Medtronic - Q1 2025

Transcript

Ryan Weispfenning (VP and Head of Investor Relations)

Good morning, and welcome to another Medtronic Earnings Day. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations, and I appreciate that you're joining us this morning for our fiscal twenty-five first 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 first quarter, which ended on July twenty-six, twenty twenty-four, and our outlook for the remainder of fiscal year twenty-five. After our prepared remarks, the executive VPs from each of our four segments will join us, and we'll take questions from the sell-side analysts that cover the company. Today's program should last about an hour.

Gary Corona (Interim CFO)

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 first quarter revenue in the current and prior year reported as other. References to sequential revenue changes compared to the fourth quarter of fiscal twenty-four 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 first fiscal quarter against our competitors' second 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.

Geoff Martha (Chairman and CEO)

Hello, everyone, and thanks for tuning in today. As you saw in our results, we're exceeding our commitments and increasing our outlook for the rest of the year. This is now our seventh quarter in a row of delivering mid-single-digit revenue growth, and we drove earnings growth, increasing adjusted EPS to 3% on a reported basis and 8% constant currency. And we're tracking to delivering high single-digit EPS growth on a reported basis as we exit the fiscal year. Our underlying markets are healthy. We're driving operating rigor, and new product innovation is fueling our diversified growth across many large, secular growth markets that matter. At the same time, we continue to invest in our pipeline, which we expect to drive growth in the short, medium, and the long term.

Gary Corona (Interim CFO)

We're at the front end of many new product cycles in markets like diabetes, pulsed field ablation, TAVR, neuromodulation, hypertension, and robotics. We're focused on driving scale across our manufacturing, technology, and commercial organizations, and making progress on our ongoing portfolio management work. Now, as we deliver innovation and continue to execute on our transformation, this will lead to strong returns for our shareholders. Now, let's turn to the details of our Q1 results and discuss our performance. Looking first at our highest growth businesses, combined, they grew 8% and made up 21% of our revenue. We expect their contribution to our overall growth to increase in the coming quarters as we continue to launch new technology. Starting with cardiac ablation solutions, we're at one of those moments in MedTech where a new technology is causing a rapid shift in the treatment of a disease.

In this case, PFA is that technology for AFib. We've been investing in and developing this technology over many years. We're well positioned here, and we're confident in our ability to execute and take advantage of this opportunity. In line with what we said last quarter, our CAS growth rate accelerated in Q1, growing over 6%. We're seeing rapid market adoption of our PulseSelect PFA catheters, and its growth is more than offsetting cryo declines. The PulseSelect launch has been successful, with more than 550 physicians in 20 countries having treated over 10,000 patients. To meet the strong market demand, we're dramatically increasing our PulseSelect catheter manufacturing capacity and expanding into new accounts. As a result, we expect PulseSelect to meaningfully accelerate our overall CAS growth rate through this fiscal year, including a strong acceleration in Q2.

And then we have our differentiated Sphere-9 focal catheter. This all-in-one catheter can perform high density mapping as well as pulsed field and RF ablations. We expect Sphere-9 will allow us to capture more revenue per procedure as it will take the place of other competitors' mapping and RF catheters. We're in limited launch in Europe, and we've submitted to FDA for approval earlier this calendar year. As we launch and scale Sphere-9 and our Affera Mapping system, we expect our CAS growth will accelerate even further over time as we reach and then exceed market growth in this large and fast-growing $9 billion cardiac ablation space. Next, in structural heart, we continue to deliver high single-digit growth, excluding the impact of our Harmony pulmonary valve that we relaunched last year.

During the quarter, we started with the limited U.S. launch of our Evolut FX+ TAVR valve and have now begun full market launch this month. FX+ is important for two reasons: one, it allows for easier coronary access due to the large windows in its frame, and two, it creates an additional opportunity to reiterate our positive SMART trial results with our customers. SMART showed our superior valve performance in small annulus patients who are primarily women, and this was just another proof point in our broader focus on health equity. The SMART patient population is sizable, making up about 40% of the TAVR space. With this combination of FX+, our superior four-year low-risk data, and SMART data, we expect to continue to grow at or above the market in the quarters ahead. In surgical robotics, we're investing in building a foundation for future growth.

In Q1, our install base continued to grow and utilization per system steadily increased, and in the U.S., we've now achieved the targeted enrollment for the EXPAND URO trial. This is a meaningful milestone, and beyond that, enrollment and procedures in our other two U.S. indication studies, hernia and gynecology, are going well. We also continue to make progress bringing our advanced surgical technologies to Hugo, such as ICG fluorescent imaging and LigaSure vessel sealing. Next, in diabetes, we had another strong quarter, growing 13%, with double-digit growth in both the U.S. and international markets. In the U.S., we reached the one-year milestone of the launch of the MiniMed 780G AID system. We're driving high single-digit growth in pump revenue and over 30% growth in CGM revenue with our high CGM attachment.

In international markets, we initiated the full market release of the Simplera Sync sensor, and we're just getting great feedback on it, on the ease of insertion and its usage. This adds to the already high satisfaction of our 780G system, where we've been the number one-rated AID system by dQ&A for the past two quarters. So we're confident in Simplera and our CGM pipeline. And to add to this, two weeks ago, we announced our global partnership with Abbott, where we'll bring to market an integrated CGM based on Abbott's most advanced CGM platform. The sensor will integrate exclusively with our AID and smart MDI systems. It will also allow us to offer more choice to patients, increase our installed base, and grow our diabetes revenue. And we expect to do this while maintaining the same revenue per patient and being neutral to diabetes gross margin.

Geoff Martha (Chairman and CEO)

Look, we're committed to being number one in the fast-growing AID and smart MDI space, and this partnership will help ensure just that. Now, turning to hypertension. Securing broad reimbursement remains key to unlocking the opportunity to our Symplicity blood pressure procedure. We were pleased that CMS has finalized the inpatient payment and has now proposed an outpatient payment, and we continue to engage with CMS at the national and local levels to establish coverage, a key enabler so that this therapy can reach patients. Now, this is important as hypertension affects more than one billion people globally and nearly half of all U.S. adults. Despite the availability of numerous classes of pharmaceuticals, only one in four adults in the U.S. have their hypertension under control.

Gary Corona (Interim CFO)

Furthermore, more than 700,000 deaths in the U.S. every year are directly attributable to hypertension, and the burden of hypertension costs the U.S. healthcare system between $100 and $200 billion a year. So you can see why there's just an important role for our Symplicity procedure to cost-effectively improve public health. Now, turning to our synergistic businesses. Neuromodulation was a highlight this quarter, growing 10%, well above the market. This is a business where the investments we've made over several years in sensing technology in the brain and the nervous system are now paying off. Sensing and closed-loop technology is becoming foundational for the neuromod space. It's reinvigorating these markets, and we have a clear lead. First, in pain stim, we grew 11%. This was the first quarter of our Inceptiv launch in the U.S.

Inceptiv is our first closed-loop spinal cord stimulator, and it's transforming the way we treat chronic pain. The device automatically senses and adjusts stimulation 50 times a second, 24/7, with no required interaction from the patient. And the therapy is delivered from the smallest and the thinnest closed-loop SCS device on the market. It also has the best full-body conditional MRI access. The other big driver of neuromod growth was our brain modulation business, which grew 14% on the continued launch of Percept RC with BrainSense technology. Percept transmits electrical signals to specific brain targets affected by debilitating neurological disorders like Parkinson's. It then captures and records these signals, equipping physicians with the valuable data and the insights needed to personalize the therapy. And just last week, we became the first and only DBS company to receive FDA approval to offer DBS surgery while the patient is asleep.

Now, this innovation means a less stressful surgery for the patient and potentially shorter procedure times. We look forward to continuing to advance our leadership position in brain modulation. Now, looking at our established market leaders. Combined, they made up just under half of our revenue and grew 5%. Collectively, we can depend on this diversification not only for reliable revenue growth, but also their disproportionate contribution to our profits and cash flow that we can then invest in higher growth areas. Cardiac rhythm management grew high single digits, with high single-digit growth in defibrillation solutions and low double-digit growth in cardiac pacing therapies. Our Micra leadless pacemaker franchise grew over 20% as the market continues to adopt our latest generation of devices. In surgical, we grew low single digits.

This was lower growth than prior quarters, primarily driven by the difficult comparison from backorder fulfillments in the first half of the last fiscal year, as well as the Korean market slowdown from the ongoing physician strikes. Now, we expect that surgical will return to more normalized growth in the back half of the fiscal year as these comparisons ease. And in cranial and spinal technologies, we grew mid-single digits. Our spine business continues to just really outperform the market, with 7% global and 9% U.S. core spine growth. This sustained share capture is being driven by our AiBLE ecosystem. AiBLE's differentiated features and the sheer scale around the world is. It's a winning formula for our spine business. It's good for patients and surgeons, and it's changing the competitive dynamics in spine.

AiBLE is helping us win, share, and attract the best sales reps and distributors to join our Medtronic team. With that, I now want to welcome Gary Corona, our interim Chief Financial Officer, to his first Medtronic earnings broadcast. Gary's taking over for Karen Parkhill, to whom we wish all the best as she starts her next chapter. Gary joined us a little less than two years ago after an impressive career with General Mills. He's been leading our corporate finance team and has been instrumental in enhancing both our capabilities and our rigor, which has been a key enabler to our beats and raises. And as he stepped into the role, we haven't missed a beat. So I want to welcome Gary.

Thanks, Geoff, and I too want to thank Karen for all her contributions to Medtronic and her support of me personally. I'm energized to step into this role and continue the momentum that we have as a company. I'm honored to lead our talented global finance team and want to send a big thank you to the entire Medtronic organization for your support. I've been able to hit the ground running, and I'm excited to work together with Geoff and the leadership team to drive performance and achieve our financial commitments. I'm looking forward to having conversations with many of you in the investment community over the coming weeks. Now, I'll recap our Q one financials and give you some additional details on our outlook.

We started this fiscal year by continuing to deliver on our commitments with revenue growth at 5.3%, a full point above the midpoint of our guidance. This translated into EPS that was $0.03 ahead of our guidance midpoint. We're driving diversified growth, and you can see this strength come through when you look by business or by geography, as both new product innovation and commercial execution is fueling our results. Our cardiovascular portfolio accelerated to high single-digit growth, and we saw continued momentum in neuroscience and diabetes. Our U.S. growth also accelerated on contributions from cardiac rhythm management, PFA, and neuromodulation. And our international markets grew in the high single digits, including mid-teens growth in emerging markets. Moving down the P&L, our adjusted gross margin was 65.9%, down 50 basis points, but ahead of expectations.

As expected, the decline was entirely driven by the 80 basis point impact of currency. However, we continue to make progress on our underlying margin improvement activities. In Q1, pricing from our new innovation and our cost out programs offset inflation, resulting in a 30 basis point increase in our gross margin on a constant currency basis. Our adjusted operating margin was 24.4%, in line with expectations. This was a decline of 40 basis points versus last year, but up 60 basis points in constant currency. Turning to capital allocation, our philosophy hasn't changed. We continue to balance investments for future growth, including tuck-in M&A, with returning capital to shareholders, primarily through our dividend... and from time to time, through opportunistic share repurchases. This calendar year, we've seen a significant value opportunity in our shares and allocated more capital to share repurchase.

Since our Q4 earnings call in May, we repurchased an incremental $1.5 billion of our shares, and in total, $4 billion over the past two quarters. We believe these buybacks will have an attractive return, given the conviction we have in growing our revenue, earnings, and free cash flow, and as we go forward, we'll continue to focus on tuck-in M&A. Now let's cover guidance. Given our Q1 outperformance and positive momentum, we're raising our full-year revenue and EPS guidance. We now expect Fiscal twenty-five organic revenue growth of 4.5%-5%, an increase from the prior range of 4%-5%. For Q2, 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 4.5%.

Based on recent rates, FX would have an unfavorable impact to fiscal twenty-five in the range of $110 million-$210 million, including $10 million-$60 million in the second quarter. Moving down the P&L, we continue to expect our operating margins to expand this year as we drive efficiencies, while also investing behind our product launches and in our long-term pipeline. And based on recent rates, currency becomes much less of an impact to our margins and bottom line after the second quarter. Taking this all together, we're raising our fiscal twenty-five non-GAAP diluted EPS guidance to a new range of $5.42-$5.50, an increase from the prior range of $5.40-$5.50. For the second quarter, we expect EPS of $1.24-$1.26.

The Fiscal Year 2025 guidance range continues to include an unfavorable 5% impact from foreign currency, including an 8% impact in Q2. Further details on our annual guidance can be found in the guidance slide in our presentation. To wrap up, I want to emphasize that we are laser-focused on driving top-line growth and restoring the earnings power of the company. You saw that in our Q1 results, and you see it in our outlook for the rest of the year. We expect our EPS growth to accelerate in the back half as the impact from currency lessens, exiting the year with high single-digit growth. Geoff, back to you.

Geoff Martha (Chairman and CEO)

All right, thanks, Gary. Now, before we go to the analyst questions, I want to close with a few thoughts. Since becoming CEO, we've made a lot of changes to this company, all designed to improve performance. Chief among these strategies is how we allocate capital to disproportionately focus our R&D, our venture, and our M&A investments on the highest growth market opportunities, while still making sure our other businesses are competitive. And now you're seeing the payoff, as we are at the front end of some exciting new product cycles. You're seeing it in diabetes and in neuromodulation, in TAVR and PFA. And as I look at our pipeline, I expect this momentum to continue as we invest heavily in future growth opportunities like hypertension and surgical robotics. We've also been working on the fundamentals. The foundation of this company is now much stronger.

Gary Corona (Interim CFO)

Quality and operations are in a better spot, and we're investing in enhancing our digital capabilities across the company to improve our speed. We're playing more offense. We're building capacity in strategic growth areas. We're looking to further increase organic investments and are on the hunt for the right tuck-in M&A opportunities. We've integrated a performance-driven mindset and an incentive structure that reinforces this, and in some cases, we've changed leadership to add increased operating rigor to our mission-driven culture. Now, taken all together, this is now translating into the top-line growth momentum and improved earnings power that you're seeing in our results. And as we continue to execute, this will create meaningful value for society and for shareholders. Finally, I'd like to thank all of our employees around the world. I realize that we've driven a lot of change, and that can be uncomfortable.

I appreciate all that you've done to embrace these changes, and it's rewarding to see your efforts paying off. As we look to the next 75 years of Medtronic, I'm excited about the possibilities before us. Together, we're building a stronger and more resilient company. So thanks for all that you do to fulfill our mission and to serve patients. So with that, let's move to Q&A, where we're going to try to get 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?

Operator (participant)

For the sell side analysts that would like to ask a question, please select the Participants button and click Raise Hand. If you're using the mobile app, press the More button and select Raise Hand. Your lines are currently on mute. When called upon, you will receive a request to unmute your line, which you must respond to before asking your question. Lastly, please be advised that this Q&A session is being recorded. For today's session, Geoff, 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.

Gary Corona (Interim CFO)

... We'll take the first question from Vijay Kumar at Evercore ISI. Vijay, please go ahead.

Vijay Kumar (Senior Managing Director and Equity Research)

Hey, guys. Thanks for taking my question. And, Geoff, congrats on a really nice quarter here. Maybe my first question here is the organic execution in the quarter, well above your guidance expectations, I think north of 100 basis points. It's also above your annual guidance, right? It seems like it was pretty broad-based. You know, based on your current outlook, it implies like your back half should be below what your 1Q performance was, right? So maybe just talk about sustainability of 1Q, why these trends can't sustain in the back half. Were there any one-offs that drove Q1 performance?

Geoff Martha (Chairman and CEO)

Hey, Vijay, good to hear from you. Yeah, let me just answer that question directly. There was no one-offs that drove the performance and, you know, overall, I'd say it's sustainable because like I said in the commentary, we're in the beginning stages of some really exciting product cycles here into high growth markets. You know, in our Q1, I'd see a couple of things stood out, like neuromod getting to 10 double digits. That is really all about the new technology that, you know. This is the first quarter we had both our pain stim closed-loop therapy, Inceptiv, as well as DBS closed-loop therapy out there at the same time.

Gary Corona (Interim CFO)

And that's that growth is really driven by that's we think that's the new foundational technology sensing in the neuromod market, and it's that growth is driven strictly by demand of these new products and pricing uplifts that came with them. You know, structural heart, there was a lot of questions around the market there, and we're seeing consistent market growth as we've signaled in that high single digit. And you know, we're just really getting launching FX+, you know, going from limited market release to full market release, which is exciting. Plus, the accumulation of all the data, SMART, low risk, et cetera, is a real tailwind for us. You know, two businesses that had a particularly strong Q1, that you know, I'm not sure is gonna...

At that high level, throughout the year, one is diabetes. You know, diabetes should continue to have growth well above the company average. But, you know, we're now annualizing the US launch of 780G, and so I can see, you know, diabetes in the teens, that last quarter. I'm not sure we're gonna be able to sustain that the whole year. And CRM also had a really good quarter, you know, we have a really nice product portfolio across CRM, all the CRM segments, but we're not banking on CRM growing 8% every quarter. Yeah, those two, you know, there was nothing one time about them, but just really strong execution and, you know, I think across the company, I could just keep going down the list.

There's just a lot of new products out there in the early stages. So, you know, overall, we feel good about the underlying fundamentals and where we're headed, and, you know, we're focused on delivering our commitments. And issuing guidance, you know, end of issuing guidance, it sets us up for success.

Vijay Kumar (Senior Managing Director and Equity Research)

That's helpful, Geoff. And maybe one follow-up related to that, on the guidance question. Gary, welcome to your first earnings call. The gross margin performance here in Q1, really strong, but your guidance still does assume a pretty meaningful step up in operating margins for back half, right? And when I look at your EPS guidance, low end was tweaked, but, you know, it looks like there was some benefit from share repurchase. I don't know if your prior guidance had baked in a $1.5 billion share repo. So maybe just talk about your margin, you know, visibility for second half, and did that change over the last three months?

Gary Corona (Interim CFO)

Yeah, thanks, Vijay, and it's nice to meet you. I look forward to having a chance to meet all of you in person. Let me tackle your question about buyback first, and I'll take you through the puts and takes of the first quarter EPS. You know, our EPS starts with our top line, and as Geoff mentioned, our revenue growth was really strong, a full point higher than the midpoint of our guide. And Geoff talked about the highlights. You know, the midpoint of our guide, two of the three cents was really driven by the top line strength that he mentioned. Gross margins were strong, about 40 basis points ahead of consensus, and operating margin was in line.

Below the line, there were some moving pieces, and that netted to about $0.01, with the benefit that you mentioned from the share count helping. But we also had lower interest income and some pressure on the tax rate. So that's a little bit more visibility into Q1. You know, as we think about the leverage first half, second half, you know, the underlying leverage we're driving is pretty similar on a constant currency basis, you know, with high single digit every quarter. The ramp is really an FX story, significant pressure on the first half due to FX, and that'll wane in the back half. Constant currency growth ticks up slightly, as we drive stronger revenue growth, as a number of our therapies get to full market release.

As you know, we tend to have a pretty strong fourth quarter on the margin front. So, you know, that's the story on how the leverage will play out throughout the year.

Vijay Kumar (Senior Managing Director and Equity Research)

Great. Thanks, guys.

Geoff Martha (Chairman and CEO)

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

Operator (participant)

Yeah. The next question comes from Robbie Marcus at JP Morgan. Robbie, please go ahead.

Vijay Kumar (Senior Managing Director and Equity Research)

Oh, great. Thanks for taking the question, and, congrats on a good quarter. With my one, I, I wanted to ask about diabetes. This is a pretty big shift in strategy for you. You've always been, you know, the provider with both the pump and the algorithm and the CGM all in one. Now, with Simplera about, you know, about to launch, maybe just walk us through the strategy of why partnering with Abbott was in your best interest. Does this change your strategy at all, and how do we think about external versus internal investment in diabetes moving forward? Thanks.

Que Dallara (EVP and President of Diabetes)

Thanks, Robbie.

Geoff Martha (Chairman and CEO)

Yeah, I'll let Que answer that question. Go ahead, Que.

Que Dallara (EVP and President of Diabetes)

Thanks, Robbie. I would say our strategy hasn't changed at all. I think what's really changed in the market is really a widespread recognition that AID really does provide better outcomes than CGM alone or MDI alone. And we always knew that there was a large installed base of users that wanted access to our technology, our AID system. We still believe in the system benefits exceed the sum of the parts. As you mentioned, wrapping it all together with our algorithm, the CGM, the pumping devices. And the typical integration you see in the market puts a technology burden on the part of patients.

Gary Corona (Interim CFO)

And so we wanted to find a way to provide the one Medtronic experience, the one phone number you can call for patients that may prefer a different sensor. And, you know, we're pleased to say that we found a path that works for patients from an experience standpoint, as well as for Abbott and for ourselves. And so that's what I would say would be the response to your question. The strategy hasn't changed. We've just found a way to expand access to a broader install base. And I think what hasn't changed is really our commitment towards the system, our confidence in our CGM. The Simplera launches, Simplera and Simplera Sync launches in Europe have gone very well. We're very pleased with the early experience, and we're pleased that we now have FDA approval for Simplera in the U.S..

and we're working with the agency to get Simplera Sync approved as well for integration with the 780G system.

Vijay Kumar (Senior Managing Director and Equity Research)

Great. Thanks a lot.

Geoff Martha (Chairman and CEO)

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

Operator (participant)

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

Vijay Kumar (Senior Managing Director and Equity Research)

Hey, guys. Congrats on the quarter. I'll ask my one question on TAVR, and just want to get kind of what you're sensing in the market today, given some of the comments from the competitor there. Looking forward, when you think about the FX+ launch, how do you expect that to impact the market, impact the share? Is that gonna help you, you know, with some of the SMART data and how you see the TAVR market playing out? Thanks a lot.

Geoff Martha (Chairman and CEO)

Hey, Travis. I'm gonna hand that one over to Sean.

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Travis, thanks for the question. Look, the TAVR market we think is pretty solid. I think we're growing in line with the market in high single digits right now. And of course, you know, the data momentum that we have, the low-risk data versus surgery, I think that's been very compelling, and we're gonna read out the five-year on that data in the coming year here as well. And of course, the SMART data has really gotten a lot of attention for the right treatment strategy for small annuli, and particularly women, and that's resonated really globally too, as small annuli is a sort of a function of body habitus as well. You know, FX plus has done exceptionally well in its early launch.

Gary Corona (Interim CFO)

We did a full limited market release in the month of July, and we saw that momentum really pick up. So I think that'll portend a really good continued access or continued growth of that part of the segment. What people really like is those bigger windows that you can then align onto the native coronary anatomy, so overlapping the cusps to making sure that you get that commissural alignment and preserving future access. So that's all done without any trade-off on deliverability. It's, you know, got the features of FX, which really improved the usability of that device. And of course, the U.S. is moving into full market launch right now, and within this year, we'll also obtain approvals in other geographies, which will keep the momentum going.

So, you know, for us, I think the market's working really well, and we're excited to bring this new technology.

Vijay Kumar (Senior Managing Director and Equity Research)

Great. Thanks a lot.

Geoff Martha (Chairman and CEO)

Thanks, Travis. Next question, please, Brad.

Operator (participant)

The next question comes from Danielle Antalffy with UBS Securities. Danielle, please go ahead.

Vijay Kumar (Senior Managing Director and Equity Research)

Great, thanks so much for taking the question. Good morning, everyone. Congrats on a good start to the year here. Q, I just wanted to follow up on diabetes, and just how should we be thinking about this partnership with Abbott? Appreciating you're not giving timelines here, but how are you thinking about it and how it could grow the installed base? Sort of, what are you thinking about? I mean, Abbott has a pretty large installed base today, so should we be thinking about that as low-hanging fruit for the pump side of the business? Any more color you can give on how we should think about this changing the trajectory for the diabetes business? Thanks so much.

Que Dallara (EVP and President of Diabetes)

I mean, I think the most obvious opportunity are for a very large install base of users that prefer the Abbott sensor to now have access to our technology. So unfortunately, I can't give you timelines, but rest assured that we're working as fast as we can to get to incorporate that sensor into our system and really providing that one Medtronic experience where there's one single app. Patients can choose between two sensor options, but still experience our AID system and the automation that comes with our algorithm. And so that's the user experience we want to bring to the market. We think that's pretty differentiated and it allows us to tap into the largest CGM install base in the world, in addition to our own, growing our own install base.

Vijay Kumar (Senior Managing Director and Equity Research)

Thank you.

Geoff Martha (Chairman and CEO)

Thanks, Danielle. Next question, Brad.

Operator (participant)

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

Vijay Kumar (Senior Managing Director and Equity Research)

Good morning. Thanks for taking the question. For my one question, I wanted to ask about the progress with Hugo for Mike and Geoff. So it sounds like you've reached the targeted enrollment in Expand Uro, the pivotal U.S. trial. When are we gonna see the data? You know, what's the timeline for U.S. filing? You know, could we see potential launch this year or next year? And Geoff, there's still questions around your commitment to Hugo. Just maybe, you know, put any of those concerns to rest here. Thank you.

Geoff Martha (Chairman and CEO)

All right. Thanks, Larry. Well, maybe I'll have Mike answer the first couple questions, and then I'll come in afterwards.

Mike Marinaro (EVP and President of Medical Surgical Portfolio)

Yeah. Good morning, Larry. So, on Hugo, we are happy with the progress we're making in the clinical work. As mentioned, we have reached targeted enrollment. There is still work to do, as we reach the final endpoints and then completing the filing. So I won't be giving a specific date in terms of submission, but very good progress and very appreciative of the work that we're doing together with our surgeon partners and our teams. Also, as noted, we're making good progress in the enrollment of both hernia and the gynecology clinical series that will allow us to then have a cadence of indications which will be critical to the U.S. launch. So very good work across the clinical series, and again, appreciative of the work of our surgeon partners and teams. Geoff?

Geoff Martha (Chairman and CEO)

Yeah, so look, as Mike said, look, there's a couple of things on Hugo here, two inflection points that need to happen for us to see the impact at the Medtronic level, you know, the U.S. approval, and then just getting our leading instrumentation onto the robot and other capabilities. As Mike mentioned, you know, we're making progress on both. So this is like a midterm growth driver for us, I'd say, beyond the fiscal year, but you know, to get back to your question on our commitment, Larry, you know, we're absolutely committed to this. I...

Gary Corona (Interim CFO)

You know, with all due respect, we do think surgery robotics is really across many different surgical areas, including orthopedics, where we play in spine, is a big driver in the space. We're committed to being not just part of it, but you know, helping to lead that, like we're doing in spine. You know, I know we're up against a really strong entrenched competitor here in the soft tissue space, but we are committed. We have levers to pull. We have a great surgery franchise. You know, we've learned quite a bit about robotics over the years, and also the understanding that it's more than just the robot.

It's a lot of other technology that goes in there: imaging, navigation, you know, the instrumentation, AI, so the digital piece. So there's a lot to it, a lot of levers to pull, and we're committed, and, and we're confident. And let's just point back to, you know, a couple years ago, other franchises that, that people were questioning, "Can you, can you compete?" Whether it's spine, or whether it's diabetes or Neuromod. You know, we're focused on it. You see those, you've seen those all, you know, get to a much, much better spot with the focus and investment, and that's where we are on surgery.

My level of confidence on this is high because of the levers we have to pull, the team we have in place, the franchise we have, but knowing that the entrenched competitor is very strong. Understanding that, but still knowing, you know, having confidence in our team.

Vijay Kumar (Senior Managing Director and Equity Research)

Thank you.

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Thanks, Larry. Next question, please, Brad.

Operator (participant)

The next question comes from David Rescott at Baird Equity Research. David, please go ahead.

Vijay Kumar (Senior Managing Director and Equity Research)

Oh, great. Thanks for taking the questions, and congrats on the strong start to the year here. Geoff, I heard your comments on, you know, being on the hunt for M&A. I'm curious if you could help us kind of understand, you know, maybe what areas strategically you think make the most sense in the portfolio when you kind of think about the size of the Medtronic portfolio? I guess, how do you balance that kind of near term, what can be needle moving versus, you know, what can move the needle over the two- to three-year period and three- to five-year period? Thank you.

Geoff Martha (Chairman and CEO)

Thanks. Thanks for the question, David. Yeah, I mean, look, it on the M&A side, this is one of the areas. Just, it's part of our larger capital allocation strategy, right? Our we talk about, you know, little c capital allocation and big C capital allocation. We're talking about allocating our money to the areas of highest growth. And the M&A strategy has to play with our organic strategy, and both are pointed towards the highest growth areas. You know, ablation, you know, AFib ablation is a case in point where we did the Affera acquisition as well as a needle crossing acquisition.

Gary Corona (Interim CFO)

Yeah, that's those are the areas that we're pointed to, but we're, you know, we are still focused on, you know, value creating tuck-in M&A, so with that growth and margin profile that I just talked about. So it's, I don't want to point out specific areas other than the high-growth areas that are, you know, with whether they be a product tuck into an existing business or an adjacency to an existing business tuck-in, that's where we're focused.

I think, you know, nothing's changed there, except that I think over the last year and a half or so, you know, we've had a lot of operational focus areas that we've had, and that's been the focus, is really getting the operations, our operations footprint in a better spot, our back orders down, things like that, quality in a better spot. We're in a much better spot there, and I think can focus more of our energies on M&A. The explanation I guess I just gave is where we'll be focused.

Vijay Kumar (Senior Managing Director and Equity Research)

Okay.

Geoff Martha (Chairman and CEO)

Thanks, David. Next question please, Brad.

Operator (participant)

The next question comes from Matt Taylor at Jefferies. Matt, please go ahead.

Matt Taylor (Managing Director)

Hi, thanks for taking the question. I guess I wanted to double-click on some of the comments that you made on the structural heart market, and I'm really curious about your thoughts on capacity now and going forward, and I know you said that you haven't seen signs of, you know, a slowdown in the market, but do you have concerns about capacity there longer term? Or more broadly, is that a limiting factor in that business or any of your businesses, and how would you deal with that as an organization to help free up more capacity to help your therapies run through?

Geoff Martha (Chairman and CEO)

Well, look, I'd say overall... I'm gonna hand this over to Sean, Matt. But, you know, the structural heart space, TAVR, you know, and mitral is coming, tricuspid, it's very under-penetrated still. So I do see a huge and the patient benefits are clear. Sean mentioned the data, whether it be low risk or now our SMART trial. The data's clear, it's under-penetrated. And, so I still think, this is a strong growth market. I'll let Sean touch again on kind of where we are, where the market is, if you will, on capacity and what we're seeing, and then maybe come back. Go ahead, Sean.

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah, thanks for the question. You know, we're not hearing from our customers about capacity constraints. And, of course, our sample size may be a little smaller than our competitor, but you know, we ask about the future for the service line as they add additional, you know, things into the structural heart component of it. And it doesn't seem like at the operator level there's concerns. In the U.S., of course, the freedom of beds for post-procedures that goes beyond TAVR, that's been a challenge. But we're seeing some shifting of procedures to lower acuity settings to make room. And, of course, the valve clinic, which works these patients up, that's something you just add a capacity to when you need future capacity to expand it, and you get a long runway to look at it.

Gary Corona (Interim CFO)

So I think with the expanding indications, you know, we're pursuing a moderate aortic stenosis population, which is about two and a half million people in the U.S., and, you know, transcatheter mitral replacement valves and things like that. So we'll work with centers to make sure that they have adequate training of operators and help them to expand capacity if it needs to be. But in the short run, I really don't see a challenge, and I think hospitals have a long enough runway to plan for, for space that they need it. So I don't think it's a constraint on the future growth prospects of structural heart in total.

Geoff Martha (Chairman and CEO)

Yeah, look, I agree with Sean on this one and but you know, when we see situations like that, when there's capacity, in the past, we've stepped in and helped the hospital, our hospital partners with capacity. Like in Europe, you know, several years ago, we helped build out a number of, and manage a number of cath labs when there was cath lab capacity constraints across Western Europe. You know, I could see us doing this in the ASC space in the U.S., you know, to help build out that. And you know, we partner, we talk with the imaging companies, 'cause a lot of the capacity is tied to imaging, and work with them and work with our you know, healthcare delivery partners to build out that capacity.

Gary Corona (Interim CFO)

So that's how we would handle it if we were to see an issue. But, you know, we're not... Like Sean said, we're not hearing that in TAVR.

Matt Taylor (Managing Director)

Great. Thank you, guys. Appreciate it.

Geoff Martha (Chairman and CEO)

Thanks, Matt. Next question, please, Brad.

Operator (participant)

The next question comes from David Roman at Goldman Sachs. David, please go ahead.

Vijay Kumar (Senior Managing Director and Equity Research)

Thank you, and good morning, everyone. I was hoping you could go into a little bit more detail on Affera. Geoff, you mentioned that it's still obviously pending FDA review, and that you're in limited market release outside the United States. Can you maybe give us a little bit of perspective of what you've seen in Europe now about a year post CE mark, and whether we should use that as a proxy for thinking about how this product ramps in the U.S.?

Geoff Martha (Chairman and CEO)

Sure. Thanks for the question, David. A lot of interest, obviously, in our CAS business and AFib right now, and maybe I'll go back to Sean on this one.

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah, David, thanks for the question. You know, the demand for PFA has really been unbelievably strong, and, you know, we're ramping up our capacity, as Geoff mentioned, to meet that stronger growing demand right now. And, you know, those gains that we're seeing are more than offsetting that cryo business, of course. And we're really in a unique position having this offering of both a kind of single-shot approach with our PulseSelect and then the point-by-point approach with Affera. PulseSelect, you know, it's really got more case volume so far, as we're moving that launch both within Europe and the United States. And what we're hearing from customers is just the precision and predictability of the handling of the catheter, and importantly, that it shows up really well both on mapping systems and on ultrasound.

Gary Corona (Interim CFO)

And that's important because you've got to put the electrodes in the right spot in the tissue, so you get good ablation and isolation without doing extraneous injury, and that's really been appreciated. And of course, the point-by-point approach with Affera is really unique and differentiated for us as well. You know, the same catheter being able to create this beautiful map, and you can use either energy source, depending on where you want to be anatomically, to avoid things like coronary spasm and the isthmus lines. And also the lattice tip, it's a really, you know, maybe underappreciated part of this Sphere-9 catheter. It's got this lattice that has excellent electrode stability, and it's three times wider than a normal kind of ablation electrode you'd use for RF. So the precision and speed of that is really fantastic.

So look, on the technology side, everything's going really well. You're asking about ramping in Europe. There are more cost constraints in Europe, of course, than what we see in markets like the U.S. and Japan, where new technology, even at a higher price, seems to get adopted. So, you know, the uptick of PFA would be relatively slower, but still robust as we go ahead with this technology. You know, I think there's some lingering questions on durability, and we'll see some data at the upcoming APHRS meeting, where we'll show longer-term durability of our PulseSelect catheters. We've already demonstrated that with the Sphere-9.

I'd say, look, the opportunity to offer patients something that's really safe, really effective, lasts a long time. I think really does open up the aperture for more and more patients to flow through. You know, waiting lists are a challenge for that business, and I think having a more efficient procedure with great workflow really helps. Of course, we can leverage the larger portfolio of Medtronic to help with sort of the economics of this in any country and around the world. Look, I think the future for pulsed field ablation, we're just getting going, but this is gonna be a really robust growth market for a long time to come.

Geoff Martha (Chairman and CEO)

Yep. And just to emphasize something Sean said, we're really, you know, excited to be the only player with, you know, differentiated offerings in both the single shot and this point-by-point segments of the market. Both PulseSelect and Affera have, you know, differentiated features. You know, Sean mentioned the handling of the catheter in PulseSelect, and that's really ramping for us, you know, quite well right now. And in Affera's the ramp, obviously, we don't have approval yet in the U.S., and the ramp for that will be a little behind, you know, where we are with PulseSelect. But PulseSelect is doing really well. And I think it's, you know, I think...

Gary Corona (Interim CFO)

You just don't – yeah, I think the analyst community is kind of has moved past PulseSelect a little bit, and I'm not sure that's the right call. I mean, it's doing really well.

Operator (participant)

Thanks, David. We'll take the next question, please, Brad. The next question comes from Jayson Bedford at Raymond James. Jayson, please go ahead.

Jayson Bedford (Managing Director and Equity Research)

Can you hear me okay?

Geoff Martha (Chairman and CEO)

Yep, we can, Jayson.

Jayson Bedford (Managing Director and Equity Research)

Okay, maybe just to follow along, on the CAS question. One, I guess, do you find that folks are waiting for, in the U.S., for Affera/Sphere-9? And then second, you did talk about an acceleration in CAS revenue growing forward and acceleration in growth. Do you expect to be in a position to grow faster than the market exiting the year?

Geoff Martha (Chairman and CEO)

Sean, you want to take these?

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah, I guess on the first question, Jayson, of course, people really, really want Affera. You know, the vast majority of the ablation market favors point-by-point solutions with mapping in the United States in particular. So you know, the appeal of that product is really strong, but no one's waiting for it. I mean, we're getting as much usage, maybe actually more, from traditional point-by-point users as we are getting from single-shot users. And, you know, as we bring that technology out, I think the uptake's gonna be pretty robust and rapid on top of what we're already doing with PulseSelect. So yes, I think that we've got the opportunity to grow fast in the market within this fiscal year, depending on the launch timing.

Geoff Martha (Chairman and CEO)

Thanks, Jayson.

Operator (participant)

Thank you, Jayson. Next question, please, Brad. The next question comes from Joanne Wuensch at Citi. Joanne, please go ahead.

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

Good morning, and thank you so much for taking the question. Can we spend some time talking about the renal denervation market and the CMS NTAP for Symplicity? How do you see this market developing now that reimbursement is getting behind the product? Thank you.

Geoff Martha (Chairman and CEO)

Yeah, thanks for the question, Joanne. I mean, look, we're like I've said before, I'm super excited about RDN, and it's good to see the reimbursement taking shape. You know, with the CMS, with the outpatient payment determined. I'm sorry, the inpatient payment now determined and the outpatient payment, you know, on the table here, you know, it's getting closer to that unlock, that reimbursement unlock. And I'll let you know, maybe Sean comment on this as well.

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah. Thanks, Geoff, and Joanne, thanks for the question. You know, the payment is one part of it. We have coding and coverage, most importantly, that need to come. So, you know, the codes are already established. We've got the, as you noted, in NTAP, we have inpatient coding, but outpatient is gonna be more of the kind of procedure volume. We think, you know, less than 10% of the procedures are gonna be done with more than a single midnight stay or on the inpatient setting. So really, it's that TPT, or transitional pass-through payment, that we're really waiting on. And we did hear from CMS on that this summer, just this month where they're supporting our approach here for that application.

Gary Corona (Interim CFO)

This is a breakthrough device, so that helps to get into those kind of payment codes, and we expect to see that, you know, happen pretty soon. And of course, we're working really closely with CMS and with commercial payers on making sure we have coverage policies that are gonna facilitate patient access. And again, being a breakthrough technology, that helps you with the kind of urgency and speed at which we'll see CMS move. So, you know, look, I think all things on the reimbursement front are pointing exactly in the direction we're hoping to get them, and we're excited to ramp this technology up and make it available.

I will say that the level of excitement we're getting from physicians and from hospital systems about this new service line they can offer, as well as patients, and the early outcomes for patients that have been treated on this sort of case-by-case basis have been really phenomenal. So, you know, look, I think that unlock, as we've said all along, is gonna be reimbursement, and we're marching toward that. So we're excited about the opportunity here.

Geoff Martha (Chairman and CEO)

Thank you, Joanne. I think we've got time for maybe two more questions. We'll take the next question, Brad.

Operator (participant)

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

Matt Miksic (Equity Research Analyst)

Hey, thanks so much for the question. And I just, if I could, just two quick follow-ups on some of the topics that have already been kind of explored here. The first, for Sean, just on TAVR. I seem to remember that with the FX launch, there was some effect of price premium. There was some period of kind of stocking as you got into the launch. I'm just wondering if you could shed any light on the sort of shape of the next few quarters as you really begin to roll out FX Plus. And then the second, for Gary, on FX.

Gary Corona (Interim CFO)

I think, you know, there's some questions around the fact that the top-line FX impact actually eased a little bit, but the FX impact on the bottom line, the headwind of 5% remained the same. You could maybe just flesh out for us again where some of the impacts of FX are in the PNL and how we think about those as the year progresses. Thanks so much.

Geoff Martha (Chairman and CEO)

Sean, you wanna take-

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah, thanks, Matt.

Geoff Martha (Chairman and CEO)

... the first question?

Sean Salmon (EVP and President of Cardiovascular Portfolio)

Yeah, sure. So, you know, we are across the board, we price for value when we think there's more value. So a modest price premium is built into our TAVR launch, but it really is about picking up more volume on cases, more implants. And, you know, the dynamics that you typically see when you bring a new product out are, you know, customers burning down their shelf inventory as they put a small amount of stocking per valve size, like a par level, as they ramp up for new technologies. And we saw both those dynamics occur, you know, in the early launch accounts, where people are picking up a little bit of inventory, but also taking down inventory for the prior model, the FX, in the case of the U.S..

Gary Corona (Interim CFO)

So it's always those sort of switching dynamics, but you know, I think that that's already baked into everything that we're forecasting for the continued growth of this product.

Hi, Matt, this is Gary. And, yeah, as you said, as you mentioned, the U.S. dollar has weakened a bit in the first quarter, and you'll see the benefits of that in the top line, where we've communicated improvement in the impact of the FX. You know, if recent rates hold, we now expect FX on revenue to be a negative impact of 120-210, and that compares to 275-375. You know, on the bottom line, the benefit is delayed due to our hedging program, but we do expect to realize the benefits in future years. You know, where FX will show up for us this year will be a little bit different.

It's gonna show up a bit more in the gross margin line for us this year, and as we mentioned, the impact of foreign exchange will wane in the back half of the year, and as our strong underlying earnings growth on a constant currency basis continues, you know, after we delivered a really nice shape of the P&L in the first quarter, we'll see that benefit flow through to reported EPS in the second half.

Geoff Martha (Chairman and CEO)

Okay, thanks, Matt. We've got time for one more question. If we didn't get to your question, if there's any analysts on the line that still have questions, feel free to follow up with me after the call. We'll go to our last question, please, Brad.

Operator (participant)

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

Patrick Wood (Managing Director)

Beautiful. Thank you so much for taking the question. Quite a high-level one. But, you know, you guys are now, I guess, getting the benefit of some heavy investment in previous years in the base business. And so I guess the question is, does that-- how does that make you feel, the interplay between, you know, reinvesting for growth on the product support side, on innovation relative to margins over the next, I don't know, year or two? Like, how do you see that interplay going forward of earnings leverage, and investing in the base business versus, you know, trying to drive the top line? Any updated thoughts there would be great. Thanks.

Geoff Martha (Chairman and CEO)

Sure. Thanks, Patrick. Look, we're committed to driving leverage down the PNL. You know, a company of our size, I mean, that's something we should be able to do. We've got a lot of levers to pull to achieve that and free up, at the same time, even more money for investment, which I'll get to. We are doing a number of things, measures to hold you know our kind of overhead and enabling expenses low, flat to low so that we can reinvest more in the top line. We're doing things that we've really, really focused on.

Gary Corona (Interim CFO)

Just like we have capital allocation focus, we also have a focus on our headcount and allocating human capital and where that goes, and got that under in a good spot. We're driving, you know, we're really trying to hold our G&A, SG&A, you know, flat, you know, as a base case, and then target areas we wanna add for growth. Like, for example, as the R&D and reimbursement comes in, you know, we'll be adding more on our direct distribution for that.

A very disciplined process to hold our expenses flat as a base case for G&A, and then, you know, invest in the high growth areas, and also through, you know, a number of programs to drive efficiencies in our enabling functions, including the use of AI to drive some of these efficiencies. A lot going on there, and really committed to investing back into the business for growth, whether it be on the direct distribute or the sales side, but more importantly, even on the R&D side. And so we've raised that organic investment over... despite some of the challenges we've had over the last couple of years, we've raised that organic investment.

Look, you know, the tuck-in M&A, as I mentioned earlier, I'd like to kinda maybe over time here increase the cadence of that to support, because the cash flow of the company's strong, you know, to support that organic R&D. So that's how we're thinking about it. I think we can drive that earnings leverage down the P&L. We've got a lot of different levers to pull to do that, at the same time, freeing up even more investment, both from our income statement into R&D, but also using the strong cash flow from the balance sheet for tuck-in M&A. That's how we're looking at it.

you know, again, prioritizing these high growth areas, but at the same time making sure that the rest of our businesses are competitive. And I feel like we've gotten to a good spot on that. And we'll see... We're seeing the benefits of that now, and we're gonna continue to see the benefits of that on into the future.

Ryan Weispfenning (VP and Head of Investor Relations)

Okay. Thanks, Patrick. Geoff, please go ahead with your closing remarks.

Geoff Martha (Chairman and CEO)

Okay. Thanks, Ryan. Thank you, and thanks, everybody, for the great questions, and we certainly appreciate your support and interest in Medtronic, and we hope you'll join us for our Q2 earnings broadcast, which we anticipate holding on Tuesday, November nineteenth. Now, that's the week before Thanksgiving in the U.S. this year. You know, again, as usual, we'll update you on our progress against our long-term strategies and our commitments, both short and long term. So with that, thanks for joining us, and have a great rest of your day.