’re seeing here recently.

[Karen Parkhill, Chief Financial Officer]

Yes. So just – it’s hard for us to parse out this quarter the impact of procedures in VBP. So we’re not doing that. But we have said on VBP that we expect to be 50% done with the impacts of VBP by the end of this fiscal year. And 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. So this quarter, we had a VBP impact from stapling and cardiac ablation and a little bit in coils from Neurovascular. And 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 in some cardio businesses including cardiac rhythm, structural heart, aortic, peripheral vascular. But again, where 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 Chief Executive Officer]

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. And that will all – we’re 50% of the way through. And the remaining 30%, we will get in FY ‘24. We don’t think the remaining 20% will be impacted certain things that are nuanced or under the radar screen. And what we’re doing here is taking out some of our selling and marketing costs in China to offset the lower prices because this business is now more contracted through this VBP. So the government is living up to the volume commitments from those VBPs at these lower prices. The discounts have gotten lower as they have gone on. I think the Chinese government has realized that med tech is not exactly like pharma, and we have more selling expenses than maybe pharma does because I think they modeled a lot of this off of pharma and based on my discussions with Chinese government officials. So that’s good. And we’re – basically, we will reset our business and grow from there. And so, FY ‘24 will be another year where China is a bit of a headwind. We factor that into our guidance. We were taking out expenses and we will rebase our business and grow from there. So, a lot of thought, a lot of conversations with the Chinese government, a lot of thought here, look, we are comfortable with our strategy.

[Ryan Weispfenning, Investor Relations]

Great. Thank you, Larry. Next question, please, Brad.

[Operator]

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

[Vijay Kumar, Evercore ISI]

Hey, guys. Congrats on the printed. Thanks for taking my question. I had a two-part and I’ll ask them upfront. When you look at Q4, what is changing sequentially here, Karen? Because when I look at 3Q, you did 4% organic despite med sort of declining, continued Diabetes headwinds and China headwinds since Q4. What are these three pieces – what are you assuming for those three buckets? And I think you mentioned the renal impact in Q4. Could you specify that? And Geoff, for you, I understand you’re not giving fiscal ‘24 guidance, but when you think about the incremental changes, right, what are the positive tailwinds and negative headwinds? Is China still declining in fiscal ‘24? What happens to Diabetes? Is that on the plus side or minus side? And any other plus or minus at a high level would be helpful.

[Karen Parkhill, Chief Financial Officer]

Yes, Vijay, let me take the first part of your question. In terms of 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. And obviously, we’re still expecting sequential improvement. That’s going to be driven by 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 Harmony valve, which will return to market as well. And then we’ve also got some launches into new markets, like diabetic neuropathy that will begin to take some hold. And 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. So 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. I hope that helps.

[Geoff Martha, Chairman and Chief Executive Officer]

Just to finish off – 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. And that – Karen mentioned supply chain issues subsiding, a big area where you’ll see that manifested is in Surgical Innovations. When you look at FY ‘24, well, let’s start with some of the known risks. You highlighted China VBP, and we – Karen and I already talked about that a bit. That will still be an issue as we go from the 50% of our portfolio that’s done in FY ‘23 to the – to another 30% that gives us 80% by the end of FY ‘24. So that will be a headwind. I don’t know what 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 – and look, there is still work to be done on supply chain. I mean it’s – our supplier – the supply chain out there is still a bit fragile. Although every quarter, it’s getting better for us and – but as you look at some of the momentum, like you’ve seen from us from Q1 to Q2, from Q2 to Q3 and then implicit in our guidance is a nice acceleration kind of from Q3 to Q4. So we’re excited about that, happy with the momentum. And as we look into FY ‘24, some of the specific businesses, you mentioned Diabetes. We’re optimistic we’re going to get 780G on the market here in the U.S., and that will have a nice impact on Diabetes plus continued performance in Europe. So that should be – assuming that happens, that should help accelerate some of the growth in Diabetes.

Surgical Robotics is doing really well. And as we move into FY ‘24, have a bit more scale and a bit more impact on our numbers. Cardiac Ablation Solutions, I’m sure we will get some questions on our mapping and navigation system as well as our various PFA catheters. You start to – we will start to feel some impact from them. And continued strong performance across the Neuroscience portfolio, I think, highlighted the CST or cranial spinal technologies business as well as you’ll see continued strength in ENT. We will anniversary the Intersect acquisition at some point and that goes organic. So those are some of the things that we look at as – in FY ‘24. But it’s – there is some, I think, broad supply chain recovery, especially in SI and then a couple of highlights, like I mentioned, CAS, Surgical Robotics, Diabetes in the U.S.

[Ryan Weispfenning, Investor Relations]

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

[Operator]

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

[Joanne Wuensch, Citi]

Thank you very much and good morning and 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? And 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 and how does that trans to sort of milestones that we can look forward to? Thank you.

[Geoff Martha, Chairman and Chief Executive Officer]

Well, thanks, Joanne, for the question. Maybe I’ll start with the second one. Look, there is – the word urgent, there is a lot of major change that we’ve got going on across the business. And I think it’s important for people to understand the depth and breadth of those changes. And I know there is the desire to see things move quicker. And yes, we’re in some ways, encouraged and we’re encouraged by the progress, but we’d like to see it go faster as well. But the speed of the – of our progress of getting the top line growth and adjusting our cost base to reflect the new reality with inflation and FX, on a company our size, the impact of these changes take a bit more time than – they take some time. But the actions that we’re taking are – we are moving quickly on these. And I think that’s the idea here. So we’re moving quickly on a number of things, whether 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 are moving our cash business forward. There is just a lot going on and 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 – was strong. Last quarter was strong too. It was just offset by some of the – the last couple of quarters offset a little bit by the China VBP. But if you look underneath it, we have been quoting that U.S. implant growth rates that have been in the double digits, I mean that’s very, very strong and something, especially for some of our level of market share by far, again, the number one market share player to be growing like that. What’s driving that is the enabling technology ecosystem. It’s something we have been working on aggressively since 2015. You have got the robot, you have got navigation, you have got interoperative imaging, you have got power instruments. Now, you have got this AI-based surgical planning system that basically – it’s we are winning over the hearts and minds of physicians as they see where we are going and actually a real commitment to changing spine surgery with this arsenal of technology. And we have integrated it and it’s not – it’s starting to help the workflow and move faster and more efficient. All of this coming together, that’s what’s driving it. And at the same time, we have been able to invest in implants, so that the implants were still the latest and greatest. And I think Brett Wall and Skip Kill and the team have done a really good job. I don’t know, Brett, if you want to make any further comments on that?

[Brett Wall]

Yes. Geoff and Joanne, thanks for the question. This has been something we have been working on for a while, and the strategy is 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 want to use it. And actually, the strategy is playing out like we have wanted to do with the significant growth in the largest market, which is the U.S. And as Geoff mentioned, now we are on the second quarter of double-digit growth there in our core spine business in the U.S. And we like our strategy, technology and how this is playing out for us.

[Ryan Weispfenning, Investor Relations]

Okay. Thanks Joanne. Next question please Brad.

[Operator]

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

[Matt Miksic, Barclays]

Hi. Thanks so much for taking the question. I had two follow-ups, if I could, just quickly on diabetes and TAVR. So Geoff, your comments this morning, I don’t know if it’s just tone or my own impression, but it seemed like incrementally, perhaps more confident and committed to diabetes and just – I know where you are at with the warning letter. But maybe if you could talk about whether you are incrementally more confident here than you were a few months ago and maybe talk about what the reentry to that market looks like, assuming that you can get that – the letter lifted and the product back to the market? And 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 are continuing to see some of the staffing challenges that they referred to, but don’t seem to be holding back your growth quite so significantly in the U.S.? Thanks.

[Geoff Martha, Chairman and Chief Executive Officer]

Sure. Thanks for the questions, Matt. Yes. I will start with the diabetes one. I am not incrementally more committed because I have been committed since day one. I mean there is no – have not blinked on diabetes, so committed to the business. Yes. Is there more confidence, yes. And that’s because we are continuing to see the impact of our technology. When we have our full suite of technology outside the U.S., we are seeing strong growth. But it’s not just the growth that’s encouraging, it’s the patient feedback, the clinical results that we are 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. And then on top of that, we have got this pipeline of technology that we have – that’s coming right behind it, new – pipeline of sensors. We have submitted our Simplera sensor for approval. And we have got more behind that. And a lot of development programs that I have a view into. And then finally, the business is just executing better, and so all that together is giving me more confidence. So, I will ask Que to make a comment. Que, do you want to add to that?

[Que Dallara]

Yes. I mean as Geoff said, we continue to expand access for the 780G system and Guardian 4 sensor. It’s in over 90 markets. And 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. And we expect to see a similar trajectory when 780G is available in the U.S. market. And 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, and we have also done that on a standalone basis to the FDA. And we continue to be very optimistic about the progress we are seeing in the market. The U.S. market needs new products. We all know that. But I think we are making forward movement on all aspects of the business.

[Geoff Martha, Chairman and Chief Executive Officer]

Thanks Que. And on the TAVR question, look, this is an area that we have been really focused on. Obviously, it’s a market where the therapy has a huge impact on patient outcomes, and then financially for us, it’s an important driver. And we have been really focused on this team and this new model, how they are really focused on this team, and they have done a great job on a number of fronts in terms of training physicians and adding new reps, training new reps and adding the field training physicians on the new techniques, but more recently here launching our Evolut effects and the results we are getting there. I have Sean, but I think the team has done a great job, and we are starting to make up some ground here with the competition globally, but in particular in the U.S. And Sean, maybe you can add some comments to this.

[Sean Salmon]

Yes. Thanks, Geoff. And we are seeing sort of mid-single digit growth underlying for the U.S. market. And obviously, we are moving faster than that 12% growth because of the launch of FX. And 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. And FX really levels the playing field on ease of use, which has been important, but also you can line the commerce [ph] up, which is great for coronary access. And as people are thinking about the lifetime of the valve, both durability and making sure that those corners are easy to get back into matters a lot. And that combination has played out well for us. We do still see spotty procedure volume challenges. 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. And also we are dependent on a particular faster access that was impacted by supply chain issues last quarter. That’s been resolved. So, the launch of FX in Japan, returning procedure volumes and no constraint from vascular sheets will help us to grow there. And of course, as Evolut FX rolls out around the world, we will still perform well. The fundamentals of that market are still very, very strong. It’s just all the multiple touch points of the healthcare system that are required to get a patient in for therapy and through that therapy. But we expect that’s going to start to abate and get better with time.

[Geoff Martha, Chairman and Chief Executive Officer]

Whether it would be our structural heart business, TAVR or diabetes, and Joanne asked about spine, and you mentioned in the comment you mean by urgent. What I like about the new – the operating model we have is these businesses, we have got – we have segmented them in the right way where we have clarity, transparency into their end markets. We are measuring them on, are you growing above, we have clarity on market growth. We are measuring them on, are you growing above or below the market and comp is tied to that. So, it creates this sense of urgency that we think is having an impact. It was kind of overwhelmed for a while by supply chain challenges. But as those mitigate, you are starting to see the impact of some of the changes we made.

[Matt Miksic, Barclays]

Thanks again.

[Geoff Martha, Chairman and Chief Executive Officer]

Thanks Matt. Next question please, Brad.

[Operator]

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

[Josh Jennings]

Good morning. Thanks for taking the questions. I was hoping to just ask about the JV. We don’t have JV in the patient monitoring and respiratory spin. Just how we should be thinking about the impact to, I guess standalone Medtronic earnings in ‘24, either from execution of those two moves or just any headwinds in terms of the earnings power in ‘24 to just the initial staging of getting to the finish line on both of those two…?

[Karen Parkhill, Chief Financial Officer]

Yes. In terms of the impact on total Medtronic earnings power, the separations are going to have minimal impact. So – and in terms of staging the moves so that 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. And we purposely put those teams in place as part of our new operating model. As we make these portfolio moves, we are focused on being best-in-class in how we do it.

[Josh Jennings]

Thanks a lot. Just a follow-up on the patient monitoring and respiratory spin. Is it possible that an unsolicited – a suitor could come into play? And how should investors think about the kind of potential for a parallel path to open up where you are moving forward a spin, but there could be potential suiters coming into the – kicking the tires on those two businesses? Thanks for taking the question.

[Karen Parkhill, Chief Financial Officer]

Yes. Thanks Josh. We are focused on maximizing shareholder value with the separation. And we have announced the spin. We are moving forward with that. Should something come along that maximizes shareholder value, we will certainly listen to it.

[Ryan Weispfenning, Investor Relations]

Thanks Josh. Next question please, Brad.

[Operator]

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

[Cecilia Furlong, Morgan Stanley]

Great. Good morning and thank you for taking the questions. Just a two-part question for me. First on Hugo and the neuro IDE in the U.S. If you could provide an update on just what dud have seen early days in enrollment? And then separately, we have heard a lot about Italy impact. Just curious if you could frame how you are thinking about the potential impact to your business going forward and thank you?

[Geoff Martha, Chairman and Chief Executive Officer]

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

[Bob White]

Great. Thanks Geoff and Cecilia, thanks for the question. As you have noted, the trial enrollment is underway for expand neuro. First patients have been enrolled and proceeding nicely on that. So, we are pleased with our progress on that IDE specifically. And then just more broadly, to Geoff’s point, last quarter, we saw accelerated installations of Hugo entered new markets across EMEA, APAC and LATAM. And again, if you think about where we are at around the world, with the geographic expansion and our CE mark allowing us to expand in the new markets. And then in CE markets, we have also added our general surgery indication on top of urology and gynecology. So, now we covered about 80% of robotic procedures in those markets. And what we have been pleased, and you asked a little bit about feedback, we are getting really good feedback. The systems been used now to successfully perform a range of urology, gynecological, general surgery procedures from kind of simple to complex. And we are seeing that Hugo is the flexible and versatile tool we designed it to be. So, it’s early innings in terms of – again, this market has 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 we are pleased with where we are today.

[Karen Parkhill, Chief Financial Officer]

And Cecilia, on the Italy question, there is a law in Italy that requires companies that are – 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 and applies to expenditures from that year onward. You have heard from some of our other competitors on this. The law is obviously applicable to the whole industry. And 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. And so, we did revised our existing accrual. We already had an accrual and 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.

[Ryan Weispfenning, Investor Relations]

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

[Operator]

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

[Shagun Singh, RBC]

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 called out inflation, FX, interest and taxes. Perhaps you can talk about how large the impact is this year and what the flow-through could be next year? And then I have a follow-up.

[Karen Parkhill, Chief Financial Officer]

Yes. Thanks Shagun. So obviously, we have said we have got tons of moving pieces on next fiscal year. So, we are not ready to give real guidance. And so, to quantify, the impact from EPS growth is difficult. But what I would say on currency, we talked about the fact that, that is a headwind. I mentioned that in the commentary. And just at recent rates, currency is about a 5% headwind to next fiscal year, so we did quantify that. We also said that inflation impacts are about a mid-single digit impact for us next fiscal year. So, those are two that we have quantified. In terms of interest and tax, those are more minor headwinds than inflation and currency, but still headwinds that we need to face. And then obviously, we have got investment that we intend to make to drive the long-term growth of this company. And where we see important investments, we are going to make them. And we have said that we think that we are going to drive R&D growth, at least in line with revenue and when we have important investments to make in some areas that may grow even more than revenue. So, hopefully that helps.

[Shagun Singh, RBC]

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

[Geoff Martha, Chairman and Chief Executive Officer]

Sure. Thanks for the question. We are definitely excited about the data that’s coming out at ACC and the PFA opportunity. I think Sean is best positioned to answer your question, Sean?

[Sean Salmon]

Yes. Thanks Shagun. So, we have a trial coming out on the six, which will be the very first IDE trial done on the rigors of an FDA trial for a study in this field. So, it’s really the first dataset. And it is two patient populations in the single trial, both paroxysmal patients as well as persistent patients. And the endpoints are primary safety endpoint, primary efficacy endpoint. And the rigorous trial design here under the hospices offices of an IDE trial mean that you have very frequent monitoring the patients, and you get a true kind of look at the way this anatomical solution performs. I would 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 allows you to astute point-by-point ablation with a highly differentiated catheter. That system is an automatic mapping system that allows you to kind of map, ablate and then valuate what you have done, and we will put all of our catheters on to that ecosystem over time, including this anatomical catheter, the [indiscernible] as well as cryocatheters. So, we will have a full array of all energies cryo, radio frequency as well as postural ablation to treat a myriad of arrhythmias that occur across the entire space. So, it really does put us on – with the newest technology early in the phase of that highly differentiated on both the mapping system as well as the therapeutic catheter side. And there is a lot of excitement among physicians for what we are bringing to the field.

[Geoff Martha, Chairman and Chief Executive Officer]

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

[Operator]

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

[Travis Steed, BofA]

Hi. Thanks for taking the question. Karen, I do want to ask on the Q4 margin step-up. Q3 was a little bit light on margins from FX and currency. Just curious if there is anything other than improving revenue to drive the Q4 margin step-up? And then I know you are not going to get much on FY ‘24, but curious if you could kind of frame the opportunity on the cost side. I don’t know if there is 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 savings side would be helpful. Thank you.

[Karen Parkhill, Chief Financial Officer]

Yes. Thanks, Travis. So, on Q4 margins, that will be – revenue growth obviously helps. So, we will start there. But we also will be driving cost reduction starting last quarter and even more into the fourth quarter, that will help as well. And then Q4 typically is our highest margin quarter. So, we are focused on that step-up and it’s typical for us. On the cost opportunity for FY ‘24, again, we are not going to size it right now. But we have said that we are focused on driving a significant cost reduction to help partially offset the impacts that we have got from the various headwinds and the investment that we need to make.

[Travis Steed, BofA]

Great. Thank you.

[Ryan Weispfenning, Investor Relations]

Thanks Travis. And we will take our final question please, Brad.

[Operator]

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

[Rick Wise, Stifel Nicolaus]

Hi. Good morning. Thanks Ryan. Maybe, I will just – interest of time here, just focus on – back on one topic, Hugo. Geoff, it seems like you are 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 some more color there. And specifically, just a little more detailed color about once Hugo is in place, the kind of adoption and maybe pull-through of instrumentation you are seeing just to – so we have a real – a better sense of exactly where you are with Hugo. Thank you so much.

[Geoff Martha, Chairman and Chief Executive Officer]

Yes. Great to hear from you, Rick. Thanks for the question. I will turn it over to Bob for some of the details there. But I would say just on Hugo, what – the evolution of the – is the feedback that we are getting, right. I mean we felt confident in the design. And as we get closer to launch, I was spending more time with physicians that were involved with the design that 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. But now we are getting feedback from physicians that are converting from the competition or have both and they are high-volume users and they have a high bar for robotic surgery and that feedback has been really, really strong. And that is, I think is very encouraging. And that word is spreading, as I talk to U.S. physicians that don’t have access to it yet because they are not part of the trial and they have a pretty detailed understanding of the robot and its features and its capabilities. And so, we are getting – and so that’s just driving really strong adoption. Yes. I will let Bob talk about any kind of constraints or supply chain and any other details on adoption now.

[Bob White]

Yes. Thanks Geoff and Rick, thanks for the question. A couple of other points I think Rick, that would be helpful for you is we are now starting to fulfill repeat orders by customers, which is nice. So, customers have not just bought one, they are coming back to buy additional ones. And the other thing is we are seeing a mix really of both early robotic adapters and experienced accounts, which is nice because we built Hugo with the differentiator that what physicians’ needs in mind. So, we are excited what we see there. And with respect to the supply chain, as it relates to Hugo, a good – that is behind us. So, we had – 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. And then as Geoff and Karen mentioned more broadly, for our surgical business, we have seen our supply chains improve dramatically through the year, and you see that in the sequential quarter-on-quarter growth in that business. So hopefully, that’s helpful. Thanks.

[Rick Wise, Stifel Nicolaus]

Thank you.

[Geoff Martha, Chairman and Chief Executive Officer]

And I think the – Rick, I think on the pull-through – for that pull-through to have an impact, it’s going to take a little bit of time. And it’s a big surgical innovations business we have, $6 billion or so. But I will point to the spine business, and Joanne asked the question earlier, 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. And we spent a lot of time on this robot, and we have invested a lot into it, and it’s not just the robot. It is visualization, it is the digital platform. And we are confident that, that ecosystem will be a differentiator for Medtronic and pull through instrumentation and be a durable growth driver for the company. And that’s why we stuck with it 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, Stifel Nicolaus]

Appreciate it. Thanks Geoff. Thank you.

[Ryan Weispfenning, Investor Relations]

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

[Geoff Martha, Chairman and Chief Executive Officer]

Alright. Well, thanks for the questions, some great questions this morning. I really appreciate your support and continued interest in the company, and we hope you will join us for our Q4 earnings broadcast, which we anticipate holding on Thursday, May 25th, where we will update you on our progress and how we finished our fiscal year. And of course, I look ahead at fiscal ‘24. So with that, thanks again for spending time with us today. Please stay healthy and safe, and have a great rest of your day.