Medtronic Plc (MDT) — Q2 2023 Earnings Call Transcript

Good morning. I am Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations and welcome to our session in Minneapolis. I appreciate that you are joining us today for Medtronic’s Fiscal Year 2023 Second Quarter Earnings Video Webcast. Before we go inside to hear our prepared remarks, I will 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 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 will 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-GAAP financial measures can be found on 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.

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 1 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 are making improvements to the operational health of the company and we are streamlining the company’s structure and taking cost out. All of this gives us confidence that we are 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 stimulation, 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 have 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 2 years ago. We created highly focused, accountable, and empowered operating units that can move with greater speed and decisiveness. And today, we are 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 Aible at the NASS conference. From planning to our best-in-class implants to navigation and robotic assistance to intraoperative imaging and surgical tools, up to and including patient follow-up. Aible brings spinal surgery together in one seamless and connected platform. Another highlight was our structural heart business, where our TAVR business grew 15% globally, including 17% in the United States. The launch of our Evolut FX valve drove 18% sequential revenue growth in our U.S. TAVR business, despite being at full market launch for only the last month of the quarter. So, we expect Evolut 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. We are looking forward to the commercial introduction of our AURORA EV-ICD in the back half of this fiscal year. While we have businesses where the changes we have made over the past couple of years are clearly having a positive impact, we are 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 mid-term and some of that already have immediate momentum. Let’s take cardiac ablation solutions, a business that we expect to be a strong future growth driver. Pulsed Field Ablation represents a large market opportunity, and we are looking forward to seeing our PULSED 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 the 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. As you know, we closed our acquisition of Affera in August, and Affera’s differentiated mapping and navigation system gives us the breadth and differentiation that we need to win share in cardiac ablation. 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 pulsed field and radiofrequency ablation in a single device. Now in diabetes, we remain focused on resolving our warning letter. We have now completed 100% of our warning letter commitments and have informed the FDA that we are ready for reinspection. We also remain in active review with the FDA on our submission of the MiniMed 780G system with the Guardian 4 Sensor. 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. Across diabetes, we are investing heavily in the development of multiple next-generation insulin delivery and sensor technologies. We remain focused on restoring strong growth to this important franchise over the coming years. Turning to our Hugo surgical robot, I am sure we are 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. Additionally, we just received FDA IDE approval last week on our product enhancements. 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. 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 ON MED, 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 have seen in our other trials. Importantly, the current standard of care for reducing blood pressure 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 multi-drug therapy for long periods of time, and eventually just stop taking their medications. That’s the advantage of Ardian; it’s always on. We have demonstrated that our Ardian procedure is safe, effective, and durable. Physicians are excited and Ardian is preferred by patients. We have submitted our PMA to the FDA and we are 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 are focused on decisively allocating capital and streamlining the company to deliver durable growth. We are 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 are 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 have announced our intent to separate three businesses that we believe will thrive outside the company. With our Renal Care Solutions business, we are 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. 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.

Thank you, Geoff. Our second quarter organic revenue increased 2.2%, up significantly from Q1 but below our guidance range, given the challenges Geoff 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 foreign exchange hedges mitigated that impact on the bottom line with EPS down only $0.01 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% 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 a 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 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, 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. Geoff referenced earlier that some procedure volumes in the second quarter didn’t recover as quickly as we were expecting. 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 5.25% to 5.75%, neuroscience to grow 6% to 6.5%, 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 Evolut FX and EV-ICD. In the third quarter, we expect organic revenue growth in the range of 2.5% to 3%, an acceleration from the second quarter. Assuming recent exchange rates hold, the third quarter would have a currency headwind between $460 million and $510 million. By segment and on an organic basis, we expect Medical Surgical to be down 2% to 2.5%, an improvement from the second quarter, given lesser event headwinds and the impact of the flu season. Cardiovascular is expected to grow 4.75% to 5.25% on the continued rollout of Evolut FX and Linq 2, neuroscience is expected to grow 5.75% to 6.25%, improving from the prior quarter with less VBP impact in spine and diabetes is expected 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 $5.25 to $5.30. That range includes an unfavorable impact of currency of approximately $0.18 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 $0.05 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, Geoff.

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 2 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. 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, increasing accountability, improving our quality, our manufacturing, and our supply chain, and turning our size and scale into an advantage. 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 2 years ago. As we do, we will create tremendous value for all of our stakeholders. So now let’s move to Q&A. We are 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?

We will take the first question from Robbie Marcus, JPMorgan. Robbie, go ahead.

Great. Thanks for taking the questions. Maybe I’ll ask a two-parter upfront. The miss in the top line in the quarter, the guide-down was pretty significant for the second half of the year. You point to slowing procedure growth or not a recovery they are 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 is 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 and fiscal ‘24, can you give some 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.

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 miss, like we said in the commentary, the primary issue is the pace of the recovery and there is the two buckets. There is 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 plaguing us, but happened a little – it happened late in the quarter and pushed out our momentum, which gets to the second part of your question, which is the effects the guide down. The other bucket is part of your second question as well as on the markets. Many of our businesses are back, the majority of them are back to the pre-COVID level of their markets. But there are some that are not. I’ll let Karen walk through those and we were – we just overstated what that market recovery would be, and we will walk you through those and how those impact the second quarter – the second half. Karen, do you want to?

Yes. Thanks, Geoff, and thanks, Robbie. 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, 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 second half guide. You talked about competitors. You have heard from some of our competitors about a slow recovery in the neuro market and the TAVR market. We are also seeing a slow recovery in basic coronary PCIs and some general surgery procedures that we mentioned in the commentary. Because these markets have not accelerated as quickly as we had anticipated, we decided to assume volumes in the back half remain at Q2 levels. 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. Those were ones that we believed would occur next fiscal year and are occurring sooner, particularly in stapling and cardiac ablation. On the second bucket of supply that Geoff mentioned, we 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. For example, particularly in SI, while we were short on supply, our competitor benefited. 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 is just a lag while the shelf inventory comes down. Hopefully, that gives you some context on our guide this morning. Just to summarize, 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. On your question on FY’24, it’s still early. We have two quarters to go, and we’re at the beginning of our planning process. We’re not going to give FY’24 guidance on this call. But I will say a few things, including currency because that was your question. 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. On currency, we now estimate that to be a $0.36 headwind on the bottom line in FY’24. That’s worse than the $0.18 that I mentioned for FY’23. Third, 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 FY’24 as we move through the back half.

Great. Thanks for all the color.

Thank you, Robbie. We will take the next question please, Ryan.

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

Hi, good morning, everybody. A little bit more color on FY’24 as it relates to China VBP. I don’t know if there is any way to think about how much of the China VBP stuff hit in FY’23 versus FY’24, 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. I’m 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?

Yes. So thanks for the question, Travis. On the – why don’t we start with the TAVR one because we – 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. I think Sean maybe comment on that, and then we will come back and help Karen talk about the VBP part of the question. Sean?

Yes. Travis, we think we took about half a point of share for that for the full quarter, and it was really driven by the late – the last month of the quarter where we picked up some of that momentum in October with the launch of the Evolut FX we’re in about 400 accounts of that so far. We’ve got some room to run there for the back half of the year, but that is very strong. I think the underlying market is still in the kind of high singles area. I think that’s really, as you know, just conspired against by the resource intensity that’s required. You get this whole chain of events where you have to have a patient go through imaging prior to their eventual procedure, and there is a lot of hand-off along the way. So those dynamics are continuing to play out around the world, probably more in Europe and France and Germany than we see in other countries. We had a little bit of slowness on our own through Japan. Japan had a flare of COVID the summer, which was difficult. 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 of supply challenges, and that led to some share loss in Japan. Overall, the TAVR is really strong for us with FX launching, and we’re excited about the back half to get a full release of that product into all the accounts.

And on your China VBP question, Travis, about 15% to 20% 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. China declined 9% in the second quarter. 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. In fact, for the full year, we’re expecting low single-digit declines in China. That said, as we look forward into FY’24, we will continue to have some VBP, but I think the vast majority will be behind us and China should be a contributor of growth again next fiscal year.

Just a little bit more color on the VBP. I mean we had visibility to these national tenders, and we factored that in earlier in the year. But we didn’t have real good visibility to some of these provincial tenders that came out here in the last couple of months. That’s part of the change in the guidance. 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. Next question please, Ryan.

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

Hey, guys. Thanks for taking my question. Geoff, my first question was on the back half guidance. When you look at 2Q, second-quarter organic slightly north of 2% and the back half guidance of 3.5% to 4%. How do you risk is that 3.5% to 4%? Can you give us a bridge of what gets easier? I think you had some easier wind comps, etc. And I think related to that, why is Medtronic confident that this is not a firm 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 have Karen talk to that one as well. In SI, our surgical innovations, first of all, this is a contracted business with health systems and mainly us and our main competitor in that space. In the past, there have been circumstances when the shoe was on the other foot when our competitor had a recall and have had recalls. We did the same thing where we got picked up some incremental revenue and share because the two big competitors make up the majority of what the hospitals are buying in the surgery space, but these hospitals honor these contracts. A lot goes into them and that revenue went back after the supply situation was resolved. We’ve seen that over the years multiple times. So these are contracted – like I said, it’s a contracted business for us. Based on our dialogue with the health systems, 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, which was the 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...

Yes. Thanks, Vijay. When we look at our back half ramp, we have new products. We’ve got TAVR with Evolut FX that Sean has 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 also got our Harmony valve returning to the market. We have also got our diabetic painful neuropathy opportunity that will be driving more in the back half. We’ve got supply returning. We’ve got supply returning for our LINQ II product in our cardiac diagnostics and improved supply in SI and ICDs. We’ve got reduced headwinds. Our sale events and aortic graphs are normalizing. All of those things really lead to the back half ramp. Hopefully, that’s helpful.

Yes. Beyond the supply returning, the back half, as Karen walked through a lot of it, is really powered by very tangible things beyond supply, product-related they are tangible and compelling.

Yes, that’s helpful, Geoff. I was wondering if Medtronic still views itself as a mid-single-digit growth company considering these results. Is that perspective still valid for the long-range plan growth? 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, we will exit the year at mid-single digits. You see throughout this year, you’re seeing acceleration from the first quarter, which was the depth of our supply issues. We were down minus 4%. Then this past quarter, on an organic basis, up 2%, and then Karen walked you 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 immediate drivers, and then we – Karen brought up a list of things that are already kind of tangible in the back half, but there are a number of other things that are still coming. The Aurora EV-ICD, PFA and Afib and Inceptiv with ECAPs and our SCS business and then there is the whole diabetes discussion with those products coming on in the U.S. in the next year. The Hugo ramp will go on for a while. There are a number of things that keep us going. That’s why we feel good about the mid-single digit. Thank you, Vijay. Next question please, Ryan.

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

Thank you. Can you, guys hear me, okay?

Yes. Hi, Larry.

Good morning. Thank you for taking the question. Maybe on diabetes for Que. So Que, just a multipart question here. Did you ask for a variance on 780G? If so, what was the response or when will you know? If you don’t get a variance, do you need reinspection for 780G clearance? How long do you expect that to take? 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, Larry. On your first question, no, we did not ask for a variance. 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. I think that’s forward progress, and that’s the clearest path because it’s not just 780, but it is a whole pipeline of innovation that we care about from a growth perspective. There is progress there. It’s very hard to say, timing on that. I think that’s up to the agency. We know they are working very hard on that. We anticipate progress there as well. On your question around 780G progress in international markets, we’re very pleased with the double-digit performance there. We do expect to see something similar in the U.S. market once approved. We are actually doing – we’ve been really happy with how 780G has performed in the U.S. market. It’s helping to stabilize attrition here. Our customers have a free upgrade option with 780 once approved in the U.S. market. Sorry, Larry, I missed your third – your second part of the question.

No, Que, that’s helpful. I guess, why didn’t you ask for a variance in the U.S., it seems like a kind of no risk option here? So why not ask for it.

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 not just about 780G, but it’s still about the pipeline. You know we submitted Simplera for CE Mark this year. We just submitted 780G with Simplera IDE last week. There is a long line of innovation that we are interested in. 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.

Alright. Thanks so much for taking the question.

Thank you, Larry. Next question please, Ryan.

The next question comes from Matt O’Brien at Piper Sandler. Matt, please go ahead.

We are very pleased with the progress we're making on addressing the warning letter commitment. Given the pace of these developments, we did not find it necessary to seek a variance. Thank you, Larry. Next question, please, Ryan. 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 will take the next question, Brad, and then we will try to come back to Matt.

Yes. Can you guys hear me okay?

Yes, we can hear you, Josh.

Okay. Great. So, I just want to make sure. Just one maybe for Geoff and maybe Sean as well, just on the renal denervation program and understand, I think it’s well understood that the totality of evidence can get the 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 6 months to 12 months, but payer decisions will ultimately be positive. Then the follow-up is just on supply and just want to make sure I am 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? Should we be expecting – I know you have got 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?

Maybe I will start with the supply situation. Are the supply chain issues gone? Not completely, but the biggest pain, or if you will, is behind us, especially in surgical innovations with the packaging, as I mentioned, issue. What lingers a bit would be, like we have talked about before, some semiconductor constraints. Changes that we have made to our supply organization with 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. These changes are durable. We are getting through this; the worst is behind us. We factored in or updated into the guidance, but there are some issues that are outstanding like the semiconductors. All that’s factored in, and we feel good about going forward, not just FY’24 but beyond that. Regarding Ardian, look, I will ask Sean to chime in here. The data is very compelling. You see that the sham arm in the trial increased their medication, and the Ardian arm reduced. The difference is 10x; it’s significant. Physicians look at it, understand this and are excited about it. We are optimistic with payers because health systems and governments are really focused on hypertension, and the current standard isn’t working. It was evident in the long-term SPRINT trial results published just last month. There is a new option, and I believe payers will be compelled to take it seriously, especially with the public health epidemic we’re facing.

Yes, you said it well, Geoff. Josh, you are 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 is really not a lot of comparisons for just how much good data we have here. It’s over 3,000 patients in the real-world data on top of the sham-controlled randomized studies. Importantly, we did a patient preference study, which is getting more and more considered by payers. There is a large majority of patients that prefer having a procedure versus adding just even one more drug. Of course, we can get their blood pressure down without the addition of drugs, which is a huge benefit. I’ll remind you also that Ardian was a breakthrough device; it had that designation and in the world of MSET ruling that would have met automatic coverage. We don’t know yet what the TSET pathway is going to look like; we will find out more about that in the fall timeframe. We do think the novelty of this therapy, the desire of patients and of course the public health benefit it provides is going to be compelling to both public and private payers around the world.

Thanks, Josh. Take the next question, please, Brad.

How about now?

Yes, we can hear you now.

Thanks for taking my questions. Sorry about that. I guess just to follow-up a little bit on Josh’s question. I know how enthusiastic you are about Ardian. The ambulatory number is robust compared to the office-based number. Why would clinicians and payers be interested in paying for these cases given the ambulatory feedback we have seen? Are you still thinking about the market is $500 million by 2026, $3 billion by the end of the decade?

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

Yes, Matt. If you just recall how that study was done, the patients were witnessed taking their blood pressure medicine in the morning. Whether they were taking that for the full six months or not or just took it that day, you saw the change in blood pressure during the daytime, not what we've seen before in these prior trials. At night, there was still a reduction in ambulatory. So, patients weren’t taking their medications, except on game day and their blood pressure drops. Now, we don’t know that for sure; we didn’t test blood in urine every day. We just tested it on game day. We know there were more medications in the patients in the control arm than in the treated arm. There’s a lot of changes in medicine, which we know were present different from prior studies. We have that proof now that we can measure the drug metabolites. A cleaner measure is the morning blood pressure; we took the office blood pressure, and it’s the standard used for studying reductions in blood pressure. It’s the primary endpoint in studies; the ones that got approvals. It’s also the primary endpoint that’s gotten every pharmaceutical approved for treating high blood pressure. It’s a robust standard; ambulatory isn’t even reimbursed in this country. We’re confident in this therapy, and if just a small amount gets us to meaningful improvement for the company.

Thanks, Sean. We believe Ardian has a significant growth opportunity. We’re proactively addressing potential challenges to ensure its wide adoption.

Yes. For Micra, we continue to grow, and you saw 18% globally; 40% of that was from international sales. Japan and China, in particular, really drove that growth and continued success. We will see continued penetration in international markets and in the U.S. and a shift between single-chamber to the AV device, which can pick up a larger proportion of patients. It’s about 30% of the market there. In the next 12 months, we are going to refresh both the VR and the AV devices in the coming year around the world. While we have some competition in the United States, we fared pretty well. The ease of use of our micro device and long-term data has made it pretty durable. For the Aurora EVICD, we have got CE Mark coming up. It’s a little bit of a different technique; you have got to put a lead underneath the breast bone, which takes some training to learn. We will be very meticulous in the way we roll that out. That device offers huge benefits, 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.

The Cardiac Rhythm business has done well and we expect it to continue to excel with products like Micra and EVICD, but also pioneering conduction system pacing. We have an excellent pipeline and a strong leadership team. Thank you for the question, Matt.

Thank you, Matt. Next question please, Brad.

Hey guys. Thanks for taking 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 on what you are seeing from behavior changes in hospitals for capital ordering in 2Q and what you guys assume in the back half of the year?

Our capital isn’t a huge piece yet of our revenue. But it ties to profitable procedures, and we had a strong capital performance in the last quarter, especially in our Cranial & Spinal Technologies business, CST. Our capital there had a number of our - whether a navigation, intraoperative imaging, had record capital quarters for us. We see strong demand in those areas. It takes a little longer to close a deal as you’re working with the hospital and how they are going to finance this. We’re very pleased with the placements we have been able to make on Hugo; that’s outside the U.S., but we are very pleased with that. Thank you, Pito. We have got time for one more question please, Brad.

Hi. Can you hear me?

Yes, Joanne. Good morning.

Wonderful. Good morning and early happy Thanksgiving. 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? 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. Yes, we have good news on Hugo. We are kicking off the U.S. IDE with our first case scheduled for December based on getting these instruments enhancements approved. We are pleased with the system placements. In terms of the color or commentary on that, I will ask Bob White to chime in.

Yes. Thanks, Geoff and thanks, Joanne. Good morning. A couple of thoughts here. First, on the overall market of Hugo, we are excited about it. Remember, around the world, still 95% of cases are not done, that could be done robotically assisted. We believe this is a true market expansion opportunity. We are excited about the long-term health of the market and excited to be the number two player in this space. We expect to begin our U.S. IDE by the end of this calendar year. Actual approval in the U.S. depends upon the agency and the process there. I can’t comment on that. Overall, with respect to the contribution, as you mentioned, I think it’s early to call that. Given our system is now installed around the world in markets in APAC, EMEA, Lat-Am. 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 EU, Canada and Australia, which opens the hernia market for us. We have started to see strong presence at some key congresses in Europe with live-stream cases.

Thank you, Bob. We appreciate the update on Hugo. We will continue to build on our momentum and address the expansive market potential as we work towards regulatory approvals. Thank you for your question, Joanne.

Geoff, please go ahead with your closing remarks.

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