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 ’25 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 26, 2024, and our outlook for the remainder of fiscal year ’25. 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. Earlier this morning, we issued a press release containing our financial statements, divisional and geographic revenue summaries, and non-GAAP reconciliations.
Before you buy stock in Medtronic, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Medtronic wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Nvidia made this list on April 15, 2005… if you invested $1,000 at the time of our recommendation, you’d have $796,586!*
Stock Advisor provides investors with an easy-to-follow blueprint for success, including guidance on building a portfolio, regular updates from analysts, and two new stock picks each month. The Stock Advisor service has more than quadrupled the return of S&P 500 since 2002*.
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 ’24 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.
Geoffrey S. Martha — Chair and Chief Executive Officer
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. 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 gross 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 Sphere9 focal catheter.
This all-in-one catheter can perform high-density mapping, as well as pulsed field and RF ablations. We expect Sphere9 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 Sphere9 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 installed base continue 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 getting — 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 No. 1 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.
Look, we’re committed to being No. 1 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 1 billion people globally and nearly half of all U.S. adults. Despite the availability of numerous classes of pharmaceuticals, only 1 in 4 adults in the U.S.
have their hypertension under control. 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 billion 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 in prior quarters, primarily driven by the difficult comparison from back order 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.
corresponding 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 is 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.
Gary Corona — Interim Chief Financial Officer
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 Q1 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 ’25 organic revenue growth of 4.5% to 5%, an increase from the prior range of 4% to 5%. For Q2, we’re expecting to deliver another quarter of mid-single-digit growth in 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 ’25 in the range of 110 million to 210 million, including $10 million to $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 ’25 non-GAAP diluted EPS guidance to a new range of $5.42 to $5.50, an increase from the prior range of $5.40 to $5.50. For the second quarter, we expect EPS of $1.24 to $1.26. The fiscal year ’25 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.
Geoffrey S. Martha — Chair and Chief Executive Officer
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 disproportionally 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. 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?
Brad Welnick — Senior Director, Investor Relations
[Operator instructions] 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. We’ll take the first question from Vijay Kumar at Evercore ISI.
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 sustain in the back half. Were there any one-offs that drove Q1 performance?
Geoffrey S. Martha — Chair and Chief Executive Officer
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, we — overall, I’d say it’s sustainable because like I said in the commentary, we’re in the beginning stages of some real — you know, really exciting, you know, product cycles here into high-growth markets. You know, in our Q1, you know, I see a couple of things like neuromod, you know, getting to 10 — you know, double digits. That is really all about the new technology that, you know, we’ve — this is the first quarter we had both our pain stim closed-loop therapy Inceptiv, as well as, you know, DBS closed-loop therapy out there at the same time. 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, etc., is a real tailwind for us. You know, two businesses that had a particularly strong Q1, that, you know, I’m not sure it’s going to — at that high level, that — 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 U.S. launch of 780G. And so, I can see, you know, diabetes in the teens last quarter.
You know, I’m not sure we’re going to be able to sustain that the whole year. And CRM also had a really good quarter. You know, some great — we have a really nice product portfolio across the — all the CRM segments, but we’re not banking on CRM growing 8% every quarter. You know, 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 — on our commitments and issuing guidance that sets us up for success.
Vijay Kumar — Analyst
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, the low end was tweaked, but, you know, it looks like there was some benefit from share repurchases. I don’t know if your prior guidance had baked in 1.5 billion share repo.
So, maybe just talk about your margin, you know, visibility for second half and did that changed over the last three months.
Gary Corona — Interim Chief Financial Officer
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, $0.02 of the $0.03 was really driven by the top-line strength that he mentioned.
Gross margins were strong, about 40 bps ahead of consensus. And operating margin was in line. Below the line, there were some moving pieces, and that netted to about a penny, 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 will 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. And as you know, we have — 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.
Yeah. The next question comes from Robbie Marcus at J.P. Morgan. Robbie, please go ahead.
Robbie Marcus — Analyst
Great. Thanks for taking the question and congrats on a good quarter. With my one, 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 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.
Yeah. I’ll let Que answer that question. Go ahead, Que.
Que Dallara — Executive Vice President and President, Diabetes Operating Unit
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 is — puts a burden — puts a technology burden on the part of patients. 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 installed base. And I think what hasn’t changed is really our commitment toward 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.
The next question comes from Travis Steed at Bank of America Global Research. Travis, please go ahead.
Travis Steed — Analyst
Hey, guys. Congrats on the quarter. I’ll ask my one question on TAVR, and I just want to get kind of what you’re sensing in the market today given some of the comments from the competitor there. And looking forward, when you think about the FX+ launch, how do you expect that to impact the market, impact the share, and is that going to help you, you know, with some of the SMART data and how you see the TAVR market playing out? Thanks a lot.
Sean Salmon — Executive Vice President and President, 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 going to read out five-year on that data in the coming year here as well. And of course, SMART data has really gotten a lot of attention for the right treatment strategy for small annulus, and particularly women, and that’s resonated really globally, too, as small annulus is a — sort of a function of body habitats as well. You know, FX+ has done exceptionally well in its early launch. 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 afford really good continued access or continued growth of that part of the segment. What people really like is those bigger windows, which you can then align onto the native coronary anatomy. So, overlapping the cusps to making sure that you get that commissure 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 is working really well, and we’re excited to bring this new technology.
The next question comes from Danielle Antalffy with UBS Securities. Danielle, please go ahead.
Danielle Antalffy — Analyst
Great. Thanks so much for taking the question. Good morning, everyone. Congrats on a good start to the year here.
Que, 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, is — 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 — Executive Vice President and President, Diabetes Operating Unit
I mean, I think the most obvious opportunity are for a very large installed base of users that prefer the Abbott sensor to now have access to our technology. So, unfortunately, I cannot 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 installed base in the world, in addition to our owning — growing our own installed base.
The next question comes from Larry Biegelsen at Wells Fargo Securities. Larry, please go ahead.
Larry Biegelsen — Analyst
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 target enrollment in Expand URO, the pivotal U.S.
trial. When are we going to 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 out any of those concerns to rest here.
All right. Thanks, Larry. Maybe I’ll have Mike answer the first couple of questions, and then I’ll come in afterwards.
Mike Marinaro — Executive Vice President and President, Surgical Operating Unit
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, we 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.
Geoffrey S. Martha — Chair and Chief Executive Officer
Yeah. So, look, as Mike said, look, there’s a couple of things on Hugo here. Two inflection points that you need to happen for us to see the impact at the Medtronic level: the U.S. approval and then just getting our, you know, leading instrumentation onto the robot and other capabilities.
And 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 — you know, and I — with all due — it’s a — we do think robotics is really across many different surgical areas, including orthopedics, where we play in spine, is a big driver in the space, and we’re committed to being not just part of it but being — you know, helping to lead that like we’re doing in spine.
And with — you know, we know we’re up against that 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, 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 we’re confident. And at this point, back to, you know, a couple of years ago, other franchises that people were questioning, 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’re seeing those all, you know, get to a much, much better spot with the focus and investment. And that’s where we are on surgery. And my level 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. So, understanding that but still knowing — you know, having confidence in our team.
The next question comes from David Rescott at Baird Equity Research. David, please go ahead.
David Rescott — Robert W. Baird and Company — Analyst
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.
Geoffrey S. Martha — Chair and Chief Executive Officer
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, are 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 toward 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. You know, 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 in 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-in to an existing business or an adjacent to an existing business tuck-in, that’s where we’re focused. And 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 order is down, things like that. Quality in the better spot. We’re in a much better spot there.
And I think we can focus more of our energies on M&A, and the explanation, I guess, I just gave is where we’ll be focused.
The next question comes from Matt Taylor at Jefferies. Matt, please go ahead.
Matthew Taylor — Analyst
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?
Geoffrey S. Martha — Chair and Chief Executive Officer
Well, look, I’d say, overall, I’m going to hand this over to Sean, Matt, but the structural heart space, TAVR, you know, the 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 is 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 — Executive Vice President and President, 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 capacity to when you need future capacity to expand it, and you get a long runway to look at it. So, I think with the expanding indications, you know, we’re pursuing a moderate aortic stenosis population, which is about 2.5 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 space that they needed.
So, I don’t think it’s a constraint on the future growth prospects of structural heart in total.
Geoffrey S. Martha — Chair and Chief Executive Officer
Yeah. And I — 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, many 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 because a lot of the capacities are tied to imaging and work with them and work with our, you know, healthcare delivery partners to build out that capacity. 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.
The next question comes from David Roman at Goldman Sachs. David, please go ahead.
David Roman — Analyst
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 those product ramps in the U.S.?
Geoffrey S. Martha — Chair and Chief Executive Officer
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 — Executive Vice President and President, 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 strong growing demand right now.
And, you know, those gains that we’re seeing are more than offsetting our 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 gotten more case volumes so far as we were 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.
And that’s important because you 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 in the isthmus lines.
And also, the lattice tip. It’s a really, you know, maybe underappreciated part of this Sphere9 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 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 uptake of PFA would be relatively slower but still robust as we go ahead with this technology. You know, I think there are 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 Sphere9. And 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. And then, 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. So, look, I think the future for pulsed field ablation, we’re just getting going, but this is going to be a really robust growth market for a long time to come.
Geoffrey S. Martha — Chair and Chief Executive Officer
Yup. 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, the ramp — you know, obviously, we don’t have approval yet in the U.S., and the ramp for that will be a bit behind — 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 — 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.
Ryan Weispfenning — Vice President and Head, Investor Relations
Thanks, David. We’ll take the next question, please, Brad.
Brad Welnick — Senior Director, Investor Relations
The next question comes from Jayson Bedford at Raymond James. Jayson, please go ahead.
OK. Maybe just to follow along just on the CAS question, one, I guess, do you find that folks are waiting for — in the U.S. for Affera/Sphere9? And then second, you did talk about an acceleration in CAS revenue growing forward, an acceleration in growth. Do you expect to be in a position to grow faster than the market exiting the year?
Sean Salmon — Executive Vice President and President, Cardiovascular Portfolio
Yeah. I guess, in 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, the appeal of that product is really strong.
But no one’s waiting for it. I mean, there’s — 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 is going to 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.
The next question comes from Joanne Wuensch at Citi. Joanne, please go ahead.
Joanne Wuensch — Analyst
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.
Geoffrey S. Martha — Chair and Chief Executive Officer
Yeah, thanks for the question, Joanne. I mean, look, we’re — like I said before, I’m super excited about RD, 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 — Executive Vice President and President, 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, an NTAP, we have inpatient coding. But outpatient is going to be more of the kind of procedure volume.
We think the less than 10% of the procedures are going to be done with more than a single midnight stay or — on the inpatient settings. 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. 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 going to 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 were hoping to get them, and we’re excited to ramp this technology up and make it available. The — 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 going to be reimbursement, and we’re marching toward that. So, we’re excited about the opportunity here.
Ryan Weispfenning — Vice President and Head, Investor Relations
Thank you, Joanne. I think we’ve got time for maybe two more questions. We’ll take the next question, Brad.
Brad Welnick — Senior Director, Investor Relations
The next question comes from Matt Miksic at Barclays. Matt, please go ahead.
Matt Miksic — Analyst
Hey. Thanks so much for the question. And I just — if I could, 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. And 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+. And then the second, for Gary, on FX.
I think, you know, there are some questions around the fact that the, you know, top-line FX impact actually eased a little bit, but the FX impact on the bottom line, the headwind of 5%, remained the same. If you could maybe just flesh out for us again where some of the impacts of FX are in the P&L and how we think about those as the year progresses? Thanks so much.
Sean Salmon — Executive Vice President and President, Cardiovascular Portfolio
Thanks, Matt. Yeah, sure. So, you know, we are — across the board, we price for value. And 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 or, 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 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. So, it’s always a 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.
Gary Corona — Interim Chief Financial Officer
Hi, Matt. This is Gary. And yeah, 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 an 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 to 210, and that compares to 275 to 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 going to 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.
Ryan Weispfenning — Vice President and Head, Investor Relations
OK. Thanks, Matt. We’ve got time for one more question. If we didn’t get to your question, if there’s any analyst on the line that still have questions, feel free to follow up with me after the call.
Yeah. The final question comes from Patrick Wood at Morgan Stanley. Patrick, please go ahead.
Patrick Wood — Morgan Stanley — Analyst
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 of 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, that would be great.
Sure. Thanks, Patrick. Look, we’re committed to driving leverage down the P&L. 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 that — to — a lot of levers to pull to achieve that. Things — and free up — at the same time, free up even more money for investment, which I’ll get to. But we are doing a number of things — measures to hold, you know, our kind of, you know, overhead and enabling expenses low — flat to low so that we can reinvest more in the top line. So, we’re doing things like we’ve really, really focused on.
Just like we have capital allocation focus, we also have a focus on our headcount and allocating human capital, where that goes, and got that under — in a good spot. We’re driving — you know, we’re holding our — really trying to hold our G&A, as you know, flat, you know, as a base case, and then target areas we want to add for growth, like, for example, as the RD reimbursement comes in, you know, we’ll be adding more on our direct distribution for that. So, a very disciplined process to put — 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. So, a lot going on there, and really committed to investing in — back into the business for growth, whether it be on the direct — or the sales side, but more importantly, even on the R&D side.
And so, we’ve raised that organic investment — despite some of the challenges we’ve had over the last couple of years, we’ve raised that organic investment. And look, it’s — you know, the tuck-in M&A, as I mentioned earlier, I’d like to kind of maybe, over time here, increase the cadence of that to support the — because the cash flow of the company is strong, you know, to support that organic R&D. So, that’s how we’re thinking about it. I think we can drive that earning — that 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 going to continue to see the benefits of that on into the future.
Ryan Weispfenning — Vice President and Head, Investor Relations
OK. Thanks, Patrick. Geoff, please go ahead with your closing remarks.
Geoffrey S. Martha — Chair and Chief Executive Officer
OK. 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 19th. 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.
Que Dallara — Executive Vice President and President, Diabetes Operating Unit
Travis Steed — Analyst
Sean Salmon — Executive Vice President and President, Cardiovascular Portfolio
Mike Marinaro — Executive Vice President and President, Surgical Operating Unit
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company’s SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool recommends Medtronic and recommends the following options: long January 2026 $75 calls on Medtronic and short January 2026 $85 calls on Medtronic. The Motley Fool has a disclosure policy.
Medtronic (MDT) Q1 2025 Earnings Call Transcript was originally published by The Motley Fool