Medtronic plc

Good morning. I'm Ryan Weisfenning, Vice President and Head of Medtronic Investor Relations, and welcome to snowy Minneapolis. I appreciate that you're joining us today for Medtronic's fiscal year 2023 second quarter earnings video 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, Medtronic Chairman and Chief Executive Officer, and Karen Parkhill, Medtronic Chief Financial Officer. Jeff and Karen will provide comments on the results of our second quarter, which ended on October 28, 2022, as well as our outlook for the remainder of the fiscal year. After our prepared remarks, the executive VPs for 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 revenue from our Q1 acquisition of Intersect ENT. references to sequential revenue changes compared to the first 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 third calendar quarter of 2022 compared to the third calendar quarter of 2021 unless otherwise stated reconciliations of all non-gap financial measures can be found on our earnings press release or on our website at investrelations.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.

Hello everyone and thank you for joining us today as we discuss our Q2 results and outlook. Our Q2 organic constant currency revenue growth of 2.2% came in about a point below expectations due to a slower than expected recovery in both procedure volumes in certain markets and in our supply chain. In terms of reported revenue, the continued strength of the dollar over the course of the quarter drove over half the difference to expectations. Now, despite the top-line results, we were able to control expenses and deliver EPS at the high end of our guidance range. We also issued guidance for the back half of our fiscal year this morning. We expect continued acceleration in organic revenue growth in the second half, although less than previously anticipated, and this partially flows through to EPS. Now, this is something that I don't take lightly. Delivering on our expectations is important to building and maintaining trust and credibility with you. Karen will walk you through the details, but some of our markets and some of our supply constraints recovered more slowly than we expected in the quarter, and that, along with incremental China volume-based procurements, led us to reduce our expectations. While the current operating environment remains challenging, we had strong growth in several businesses and geographies where our strategy, our operating model, and execution are yielding solid results. We have near-term product catalysts in our pipeline. We are decisively allocating capital internally and selectively making focused acquisitions. We're making improvements to the operational health of the company, and we're streamlining the company structure and taking costs out. All of this gives us confidence that we're on the path to creating durable growth and shareholder value. Now diving deeper into our Q2 results. For reported revenue, as I said earlier, currency drove over half the miss to consensus. Organically, the miss was primarily split evenly between two challenges. One, procedure volumes in some markets have been slower to return to normal levels. And two, some of our supply challenges have persisted longer than we anticipated. With regard to procedural volumes, in addition to an incremental China VBP, we are still seeing lower volumes in elective coronary PCI, GI procedures, TAVR, spinal cord stem, and some less emergent surgical procedures. the slower-than-anticipated recovery in procedural volumes primarily occurred in developed markets, as healthcare systems continue to work through staffing and other challenges. Now, with regard to supply, we've made meaningful recovery, and many of the most acute issues are now behind us, including the acute packaging issues, which we highlighted last quarter. But some of the improvements did come later than we expected in Q2, and as a result, we missed cases in businesses like Surgical Innovations, and it has delayed our expected momentum. Now, focusing beyond challenges impacting our markets and product availability, we have a number of businesses where our strategy and execution are yielding results. Recall that we moved to the new operating model two years ago. We created highly focused, accountable, and empowered operating units that could move with greater speed and decisiveness. And today, we're clearly seeing the benefit of this model across many of our businesses, starting with cranial and spinal technologies. CST grew 5%, and this is despite a large negative impact from China VBP. In fact, our U.S. core spine business grew 15%. Additionally, this quarter, we launched our spine technology ecosystem, which we call ABLE, at the NASS conference. From planning to our best-in-class implants to navigation and robotic assistance to interoperative imaging and surgical tools, up to and including patient follow-up. Able brings spinal surgery together in one seamless and connected platform. And another highlight was our structural heart business, where our TAVR business grew 15% globally, including 17% in the United States. The launch of our Evolute FX valve drove 18% sequential revenue growth in our US TAVR business, despite being at full market launch for only the last month of the quarter. So we expect Evolute FX to drive momentum for us over the coming quarters. Our cardiac rhythm management business continues to execute and win share, with 4% growth in this quarter. Within CRM, our pacing business grew 6%, well above the market, with 18% growth of our micro family of leadless pacemakers. And we're looking forward to the commercial introduction of our Aurora EVICD in the back half of this fiscal year. So while we have businesses where the changes we've made over the past couple of years are clearly having a positive impact, we're also focused on ensuring these efforts translate into improved performance in all of our businesses. It's worth highlighting a few businesses where we are making strong progress to drive future growth over the near to midterm, and some that already have immediate momentum. Let's take Cardiac Ablation Solutions, a business that we expect to be a strong future growth driver. Pulse field ablation represents a large market opportunity, and we're looking forward to seeing our Pulse to AF pivotal trial results in the first half of the next calendar year, putting us on the path to be one of the first companies with a PFA catheter in the U.S. market, which we think is underappreciated. This is a meaningful growth opportunity for Medtronic in the next 18 to 24 months. And as you know, we closed our acquisition of Affair in August, and Affair's differentiated mapping and navigation system gives us the breadth and differentiation that we need to win share in cardiac ablation. And we expect to complete enrollment this quarter in the pivotal. This fully integrated system will be the first of its kind to offer a unique catheter that can perform high-density mapping and deliver both pulse field and radiofrequency ablation in a single device. Now in diabetes, we remain focused on resolving our warning letter. We've now completed 100% of our warning letter commitments and have informed the FDA that we're ready for re-inspection. We also remain in active review with the FDA on our submission of the MiniMed 780G system with the Guardian 4 sensor. And outside the U.S., we continue to receive positive customer feedback on the performance of the 780G, which is now available in over 60 countries. In Q2, 780G drove mid-teens growth for our diabetes business in international markets. And across diabetes, we're investing heavily in the development of multiple next-generation insulin delivery and sensor technologies. and we remain focused on restoring strong growth to this important franchise over the coming years. Turning to our Hugo Surgical robot. Now, I'm sure we're going to get into this in Q&A, but we saw a lot of positive momentum this quarter as we scale manufacturing production, expand regulatory approvals, and ramp installations. In addition, we just received FDA IDE approval last week on our product enhancements. Now, this allows us to start our U.S. urology clinical trial by the end of the calendar year and is a catalyst for continued progress with our international sales. Now, before I talk about our capital allocation and portfolio management, let me share my thoughts on the Ardian opportunity. Despite the impact we believe COVID and medication changes had on the ambulatory endpoint in OnMed, the totality of the data is compelling. The large drop in office blood pressure in the Ardian arm was impressive, and it was consistent with what we've seen in our other trials. Importantly, the current standard of care for reducing blood pressure, it just isn't working, which was evident in the long-term sprint trial results published just last month in JAMA Cardiology. Patients don't seem to stay on multidrug therapy for long periods of time and eventually just stop taking their medications. And that's the advantage of Ardian. It's always on. We've demonstrated that our Ardian procedure, it's safe, it's effective, and it's durable. Physicians are excited, and Ardian is preferred by patients. Now, we've submitted our PMA to the FDA, and we're looking forward to working with governments and payers in the U.S. and around the world who are searching for improvements to control high blood pressure and avoid the costly and devastating consequences of this disease. In addition to advancing our pipeline, we're focused on decisively allocating capital and streamlining the company to deliver durable growth. We're freeing up resources to invest more in R&D, feeding our fast-growing businesses in areas where we can see the strongest returns. Cardiac ablation solutions and diabetes are two clear examples of this. We're also making moves with our portfolio to focus our company and our capital on opportunities that are better aligned with our long-term growth acceleration strategies. Over the past two quarters, we've announced our intent to separate three businesses that we believe will thrive outside the company. With our renal care solutions business, we're progressing on the separation, forming a new kidney health technology company together with DaVita. We continue to expect this transaction to close in calendar 2023. And last month, we announced our intention to separate our combined patient monitoring and respiratory interventions business. We remain focused on active portfolio management, evaluating both potential additions and subtractions to further accelerate our growth and create value for our shareholders. Now with that, I'll turn it over to Karen to discuss our second quarter financial performance and our guidance. Karen?

Thank you, Jeff. Our second quarter organic revenue increased 2.2%, up significantly from Q1, but below our guidance range, given the challenges Jeff mentioned. Yet with a focus on expenses, our adjusted EPS of $1.30 landed at the upper end of our guidance range. Currency had a significantly unfavorable impact of 5.8% on our reported revenue growth. our FX hedges mitigated that impact on the bottom line, with EPS down only one cent, or 80 basis points, from currency. Looking at our results from a geographic perspective, our U.S. revenue grew 1%, our non-U.S. developed increased 3%, and emerging markets grew 4%. Our emerging markets growth continued to be affected by China, which declined 9% given the impact of a national tender in our spine business and several provincial tenders in certain other businesses. However, we continue to see strong double-digit growth in our other markets, including mid-20s growth in Eastern Europe and mid-teens growth in Latin America. In fact, excluding China, our emerging markets grew 15%. Turning to our margins, our adjusted gross margin of 67.6 percent declined 120 basis points from inflationary pressures in materials, direct labor, freight, and utilities. We expect these inflationary pressures to continue and to impact the back half of this fiscal year more than what we experienced in the first half. Our adjusted operating margin of 26.6% declined 40 basis points, including 120 basis point benefit from our currency hedging program. Compared to the first quarter, our operating margin improved 270 basis points, given accelerated revenue growth. We expect sequential improvement throughout the fiscal year. We continue to maintain a strong balance sheet, I would note that the vast majority of our debt is fixed at low rates as we move into a higher rate environment. Regarding our capital allocation, we continue to balance investing for the future with returning capital to shareholders, and we remain committed to our dividend and to returning a minimum of 50% of our free cash flow to our shareholders. Now turning to our guidance, Today, we set our second half revenue guidance at 3.5% to 4% organic, which excludes currency movement and revenue from our Intersect ENT acquisition. If recent exchange rates hold, foreign currency would now have a negative impact on our back half revenue of $930 million to $1.03 billion. Our back half guidance translates into a reduction of our annual guidance, driven by a slower pace of market and supply recovery. On market, we are expecting incremental provincial tenders in China, particularly in stapling and cardiac ablation. And Jeff referenced earlier that some procedure volumes in the second quarter didn't recover as quickly as we were expecting. So at this point, we are assuming no incremental improvement in the back half. On supply, while we have had a meaningful recovery, it came later than anticipated, particularly in SI and cardiac diagnostics. And that simply delays our pace of recovery ahead. By segment in the back half, the majority of the reduction is in our medical surgical portfolio. which we now expect to be flat to up 0.5%. We expect cardiovascular to grow five and a quarter to five and three quarters, neuroscience to grow six to six and a half, and diabetes to decline in the low single digits, all on an organic basis. Our total company revenue guidance does assume continued revenue growth acceleration. which we saw in each month of the second quarter. We expect the third quarter growth rate to be better than the second and the fourth quarter better than the third. We will have easing comparisons in ventilators, improving supply in certain businesses like cardiac diagnostics and SI, and the benefit from product launches like Evolute FX and EVICD. In the third quarter, we expect organic revenue growth in the range of 2.5% to 3%, an acceleration from the second quarter. And assuming recent exchange rates hold, the third quarter would have a currency headwind between $460 and $510 million. By segment and on an organic basis, We expect medical-surgical to be down two to two and a half percent, an improvement from the second quarter, given lesser vent headwinds and the impact of the flu season. Cardiovascular to grow four and three quarters to five and a quarter on the continued rollout of EvolutFX and Link2. Neuroscience to grow five and three quarters to six and a quarter improving from the prior quarter with less VBP impact in spine, and diabetes to decline in the low single digits. On the bottom line, we are driving significant expense reduction throughout the company to help offset the lower revenue and continued inflation impact. And now expect fiscal 23 non-GAAP diluted EPS in the range of 525 to 530. That range includes an unfavorable impact of currency of approximately 18 cents at recent rates. For the third quarter, we expect non-GAAP diluted EPS to be in the range of $1.25 to $1.27, including an FX headwind of about 5 cents at recent rates. Amidst the macro-environmental headwinds we face from inflation, China VBP, softer procedure volumes in certain markets, and currency, we are laser-focused on driving operational and expense efficiencies. We are also committed to invest appropriately for the long term, allocating capital to our most promising growth drivers and executing tuck-in acquisitions designed to reach more patients and create value for our shareholders. As we approach Thanksgiving, I want to share my gratitude to our employees who have been committed, particularly during these challenging times, to deliver on our mission to alleviate pain, restore health, and extend life for millions of people around the world. Back to you, Jeff.

Thank you, Karen. Now, before we open the lines for questions, I want you to know that our growth rate and our consistency are not where we want them to be. That's why I shared with you our aggressive agenda to transform this company two years ago when I became CEO. We embarked on a plan of implementing a new operating model, eliminating the bureaucracy of our groups and forming more nimble operating units, while at the same time learning to leverage our scale. We set in motion a new performance-driven culture, and we changed our incentive plans to reward new behaviors and performance. We brought in new leaders to inject new ways of thinking in the organization, and we implemented new capital allocation and portfolio management processes. Now, these changes take time, and we face setbacks along the way that have slowed us down. Some are environmental, like COVID recovery rates, raw material shortfalls, and Chinese procurement policy, while other setbacks are of our own doing, like our quality and operational challenges and the pace of improvement we anticipated. Look, I know we have more work to do here, but we understand the root causes that led to the years of underperformance from this company. And our aggressive transformation agenda is designed to fix these issues. I know we will get this right. Choosing the right markets. Being more efficient and productive with our resources. Empowering businesses and increasing accountability. Improving our quality, our manufacturing and our supply chain. And turning our size and scale into an advantage. And I know we are on the right path. The progress we've made so far gives me that confidence. We have experienced leaders, a compelling pipeline, and positions of strength in some of the most attractive medtech markets, which address significant unmet needs for patients. We will execute on our plan to deliver durable growth that we began two years ago. And as we do, we will create tremendous value for all of our stakeholders. So now let's move to Q&A. 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. With that, Brad, can you please give the instructions for asking a question?

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

All right, we'll take the first question from Robbie Marcus, JP Morgan. Robbie, please go ahead.

Great, thanks for taking the questions. Maybe I'll ask a two-parter up front. You know, the missing in the top line in the quarter and the guy down was pretty significant for the second half of the year. You know, you point to slowing procedure growth or not a recovery that you were hoping for, yet it's different from what we're hearing from most of your peers in terms of stabilizing volume growth. So I was hoping you could spend more time, walk us through what Medtronic's seeing and maybe why it's a little different relative to peers in terms of the recovery and the stabilization in volumes. And then as we think out to next year in fiscal 24, you gave some rough thoughts on the last call about FX and how we should be thinking about growth for next year. Any updates to that growth, and does it change with the updated second half guidance range? Thanks a lot.

Robert Hopkinson Okay, thanks, Robbie.

Okay, I saw three parts there. I'm going to ask Karen to chime in to help me here on this one, but provide some details. But on the MIS, like we said in the commentary, The primary issue is the pace of the recovery, and there's the two buckets. There's the pace of our supply recovery, which we did make quite a bit of progress there, and they got over the most acute issues that were that were plaguing us, but, but happened a little, uh, it happened late in the quarter and pushed out our momentum, which gets to the second part of your question, which is the, uh, affects the guy down. The, the other bucket is part of your second question as well as on the markets. You know, many of our businesses are back, uh, you know, the, the majority of them are back, uh, to that pre COVID level, their markets, but there are some that, that are not. And I'll let Karen walk through those. And, and we, we, you know, we were, um, you know, we just overstated what that market recovery would be. And we'll walk you through those and how those impact the second quarter, the second half. Karen, you want to?

Yeah, thanks, Jeff. And thanks, Robbie. So, you know, let me talk about it more broadly than your question to Robbie, because I know you asked a specific question on procedure growth. So I'll talk about that and a little bit more broadly. So just on those two buckets, first on our markets, you know, some of our markets have not returned to normal growth levels. And this does account for about for over half of the reduction in our in our second half guide. You know, you talked about competitors. You know, you've heard from from some of our competitors about a slow recovery in the neuromon market and the TAVR market. And, you know, we're also seeing a slow recovery in basic coronary PCIs and some general surgery procedures that we mentioned in the commentary. And because these markets have not accelerated as quickly as we had anticipated, we've decided to assume volumes in the back half remain at Q2 levels. You know, if those volumes improve in those markets, that would be upside. We also talked about related to markets that we're expecting additional provincial tenders in China. And those were ones that we believed would occur next fiscal year and are occurring sooner, particularly in stapling and cardiac ablation. And then, you know, on the second bucket of supply that Jeff mentioned, we obviously did see meaningful improvement over the second quarter. But some of that happened late in the quarter, as we said, and that pushes out our assumptions for share recapture. You know, for example, and particularly in SI, while we were short on supply, our competitor benefited. You know, they stepped in to fill the shelves with our customers. We're under long-term contracts with those customers, so we will gain our share back. There's just a lag while the shelf inventory comes down. So hopefully that gives you some context on our guide this morning, but just to summarize, You know, in addition to our assumptions on market growth, we assume incremental contribution from products that we've recently launched and supply that has recently improved. You know, on your question on FY24, you know, it's still early. We have two quarters to go, and we're at the beginning of our planning process, so we're not going to give FY24 guidance on this call. But I will say a few things, including currency, because that was your question. You know, first, on the top line, you can see that we expect to exit the year with mid-single-digit growth. And that's a great place to start the following year. Second, down the P&L, we're still in a challenging operating environment with inflation, interest rates, and currency, as you mentioned. And on currency, we now estimate that to be a 36-cent headwind on the bottom line in FY24. And that's obviously worse than the 18 cents that I mentioned for FY23. And third, you know, we're purposely driving significant expense reduction given these headwinds and given our focus on continuing to drive long-term investments for the company. So we've got several puts and takes for next fiscal year, and we plan on giving you more on FY24 as we move through the back half.

Great.

Thanks for all the color. Thank you, Robbie. We'll take the next question, please, Brad.

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

Hey, good morning, everybody. A little bit more color on FY24 as it relates to China VBP. I don't know if there's any way to think about how much of the China VBP stuff hits in FY23 versus FY24, given some of the new ones like EP and even Neuro. And then I did want a little bit more color on TAVR as well, given the strong U.S. result there. Curious if you could kind of comment a little bit on the TAVR market and also share. I don't know if you can say how much share you think you took this quarter in U.S. TAVR.

Yeah, so thanks for the question, Travis. Why don't we start with the TAVR one, because the market didn't grow quite as much as we had hoped, but it still was a strong growth driver for us, and we did do well from a share perspective. And why don't we have Sean maybe comment on that, and then we'll come back and help Karen talk about the VBP part of the question. Sean?

Yeah, Travis, I think we took about a half a point of share for the full quarter, and it was really driven by the last month of the quarter where we picked up some of that momentum in October with the launch of the Evalute FX. We're in about 400 accounts with that so far, so we've got some room to run there for the back half of the year. But that's very strong. I think the underlying market is still in the kind of high singles area, and I think that that's really, as you know, just conspired against by the resource intensity that's required. You've got this whole chain of events where you have to have a patient go through imaging prior to their eventual procedure, and there's a lot of handoffs along the way. So those dynamics continue to play out around the world, but probably more in Europe and France and Germany than we see in other countries. And then we had a little bit of slowness on our own throughout through Japan. Japan had a flare of COVID through the summer, which was difficult. And we also had a problem where there was a sheet that we use for the procedure that we don't make that became unavailable because supply challenges and that led to some share loss in Japan. But overall, you know, the TAVR momentum is really strong for us with FX launching and we're excited about back half to get to a full release of that product into all the accounts.

And on your China VBP question, Travis, you know, about 15 to 20 percent of our back half guide down is due to the incremental China VBP being pulled forward from next year from our perspective, from what we had assumed. You know, China declined 9 percent in the second quarter, and that was because of an impact of VBP and spine. For the rest of this fiscal year, we don't expect China to be a material growth driver for us. And in fact, for the full year, we're expecting low single digit declines in China. That said, as we look forward into FY24, you know, we'll continue to have some VBP, but I think the vast majority will be behind us. And, you know, China should be a contributor of growth again next fiscal year.

Just a little bit more color in the VBP. I mean, we had visibility to these national tenders, and we factored that in earlier in the year. But what we didn't have real good visibility to some of these provincial tenders that came out here in the last couple of months. And that's part of the change in the guidance. And to Karen's point, longer term, we still think China is a growth market, but it's not right now. And we factored that into our guidance.

Great. Thank you. Thank you, Travis.

Yep. Next question, please, Brad.

The next question comes from Vijay Kumar at Evercore ISI. Vijay, please go ahead.

Hey, guys. Thanks for taking my question. Jeff, my first question was on this back half guidance. You know, when you look at 2Q, second quarter organics, like north of about 2%, and the back half guidance of 2.5% to 4%, how big a risk is that 2.5% to 4%? Can you give us a bridge on what gets easier. I think you had some easier when comes, et cetera. And I think related to that, you know, is this, you know, why is Medtronic confident that this is not a permanent share loss in surgical innovations?

Okay. Thanks for the question, Vijay. Let me take the, well, I'll take the share loss question first and then I'll get to the back half and maybe I'll Karen talk to that one as well. But in SI, or surgical innovations, first of all, this is a contracted business with health systems, but mainly us and our main competitor in that space. And in the past, there have been circumstances when the shoe is on the other foot, when our competitor had a a recall and and have had recalls and and we did the same thing where we you know got a picked up some incremental revenue and some share uh you know because uh the the the two big competitors are make up the majority of of of what the hospitals are buying in the surgery space But these hospitals do honor these contracts. There's a lot that goes into them. And, you know, that revenue went back after the supply situation was resolved. And so we've seen that over the years on multiple times. So these are contracted, you know, like I said, contracted business for us. And based on our dialogue with the health systems, you know, we're confident this is going to come back as our supply, which we mentioned, We did get past the most acute part of our supply issues in the surgical innovations business was this packaging issue. It did come later in the quarter and slower momentum, but we do have momentum now, and you should see that business recover. On the back half, I'll ask Karen to...

Yeah, thanks, BJ. You know, when we look at our back half ramp, we have new products. We've got TAVR with Evolute FX that Sean's mentioned was only in the market for a month in Q2. So we expect continued growth from that. We've got Hugo starting to ramp. We've got our Harmony Valve returning to the market. We've also got our diabetic painful neuropathy opportunity that will be driving more in the back half. And we've got supply returning, you know, we've got, you know, supply returning for our link to product and our cardiac diagnostics, and also better supply and SI and ICDs. And we've got reduced headwinds, you know, our sale events and aortic grafts are normalizing. So all of those things really lead to, you know, the back half ramp. Hopefully that's helpful.

Yeah.

So, I mean, beyond the supply returning, you know, the back half is, you know, Karen walked through a lot of it, is really powered by, you know, very, you know, very tangible things beyond supply, product related. They're tangible and compelling.

That's helpful, Jeff.

And then maybe one related, you know, I think in the past, Medtronic has, you know, you know, thought about itself as a mid-single-digit top-line company in light of these results, but is that mid-single-digit LRP still intact? Does Medtronic need to supplement this growth with M&A? Thank you.

I didn't hear the very last part of it. Does Medtronic...

But the answer to your question is yes. I mean, the mid single digit growth will exit the year at mid single digits. You see throughout this year, you're seeing the acceleration from the first quarter. which was the depth of our supply issues. We were really in a tough spot. We were down minus four. Then this past quarter, on an organic basis, up two. And then Karen walked us through the back half guide. But we exited the year at mid-single digits. And we believe that's durable, like I said, based on these product launches that are here now. So immediate drivers. And then Karen brought up a list of of things that are, you know, already kind of tangible in the back half. But, you know, there's a number of other things that are still coming, you know, the Aurora EVICD, you know, PFA, you know, and AFib, and Inceptive with eCAPS and our SCS business. And then there's the whole diabetes discussion with those products coming on in the U.S. in the next year. And, you know, the Hugo ramp will go on for a while. So there's a number of things that keep us going.

And so that's why we feel good about the mid-single digit.

Thank you, Vijay. Next question, please, Brad.

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

Hey, can you guys hear me okay? Yes. Hey, Larry.

Great. Hey, good morning. Thank you for taking the question. Maybe on diabetes for Q, So, Q, just a multi-part question here. Did you ask for a variant on 780G? And if so, what was the response, or when will you know? And if you don't get a variant, you know, do you need re-inspection for 780G clearance, and how long do you expect that to take? And just lastly, on 780G, do you expect it to have the same impact in the U.S. as you've seen outside the U.S.? Thanks for taking the question.

Thanks, Larry. So on your first question, no, we did not ask for variants. We've been focused on lifting the warning letter. I'm pleased to say that we are 100% complete on the warning letter commitments, and we have welcomed the FDA back in to assess our current status. So I think that's forward progress and that's the clearest path because obviously it's not just 780, but it is a whole pipeline of innovation that we we care about from a growth perspective. So there's progress there. It's very hard to say timing on that. I think that's up to the agency. We know they're working very hard on that. So we anticipate you know, progress there as well. On your question around 7AG progress in international markets, we're very pleased with the double digit performance there. We do expect to see something similar in the US market once approved. We are actually doing, we've been really happy with how 770G has performed in the US market. It's helping to stabilize attrition here. And as you know, our customers have a free upgrade option with 770 once approved in the US market. And sorry, Larry, I missed your second part of the question.

No, that's helpful. I guess why didn't you ask for a variant in the U.S.? It seems like a, you know, kind of no risk, you know, option here. So why not ask for it? Thank you.

Primarily because, as we've stated, we've been focused on really the long-term lifting up the warning letters is critically important. It's, you know, It's not just about 780G, but it's all about the pipeline. You know we submitted Simplera for CE Mark this year. We just submitted 780G with Simplera IDE last week. So there's a long line of innovation that we are interested in. And we were also very pleased with the progress we're making on correcting the warning letter commitment. So with those things progressing at the pace, we did not feel it was necessary to seek a variance. All right.

Thanks so much for taking the question.

Thank you, Larry. Next question, please, Brett. The next question comes from Matt O'Brien at Piper Sandler.

Matt, please go ahead. Okay, there seems to be a problem, Matt, with your audio.

Maybe we'll take the next question, Brad, and then we'll try to come back to Matt. Yep. The next question comes from Josh Jennings at Cowan & Company.

Josh, please go ahead. Josh, you there? Hi, yes. Hi, can you guys hear me okay? Can you guys hear me? Yeah, we can hear you, Josh.

Oh, okay, great. Sorry, just want to make sure. Just one, maybe for Jeff and maybe Sean as well, just on the renal denervation program and I think it's well understood that the totality of evidence can get you approval. I believe that your team has had preliminary discussions with payers, and it might be helpful just in terms of better understanding your optimism that not just approval could be in hand in the next six to 12 months, but payer decisions will ultimately be positive. And then the follow-up is just on supply, and just want to make sure I'm clear on the dynamics here. and just the recovery and regaining momentum is what's left, but is the supply chain, are those headwinds gone? And just should we be expecting, I know your team has executed on the streamlining or consolidation of operations and supply chain functions, and we start to see a benefit from those efforts in fiscal 24. Thanks for taking the questions.

Well, maybe I'll start with the, you know, the supply, you know, situation. You know, are the supply chain issues gone? Not completely, but, you know, the biggest issue pain, or if you will, is behind us, especially in surgical innovations with the packaging, as I mentioned, issue. You know, what lingers a bit would be, like we've talked about before, some semiconductor, I'd say, constraints. But the changes that we've made to our supply organization, you know, with the new leadership under Greg, the new structure, bringing in new people to help us with capabilities where we thought we weren't where we needed to be implementing new systems and new processes. And these changes, you know, I believe are are durable. I mean, they are. So, you know, we're going to get we're getting through this. The worst is behind us. We factored in the update into the guidance. But there are some, I mean, like some issues that are outstanding, like the semiconductors, but all that's factored in. And we feel good about going forward, not just FY24, but beyond that. You know, regarding Ardian, you know, look, I'll ask Sean to chime in here. But look, as you look at the data, you know, we believe it's very compelling, you know, and you see that the sham arm, in the trial and increased their medication and the RDNR reduced. And the difference is 10X. I mean, it's a significant difference. And when physicians look at it, they understand this and are excited about it. And why we're optimistic with payers is because health systems and governments are really focused on, and payers are focused on hypertension. which, you know, and like the current standard, as I mentioned, the commentary just isn't working. And more data came out to substantiate that in September and physician, you know, to substantiate what people already know. And so now there's a new option. And I think payers are going to be compelled to take it seriously, especially with the public health epidemic that we're facing here. Oh, Sean, do you want to chime in and add some more color to this?

Yeah, you said it well, Jeff. And, you know, Josh, you're right. The totality of the data is really the strength of this program compared to just about any other new therapy I can think of. There's really not a lot of comparisons for just how much good data we have here. Some are 3,000 patients with real-world data on top of the sham-controlled randomized studies. And importantly, we did a patient preference study, which is getting more and more considered by payers because they know that patients have a say in what they want to go do. And there's a large majority of patients that prefer having a procedure versus adding just even one more drug. And of course, we can get their blood pressure down without the addition of drugs, which is a huge benefit. And I'll remind you also that Ardian was a breakthrough device, had that designation, and in the world of MSIT ruling, that would have meant automatic coverage. We don't know yet what the T-SIT pathway is going to look like. We'll find out more about that in the fall timeframe, I suppose, or in the spring timeframe. But we do think that the novelty of this therapy, the desire of patients, and of course, the public health benefit that this can provide is going to be compelling to both public and private payers around the world.

Thanks, Josh.

Take the next question, please, Brad. Yeah, we'll try Matt again. The next question will come from Matt O'Brien at Piper Sandler. Matt, are you there?

How about now?

We can hear you now.

Yeah, we can. Thanks for taking that question. Sorry about that. I guess, you know, just to follow up a little bit on Josh's question, and I know how enthusiastic you still are about RDN, but, you know, I think the ambulatory number is one that is a little bit more robust than the office-based number. So why would clinicians and payers be so interested in doing these cases or paying for them, given the ambulatory feedback that we've seen? And are you guys still thinking about the market as $500 million by 26 and $3 billion by the end of the decade?

Sean, you want to get into the specifics on the ambulatory versus the office?

Yeah, Matt, I think if you just recall how that study was done, the patients were witnessed taking their blood pressure medicine in the morning. And, you know, whether they were taking that for the full six months or not, or if they just took it that day, you saw this change in blood pressure that was during the daytime, not what we'd seen before in this prior trials. But at nighttime, there was still a reduction ambulatory. So I think the simple story here is that patients weren't taking their medications except on game day, and their blood pressure dropped. Now, we don't know that for sure. We didn't test blood and urine every day. We just tested on game day. And we know that there were more medications in the patients that were in the control arm than in the treated arm. And as Jeff said, the changes, increasing medication, decreasing medication, taking even medications for blood pressure that weren't even prescribed, maybe from their medicine cabinet, maybe from their spouse or partner's medicine cabinet. There's a lot of changes in medicine in which we know were present, different than the prior studies. We actually have that proof now that we can measure the drug metabolites. So a cleaner, if you will, measure is that morning blood pressure we took, the office blood pressure. And that blood pressure is the one that's used for all the epidemiology tests, studies that show what the reduction in blood pressure means for the avoidance of events and reduction of cost. And it's also the primary endpoint that's gotten just about every, I think maybe every pharmaceutical approved for the treatment of high blood pressure. So it is the robust standard. In fact, ambulatory is not even reimbursed in this country. So it's not used routinely in clinical practice. So it is a robust measurement that was consistently performed throughout this trial and across the other trials that we've done. So I'm confident in that part. In terms of the market size, we're very confident in this therapy. There's a billion people with blood pressure problems around the world. Even a very small amount gets you to the kind of market growth that we think is going to be meaningful for the company. So we're very confident in this therapy and about its approval and ultimate uptake.

Okay, that makes sense. I appreciate that. And it's not a related follow-up, but turning over to cardiac rhythm for a second, just, you know, I'd love to hear about the competitive dynamics that are going on with micro because you've got a competitor there now, and then what the expectation is with EVICD, you know, given the longstanding presence of another What should we be expecting between those two as we progress over the next 12 months? Thanks.

Yeah, so for micro, we're continuing to grow. And you saw 18% globally. 40% of that was from international sales. And really, Japan and China in particular really drove that great and continued success. And we'll see continued penetration in international markets and in the U.S. And a shift between single chamber to the international market AV device, which can pick up a larger proportion of patients. It's about 30% of the market there. And the next 12 months, we're going to refresh both the VR and the AV devices in the coming year around the world. So, you know, while we have some competition here in the United States, we've shared pretty well. I think the ease of use of our micro device and the long-term data that we have, as well as just, you know, the familiarity with our system has made it pretty durable. On Aurora EVICD, as you know, we've got CE Mark coming up. That's a little bit of a different technique. You've got to put a lead underneath the breastbone, which takes some training to learn and will be very meticulous the way we roll that out. But make no mistake, that is a product that really offers a huge benefit, getting leads out of the heart, having half the size in the can and twice the battery life compared to the other device in that realm. and being able to avoid shock by pacing people out of their fatal arrhythmia, as opposed to having to have a painful shock. Those are all really, really welcome improvements, and we're excited to roll that technology out, first in Europe and then the United States next year.

Yeah, our cardiac rhythm business has done well, and we expect it to continue to do well with products like Micron, EVICD, but also you know, pioneering conduction system pacing. And we've got a nice pipeline there and a really strong leadership team and strong position. So thanks for the question, Matt.

Thank you, Matt. Next question, please, Brad.

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

Hey, guys. Thanks for taking the question. You can hear me okay. Sorry guys. Did you hear me?

Okay.

Yeah, we can Matt.

Okay. Sorry. So I wanted to just explore, you talked about, you know, the slower recovery and some of these elective and developed markets. And obviously there's staffing, but you said other challenges, I guess maybe you could just give us some insight into two things. One is, could you talk a little bit more about procedure trends through the quarter? Did you see any, any improvement? And then what gives you the, the confidence or what intelligence do you have to point to whether this is really staffing or I think investors are worried about lack of pent-up demand. Could you just address that?

Sure. I'll ask Karen to comment on the procedure trends through the quarter, and then we can talk to the staffing issue here.

Yeah, so I would say through the quarter, we did see, particularly in the markets that we had mentioned, not as robust recovery, but some recovery. But as we ended the quarter with less robust recovery, we're just assuming that in those areas, those procedures stay where they were in the back half. We'll see if that's a good assumption or not. As we look at the first quarter, you know, few weeks of our current quarter, of the third quarter, we are seeing improvement from the second quarter. You know, so that's, you know, that's pointing to some good things, but we'll see.

Yeah, so just to, you know, highlight what Karen's saying there. I mean, we, you know, we are disappointed that we missed the call on this one for the Q2. And so now in our guidance, we've assumed a prolonged recovery here, especially for those segments that we called out. You know, not all the segments, you know, like we said, many of the segments are back to pre-COVID, but there are a handful in those electives and developed markets that we've called out. And Karen walked you through the assumption for the back half of the year. In terms of the staffing, you know, I hear that dynamic in some of the cardiology spaces, you know, more than others. And maybe I'll have Sean comment on that.

Yeah, I'd say a couple of things to that. Jeff, first of all, you take a therapy like TAVR where there's multiple handoffs. You have to have pre-imaging. You have to get the patient worked up. They get their procedure done. And then there's sometimes even post-imaging that's done. So a lot of handoffs, and the patients tend to be elderly. So you want to make sure you schedule that in a way that's okay, that they can get it all done in an efficient way. You don't want them exposed to the healthcare environment for a long time. And I think that's challenging. It's also true that you can't wait forever. You've got, with severe aortic stenosis, there's about a 80% mortality rate for two years from your diagnosis of that. So it's more lethal than cancer, for example, most cancers. So it's not something you can put off forever, but it is resource intensive. And I think the other thing we're seeing with staffing just in general is there's a prioritization for patients that can get in and out relatively quickly so they can make downstream staffing available. So whether that's ICU recovery or you've got to even transport that you've got to move. And I think there's some arbitrage in some countries, even on the margin that they make on those procedures. Cardiac surgery has been growing like at 5.5% for us, so very robust. There's a lot of margin that comes out of cardiac surgery patients. They tend not to be as deferrable as, say, like a PCI patient, for example. So, you know, we hear it in pockets. I mentioned before, France and Germany seem to be some places that are really struggling with staffing in Europe, and we see it just in pockets around the United States and other places. So it is a dynamic situation, and we think it has gotten better, certainly a lot of places, but not everywhere yet.

Okay. Thank you, Matt. Next question, Brad.

Yeah, the next question comes from Pito Chickering at Deutsche Bank. Pito, please go ahead.

Hey guys, thanks for fitting me in here. I know that you don't have a ton of exposure here, but there has been a healthy debate around hospital demand for capital equipment this year. Can you give us any color in what you're seeing from behavior changes in hospitals for capital ordering and 2Q and what you guys assume with the back half of the year?

Our capital, first of all, isn't a huge piece yet of our revenue, but it tends to be tied to profitable procedures. We actually had a strong capital performance in the last quarter, especially in our cranial and spinal technologies business, CST. Our capital there, we had a number of our navigation, interoperative imaging, had record capital quarters for us. So we're, you know, we definitely see a bit of a, takes a little longer to close a deal, but the demand as you're working with the hospital on how they're going to pay or finance this, but we're having strong demand in those areas. And then, of course, we mentioned Hugo. Hugo's still new for us, but we are very happy with the placements we've been able to make on Hugo here.

Of course, those are outside the U.S., But very pleased with that.

Male Speaker 1 Great.

Thanks so much.

Male Speaker 2 Thank you, Beto. We've got time for one more question, please, Brad.

Male Speaker 1 Yep. Our final question comes from Joanne Wench, Citi. Joanne, please go ahead.

Joanne Wench Hi. Can you hear me?

Male Speaker 2 Yes, Joanne. Good morning.

Joanne Wench Wonderful. Good morning and an early happy Thanksgiving. You know, this led straight into my Hugo question. Could you give us a little bit of an update on how you feel about the market potential for the product, the timing of U.S. approval? And at one stage, several years ago, you were talking about the potential contribution. Is there a way to start thinking about that again? Thank you.

Sure. Well, thanks for the question, Joanne. Like I said, we have good news on Hugo. We're kicking off the U.S. IDE with our first cases scheduled for December based on, you know, getting these instruments enhancements approved. And like I just said to Peter, you know, we are pleased with the system placements. And in terms of the other color commentary on that, I'll ask Bob White to chime in.

Bob White Yeah. Thanks, Jeff. And thanks, Julian. Good morning. A couple of thoughts here. First, on the overall market for Hugo, we continue to be really excited about it. Remember, there's around the world still, you know, 95% of eligible cases are not done that could be done robotically, assistively. So we believe this is a true market expansion opportunity. So we feel really excited about the continued long-term health of the market and excited to be the number two player in this space. With respect to the timing of U.S. approval, as Jeff mentioned, we expect to begin our U.S. IDE by the end of this calendar year, so that's exciting. Actual approval in the U.S., of course, depends upon the agency and the process there, so I really can't comment on that. And overall, with respect to the contribution, as you mentioned, I think it's early to call that, but given our system is now Installed around the world in markets in APAC, EMEA, LATAM. We just received regulatory approvals and indication expansions in Japan, which is the third largest robotics market in the world. We have general surgery approval in the EU, Canada, and Australia, which opens up the hernia market for us. And we've started to see really strong presence at some really key Congresses in Europe where, you know, live stream cases, et cetera. So a little earlier to call it contribution, Joanne, but we're starting to see the momentum and the acceleration that we talked about. So thank you.

Thanks, Joanne. Thank you, Joanne. Jeff, please go ahead with your closing remarks.

Okay, thanks, Ryan. Well, first of all, thank you everybody for the questions. And we do really appreciate your support and continued interest in Medtronic. And we look forward to updating you on our progress on our Q3 earnings broadcast, which we anticipate holding on February 21st. So with that, thanks again for tuning in today. Please stay healthy and safe. I understand there's a lot of people traveling this holiday. And for those of you in the U.S., I'd like to wish you and your families a very happy Thanksgiving.