Q2 2025 Earnings Call Transcript

Good morning. I’m Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations and I appreciate that you’re joining us for our Fiscal '25 Second Quarter Video Earnings Webcast. Before we go inside to hear our prepared remarks, I’ll share a few details about today’s webcast. Joining me are Geoff Martha, Chairman and Chief Executive Officer; and Gary Corona, Interim Chief Financial Officer.

Geoff and Gary will provide comments on the results of our second quarter, which ended on October 25, 2024, and our outlook for the remainder of fiscal year 2025. After our prepared remarks, the Executive VPs from each of our four segments will join us and 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, divisional and geographic revenue summaries, and non-GAAP reconciliations. We also posted an earnings presentation that provides additional details on our performance.

The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com. During today’s program, many of the statements we make may be considered forward-looking statements and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause our actual results to differ is contained in our periodic reports and other filings that we make with the SEC and we do not undertake to update any forward-looking statement. Unless we say otherwise, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign currency and second quarter revenue in the current and prior year reported as other.

References to sequential revenue changes compared to the first quarter of fiscal '25 and are made on an as-reported basis. All references to share gains or losses are on a revenue and year-over-year basis and compare our second fiscal quarter against our competitors’ third calendar quarter. Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year.

With that, let’s head into the studio and hear about the quarter.

Hello, everyone, and thanks for tuning in today. Our momentum is building as we keep executing on our commitments, delivering yet another quarter of strong results that came in ahead of expectations and another guidance raise. This makes it eight quarters in a row now of solid mid-single-digit organic revenue growth. And we translated that 5% organic top line growth into 8% EPS growth on a constant currency basis and we remain on track to deliver high single-digit EPS growth on a reported basis in the back half of the fiscal year.

We know that innovation matters. And innovation is what really is driving our growth today across multiple areas. We're seeing strong performance from franchises like TAVR, PFA, leadless pacemakers, diabetes, spine and neuromodulation, just to name a few. And we're confident that this diversified growth will keep going, especially with the strength of our pipeline in high-impact markets like hypertension, which is a big, exciting opportunity for us.

If you look at our recent performance, it's clear. The foundation of the company is much stronger. We've integrated a real performance mindset alongside our mission-driven culture and it's making a difference. And as we continue to drive durable top line growth, use our scale to deliver leveraged earnings, generate strong free cash flow, pursue smart tuck-in M&A, and grow our dividend, we're setting ourselves up to create strong long-term returns for our shareholders.

Now let's turn to the details of our Q2 business results and discuss our performance. Looking first at our highest growth businesses, combined they grew 8% again this quarter and made up 20% of our revenue. Starting with Structural Heart, we grew high single digits on the strength of our TAVR franchise. In the U.S., we launched Evolut FX+, and we're seeing strong customer adoption.

We also received CE Mark for FX+ last month and began commercializing in Europe last week. FX+ is important not only for the lifetime management benefit of offers, but also because it creates an additional opportunity for us to reiterate our positive SMART trial results. Now, you'll recall that SMART demonstrated our superior valve performance in small annulus patients who are primarily women, and they make up about 40% of the TAVR segment. With this combination of FX+, low-risk data and now SMART data, we expect to continue to grow at or above market in the quarters ahead.

Next, in Cardiac Ablation Solutions. Our technology is helping to drive the rapid shift of the market to pulse field ablation. We've been significantly expanding our manufacturing capacity to meet this growing demand and we're well positioned as the only company with both single shot and focal PFA catheters. We continue to drive our growth of our PulseSelect PFA single-shot catheter.

This is offsetting cryoablation declines and our rate of cryo sequential decline significantly improved versus what we saw in Q1. With PFA this quarter, we nearly doubled the number of physicians using PulseSelect and we more than doubled the total number of patients treated with this catheter in Q2. That said, our overall CAS growth did not accelerate as expected this quarter due to a third-party component supplier interruption. They've now expanded capacity, allowing us to continue to ramp PulseSelect availability and activate new accounts. On top of PulseSelect, we were pleased to receive FDA approval late last month for Affera mapping and ablation system, and Sphere-9 focal catheter.

This all-in-one catheter was designed from the ground up to perform high-density mapping as well as pulse field and RF ablations. Sphere-9 replaces competitors mapping and RF catheters, allowing us to increase our revenue per case. We're ramping commercial availability now, having already entered some of the top U.S. centers by volume -- and this will accelerate over the coming weeks and quarters to meet the significant demand. And we continue to rapidly hire mapping specialists in advance of entering new centers, giving us confidence in our ability to accelerate account activations.

With the strong customer response to the breadth of our new PFA portfolio, we expect our overall CAS growth rate to accelerate through the back half of the fiscal year, including strong double-digit growth in Q3, and we expect to reach and then exceed market growth in this large and fast-growing $9 billion cardiac ablation space. Next, in surgical robotics. We continue to invest in our Hugo platform, building a strong foundation for future growth. In the U.S., we've completed capturing the necessary data for urology submission and expect to file with the FDA in the first quarter of calendar 2025. We're also seeing fast enrollment in our next two U.S. indication studies, hernia and gynecology.

In digital, we commenced commercial rollout of our Touch Surgery, live stream, remote connectivity solution across the U.S. and Western Europe as we continue to digitize operating rooms globally. And we're making progress bringing our advanced surgical technologies to Hugo. We expect ICG fluorescent imaging to be available in certain countries soon, followed by adding our market leading LigaSure vessel sealing technology to Hugo next calendar year. Next, in diabetes, we delivered another quarter of double-digit growth, growing 11%, despite more difficult comparisons from the 780G U.S. launch last year.

Our CGM sales grew over 20% in both the U.S. and international markets, driven by the high CGM attachment rates to the 780G. In addition, our Simplera Sync sensor, which is half the size and much easier to apply than our previous sensor is gaining strong acceptance in international markets. On the SMART MDI front, we just secured FDA clearance for our InPen app, which paves the way for a limited U.S. release of our SMART MDI system with our Simplera CGM. So we continue to add new patients with the 780G system.

The majority are coming from MDI, and we're also seeing success from our competitive switch programs. Patients are attracted to 780G's highest time and range of any commercial AID system and achieving this control with less burden. In the dQ&A survey of over 1,500 AID users in the U.S., the 780G had highest user satisfaction of any AID system including scoring 20 percentage points higher than the Tandem DexCom combination and 25 points higher than the Insulin DexCom combination. We're investing heavily in diabetes to expand manufacturing capacity and advance our robust technology pipeline, including our partnership with Abbott on an integrated sensor.

These activities support our strategy to be number one in the fast growing AID and SMART MDI space with a technology ecosystem that is focused on achieving better control with less burden. Now turning to hypertension, and the large future growth opportunity of our Symplicity blood pressure procedure with a proven track record of long-term efficacy and safety and unique design, this innovative solution is poised to transform hypertension management. We're pleased that CMS earlier this month finalized the outpatient transitional pass-through payment, which will take effect on January 1st. With coding and sufficient Medicare payment now in place, the key step for broader adoption is to establish standardized coverage.

On this front, we continue to engage with CMS to facilitate access for patients to this important therapy. And we're working with private payers to advance coverage as well. Hypertension is a global health challenge and the leading cause of cardiovascular disease and premature death worldwide. In fact, it impacts more than 1 billion people globally, including nearly half of all U.S. adults, despite the availability of numerous medications only one in four adults with hypertension in the U.S. have it under control, and the direct cost to the U.S. healthcare system for hypertension are massive, somewhere between $100 billion and $200 billion a year.

So our Symplicity procedure can play a very important role in cost-effectively improving public health. Now looking at our established market leaders. Combined, they made up nearly half of our revenue and grew mid-single digits. In many cases, we've innovated on the technology and business models to reinvent these businesses over the past few years, and we continue to invest in them to ensure durable growth.

They are a key part of our financial model, helping us to consistently deliver on the top line, and they contribute a disproportionate amount of profit and cash flow. In Cranial & Spinal Technologies, we grew 6% worldwide, including 7% growth in U.S. Core Spine and Biologics. In a market that rewards scale, we're continuing to win.

This is driven by our leading AiBLE ecosystem of differentiated spine implants and enabling technologies, including AI-driven, preop planning software, imaging, robotics, navigation and powered surgical instruments. Our large global AiBLE installed base is changing the competitive dynamics in spine, and we continue to expand its features and its capabilities. At the NAS conference in September, we announced a new partnership with Siemens Healthineers to co-market and integrate their imaging technologies for spine care. We expect CST to continue to deliver sustained above-market growth with AiBLE and its differentiated best-in-class solutions, attracting not only spine surgeons around the world, but also the best sales reps and distributors who continue to leave the competition to join our winning team.

Next, in Surgical, we had flat results. As I mentioned last quarter, we had difficult year-over-year comparisons given the supply recovery last year as well as the Korean market slowdown from the ongoing physician strikes. It's worth noting that on a sequential basis, Surgical had strong high single-digit growth, both globally and in the U.S. We had outsized strength in advanced energy, driven by accelerated adoption of our LigaSure XP Maryland vessel sealer.

Overall, we continue to expect Surgical to return to more normalized growth starting next quarter as these comparisons ease. In Cardiac Rhythm Management, we had another strong quarter, growing in the mid-single digits, including high single-digit growth in both defibrillation solutions and in cardiac pacing therapies. Our Micra leadless pacemaker franchise, grew high-teens with broad strength around the world. Now turning to our synergistic businesses, which collectively grew mid-single digits and represented over 30% of our revenue.

The highlight again this quarter was Neuromodulation, where growth accelerated to 12% and the business continues to grow well above the market. We're seeing broad-based growth across product lines, including Pain Stim and Brain Modulation. In Pain Stim, we grew 10%, including 12% growth in the U.S. on the continued launch of the Inceptiv closed-loop spinal cord stimulator. The innovation in Inceptiv is transforming the treatment of chronic pain for patients.

It automatically keeps therapy at the optimal dose and allows patients to focus on everyday life, not on managing their chronic pain. In addition, has the best full-body MRI conditional access on the market and the competition really isn't even close. This is important given that over 80% of these patients need an MRI within five years and nearly all of them need one within 10 years. In Brain Modulation, growth accelerated to 17%, the third quarter in a row of double-digit growth.

This innovation-driven growth is built on the ongoing launch of our Percept RC with BrainSense technology. Percept is having a huge impact for patients with movement disorders like Parkinson's, essential tremor, dystonia and epilepsy. It not only delivers therapy to specific brain targets, but it is the only DBS system that captures and records brain signals. Now this equips physicians with valuable data and the insights needed to personalize the therapy.

And just like in Pain Stim, our DBS devices have differentiated MRI advantages versus the competition. In addition to Neuromod, we also had strong performances in other synergistic businesses. Cardiac surgery grew 10%, with the broad strength coming from innovative products like our Avalus Ultra surgical valve, Penditure LAA Exclusion System and VitalFlow ECMO system. Acute care & Monitoring grew 3%, including 9% in Nellcor pulse oximetry, and Pelvic Health accelerated its growth to 5%.

Now with that, let's go to Gary, who will give you a deeper look at our Q2 financial performances and our outlook. Gary, over to you.

Thanks, Geoff. We delivered a strong top line performance again this quarter with revenue growth of 5%, 50 basis points above our guidance. On the bottom line, adjusted EPS was $1.26, $0.01 above the midpoint of our guidance. We continue to invest in our pipeline and behind our emerging growth drivers while also delivering bottom line growth, which was up 8% on a constant currency basis.

The EPS beat was driven by $0.02 from greater operating profit on the revenue beat, partially offset by $0.01 from tax. The sources of our revenue growth continue to be diversified, both by business and geography, which gives us confidence in its durability. From a segment perspective, we had double-digit growth in diabetes, high single-digit growth in neuroscience and mid-single-digit growth in cardiovascular. The low single-digit growth in our medical surgical portfolio was expected, given the comparisons in surgical that Geoff addressed.

It's worth noting that Med Surg grew 7% sequentially and we expect to return to more normalized year-over-year growth starting next quarter. From a geographic perspective, our international markets grew revenue high single digits, including mid-single-digit growth in Western Europe and Japan and low double-digit growth in emerging markets. Moving down the P&L, our adjusted gross margin was 65.2%, down 70 basis points, but in line with our expectations. The decline was entirely driven by foreign currency as our adjusted gross margin was up 40 basis points on a constant currency basis.

Our adjusted operating margin was 24.3%, also in line with our expectations. The 90 basis point year-over-year decline was entirely driven by FX. On a constant currency basis, operating margins increased 100 basis points. The organization remains extremely focused on improving our margins.

We're more than doubling our underlying productivity in the COGS line through centralizing operations, consolidating factories and suppliers, and driving the Medtronic performance system across our manufacturing network. We are also laser-focused on our pricing, discipline, and optimization, particularly behind our new innovation. At the same time, we're very early in a number of new product launches that aren't fully at scale, including Affera, Simplera, and Hugo, which can create a mix headwind for us. That said, on the SG&A line, we're focused on growing at less than sales like we did again this quarter as we drive efficiency and productivity gains, particularly in our back office functions.

Given all the levers we have, we have line of sight to improving our margins over time, while continuing to prioritize and make significant investments in our organic pipeline and product launches. Now, regarding capital allocation. We continue to make choices and invest to drive future profitable growth, while also returning capital to shareholders, primarily through our dividend and from time-to-time, opportunistic share repurchases. As I mentioned last quarter, we've increased our focus on tuck-in M&A.

We're also continuing to work to evaluate our portfolio. Overall, we view active portfolio management as an important lever to delivering on our long-term strategic and financial objectives. Now, turning to guidance. Given our continued outperformance and positive momentum, we're raising our full year revenue and EPS guidance.

We now expect fiscal '25 organic revenue growth of 4.75% to 5%, an increase from the prior range of 4.5% to 5%. For Q3, we're expecting to deliver another quarter of mid-single-digit growth on the top line and we'd have you model organic revenue growth of approximately 4.75%. Based on recent rates, FX would have an unfavorable impact to fiscal '25 in the range of $225 million to $325 million, including $100 million to $150 million in the third quarter. Moving down the P&L, we expect our third and fourth quarter gross margins to improve sequentially as currency becomes much less of an impact.

We also continue to expect our full year operating margins to expand as we balance driving efficiencies with investing behind our product launches and in our long-term pipeline. On the bottom-line, we're raising our fiscal '25 non-GAAP diluted EPS guidance to a new range of $5.44 to $5.50, an increase from the prior range of $542 to $5.50. For the third quarter, we expect EPS of $1.35 to $1.37. The fiscal year 2025 guidance range continues to include an unfavorable 5% impact from foreign currency including an unfavorable 1% impact in Q3. Further details on our annual guidance can be found in the guidance slide in our presentation.

So, to conclude, we remain focused on restoring our earnings power having just delivered another quarter of leveraged EPS growth on a constant currency basis. We continue to expect to report high single-digit adjusted EPS growth in the back half of our fiscal year in line with our long-term commitment to deliver durable mid-single-digit organic revenue growth with EPS leverage. Geoff, back to you.

Thank you, Gary. Now before we go to analyst questions, I want to close with a few thoughts. We're delivering durable mid-single-digit revenue growth, which we've been doing consistently now for two years. This is the direct result of all the changes we've made to the company over the past few years from the resiliency of our operations and supply chain to our performance incentive plans, to our culture and our people.

We've also been investing to position ourselves in high-growth markets, and this has led to a wave of recent product approvals across many of our businesses. Look, it's exciting, and it creates a tailwind that this company hasn't had in a while. We've been working hard to put ourselves in a position to win with revenue growth tailwinds on top of a strong foundation. And now it's up to us, it's just up to us to execute and deliver on these opportunities, and then as we go down the P&L, the significant work that we've been implementing to drive cost savings and earnings power will start to show up in our reported results in the back half of this fiscal year, and when our organization delivered strong earnings, we translate this into strong free cash flow.

This creates a virtuous cycle with incremental firepower for investment and returning capital to our shareholders. And when you combine all of this with the work that we've been doing with portfolio management, we expect to deliver significant long-term value for our shareholders. Finally, I want to thank all of our employees around the world. I know, many of you are watching today and it's because of your efforts and those that came before you that Medtronic has accomplished so much in the 75 years since this company was founded.

Your work directly benefits the lives of over 78 million people this year. That's an incredible accomplishment. And when I think about the work you're doing to create our future, the innovations that you're inventing, engineering, manufacturing and preparing to sell, this work has the potential to alleviate pain, restore health and extend life for hundreds of millions of people and create tremendous value for many other stakeholders. Thank you for everything that you do.

With that, let's move to Q&A where we're going try to get to as many analysts as possible, so we ask that you limit yourself to just one question and only if needed a related follow-up. If you have additional questions, you can reach out to Ryan and the Investor Relations team after the call. With that, Brad, can you please give the instructions for asking a question?

A - Brad Welnick: [Operator Instructions] For today's session, Geoff, Gary and Ryan are joined by Que Dallara, EVP and President of Diabetes, Mike Marinaro, EVP and President of the Medical Surgical portfolio; Sean Salmon, EVP and President of the Cardiovascular portfolio; and Brett Wall, EVP and President of the Neuroscience portfolio. We'll pause for a few seconds to assemble the queue. All right. We'll take the first question from Larry Biegelsen at Wells Fargo. Larry, please go ahead.

Good morning. Thanks for taking the question. Congrats on a nice quarter here. I heard you guys talk about the hypertension opportunity a few times on this call.

I think we saw video before the call highlighting Renal Denervation. So I wanted to ask Sean about that. Sean, you have the TPT for Ardian beginning in January. How much of a benefit are you expecting from that?

And when are you anticipating the national coverage decision? And are you planning to use new TSAT process for that? And Sean I think it's been a while since we've heard you talk about just your overall thoughts on the Renal Denervation opportunity. Thanks for taking the question.

Okay. Thanks, I appreciate the question. Look, we continue to make really great progress on the reimbursement front. As you mentioned, TPT or the outpatient coverage for devices, and what that really addresses is a proportion of the patients in Medicare, roughly half of the Medicare patient population, those on fee-for-service would now be covered with this transitional pass-through payment, which is certainly going to be an accelerator for the therapy.

But as you noted, getting broader coverage will get us out of the prior authorization loop, allowing you to just build to the codes that have already been established. So making that headway is important. We also have to go further with the private PAIR universe. That does take longer.

You go PAIR by PAIR, state by state. In terms of the efforts on coverage, what we're doing is going for coverage with evidence development, there are numerous pathways that, and we'll be giving an update on that in the future. But I've got no incremental update today.

Thank you.

Thanks, Bieg. We’ll take the next question. Please, Brad.

The next question comes from Robbie Marcus at JPMorgan. Robbie, please go ahead. Hello, Robbie? The next question comes from Travis Steed at Bank of America. Travis, please go ahead.

Hi, thanks for taking the question. I guess, I wanted to just talk about your ability to grow earnings high single digits longer term, despite maybe some potential for, you've got maybe a stronger dollar tariff potential, it sounds like some of the initial Affera Ardian and launches could be negative on margins initially, but is there enough upside on some of those programs to offset potential headwinds? Is there a potential cushion on some of the COGS productivity? I just want to know your flexibility and your commitment to continue to grow earnings despite some of those potential headwinds that investors have been starting to worry about?

Yes, Travis, thanks for the question. And yes, we are definitely committed to the earnings. I'll let Gary walk you through some of your specifics of your questions. .

Thanks, Geoff. We're pleased to raise our guidance on both revenue and EPS for the year as we continue to move, kind of, build momentum. There's a lot to be excited about and we're focused on driving durable, both revenue growth as well as restoring the earnings power of the company. On the margin front, what I want you to hear from us is there's no change to our margin expectations.

In Q3, we expect margins of 25.6%, up 30 basis points year-over-year. Full year, we expect operating margins to be 25.7%, up year-over-year by 10 basis points. Gross margins will be up sequentially in both Q3 and Q4, and that will deliver our guidance. On the SG&A front, we'll drive leverage through a focus on our highest priorities, leveraging what we talked about before automation and digitization, we'll make some structural changes, and we have strong discipline on our discretionary expenses to help drive that margin expansion.

You mentioned the early launches, and we're committed to investing behind those, both commercially and in R&D. So taken together, that mid-single-digit revenue growth will deliver upwards of 10%, EPS on a constant currency basis. You mentioned the foreign exchange. That will be a five-point headwind in line with what we've talked about before.

And that will get us to the $5.44 to $5.50 guidance that we gave today. So overall, we feel good and worth mentioning wants to set guidance up that sets us up for success.

Great. Thanks a lot.

Thanks, Travis. Next question, please Brad.

Yes. Robbie, we'll go back to you if you're on. Otherwise, we'll move on.

Yes. Can you hear me this time?

Yes. Thanks, Robbie.

Great. Sorry about that. I forgot to unmute before. So thanks for taking the question.

I wanted to ask kind of as a counter to Travis' question. Some of the products you mentioned that were important growth drivers on sales, but early in their life cycle on margin expansion, renal denervation, both PulseSelect, which had the supplier issue this quarter, and the upcoming or ongoing Sphere-9, Affera launch, and Hugo robotic and renal denervation. Maybe you could just talk about, especially over the next six to 12 months as some of these products start to launch and progressively launch how you're thinking about the cadence of growth for them and then also margin implications as we think about some of these lower-margin products, maybe adding some of the most incremental growth?

Thanks a lot.

Yes. Thanks, Robbie. Thanks for the question. Yes, I mean, look, on the margin side, obviously, you're asking a question around mix.

That's a piece of it. But in addition to that, the pricing is -- continues to be an opportunity for us. I think that's been a positive here over the last couple of quarters. And I think there's more upside for us there in pricing, and our cost-down programs have kicked in and are helping as well.

So those are, I think, both tailwinds for us. So on the mix side, it is a bit of a mixed bag. And Gary give you some details, but some of the programs like Hugo and Affera that involve capital can be a little -- can be lower, especially earlier in the cycle, as you're ramping them up. But then we have some others like Ardian and Neuromod, which are -- Neuromod's out there now having a pretty big positive impact on price and on our margins. and our mix and Ardian would do the same.

I don't know if you -- how you want to add to that, Gary. .

Yes, not much to add, Geoff. I would just say, first of all, all of the -- all of this is contemplated in our guidance. And for 2025, we're expecting gross margins to be flat on a constant currency with foreign exchange driving about 0.5 point of headwind. I talked about the sequential improvement that we expect in both Q3 and Q4 and our focus on stabilizing and improving from there.

Geoff talked about some of the headwinds, but I also say we're really laser-focused on cost reduction on price, especially behind our innovation across the board, to fund the investment to ensure commercial success of these critical launches.

Thank you very much.

Thanks, Robbie. Next question, please Brad.

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

Hi, guys. Thanks for taking my question and congratulations on a steady execution here. Geoff, maybe I wanted to focus on ablation here. You mentioned flattish growth in the quarter due to some disruption, what was the issue?

When was it resolved? What gives us the confidence of strong double-digit growth in third quarter, is that some revenue catch-up from second quarter? When do you think cryo could bottom out, is that in third quarter? And you did -- I thought it was interesting, you mentioned the revenue per case in Affera, is that a 3x increase versus cryo?

Thank you.

Yes. So as I said in the commentary, CAS, our ablation business didn't accelerate as we expected this quarter because of this third-party component supplier that experienced an interruption in their supply. That supplier is back on track. That issue is resolved.

They've expanded capacity as well, and which is allowing us to ramp the PulseSelect supply and activate new accounts, PulseSelect is doing well. I mean -- and it's in a good spot from a supply perspective going forward. Like we literally saw the unit we had in Q2. And as I mentioned, we did double -- or close to double the physicians using PulseSelect, and we'll now have confidence to open more accounts, so that should continue. And then we more than doubled the number of procedures, a number of patients treated, and as for cryo, the declines actually got better sequentially.

And so cryo wasn't the issue, Q2 versus -- I'm sorry, Q1 versus Q2 because in Q2 the declines got better than Q1. And so it really was the supply issue that's been resolved. So we now have -- we expect PulseSelect to continue to ramp. We have this -- and now we have Sphere-9, and that gives us all this combined the supplier issue should being resolved and what we're seeing on PulseSelect demand and Affera demand. That gives us the confidence in the strong double-digit growth in Q3. So this is an important area for us.

It's an area of focus. And we feel like we're well positioned with both the single shot and the only player with single shot and focal going forward.

And sorry, the revenue per case on Affera is that 3x versus cryo?

Sean, do you want to handle that one? The revenue per case on Affera?

So Vijay, when you do cryo is really just the balloon catheter that you're using and when you're doing thermal with RF or non-thermal with PFA, there's additional components that can be used, including like a mapping catheter, the patches that you use for a navigation system. So the case revenue goes up. And there's also the use of other technologies like crossing needles that we sell as well. So the revenue per case does go up.

I don't think it's 3x quite, but it's certainly more, and that that correlates to too, is with the Sphere-9 catheter since you don't need a dedicated mapping catheter, it actually saves them money per case for the hospital. So, it's the value proposition of having one catheter that can do the entire job with a single stick across transseptal is really appealing to physicians.

Thank you guys.

Better workflow and better workflow for them. And even though as excited as hospitals are about PFA, they are still conscious on the price. And so the fact that if you can save them the catheters, like Sean just mentioned, that helps.

Thanks, Vijay. We go to the next question, please, Brad.

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

Great. Thank you so much for taking the question. Geoff, I was wondering if you could share your thoughts on the MedTech landscape, under the Trump administration. Specifically, what are your thoughts on tariffs? How do you plan to navigate your supply chain? And perhaps you can touch on your exposure to imports from China?

Well, first, before I jump into the election questions, the MedTech landscape, the underlying market is healthy. We're seeing good procedure growth, and we think that's steady going forward, really driven by innovation, whether it be growth of minimally invasive procedures like TAVR or innovation and pacing like leadless and conduction system pacing or we just -- the PFA conversation we just added, that's pooling patients from drug solution to a MedTech solution, all these things are -- this innovation is what's driving a lot of this growth plus just demographics. So, I think it's a healthy market.

And under any administration, if you back decades, whether it be in the U.S. or other countries, healthcare is an important priority for any government, and so we feel good in that way. When you come to the specific election. I do think it's -- with the President Elect Trump coming in, I do think it's still a bit early to speculate about different policies, whether it be healthcare policy or exactly what's going to going to happen or not happen to tariffs. It's -- like I said, it's still too early.

We're running different scenarios here, obviously, in preparing for different scenarios, but I don't want to get into that speculation. In terms of though our exposure to importing products from China, it's small, it's less than 1% of our revenue.

Thank you.

Thanks Shagun. Go to the next question, please, Brad.

The next question comes from Chris Pasquale, Nephron. Chris, please go ahead.

Thanks. I wanted to ask about the Diabetes segment and your upcoming FDA submission for a Type 2 label expansion. How much of your current insulin pump installed base maybe in the U.S., that's easier, is made up of Type 2 patients? And how do you think about your opportunity in that segment without a more discrete on-body form factor, which seems to be a priority for many of those users?

I'll let Que answer the question on Diabetes. Que?

Thanks for the question. On Type 2, we finished enrollment. We expect to submit to FDA with expanded indication in the first half of next calendar year. So, that's progressing very well.

Today, as a percentage of our installed base, we are still largely a Type 1 business. We do see Type 2 as being quite a large opportunity, and the clinical data that we've generated for Type 2 is extremely good. So, we are actually quite optimistic about the Type 2 opportunity.

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

The next question comes from Pito Chickering at Deutsche Bank. Pito, please go ahead.

Hi. Good morning, guys. Going back to the 2025 guidance, in your updated guidance, you're absorbing more FX headwinds on increasing our EPS guidance. I think you told Travis that your margin guidance is 25.7% for the year.

I think it was 25.8% last quarter or so with revenue guidance up a little bit, FX headwinds increasing, EPS moving up, is tax rate a positive tail end of the back half of the year versus the previous guidance? I'm just trying to bridge the moving parts into the EPS guidance raise? Thank you.

Gary, do you want to take that.

Yes, happy to take that. What I would say is FX on an EPS basis is very much in line with what we've been sharing all year, and that's really the power of our hedging program, giving us good visibility. Revenue is up, gross margins are essentially in line with our expectations. And we are, as I mentioned, investing behind the power of these launches, both commercially as well as R&D.

Tax is up a little bit. We're navigating Pillar 2. But all-in-all, EPS up $0.01 at the midpoint, and we're pleased we've taken our guidance up today.

Thank you, Pito. Next question, please, Brad.

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

Thanks, and congrats on the quarter here. Back to Renal Denervation, just looking at some data. CMS is quoting 16 million patients, 65 plus that have uncontrolled hypertension, but they're also on medication. So just maybe a recap here, with the NTAP and TPT in place now, how much of that population can you go after and how much is still out there that you would need an NCD to sort of address that patient population?

Thanks.

Sean you want to take this one.

Yes. Sure. So the PAIR mix is roughly 50-50 between those in those in Medicare and those not Medicare, Medicare and Medicaid, I'd say. The TPT addresses the fee-for-service component of the Medicare-eligible patients that does not include those on Medicare Advantage.

So that's roughly split evenly between the two of those. So the base population is obviously very, very large here for those uncontrolled hypertension, those with taking drugs still having elevated blood pressure. As Geoff noted in the beginning, it's really the minority of patients that actually get control despite the availability of those drugs. So -- Medicare it's $16 million, if that's the baseline, our numbers are more like 18 million for the uncontrolled hypertension patients greater than 150 that are drug treated.

The addressable market with in and outpatient is about half the Medicare population. Medicaid is going to be a state-by-state determination like commercial insurance would be, but suffice to say, hey, there are a lot of patients that could be addressed with this therapy. The demand is really not the issue. It's going to be making sure we get that coverage and we establish centers that can do the procedure.

Thank you.

Thanks, Anthony. Next question, Brad.

The next question comes from Rich Newitter at Truist Securities. Rick, please go ahead.

Hi. Thanks for taking the question. Maybe just going to Spine. That continues to be a strong business for you guys.

You're growing above market, especially in the U.S. I guess, can you parse out a little bit, the market has been stronger here. So I'd just love to hear how much of the underlying market strength or pickup in recent quarters or years is attributable to that? And I'm just trying to get a sense for how sustainable a high single-digit growth profile for your U.S. core Spine franchise could be?

Yes. First of all, look, it is a bit of – we're seeing a bit of market expansion here. We're also seeing a bit of market consolidation. There's a large tail of spine companies out there that are going away. And as I said in the commentary, this market is leaning towards those with scale and technology. But I'll let Brett go into some of the details here.

Yes. Thanks, Rich. The market itself still remains strong. And as Geoff said, it really benefits companies with scale because of the consolidation and technology with the AiBLE system.

And if you look at the technology that we're bringing to this, it recruits the best reps, it recruits the best physicians, and brings together more market opportunity, much more significant opportunity across the world. So we see this as sustainable and we see this as a platform that we will continue to take share and continue to grow this business.

Okay. Maybe just as a follow-up to that. You have a competitor, the other main consolidator right now in the space who's approaching the anniversary of what feels like it could be the worst case for disruption in the marketplace. You talked about opportunity to take share as consolidation disruption is unfolding. Can you just update us on what you're seeing on that front? Thank you.

Yes. You bet, Rich. We have a good pipeline there, and we have had a good pipeline there of strong growth and good consolidation with more high-quality reps and other people coming towards Medtronic. And we're continuing to see that develop, and we have a pipeline and significant opportunity into the future.

And once again, it benefits companies with scale and benefits with technology, and we see that continuing to occur and continuing to happen.

Thank you.

Thanks Rich. Next question please, Brad.

Next question comes from Danielle Antalffy at UBS. Danielle, please go ahead.

Thanks so much. Good morning, everyone. Thanks for taking the question. Just a question on TAVR.

There's been a lot of data over the last few weeks here in TAVR, you guys still are benefiting from the SMART trial. I'd just love to get a state of the nation on the TAVR market. And where do you see that going from here, especially with a recent asymptomatic data that we saw. And also one of your potential competitors at the very least delayed from entering the U.S. market.

Thanks so much.

Sean, you want to hit the TAVR question?

Yes. Thanks, Danielle. I think the market is in good shape. I think in line with what we've been saying in prior quarters, it's in that high single-digit range for growth, the expansion of patient population, there's continued opportunities for that.

As you mentioned, the asymptomatic patient population, which I think fixes as a class effect would increase that. But the bigger unlock would be moderate aortic stenosis down the road, where we get with our trials read out there. And then there's sort of TAVI and TAVR indications that would also help expand that along with continued global growth of the therapy. So look, I think the evidence base that we've got, the strength of our product just gets better and better.

And the longer-term data really starts to distinguish what we've got, and we've got certain use conditions like small annulus that clearly, hemodynamics of our valve are better. And what's really opened up the aperture for us as well as really eliminating the concerns of coronary access with the new FX+ product, which we've launched in the United States, just began launching also this quarter in Europe, and we'll be pursuing that technology into other world markets, including Japan within the year. So I think we're well positioned. The market is healthy, and we still see lots of room for growth for a long-time.

Hi, thanks, Daniel. Next question, please Brad?

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

Thank you so much. And good morning. It's been a while, I think, since we've heard an update on your mitral valve replacement and repair programs. Could you sort of just give us an update on where you're thinking about that as well as tricuspid opportunities. Thank you very much.

Well, we'll stick with Sean on the structural heart questions.

Yes. Thanks for the question. So the Intrepid valve which is used in both the mitral position as well as in the tricuspid position continues in its trial for U.S. and European approval APOLLO trial. We're doing well in that study.

I think the acceleration for the trial is really had by going to a 29 French version of the transseptal side of that. And we've seen really, really good results when we completely eliminate the regurgitation, which is very different than what we see with repair technologies. The clinical outcomes have been really excellent. We've taken on a population of those who are not clippable, those who can't get surgery and patients with severe mitral annual calcification or MAC.

So that's really going to be the first indication for that. On the tricuspid front, it is the same valve, we are making some modifications for that in the future. But right now, we're using the existing Intrepid valve and the tricuspid position in the early feasibility study. The iterations that we'll make are, include sizes and just making it more fit for purpose in that location.

But we continue to do well. We believe that elimination of regurgitation is better for patients. And that's been our primary focus. And we have some other investments in repair technologies as well.

I think just overall, just kind of recapping the last two questions. Our Structural Heart business is in a good spot. It's -- as Sean mentioned, we built on our TAVR franchise with data and product improvements, and then in the pipeline, he just went through mitral and tricuspid with Intrepid. And this is getting back to other questions on mix, this is a good guy on our mix.

It's a very profitable franchise for us. So it's good to see that it's doing well and the underlying market is also doing well.

Thanks, Joanne. I think we have time for two more questions. So Brad, we’ll take the next question, please.

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

Hi, thanks for taking the question. So I was hoping to keep in the Q&A here, just maybe clarify a couple of things, and come up during Q&A and questions you get often from investors. So just on a couple of the key pipeline programs. So maybe pace and timing for Affera in the U.S.

I think, Sean, you talked about the NCD, but it wasn't clear for Ardian whether that's sort of sort of in calendar 2025, any sort of timing? I know that's a tough process to now down. And in diabetes, the patch pump is a topic we get off and when and what can you tell us, and just to again clarify something, I think it's come up a couple of times is on earnings growth in the back half. So the 5% head win with EPS is about $0.26, $0.27, I think, if we do the math on that right, and you got about $0.10 of that left and the impact of back half or most of the impact that FX headwind on EPS growth has been in first half?

Just any color or cadence or mechanics, you can help us understand how that plays out in Q3 and Q4. I guess that's for Gary. But thanks so much.

Yes, I think -- thanks for the question, Matt. Look, on Affera, look, it's part of our PFA story. Obviously, we just got the approval. And this is one that we're in the process of ramping.

We didn't quantify that exactly. But when you put it all together with PulseSelect, which is at a more scale position, that's where we're getting the strong double-digit growth in Q3 and beyond. So, it's -- we're not breaking out of Affera specifically, but -- we are in the process of scaling that. Already in the coverage, Sean went through the ins and outs of that.

But to your point, Matt, it is difficult to predict exactly when -- how -- when CMS gives some indication on coverage, we got like, as you know, a strong indication or strong approval from the FDA with a broad indication. And so we've got to see where CMS ends up. And as we've talked about, the conversations have been very constructive. But it's -- we don't want to -- it's hard to predict timing on when they'll get back us and publicize something.

As far as diabetes goes, I think the patch programs remain dynamic. We've got a couple of shots on goal there. I don't believe we've given any timing on that other than, look, we've been investing heavily in diabetes across the entire -- one of our strengths is just the fact that we have the entire ecosystem and patch needs to be part of that. We've got a couple of shots on goal here, and it's -- but we have not given a timing on that.

And then as far as the earnings growth, as Gary mentioned, we -- in the back half of the year, and we mentioned in the commentary as well, we see a high single digit, we see that earnings growth that you saw on a constant currency basis that was high single-digit, even double-digit, we see that trend translating into the back half of the year, high single-digit realized EPS growth I don't know if you have anything to add to that?

Yes. You hit the EPS, Matt. The foreign exchange headwind is pretty much spot on 5 points for the year and about a dime in the second half. I know currencies on a lot of folks' mind.

We're a global company. And historically, it has been for us. But this is where you see the benefit of our hedging program. And it's a key part of our strategy as we think about the impact going forward.

One of the best things we can do is grow our U.S. business, we're also looking aggressively at dynamically pricing in devaluing currency environments, and we're seeing that in our results. And we're also looking at balancing our cost base around the world. So, we're taking action. It's a priority of mine.

And as Geoff said, we'll see that high single-digit EPS in the second half.

Yes. No, I think on the currency thing, it's important -- I just want to reemphasize what Gary said. I mean, yes, our hedging program can delay impact and help with stability in a given year. But we're really attacking this the underlying issue so that we don't -- we aren't exposed to it as much.

And whether it's prioritizing, putting a lot more investment into U.S. growth, but also a number of other actions, like Gary mentioned, like in some of these devalued countries that have constant valuation of currency, a whole different pricing regimen there, that's much more dynamic. And this is something that we really committed to. Gary is really championing this and yelling from the mountain tops as you can tell from his voice on this call. This is a priority for him and for us.

Okay. Thanks, Matt. We'll take our last question, please, Brad.

Our final question comes from Patrick Wood at Morgan Stanley. Patrick, please go ahead.

Beautiful. I'll keep it tied on this one. Given the focus on tuck-in M&A, I'm just curious, the kind of assets you're most interested on that side. And then obviously, there's language around looking at the portfolio of assets that you're running. Should we expect the potential for any slightly more radical repositioning of the business over the next coming years? Thanks.

Okay. Thanks Patrick. In terms of M&A, this is something we talked about in the last quarter as well. I mean this is an important part of our growth algorithm.

And the type of assets -- or the type of M&A we want to do is more tuck-in, and don't want to forecast exactly where we're prioritizing, but it is more of a top-down approach here where we're looking at the -- our leadership team looking at the areas that we're prioritizing and really looking to those areas for that to be the priority areas for M&A. So, our high-growth markets, but also our high-growth segments that we've talked about, but also some of our well-established businesses from time-to-time need some tuck-in support to keep them going because we're counting on a minimum amount of growth from them and a disproportionate amount of profits and cash flow.

So, we want to make sure they're healthy. So, that's -- it's kind of -- within that, we're not getting much more specific. And then in terms of portfolio management, look, I just can't emphasize enough how important it is for us to -- this portfolio management is an ongoing process, not a destination. We're constantly looking at the portfolio, to make sure it's constructed in a way that's aligned with our mission, align with our strengths.

I mean it's a competitive world out there. We want to make sure we're playing to our strengths, and we've got a number of those. But it also is constructed in a way that can give the company from a financial performance perspective, that reliable, durable mid-single-digit innovation-driven growth at that mid-single-digit level. On the top line, that can translate with the profitability mix, like we went through some of the mix dynamics where we have some points or negative on the mix and some that are businesses a good guy on the mix, we want to make sure that all adds up to that earnings leverage down the P&L and the translation to cash flow that gets you to the dividend and get you to that double-digit shareholder return.

So we are really actively looking at the portfolio to make sure it's constructed in a way to durably deliver that. And that's about as far as I can go on context on portfolio.

Thanks so much, guys.

Thanks, Patrick. And we apologize, if we weren't able to get to everyone in the queue this morning. So feel free to follow up with me or anyone on the IR team after the call. So with that, Geoff, please go ahead with your closing remarks.

Okay. Well, thanks to all the analysts for the questions. And to all of you that joined us today, and like always, we certainly appreciate your support and your continued interest in Medtronic and, we hope you'll join us for our Q3 earnings broadcast, which we anticipate holding on Tuesday, February 18, where we'll update you on our continued progress against our long-term strategies and our commitments. So with that, again, thanks for joining us, and have a great rest of your day.

And for those of you in the U.S., wishing you and your families all a very Happy Thanksgiving next week. So thank you and have a good day.