Medtronic Q1 2024 Earnings Call Transcript

Presentation

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Good morning. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. I appreciate that you're joining us today for our Fiscal 2024 First Quarter Video Earnings Webcast. We're broadcasting to you today from our operational headquarters here in Minnesota, where summer is in full force.

Before we go inside to hear our prepared remarks, I'll share a few details about today's webcast. Joining me are Geoff Martha, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide comments on the results of our first quarter, which ended on July 28th, 2023, and our outlook for the remainder of the fiscal year. After our prepared remarks, the Executive VPs from each of our four segments will join us, and we'll take questions from the sell-side analysts that cover the Company. Today's program should last about an hour.

Earlier this morning, we issued a press release containing our financial statements and divisional and geographic revenue summaries. 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 actual results to differ is contained in our periodic reports and other filings that we make with the SEC. And we do not undertake to update any forward-looking statement.

Unless we say otherwise, all comparisons are on a year-over-year basis and revenue comparisons are made on an organic basis, which excludes the impact of foreign currency and first quarter revenue in the current and prior year reported as Other, which stems from prior business separations. References to sequential revenue changes compared to the fourth quarter of fiscal '23 and are made on an as-reported basis and all references to share gains or losses refer to revenue share in the second calendar quarter of 2023 compared to the second calendar quarter of 2022 unless otherwise stated.

Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at investorrelations.medtronic.com. And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year.

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

[Music]

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Hello, everyone, and thank you for joining us today. We are pleased with the strong start of our fiscal year. We executed and delivered another quarter of mid-single digit organic revenue growth. Our solid results were broad-based with each of our four segments delivering 6% growth driven by execution, innovation, and much improved underlying fundamentals in our markets and supply chain. We also continue to make great strides on our comprehensive transformation, which is designed to get at the root of what has held back our growth. We're executing large-scale functional improvements to global operations, supply chain and quality.

And we're also decisively allocating capital, particularly to our programs and fast secular growth markets, as well as focusing our R&D investments on technology megatrends like robotics and artificial intelligence that will drive growth in our industry over the next decade. And at the same time, we remain focused on our ongoing portfolio management efforts. And taken together, we expect this continued focus on executing our transformation will ensure durable top and bottom line growth and create value for our shareholders.

So, let's turn now to the details of our Q1 results. We had another strong quarter of growth from our largest businesses: Cranial & Spinal, Surgical and Cardiac Rhythm. These businesses have durable established leadership positions. And combined, they made up just under half of our revenue and grew 6% organic.

Starting with Cranial & Spinal Technologies, we had another great quarter, growing 6% globally and 8% in the US, driven by our market-leading Aible ecosystem. We're seeing growth in both neurosurgery capital equipment and the associated pull-through of our best-in-class spinal implants and biologics as surgeons continue to adopt Aible. Neurosurgery grew 5%, including double-digit growth in Mazor Robotics and high-single digit growth in StealthStation Navigation. And Spine & Biologics grew 7% globally and 9% in the US. These results demonstrate our successful strategy of offering surgeons a differentiated and innovative ecosystem including our AI-enabled surgical planning platform and patient-specific customized implants, along with imaging, navigation and robotic technologies.

Now, moving to Surgical, we grew 7%. Supply continued to improve and this drove high-single digit growth in Advanced Surgical Technologies. And we had particular strength in Advanced Energy as we continue the rollout of our LigaSure XP and cordless Sonicision 7.

Cardiac Rhythm grew 5% with mid-single digit growth in Defibrillation Solutions, Diagnostics and Cardiac Pacing. And now with in-pacing, we had strong mid-teens growth in our Micra leadless pacemaker franchise and we launched our next-generation microdevices AV2 and VR2 in the US. These tiny 0.8 cc devices have a battery life of 16 and 17 years, respectively; 40% longer than our previous generation and well beyond average battery life of competing products. We're also seeing EPs rapidly adopt conduction system pacing as an alternative to traditional single or dual-chamber pacing. Our 3830 lead is the only one approved for conduction system pacing in the US and it grew 45% in the quarter.

Looking ahead, we're preparing to launch the Aurora EV-ICD later this year. Aurora is a game-changer for the ICD space. It delivers the benefits of a traditional ICD including the same size, longevity and pacing features, but without leads in the heart or veins.

Turning to our Synergistic businesses, there were several notable performances this quarter. Cardiac Surgery grew 8% again this quarter with strength in Perfusion and Cannula. Our Aortic and ENT businesses, both grew double-digits, driven in part by improved product availability. Peripheral Vascular grew mid-single digits with low-double digit growth in drug-coated balloons and high-single digit growth in superficial vein therapy. Neuromodulation grew mid-single digits in both Pain Stim and Brain Modulation, driven by new implants of Intellis with DTM and Percept PC with BrainSense.

And just last week, we received CE Mark approval for our next-generation spinal cord stimulator, Inceptiv, which will be available in Europe in the coming months. Inceptiv incorporates closed-loop therapy with e-caps, the result of decades of Medtronic R&D to unlock the ability to listen and respond to signals along spinal cord. Both our largest and synergistic businesses had really strong quarters and our businesses that compete in high secular growth MedTech markets they did as well. All combined, these businesses made up 20% of our revenue and grew in the high-single digits in Q1. We continue to disproportionately invest in these businesses, and we expect them to become a larger part of our revenue mix and be large contributors to our durable growth in the future.

Starting with Structural Heart. Transcatheter valves grew 11% globally, including 12% growth in the US and 21% growth in Japan. We continue to see improvements in the TAVR space and adoption of our differentiated Evolut FX valve. Evolut FX combines enhanced and predictable valve deployment with industry-leading durability. And next Monday, we're looking forward to the presentation of the notion 10-year data at ESC, which will look at the durability of the CoreValve and Evolut valves compared to surgery over a decade.

In Neurovascular, we grew mid-single digits when you exclude China, where the market is subject to volume-based procurement. Global growth was fueled by continued strength and flow diversion. We're seeing strong adoption of our Shield Technology for treating aneurysms, which is available on our Pipeline Flex and Pipeline Vantage flow diverters.

And Cardiac Ablation Solutions grew 5%. And as you know, Pulse Field Ablation has become one of the most anticipated technologies in MedTech and we will be leading the way in bringing PFA catheters to market for both focal and single-shot segments. We're continuing the limited market release in Europe for our Affera mapping and ablation system including our Sphere-9 focal catheter. Sphere-9 can perform both PFA and RF Ablation and delivers high-density mapping all from the same catheter.

Turning to our single-shot PFA catheter, PulseSelect. We filed for approval with US FDA and expect to be one of the first companies with a PFA catheter in US market. With our PFA catheters and the Affera map/nav system, combined with our leading Arctic Front cryo solution and differentiated AcQCross Transseptal Access System, we're poised to become a more meaningful player in the fast-growing $8 billion EP ablation space.

In robotic surgical technologies, we increased our installed base as we continue the international rollout of our differentiated Hugo robotics system. And we've activated new sites in our Expand URO US pivotal trial, which continues to progress to plan. We expect Hugo to be a meaningful growth driver for us in the years ahead, given its differentiated value proposition, our leading position in minimally-invasive surgery and the low penetration of robotic surgery around the world.

And in Diabetes, we had a good quarter as we continue to see very strong demand for the MiniMed 780G AID system in markets around the world. 780G is a true second-generation AID system and is the only one with five-minute adjustments and auto-corrections and meal-detection technology. We're getting great feedback that users are feeling a difference within one to two days. And our real-world evidence indicates that 90% of users are achieving or exceeding their glycemic targets when using our recommended settings, as well as getting burden reduction in their diabetes management. And this differentiated value proposition is showing up in our results. Non-US developed markets grew 18%, our highest growth in four years driven by both 780G adoption and increased CGM attachment rates.

And in the US, we're seeing great results and momentum from the 780G launch. First, the launch drove low-30s growth in our US durable pump sales. Second, we're seeing our prescriber base rapidly expand. Since we last talked to you at ADA in late-June, we've had a 30% increase in unique prescribers, with now over 13,000 since launch. Third. We've had over half of our 770G installed base upgrade or place an order for the 780G since launch. And not only is demand coming from our existing installed base, but we're also getting competitive conversions. And finally, we're seeing very high CGM attachment rates in the 780G installed base, which will drive our economics and gives us confidence in accelerating growth.

So the turnaround in diabetes is real and underway. And I am pleased with the progress the team is making. And we're just at the beginning of this inflection point for the business. As we shared with you at our ADA investor briefing in June, we see the intensive insulin space moving from primarily standalone CGM today to one that is smart dosing through either AID systems or smart MDI and we are well-positioned for this trend. We continue to invest heavily in next-generation durable pumps, smart pens, patch pumps, sensors and algorithms, with multiple programs under development. And importantly, we're the only company assembling this complete ecosystem of differentiated technology for people living with diabetes.

With that, I'll turn it over to Karen to discuss our financial performance and our fiscal '24 guidance raise. Karen?

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Thanks, Geoff. As Geoff mentioned, we had a strong start to our fiscal year with 6% revenue growth coming in ahead of expectations. We also had good growth on the bottom-line with non-GAAP EPS of $1.20, up 6%. This was $0.09 above the mid-point of our guidance range with $0.07 coming from better-than-expected operational performance and $0.02 from FX.

We're focused on positioning Medtronic to drive durable growth. You've seen that over the last several quarters on the topline. And as we talked about on our last call, stabilizing and then ultimately improving gross margins remains a priority for us. The breadth of our revenue growth this quarter is notable. As Geoff mentioned, each of our four business segments grew 6%. And by geography, non-US Developed and Emerging Markets, both grew in the high-single digits with the US growing mid-single digits. Western Europe grew 8% again this quarter with high-single digit growth in Cardiovascular and Medical Surgical and high-teens growth in Diabetes. Emerging Markets grew 8% and were affected by new sanctions in Russia and ongoing VBP impact in China.

That said, China growth at 4% was better than expected given some provincial VBP delays to later in the year and strong procedure recovery. Excluding China and Russia, Emerging Markets grew in the high-teens with mid-teens growth in Southeast Asia and the Middle East and Africa and high-teens growth in Latin America and South Asia.

Turning to margins. Our adjusted gross margin was relatively stable year-over-year and ahead of expectations, with better-than-expected pricing and less-than-expected impact from currency, offsetting inflationary pressures. Our operating margin increased 90 basis points, driven by revenue outperformance and our focus on expense management, particularly in our G&A line.

Below the operating profit line, our adjusted nominal tax rate was 15.8%, above expectations, driven by a change in Puerto Rico tax law. The change drove an approximate 120 basis point increase in our tax line, offset by a corresponding decrease in other operating expense. So the change was net neutral to earnings.

Turning to capital allocation. We're prioritizing investments in innovation as we disproportionately invest in high-growth, high-return opportunities. We do this through multiple channels including organic R&D, minority investments, strategic partnerships and disciplined acquisitions. At the same time, we prioritize returning a minimum of 50% of our free cash flow to our shareholders primarily through our strong and growing dividend.

We also continue to advance our active portfolio management. Last quarter, we moved our Renal Care Solutions business into a joint venture with DaVita. We've been focused on the separation of patient monitoring and respiratory interventions. And as we noted in our 10-K, we now expect to complete the separation in the first half of next fiscal year, if not sooner, as we've been evaluating different types of transactions to maximize shareholder value. We've always said a spin sets a high bar and it remains the likely way we'll separate these businesses.

Now, turning to guidance. With our outperformance in the first quarter and improved underlying fundamentals, we're raising our full-year revenue and EPS guidance. We now expect fiscal '24 organic revenue growth of 4.5%, an increase from the prior range of 4% to 4.5%. This guidance excludes the impact of foreign currency and revenue from our new other segment. And I direct you to the guidance slide in our earnings presentation for additional details.

In the second quarter, we're expecting organic revenue growth to be in the range of 4% to 4.5%. On a comp-adjusted basis, this represents an acceleration over the first quarter. And we expect a steady acceleration and underlying growth in the back half of the year as well. While the impact of currency is fluid, based on recent rates, foreign currency would have a neutral impact on full-year revenue, including a favorable impact of $85 million to $135 million in the second quarter.

Moving down the P&L. As we have said before, we expect inflation and currency pressures this fiscal year and we do expect some of the delayed impact from the provincial VBPs that benefited us in the first quarter to come later in the year. However, you are beginning to see the results from the actions we are taking to drive structural changes in our global operations and supply chain. To give a few examples. We're moving to fewer, more strategic suppliers that are giving us better terms. And we're implementing improvements to run our factories more efficiently and reliably. There is more to come. And we expect this will drive stabilization in our gross margin over time and then improve it from there.

On the bottom-line, we're raising our fiscal '24 non-GAAP diluted EPS guidance to the new range of $5.08 to $5.16, an increase from the prior range of $5 to $5.10. This is a $0.07 increase at the midpoint, in line with the first quarter operational beat. The guidance range continues to include an unfavorable 6% impact from foreign currency based on recent rates. The projected 6% annual FX impact is unchanged from May, as the $0.02 of FX upside in the first quarter is now offset later in the year. For the second quarter, we expect EPS of $1.16 to $1.20, including a 6% unfavorable impact from foreign currency based on recent rates.

Before sending it back to Geoff, I'd like to acknowledge our employees who are watching today. I truly appreciate your focus on driving change to execute well and deliver on our priorities. It is that focus that contributes to these results and fulfills our enduring mission to alleviate pain, restore health and extend life for millions of patients around the globe. Thank you.

Back to you, Geoff.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Okay. Thank you, Karen. Now, before we go to analyst questions, I'll close with a few thoughts. First, Q1 was a strong start to our year and we're establishing a track record of delivering dependable mid-single digit growth. We're executing and bringing innovation to the market. We're making progress in countering the impacts that inflation and currency are having on our margins and we expect this to lead to stabilization and then improvement over time.

We're also seeing improved underlying fundamentals in our supply chain and in our markets across our businesses and geographies. And like I said earlier, we're at the beginning of an inflection point in our Diabetes business. And we're seeing strength in our established market-leading businesses like CRM and Spine. And with our pipeline, we have several important growth catalysts that we expect to come to market over the coming quarters. So we're on the right path and building momentum.

And underneath all of this, what may be less visible to you are the steps we've taken to transform the Company, tackling the root causes of what have made our growth less dependable in the past. We're ensuring a performance-driven culture, partially driven by a number of new leaders in the Company. We're advancing our capital allocation and portfolio management priorities to take advantage of high-growth opportunities and we're executing on the programs that we believe will lead to scale advantages, whether that's in our now centralized global operations and supply chain organization or -- and how we go to market with large enterprise customers around the world or how we're leveraging core technologies in implementing new innovations across our businesses.

Now, to accelerate this last area, we created a new position of Chief Technology and Innovation Officer and hired Ken Washington this past quarter to fill that role. Ken was recently at Amazon, where he led Consumer Robotics, and before that was Chief Technology Officer at Ford Motor Company, and VP of the Advanced Technology Center at Lockheed Martin Space Systems. I look forward to sharing more details in the quarters ahead on how Ken is leading our efforts to leverage technologies like robotics and AI across the enterprise, which we believe will lead to new, differentiated therapies for patients and better experiences for our customers.

So, this is an extensive transformation. Yes, there's still work to be done, but you're seeing some of the benefits in our results. And you should expect to see more of this over time as we continue to work toward delivering durable revenue and earnings growth, which, combined with a growing dividend, is a winning formula for creating value for our shareholders.

Now, let's move to Q&A, where we're going to try to get to as many analysts as possible. So, we ask you to 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.

I also want to note that today is the first time we have Mike Marinaro, who runs our Surgical and our Endoscopy businesses joining us for the Q&A. Now, Bob White's focus is on the PMRI businesses as we separate, which is a heavy lift. And we have Mike focused on the other two med-surg businesses. So today, if you have questions on Surgical or Endoscopy, direct them the Mike; and PMRI, questions can go to Bob.

With that, Brad, can you please give the instructions for asking a question?

Questions and Answers

[Brad Welnick, Vice President - Investor Relations at Medtronic]

[Operator Instructions] For today's session, Geoff, Karen and Ryan are joined by Que Dallara, EVP and President of Diabetes; Mike Marinaro, EVP and President of the Surgical and Endoscopy businesses; Sean Salmon, EVP and President of the Cardiovascular portfolio; Brett Wall, EVP and President of the Neuroscience portfolio; and Bob White, EVP and President of the Medical Surgical portfolio. We'll pause for a few seconds to assemble the queue.

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

[Vijay Kumar, Analyst at Evercore ISI]

Hey, guys. Thanks for taking my question. And Geoff, congrats on a good print here, good execution. Maybe my first one on Diabetes here. The 30% US growth numbers here, I think that's a revenue number. You know what the comp growth number was in US and how much of this was existing customers? How much of this growth is driven by existing customers upgrading, the 770G users upgrading versus new customer adds?

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Thanks, Vijay, for the question. Yeah. Well, first off, let me just say we're really pleased with the momentum we have in Diabetes. I mean -- and I think we're on the kind of early stages of growth acceleration there. We're seeing great outcomes in patients. Like I mentioned in the commentary, a significant increase in unique prescribers, a much higher attachment rate of CGM, which will really impact our economics. That's where a lot of the profit comes from. And we think this is durable and in line with the market trends of time and range and moving to automated insulin delivery. So -- and we've got a nice pipeline coming down the path as well.

But to answer those specific questions, I'm going to turn to Que, as you know, who runs that business. Que, do you want to touch on Vijay's specific questions?

[Que Dallara, Executive Vice President and President Diabetes Operating Unit at Medtronic]

Yes. Thanks, Geoff. Thanks, Vijay. We're really pleased with the momentum we're seeing in the US so far. In terms of what's driving the low-30s AID growth in the US, it's both existing installed base of 770G users that have upgraded. We've had more than 50% of that cohort upgrade or in the process of upgrading. But we're also seeing growth coming from new patients. We've had the highest new patient growth in three years and that's coming from MDI, as well as competitive switches.

[Vijay Kumar, Analyst at Evercore ISI]

That's helpful, Que. Maybe, Geoff, I have one quick follow-up. A lot of questions here on China, a new anticorruption campaign, we're seeing some headlines, a lot of questions on how this would impact device companies. Maybe just talk about the high level what you're seeing in China. What was the VBP impact in the quarter and any signs of perhaps the channel pausing here, because of this anticorruption campaign? Thank you.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Yeah. You asked about the anticorruption and VBP, so -- in China. So, look, on the anticorruption, I recognize that there are concerns out there. And we're -- look, we're actively monitoring the situation, which is fluid in nature. But I'll say, thus far, we're not seeing any material headwind for our business. And it is kind of pivoting to -- there's a linkage to VBP.

It's worth noting that we -- you could argue that we're somewhat a bit insulated from some of this anticorruption with the coverage under VBPs, I mean, volume, in this case, is contracted. And with the hospital, pricing is determined with VBP and we're less reliant on the field team and distribution, which has also allowed us to take cost out to mitigate the price impact. So no impact at this point from the anticorruption campaign that you read about.

And then regarding VBP, I mean, this -- it's -- we feel it's been -- it's a 2.5-year kind of impact here and we're -- for us, that fully -- that impact fully takes effect in this fiscal year, FY '24. It's all in our guidance. As Karen pointed out in the commentary, the China growth this past quarter was at 4%, which is slightly higher than we expected, still well below what it used to be, but -- and where we think it's going to get back. As we kind of lap these last couple of VBP areas in FY '24, we expect this revenue to get back to historical high-single digit, low-double digit growth for us.

So, hope that answers the question. This is something, as you look forward, it's a multibillion dollars of revenue for the Company that over the last couple of years has been negative, more recently flat, now starting to get positive. And as we lap -- as we get out of FY '24, again, we expect a tick-up in this growth. So that's coming.

[Vijay Kumar, Analyst at Evercore ISI]

[Technical Issues] Thanks.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Yeah. Thanks for the questions, Vijay. We'll take the next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Robert Marcus, Analyst at JP Morgan Cazenove]

Oh, great. Good morning. Congrats on a good quarter. Maybe to start, for Geoff or Karen, as we think about guidance for the rest of the year, you raised the organic sales growth from the low end of 4% to 4.5% up to 4.5%, you did 6% in the first quarter. So maybe just walk us through why growth is going to decelerate for the rest of the year and what are some of the factors affecting what could drive you above that. Thanks.

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yeah. Thanks for that question, Robbie. Appreciate it. Q1 was a really great start to our year, and we're really pleased with the breadth of our performance. As Geoff mentioned, it's the third consecutive quarter that we've had of solid mid-single digit growth. And we're carrying the beat that we had in Q1 and raising our Q2 guide to 4% to 4.5%, and all of that puts our FY '24 guidance at 4.5%. It's still early in the year, and we're focused on providing guidance that sets us up for success.

I've talked about some of the puts and takes that we've got. We're a little more optimistic on China, Geoff talked about it. We've had procedure volume recovery. We also had some of the VBP impacts that we expected in the first quarter delayed into the -- later in the fiscal year. And we're expecting Russia to be a bigger drag given the new sanctions that were put in place in late-May. But we're focused on offsetting that just as we did in Q1, and we feel good about the improved underlying fundamentals and we're intensely focused on hitting our commitments.

Just on the acceleration for the rest of the year, on a comp-adjusted basis, Q2 represents an acceleration from Q1. And then we expect continued acceleration into the back half each quarter of the fiscal year into the back-half. So hopefully, that answers your question.

[Robert Marcus, Analyst at JP Morgan Cazenove]

Yeah. Great. Thank you. Maybe just one more on margins. Margin expansion or the upside in the quarter came from gross margin. SG&A, I know you had some reductions in the headcount. So, as we just try and think about operating margins for this year and going forward, how should we think about how much more there is to come out of SG&A? And how much more upside there is in gross margin moving back towards where we were pre-COVID? Thanks a lot.

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yeah. Thanks for the question, Robbie. Clearly, we're focused on driving margin expansion and ultimately on the gross margin getting back to pre-COVID levels over time. We saw improved margins this quarter and we're increasing our full-year guidance on gross margin expectations given some of that outperformance. But in Q1, we did have some better-than-expected currency and pricing. And some of that was due to timing with some provincial tenders in China being delayed a bit and some of the FX improvement that we saw this quarter, we expect to -- FX to impact us a little bit more in the back half of the year.

So, as we think about margins, we are making investments in our global operations and supply chain to drive cost out of the organization. And I mentioned a couple of examples where we're consolidating our suppliers and focused on improvements in our manufacturing operations to drive continued improvement. And over time, we're focused on stabilizing and improving our margins. And so that will continue to impact us on the operating margin line. And on SG&A, as you mentioned, we're focused on continuing to drive leverage in our SG&A line, as you've seen us do for a long period of time.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Okay. Thank you, Robbie. We'll take the next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Larry Biegelsen, Analyst at Wells Fargo Securities]

Good morning. Thanks for taking the question. I guess, two for Sean, given the upcoming events here with the Simplicity Ad Comm and then the Affera pulse data this weekend. Sean, how are you feeling about the Simplicity panel tomorrow? And if we see a positive recommendation, help us think about timelines for approval and the ramp in the US for renal denervation.

And second, we're going to see the Affera pulse data this weekend as well. You guys are growing mid-single digits, looks like a little bit below the market right now. What should we be looking for in the Affera pulse data? And how are you feeling about being able to grow your AFib business at or above the market going forward? Thank you.

[Sean Salmon, Executive Vice President and President Cardiovascular Portfolio at Medtronic]

Excellent question, Larry. So I guess starting with the Ad Comm panel. Obviously, we've been very confident about the prospects of US approval, and we're exclusively well-prepared for that panel. I'm not going to handicap the timing, but typically, it's three to four months post-panel recommendation, you tend to see things. I'd say, an approval in the second half of fiscal year '24 is certainly in order with that kind of timing. And the RAP [Phonetic] itself of course, is going to be dictated by the pace of reimbursement and we're well-prepared on that front as well.

As far as our Pulse Field Ablation, we're looking forward to seeing the results like everyone else is. This is a randomized trial, as you know. So that comparative efficacy compared to both cryo and RF Ablation for the populations being studied and will be of interest to us. And I think our distinction really in pulse field is that we are the only player that has both a focal solution, as well as an anatomic solution in the bag. The anatomic solution or single-shot market is about 15% of the market and the other 85% is what the point-by-point ablation will bring to us. So certainly very confident in both technologies, both the PulseSelect and Affera mapping and Sphere-9 catheter system, which is very different than everything else that's out there. And we look forward to bringing those to customers all around the world.

[Larry Biegelsen, Analyst at Wells Fargo Securities]

All right. Thank you.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Larry. Next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Danielle Antalffy, Analyst at UBS Group]

Hey, good morning, everyone. Thanks so much for taking the question and congrats. This was quite a good quarter. Just a quick question on GLP-1s. Geoff, I know this is probably an annoying question for you, but this is something that's been impacting the market broadly. I'm just curious, you guys touched on many, many areas within medical devices. How are you guys thinking about the impact of GLP-1s over the next, I would say, even a few years, but maybe let's focus on more the next year as these drugs get more readily adopted?

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Sure. Thanks, Danielle, for the comments and the question. And yeah, it is interesting. First of all, I'd say it's an important class of drugs and like you were monitoring to see how the GLP-1 therapy is being adopted. That said, our initial work indicates minimal impact to our business. When you -- the one area we've seen some modest impact is bariatric, but this is really a small impact, and this is a relatively small part of our Surgery business.

And we are hearing from -- the work we do is our internal analysis plus dialog that we're having with physicians around the world. We actually operate obesity clinics in Europe as well. And they're talking about longer term, this could actually bring in the bariatric space more patients into the funnel. Short-term, we've seen some impact, again, modest and relatively -- bariatric is a relatively small part of our Surgery business. Longer term, we'll see how it plays out. There's a bit of optimism there though.

No impact in Type 1 diabetes, which is the vast majority of our Diabetes business. And just overall, I just don't see GLP-1s having a material impact on our business and medical device therapies at large. That's what our work is showing us at this point.

[Danielle Antalffy, Analyst at UBS Group]

And then I guess just one quick follow-up to that, thinking about, again, the Diabetes business; Type 2 is a big growth area. You guys have an AID pen. So what are your thoughts specifically on the Type 2 diabetes side of things? Thanks so much.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Thanks. Look, I think this is -- AID for insulin-dependent patients, whether they're Type 2 or Type 1 is pretty underpenetrated and we see way more upside there than headwinds.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Danielle. We'll take the next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Travis Steed, Analyst at Bank of America Global Research]

Hey, congrats on the good quarter. I guess, I'll ask about TAVR, double-digit growth this quarter. And curious how much success you've had with the new valve versus the five-year data. I know your competitor is going to have five-year data pretty soon. And then the 21% Japan growth really stood out. Just curious if that's sustainable or that was more of a one-off in the quarter?

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Well, first, before I turn it over to Sean, we are -- if you go back to the last couple of quarters, we are pleased with how our TAVR business is performing relative to competition and how the new valve is performing and also the pipeline for the future.

But, Sean, why don't you give the specifics on that question?

[Sean Salmon, Executive Vice President and President Cardiovascular Portfolio at Medtronic]

Sure. Yeah, Travis, the new valve is certainly being well-received where we've launched it. It's been launched in the United States and a number of other geographies and Japan notably. The other thing that drove Japan growth was that we've got a new indication for end-stage renal disease, which is something we've been lacking in Japan. So it's a large consideration for that population that really helps drive the performance.

But yes, our long-term data have been really the signature of that device and we'll see more of that this coming weekend, as well as the 10-year notion data, so this is the first 10-year data being reported out for TAVR will be on display. And then, of course, we have four-year data coming up on our low-risk study as well to look forward to this fall. So we stand behind the valve performance all the way around. And whether it's the acute ease of use or the long-term durability of the valve, it's really shining and we're getting a lot of traction from all of that.

[Travis Steed, Analyst at Bank of America Global Research]

That's helpful. And then the PMRI spend, I assume, the time change is more because spends take longer than sales. But maybe some other comments on when we could see the Form 10, can you confirm the operating margin profile of that business is still kind of slightly higher than the overall Medtronic? And then do we need to wait for this to get through to see more on the portfolio management side of things? Thank you.

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yeah. Thanks, Travis. I think there's nothing to read into this other than we're focused on maximizing shareholder value. And we've been taking our time to evaluate the alternatives. And we've said all along that the spin sets a high bar and that remains a likely way that we'll separate. And so, we'll -- we're expecting to close it first half of next fiscal year, if not sooner. In terms of Form 10, we'll -- you'll see it when you see it. And in terms of the margins of the business, yes, they are good margins and slightly higher than the Company. Hopefully, that helps.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Yeah, the business continues to perform well. Like Karen said, the margin profile has remained strong. And actually, the competitive dynamics, particularly in the patient monitoring side of it, have probably improved a bit in our favor. So it's a good business. And I think with more focus, I think these numbers can even improve.

[Travis Steed, Analyst at Bank of America Global Research]

All right. Thanks a lot.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Travis. Next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Matt Miksic, Analyst at Barclays]

Hi. Thanks so much [Technical Issues] question. So -- and congrats on a really strong quarter across the board. There's a lot to talk about, but maybe one question on Diabetes for Que and then one follow-up.

So, just would love to hear how things are progressing with some of the programs that you talked about at ADA, the next-gen sensor and integrated testing and the patch pump that you're in the process of acquiring here? And then if I could on that, Geoff mentioned something about a next-gen AID pump and I know it's way early to even ask the question, but just curious if you are ready to share any hints about that. And then one quick follow-up, if I could.

[Que Dallara, Executive Vice President and President Diabetes Operating Unit at Medtronic]

Yeah. Thanks. Thanks for your questions. As you know, Simplera CGM, our next-generation CGM is under review with the EMA and FDA. We're in the process of doing that and it's very difficult to put a precise timeline on when we expect to have approval, but that is progressing.

In terms of the integration with 780G, we have completed adult enrollments for the clinical trial in Q1. We expect to complete the peds enrollment in Q2. But that's at the clinical trial stage.

We're also -- in terms of the patch, we're making progress there as well in terms of completing that transaction and we expect that we would close out the EOFlow acquisition at the end of this calendar year.

And again, very sorry to disappoint you, but difficult to comment on our further programs. They're progressing as we expect in our internal timelines. But at this stage, it's a bit too early to put details on specific timing.

[Matt Miksic, Analyst at Barclays]

That's very helpful and understandable. Just one -- the follow-up is on seasonality. You've seen July here and I know there's been a number of questions across the sector, given what we've seen over the last couple of [Technical Issues] year-to-date in surgeries and procedure volumes and so on. Just any sense of what kind of summer quarter we should expect, which for you [Technical Issues] August, but softer than usual, seasonally normal, how would you describe what you've seen in July and what your expectations are built into Q2 -- your fiscal Q2 here? Thanks.

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

So I would just say, Travis, that the first few weeks of the quarter and what we've seen in July are tracking well. We continue to have strength in the underlying performance and it's tracking to the expectations we set in our guidance.

[Matt Miksic, Analyst at Barclays]

That's fair. All right. Thanks so much.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Matt. We'll take the next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Chris Pasquale, Analyst at Nephron]

Hi. Geoff, one for you and then a quick follow-up for Karen. You mentioned artificial intelligence as one of the areas Medtronic is investing in. It's obviously a hot topic in the market more broadly. Could you provide any examples of the work you guys are doing there and maybe talk about which businesses you see AI is being most relevant for in the near future?

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Sure. Well, first of all, I think for the medical device industry, the kind of the intersection of traditional biomedical engineering with these digital technologies, whether it'd be connectivity or data analytics techniques like AI and deep learning, robotics, these are all just a huge opportunity for the industry. This is -- and these are areas that we intend to lead in.

AI specifically, we've got a number of businesses that have first-of-their-kind AI-powered solutions that have received regulatory approval by the FDA and other regulatory bodies around the world. And what we're seeing here is just improved from the AI -- just improved outcomes and access. And it's the -- when you combine the AI with good data, not just quantity, but the quality of data and that data is labeled properly, we're seeing the ability to even personal -- like evolve and improve the efficacy over time through the AI and even personalize it.

The FDA has approved a couple of products for us in the Cardiac Rhythm space, in Spine, in GI, where you have what they call a predetermined change control plan, where you're allowed to kind of approve -- improve that efficacy over time. And some of the businesses that are impacted, like I mentioned, our GI are now calling Endoscopy space where we have AI in the Colonoscopy, you're kind of redefining traditional Colonoscopies where the AI is finding polyps that physicians were missing. And this is a significant amount of polyps and it's obviously good for patient outcomes because there's a high correlation to cancer -- colon cancer from these polyps and it's also economically aligned with the hospital's interest, as you find more polyps and remove them.

Another area is in our Spine business. This is an industry that's being completely redefined by enabling technology -- transformed and redefined by enabling technology. We talk about robotics and imaging and navigation and powered instruments, but AI is a key piece of this and we have thousands of surgeries in our AI -- that's powering our AI algorithm. And with each -- and Spine is a complicated surgery, especially whether it be degen or for sure, deformity complex cases, highly reliant on surgeon training. And AI is really just improving outcomes here, especially when it's combined with enabling technology.

I could go on, Cardiac Rhythm in our monitoring, our loop -- our LINQ monitoring business there, we are cutting down false-positives for -- in detecting AFib by 50% using AI and that's creating multiple hours of productivity for these clinics around the country and given -- and this really driving the deployment of that technology.

So I'd say it's a huge opportunity. It's a differentiator. I mentioned we hired a new Head of Technology, Ken Washington, to really help us scale this across all our businesses and better partner with some big tech companies. We've talked about our partnership with NVIDIA. And in the end, I'd say what we're going to see over the next couple of years is, you may not be replacing -- AI is not going to be replacing surgeons, but I'll tell you what, surgeons who use AI will be replacing surgeons that don't and we are going to be right in the middle of that mix.

[Chris Pasquale, Analyst at Nephron]

Thanks for those great examples. Karen, you mentioned price as a contributor to the gross margin strength in the quarter. Could you give us a sense for what price looks like across the Company today? Maybe how it compares to where you were a couple of years ago? And if you think that it's sustainable as we move into a less inflationary environment going forward?

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yes. Thanks for the question. As you've heard us talk about, we have been building a pretty strong muscle around pricing. And we're focused on ensuring that we price for the value that we deliver. Typically, historically, pre-COVID, we would experience up to 200 basis points of pricing pressure every year and we've been able to neutralize that these last couple of years, including this quarter. We obviously have had VBP pressure this year. And last year, we were able to neutralize that as well at the total Company level.

By quarter, it may not be fully neutralized depending on how VBP hits us. But we do believe that this pricing muscle that we've built is going to be lasting and we fully intend to continue to track, monitor, talk about pricing, so that even as we move into a lower inflationary environment, we're focused on continuing this pricing muscle that we've built.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Yeah, I just want to reemphasize that last point there on kind of -- we'll start on margins. On gross margins, there was a question earlier, Karen went into detail, I'm not going to repeat that. But on gross margins, the pricing muscle that we've been building I think we intend that to be enduring. And then Karen mentioned the cost of goods sold improvements that we're making, productivity around our cost of goods sold line, really driven by our new structure, strategy and capabilities in our global operations and supply chain. That will help -- all help gross margin. And as you get down the P&L, we're really focused on getting leverage from SG&A and excited about stabilizing and then improving the margins over time.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Okay. Thanks, Chris. We'll take the next question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

The next question comes from Jayson Bedford at Raymond James. Jayson, please go ahead.

[Jayson Bedford, Analyst at Raymond James]

Good morning. Can you hear me okay?

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Yeah, Jason. We can hear you.

[Jayson Bedford, Analyst at Raymond James]

All right. Thanks. So not to make this call all around gross margin, but I did have a question. You mentioned stabilization, and I just wanted to put a little context around that. What is the expected gross margin for fiscal '24?

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

At this point -- when we gave our guidance back in May, we said we expected it to be around 65.25%. And at this point, we're expecting it to be about 65.5%. We've seen some improvement in the first quarter, we're carrying some of that through.

[Chris Pasquale, Analyst at Nephron]

Okay. And just, Karen, the drop-down for the rest of the year versus first quarter levels, revenue is higher. Is this just strictly a function of the VBP impact hitting more in the back-half?

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yes, it's both VBP and currency. And you're right, higher revenue growth clearly helps on the margin front. But we have seen some timing on VBP that we talked about. We also have some timing on FX. It was a little bit better than we expected down the P&L in the first quarter and we expect to give some of that back as we look at the currency impact going forward.

[Jayson Bedford, Analyst at Raymond James]

Thank you.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Jayson. Brad, I think we have time for two more questions.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

Yeah. The next question comes from Joanne Weunsch at Citi. Joanne, please go ahead.

[Joanne Weunsch, Analyst at Smith Barney Citigroup]

Good morning, and thank you very much for taking the question and nice quarter, a nice way to start the fiscal year. Two quick questions. Volumes, we've seen throughout MedTech this season have been quite strong, which leads me to wonder is this sort of a new normalized base or whether or not we're just catching up on some pent-up demand. I'd love your opinion on that.

And then for Hugo, you talked about activating new sites in the United States. Can you give us maybe an update on the thoughts on timing of a launch in the US and then anything else you can add for OUS robotic placements would be appreciated? Thank you.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Sure, Joanne. Yeah, good to hear from you. Thanks for the questions. I'll take the first one and then I'll turn it over to Mike Marinaro to handle the Hugo questions. I think, on procedure trends, we're -- as Karen mentioned, I mentioned in the commentary, they're definitely improved, and I'll start in the US where we're up about 5% or so.

But across the board, we're seeing very good procedural trends and we're largely back to pre-COVID or better. Pre-COVID levels are better, as you know, over the last, I don't know, 18 months or so. The rebound has been, I'd say, held back a bit by staffing issues and those have seem to have abated. And like I said, we're getting pretty broad-based procedural pickups and are back to pre-COVID or even better levels.

And outside of the US, I'd say it's even stronger. In Western Europe, high-single digits and the recovery in Europe is definitely in full swing. Latin America, high-teens. And just our -- like our Emerging Market base, when you -- you got to pull out -- if you pull out China, which is VBP, and like I said before, this is -- we see the kind of the stabilizing year here for VBP FY '24. And then as you get into FY '25, you get back to some higher growth in China like we've seen before. But if you take out China and Russia with the sanctions, we're in the teens -- mid-teens and high-teens actually in Emerging Markets.

So Emerging Markets trends are strong. I mentioned Latin America as a standout, Western Europe. So pretty good trends. We're not seeing like this -- at least in the areas we're in, I've heard some -- like orthopedics, there's been a pent-up demand, but we're not seeing it in the areas we're in. It's been a steady flow versus like a pent-up demand. So I think that's good news for the industry.

On the Hugo-specific questions, I'd like to turn it over to Mike Marinaro, who runs our Surgical business, which includes Hugo and also our Endoscopy or formerly called GI business reports up to him as well.

[Mike Marinaro, Executive Vice President and President, Surgical Operating Unit at Medtronic]

Yeah. Thanks for the question, Joanne. And specifically on the US, we did comment that we added sites in the quarter. And that's true we had all sites and enrollments, and continue to progress according to plan in our Expand URO study. We're pleased with the progress we're making there and seeing that progress continue here as we've moved into this quarter.

More broadly, we've seen good progress really and continue to be encouraged about the progress we're making across the program. We're now selling in five regions around the globe: Greater China, Asia, Western Europe, LatAm, North America and Canada. And had -- and increased our installations again here in this quarter.

I think importantly, we've also seen an increasing flow or a steady flow of increasing indication approvals. So we received the general surgery indication in Japan. And so now we have a full suite of approvals across general surgery, gynecology and urology in both Japan and Western Europe, which are two of the three largest markets around the globe. Of course, US is the largest and that's one we remain incredibly focused on.

Overall, we're seeing that the growth here in Hugo is contributing to the growth we've seen now in the Surgical business across the last couple of quarters and it will become a more and more important part of our business as we move forward.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Yeah, really look -- I'm excited about the setup we have for our business. It's a very large business for us that where the supply capacity has been an issue, that's in a much better spot. The robots out there might just walk through kind of indication expansion and geographic expansion and update on the US trial. I'd like the setup and the competitive dynamics going forward over the next couple of years. We got two major competitors, one with a robot, one without. And we're feeling pretty good about where we are with Surgery.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

Thanks, Joanne. I still see a number of people in the queue, and I apologize that we won't be able to get to all of you today given timing. We've got time for one more question please, Brad.

[Brad Welnick, Vice President - Investor Relations at Medtronic]

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

[Patrick Wood, Analyst at Morgan Stanley]

Fabulous. Thank you so much. I'll keep it to one given the timing. S&OP and supply chain is obviously not a very sexy topic, but you guys are doing a lot of work on that side. I'm just curious, typically, when we put processes and rationalization in place, there's kind of upfront cost and like your dual running systems and it's kind of difficult for people to transition. Are you seeing any slight, let's say, short-term challenges or costs associated with that, where the payback is obviously going to come in the next, I don't know, a year or two? Just help us understand how that's looking in the business. Thanks.

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Well, let me just start off by saying, I appreciate your question on supply chain. It's been a big focus area for us. And I know a couple of thousand people at Medtronic that do think it's a pretty sexy place to be and are pretty proud of the work that we're doing.

To answer the question, I'll turn it over to Karen on the cost question.

[Karen Parkhill, Executive Vice President and Chief Financial Officer at Medtronic]

Yeah. Thanks, Patrick. Yes, when we're working on improving processes and driving better cost down, it does take investment. That investment is included in the guidance that we've given and is -- it's part of the reason that our gross margins are not yet stable. But we fully expect those investments to pay off over time and to help drive costs down more than inflation as we work to bring our gross margins up. Hopefully, that's helpful.

[Patrick Wood, Analyst at Morgan Stanley]

Amazing. Thank you.

[Ryan Weispfenning, Vice President, Head - Investor Relations at Medtronic]

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

[Geoff Martha, Chairman and Chief Executive Officer at Medtronic]

Sure. Well, first of all, thanks, everyone, for the questions. And as always, we appreciate your support and your continued interest in Medtronic. And we look forward to updating you on our continued progress on our Q2 earnings broadcast, which we anticipate holding on Tuesday, November 21st.

With that, thanks again for joining us today. And have a great rest of your day.

Participants

Corporate Executives

• Ryan Weispfenning, Vice President, Head - Investor Relations
• Geoff Martha, Chairman and Chief Executive Officer
• Karen Parkhill, Executive Vice President and Chief Financial Officer
• Brad Welnick, Vice President - Investor Relations
• Que Dallara, Executive Vice President and President Diabetes Operating Unit
• Sean Salmon, Executive Vice President and President Cardiovascular Portfolio
• Mike Marinaro, Executive Vice President and President, Surgical Operating Unit

Analysts

• Vijay Kumar, Evercore ISI
• Robert Marcus, JP Morgan Cazenove
• Larry Biegelsen, Wells Fargo Securities
• Danielle Antalffy, UBS Group AG
• Travis Steed, Bank of America Global Research
• Matt Miksic, Barclays PLC
• Chris Pasquale, Nephron
• Jayson Bedford, Raymond James
• Joanne Weunsch, Smith Barney Citigroup
• Patrick Wood, Morgan Stanley