Medtronic - Earnings Call - Q4 2025

Executive Summary

• Q4 FY25 revenue $8.93B (+5.4% organic) and non-GAAP EPS $1.62, both ahead of Street; consensus was $8.83B and $1.58, respectively, while EBITDA missed versus consensus ($2.22B vs $2.76B)*.
• Growth led by Cardiovascular (+7.8% organic), with Cardiac Ablation Solutions nearly +30% and TAVR Evolut strength; Diabetes posted its 6th straight double-digit quarter (+12% organic).
• FY26 guide: ~5% organic revenue growth, ~4% EPS growth ex-tariffs; EPS $5.50–$5.60 including tariffs (COGS headwind $200–$350mm, back-half weighted). Q1 FY26 EPS guided to $1.22–$1.24.
• Strategic catalyst: announced separation of Diabetes via IPO/split-off within 18 months; expected to lift Medtronic margins (~+50bps gross, ~+100bps operating) and be EPS accretive immediately upon completion.

What Went Well and What Went Wrong

What Went Well

• Cardiovascular acceleration: CAS nearly +30% on PFA adoption; CV portfolio +7.8% organic with double-digit Structural Heart and strong CRM (Micra +17%, 3830 lead +19%).
• Neuroscience momentum: Neuromodulation +10% with U.S. Pain Stim mid-teens growth and BrainSense Adaptive DBS FDA approval/launch; CST U.S. +6.7% on AiBLE ecosystem pull-through.
• Earnings leverage: adjusted operating margin 27.8% (+90bps YoY; +200bps cc) and non-GAAP EPS +11% YoY, supported by pricing and COGS efficiencies (labor, insourcing, scrap reduction).

Management quote: “We had a strong finish to our fiscal year, growing 5.4%… translated our revenue growth into leveraged earnings with high single-digit operating profit and low double-digit EPS growth”.

What Went Wrong

• Gross margin mix headwinds (~80bps) from CAS capital mix and Diabetes ramp; adjusted gross margin 65.1% (−70bps YoY).
• Specialty Therapies declined low-single digits in Q4, and CPV was roughly flat (−0.1% reported; +1.0% organic).
• Tariffs risk: FY26 COGS headwind $200–$350mm, weighted to Q3/Q4 (~30%/~60% of full-year impact), though mitigation plans underway.

Transcript

Ryan Weispfenning (VP and Head of Investor Relations)

Good morning. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations, and I appreciate that you're joining us for our Fiscal 25 Fourth 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 Jeff Martha, Chairman and Chief Executive Officer, and Thierry Piéton, Chief Financial Officer. Jeff and Thierry will provide comments on the results of our fourth quarter, which ended on April 25th, 2025, and our outlook for fiscal year 26. After our prepared remarks, the executive VPs from each of our four segments will join us and will take questions from the sell-side analysts that cover the company. Today's program should last between 60 and 90 minutes. Earlier this morning, we issued a press release containing our financial statements, divisional and geographic revenue summaries, and non-GAAP reconciliations.

We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed in our earnings press release or on our website at investorrelations.medtronic.com. During today's program, many of the statements we make may be considered forward-looking statements, and actual results may differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause our actual results to differ is contained with 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 fourth quarter revenue in the current and prior year reported as other.

References to sequential revenue changes compared to the third quarter of fiscal 2025 are made on an as-reported basis. All share references are on a revenue and year-over-year basis and compare our fourth fiscal quarter to our competitor's first 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. 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 and our outlook for fiscal 2026.

Geoff Martha (Chairman and CEO)

Hello everyone, and thanks for joining us today. As you can see in our Q4 results release this morning, we had a strong finish to our fiscal year, growing 5.4%. Our growth drivers are having an impact and are still building momentum. We've proven to you that our growth is durable, as we've now delivered mid-single-digit revenue growth for two and a half years. Our cardiovascular growth accelerated as forecasted, growing 8% on broad strength across the portfolio, including nearly 30% growth in CAS. We also delivered double-digit growth in neuromodulation and diabetes and high single-digit U.S. growth in cranial and spinal technologies. Two of our businesses, CAS and ENT, reached important milestones, entering the $1 billion annual revenue club alongside 10 of our other businesses. We've had a number of important clinical and regulatory updates during the quarter as we continue to advance our pipeline.

Operationally, we translated our revenue growth into leveraged earnings with high single-digit operating profit and low double-digit EPS growth. Coupled with our Q3 results, we delivered a very strong 9% EPS growth in the back half of the year. For the full year, we delivered at the upper end of the commitments that we laid out a year ago. We shared with you this morning our view on the potential impact from tariffs, which we have included in our newly issued guidance. Thierry will walk you through this later in the broadcast, but you can see from the significant amount that we've already been able to offset that we are extremely focused on mitigating actions. You also see from our guidance that the underlying fundamentals of the business are strong, and they're getting stronger.

We had also announced this morning that we have decided to separate our diabetes business as we continue to execute on our active portfolio management. Look, we see this as a win for both diabetes and for Medtronic, and I'm going to touch upon this a bit later. We have several details to cover today, and let's start with our Q4 performance highlights. Starting first with the cardiovascular portfolio, innovation drove broad-based growth in the quarter, which accelerated to 8%. We delivered double-digit growth in cardiac ablation solutions, structural heart, and cardiac surgery, and high single-digit growth in cardiac rhythm management. Cardiac ablation solutions growth accelerated, as forecasted, to nearly 30%, with high 30s growth in the U.S. and low 20s in international markets. Our portfolio of pulse field ablation products, the broadest in the space, continues to drive rapid growth around the world.

We're opening up new accounts as our supply continues to quickly increase, and demand for our Affera PFA products is extremely high. This quarter, I spent a lot of time talking to EPs, and we're hearing great feedback. Physicians are saying that our Sphere-9 focal catheter is the most desired PFA catheter on the market, and we're seeing large centers switch to Medtronic. EPs appreciate the efficiency that comes from fewer catheter exchanges, given that Sphere-9 can do mapping, PFA, and RF ablation all from the same catheter. Now, across our PFA platforms, customers appreciate their ease of use, their precision, durable efficacy, and of course, the safety. Now, if there's a PFA catheter that is driving even more customer excitement than Sphere-9, it's our next-gen Affera Sphere-360 single-shot catheter.

Sphere-360 is an integrated mapping and ablation catheter where the entire lattice tip delivers pulse field energy, so the EP doesn't have to rotate the catheter. One-year data for Sphere-360 was presented last month at the HRS meeting, which showed excellent efficacy, durability, and safety, as well as very fast procedure times. We plan to start our U.S. pivotal trial for 360 later this calendar year. Our CAS business has a lot of momentum, and its contribution to total company growth continues to increase, including 70 basis points this quarter. We expect CAS's growth rate to accelerate again next quarter. The business reached $1 billion in revenue in FY2025, and we have near-term line of sight to doubling that as we continue to enter new accounts globally with Affera and with PulseSelect.

With the cardiac ablation space now at roughly $10 billion and growing double digits, this is a huge growth opportunity for Medtronic, and our focus is to be the leader in this space. Next, our cardiac rhythm management business had a very strong quarter, growing 7% with high single-digit growth in both defibrillation solutions and cardiac pacing therapies. With defib solutions, we're seeing strong customer adoption of our Aurora EV-ICD, with its revenue doubling year over year as we're taking meaningful share from the incumbent. We are seeing our customers placing larger and faster repeat orders for Aurora. Now, in pacing, we continue to have strong growth in leadless pacing and conduction system pacing. Our Micra leadless pacemaker had strong 17% growth, and our 3830 Conduction System Pacing Lead grew 19%.

In structural heart, we grew 10% with strong growth of our Evolut TAVR platform in the U.S., Japan, and emerging markets. We continue to differentiate Evolut with positive clinical evidence. Our five-year low-risk data was presented at ACC during the quarter, showing outstanding valve performance for Evolut. Our two-year data from our head-to-head SMART trial was presented at CRT, showing continued superior performance versus the leading competitor's valve. The SMART data and FX Plus launch continue to have an impact. To give you just a few examples, a large nonprofit system in the Upper Midwest that does over 200 TAVR implants a year recently reviewed their own patient data and found that SMART was consistent with their outcomes: better valve performance with Evolut. As a result, we went from a low single-digit share to Evolut being their valve of choice.

Another example would be an East Coast academic center that implants about 200 valves a year and whose physicians participated in the competitor's first balloon expandable TAVR trials. Now they've moved from using the competitor's valve almost exclusively to using our Evolut valves in a majority of their patients. I could keep going with such examples. The point is that our data, our technology, and our sales execution are having a significant impact, giving us confidence that we can continue to grow structural heart at or above the market. In hypertension, we continue to ramp our market development activities for our Simplicity blood pressure procedure as we await reimbursement coverage from CMS. CMS has indicated that they will finalize the NCD on or before October 11, and ahead of this, they will issue a draft on or before July 13.

Many large healthcare systems are establishing outpatient Simplicity service lines today so that they're prepared to rapidly scale to meet the large demand. We're right there with them. We're hiring market development managers, clinical specialists, and healthcare economics managers to supplement our existing coronary sales force. We expect Simplicity revenue to meaningfully ramp when it's covered. Just like PFA, over time, it will become an important contributor to overall Medtronic growth. Nearly half of U.S. adults have hypertension, and one in four of those with hypertension don't have their blood pressure under control, despite the broad availability of numerous generic drugs. Look, the opportunity here is massive, and we will be the leader in addressing this large unmet need. Now, turning to the neuroscience portfolio, our Cranial and Spinal Technologies business grew mid-single digits, including 7% growth in the United States as we continue to win share.

We've changed the basis of competition in spine to one where enabling technology drives spine implant decisions. Our differentiated AiBLE spine ecosystem, including AI-driven pre-op planning software, imaging, robotics, navigation, and powered surgical instruments, has by far the largest install base with over 10,000 capital units, well ahead of our competition. This is important because when a customer upgrades one of our pieces of capital, they're not just upgrading one product; they're upgrading to the full AiBLE ecosystem. You don't go just from OARM to new OARM, or navigation to new NAV, or robot to new robot. You go from one of these pieces of equipment to the entire AiBLE ecosystem. AiBLE is not only appealing to spine surgeons around the world; it's also attracting the competition's best sales reps and distributors to join Medtronic.

Some of the world's leading spine and neurosurgery centers, including large, iconic teaching institutions, are moving to Medtronic. Combined with the investments we're prioritizing to even further enhance the AiBLE spine surgery ecosystem, we expect our strength in CST to continue. Another business that continues to win share is neuromodulation, which grew 10%. Our closed-loop sensing technology is driving strong growth in both pain stim and brain mod. In pain stim, we grew 12%, including 15% growth in the U.S. on the continued strength of our Inceptiv closed-loop spinal cord stimulator. We continue to win share and have now reached the number one global position in SCS. Inceptiv is changing patients' lives as they no longer have to adjust their therapy throughout the day, and they aren't having to come back to the doctor's office to have their device settings changed.

Inceptiv is reducing burden for the patient and for the physician. In brain modulation, we grew mid-single digits, including 9% growth in international markets on the continued adoption of our BrainSense Adaptive DBS for people with Parkinson's. Look, this is a groundbreaking technology, a fully closed-loop brain-computer interface that automatically provides personalized, real-time therapy based on brain activity feedback. In the U.S., we received FDA approval for BrainSense during the quarter. Now, following stories on adaptive DBS technology on Good Morning America, the BBC, and several other media outlets, we are seeing patients now proactively talking to their doctors and requesting adaptive devices. The early results are very exciting, and we're now entering full market release in the U.S. and Europe, with Japan launching next month. In neuromod, we have near-term growth drivers.

We're the category leader, and we're well positioned to capture the future innovations that are coming. Now, turning to our Medical Surgical Portfolio and our Surgical business, which improved and grew 2%. We continue to drive strong growth in emerging markets and advanced energy. Our market-leading LigaSure Vessel Sealing technology continues to attract strong surgeon adoption, resulting in our 11th straight quarter of winning share in advanced energy. Now, we expect our surgical growth to improve over time as we expand and launch our Hugo soft tissue robotic platform. Hugo continues to reach important milestones. Like last quarter, we filed with the U.S. FDA for a urologic indication, and the pivotal data from the urology trial, which met its primary safety and effectiveness endpoints, was presented last month at AUA. We expect to follow our urology indication in the U.S.

with hernia and benign gyne indications, and we will begin enrollment in our gyne oncology trial in the coming months. We also continue to expand instrumentation, having conducted our first cases with LigaSure on Hugo this past quarter. We're expanding Hugo's installed base and are now in 30 countries around the world, and we continue to see strong increases in Hugo procedure volumes and utilization. In surgical, we are also driving impressive expansion in our AI-powered Touch Surgery ecosystem. Touch Surgery is a foundational intelligence technology used across both robotic and laparoscopic surgery, and we're leading the industry in establishing this digital surgical ecosystem globally. We see our growing digital footprint as a long-term strategic advantage for our surgical business, and this will apply to other businesses across Medtronic over time. Finally, in diabetes, we grew 12%, our sixth quarter in a row of double-digit growth.

The growth was broad-based, with strength in pumps, CGM, and consumables. We continue to grow our MiniMed 780G install base in both the U.S. and international markets. People with diabetes are attracted to 780G's highest time in range of any commercial AID system, giving them the ability to achieve more control with less burden. In Europe, the launch of our Simplera Sync sensor is driving strong mid-teen CGM growth. Simplera is half the size and much easier to apply than our previous sensor. Now, in the U.S., we received FDA approval for Simplera Sync just last month and expect to begin the launch this fall. Regarding our Abbott-based sensor, back-end integration and development work is progressing well. We submitted our interoperable pump and controller for FDA clearance, which paves the way for bringing our AID system with this sensor to the market.

We also submitted to the FDA for a 780G label expansion, including for type 2 diabetes and rapid-acting insulins. Looking ahead, we expect to submit for our eighth series next-generation pump, the MiniMed Flex, by the end of the fiscal year. As you can see, we've significantly turned around our diabetes business, and it's very well positioned. This morning, we announced our plan to separate diabetes into a standalone public company with a capital market separation through our preferred path of an IPO split. This is a win for both companies. For Medtronic, our portfolio becomes more focused on high-margin growth markets like PFA and renal denervation. At the same time, the independent new diabetes company will be a scaled leader and the only diabetes company to commercialize a complete ecosystem to address intensive insulin management.

Today's announcement marks a significant milestone in our ongoing active portfolio management efforts, an important lever to delivering on our long-term strategic and financial objectives. Look, there is a clear strategic rationale for diabetes to be a standalone company. Diabetes is predominantly B2C, whereas Medtronic, our businesses are predominantly B2B. We sell different types of products to different types of customers. Medtronic's commercial manufacturing and technology platform synergies are less applicable to the diabetes business, given their distinct customer go-to-market and supply chain infrastructure. For Medtronic, we will continue to have leading franchises in attractive medtech markets, and this separation shifts and simplifies our portfolio to have even more intense focus on our highest margin growth drivers. These growth drivers are already building momentum, and this increased focus will ensure that they reach their full revenue growth potential.

Our portfolio also shifts to higher profitability, allowing us to pick up both margin and earnings, and the shift increases our exposure to markets where we demonstrate our strongest core capabilities and have scale and synergy benefits, which importantly lowers the overall risk profile of the company. Now, taken all together, we'll be in a great position to continue delivering mid-single digit or higher organic revenue growth, as well as accelerating our earnings leverage. Our direction of travel here is clear. This is about greater focus on the significant opportunities in high-margin growth markets where we are well positioned, and we believe that this will result in a win for Medtronic. Look, I'm also excited about what the future holds for the diabetes business. Now I'd like Que Dallara, who will become the CEO of the new diabetes company, to share some of her thoughts.

Que joined Medtronic in 2022 and has been instrumental in turning the diabetes business into what it is today. She's an inspirational, transformative leader who is also strategic and pragmatic. Her impressive track record in driving growth and innovation has set the diabetes business on a path to continued success, ensuring the needs of people with diabetes are met around the globe. Over to you, Que.

Que Dallara (Executive VP and President of Diabetes)

Thanks, Jeff. I want to start by thanking you for your leadership and vision. Your decision a few years ago to double down on the diabetes business and significantly increase investment has positioned us well, setting us up to generate significant returns for stakeholders. We wouldn't be where we are without your unwavering support. I'm very excited to be leading this large-scale direct-to-consumer diabetes business. We have over 8,000 employees and two global manufacturing facilities and a lot of innovation in the works.

Our innovations are driven by the desire to improve outcomes while reducing burden. As an independent company, we will have a shareholder base that is aligned to our business and financial profile. This will enable more focused investment in innovation, as well as manufacturing scale and automation, positioning us for success in automated insulin delivery and smart MDI, while also driving margin expansion over time. Our $2.8 billion diabetes business has strong momentum in a large $16 billion global addressable market. We've delivered double-digit growth now for six consecutive quarters, along with several recent product approvals and the strategic partnership that we have established with Abbott Diabetes Care. We have a deep pipeline as we've been investing in CGM options, insulin delivery options such as a pen patch and durable pump, a fully automated algorithm, and a unified digital customer experience.

This full ecosystem not only enables people with diabetes to have a seamless transition between therapies without changing companies, but it also allows them to achieve better control with less burden. Finally, I want to thank and celebrate the dedication of our diabetes team. Their passion and perseverance is transforming diabetes care to give people the freedom to forget about diabetes and live their best lives. Back to you, Jeff.

Geoff Martha (Chairman and CEO)

Thanks, Que. I couldn't agree more. Next, I'm going to turn it over to Thierry to share some additional transaction and financial information on the diabetes separation, as well as take you through a deeper look at our Q4 financial performance and our guidance for the coming year. Before I do that, I want to officially welcome Thierry to his first earnings call with Medtronic.

He's now in his 12th week and has already hit the ground running, including playing a critical role in preparing for today's announcement. Thierry is a proven, experienced CFO, having most recently been in the automotive industry, where he created significant value for shareholders by increasing margins, earnings power, and free cash flow. His extensive experience with M&A, divestitures, and forming innovative partnerships is proving to be highly relevant to work here at Medtronic. His presence is already having a significant impact on our organization. He's brought forward many new ideas on how we can further invest in innovation, accelerating R&D while also driving operating leverage, and he brings with it the expertise to ensure we get it done. It's great having you on board, Thierry.

Thierry Piéton (Executive VP and CFO)

Thank you for the warm welcome, Jeff. This is certainly an exciting time to join Medtronic.

I've had the pleasure of visiting many of our facilities and meeting our employees, and also starting to meet with many of you in the investment community. A common question from many of you has been, "Why did I come to Medtronic?" For me, healthcare is a special industry given the connections to patients, and I've always wanted to return since working in healthcare earlier in my career. In addition to the sector, there were two specific things that stood out about Medtronic. First, I saw an opportunity to apply my background to enhance the operations of the company. Second, Medtronic has a few large, exciting growth opportunities that do not come around very often, and the company is at an inflection point. I'm energized by the opportunities for durable growth and value creation that are ahead of us, and I'm really looking forward to hopefully making a difference here.

Now, let's cover our plan to separate the diabetes business, which represented about 8% of our revenue and 4% of our segment operating profit in fiscal year 2025. We intend to separate diabetes through a series of capital market transactions. Our preferred path involves two steps. First, we plan to execute an IPO of up to 20% of the diabetes business. The proceeds are expected to appropriately capitalize the new diabetes company and provide the ability to retire Medtronic shares. Second, we intend to execute a spinoff where Medtronic will exchange our remaining new diabetes company shares for Medtronic shares from willing shareholders. We plan to retire those shares, resulting in a lower Medtronic share count. We're targeting completion of the entire separation within 18 months, and taking this preferred path should result in a tax-free impact to Medtronic shareholders for U.S. federal income tax purposes.

From a financial standpoint, there are several benefits to Medtronic. Diabetes has lower gross margins and operating margins than overall Medtronic, so upon full separation, we're expecting our adjusted gross and operating margins to improve by approximately 50 and 100 basis points, respectively. Given the share retirement, this separation is expected to be immediately accretive to Medtronic EPS upon completion. We don't expect any change to our dividend policy. Financially, there are some clear short-term financial benefits, but the most important aspect is what Jeff mentioned earlier. This separation will allow us to increase our growth-accretive investments in our core businesses where margins are structurally higher. This is all about capital allocation and creating the conditions to fuel our future growth. Clearly, this separation will be beneficial for both Medtronic and the new diabetes company, unlocking both strategic value and shareholder value.

With that, let's now come back to Medtronic overall and recap our Q4 results. As Jeff mentioned earlier, Q4 revenue of $8.9 billion grew 5.4% organic. On the bottom line, adjusted EPS was $1.62, up 11%. Both revenue and EPS were ahead of expectations, driven by outperformances in CRM, structural heart and aortic, diabetes, and neuromod, among others, along with better-than-expected interest and tax expenses. Our revenue growth was broad-based from a geographic perspective. We grew 5% in the U.S., our strongest quarterly U.S. growth in 15 quarters, as we accelerated on the strength of new technology. Japan grew high single digits, and Western Europe and emerging markets grew mid-single digits, with strength in India, Southeast Asia, and Eastern Europe.

Moving down the P&L, our adjusted gross margin was 65.1%, down 70 basis points year over year as a result of mix from diabetes and CAS, as well as foreign exchange. Our gross margin was actually unchanged on a constant currency basis. On the positive side, we continue to see the benefit of increased pricing, in particular in areas where we introduced new products such as neuromod, CRM, and structural heart, and we continue to improve our ability to offset effects with price in emerging markets. This quarter, again, the savings from our COGS efficiency programs more than offset the impact of inflation. Our Medtronic performance system, which we implemented across our manufacturing network, resulted in high single-digit improvement in labor efficiency. We insourced three of our distribution centers to drive cost savings and further improve supply. Finally, we were able to significantly reduce our scrap and obsolescence charges.

With SG&A, we drove significant leverage, particularly with G&A, while at the same time increasing investment in R&D. More to come on that later. The net of this was leverage on our adjusted operating profit line, which grew 7.6%, or $175 million. Our adjusted operating margin was 27.8%, an increase of 90 basis points, or 200 basis points on a constant currency basis. Below the operating profit line, our adjusted tax rate of 16% was better than expected due to favorability in our actual jurisdictional mix of profits for the year, which also resulted in a modest pickup from prior quarters. All in all, as stated in Q4, we delivered EPS of $1.62, up 11%, and 16% at constant currency. This was a strong close to the year, where in fiscal year 2025, we grew revenue 5% organic and EPS 6%, or 10% on a constant currency basis.

From a capital allocation perspective, we returned $6.3 billion to shareholders in 2025 through share repurchases and through our dividend. This morning, we announced that we're increasing our dividend for the 48th consecutive year. Now, let's move to our 2026 guidance. We've now delivered mid-single digit organic revenue growth for 10 quarters in a row, and we expect this to continue through fiscal year 2026 with an increasing contribution from our key growth drivers. We expect organic revenue growth of approximately 5% in fiscal year 2026, including 4.5%-5% growth in Q1. Based on recent FX rates, we would expect a tailwind from FX of $0-$100 million in the total year, with a roughly neutral impact in Q1. Moving down the P&L, I'll first talk about our underlying business, excluding the impact of tariffs.

Like we saw in the fourth quarter, we expect continued mixed headwinds within gross margin from CAS and diabetes, with an increasing impact from diabetes as we are early in the manufacturing ramp of the Simplera sensor. We will continue to drive pricing discipline, in particular on the back of new product introduction and to cover FX. We will also accelerate our COGS efficiency programs to significantly outpace inflation. Given my background, this will be a key area of focus for me, together with our businesses and Greg Smith and our global supply chain team. In fiscal year 2026, we will significantly increase investment in our growth drivers to maximize future growth. For the first time in four years, we're planning to grow R&D faster than revenue. We will also invest in sales and marketing.

These investments will be deliberately focused on areas like cardiac ablation, as well as in surgical robotics and RDN, as we prepare for scaling the U.S. launches of our Hugo robot and Simplicity hypertension procedure. On the flip side, we do expect to drive significant leverage with G&A expenses. The net of this will be an operating profit line that grows materially faster than revenue. Below the profit line, we're expecting increases in both interest and tax expense, which combined results in a 300 basis points impact on EPS growth. On the interest, this is driven by the fact that any debt we refinance will likely be at higher rates given the current higher interest environment, whereas the pressure on the tax side derives primarily from the effects of Pillar II.

This leads to our expectation for approximately 4% EPS growth in fiscal year 2026, excluding the impact of tariffs, and foreign exchange is a neutral impact to fiscal 2026 at recent rates. For Q1, we would expect EPS in the range of $1.22-$1.24, which includes minimal expected impact from tariffs and a 1%-2% headwind from foreign exchange at recent rates. Next, I'll share with you our thinking on tariffs, which we laid out in our earnings presentation this morning. We built our expectations based on two potential scenarios. The low end of the potential impact assumes that the current bilateral U.S.-China tariffs that are in place during the 90-day pause remain throughout fiscal year 2026, while the high end assumes that they resume at the higher levels following the 90-day pause.

Through focused efforts from teams across Medtronic, we already have visibility to offsetting a good portion of this headwind, and we have high confidence in our ability to execute additional mitigation efforts. As a result, we forecast a net tariff impact to COGS in fiscal year 2026 of approximately $200 million to $350 million. From a quarterly breakout, we would expect minimal impact in Q1, as I mentioned earlier, and then approximately 10% in the second quarter and approximately 30% and 60% in Q3 and Q4, respectively. All that said, it's highly likely that the impact from tariffs will change and we'll keep you updated periodically as we go through the year. Combining our underlying performance with our current tariffs expectations, we would have you model fiscal year 2026 EPS in the range of $5.50-$5.60.

We've shown you that we can deliver high single-digit EPS growth, as we did with the 9% growth in the back half of fiscal year 2025. As we look beyond next year to fiscal year 2027, we expect to return to high single-digit EPS growth upon the diabetes separation, driven by several factors, including strong revenue growth and further underpinned by FX tailwind at recent rates and the margin and share retirement benefits of the separation. Jeff, back to you.

Geoff Martha (Chairman and CEO)

Okay, thank you, Thierry. Now, before we go to Q&A, I'll make a few closing remarks, starting with that we had a strong close to the fiscal year with two and a half years of mid-single-digit revenue growth that is now also translating into strong operating profit and EPS leverage.

We have durable growth drivers that are taking hold, and we also have a clear line of sight to improving growth drivers in other businesses. For example, peripheral vascular, where we're working with Contigo Medical in the carotid market, and we will soon enter the peripheral thrombectomy segment as well. In pelvic health, we are working to open a large new market when our revolutionary tibial stimulation device is approved. As for Hugo, procedures annualization are growing, and the cadence of key milestones is accelerating. We're also working aggressively to manage external factors that are impacting our 2026 guide. As Thierry pointed out, we'll be back to high single-digit EPS growth in 2027. As I assess the overall business, the underlying fundamentals are strong, and they are getting stronger. We've been working on a number of changes to the company, and those changes are making a difference.

We streamlined the operating model and implemented performance-driven incentives. We brought in outside leadership with creative skill sets, which are enhancing execution and improving operating rigor. We prioritized investments in groundbreaking innovation that are now paying off and accelerating company growth. We centralized global operations, supply chain, and quality, resulting in improved KPIs. We are adding a performance culture to this mission-minded company and transforming our portfolio. Today's diabetes announcement accelerates our speed of travel to higher profitable growth, aligned around our core strengths, giving all of our stakeholders increased conviction in our ability to deliver. I want to thank our employees around the world who are listening today. You've truly embraced our culture, our culture of driving both our Medtronic mission and performance.

This is directly leading to our strong financial outperformance, and it's making a difference for the millions of people around the world that depend on Medtronic to alleviate pain, restore health, and extend life. We've made a lot of progress this past year, and your efforts have laid the groundwork for the inflection point that we're now entering. I couldn't be more excited about what we're going to accomplish here in the new fiscal year. Thank you for your dedication and service. Finally, as you may have seen in our earnings press release this morning, Sean Salmon is moving on, and this will be his last earnings call with us after more than 20 years of service to Medtronic. Sean has been responsible for leading a number of our successes.

He leaves a legacy of having developed strong, capable leaders in our cardiovascular businesses, as well as a robust technology pipeline, both of which are responsible for driving the CV growth acceleration you saw this quarter. Sean departs with our cardiovascular portfolio in a leading position. To lead CV going forward, we're promoting Skip Keel. You've seen Skip's impact in driving above-market growth in our cranial and spinal technologies business. He had success in other parts of MedTech prior to joining Medtronic. Skip will augment our deep CV leadership team with his strategic mindset, broad global expertise, strong customer focus, and demonstrated track record of developing new markets and driving commercial success. I want to thank Sean for his service, and we're looking forward to Skip leading our continued success in cardiovascular.

So with that, let's move to Q&A, where we're going to try to get to as many analysts as possible. 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. Wynne, can you please give the instructions for asking a question?

Operator (participant)

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

For today's session, Jeff, Thierry, and Ryan are joined by Q 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.

Hello? Hello? Oh, hey, this is Travis. I didn't hear anything. Thanks for taking the question. I wanted to ask on, first of all, congrats on all the good news this morning. I wanted to ask on the guidance philosophy with the new CFO. Thierry's confident enough to put out the 5% no range. What's being assumed on the pipeline on the revenue side? I wanted to ask on the 4% EPS growth ex tariffs.

Curious how you're thinking about what you kind of built in on conservatism on some of the below-the-line items there, and if it's possible to offset some of the headwinds over the course of the year if the revenue comes in better. And then on FY2027, the high single-digit EPS growth, maybe talk about the framework and the visibility to be able to go ahead and kind of give that two years ahead that you can kind of get to the high single-digit EPS growth on FY2027.

We're not hearing anything if someone's responding.

They said I had the first question.

I think all our mics are open, Travis. It's Larry. Okay. It was a good question.

It's a great question. Yeah.

This is all mindfulness minute, just to relax. Waiting for the answer.

Good morning, everyone. This is Danielle. I have an answer for you. Just kidding.

Danielle, your mic is live. Everyone can hear you.

So is yours, Larry.

How do you know it was Larry?

Because you have a very distinct voice, Larry. This is all being taped and everyone can hear it.

Geoff Martha (Chairman and CEO)

Should we log off and log on?

No. Let them fix it.

No.

It should be up. It says go again.

All right. You should be up. Go ahead.

Okay, Travis, can you hear me now?

Yes, go ahead.

All right. Hey, I got some—Okay. [crosstalk]

Travis, are you there?

I can. Can you hear me?

Okay. Yeah. So we got your question. Sorry about that. There was some sort of connection issue here, but I got your question. I am going to—first of all, good question, as Danielle pointed out. I will take the first part of it and then hand it to Terry to go through the earnings stuff.

On the growth side, look, we're very bullish on the growth drivers. Even in Q4, in the markets that we're in and the growth drivers that we have. Even in Q4, our markets grew 7% even without diabetes. We've got strong positions in these markets, and we see growth from our big three portfolios to be mid-single and then some. We're running the company at higher expectations than we're guiding here. Just some examples. I mean, you see our CV business accelerating to 8% with nearly 30% growth in CAS, which added—that alone added 70 basis points to the company growth. That's without Ardian. I mean, Ardian will start ramping through 2026. You got Neuroscience with double-digit growth and Neuromod. Look, CST, what can I say? I mean, it's just separating itself from the pack. We've got Tibial coming in pelvic health.

We have got some growth drivers there. Of course, in surgical, Hugo, as we talked about in the commentaries, is building momentum. We will start to have more of a meaningful impact on MedSurge next year and then beyond that on the company. We are bullish about the markets that we are in, the positions we have in those markets, and our growth potential. That is what is baked into the next year's guide and going into 2027. I mean, we are at the early stages of these growth drivers with more to come. On the earnings, I will turn it over to Terry. Anything else you want to add on the growth?

Thierry Piéton (Executive VP and CFO)

No, thanks. I think, Jeff, you were pretty complete on the growth. We feel comfortable that we have got a good opportunity from a growth perspective.

From a profitability standpoint, what the construction has, as you may have seen in the details that we've given in the commentary, is actually still getting quite a bit of leverage before tariffs at the operating profit level. We've got a construction that has operating profit that's growing around 7%, significantly in excess of revenue. That's despite making a significant investment for the future of the business here. I mentioned it in the commentary. For the first time in four years, we actually have a plan that has R&D growing quicker than revenue. That's even with revenue up 5%. Our R&D spend should be increasing around $200 million next year, which is about 7% versus the 5% growth rate. Despite that, we have significant leverage at the upper profit level.

To your point, we've got a couple of pressure points below the line. One is around the tax rate, and that's primarily driven by Pillar Two. Our tax rate should go from about 16.7% this year to about 18% next year. As we refinance our debt in a higher interest rate type of environment, that also puts some pressure. We lose about 300 basis points between the upper profit level and the net. On the opportunity to do better, hey, look, first of all, operationally, we're, as usual, going to drive the teams to a higher number than this, whether it's from a growth perspective or from a margin standpoint. On the margin side, given my background, this is going to be a key area of focus for me. My initial view is that there is some opportunity from a cost perspective.

I think the supply chain team with Greg has kicked off a lot of very positive initiatives, and we're starting to see the results. I think there's more to come. I'll be focusing on that deeply. On the below-the-line items, sure, on the tax front, we'll keep working it. Some of the increase between 2025 and 2026 is due to the temporary safe harbors that we've got in Pillar Two. There's uncertainty in terms of our ability to qualify for some of those safe harbors going into next year. We'll do everything we can to secure being able to capture that opportunity. Sure, we'll be working on it. Look, we've tried to give the guidance that's all in, and we'll work from there.

That's helpful. Just a quick follow-up.

You also had a part of the question on 2027.

Sorry, I wanted to address the 2027 part of the question. Hey, look, as Jeff mentioned, the growth is not a one-off thing in 2025 or in Q4 2025. It's going to carry into 2026. Some of the new products that are carrying this are going to carry us well into 2027. Jeff mentioned CAS and Ardian and Tibial that will start having a small impact towards the end of 2026 and will carry into 2027. First, we expect to continue to have good growth into 2027, and that's regardless of the separation of the diabetes business. Just to give you some clarity on that, diabetes drives about 40 basis points of our growth. We're comfortable. We could still achieve the mid-single-digit growth even after the diabetes separation. We'll continue to drive the cost-out initiatives, as I mentioned earlier.

Effects should start turning into a small or a headwind towards the end of 2026 and into 2027. The last item I wanted to mention is we'll probably talk about it more in detail in the rest of the conversation. The deal that we're—the structure that we're taking on the diabetes deal actually provides us the opportunity to retire some shares. This will be immediately accretive to our EPS and help strengthen the construction to get back to high single-digit growth into 2027.

I just wanted a clarification there on the effects. On the effects, it flips to a tailwind.

Oh, did I say headwind? Yeah, sorry. Tailwind. Tailwind, sorry.

Geoff Martha (Chairman and CEO)

Yeah, tax on your mind. That's headwind. Effects flips to a tailwind.

Is the 7% operating profit—

Thanks for the question, Travis. Yep. Go ahead.

I was going to ask, is the 7% operating profit, including or excluding tariffs, is there an extra week this year? And then why is there a diabetes EPS headwind this year if it's 18 months away? Those are just a few quickies.

Thierry Piéton (Executive VP and CFO)

Yeah, the 7% is excluding the impact of tariffs. The impact of tariffs, again, as you probably saw in the commentary, is $200 million-$350 million of cost at the cost of goods sold level. From an impact on the operating profit growth, I guess it's something between 2.2 and 3.2 percentage points, depending on the outcome on China. The pressure on diabetes, I think it's primarily driven by the rollout of Simplera. It's the launch of this product. As we grow it, the cost is going to go down.

Initially, it does put quite a bit of pressure on our margin rate to the tune of about 60 basis points at the GM level, which will translate into the earnings. Again, that will get better as the manufacturing ramps up.

Helpful. Thanks a lot.

Okay. Thanks, Travis.

Geoff Martha (Chairman and CEO)

Let's take the next question, please, Gwen.

Operator (participant)

We'll take the next question from Robbie Marcus at JP Morgan.

Robbie Marcus (Managing Director and Senior Analyst)

Oh, great. Good morning, everyone. And Terry, welcome. Maybe a question for you, and I'll just have one. You said you'll be back to high single-digit EPS growth in fiscal year 2027. That's with assuming currency remains the same and favorable, and you execute the diabetes spin and resulting share buyback, which aren't really quite sustainable in nature. Without those benefits, which are kind of one-time, would fiscal 2027 EPS still grow high single digits? Thanks.

Thierry Piéton (Executive VP and CFO)

Hey, look, I want to insist on the fundamentals here. I think the first thing to look at if you think about the construction for 2027 is to come back to the performance that we're showing for Q4 here and for the second half of the year. This is with no FX tailwind and with diabetes in the portfolio. We just delivered a quarter that's up 5.4% organically on revenue. That has operating margin up 90 basis points, which is 200 basis points if you actually exclude FX. We've got EPS that's up 11%, which is really 15.8% if you exclude FX. That earnings growth is actually 9% in the second half of the year. That's the fundamentals of the business that we're trying to build on.

Now, back to 2027, as I said, we're looking at a growth rate that should continue to be positive with all the momentum that Jeff mentioned. We're going to continue driving the leverage on the cost side. Here you see some signs of improvement that are pretty significant from an operating profit perspective. We're going to continue to work on that. FX, we're just assuming that it's flat. We're not assuming that it improves. The tailwind that I mentioned on 2027 is just the effect of the carryover of the goodness that we'll have based on the current FX rate. You're right, there should be some accretion that comes from diabetes from the separation. That's going to help. The target that we have for the teams is to deliver on the framework regardless of the transaction.

Robbie Marcus (Managing Director and Senior Analyst)

Great. Thanks, Thierry. Appreciate it.

Geoff Martha (Chairman and CEO)

Thank you, Robbie. Take the next question, please, Gwen.

Operator (participant)

We'll take the next question from Larry Biegelsen from Wells Fargo.

Larry Biegelsen (Managing Director and Senior Analyst)

Good morning. Thanks for taking the question. So Jeff, I wanted to focus on the decision to spin diabetes. I guess a couple of questions. One, did you consider breaking Medtronic up into four separate businesses? One could argue that the remaining three businesses have scale on their own and have different customers and capital allocation requirements. Why not go further in breaking up the company? The pushback you think you're going to get on diabetes is that it's growing above Medtronic's corporate average. Why spin it off if your focus is on accelerating top-line growth? Thank you. Look,

Geoff Martha (Chairman and CEO)

yeah, good question, Larry. Why diabetes? Why now?

First of all, on the diabetes business, like I said earlier, we believe this is a win-win for both diabetes and Medtronic. On diabetes, we're well down the path of the turnaround. It's ready to stand alone. We think it's well-suited for public markets. This move is going to ensure that they get really both the funding and the focus the franchise needs to reach its full potential. As much as we're sitting here today, much progress as we've made. We talked about six quarters in a row of double digits. There's more to come here. The product pipeline is very robust. We submitted several files to the FDA for approvals on multiple products here in the last couple of months. We believe with this focus and funding, the business will be a top-tier diabetes franchise well into the future.

For Medtronic, though, it allows us to focus more on our high-margin growth drivers that we just walked through. Like I just mentioned, even without diabetes, we're in great markets. 7% growth last quarter, stable. These are higher-margin sectors for us. This accelerates our speed of travel to these high-margin growth areas. It is aligned around our core strengths of the company, not technology strengths, as well as our go-to-market channel to healthcare systems. We think it's a win-win. It's going to create shareholder value short and long-term. Thierry walked through the accretive nature of the deal, accretive to our EPS, our operating margin, and gross margin. I think I don't want to speculate, but I think the diabetes business is probably worth more outside the company than in.

Then back to Robbie's point, I mean, yeah, it'll provide a kind of a one-time step-up in margins. The whole idea, to Terry's point, is that we're growing them from there and getting to that. You saw a little bit of that in the last two quarters. We're going to continue to do that once we get through some of these below-the-line issues. That's it. The rest of the company, we believe, I said, are—you’re right. They do have scale. We think it's better together. There's a lot of synergies. We've got really robust growth drivers across all three of those portfolios of businesses.

Larry Biegelsen (Managing Director and Senior Analyst)

All right. Thanks so much.

Geoff Martha (Chairman and CEO)

Thank you, Larry. Next question, please, Gwen.

Operator (participant)

We'll take the next question from Vijay Kuma from Evercore.

Vijay Kumar (Senior Managing Director and Head of Equity Research)

Hey, guys. Thanks for taking my question.

Jeff and Terry, maybe one sort of on the earnings and margins kind of question. You look at the guidance of 4% EPS growth, ex-tariffs, right? Q1, I think it's implied as flat-ish earnings growth. Why is earnings growth back-loaded? Is this a mix impact on margins? I think Q4 gross margins came in below. Was there a product mix issue? And Jeff, sort of when you look at the earnings algorithm, can you commit to EPS growing above revenues irrespective of the FX environment? Thank you.

Geoff Martha (Chairman and CEO)

Terry, you want to take the first part there?

Thierry Piéton (Executive VP and CFO)

Sure. Look, I think the question is, why is the construction back-loaded? I think in the first quarter, a couple of things I would say. First, it's always a bit lower from a revenue perspective than the fourth quarter and the rest of the year. That generates lower absorption from the factories, etc.

We typically have a dip between the first quarter and the rest of the year. The second element, which I think is important this year, is, as I mentioned previously, we're investing in the growth areas, both in R&D for cardiovascular, for CAS, for Ardian, and also in sales and marketing to make sure that we capture the opportunities of growth that are provided by these areas. In Q4, what you're going to see is a bit of that investment ahead of the return from a growth perspective. The growth in Q4 is slightly lower than the average of the year. We're looking at roughly 4.5% growth versus the 5% on the full year. We're invested ahead and investing ahead, and we'll reap the benefits of that towards the second half.

The final element is there's a little bit of FX headwind into the first quarter that will turn into a tailwind towards the rest of the year. That kind of explains why we have better performance towards the backend.

Geoff Martha (Chairman and CEO)

Your question on the leveraged P&L, leveraged EPS growth, regardless of FX, I think that was your question. First, just getting to Thierry's point, just one more point is I do not think it is as back-end-loaded as last year. We did end up hitting—I remember a year ago, we put out guidance that had the back half of the year growing quite a bit. There was some skepticism from the fall. We did end up hitting on the higher end of that guidance across the board. I just want to point that out. To your other more strategic question, the answer is yes.

FX over the years, as you guys have—we all always dogged us a bit. Yes, we believe, and the economists that we're talking to, which is quite a many, is that FX is going to be a tailwind for us for the next couple of years. That being said, what we're doing here is underlying in the operations of the company is creating natural hedges and lowering our exposure to FX through a number of different areas, including something we've already really made a lot of progress on, is dynamic pricing in countries that are serial, where the currencies are devaluating on a consistent basis. That has had a fairly meaningful impact, positive impact for us.

In addition to that, and expanding that to other countries around the world, paying our teams on kind of actual FX basis, we are making some structural changes that just lower our overall exposure to FX. You combine it with our hedging program, I think it's a good formula. We're putting in place natural hedges. The answer is yes.

Thierry Piéton (Executive VP and CFO)

Hey, I just wanted to give some incremental color maybe to give visibility on the gross margin side. What we're seeing in Q4 and what we'll see for a part of 2026 is really two things that are offsetting each other. We do have a negative impact coming from mix. That's about 80 basis points. It's a combination of CAS and diabetes. That mixed impact is offset by the progress that we're making from a pricing and from a cost standpoint, right?

The progress we're making on pricing and cost, that's going to carry forward. I'm going to be focusing on what I can do to help accelerate that. The mixed effect on CAS and diabetes. Look, the diabetes part, I guess, will be addressed through the portfolio move that we're making. It's not why we're doing it, but it will help. The CAS impact on mix actually translates into good news at the operating profit level, number one. Number two, some of it is driven by the fact that right now, a lot of the growth is done on the capital equipment sales. We're shipping capital equipment first, and the catheters will come after.

The fact that the mix within CAS is towards the capital equipment is actually good news for the future because as we increase the catheter sales, that's going to alleviate a big portion of that mixed effect. The dynamic you should see is the mix getting better and the cost initiatives hopefully accelerating. I hope that gives some additional color on why we should be able to continue to leverage.

Vijay Kumar (Senior Managing Director and Head of Equity Research)

Very helpful. Thank you.

Geoff Martha (Chairman and CEO)

Thank you, Vijay. Next question, Gwen.

Operator (participant)

We'll take the next question from Joanne Wentch from Citi.

Joanne Wuensch (Managing Director and Senior Equity Research Analyst)

Good morning. Congratulations on all the news this morning. I want to pivot here a little bit to products. I was curious about your commentary regarding the preparation that you and you're seeing hospitals do for renal denervation and reimbursement.

If you could just sort of share a little bit more about what you're seeing, that would be fabulous. Thank you.

Geoff Martha (Chairman and CEO)

Sure. Maybe I'll call on Sean for that one.

Sean Salmon (Executive VP and President of the Cardiovascular Portfolio)

Yeah, certainly, Sean. Thanks for the question. As you imagine, our focus has been about opening centers that are getting ready to take on this new service line. That involves making sure that we train physicians how to do the procedure, of course, and educate them on coding and billing for the current fee-for-service Medicare patients. In addition to that, of course, with the NCD in the frame, that's going to open up a lot of patients.

Really, it's about focusing as they build a service line, making sure they are able to work the patients up, rule out secondary causes of the disease, and then get them appropriately to the cath lab for renal denervation, which they perform safely. There's a lot of enthusiasm, as you can imagine, from customers who are looking for new service lines to grow their practices and absorb their cath labs. It's really about that. It's training, education, and support for their programs as they build that up. Now, upon getting reimbursement, there's more to do to activate patients more directly. We will channel those patients to a physician finder in geographies where patients can then find their way to the treatment. As you probably recall from the clinical trials, a large proportion of our patients were self-referred by using social media tools.

It is a very efficient way to recruit patients to the effort. Of course, we want to do that when all the reimbursement barriers come down. That is what we are hopeful for as we move forward into the NCD.

Joanne Wuensch (Managing Director and Senior Equity Research Analyst)

Thank you. If I could do a follow-up, how do you think about this revenue ramping? You sort of paralleled it to PFA adoption. I just want to sort of get expectations set of how to think about that. Thank you.

Sean Salmon (Executive VP and President of the Cardiovascular Portfolio)

Yeah, Joanne, I think that is a very different thing, right? PFA is replacing an incumbent procedure. This faster, safer procedure that appears to have just excellent efficacy is really a pretty easy switch. It is not so difficult to train on our tools and techniques for that. This is a little bit more involved, of course, because there are other reasons why people have high blood pressure.

You have to sort those causes out to get patients into the service line. It is a longer ramp, but it is a long annuity. This is a massive patient population, as you know, and be able to build that practice. I think you have to think about this as one of those really important durable growth drivers for the company that will set us up well for a lot of success for a long time.

Geoff Martha (Chairman and CEO)

Yeah, just to build on that point, Joanne, to build on that point that Sean is making, the larger health systems around the country, I mean, not just the larger ones, but a lot of them are really proactively calling us for partnerships around hypertension, building these clinics, a lot of them virtual, some not, and establishing these patient pathways with us, jointly investing.

This is going to be a big one for us for a long time. Of course, we're going to continue to invest in the innovation around this too. Thank you, Joanne. Next question, please.

Operator (participant)

We'll take the next question from Matt Taylor at Jefferies.

Matthew Taylor (Managing Director and Senior Equity Research Analyst)

Hi, thanks for taking the question. I was wondering, actually, if you could expound on some of the pipeline ideas that you had for diabetes and about their differentiation and timelines, if you can.

Geoff Martha (Chairman and CEO)

Sure. I will hand that one off to Q.

Que Dallara (Executive VP and President of Diabetes)

Yeah, thanks for the question. I start with a recent approval of Simplera Sync in the U.S. We're ramping that. We're going to be launching that in a limited fashion in the fall. In Europe, that product has already launched commercially.

Just to give you an idea of the volume ramp versus last year, we expect to ramp our volume at least five times what we did last year. We have not really begun to see the potential of Sinclair on the business yet. We have submitted for an ACE pump and IAGC algorithm to FDA in April. We are ready to launch that, working very well with Abbott to make that happen. We are ready to launch soon after we receive clearance on that. That is our CGM option. It is going to address a lot of the Achilles heel of our current CGM lineup. We also have multiple insulin options. We have InPen in market today, our next-generation durable pump. We expect to submit by the end of this fiscal year. Following that, the patch will follow after that.

What you can see in the lineup is significant improvement to our form factor. That is feedback we have been given. That makes it more wearable with all these pumps having phone control, which is a feature a lot of our customers have asked for. In addition to that, we have our third-generation closed-loop algorithm that we believe will be a very exciting development in terms of burden reduction while driving the clinical outcomes that people expect from us. When you look at the total ecosystem, I would say a couple of things. One, the form factors are completely upgraded. Not only that, we have completely re-architected the software, including the algorithm that drives everything. You can see the wearability of the entire system.

It is not talked about in the product itself, but when you think about the burden of diabetes management, there is something very attractive in burden reduction that patients have to only deal with one company, especially when things go wrong. Our tech support and our customer service, not just for patients, but also physicians, is also a differentiator.

Matthew Taylor (Managing Director and Senior Equity Research Analyst)

Great. Thank you very much.

Geoff Martha (Chairman and CEO)

Okay, thanks, Matt. Gwen, we have time probably for three more.

Operator (participant)

Okay. We will take the next question from Matt Nixick at Barclays.

Matt Nixick (Analyst)

Hey, thanks so much for taking the question and congrats on the strong finish here. Just to make sure you understand the operating line growth, 7% with about 300 basis points, getting you back to 4% EPS growth for the full year. That is inclusive of all the investments that you are talking about. That's inclusive of the sort of gross margin headwinds around investments and so on, just to be crystal clear. Is that right?

Thierry Piéton (Executive VP and CFO)

Yes, that's correct. But it's before the tariffs impact, right? Just to be clear. Again, the tariffs impact are about 3.2-3.2 points on that.

Matt Nixick (Analyst)

Right. Congrats on that leverage. I mean, I just take a minute to, I know it's been difficult getting growth of EPS above sales with other headwinds and so on. Getting that operating line growing. On tariffs, you mentioned high confidence in getting to the mitigations you've described, opportunity to take those further.

If I could drill down a bit on the spine business, just get a sense of above-market performance, where if we were to sort of like-for-like spine growth comparing to your pure play peers, where do you see your growth? Where do you see the market? Any color you provide on that would be great as well. Thanks so much.

Geoff Martha (Chairman and CEO)

Sure. Yeah. First of all, thanks for acknowledging the proper growth. We did, like I said, 8% in Q4, and the guidance for next year is 7%. If you take out the diabetes, that would go to 8%. We built that muscle, and that's going to continue. In terms of the spine business, again, the markets, I would say the demand is there. The markets have been stable. Technology is a differentiator here, and it's pretty extreme.

If you go back over the last couple of years, you're seeing a number of our competitors tap out because of the investment and expertise it takes to build out the capital equipment, the enabling technology strategy around this. We've got a big lead here. Like I said in the commentary, the dynamic that we're seeing by us taking this portfolio of enabling technology and integrating the workflow, we've gone from a product story to a solution story. We brand it AI-enabled technology. As our customers are upgrading, they're upgrading from a product to a broader ecosystem. It's not a linear upgrade. It's more algorithmic. That's giving us, and that is a durable advantage. We're seeing the market growth is stable. We're seeing our competitive advantage growing. You've seen a bunch of our competitors tap out.

Like I said, you see our probably primary competitor this quarter put up some results that we'll see where it goes from here. There is a pretty big difference between us and them this past quarter. We'll see where it goes from here. We're feeling good about spine. It's something that Brett's been highly involved with and leading along with Skip. I mean, Brett, would you like to comment on this?

Brett Wall (Executive VP and President of the Neuroscience Portfolio)

Yeah, sure, Jeff. And Matt, thanks for the question. We're just seeing, as Jeff said, good stable demand. The ecosystem is driving that. If you look at our enabling technology growth this last quarter, it remains very attractive, very strong. We just see that stability continuing. It's an attractor for not only customers. We're seeing large-scale, important academic centers come to Medtronic for this.

We're also getting very good response from other sales reps and other individuals that want to join Medtronic. We are comfortable with how this is moving forward.

Geoff Martha (Chairman and CEO)

I just think I'm glad you asked the question, Matt, because we talk a lot about PFA and RDN and robotics. A key part of our growth story is the rest of the company. We talked about CST, or our spine business, CRM, high single-digit quarter there, strong growth from leadless, conduction system pacing, EVICD. Again, these are durable growth drivers for us that are going to go out.

The other thing we mentioned in the commentary, some of the slower-growing parts of the company, we have plans for, like peripheral vascular as we enter the carotid space with Contigo and enter through an organic program into thrombectomy, taking some technology from our neurovascular business to get into that space. We have things like public health, which I think is going to surprise people with the growth there once we launch this tibial system. We think that is going to be very disruptive. We do not see a real answer from our competitors. The growth story is pretty broad at the company. It is not just the lightning bolts of PFA and RDN. Thanks for the question. Thanks, Matt.

Two more questions, please, Gwen.

Operator (participant)

We will take the next question from Danielle Antalfi from UBS.

Danielle Antalfi (Senior Equity Analyst)

Hey, good morning, guys.

Thanks so much for squeezing me in here. I'll echo everyone's congrats on all the news this morning. Just a quick question to clarify on some of the commentary around PFA, obviously a really important growth driver. I think you talked about reaching $2 billion in sales, so essentially just about doubling. I'm just curious how to think about the ramp from just over $1 billion to $2 billion in that CAS business. I mean, is that something that, based on your commentary, it seems like that's more near-term versus long-term, but anything you can add there as far as how we think about getting from that $1 billion to $2 billion? I mean, one of your competitors that was first to market here or close to, I mean, you guys came to market about the same time. Sorry about that. They ramped pretty quickly.

Just curious if you could give any more color there.

Geoff Martha (Chairman and CEO)

Yeah, no, they did. They ramped really quickly. I think we feel very good about our product portfolio here in PFA. What we are seeing right now is just an incredible demand for Affera. We have to get those capital systems out there, which we are doing. You get these high-volume centers, they get one. Like I said, I spent the last couple of weeks, I would say 80% of my time or so has been on PFA, just going to Heart Rhythm Society meeting, and then a trip to the Northeast United States, just meeting with the leading centers. The dynamic we are hearing is they get the one Affera system, and then there is fighting over that system amongst the different EPs at these systems. Now they are getting their second Affera system.

The catheter sales built from that. Again, once you get the installed base, it's not linear. The systems are getting this technology. They're not being held back by capital constraints. If that is an issue, we have opportunities here through contracting to eliminate that friction. Our supply chain has really ramped, right? We bought Affera. It's a super innovative technology. We had to spend quite a bit of time innovating the manufacturing process because that wasn't really designed in with the acquisition. That's up and running, and we're scaling that, and we're really happy with that. You've got a nice robust demand, a robust pipeline. Like I said in the commentary, the only thing that's more exciting than our Sphere-9 catheter out there right now is Sphere-360.

That goes right at the heart of the competition, right at them. We have PulseSelect, which is not under any kind of supply constraints. It gives centers around the world an option and a way to blend their pricing as well. Especially in the global areas where the resources are not as much, you have PulseSelect, a very good system, high quality, very safe, and it is not priced where the Affera is. What I would say is that we strongly believe in doubling the business. We did not put a specific time frame on it, but it is not far off. I mean, it is not far off. I would say it is more near-term, the next couple of maybe I do not know if it will exactly happen in the fiscal year, but we are in that ballpark and really excited about it.

Danielle Antalfi (Senior Equity Analyst)

That is so helpful. Thanks so much.

Geoff Martha (Chairman and CEO)

Thank you, Danielle. Let's take the last question, please, Gwen.

Operator (participant)

Our last question comes from Shagun Singh at RBC. Great.

Shagun Singh (Senior Equity Analyst)

Thank you so much. So a couple of follow-ups on the CAS business. Impressive growth. Can you talk about the mix of cryo? It seems like it's becoming less and less of a headwind. Any color on pricing there? And then on RDN, any updated thoughts on what patient subset you think you could get coverage for? Thank you for taking the questions.

Geoff Martha (Chairman and CEO)

Sean, do you want to take the first shot at this one?

Sean Salmon (Executive VP and President of the Cardiovascular Portfolio)

Sure thing. Check it. So first of all, on CAS, cryo will become less and less a part of the mix, but I think that rate of decline will slow. That will really aid in the growth of that business going forward.

It's still a really valued tool, and particularly in places that don't use general anesthesia and are more cost-constrained. It really is holding up very, very well. I think it hits kind of a near and a dear, and it'll stay there. We'll have growth on top of that. With regard to your question on what we're expecting for coverage or the population of patients, I think what I'd just say is I will front-run the CMS decision-makers here, but what we've been presenting to them is what is the evidence and what are the guidelines and professional society saying. Those really track pretty closely. To meet the standard of reasonable and necessary for CMS, I think it's going to be very close to what we've studied and what's being recommended by the guidelines.

That would be patients that both are not able to control their blood pressure despite lifestyle medications, but also those patients that are unable to take medications due to side effects and such. I think relatively broad. We will find out soon enough in July. I think just following that evidence and expert opinion and the commentary that was collected in the public commentary period will lead to that decision.

Shagun Singh (Senior Equity Analyst)

Got it. If I could just squeeze in one last one, just your strategy around portfolio management. I think, Jeff, at some point, you had indicated that you are committed to areas where you can build an ecosystem, and diabetes was one of those areas. You are now looking to separate that. Just how should we think about your portfolio management strategy going forward? Thank you for taking the questions. Sure.

Geoff Martha (Chairman and CEO)

I mean, look, as I said before, it's a continuous process. We've been at it. We're going to stay at it. Diabetes isn't an end. We exited ventilation for different reasons. We exited ventilation. We exited our LVAD business. We exited dialysis. And now diabetes. It really comes down to where do we have these secular growth opportunities along with a financial profile like higher margins that works for us where we have core strengths. Those four, they're different degrees, but I think there's other stuff inside the company that is a higher degree of higher margin growth and aligned around our core synergies and capabilities. That's what's really driving it. We like where we are. Like I mentioned before, we're in high-growth markets. We'll continue looking at the portfolio. I want this to be both additions and subtractions.

We want to do more deals. I think the fundamentals of the company are the best I've seen them in my nearly 14 years here. We are the markets that we're in, the technology that we have, our operational, how we're executing operationally. We're at a point now where I would like to turn up the heat on some tuck and M&A to support these strong market positions. That's part of the portfolio piece. On the divestiture side, I just talk through that. It's an ongoing process. On that note, just seeing some of the chatter back and forth here, on the diabetes deal, I do want to clarify the mechanics of it a bit and how this transaction will work because it is unique and has unique benefits for Medtronic. Terry, could you just hit on that before we?

Thierry Piéton (Executive VP and CFO)

Sure. Yeah. Thanks, Jeff. Look, the preferred path that we've laid out really has two steps. The first step is we do an IPO of up to 20% of the shares of the new diabetes company. What that does is it enables us to raise capital to make sure that the new diabetes company is fully capitalized. Those proceeds will also cover the costs that are relative to executing the deal overall. In our projections, it will enable potentially to have some of the proceeds go to Medtronic to potentially apply our capital allocation typical policy. It provides an opportunity to do a buyback in the first phase. There is a second phase, which should occur, I guess, roughly six months after the first phase. In that second phase, we do a split. What that means is we post a lockup period.

We give an opportunity for Medtronic shareholders, some of which will have entered the stock to participate to the split. We give them the option either to keep the Medtronic stock or to swap for stock in the shares in the new diabetes companies. The result of that is that it will reduce the share count of Medtronic on a permanent basis. This is the accretive effect that it will have on EPS. It's not a one-off buyback. I want to be clear. It's a permanent retirement of the shares corresponding to something probably around 80% of the shares of the new diabetes company. All this should be a tax-free transaction for U.S. federal income taxes.

The goal is to get everything done within the next 18 months, which means that we will fully consolidate the diabetes business through 2026 and see the impacts of the deconsolidation and the EPS accretion primarily in 2027. Right. That one-time EPS bump, we're not looking at that. We see it for what it is. It's a one-time bump, and we're going to apply our algorithm on top of that and grow that EPS year over year, like we talked about as part of our algorithm. Additionally, the other benefit, it does reduce with the retired shares, does reduce the cash burden on the dividend liability. That's another benefit of it. It's a unique structure. It's a unique deal. It's a unique structure. That's why I say it's a win-win.

Geoff Martha (Chairman and CEO)

With that, look, sorry for the little technical challenge at the beginning of the call. Thanks for your patience on that. Thanks for going the extra half hour plus and all the great questions and engagement. I'm sure there'll be a lot of conversation throughout the day. There's a lot of news, a lot of good news, I think. Like I said, I'm as excited about the setup as I've ever been, and we're at the early stages of it. Thanks for all the questions. To all of us who joined today, we appreciate your support and the continued interest in Medtronic. We hope that you'll join our Q1 earnings broadcast, which we anticipate holding on Tuesday, August 19th, where we'll continue to update you on all the progress here.

Thanks for spending time with us today, and have a great rest of your day.