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Medtronic Plc

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As the global market leader, Medtronic Cranial and Spinal Technologies is transforming the standard of care in spine and cranial surgery by putting patients first and addressing the complex challenges faced by spine and neurosurgeons. With a portfolio of 150 products covering more than 20 pathologies, we serve over 4 million patients annually. Building on a legacy of innovation, our AiBLE™ ecosystem integrates advanced technologies, data, and AI with a patient-centric approach, offering customizable solutions to enhance surgical precision, improve workflow efficiency, and achieve better outcomes, before, during, and beyond surgery. About Medtronic Bold thinking. Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.

Did you know?

Free cash flow has been growing at -2.1% annually.

Current Price

$78.30

-2.13%

GoodMoat Value

$53.32

31.9% overvalued
Profile
Valuation (TTM)
Market Cap$100.38B
P/E21.76
EV$131.44B
P/B2.09
Shares Out1.28B
P/Sales2.83
Revenue$35.48B
EV/EBITDA12.87

Medtronic Plc (MDT) — Q3 2026 Earnings Call Transcript

Apr 5, 202613 speakers6,483 words52 segments

AI Call Summary AI-generated

The 30-second take

Medtronic reported a strong quarter with revenue growth accelerating to 6%. The company is seeing major success from its new heart ablation business and is launching several other promising new products, including devices for high blood pressure and overactive bladder. Management is confident this wave of innovation will keep growth strong into next year.

Key numbers mentioned

  • Revenue of $9 billion
  • CAS (Cardiac Ablation Solutions) growth of 80% year-over-year
  • Adjusted EPS of $1.36
  • Adjusted operating margin of 24.1%
  • Simplicity website traffic increased 50-fold compared to the previous quarter
  • Touch Surgery installations grew by over 20% sequentially, exceeding 1,000 systems globally

What management is worried about

  • The structural heart business was "a little softer as expected" and faces some competitive pressure in the U.S.
  • The Neuroscience portfolio growth was "a little below our expectations this quarter."
  • Gross margin was negatively impacted by mix, "mostly driven by CAS and Diabetes."
  • Tariffs impacted the business by $93 million or 110 basis points.
  • The Specialty Therapies business delivered flat results in the third quarter.

What management is excited about

  • The Simplicity Spiral device for hypertension has a "solid foundation with strong clinical data, an expansive label, and increasing reimbursement support."
  • The Hugo surgical robot received FDA clearance and has completed its first U.S. installations and cases.
  • The company received FDA clearance for the Stealth AXiS surgical system, which "merges AI-driven planning, robotics, and navigation into one integrated platform."
  • The Diabetes business delivered 15% reported growth, accelerated in the U.S., and the 780G system is now available through pharmacies.
  • The Cardiac Rhythm Management business grew a healthy 5%, driven by strong performance in Micra, leads, and a new ICD.

Analyst questions that hit hardest

  1. Travis Steed at Bank of AmericaRevenue acceleration and earnings growth drivers — Management gave a long, multi-part response detailing contributions from multiple new products and margin dynamics to justify their confidence.
  2. Robert Marcus at JP MorganDrivers for achieving high single-digit EPS growth in FY27 — The CFO gave an unusually detailed breakdown of gross margin, overhead, below-the-line pressures, and temporary dilution effects to explain the path.
  3. Matthew Miksic at BarclaysCAS gross margin headwinds and market penetration pace — Management provided a defensive justification for the margin mix, calling it "a good problem to have," and emphasized their focus on hiring to overcome expansion bottlenecks.

The quote that matters

We are translating extensive innovation into sustainable growth.

Geoffrey Martha — CEO

Sentiment vs. last quarter

The tone was more confident and forward-looking, with specific emphasis on new product launches (Simplicity, Altaviva, Hugo, Stealth AXiS) beginning to contribute to growth, whereas last quarter's focus was more on laying the groundwork for these launches.

Original transcript

Operator

We are making significant advancements with Simplicity Spiral for hypertension and Ulta Viva for urge urinary incontinence. Symplicity offers a single, durable, minimally invasive treatment for hypertension, and it is among our key growth drivers. Given the 18 million patients in the U.S. suffering from uncontrolled hypertension, this will contribute to our success for many years. We are observing impressive patient outcomes, and the value proposition is well-received by both doctors and patients. We have a solid foundation with strong clinical data, an expansive label, and increasing reimbursement support. We are now focused on growing this new segment and reshaping hypertension treatment. Our recently launched Go Beyond campaign is generating significant patient interest, with a 50-fold increase in website traffic compared to the previous quarter. Establishing a new market takes time, but Medtronic excels in this area. Simultaneously, we are innovating for the future, including our Transradial Catheter, set to launch in the second half of fiscal year '27, and our Spiral Gemini trial aiming to enhance multi-organ ablation efficacy. We are also scaling Altaviva, our tibial neurostimulation device, which offers a straightforward yet revolutionary solution for treating urge urinary incontinence affecting 1 million people in the U.S. Altaviva is compact, requires no imaging or sedation, activates the same day, is MRI-ready, and boasts a 15-year battery life, the longest in its category. We're getting positive initial feedback from physicians and patients and are training doctors, supporting hospital staff, and investing in consumer outreach. While it's early for both launches, we are committed to executing effectively to turn initial interest into procedures. Moving to Hugo, our robot received FDA clearance for urologic surgery this quarter, allowing us to start our planned U.S. launch. I'm pleased to report that we've already completed our first installations and cases, including at Cleveland Clinic, where surgeons praised Hugo's unique advantages like flexibility, portability, and trusted instrumentation. When combined with our Touch Surgery Digital Ecosystem, which offers AI-powered data connectivity and analytics, Hugo becomes even more compelling. This quarter, Touch Surgery installations grew by over 20% sequentially, exceeding 1,000 systems globally. We continue to enhance the Hugo system with fourth-generation software and ongoing improvements. We plan to broaden its applications in the U.S. for general surgery, particularly hernia procedures, as our system excels in this area. Customers truly value having a comprehensive partner across all surgical fields, and Medtronic is the only company with approved solutions for open, laparoscopic, and robotic-assisted surgeries, which is crucial as hospitals expand their surgical offerings. We are excited about these four key growth drivers, but our innovation pipeline is extensive. We remain dedicated to fostering sustained innovation across our portfolio, regularly introducing new technologies in high-demand and high-growth sectors where we are well-equipped, such as MMA, carotid stenting, thrombectomy, coronary DCB, cardiac rhythm management, and spine surgery. I am particularly thrilled to announce a significant advancement in our Neuroscience business, as we recently received FDA clearance for our Stealth AXiS surgical system for spinal surgery. This system merges AI-driven planning, robotics, and navigation into one integrated platform, enhancing surgical workflows. Navigation, which we pioneered and lead, is critical, influencing 70% of U.S. spine surgeries. Stealth AXiS aims to capture market share with its enhanced features while facilitating robotic integration for physicians. We have an established base of 10,000 units and are expanding into cranial and ENT applications. This is pivotal for our CST business and an exciting step toward improving precision and personalization in patient care. Our M&A strategy is also advancing with the Cat Works acquisition and CRDN, along with expanding our venture investments like Enteris in structural heart. These initiatives support our long-term strategy of digitizing and enhancing ecosystems within our core markets. Before I hand it over to Thierry for a detailed discussion on our business performance, finances, and guidance, I want to emphasize that Medtronic is translating extensive innovation into sustainable growth. Our businesses are at different stages of development, but our continual innovation suggests a promising growth outlook for Medtronic overall. We have strong areas executing well, such as CAS with its robust PFA pipeline, CST with Stealth, and CRM, which is a reliable growth driver with significant innovation in defibrillators and pacing systems. We also have emerging opportunities in areas like CRDN with Simplicity, pelvic health with Altaviva, peripheral vascular health with NeuroGuard and Libero, and neurovascular advancements with Artis, Neurogard, and expanding MMAE indications for Onex, along with the initial launch of Hugo in the U.S. These are real catalysts for growth. While we have challenges to address, particularly in structural heart, we have plans in place to enhance our portfolio and growth trajectory. With strong contributors set to deliver today and the potential for significant improvements in areas where we are focusing on competitiveness, we are confident in our long-term growth prospects. Now, I'll turn it over to Thierry to provide more details on our business performance.

O
TP
Thierry PietonCFO

Thanks, Geoff, and hi, everyone. I appreciate all of you joining today. Let's start with our Cardiovascular portfolio, where this quarter, we delivered 11% year-over-year revenue growth, with 13% growth in the U.S. This represents the strongest growth we've seen in cardiovascular in the last 10 years, excluding COVID comps. CAS grew 80% year-over-year, with PFA accounting for 80% of that revenue. Beyond CAS, the remainder of the cardiovascular portfolio delivered combined mid-single-digit growth. Cardiac Rhythm Management also had a strong quarter. CRM continued to contribute 15% of our total revenue, and it grew a healthy 5%. This was primarily driven by continued double-digit growth in Micra, mid-teens growth in 3830 CSP lead, and over 70% growth in Aurora EV ICD. In peripheral vascular health, we posted high single-digit growth driven by broad strength across our endovenous portfolio. We look forward to the continued launch of NeuUrOGARD-IAP carotid stent and the full market release of our Librac mechanical thrombectomy system. In structural heart, Q3 was a little softer as expected and grew low single digits. We had a stronger quarter internationally and continue to gain share in Europe. This was partially offset in the U.S., where we annualized our Evolut FX Plus launch and saw some competitive pressure. I'll now pivot to our Neuroscience portfolio, which grew 3%. Growth was a little below our expectations this quarter, but Neuroscience is also where we have one of our broadest pipelines and some of our most exciting opportunities. Importantly, we expect that pipeline to begin impacting growth in the fourth quarter. Cranial and Spinal Technologies continues to be a powerful engine for Medtronic. This large business delivered mid-single-digit growth, including 8% growth from strong pull-through in core spine. We're excited to offer customers our new navigation and robotics platform, Stealth AXiS, which Geoff just mentioned. With FDA clearance achieved, we expect to see Stealth AXiS contribute to Neurosurgery and CST overall as soon as the fourth quarter. Specialty Therapies delivered flat results in the third quarter. This is an area where we expect improved performance in the coming quarters given the series of new product developments. Neurovascular has been challenged over the last quarters due to China VBP and the recall of Vantage, both of which are now mostly behind us. We also have line of sight to a higher level of growth from the contribution of Onex's expanded indication. The NeuroGuard carotid stent launch will also contribute as it's being commercialized by both our Neurovascular and Peripheral Vascular businesses. In Pelvic Health, we saw a slightly softer sacral nerve stimulation market environment, but look forward to seeing the increased contribution from Altaviva. In Neuromodulation, we grew 4%, driven by the continued rollout of our differentiated, fully closed-loop technologies, in septive SCS, and brain sends ADS. Next, our Med Search portfolio grew 3% ahead of expectations. First, endoscopy and ACM had strong quarters. Endoscopy revenue grew 10%, led by mid-teens growth in our esophageal portfolio, driven by Next Powder and strong market adoption of Endoflip 300. Acute care and monitoring saw a 7% growth, led by strength in blood oxygen management and airway access. And finally, our Surgical business grew by 1%. We saw strength in energy and wound management and hernia with expected softness in stapling. The next phase of growth for this business is the rollout of Hugo, and we're thrilled to see our first installations and first cases so swiftly after the U.S. launch. Wrapping up our business performance is MiniMed, our diabetes business, which delivered 15% reported and over 8% organic growth. Performance was led by double-digit strength in international markets, but we also saw acceleration in the U.S. with strong sequential lift driven by Simplera Sync and Instinct, which both just launched in December. Our Diabetes business continues its strong innovation cycle, supported by multiple recent regulatory and pipeline milestones. In addition to introducing Instinct and Simplera to the market, we secured several FDA clearances that further expand 780G's indications. We also announced that the 780G system is now available through pharmacies with agreements that cover the majority of commercially insured lives in the U.S. And we submitted MiniMed Flex to the U.S. FDA and began the U.S. pivotal study for Vivera, our third-generation fully closed-loop algorithm, which we believe will help maintain our leadership in delivering industry-leading outcomes. Finally, our MiniMed Fit patch pump remains on track, and we intend to submit it to the U.S. FDA by this fall. The planned separation of MiniMed is perfectly on track. Our preferred path continues to be a two-step IPO and split. We continue to expect the separation to be complete by the end of calendar year '26. Now turning to the financials. This quarter, revenue of $9 billion grew 8.7% reported and 6% organic, a 50-basis-point acceleration from the prior quarter and 50 basis points above our guidance. Geographically, this performance was balanced, led by high single-digit growth in Western Europe, with mid-single-digit growth across the U.S. and Japan. U.S. growth was 6% year-over-year, the strongest performance we've delivered since fiscal year 2019, excluding COVID comps. In China, we delivered low single-digit growth while navigating ongoing but manageable volume-based procurement in a few businesses. Excluding DBP, our growth rate in China was mid-single digit. Our adjusted gross margin was 64.9%, ahead of expectations. As I've done in the last several quarters, let me walk you through the rough breakout of the components. We realized 30 basis points of benefit from pricing. Net of inflation, cost down was negative 20 basis points as the third quarter is typically our lowest quarter for generating cost efficiency savings, and we had some prior year nonrecurring items. Mix was negative 100 basis points, mostly driven by CAS and Diabetes. As discussed in prior disclosures, with CAS in the early stages of launch, this business is currently impacted by the mix of lower margin capital to higher-margin catheters, and Diabetes is in its early manufacturing ramp-up of Simplera. Over time, as you know, we expect this mix dynamic to improve as we scale CAS and separate the diabetes business. Tariffs impacted the business by $93 million or 110 basis points, in line with forecast. And finally, foreign exchange provided an approximate 40 basis points tailwind. Adjusted R&D was 8% of revenue and increased 7.4%. On an organic basis, this outpaced revenue by 50 basis points. Our adjusted SG&A was 32.3% of revenue, which is 30 basis points lower than the third quarter of last year. We continue to fuel our PFA launch and develop and build the markets for Simplicity, Altaviva, and HUGO, but at the same time, we delivered disciplined leverage in G&A. Our adjusted operating profit was $2.2 billion, resulting in an adjusted operating margin of 24.1% ahead of expectations again. Our adjusted tax rate was 17.3%, about 100 basis points higher than forecast, largely due to jurisdictional mix of profits. All in all, adjusted EPS was $1.36, and $0.03 above the midpoint of our guidance range. Now turning to guidance. On the top line, we're reiterating fiscal '26 organic revenue growth guidance of approximately 5.5%. In the fourth quarter, we expect revenue growth similar to Q3, so around 6% off a stronger Q4 '25 comp. Moving down the P&L, we expect our fiscal '26 gross margin to increase slightly ex tariffs. Pricing, FX, and COGS efficiency programs are expected to more than offset the negative impacts of business mix, primarily from CAS and Diabetes. We anticipate a tariff impact to COGS of approximately $185 million, including $75 million in the fourth quarter. Including tariffs, we expect fiscal 2016 gross margin decrease of roughly 30 basis points. We expect fiscal '26 adjusted operating profit to grow approximately 5% or 7% excluding tariffs. Our fiscal 2016 operating margin is expected to be roughly flat, excluding tariffs, and down about 50 basis points, including the tariff impact. In totality, we expect these results to deliver gross margin and operating margin leverage ex tariffs in the second half of the fiscal year '26, as we stated last quarter. Turning to EPS. This quarter, we saw a beat of $0.03. This was largely due to a slightly better-than-expected revenue in the quarter, mainly from CRM and ACM. This was partially offset by the aforementioned tax pressure that we saw in the quarter. As we expect CRM and ACM to normalize, and the tax pressure to carry into Q4, we are maintaining our fiscal '26 EPS guidance in the range of $5.62 to $5.66. Look, we're excited about the quarter, and we think Q4 is going to be another robust quarter and that we will sustain our growth at a high level and into the next year. We're making progress on margin expansion, and the negative mix effect from CAS and Diabetes are going to get better. We're going to continue to invest in growth areas like R&D, sales and marketing, and M&A to capitalize on the opportunities ahead of us. And we will also continue to drive efficiency in functional areas. All told, we are committed to our guidance, and we maintain our expectation for high single-digit EPS growth in fiscal year '27. Back to you, Geoff.

GM
Geoffrey MarthaCEO

Okay. Thanks, Thierry. Now before we go to Q&A, let me close with a few final thoughts. So we're encouraged by the progress across the business, as Thierry just said, and we remain committed to stronger, durable revenue and earnings growth. Our PFA trajectory is strong, and we're progressing on multiple billion-dollar opportunities. We're reinforcing our future pipeline, and we're committed to organic and inorganic investment to further bolster the portfolio. Bottom line, we are delivering. Now to our Medtronic colleagues around the world, thank you for your unwavering commitment to our mission and to the patients we serve. You are delivering for customers and for patients, and you're turning our strategy into performance. So thank you. With that, let's turn to Q&A. So first, Ingrid, welcome to your first earnings call. And now can you please provide the instructions and queue up the analysts.

Operator

We'll take our first question from Travis Steed at Bank of America.

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TS
Travis SteedAnalyst

First, I'll start with comments on accelerating revenue growth next year and growing earnings in the high single digits. When you think about CAS, can you hear me okay?

GM
Geoffrey MarthaCEO

There we go.

TP
Thierry PietonCFO

Yes.

TS
Travis SteedAnalyst

Okay. I just wanted to ask about the accelerating revenue growth for next year and also the commitment to grow earnings in high single digits. I guess when you think about the overall portfolio, obviously, CAS is starting to hit tougher comps and this quarter, surgical is only growing 1%. So just trying to think about how you get that business accelerating with Hugo and just like the commitment to be able to deliver on the commitments that you've kind of laid out for FY '27?

GM
Geoffrey MarthaCEO

Thank you, Travis, for your question. I'll start and then pass it to Thierry. On the top line, as you mentioned, we had a very strong quarter with CAS, and we believe that growth will continue, becoming a larger part of the company. We're well positioned in that area. Additionally, we have other significant growth drivers, particularly Simplicity for hypertension and Altaviva for overactive bladder, which we expect to start contributing even in Q4. There are also several other businesses that are set to grow at a faster pace than recently. One such example is CST with Stealth AXiS, which I believe is somewhat overlooked by the market. This isn't just a new robot or a simple extension; it's a completely new platform that offers numerous benefits and will drive growth for CST both in the short and long term. Neurovascular is also expected to increase, thanks to new products like the Onyx indication for MMAE and our NeuroGuard carotid stenting product, along with anniversaries for BBP and other initiatives. Therefore, we are optimistic about continued growth not only in Q4 but also extending into FY '27.

TP
Thierry PietonCFO

Yes. Regarding EPS, the growth trajectory is clear. We're experiencing accelerated growth, with improvements in gross margins, especially in the second half of the year, as we benefit from the mix effect from CAS and the separation of Diabetes. We will maintain our focus on leveraging functional areas, particularly in G&A, while continuing to invest in R&D and M&A. We are reaffirming our high single-digit EPS growth guidance for 2027. There are several significant factors affecting next year's numbers, and as we gain more clarity, we will provide updates on their impacts. A few noteworthy points include the carryover from the tariffs settlement into next year, where we anticipate approximately $75 million per quarter, leading to around $300 million in headwinds compared to the $185 million experienced in 2026. Additionally, we will benefit from having 53 weeks in fiscal year 2027 instead of the usual 52 weeks. We expect the Diabetes deal to be accretive, but there may be some dilution of about $0.01 to $0.02 per month between the IPO and the split, as most of the stock retirement that drives the accretion will occur only upon separation. Furthermore, we've accounted for $0.04 to $0.05 of dilution in our guidance due to M&A activity, including our announcements of Cath Works and Antares. As we receive more information on the timing of the Diabetes deal and the completion of the M&A transactions, we will provide further details on the respective impacts in our Q4 release. Nonetheless, we remain dedicated to accelerating growth and maintaining our investment in M&A and R&D, as well as upholding our guidance.

GM
Geoffrey MarthaCEO

Yes. And just on the acceleration. Go ahead, Travis.

TS
Travis SteedAnalyst

There's an extra selling week next year. Is the growth acceleration excluding the extra selling day?

TP
Thierry PietonCFO

So that will be part of it. That will be part of it. And again, we'll give you the details of the impact as we go into the Q4 announcement.

GM
Geoffrey MarthaCEO

When I consider the growth acceleration, you referenced CAS in Q3. Beyond cash, you observed our CRM business and our Peripheral Vascular Health business both improve in Q4, as I mentioned, and looking further, think about CST and neurovascular beginning to gain momentum. As we move into FY '27, that's when Ardian and Altaviva really come into play, along with Hugo. Therefore, we are optimistic about that acceleration.

Operator

Our next question comes from Vijay Kumar at Evercore Vijay.

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VK
Vijay KumarAnalyst

Geoff, congratulations on a great presentation. I have one product question and one clarification regarding the guidance. You mentioned that RDN and Altaviva will be growth drivers in fiscal '26. How should we track their progress? Are there specific milestones we can anticipate to monitor the launch curves for RDN and Altaviva?

GM
Geoffrey MarthaCEO

That's a great question. I believe we'll start to establish more specific benchmarks as we move ahead. Currently, we’ve been discussing the strong leading indicators we’re seeing with both products. For Altaviva, we mentioned training over 500 physicians, which indicates strong demand. As I noted last quarter, this often involves weekend travel, highlighting our commitment. In terms of renal denervation, we've opened over 200 new accounts this quarter, and our physician finders have increased to 150 physicians. It's important to remember that there is a high requirement to participate; physicians need to perform five cases and opt-in. Many more physicians are currently performing cases. We'll also keep tracking the covered lives, as we’re now at around 100 million, which represents about a third of the population in the U.S. These are all encouraging leading indicators, and we'll begin to communicate additional benchmarks as these launches progress. Thierry, do you have anything to add?

TP
Thierry PietonCFO

No.

VK
Vijay KumarAnalyst

Great. And just one clarification on the extra week Geoff, we're looking at exit rates of 6% organic, right? And let's assume next year is north of 6%. The extra week is almost 2 points of growth. So are we looking at base organic excluding extra week somewhere in the 5%-ish range or any thoughts on how to think about extra week contribution?

TP
Thierry PietonCFO

So maybe I'll take that one, and thanks for the question. Look, first, it's a little bit less than 2 points of full growth. And again, we'll give you the specific calculations as we close the year, but the way to think of it is that there's going to be growth acceleration, excluding the extra week, right? So it should be upside. So we should have better growth than we have in fiscal year '26, in '27 and the extra week should be on top of that.

GM
Geoffrey MarthaCEO

That clear, Vijay?

VK
Vijay KumarAnalyst

Crystal clear, yes.

Operator

And our next question comes from Larry Biegelsen at Wells Fargo.

O
LB
Larry BiegelsenAnalyst

Geoff, I wanted to ask about cash and your growth continued to accelerate this quarter to 80% worldwide, which implies the worldwide EP market grew about 20% in calendar year Q4. So my question is, how are you thinking about the EP market growth in calendar year '26, and your CAS growth going forward now that you're lapping the Affera U.S. launch? I think to achieve the trailing 12-month $2 billion goal, it looks like your CAS growth has to kind of sustain about 80% in the next 2 quarters. Is that directionally accurate?

GM
Geoffrey MarthaCEO

Well, first, I want to say we agree with you about the market growth being around 20% in our fiscal Q3 and Q4. We believe this growth will continue in the near term. For our fiscal '27, we expect growth to be at least in the high teens and then shift to strong double-digit growth thereafter. We see the market continuing to grow, and we feel we are well positioned with our catheter and mapping portfolio. In terms of our business growth, we anticipate sustaining it in Q4, and we haven't provided guidance beyond that. However, I would like to emphasize that we are confident in our position. When considering the four players in PFA, two of them focus primarily on mapping, and we believe we are well positioned against them since we think catheters are key and we have integrated mapping. Looking at our competitor whose focus is mainly on catheters, we believe our catheter portfolio is superior. Our Sphere-9 has proven to be quite versatile, and although our competitor initially portrayed it as a niche product, it has been successfully used in various situations, including both persistent and paroxysmal cases, new cases, and re-dos. Additionally, our SER-360 has received CE marking and is a single-shot catheter that has generated considerable excitement, and we have started the U.S. trial. We will also continue to make regular upgrades to our mapping technology. Overall, we feel optimistic about our current and future position, and we believe the underlying markets remain really strong.

Operator

Our next question comes from Patrick Wood at Morgan Stanley.

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PW
Patrick WoodAnalyst

I'll keep it to one, considering everything happening. Obviously, there are deals going on. I know you were close to a particular deal for a long time. How are we approaching capital allocation and mergers and acquisitions? Many companies are making significant deals in this space. I'm trying to understand if you still prefer bolt-on M&A and technology enhancements rather than larger deals. How are you viewing capital allocation moving forward?

GM
Geoffrey MarthaCEO

Thank you for the question, Patrick. As we've mentioned, we are fully committed to accelerating mergers and acquisitions, and you can see that with developments like Cathworks. Our approach is very focused on strategic venture investments that may eventually lead to M&A opportunities, particularly tuck-in deals that could be worth several billion dollars. These deals are closely aligned with our existing business, and we are exploring multiple options. We have a significant amount of capital allocated for various tuck-in ventures across our portfolio, prioritizing higher growth areas. In some cases, we may pursue several opportunities simultaneously, similar to our approach with Ablation. We initiated an organic program, acquired Affera, and we might consider similar strategies in key high-growth markets, which reflects our tuck-in strategy across different segments and sub-segments, as well as venture opportunities.

Operator

So Robbie Marcus from JP Morgan will be our next question.

O
RM
Robert MarcusAnalyst

Great. Can you hear me okay?

GM
Geoffrey MarthaCEO

Yes.

TP
Thierry PietonCFO

Yes.

RM
Robert MarcusAnalyst

Great. Two for me. Maybe I'll ask them just as one. Jeff or maybe Thierry. As you think about the fiscal '27 guidance and especially, I imagine you'll have you go in renal denervation and tibial spend to support those launches and continued investment in CAS, how do you think about getting to the high single-digit EPS growth? If you could give us some high-level drivers there? And then second part, the Street is sitting at 8.5% EPS growth. I know traditionally, you do something like 6.5% to 9.4% as high single. Do you think the Street at 8.5%, is that a good midpoint of the range to start here?

TP
Thierry PietonCFO

Thank you for the question. Regarding EPS, some key factors to consider are the accelerated growth, which will contribute positively to leverage. In terms of gross margin, we've seen operational improvements in pricing and cost management, although these have been countered by mix effects from CAS and Diabetes. However, I believe these aspects will improve. The CAS enhancement is a result of a shift towards more catheters and less capital equipment, which should benefit our margins. On the Diabetes front, the separation will be beneficial as it has a lower gross margin compared to the rest of the business. Once that segment is separate, our gross margin should receive a natural boost. When looking at overhead, we will keep investing in R&D and sales and marketing to build the franchises we've discussed. We're allocating resources to Ardian and CAS, hiring the necessary personnel, and conducting direct-to-consumer marketing, especially for renal denervation and Altaviva. Despite these investments, we expect the SG&A line to provide leverage, as seen this quarter. For instance, in Q3, our G&A leverage more than compensates for the resources allocated to sales and marketing, which should improve our operating margin. However, we anticipate some challenges below the line, particularly with interest expenses as we refinance older debt that's been at nearly 0% interest for the past 4 to 5 years with new debt at around 3.5% to 4%. We also expect some pressure on taxes, although that line is stabilizing. There are factors we need to monitor regarding the timing of the Diabetes separation. Between the IPO and the split, we expect a dilution of about $0.01 to $0.02 due to the loss of 20% of Diabetes profits, and we won't benefit from the share count reduction until later, which is based on a 12-month rolling average. As we gain clarity, we will communicate more about these impacts, including potential dilution from M&A. Overall, we're guiding for high single-digit EPS growth. As for the 8.5% projection from the Street, it seems that some of the temporary dilution effects from Diabetes and M&A might not be fully reflected in their estimates yet, and we'll clarify this as we gain more visibility.

Operator

Our next question comes from Matt Taylor at Jefferies.

O
MT
Matthew TaylorAnalyst

I wanted to follow up on the question around capital allocation in TAVR. I guess it was interesting to see the investment in tariffs. I was wondering if you could comment about why you didn't just buy the whole company versus invest? And we also saw over the weekend, the results of a longer-term follow-up for CoreValve published in JAK. And similar to the Edwards trials, there was some late catch-up in mortality. I was wondering if you could comment on that in the TAVR arm?

GM
Geoffrey MarthaCEO

Sure. We feel that the structural heart space is one we helped pioneer, and we have a strong position and good reputation in that area. However, we want to expand further. We have an organic program, including our Evolut platform, as well as mitral and tricuspid replacement programs, but we still see growth opportunities. In TAVR, the balloon expandable market is the larger segment, presenting us a chance to enter that space. We believe there are multiple avenues for success here, and partnering with [indiscernible] is a worthwhile investment moving forward. Regarding the JAK article, I want to clarify that the valve discussed is outdated and no longer available commercially, and the procedural technique has been previously communicated. Essentially, that information just restates our guidance from 2020. We are working closely with our physicians to ensure they understand all of this as we progress. I'm optimistic about the structural heart space and the investment in [indiscernible], with potential for further opportunities ahead.

Operator

Our next question comes from Matt Miksic from Barclays.

O
MM
Matthew MiksicAnalyst

Great. And congrats on the Antares investment, by the way. So on cash, I'll just ask one question. You mentioned generator sales or kind of a headwind to gross margins at this point, the mix is maybe shifting a little more towards capital you can give us a sense of when that starts to normalize? And then also in terms of the runway, I think we understand that hiring mappers is maybe the bottleneck here if there if you want to put it that way. You need more people to open more centers to get more catheter use. Any sense of where you are in that continuum through the academic centers or into the general centers in the U.S. and some sense of the pace that you're able to maintain for hiring centers? So helpful color.

GM
Geoffrey MarthaCEO

Thanks, Matt. Regarding the current status, I believe we're still in the early stages of our launch and have a significant opportunity to expand our reach into high-volume academic centers and beyond. As you mentioned, hiring mappers has been essential. While it's not the main topic, it remains a crucial focus for us. We have managed to stay ahead in this area, and our priority right now is to continue bringing in mappers. Many of these mappers are quite committed to the field and have a good sense of where the industry is heading. This support is invaluable. That's my perspective on that. What was the first part of the question?

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Thierry PietonCFO

The first part was on the dilution that comes from the capital equipment and when does the mix turnaround? So first, what I want to say is CAS is a fantastic business from an operating margin perspective, right? So it is slightly dilutive because of this mix issue at the GM level, but it's driving significant profitability at the total business level at the operating margin level. When it's going to turn around between capital equipment and catheters, I want to say it's almost a good problem to have. So I hope it turns around as late as possible because as we're building the installed base, it's always going to be good news going forward. That being said, I think you'll start to see an inflection in the second half of next year. The mix is starting to improve with the catheter sales increasing. And look, year-over-year, CAS is going to drive gross margin improvement as early as '27. So look, it's a great business to be in, and it's all good news going forward.

Operator

Our next question comes from Chris Pasquale at Nephron.

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Christopher PasqualeAnalyst

I wanted to ask about Hugo. Geoff, you talked about the impact of Simplicity and Altaviva really beginning to kick in as soon as next quarter. I don't think you included Hugo in that group. So I would love to hear how you're thinking about the timeline for Hugo to really begin to move the needle within the surgical business? And any qualitative comments you can make about the system pipeline right now?

GM
Geoffrey MarthaCEO

We are very excited about the progress with Hugo. This past quarter was significant for us, particularly with the FDA approval. We just shared that we completed our first cases in the U.S. at the Cleveland Clinic earlier this month and have more scheduled this week at other centers. All the key indicators for Hugo are looking positive, including feedback on system performance and future opportunities in the U.S. market. We are monitoring the smooth case rate, global procedure growth, and utilization closely, and all signs indicate strong performance. We are witnessing a notable increase in installations worldwide, especially now that the U.S. is ramping up. We anticipate a boost in Q4. While the surgical business is substantial and has its challenges, Hugo is experiencing rapid growth. Eventually, it will start to contribute significantly to the $6 billion surgical business. We are pleased with our position, thrilled about entering the U.S. market, and encouraged by the reception and orders we are receiving.

Operator

Next question comes from Danielle Antalffy at UBS.

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Danielle AntalffyAnalyst

Geoff, could you elaborate on how we should consider renal denervation, Simplicity, and the market development you're discussing? We've spoken with some referring physicians who have been involved in renal denervation since its inception, and one mentioned receiving many inquiries. I'm interested in what it takes to actually develop this market, assist centers in establishing referral networks, and so forth. Additionally, do you have any specific figures available to date, even if they're approximate?

GM
Geoffrey MarthaCEO

Thank you, Danielle. I appreciate your question. First, regarding the increase in calls to physicians, we are seeing significant growth. To illustrate, our direct-to-consumer website for Simplicity had around 50,000 visits in Q2, which surged to 2.5 million visits in Q3. This spike in consumer demand is impressive, and we are just beginning. As mentioned, we have opened over 200 accounts, the Physician Finder is operational, and reimbursement is strong, driving consumer interest. Most importantly, we are achieving excellent patient results, particularly in reducing blood pressure, which patients are responding to positively, sparking interest among doctors. We have been expanding our market development team to establish a referral pathway from general practitioners and hypertensive specialists to hospitals and procedures. This involves hiring for various roles, including health economics, coding, and billing, to support hospitals in these efforts. Overall, the initial building blocks of our market have been solidified, with FDA breakthrough approval and broad CMS reimbursement. We are performing better than expected compared to other competitors in the market. We need to continue developing this market, focusing on those key components. We are excited about the positive patient outcomes and how they resonate with consumers. In addition to enhancing our referral pathways and collaborating with hospitals, we aim to strengthen the Simplicity brand to associate it with hypertension management. The increase in site visits from 50,000 to 2.5 million is part of our lead generation strategy. We plan to invest in brand building for Simplicity, as outlined by Thierry for FY '27. Much excitement surrounds Ardian right now, and we expect to see more meaningful revenue results in FY '27, which we anticipate will be profitable right from the start.

Operator

And as we reach the top of the hour here, our last question is going to come from Joanne Wuensch from Citi. And before we move to Joanne, please, of course, e-mail us for any of those we did not reach today. Sorry, and thank you, and we'll look forward to talking to you soon.

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Joanne WuenschAnalyst

I'm going to ask the Stealth AXiS question and what you can share with us about the product and why you're so excited about it?

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Geoffrey MarthaCEO

Thanks, Joanne, for your question. I believe this aspect has been significantly overlooked, particularly in the investment community. The robot we have does two important things. First, it is not just an extension of Mazor; it is a completely new platform with many added functionalities that will provide great value. Moreover, its integration into the workflow is crucial. Currently, 70% of procedures in the U.S. utilize navigation, which we pioneered and lead. However, robotics has not integrated well with this workflow, leading to lower adoption rates than the navigation figures suggest. The Stealth AXiS integrates seamlessly into that workflow, offering a comprehensive system from initial imaging to AI-based surgical planning, and into navigation and robotics. This creates a fluid workflow that surgeons have been eagerly awaiting. We have improved the robot's functionality and enhanced the workflow, which is essential for physicians and health systems. This innovation lowers the barriers for adopting robotics in spine surgery, likely expanding the market, and ensuring we continue to gain market share. I believe this also strengthens our position against our main competitor, whose dynamics have shifted significantly in recent years. Our technology is enabling us to advance, and the AiBLE suite is crucial for our success. We are excited about our progress, and in addition to the substantial growth drivers we've discussed, including CAS, Ardian, Altaviva, and Hugo, I would highlight the importance of Stealth AXiS. Medtronic currently has a wide array of innovations, which is fueling our enthusiasm. You may have noticed the meaningful growth in CRM and peripheral vascular health from new products like carotid and thrombectomy systems. Our CST is accelerating, neurovascular is gaining momentum with the NeuroGuard carotid product and MMAE, and we have those major growth drivers like Ardian, Altaviva, and Hugo in their nascent stages. The diversity of innovation is starting to flourish, which is wonderful to witness. Innovation is crucial in our business, and we have both major growth drivers and a broad spectrum of new developments. As Thierry mentioned in response to Robbie's question, we are employing various strategies to ensure appropriate investment levels, such as increasing R&D, supporting direct-to-consumer initiatives, expanding our workforce, especially mappers, and pursuing M&A opportunities. We are adopting a more offensive stance based on our current momentum and the positive outlook ahead.

Operator

All right. Thank you, everyone, and I'll turn to Geoff for some closing remarks.

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GM
Geoffrey MarthaCEO

I thought that was the close. Okay. Thank you. Thank you all for joining today, and for all of your questions, and appreciate your support and continued interest in Medtronic. And we hope that you'll join us for our Q4 and our full-year fiscal '26 earnings broadcast, where we're going to update you on the continued progress that we just talked about against our short- and long-term strategies. With that, have a great rest of your day. Thank you.